**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 i**  **n 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 a**  **ppear 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 **( [**  **---------- ]**  **)** from **[ BASF Corporation**  **] ,**  **[ 26 Davis**  **Dri ve,**  **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 the fu ngicide **[ Fluxapyroxad**  **, (**  **BAS 700 F )**  **; 1**  **H -**  **Pyrazole -** **4 -**  **carboxamide, 3**  **- (difluoromethyl)**  **- 1**  **- methyl**  **- N** **- (3',4',5'**  **- trifluoro[1,1'**  **- biphenyl]**  **- 2**  **- yl)**  **- , its**  **metabolites, and degradates**  **]** in or on the following raw agricultural commodit ies **[ almond**  **]** at **[ 0.05**  **]** parts per million ( ppm ); **[ almond, hulls**  **]** at **[ 4.0**  **]** ppm; **[ berry, low growing, subgroup 13**  **- 07G**  **]** at **[ 4.0**  **]** ppm; **[ bushberry, subgroup 13**  **- 07B**  **]** at **[ 6.0**  **]** ppm ; **[ caneberry, subgroup 13**  **- 07A**  **]** at **[ 6.0**  **]** ppm ; **[ fruit, small, vine climbing, except fuzzy**  **kiwifruit, subgroup 13**  **- 07F**  **]** at **[ 2.0**  **]** p pm ; **[ grapes**  **]** at **[ 2.0**  **]** ppm ; **[ grapes, raisin**  **]** at **[ 5.7**  **]** ppm ; **[ pecans**  **]** at **[ 0.05**  **]** ppm ; **[ rice, bran**  **]** at **[ 8.5**  **]** ppm ; **[ rice, grain**  **]** at **[ 5.0**  **]** ppm ; **[ rice, hulls**  **]** at **[ 15.0**  **]** ppm ; **[ rice, straw**  **]** at **[ 20.0**  **]** ppm ; **[ strawberry**  **]** at **[ 4.0**  **]** ppm ; **[ sugarcane, cane**  **]** at **[ 3.0**  **]** ppm ; **[ v** **egetable, brassica leafy , group 5**  **]** at **[3.0 ]**  ppm; **[ vegetable, bulb, g**  **roup 3**  **- 07**  **]** at **[ 0.8**  **]** ppm ;2

**[ vegetable, cucurbit, g**  **roup 9**  **]** at **[ 0.4**  **]** ppm ; **[ vegetable,**  **le afy, except brassica**  **, group 4**  **]** at **[ 15.0**  **]** ppm ; **[ vegetable, root, except sugarbeet, subgroup 1B**  **]** at **[ 0.7**  **]** 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 d a ta at this time or whether the data supports g ranting of the petition. Additional data may be needed before EPA rules on the petition.
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**  **(fluxapyroxad) in all crop ma**  **trices. Two radiocarbon labels w ere studied in each crop, with 14** **- C labels positioned**  **i n**  **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 and 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**  **rotational crops of wheat, radish, and**  **spinach .**  **]**

2. Analytical method. **[ Independently validated analytical methods have been**  **submitted for analyzing residues of parent BAS**  **700 F (fluxapyroxad)**  **plus metabolit es**  **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 vegeta bles (gr** **oup 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 kidne** **y matrices , poultry meat, fat,**  **liver and skin, milk, cream and eggs for which**  **tolerances have been established**  **.** ]

3. Magnitude of residues. **[ Field trials were carried out to determine the magnitude of**  **the residue in/on Blueberry, Raspberry, Broccoli,**  **Cabbage, Mustard greens,**  **Green onion, Bulb onion, Cucumbers, Cantaloupe, Summer squash,**  **Grapes, Head lettuce, Leaf lettuce, Celery,**  **Spinach, Rice grain and straw,**  **Carrot, roots, Radish, roots and tops, Sugarcane, Almond, nuts**  **and hulls and Pecans, and**  **a fi eld accumulation study**  **was performed in**  **Crayfish. 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 maximum 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 .** 3

**Residues of M700F 008 were significantly less than**  **residues of BAS 700 F. Detec** **ted r esidues of**  **BAS 700 F in all crops support the proposed tolerances**  **based on parent BAS 700 F**  **. Residues of BAS 700 F and M700F008 were monitored in the field accumulation study in**  **crayfish, and residues of each were <10 ppb at all time points in crayfish ti ssue.**  **The impact of the new commodities on the animal Maximum Reasonably Balanced Diets was minimal, and**  **thus no change s**  **in tol erances in animal commodities are**  **proposed. ]** 

B. Toxicological Profile

1. Acute toxicity. **[ BAS 700 F displayed low acute toxic**  **ity 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 mammalia n 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**  **to xicity 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 th**  **e 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 developme**  **nt 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 clin**  **ical 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.**4

**At the highest dose tested in the rabbit teratology study (60 mg/ kg bw/d), maternal toxicity**  **consisted of clinical signs, abortion, reduced food consumption, 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. 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 changes. The lowest NOAEL in**  **subchronic oral toxicity studies was approximately 7.3**  **mg/kg bw/day in the rat 90**  **- day study.** 
**No systemic toxicity was observed in a 28 -**  **day repeat dose d ermal toxicity study at doses as**  **high as 1000 mg/kg bw/day.**
**The neurotoxic potential 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**  **increases 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 effect**  **s on these parameters were observed on study days 7 and 14. Additionally, no treatment** **- related**  **neuropathological findings (brain weight changes, neurohistopathological findings) were observed. Therefore, the affected parameters indicated a neuropharmacolog**  **ical effect rather than neuronal damage. Based on the results of this study the NOAEL 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 neurohi**  **stopathological 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) fo r neurotoxicity**  **was 5000 ppm (approximately 320 mg/kg bw/d), the highest dose tested. ]** 5 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 cli nical**  **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 mice 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** **- Phase response in the**  **liver , and indicates there is a threshold for tumor development and a margin of exposure**  **cancer risk assessment is appropriate. In the rat chronic/oncogenicity study, the NOAEL in mal**  **es 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/d**  **ay). ]** 

6. Animal metabolism. **[ The rat, goat and hen metabolism studies were conducted to**  **det ermine 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 only) .**  **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.**  **U nchanged parent compound w** **as found as the predominant component in most animal 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** **- a**  **nd N -**  **conjugation reactions to**  **produce metabolites that are rapidly excreted, along with parent, and do not readily accumulate in tissues or milk.**  **Residues in m ilk and most edible tissues are**  **low. The same**  **metabolic reactions were observed in each of the an imals 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 s oybean 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**6

**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 bon**  **d. M700F002 was seen at levels >10 TRR in soybean 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 upta**  **ke in tissue. ]** 

7. Metabolite toxicology . **[ The 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. Both 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 most 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, goa**  **t and hen. Animal metabolism studies were performed 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 completely excreted unchanged with almost no upta**  **ke in tissue, milk or eggs. M700F002 is not metabolized 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 me** **tabolism 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 vit ro mutagenicity test in mammalian**  **cells, in vitro chromosome aberration test, in vivo mouse micronucleus, 28/90 -** **day rat feeding and developmental toxicity in rabbits) were conducted on**  **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.**  **]**7 8. Endo crine 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 Expos ure

1. Dietary exposure. **[ The tolerance expression**  **for dietary risk**  **assessment is**  **BAS 700 F and M700F008 in plant and animal commodities except milk** **, for which M700F01**  **0 is also**  **included. Exposure assessments were conducted to evaluate the potential ris**  **k due to acute and chronic dietary exposure of the U.S. population**  **and all sub -**  **populations. The assessments**  **included all current established tolerances and**  **the commodities proposed for tolerances and 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 (group 20)** **, peanut and animal matrices including egg,**  **milk and cream .**  **]**

i. Food. **[ Acute Dietary Exposure Assessment**  **Acute dietary exposure estimates were based on a)**  **tolerance v alues on crops approved as of**  **May 14, 2012 with the factor of 1.5 that was used in the acute dietary assessment conducted as part of the evaluation by EPA (a fe** **w input values were changed as discussed below) b) proposed tolerance values**  **for crops included in this submission and processing factors for sugarcane refined sugar (0.04) and molasses (0.16) and c) current tolerances for animal**  **commodities. A**  **1.5 facto r was not used to adjust the tolerances**  **for the new commodities used in the assessment since the levels of metabolite M700F008 were**  **always much less than 5**  **0% of the tolerance .**  **The analysis assumed 100% of all crops treated.**  **Values changed from the EPA**  **di etary**  **analysis of February 2012 are soybean seed commodities changed from 0.75 mg/kg to 0.15**  **mg/ kg** **, sweet corn changed from 0.015 to 0.15 mg/kg and rice comm odities to**  **reflect new rice use. The impact of the new commodities on the animal Maximum Reasonably Balanced Diets was minimal and thus no change**  **s in tol**  **erances in animal commodities are proposed.** 8

**For drinking water a ll BAS 700 F uses were examined at maximum use rates, maximum**  **number of applications, and all proposed application methods to determine which use would**  **result in the highest water concentrations. The highes t**  **acute water concentration**  **occurred from the**  **rice use**  **scenario. T**  **he highest acute Estimated Drinking Water Concentrations (EDWC) for BAS 700 F were estimated to be**  **26.1 μ** **g/L (ppb) in**  **surface water .**  **The consumption of water was included in the analysis, and the residue concentration in water**  **was set at 0.0 261**  **mg/L based on the surface water concentration determined for the use in rice**  **. The consumption data was from the**  **NHANES 2 -**  **day f ood consumption data for 2003 to**  **2008 and**  **the assessment was performed using the Dietary Exposure Evaluation Module (DEEM**  **** **FCID) software.**

**The result ing**  **exposure estimates were compared against the BAS 700 F**  **acute Population Adjusted Dose (aPAD) of**  **1.25 m**  **g/kg b.w./day for all populations.**  **The endpoint 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 children 1**  **- 2 years old**  **with 8.9**  **% utilization of the aPAD. The results of the acute dietary**  **assessment are presented in Table 1.** 
**Table 1**  **. Results**  **for BA** **S 700**  **F Ac**  **ute Dietary**  **E xposure**  **(Food and**  **Water) Considering**  **all Current**  **and Proposed**  **Toler ances**  **using DEEM**  **- FCID**  **at the**  **95 th**  **Percentile Population**  **Exposure Estimate % a**  **PAD**

**Subgroups (mg/kg b.w./d**  **ay) U.S. Population**  **0.047194 3.8**  **All Infants (< 1 year old) 0.090603**  **7.2 Children (1**  **- 2 years old)**  **0.111309 8.9**  **Children (3 -**  **5 years old) 0.090178**  **7.2 Children (6**  **- 12 years old)**  **0.047793 3.8**  **Youth (13 -**  **19 years old) 0.031709**  **2.5 Adults (20**  **- 49 years old**  **) 0.039777**  **3.2**9 **Adults (50+ years old) 0.03779**  **3.0 Females (13**  **- 49 years old)**  **0.039958 3.2** 

**Th e**  **results of the analysis show that for all populations, the estimated exposures are well below the Agency's level of concern (< 100% aPAD). Additional refinemen**  **ts 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**  **c hronic dietary e** **xposure estimates were based on combin**  **ed residues of the highest average field trial (HAFT) values for parent and HAFT**  **values for residues of**  **M700F008 for all**  **registered raw agricultural commodities and all newly proposed raw agricultural commodities except for the use of the mean residue valu**  **es of BAS 700 F and HAFT**  **values for residues of**  **M700F008 for the commodities of**  **barley , buckwheat, millet, oat,**  **and rice. Processing factors for appl**  **e juice (0.2), apple sauce (0.25 )**  **, potato dry granules (1.17) ,**  **sugarcane refined sugar (0.04) and molasse**  **s (0.16) as**  **determined in processing studies were used. Some other**  **changes were made to values used in the EPA evaluation of February 2012 in that apricot and**  **nectarine residues were set equal to peach residues** **, rye and triticale residues**  **were set equal t**  **o wheat residues and sweet corn was set to 0.15 mg/kg rather than 0.01 mg/kg.**
**For drinking water a ll BAS 700 F uses were examined at maximum use rates, maximum**  **number of applications, and all proposed application methods to determine which use would resul**  **t in the highest water concentrations. The highest chronic water concentration**  **occurred from the**  **use in paddy rice scenario**  **. T**  **he highest chronic EDWC’s for BAS 700F were estimated to be**  **23.623 μ** **g/L in surface water .**  **The consumption of water was included i n the analysis,**  **and the residue concentration in water was set at 0.0236 mg/L based on the surface water concentration determined for the use in paddy rice.** 
**The consumption data was from the NHANES 2**  **- day food consumption data for 2003 to**  **2008 and**  **the asse ssment was performed using the**  **Dietary Exposure Evaluation Module (DEEM**   ** FCID) 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 m**  **g/kg bw/day using** 10

**a FQPA safety factor of 1. The most highly expos ed**  **population sub -** **group was children 1 -**  **2 years of age which utilized**  **70.3 % c**  **PAD. The results of the chronic dietary ass e**  **ssment are presented in Table**  **2 .** 
**Table 2 . Results for BAS 700 F Ch**  **ronic Dietary Exp osure**  **(Food and Water) Considering All**  **Commodities using DEEM**  **- FCID** 

**Population Exposure Estimate**  **% cPAD Subgroups**  **(mg/kg b.w./day) U.S. Population**  **0.005725 27.3**  **All Infants (< 1 year old) 0.009033**  **43.0 Children (1**  **- 2 years old)**  **0.01476 9**  **70.3 Children (3**  **- 5 years old)**  **0.011421 54.4**  **Children (6 -**  **12 years old) 0.006514**  **31.0 Youth (13**  **- 19 years old)**  **0.003794 18.1**  **Adults (20 -** **49 years old) 0.004983**  **23.7 Adults (50+ years old)**  **0.005376 25.6**  **Females (13 -** **49 years old) 0.005047**  **24.0**

**The resu lts of**  **the risk assessment**  **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. **[ The consumption of BAS 700 F residues in drinking water was**  **included in the dietary assessments above. For drinking water a**  **ll BAS 700 F uses were examined at maximum use rates, maximum number of**  **applications, and all proposed application methods to determine which use would result in the highest water**  **concentrations. The highes t acute**  **and chronic water concentration**  **occurred from the rice**  **use scenario. T**  **he highest acute Estimated Drinking Water Concentrations (EDWC) for BAS 700 F**  **were estimated to be 26.1**  **μ g/L**  **(ppb) in surface water .**  **The consumption of water was**11

**included in the analysis, and the residue concentration in water was set at 0.0**  **261 mg/L based**  **on the surface water concentration determ ined for the use in**  **rice.**
**The highest chronic water concentration**  **occurred from the use in paddy rice**  **. The highest**  **chronic EDWC’s for BAS 700F were estimated to be 23.623**  **μ g/L in surface water**  **. The**  **consumption of water was included in the analysis, an d the residue concentration in water**  **was set at 0.0236 mg/L based on the surface water concentration determined for the use in paddy rice.** 

**Short -**  **and Intermediate -** **Term Aggregate Exposure and Risk (food, water, and residential) Short**  **- and intermediate**  **- term**  **aggregate risk assessments include exposure from food, water, and residential uses.**  **BAS 700 F**  **is registered for use on residential turf. Because no dermal**  **hazard of concern was identified for BAS 700 F (**  **fluxapyroxad )**  **, only inhalation exposure was assess**  **ed for residential handlers, and incidental ingestion was assessed for activities of children on treated turf.** 

**The short**  **- term oral NOAEL is 9.0 mg/kg bw/day and the**  **intermediate -** **term NOAEL is 7.3**  **mg/kg bw/day. The short -** **term aggregate risk assessment is**  **presented in Table 3 and the intermediate**  **- term aggregate risk assessment is presented in Table 4.** 

**Table 3: Short -** **Term Aggregate Exposure and Risk for BAS 700 F**

**Sub -**  **Populations Short**  **- term Aggregate**  **Food + water exp. (mg/kg**  **bw/day) Residential** 

**exp (mg/kg**  **bw/day) Total exp** 

**(mg/kg bw/day)**  **MOE**
**US Population 0.005725**  **0.000000 0.005725**  **1572 Children 1**  **- 2 years old**  **0.014769 0.021385**  **0.036154 249** 

**Table 4: Intermediate -** **Term Aggregate Exposure and Risk for BAS 700 F**12

**Sub -**  **Populations Intermediate**  **- Term Agg**  **regate Food + water**  **Exp. (mg/kg bw/day)**  **Residential**

**Exp. (mg/kg bw/day)**  **Total Exp.**

**(mg/kg bw/day)**  **MOE**
**US Population 0.005725**  **0.000000 0.005725**  **1275 Children 1**  **- 2 years old**  **0.014769 0.021385**  **0.036154 202** 

**The aggregate MOEs for dietary (food + water) and residential exposures are 202**  **and 24 9**  **for children 1**  **- 2 years old and 1275 and**  **15 72**  **for the general US population. These MOE values indicate that aggregate risk from the use of BAS 700 F is not a concern.**  **]**

2. Non - dietary exposure . **[ A reside**  **ntial exposure and risk assessment was conducted for the proposed residential use of fluxapyroxad products for disease control in turf. Because no dermal hazard of concern was**  **identified for fluxapyroxad, only inhalation exposure was assessed for residenti al handlers,**  **and incidental ingestion was assessed for activities of children on treated turf. In all exposure scenarios, the MOEs for residential use of fluxapyroxad were well above EPA’s level of**  **concern (MOE < 100) indicating that these exposures are no t of concern.** 
**The combined post -**  **application exposure for children 1 to <2 years old was estimated using highly conservative assumptions including: a) basing the transferable residue on the seasonal**  **maximum application rate; b) combining all sources of inc idental exposure; c) using EPA**  **default values for children’s activities. With these highly conservative assumptions the incidental exposure was calculated to be 0.021385 mg/kg/day, resulting in short** **- and**  **intermediate -** **term MOEs of 420 and 341, respectively .**  **]**13

D. Cumulative Effects **[ "Section 408(b)(2)(D)(v) requires that, when considering whether 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 .**  **Fo r the purposes of this**  **tolerance action, therefore, BASF has not assumed that BAS 700 F has 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 gregate**  **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 n o harm will result to infants or children from**  **the aggregate exposure to BAS 7**  **00 F**  **from the proposed uses. ]** 

F. International Tolerances
**[ European Maximum Residue Limits (MRL) were established for fluxapyroxad on**  **multiple crops in October 2011 [**  **Commissio n Regulation (EU) No**  **978/2011 of 3 October**  **2011 ;**  **MRLs for fluxapyroxad (BAS 700 F) in various commodities of plant and animal origin. EFSA Journal 2011; 9(6):2196 [68 pp.].**  **]**

**There are no CODEX maximum residue levels established for residues of**  **BAS 700 F i**  **n root and**  **tuber vegetables (subgroups 1A, 1C, D) legume vegetables**  **including soybean (group 06),**  **foliage o f legume vegetables (group 07)**  **, fruiting vegetables (group 8),**  **pome fruits (group 11), stone fruits (group 12), cereal grains (group 15), forage, fod**  **der 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 201**  **1 tentative**  **CODEX evaluation schedule and the**  **Data Di rectory for fluxapyroxad has been submitted for the 2012 Joint Meeting on Pesticide**  **Residues (JMPR).**14