EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER EPA Registration Division contact: [Mark Suarez, (703) 305 - 0120]

INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In cases where the outline element does not apply, please insert “NA-Remove” and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green , i.e., “ [ insert company name ] ,” with the information specific to your action. TEMPLATE: [ BASF Corporation ] [Insert petition number] EPA has received a pesticide petition ( [insert petition number] ) from [ BASF Corporation ] , [ 26 Davis Drive, P.O. Box 13528, Research Triangle Park, North Carolina 27709 -3528 ] 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 [ Fluxapyroxad , (BAS 700 F) ; 1H - Pyrazole-4 - carboxamide,3 - (difluoromethyl) - 1 - methyl-N - (3',4',5' -trifluoro[1,1' -biphenyl] -2 -yl) -) in or on the following raw agricultural commodities [apple, wet pomace] at [3.5] parts per million (ppm); [barley, bran] at [6.0] ppm ; [ beet, sugar, tops ] at [4.0] ppm ; [beet, sugar, dried pulp ] at [0.16] ppm ; [ corn, field , grain ] at [0.01] ppm; [corn, oil, refined] at [0.05] ppm ; [ cotton, gin byproducts ] at [ 0.01 ] ppm ; [cotton , undelinted seed] at [ 0.01 ] ppm ; [ f

ruit, pome, group 11] at [0.7 ] ppm ; [ fruit, stone , group 12] at [1.4] ppm ; [ grain, aspirated fractions ] at [ 16.0 ] ppm ; [ grain, cereal, group 15 , except field corn grain ] at [2.5] ppm ; [ grain, cereal, forage, fodder and straw, group 16)] at [25.0] ppm ; [peanut] at [0.02] ppm ; [peanut, meal] at [0.03] ppm ; [peanut, refined oil] at [0.06] ppm ; [plum, prune at [4.0] ppm ; [potato, wet peel] at [ 0.2 ] ppm ; [ rapeseed , (cultivars/varieties and/or hybrids including canola and crambe) ] at [0.60] ppm ; [ rice , hulls] at [10.0] ppm ; [s oybean , hulls ] at [6.5] ppm; [soybean , seed ] at [0.20] ppm ; [sunflower, seed] at [0.60] ppm ; [vegetable, foliage of legume, group 7 ] at [18.0] ppm ; [vegetable, fru iting, group 8 ] at [0.60] ppm ; [vegetable, legume, dried shelled pea and bean (except soybean), subgroup 6C ] at [0.35] ppm ; [vegetable, legume, edible pod ded, subgroup 6A] at [1.40] ppm ; [vegetable, legume, succulent shelled pea and bean, subgroup 6 B ] at [0.45] ppm ; [vegetable, root, subgroup 1A) at [0.10] ppm ; [vegetable, tuberous and corm, subgroup 1C ] at [0.04] ppm ; [vegetable, tuberous and corm, (except potato), subgroup 1D ] at [0.04] ppm ; [wheat, bran] at [6.0] ppm ; [wheat, germ] at [3.0] ppm ; and in or on the following food commodities [cattle, fat] at [ 0.1 ] ppm ; [cattle, kidney] at [ 0.01 ] ppm; [cattle, liver] at [ 0.10 ] ppm; [ cattle , meat] at2

[ 0.01 ] ppm ; [cattle, meat byproducts] at [ 0.10 ] ppm; [egg] at [ 0.01 ] ppm; [goat, fat] at [ 0.1 ] ppm ; [goat, kidney] at [ 0.01 ] ppm; [goat, liver] at [ 0.10 ] ppm; [goat, meat] at [ 0.01 ] ppm; [goat, meat byproducts] at [ 0.10 ] ppm; [hog, fat] at [ 0.01 ] ppm; [hog, liver] at [ 0.01 ] ppm; [hog, meat] at [ 0.01 ] ppm; [hog, meat byproducts] at [ 0.01 ] ppm; [horse, fat] at [ 0.1 ] ppm ; [ horse kidney] at [ 0.01 ] ppm; [horse, liver] at [ 0.10 ] ppm; [horse, meat] at [ 0.01 ] ppm ; [horse, meat byproducts] at [ 0.10 ] ppm; [milk] at [ 0.02 ] ppm; [milk, fat] at [ 0.2 ] ppm ; [egg] at [ 0.01 ] ppm; [poultry, byproducts ] at [ 0.01 ] ppm ; [poultry, fat] at [ 0.01 ] ppm ; [poultry, liver] at [ 0.01 ] ppm ; [poultry, meat] at [ 0.01 ] ppm ; [poultry, skin ] at [ 0.01 ] ppm ; [sheep, fat] at [ 0.1 ] ppm; [sheep, kidney] at [ 0.01 ] ppm; [sheep, liver] at [ 0.10 ] ppm; [sheep, meat] at [ 0.01 ] ppm; [ sheep, meat byproducts ] at [ 0. 10 ] 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 petiti on. A. Residue Chemistry 1. Plant metabolism

. [Nature of the residue studies were conducted in wheat, soybean and tomato as representative crops in order to characterize the fate of BAS 700 F in all crop matrices. Two radiocarbon labels w ere studied in each crop, with 14 - C labels positioned in aniline and pyrazole ring stru ctures. BAS 700 F was the predominant residue in most crops. In all crops the BAS 700 F Residues of Concern (ROC) were characterized as parent BAS 700 F plus metabolites M700F048 an d M700F002 . A conf

ined rotational crop study added metabolite M700F008 and confirmed that parent BAS 700 F plus metabolites M700F008 , M700F048 and M700F002 w ere the residue s of concern in the representative crops of wheat, radish, and spinach . ] 2. Anal ytical method. [Independently validated analytical methods have been submitted for analyzing residues of parent BAS 700 F plus metabolites M700F008 , M700F048 and M700F002 with appropriate sensitivity in all the crop and processed commodities for root and tuber vegetables (subgroups 1A, 1C, D) , sugar beet tops, legume vegetables including soybean (group 6), foliage o f legume vegetables (group 7) , fruiting vegetables (group 8), pome fruits (group 11), stone fruits (group 12), cereal grains (group 15), forage , fodder and straw of cereal grains (group 16), cotton, canola (rapeseed) , sunflower and peanut and in animal meat, fat, liver and kidney matrices , poultry meat, fat, liver and skin, milk, cream and eggs which tolerances are being requested. ] 3. Magnitude of residues. [ Fi eld trials were carried out to determine the magnitude of the residue in/on root and tuber vegetables (subgroups 1A, 1C], legumes vegetables (crop group 6 and 7 including soybean), fruiting vegetables (crop group 8), pome fruits (crop g roup 11), stone fruits (crop group 12), cereal grains (crop groups 15 and 16), canola (rapeseed) , sunflower, peanut, and cotton. The number and locations of field trials are in accordance with OPPTS Guideline 860.1500. Field trials were carried out using the maximum label rates, the maximum3

number of applications, and the minimum pre- harvest interval (PHI) for all the crops. Residues of M700F048 and M 700F002 were generally less than the limit of quantitation and often less than the limit of detection, there fore, these residues are not proposed for monitoring. Residues of M700F 008 were significantly less than residues of BAS 700 F unless both were close to the limit of quantitation and thus M700F 008 residues are not proposed for monitoring . Detected residues of BAS 700 F in all crops support the proposed tolerances based on parent only . ] B. Toxicological Profile 1. Acute toxicity. [BAS 700 F displayed low acute toxicity via the oral, dermal and inhalation routes of exposure. It was not irritating to the eyes, only slightly irritating to the skin, and not a dermal sensitizer. The acute toxicity studies place technical BAS 700 F in toxicity category III for acute oral and dermal and category IV for acute inhalation, eye and skin irritation. BAS 700 F is not a dermal sensitizer. ] 2. Genotoxicty. [ BAS 700 F was not genotoxic in a battery of assays. BAS 700 F was negative for inducing mutations in bacterial and mammalian cell assays. No evidence of a clastogenic effect was observed in vitro or in vivo, and BAS 700 F did not cause unscheduled DNA synthesis in hepatocytes of treated rats. ] 3. Reproductive and developmental toxicity. [ The reproductive and developmental toxicity of BAS 700 F was investigated in a 2 - generation rat reproduction study as well as in rat and rabbit developmental toxicity studies. In the reproduction study, there were no effects on fertility, up to the highest dose tested of 300 mg/kg bw/d. At the high - and mid - (50 mg/kg bw/d) doses tested, BAS 700 F administration resulted in decreased food consumption, impaired body weight development, clinical chemistry and select organ weight changes and histopathology. Impairment of pup body weight development was also seen at these doses. The NOAEL for systemic and developmental toxicity was 10 mg/kg bw/day. In the rat developmental toxicity study, slight maternal toxicity was observed at the high dose level of 1000 mg/kg bw/d, in the form of limited clinical chemistry, liver and thyroid weight effects, and thyroid histopathology. No evidence of developmental toxicity was observed in the rat up to the highest dose tested of 1000 mg/kg bw/d. At the highest dose tested in the rabbit teratology study (60 mg/kg bw/d), maternal toxicity consisted of clinical signs, abortion, reduced food c onsumption, and impaired body weight development. The only developmental effect at the high dose, which caused substantial maternal toxicity, consisted of a commonly observed, reversible external variation, paw hyperflexion. Based on the effects described, the maternal and developmental NOAEL in rabbits was 25 mg/kg bw/d. ]4 4. Subchronic toxicity. [ The principal target organ in all studies in rats, mice and dogs was the liver, as indicated by organ weight changes and altered clinical chemistry parameters, which were consistent with liver enzyme induction. Histopathological changes in the liver were only evident in rats. The thyroid was also identified as a target organ in rats, as indicated by organ weight changes, histopathology and thyroid hormone change s. The lowest NOAEL in subchronic oral toxicity studies was approximately 6 mg/kg bw/day in the rat 90 - day study. No systemic toxicity was observed in a 28 - day repeat dose dermal toxicity study at doses as high as 1000 mg/kg bw/day. The neurotoxic poten tial of BAS 700 F was studied following both acute and subchronic oral administration in the rat. In the acute study, treatment- related neurobehavioral effects were noted in mid and high dose animals on the day of treatment. These consisted of slight incre ases of the landing foot- splay in high dose males, reduction in the number of rearings in males, and impaired motor activity in high and mid dose males and females. No effects on these parameters were observed on study days 7 and 14. Additionally, no treat ment- related neuropathological findings (brain weight changes, neurohistopathological findings) were observed. Therefore, the affected parameters indicated a neuropharmacological effect rather than neuronal damage. Based on the results of this study the NO AEL for acute neurotoxicity was 125 mg/kg bw/d in male and female rats. There was no indication of clinical (general clinical observation, FOB and motor activity) or neurohistopathological neurotoxicity in a subchronic neurotoxicity study. Systemic signs of toxicity were consistent with those seen in repeated dose studies with BAS 700 F. Under the conditions of the present study the no observed adverse effect level (NOAEL) for neurotoxicity was 5000 ppm (approximately 320 mg/kg bw/d), the highest dose test ed. ] 5. Chronic toxicity. [ Systemic toxicity in long term oral exposure studies in dogs, mice and rats included effects on food consumption, body weight development and clinical chemistry changes. The liver was identified as the main target organ in all species tested, as indicated by liver weight changes and non - neoplastic lesions. Additional target organs in the rat included the thyroid and bones. The spleen, gall bladder and prostate were affected in dogs. BAS 700 F was not carcinogenic in C57BL mic e following continuous dietary administration for 18 months at dietary concentrations up to 6000 ppm (approximately 1000 mg/kg bw/d). Treatment of BAS 700 F for 2 years in rats resulted in the induction of hepatocellular tumors in males at dose levels ≥ 250 ppm and in females at ≥ 1500 ppm. A mitogenic, Phenobarbital-like mechanism is proposed as the probable mode of action for liver tumor development in rats. This was supported by mechanistic studies on enzyme induction and S -P hase response in the liver, and indicates there is a threshold for tumor development and a margin of exposure cancer risk assessment is appropriate.5

In the rat chronic/oncogenicity study, the NOAEL in males and females was 50 ppm (2.1 and 2.7 mg/kg bw/day, respectively). NOAEL’s in the mouse oncogenicity study were 150 ppm in males (21 mg/kg bw/day) and in females (33 mg/kg bw/day). In a chronic dog study, the NOAEL was 300 ppm (approximately 8 mg/kg bw/day). ] 6. Animal metabolism. [ The rat, goat and hen metabolism studies were conducted to determine the nature of the BAS 700 F residues in animals. S tudies were conducted with radiolabeled BAS 700 F with 14 - C labels positioned in aniline and pyrazole ring structures (hen metabolism, aniline ring label o nly) . BAS 700 F was either excreted rapidly in urine and feces or transformed to a number of metabolites after administration to animals. All relevant metabolites were identified. Unchanged parent compound was found as the predominant component in most ani mal matrices. The metabolism of BAS 70 0 F in the animals is well understood. Degradation proceeds via N- demethylation of the pyrazole ring and/or hyroxylation of the biphenyl ring followed by subsequent O - and N- conjugation reactions to produce metabolites that are rapidly excreted, along with parent, and do not readily accumulate in tissues or milk. Residues in milk and most edible tissues are low. The same metabolic reactions were observed in each of the animals studied, so there is a consistent metabolic pathway for BAS 700 F in animals. Rat. goat and hen metabolism studies were also conducted with radiolabeled M700F048, a N- glucoside of N- desmethyl BAS 700F, a plant metabolite, seen at levels >10 TRR in soybean seed in the plant metabolism study . In all animals, the glucoside was readily hydrolyzed to generate M700F008, a key intermediate in the metabolism of BAS 700 F in animals. The radiolabeled residue was rapidly excreted with little uptake in tissue, following a metabolic pathway in all animals like that for BAS 700 F. Rat. goat and hen metabolism stu dies were also conducted with radiolabeled M700F002, a carboxylic acid attached to the pyrazole - ring formed by cleavage of the BAS 700 F carboxamide bond. M700F002 was seen at levels >10 TRR in soybea n seed in the plant metabolism and was present only at low levels in the rat urine. In all animal studies, M700F002 was not metabolized and was almost completely and rapidly excreted unchanged , with no uptake in tissue. ] 7. Metabolite toxicology

. [ Th e metabolism of BAS 700 F is similar in plants and mammals. The metabolism of BAS 700 F, both in plants and animals, is largely based on two key transformation reactions, N- demethylation of the pyrazole moiety and hydroxylation of the biphenyl moiety. Bo th reactions, combinations thereof, and subsequent conjugation reactions (e.g. glucose, glucuronic acid, cysteine) result in a range of common and structurally related compounds. Due to the similar structural nature of most metabolites, the toxicity of mo st plant metabolites is adequately estimated from the results of studies performed with BAS 700 F in animals. In addition, the metabolism of metabolites M700F002, and M700F048 were each investigated in rat, goat and hen. Animal metabolism studies were perf ormed with M700F002 since the plant metabolite was seen in the rat metabolism only at low levels in urine. In rat, goat and hen, M700F002 is rapidly and almost completely6

excreted unchanged with almost no uptake in tissue, milk or eggs. M700F002 is not m etabolized in animal to any significant extent. Animal metabolism studies were performed with M700F048, a glucoside conjugate since the plant metabolite would not be formed in animal metabolism. In animal metabolism studies, M700F048 was rapidly hydrolyzed to metabolite M700F008, a key metabolite in the metabolic pathway of BAS 700 F. Unchanged M700F048 was not detected in edible animal commodities. Toxicology studies (Acute oral toxicity, Ames test, in vitro mutagenicity test in ma mmalian cells, in vitro chromosome aberration test, in vivo mouse micronucleus, 28/90 - day rat feeding and developmental toxicity in rabbits) were conducted on all three metabolites . Overall, M700F001, M700F002 and M700F048 are of low acute and subchronic toxicity in rats. The metabolites showed no genotoxic potential in a battery of genotoxicity studies. In addition, no adverse effects were observed up to the highest doses tested in developmental toxicity study with rabbits. ] 8. Endocrine disruption

. [No specific tests have been conducted with BAS 700 F to determine whether the chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects. However, there were no significant findings in other relevant toxicity studies (e.g., sub - chronic and chronic toxicity, developmental toxicity and multi- generation reproductive studies) which would suggest that BAS 700 F produces any endocrine disruption. ] C. Aggregate Exposure 1. Dietary exposure. [ The tolera nce expression for BAS 700 F has not been finalized. Based on the results of field trials, animal transfer studies and exposure analysis, BASF is proposing that the tolerance expression for monitoring should be BAS 700 F only . Exposure assessments were conducted to evaluate the potential risk due to acute and chronic dietary exposure of the U.S. population and all sub -populations for two scenarios 1 ) BAS 700 F only and 2 ) BAS 700 F and metabolites M700F008 , M700F002 and M700F048 (expressed as parent equivalents) . For assessments with combined residues of BAS 700 F and metabolites the analysis included tolerance values based on combined residues of BAS 700 F, M700F008 , M700F002 and M700F048. For assessments with residues of BAS 700 F parent only, the analysis included proposed tolerance values for BAS 700 F only. The assessments included root and tuber vegetables (subgroups 1A, 1C, D) , legume vegetables including soybean (group 06), fruiting vegetables (group 8), pome fruits (group 11), stone fruits (group 12), cereal grains (group 15), cotton, canola, sunflower, peanut, anticipate d residues in succeeding crops and animal matrices including egg, milk and cream . ]7 i. Food. [Acute Dietary Exposure Assessment Acute dietary exposure estimates were based on tolerance values for combined residues of BAS 700 F, M700F008 , M700F002 and M700F048 or proposed tolerance values (based on parent only), anticipated residues in succeeding crops based on the limited field rotational study, process factors from processing studies and 100% of all crops treated. The consumption data was from the USDA Continuing Survey of Food Intake by Individuals (CSFII 1994 - 1996, 1998) and the EPA Food Commodity Ingredient Database (FCID) using Exponent's Dietary Exposure Evaluation Modul e (DEEM-FCID) software. The resulting exposure estimates were compared against the BAS 700 F acute Population Adjusted Dose (aPAD) of 0.25 mg/kg b.w./day for females ages 13 -49 and 1.25 mg/kg b.w./day for all other populations. The endpoint for women of childbearing age is based on the NOAEL of 2 5 mg/kg/day with an FQPA safety factor of 1 , and the endpoint for remaining populations is based on the NOAEL of 12 5 mg/kg/day with an FQPA safety factor of 1. The most highly expos ed sub population was females 13 - 49 years old with 3.4 % utilization of the aPAD. The results of the acute dietary assessment are presented in Table s 1 and 2 for the assessments using tolerances based on combined residues or parent only, respectively. Table 1. Results for BAS 700 F Acute Dietary Exposure An alysis Considering All Tolerances (combined residues of BAS 700 F, M700F008 M700F002 and M700F048) using DEEM- FCID at the 95 th Percentile

Population Exposure Estimate %aPAD Subgroups (mg/kg b.w./day) U.S. Population 0.0 13314 1. 1 All Infants (< 1 year old) 0.0 28796 2.3 Children (1 -2 years old) 0.0 31371 2.5 Children (3 - 5 years old) 0.0 26442 2. 1 Children (6 - 12 years old) 0.0 17246 1.4 Youth (13 - 19 years old) 0.0 09071 0.73 Adults (20 -49 years old) 0.0 08572 0. 69 Adults (50+ yea rs old) 0.0 08688 0.7 0 Females (13

– 49 years old) 0.0 08382 3.48

Table 2. Results for BAS 700 F Acute Dietary Exposure Analysis Considering all Proposed Tolerances (parent only) using DEEM- FCID at the 95 th Percentile Population Exposure Estimate % aRfD Subgroups (mg/kg b.w./day) U.S. Population 0.011951 0.96 All Infants (< 1 year old) 0.024050 1.92 Children (1 -2 years old) 0.027721 2.22 Children (3 - 5 years old) 0.023857 1.91 Children (6 - 12 years old) 0.015875 1.27 Youth (13 - 19 years old) 0.008342 0.67 Adults (20 -49 years old) 0.007935 0.63 Adults (50+ years old) 0.007804 0.62 Females (13 - 49 years old) 0.007810 3.12 The results of the analysis sh ow that a risk assessment using proposed tolerances based on parent only provides results comparabl e to that based on tolerances that take into account combined residues of BAS 700 F and metabolites M700F008 , M700F002 and M700F048 . Th e results of the analysis show that for all populations, the estimated exposures are well below the Agency's level of con cern (< 100% aPAD). Additional refinements in the dietary risk assessment (i.e. utilizing anticipated residue values, percent crop treated values) would further reduce the estimated exposure values. Chronic Dietary Exposure Assessment The initial c hronic dietary exposure estimates were based on tolerance values for combined residues of BAS 700 F, M700F008 , M700F002 and M700F048, or proposed tolerance values (based on parent only), and anticipated residues in succeeding crops based on the limited field ro tational study, process factors determined in processing studies and 100% crop treated values for all commodities. The consumption data was from the USDA Continuing Survey of Food Intake by Individuals (CSFII 1994 - 1996, 1998) and the EPA Food Commodity Ingredient Database (FCID) using Exponent's Dietary Exposure Evaluation Module (DEEMFCID) software. The chronic Population Adjusted Dose (cPAD) used for U.S. population and all sub populations is 0.021 mg/kg bw/day. This endpoint is based on the NOAEL valu e of 2.1 mg/kg bw/day using a FQPA safety factor of 1. The most highly expos ed population sub - group was children 1 -2 years of age which utilized 66.5% cPAD. The results of the chronic dietary ass essment are presented in Tables 3 and 4 for the assessm ents using tolerances based on combined residues or parent only, respectively .9

Table 3 . Results for BAS 700 F Chronic Dietary Exposure An alysis Considering all Tolerances (combined residues of BAS 700 F,M700F008 , M700F002 and M700F048) using DEEM- FCID

Population Exposure Estimate %cPAD Subgroups (mg/kg b.w./day) U.S. Population 0.00 4629 22.0 All Infants (< 1 year old) 0.00 7719 36.8 Children (1 -2 years old) 0.0 13962 66.5 Children (3 - 5 years old) 0.0 11420 54.4 Children (6 - 12 years old) 0.00 7017 33 .4 Youth (13 - 19 years old) 0.00 3662 17.4 Adults (20 -49 years old) 0.00 3432 16.3 Adults (50+ years old) 0.00 3564 17.0 Females (13 - 49 years old) 0.00 3317 15.8 Table 4. Results for BAS 700 F Chronic Dietary Exposure Analysis Considering all Proposed To lerances (parent only) using DEEM- FCID

Population Exposure Estimate % cPAD Subgroups (mg/kg b.w./day) U.S. Population 0.004117 19.6 All Infants (< 1 year old) 0.006564 31.3 Children (1 -2 years old) 0.012184 58.0 Children (3 - 5 years old) 0.010104 48.1 Children (6 - 12 years old) 0.006197 29.5 Youth (13 - 19 years old) 0.003243 15.4 Adults (20 -49 years old) 0.003088 14.7 Adults (50+ years old) 0.003189 15.2 Females (13 - 49 years old) 0.002974 14.2 The results of the analysis sh ow that a risk assessmen t using proposed tolerances based on parent only provides results comparable to that based on tolerances that take into account combined residues. The results of the analysis show that for all pop ulations, the exposures are below a level of concern (< 100% cPAD). Additional refinements in the dietary risk assessment (i.e. utilizing anticipated residue values, percent crop treated values) would further reduce the estimated exposure values. ii. Drinking water

. [All BAS 700 F uses were examined at maximum u se rates, maximum number of applications, and all proposed application methods to determine which use would result in the highest water concentrations. The highest water concentrations occurred from the North Carolina apple crop scenario based on an aerial application at 0.1 lb/AC rate x 4 at a 7 day interval. Based on results from the PRZM/EXAMS and SCI- GROW models estimates, the highest acute10

Estimated Drinking Water Concentrations (EDWC) for BAS 700 F were estimated to be 15.0 ug/L (ppb) in surface water and 0.19 ug/L in ground water. The highest chronic EDWC’s for BAS 700F were estimated to be 5.1 ug/L in surface water and 0.19 ug/L in ground water Drinking water exposure contributions were assessed based on the maximum estimated BAS 700 F water co ncentrations (acute 15 ug/L, chronic 5.07 ug/L), and water consumption and body weights reported in CSFII, using DEEM-FCID software. The acute and chronic estimated water exposure values are summarized in Tables 5 and 6 , respectively. Drinking water expo sure accounts for less than 0.2 9 % of the aPAD and 1.7 % o f the cPAD for all populations. Table 5 . Results for BAS 700 F Acute Water Exposure Analysis Considering the Maximum Estimated Acute Drinking Water Concentration using DEEM-FCID at the 95 th Percentil e

Population Water Exposure Estimate % aPAD Subgroups (mg/kg b.w./day) U.S. Population 0.000 784 0.06 All Infants (< 1 year old) 0.00 2954 0.24 Children (1 -2 years old) 0.00 1230 0.10 Children (3 - 5 years old) 0.00 1123 0.09 Children (6 - 12 years old) 0. 000 782 0.06 Youth (13 - 19 years old) 0.000 636 0.05 Adults (20 -49 years old) 0.000 726 0.06 Adults (50+ years old) 0.000 656 0.05 Females (13 - 49 years old) 0.000 730 0.29 Table 6 . Results for BAS 7 00 F Chronic Water Exposure Analysis Considering the MaximumEstimated Chronic Drinking Water Concentration using DEEM-FCID

Population Water Exposure Estimate %cPAD Subgroups (mg/kg b.w./day) U.S. Population 0.000107 0.5 All Infants (< 1 year old) 0.000 350 1.7 Children (1 -2 years old) 0.000 159 0.8 Children (3 - 5 years old) 0.000 149 0 .7 Children (6 - 12 years old) 0.000 102 0.5 Youth (13 - 19 years old) 0.000 077 0.4 Adults (20 -49 years old) 0.000 100 0.5 Adults (50+ years old) 0.000 105 0.5 Females (13 - 49 years old) 0.0000 99 0.511

Acute Aggregate Exposure and Risk (food and water) The aggregate acute risk includes exposure of BAS 7 00 F from food and water (Table s 7 and 8). The results of the analysis sh ow that a risk assessment using proposed tolerances based on BAS 700 F only provides results comparable to that based on tolerances that take into account combined residues of BAS 700 F, M700F008, M700F002 and M700F048 . The results demonstrate that there are no safety concerns for any subpopulation based on the proposed uses and the results meet the FQPA standard of reasonable certainty of no harm. Table 7 . Estimated Acute Aggregate Exposure and Risk of BAS 700 F (considering tolerances for combined residues of BAS 700 F, M700F0008 , M700F002 and M700F048) using DEEM- FCID at the 95 th Percentile Population Subg roup aPAD

(mg/kg/day) Food

Exposure (mg/kg/day) Water

Exposure (mg/kg/day) Total

Exposure (mg/kg/day) %

aPAD U.S. Population 1.25 0.013314 0.000784 0.01361 0 1.1 All Infants (< 1 yr old) 1.25 0.028796 0.002954 0.029960 2.4 Children 1 -2 years 1.25 0.03137 1 0.001230 0.031943 2. 6 Children 3 - 5 years 1.25 0.026442 0.001123 0.026878 2.2 Children 6

– 12 years 1.25 0.017246 0.000782 0.017455 1. 4 Youth 13 - 19 years 1.25 0.009071 0.000636 0.009418 0. 75 Adults 20 -49 years 1.25 0.008572 0.000726 0.008917 0. 71 Adu lts + 50 1.25 0.008688 0.000656 0.009021 0. 72 Females 13 -49 years 0.25 0.008382 0.000730 0.008744 3. 5 Table 8 . Estimated Acute Aggregate Exposure and Risk of BAS 700 F (considering proposed tolerances for parent only) using DEEM-FCID at the 95 th Percentile Population Subgroup aPAD

(mg/kg/day) Food

Exposure (mg/kg/day) Water

Exposure (mg/kg/day) Total

Exposure (mg/kg/day) %

aPAD U.S. Population 1.25 0.011951 0.000784 0.012317 0.99 All Infants (< 1 yr old) 1.25 0.024050 0.002954 0.024850 1.99 Children 1 -2 years 1.25 0.027721 0.001230 0.028505 2.28 Children 3 - 5 years 1.25 0.023857 0.001123 0.024254 1.94 Children 6

– 12 years 1.25 0.015875 0.000782 0.016071 1.29 Youth 13 - 19 years 1.25 0.008342 0.000636 0.008567 0.69 Adults 20 -49 years 1.25 0.007935 0. 000726 0.008268 0.66 Adults + 50 1.25 0.007804 0.000656 0.008173 0.65 Females 13 -49 years 0.25 0.007810 0.000730 0.008118 3.25 Short- and Intermediate- Term Aggregate Exposure and Risk (food, water, and residential)12

Short- and intermediate-term aggregat e risk assessments include exposure from food, water, and residential uses. There are no residential uses for BAS 700 F , therefore, a short- and intermediate -term aggregate risk assessment is not required. Chronic Aggregate Exposure and Risk (food and water) The aggregate chronic risk includes exposure of BAS 7 00 F from food and water (Table s 9 and 10 ) . The results of the analysis sh ow that a risk assessment using proposed tolerances based on parent only provides results comparable to that based on tol erances that take into account combined residues. The results demonstrate there are no safety concerns for any subpopulation based on the proposed uses and the results meet the FQPA standard of reasonable certainty of no harm. Table 9 . Estimated Chronic Aggregate Exposure and Risk of BAS 7 00 F considering tolerances for combined residues of BAS 700 F, M700F0008 and M700F048 Population Subgroup cPAD

(mg/kg/day) Food

Exposure (mg/kg/day) Water Exposure

(mg/kg/day) Total

Exposure (mg/kg/day) %

cPAD U.S. Pop ulation 0.021 0.004629 0.000107 0.00 4736 22.6 All Infants (< 1 yr old) 0.021 0.007719 0.000350 0.00 8069 38.4 Children 1 -2 years 0.021 0.013962 0.000159 0.014121 67.2 Children 3 - 5 years 0.021 0.011420 0.000149 0.011568 55.1 Children 6

– 12 years 0.021 0 .007017 0.000102 0.007120 33.9 Youth 13 - 19 years 0.021 0.003662 0.000077 0.003729 17.8 Adults 20 -49 years 0.021 0.003432 0.000100 0.003532 16.8 Adults + 50 0.021 0.003564 0.000105 0.003669 17.5 Females 13 -49 years 0.021 0.003317 0.000099 0.003416 16.3 Table 1 0 . Estimated Chronic Aggregate Exposure and Risk of BAS 700 F considering proposed tolerances for parent only Population Subgroup cPAD

(mg/kg/day) Food

Exposure (mg/kg/day) Water Exposure

(mg/kg/day) Total

Exposure (mg/kg/day) %

cPAD U.S. Population 0.021 0.004117 0.000107 0.004214 20.1 All Infants (< 1 yr old) 0.021 0.006564 0.000350 0.006915 32.9 Children 1 -2 years 0.021 0.012184 0.000159 0.012343 58.8 Children 3 - 5 years 0.021 0.010104 0.000149 0.010253 48.8 Children 6

– 12 years 0.021 0.006 197 0.000102 0.006299 30.0 Youth 13 - 19 years 0.021 0.003243 0.000077 0.003320 15.8 Adults 20 -49 years 0.021 0.003088 0.000100 0.003188 15.2 Adults + 50 0.021 0.003189 0.000105 0.003294 15.7 Females 13 -49 years 0.021 0.002974 0.000099 0.003073 14.6 ]13

2. Non

- dietary exposure

. [ There are no current or proposed residential uses for BAS 7 00 F . Therefore, a residential exposure and risk evaluation was not conducted. ] D. Cumulative Effects [ "Section 408(b)(2)(D)(v) requires that, when considering wheth er to establish, modify, or revoke a tolerance, the Agency consider “available information'' concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity." Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to BAS 700 F . For the purposes of this tolerance action, therefore, BASF has not assumed that BAS 700 F h as a common mechanism of toxicity with other substances. ] E. Safety Determination 1. U.S. population. [ Based on this risk assessment, BASF concludes that there is a reasonable certainty that no harm will result to the general population from the ag g regate exposure to BAS 7 00 F from the proposed uses. ] 2. Infants and children

. [Based on this risk assessment, BASF concludes that there is a reasonable certainty that no harm will result to infants or children from the aggregate exposure to BAS 7 00 F from the proposed uses. ] F. International Tolerances [ There are no CODEX maximum residue levels established for residues of BAS 700 F in root and tuber vegetables (subgroups 1A, 1C, D) legume vegetables including soybean (group 06), foliage o f legum e vegetables (group 07) , fruiting vegetables (group 8), pome fruits (group 11), stone fruits (group 12), cereal grains (group 15), forage, fodder and straw of cereal grains (group 16), canola, sunflower (group 20), peanut, cotton, and animal matrices . These crops have been nominated for inclusion on the 2011 tentative CODEX evaluation schedule . ]