Document ID: EPA-HQ-OPP-2010-0889-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-07-25T04:00Z

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  
EPA Registration Division contact: Venus Eagle, 703-308-8045
[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.
   	1. by establishing a tolerance for residues of 
	Sulfoxaflor (1-(6-trifluoromethylpyridin-3-yl)ethyl](methyl)-oxido-λ4-sulfanylidenecyanamide) in or on the raw agricultural commodity Crop group 1, subgroup 1A, 1B. Root Vegetables at 0.05 ppm; (from carrot, roots at 0.05 ppm; beet, sugar, roots at 0.03 ppm; radish, roots at 0.03 ppm); carrot, juice at 0.15 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; subgroup 1C, 1D. Tuberous and Corm Vegetables at 0.01 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; Crop group 2. Leaves of Root and Tuber Vegetables at 4 ppm; (from carrot, tops at 4 ppm; beet, sugar, tops at 3 ppm; radish, tops at 0.7 ppm); Crop group 3, subgroup 3-07A Bulb vegetables, Onion, bulb, subgroup at 0.01 ppm; (from onion, dry bulb at 0.01 ppm); subgroup 3-07B Bulb Vegetables, Onion, green, subgroup at 0.6 ppm; (from onion, green at 0.6 ppm);  Crop group 4, subgroup 4A. Leafy Vegetables (except Brassica), Leafy greens, subgroup at 5 ppm; (from leafy greens at 1.6 ppm); subgroup 4B. Leafy Vegetables (except Brassica), Leafy petioles, subgroup at 1 ppm; (from celery at 1 ppm); Crop group 5, subgroup 5A. Brassica Leafy Vegetables, head and stem (except cauliflower) at 1 ppm; (from cauliflower at 0.08 ppm; broccoli at 0.45 ppm; cabbage at 1 ppm); subgroup 5B. Brassica Leafy Vegetables, (from mustard greens at 1.6 ppm); green bean, snap, succulent at 0.7 ppm; beans, dry at 0.25 ppm; Crop group 8. Fruiting Vegetables (except cucurbits, plus okra) at 1.2 ppm (from tomato at 0.45 ppm; pepper, bell and non-bell at 1.2 ppm); tomato, puree at 0.7 ppm; tomato, paste at 1.6 ppm; tomato, catsup at 0.8 ppm; Crop group 9. Cucurbit Vegetables (except squash) at 0.3 ppm; (from cucumber at 0.3 ppm; melon at 0.3 ppm); squash at 0.03 ppm; Crop group 10. Citrus Fruits at 0.6 ppm; (from orange at 0.6 ppm; lemon at 0.45 ppm; grapefruit at 0.25 ppm); citrus, peel at 1 ppm; citrus, dried pulp, at 0.9 ppm;  Crop group 11. Pome Fruits at 0.4 ppm; (from apple at 0.3 ppm; pear at 0.4 ppm); apple, dried pomace at 1.3 ppm; Crop Group 12. Stone Fruits (except cherry) at 0.6 ppm; (from nectarine, pitted fruit at 0.3 ppm; peach, pitted fruit at 0.6 ppm; plum, pitted fruit at 0.25 ppm);cherry, pitted fruit at 2.5 ppm; cherry, dried cherry at 15 ppm;  Crop group 13, subgroup 13-07F. Small Fruit Vine Climbing subgroup, (except fuzzy kiwifruit) at 1.3 ppm; (from grape at 1.3 ppm); grape, raisins at 5 ppm; subgroup 13-07G Low Growing Berry subgroup at 0.6 ppm; (from strawberry, fruit at 0.6 ppm); Crop group 14. Tree Nuts (plus pistachio) at 0.02 ppm; (from almond at 0.02 ppm; pistachio at 0.02 ppm;  pecan at 0.01 ppm); almond, hulls at 4 ppm; Crop group 20, subgroup 20-A. Rapeseed subgroup at 0.25 ppm; (from canola, seeds at 0.25 ppm); canola, meal at 0.5 ppm;  subgroup 20C. Cottonseed subgroup at 0.2 ppm; (from cotton, seed at 0.2 ppm); cotton, hulls at 0.4 ppm; cotton, gin byproducts at 8 ppm; cotton, aspirated grain fractions at 4.6 ppm;  wheat, grain at 0.07 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 1.5 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 0.08 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 0.25 ppm; fat and meat of hog at 0.01 ppm; meat byproducts of hog at 0.04 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  FFDCA; 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: Residues of sulfoxaflor after two foliar broadcast applications of GF-2032 at a total rate of 0.176-0.184 lb a.i./A (197 - 206 g a.i./ha) in six USA trials, ranged from <LOQ (0.010 ppm) to 0.013 ppm in/on almond nutmeat and from 1.04 to 3.12 ppm in/on almond hulls harvested at 7-day PHI.   
2. Apple: Residues of sulfoxaflor after two, or four foliar broadcast applications of GF-2032 at a total rate of 0.29-0.375 lb a.i./A (325 - 420 g a.i./ha) in twenty two Australian/New Zealand, European and USA trials, ranged from ND (< LOD=0.003/0.005 mg/kg) to 0.297 ppm in/on apples whole fruits harvested at 7-day PHI.    
3. Apricot: Residues of sulfoxaflor after two or four foliar broadcast applications at a total rate of 0.339 - 0.348 lb a.i./A (~379-388 g a.i./ha) in two Australian and New Zealand trials ranged from 0.144 to 0.482 ppm, in/on apricot fruit harvested at 7-day PHI.
4. Barley: Residues of sulfoxaflor after two foliar broadcast applications of GF-2032 at a total rate of 0.088-0.097 lb a.i./A (94 - 108 g a.i./ha) in twenty-seven Australian, New Zealand, European and USA trials ranged from ND (<0.003 ppm) to 0.366 ppm and 0.004 to 2.15 ppm in/on barley grain and straw, respectively, harvested at ~14-day PHI. Residues of sulfoxaflor ranged from 0.007 to 0.643 ppm in/on barley hay, respectively, harvested at ~7-day PHI.  
5. Dry Beans: Residues of sulfoxaflor after four foliar broadcast applications of GF-2032 at a total rate of 0.35-0.366 lb a.i./A (393 - 411 g a.i./ha)  in six Brazilian and European trials, ranged from 0.02 ppm to 0.112 ppm in/on dry beans (shelled) harvested at 7-day PHI.  

6. Succulent, Edible Podded Beans: Residues of sulfoxaflor after four foliar broadcast applications of GF-2032 at a total rate of 0.353 - 0.373 lb a.i./A (395 - 418 g a.i./ha) in six European trials ranged from 0.024 ppm to 2.0186 ppm in/on green beans pods harvested at 7-day PHI.  

7. Broccoli: Residues of sulfoxaflor after four foliar broadcast applications of GF-2032 at a total rate of 0.348-0.380 lb a.i./A (390 - 426 g a.i./ha) in fifteen Australian, European, and USA trials ranged from ND (<0.003 ppm) to 1.6 ppm in/on broccoli head/stems harvested at 3-day PHI.  
8. Cabbage: Residues of sulfoxaflor following four foliar broadcast applications at a total rate of 0.342-0.384 lb a.i./A (383 - 430 g a.i./ha), ranged from ND (< LOD = 0.003/0.005 ppm) to 0.4 ppm in/on cabbage heads harvested at targeted 3-day PHI.
9. Canola / Oilseed Rape: Following two foliar broadcast applications of sulfoxaflor at a total rate of 0.079  -  0.099 lb a.i./A (88.1 - 110.8 g a.i./ha), residues of sulfoxaflor from samples harvested at 14-day PHI ranged from ND (<LOD=0.003/0.005 ppm) -  0.224 ppm in/on canola seed; from 0.026  -  1.49 ppm in/forage (0.05  -  1.7 ppm, forage -dry basis); from 0.02 -1.1 ppm in/on stubble (0.05 - 1.2 ppm, stubble- dry basis); from 0.30 - 0.54 ppm on whole plants.

10. Carrot: Residues of sulfoxaflor after four foliar broadcast applications of GF-2032 at a total rate of 0.358-0.377 lb a.i./A (401 - 423 g a.i./ha) in twelve European and USA trials ranged from 0.3113 - 2.2834 ppm and ND-0.032 ppm in carrot top and carrot root at 7-day PHI, respectively.  

11. Cauliflower: Residues of sulfoxaflor after treatment of four foliar broadcast applications of GF-2032 at a total rate of 0.321  -  0.372 lb a.i./A (360 - 418 g a.i./ha) in ten Australian and European trials ranged from ND to 0.07 ppm in/on cauliflower harvested at ~3-day PHI.   
12. Celery: Residues of sulfoxaflor after four foliar broadcast applications of GF-2032 at a total rate of 0.36-0.361 lb a.i./A (404 - 406 g a.i./ha) in six USA trials ranged from 0.0583 ppm to 0.8037 ppm in/on celery root stalks harvested at targeted 3-day PHI.  
13. Cherry: Residues of sulfoxaflor after two foliar broadcast applications of GF-2032 at a total rate of 0.338-0.366 lb a.i./A (379 - 410 g a.i./ha) in fourteen Australian, European and USA trials ranged from 0.28 to 1.77 ppm in/on cherry pitted fruit harvested at 7-day PHI.  

14. Cotton: In 22 trials with 4 foliar applications of sulfoxaflor (GF-2032 240 SC) at a rate of 0.347 to 0.376 lb a.i./A (389 to 422 g a.i./ha), residues of sulfoxaflor ranged from an estimated 0.0050 ppm to 0.1818 ppm in/on cotton seed and from 0.0374 ppm to 4.2000 ppm in/on cotton gin by-products at the target 14-day PHI.  

15. Cucumber: Residues of sulfoxaflor ranged from 0.0041 to 0.172 ppm in/on cucumber fruit harvested at 1-day PHI. 
 
16. Grapes: Residues of sulfoxaflor after four foliar broadcast applications of GF-2032 at a total rate of 0.277-0.391 lb ai/A (310-437.7 g ai/ha) in thirty-three trials ranged from 0.0117 - 1.942 ppm in/on grapes harvested at 7-day PHI.

17. Grapefruit: Following two foliar broadcast applications of sulfoxaflor at a total rate of 0.36 lb a.i./A (404 g a.i./ha) in eight USA trials, residues of sulfoxaflor ranged from 0.007 (LOQ=0.010 ppm) to 0.186 ppm in/on grapefruit whole fruit; from 0.045 to 0.882 ppm in/on peel, and; from not detected, ND (<LOD=0.003 ppm) to 0.005 (<LOQ) ppm in/on pulp harvested at 1-day PHI.
Residues of sulfoxaflor found in/on whole fruit declined over the 14 day sampling period, averaging 0.063, 0.015, 0.007 and 0.005 ppm at 0, 1, 7 and 14-days after last application (DALA). Residues of sulfoxaflor found in/on grapefruit peel declined over the 14 day sampling period, averaging 0.081, 0.065, 0.039 and <0.003 ppm at 0, 1, 7 and 14-DALA.  Residues of sulfoxaflor were not detected in the samples of grapefruit pulp from the residue decline trials.
18. Lemon: Residues of sulfoxaflor after two foliar broadcast applications of GF-2032 at a total rate of 0.360 lb a.i./A (404 g a.i./ha) in six USA trials ranged from 0.252  -  0.3169 ppm in/on lemon harvested at 1-day PHI.
19. Head Lettuce: Residues of sulfoxaflor after four foliar broadcast applications of GF-2032 at a total rate of 0.328-0.387 lb a.i./A (368 - 435 g a.i./ha) in fourteen Australian, European and USA trials ranged from ND (<0.003 ppm) to 0.528 ppm in/on head lettuce heads harvested at 3-day PHI.  
20. Leaf Lettuce: Residues of sulfoxaflor after four foliar broadcast applications of GF-2032 at a total rate of 0.343 - 0.378 lb a.i./A (384-424 g a.i./ha) in eighteen Australian, European and USA trials ranged from 0.050 to 3.068 ppm in/on leaf lettuce leaves harvested at 3-day PHI.
21. Melon: Residues of sulfoxaflor ranged from 0.0042 to 0.3044 ppm in/on melon whole fruit harvested at 1-day PHI.  
22. Mustard Greens: Residues of sulfoxaflor after four foliar broadcast applications of GF-2032 at a total rate of 0.354 - 0.367lb a.i./A (397 - 411 g a.i./ha) in eight USA trials ranged from 0.2778 to 1.1666 ppm in/on mustard greens harvested at targeted 3-day PHI.
23. Nectarine: Residues of sulfoxaflor after two or four foliar broadcast applications of GF-2032 at a total rate of 0.342 - 0.352 lb a.i./A (383 - 394 g a.i./ha) in five Australian/New Zealand trials, ranged from 0.0738 mg/kg to 0.2474 ppm in/on nectarines pitted fruits harvested at 7-day PHI.  

24. Bulb Onion: Residues of sulfoxaflor after four foliar broadcast applications of GF-2032 at a total rate of 0.357 - 0.365 lb a.i./A (401 - 410 g a.i./ha) in six USA trials were all ND except one sample of (0.0051) ppm.
25. Green Onion: Residues of sulfoxaflor after four foliar broadcast applications of GF-2032 at a total rate of 0.36 - 0.366 lb a.i./A (404 - 411 g a.i./ha) in six USA trials ranged from ND ((<0.003 ppm) to 0.4404 ppm in/on green onions harvested at 7-day PHI.  

26. Orange: Following two or four foliar broadcast applications of sulfoxaflor at a total rate of 0.264  -  0.368 lb a.i./A (296- 412.5 g a.i./ha), residues of sulfoxaflor ranged from 0.0369 ppm to 0.46 ppm in/on orange whole fruit; from 0.5012 to 1.3298 ppm in/on peel, and; from it was not detectable, ND (<LOD=0.003/0.005 ppm) in juice from samples harvested at 1-day PHI. There were no significant differences in four side-treatments done with non-ionic surfactant versus crop oil concentrate.

27. Peach: Residues of sulfoxaflor after two or four foliar broadcast applications of GF-2032 at a total rate of 0.339 - 0.373 lb a.i./A (380 - 418.6 g a.i./ha) in twenty two Australian/New Zealand, European and USA trials, ranged from ND (< LOD=0.003/0.005 mg/kg) to 0.6365 ppm in/on peaches pitted fruits harvested at 7-day PHI.

28. Pears: Residues of sulfoxaflor after two or four foliar broadcast applications of GF-2032 at a total rate of 0.28 - 0.38 lb a.i./A (314 - 426.3 g a.i./ha) in fourteen Australian, European and USA trials, ranged from 0.0438 to 0.2665 ppm in/on pears, whole fruits harvested at 7-day PHI.

29. Pecans: Residues of sulfoxaflor after two foliar broadcast applications of GF-2032 at a total rate of 0.360 - 0.363 lb a.i./A (404 - 408 g a.i./ha) in six USA trials ranged from ND (0.003 ppm) to 0.0041 ppm in pecan nutmeat harvested at 7-day PHI.  

30. Peppers: Residues of sulfoxaflor after four foliar broadcast applications of GF-2032 at a total rate of 0.322 - 0.429 lb a.i./A (361 - 481 g a.i./ha) in twenty Australian, European and US trials, ranged from 0.004 ppm to 0.465 ppm in/on peppers harvested at 1-day PHI.

31. Plum: Residues of sulfoxaflor after two foliar broadcast applications of of GF-2032 and GF-2372 at a total rate of 0.343 - 0.37 lb a.i./A (384 - 415 g a.i./ha) in six USA trials and one Australian trial, ranged from 0.0136 mg/kg to 0.3623 ppm in/on plum pitted fruits harvested at 7-day PHI.

32. Potato: Residues of sulfoxaflor after four foliar broadcast applications of GF-2032 at a total rate of 0.356-0.374 lb ai/A (399 - 419.7 g ai/ha) in eighteen trials ranged from not detected (ND)  -  0.009 ppm in/on potato tubers harvested at 7-day PHI.

33. Radish: Residues of sulfoxaflor after four foliar broadcast applications of GF-2032 at a total rate of 0.36 - 0.3627 lb a.i./A (404 - 408 g a.i./ha) in six USA trials ranged from 0.0032 ppm to 0.0155 ppm in/on radish roots and from 0.1826 to 0.5055 ppm in/on radish tops harvested at 7-day PHI. 
34. Soybean: Residues of sulfoxaflor ranged from 0.0132 ppm to 1.7339 ppm in/on soybean forage, from 0.0565 to 1.3782 ppm in/on soybean hay and from ND (<0.003) to 0.2141 ppm in/on soybean seeds at target 7-day PHI.

35. Spinach: Residues of sulfoxaflor after four foliar broadcast applications at a total rate of 0.342 - 0.371 lb a.i./A (385 - 418 g a.i./ha) in eight Australian and USA trials ranged from 0.039 to 3.26 ppm in/on spinach/silverbeet foliage harvested at a 3-day PHI.    
36. Squash: Residues of sulfoxaflor after four foliar broadcast applications of GF-2032 at a total rate of 0.357 - 0.364 lb a.i./A (400 - 408 g a.i./ha) in six USA trials ranged from ND (<0.003 ppm) to 0.0068 ppm in/on for summer squash and ND to 0.0213 ppm in/on winter squash harvested at 1-day PHI.

37. Strawberry: Residues of sulfoxaflor after four foliar broadcast applications of GF-2032 at a total rate of 0.340 - 0.369 lb a.i./A (381 - 414 g a.i./ha) in thirteen Australian, and USA trials ranged from 0.02 to 0.5 ppm in/on strawberry harvested at 1-day PHI.

38. Sugar beet: Following four foliar broadcast applications of sulfoxaflor (XDE-208) at a total rate of 0.351-0.374 lb a.i./A (393 - 419 g a.i./ha) in thirteen EU and USA trials, residues of sulfoxaflor ranged from ND (< LOD = 0.003 ppm) to 0.0253 ppm in/on sugar beet root samples and from 0.1409 to 1.6846  ppm in/on sugar beet tops harvested at 7-day PHI.  

39. Tomato: Residues of sulfoxaflor ranged from <LOQ (0.004 ppm) to 0.76 ppm in/on tomato fruits harvested at 1-day PHI.
40. Wheat: Residues of sulfoxaflor after two foliar broadcast applications of GF-2032 at a total rate of 0.083 - 0.098 lb a.i./A (93 - 110 g a.i./ha) in thirty-eight Australian, Brazilian, European and USA trials ranged from ND (<0.003 ppm) to 0.067 ppm and 0.030 to 1.64 ppm in/on wheat grain and straw, respectively, harvested at ~14-day PHI. Residues of sulfoxaflor ranged from 0.010 to 1.35 ppm and 0.024 to 1.024 ppm in/on wheat forage and hay, respectively, harvested at ~7-day PHI.]
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. [The toxicological properties of the sulfoxaflor environmental metabolites have been characterized.]

	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(TM) 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.

	   2. 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(TM) 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 ug/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 0.014817 mg/kg/d (5.93% aPAD) for adults 50+ years old to 0.049126 mg/kg/d (19.65% % aPAD) for children aged 1-2 years, the most highly exposed subpopulation.  The 95th percentile acute dietary exposure for the U.S. population is 0.019519 mg/kg/d (7.81% aPAD).  Thus, acute dietary exposures correspond to 19.65% 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(TM) 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 ug/L, based on water modeling conducted by DAS.  Chronic dietary exposures range from 0.000745 mg/kg/d (7.4% cPAD) for youth 13-19 years old to 0.003388 mg/kg/d (33.9% cPAD) for children aged 1-2 years, the most highly exposed subpopulation.  The chronic dietary exposure for the U.S. population is 0.001044 mg/kg/d (10.4% cPAD).  Thus, chronic dietary exposures correspond to 33.9% 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 far 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:

Based on the estimated concentrations, an estimated parent-equivalent residue of 18.21 ug/L is assumed in the acute dietary assessment, and an estimated parent-equivalent residue of 9.54 ug/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 the toxicity data, the aggregate exposure to XDE-208 from the proposed tolerances in fruit and vegetable commodities will utilize 10.4% or less of the chronic population adjusted dose, cPAD, for the general U. S. population.  The population subgroup with the highest exposure of 33.9% 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 ug/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.

FFDCA section 408 provides that the U.S. EPA may apply an additional safety factor for infants and children in the case of threshold effects to account for pre- and post-natal toxicity and the completeness of the database.  Based on the current toxicological data requirements, the database for XDE-208 relative to pre- and post-natal effects for children is complete.  No effects were seen in rabbits at the highest dose level tested. Effects 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 33.9% 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 (6.26% 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.]