**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 ap**  **pear 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**  **Driv e,**  **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 fun gicide **[ 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 : **[ n**  **ongrass a nimal**  **f eeds, group 18**  **]** at **[ 0**  **.5 ]**  parts per million ( ppm ); **[ mint**  **]** at **[ 0.05**  **]** 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 granting of the petition. Additional data may be needed before EPA rules on the petition.
A. Residue Chemistry2 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 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 so** **ybean (group**  **6), foliage o f legume vegeta**  **bles (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 an**  **d peanut**  **and in animal meat, fat,**  **liver and kidney 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**  **t he residue in/o**  **n Alfalfa, Clover, and Mint as rotational crops. 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 .**  **Residues of M700F** **008 were significantly less than residues of BAS 700**  **F. Detec** **ted residues of BAS 700 F in all crops support the proposed tolerances**  **based on parent BAS 700 F**  **. 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 commoditi es are**  **proposed. ]** 

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 sen**  **sitizer. The acute toxicity studies place technical BAS 700 F in**3

**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 gen**  **otoxic 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 reproduc** **tion 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 highe**  **st 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 consumption, and impaired body weight development. The only developmental e** **ffect 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 chang** **es 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.** 4

**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 potential of BAS 700 F was studied following both acute and subchronic oral ad**  **ministration 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 numbe r 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 treatment** **- related**  **neuropathological findings (brain weight changes, neurohisto pathological findings) were**  **observed. Therefore, the affected parameters indicated a neuropharmacological 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 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 tested.**  **]**

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 l**  **esions. 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 conc**  **entrations 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.** 5

**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 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**6

**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.**  **]**

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** **, pending tolerances, the**  **crop commodities**  **proposed for tolerances ,**  **and animal matrices including egg, mi lk and cream**  **. ]**  i. Food. **[ Acute Dietary Exposure Assessment** 7

**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 th**  **e evaluation by EPA (a few input values were changed as discussed below) b) proposed tolerance values**  **for crops for which tolerances are pending, and crops included in**  **this submission. A**  **1.5 factor was not used to adjust the tolerances for the new commodi**  **ties 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**  **dietary analysis of February 2012 are soybean seed commoditie**  **s 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 pending**  **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.** 
**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 concen**  **trations. 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 inclu ded 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 pending**  **use in rice**  **. The consumption data was from the**  **NHANES 2 -**  **day food consumption data for 2003 to 2008**  **and t**  **he 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 mg/kg b.w./day for all**  **populations. The**  **endp oint 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.**8

**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./day)**  **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 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 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**9

**The c**  **hronic dietary e xposure estimates were based on**  **combined 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 values of BAS 700 F and HAFT**  **values fo r**  **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 molasses (0.16) as**  **determined in processin g 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**  **to 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 result in the highest water concentratio**  **ns. 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 in the analysis, and the residue con**  **centration 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 assessment was performed using the Dieta**  **ry 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 mg/kg bw/day**  **using a FQPA safety fact**  **or 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 Chronic Dietary Exp**  **osure (Food and Wat**  **er) Considering All**  **Commodities using DEEM**  **- FCID** 

**Population Exposure Estimate**  **% cPAD Subgroups**  **(mg/kg b.w./day) U.S. Population**  **0.005725 27.3** 10 **All Infants (< 1 year old) 0.009033**  **43.0 Children (1**  **- 2 years old)**  **0.014769 70.3**  **Children (3 -**  **5 years old) 0.0**  **11421 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 results 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**  **appl ication 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**  **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 highe st**  **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, and the residu**  **e c**  **oncentration 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)**11

**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 assessed for residential handlers, and inc**  **idental 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 interm**  **ediate -** **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/d**  **ay) 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**

**Sub -**  **Populations Intermediate**  **- Term Aggregate**  **Food + water Exp. (mg/kg**  **b w/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** 12

**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 residential 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 residential handlers, and incidental ingestion w** **as 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 not of concern.**
**The combined post -**  **applic ation 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 incidental 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.**  **]**
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 m**  **echanism 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 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 rotational crops**  **. ]** 13 2. Infants and children
. **[ Based on this risk assessment, BASF concludes that there is a**  **reasonable certainty that no harm will result to infan ts or children from**  **the aggregate exposure to BAS 7**  **00 F**  **from the proposed rotational crops**  **. ]** 

F. International Tolerances
**[ European Maximum Residue Limits (MRL) were established for fluxapyroxad on**  **multiple crops in October 2011 [**  **Commission Regulation (E U) 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 in**  **root and tube**  **r 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, 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 201**  **1 tentative**  **CODEX evaluation**  **schedule and**  **the Data**  **Director y**  **for f** **luxapyroxad has**  **been submitted**  **for the**  **2012 Joint**  **Meeting on**  **Pesticide Residues (JMPR).**