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 ([----------]) 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 the fungicide

[Fluxapyroxad, (BAS 700 F); 1H-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 commodities[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] ppm; [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;

[vegetable, brassica leafy, group 5] at [3.0] ppm; [vegetable, bulb, group 3-07] at [0.8] ppm;
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[vegetable, cucurbit, group 9] at [0.4] ppm; [vegetable, leafy, 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 data at this time or whether the data supports granting of the petition. Additional 

data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism.[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 matrices. Two radiocarbon labels were studied in each crop, with 14-

C labels positioned in aniline and pyrazole ring structures. 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 confined 

rotational crop study added metabolite M700F008 and confirmed that parent BAS 700 F plus 

metabolites M700F008, M700F048 and M700F002 were the residues 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 soybean (group 6), foliage of 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 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 field 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 M700F002 

were generally less than the limit of quantitation and often less than the limit of detection.
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Residues of M700F008 were significantly less than residues of BAS 700 F. Detected residues 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 tissue. The impact of 

the new commodities on the animal Maximum Reasonably Balanced Diets was minimal, and 

thus no changes in tolerances in animal commodities 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 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.
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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 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 

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 effects 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 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.]
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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 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 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. Studies 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. Unchanged parent compound was found as the predominant 

component in most animal matrices. The metabolism of BAS 700 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 
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little uptake in tissue, following a metabolic pathway in all animals like that for BAS 700 F. 

Rat. goat and hen metabolism studies 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 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 uptake 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, goat 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 uptake 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 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 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.]
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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 tolerance expression for dietary risk assessment is BAS 700 F

and M700F008 in plant and animal commodities except milk, for which M700F010 is also 

included. 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. 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 values 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 few 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 factor 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 

50% of the tolerance. The analysis assumed 100% of all crops treated. Values changed from 

the EPA dietary 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 commodities to 

reflect new rice use. The impact of the new commodities on the animal Maximum Reasonably

Balanced Diets was minimal and thus no changes in tolerances in animal commodities are

proposed. 
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For drinking water all 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 highest acute water concentration occurred 

from the rice use scenario. The highest acute Estimated Drinking Water Concentrations 

(EDWC) for BAS 700 F were estimated to be 26.1 μg/L (ppb) in surface water. The 

consumption of water was included in the analysis, and the residue concentration in water 

was set at 0.0261 mg/L based on the surface water concentration determined for the use in 

rice.

The consumption data was from the NHANES 2-day food consumption data for 2003 to 2008

and the assessment was performed using the Dietary Exposure Evaluation Module (DEEMFCID) software. 

The resulting 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 endpoint is based on 

the NOAEL of 125 mg/kg/day with an FQPA safety factor of 1. The most highly exposed subpopulation 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 BAS 700 F Acute Dietary Exposure (Food and Water)

Considering all Current and Proposed Tolerances using DEEM-FCID at the 95th

Percentile

Population Exposure Estimate % aPAD

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
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Adults (50+ years old) 0.03779 3.0

Females (13-49 years old) 0.039958 3.2

The 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

The chronic dietary exposure 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 for residues of 

M700F008 for the commodities of barley, buckwheat, millet, oat, and rice. Processing factors 

for apple juice (0.2), apple sauce (0.25), potato dry granules (1.17), sugarcane refined sugar 

(0.04) and molasses (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 

to wheat residues and sweet corn was set to 0.15 mg/kg rather than 0.01 mg/kg.

For drinking water all 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 highest chronic water concentration occurred 

from the use in paddy rice scenario. The highest chronic EDWC’s for BAS 700F were estimated 

to be 23.623 μg/L in surface water. The consumption of water was included in 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 assessment was performed using the 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 value of 2.1 mg/kg bw/day using 
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a FQPA safety factor of 1. The most highly exposed population sub-group was children 1-2

years of age which utilized 70.3% cPAD. The results of the chronic dietary assessment are 

presented in Table 2.

Table 2. Results for BAS 700 F Chronic Dietary Exposure (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) 0.014769 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 results of the risk assessment show that for all populations 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 all 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 highest acute and chronic water concentration occurred from the rice use

scenario. The highest acute Estimated Drinking Water Concentrations (EDWC) for BAS 700 F 

were estimated to be 26.1 μg/L (ppb) in surface water. The consumption of water was 
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included in the analysis, and the residue concentration in water was set at 0.0261 mg/L based 

on the surface water concentration determined 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 μg/L in surface water. The 

consumption of water was included in 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.

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 

assessed 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
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Sub-Populations Intermediate-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 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 249 for 

children 1-2 years old and 1275 and 1572 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 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 not 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 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.]
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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. 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 aggregate 

exposure to BAS 700 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 700 F from the proposed uses.]

F. International Tolerances

[European Maximum Residue Limits (MRL) were established for fluxapyroxad on 

multiple crops in October 2011 [Commission 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 in root and 

tuber vegetables (subgroups 1A, 1C, D) legume vegetables including soybean (group 06), 

foliage of 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 2011 tentative CODEX evaluation schedule and the 

Data Directory for fluxapyroxad has been submitted for the 2012 Joint Meeting on Pesticide 

Residues (JMPR).
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