EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: [Shaja Joyner, (703) 308-3194]

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 (5F8344) 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 tolerances 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. [Citrus, dried 

pulp] at [2.7] parts per million (ppm); [Citrus, oil] at [19] ppm; [Fruit, citrus, group 

10-10] at [1.0]; ppmnd[Grass forage, fodder and hay, group 17] at [30] ppm; 

[Nongrass animal feeds, group 18] at [30] ppm; [Poultry, fat] at [0.005] ppm; and to 

revise the established tolerance for [Egg] from 0.002 ppm to [0.01] ppm; and revoke the 

established tolerance for inadvertent residues for nongrass animal feeds, group 18, at 0.3 

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 

fluxapyroxad (BAS 700 F) in all crop matrices. Two radiocarbon labels were studied 

in each crop, with 14-C labels positioned in aniline and pyrazole ring structures. 

Fluxapyroxad was the predominant residue in most crops. In all crops the 

fluxapyroxad Residues of Concern (ROC) were characterized as parent

fluxapyroxad plus metabolites M700F048 and M700F002. A confined rotational 

crop study added metabolite M700F008 and confirmed that parent fluxapyroxad

plus metabolites M700F008, M700F048 and M700F002 were the residues of concern 

in the representative rotational crops of wheat, radish, and spinach.]
2

2. Analytical method. [Independently validated analytical methods have been 

submitted for analyzing residues of parent fluxapyroxad (BAS 700 F) plus 

metabolites M700F008, M700F048 and M700F002 with appropriate sensitivity in/on

plant/crop raw agricultural commodities and processed fractions and in animal 

meat, fat, liver and kidney matrices, skin milk, cream, poultry meat, fat, liver and 

eggs for which tolerances have been established or are being proposed.] 

3. Magnitude of residues. [Crop field trials were conducted using foliar 

treatment with a fluxapyroxad end-use product on the following crops: orange, 

lemon, and grapefruit representing the citrus crop group 10-10; alfalfa and clover, 

representing the nongrass animal feeds;, and Bermuda grass, bluegrass, fescue, and 

bromegrass representing Grass forage, fodder, and hay crop group 17. The studies 

were conducted to determine the magnitude of the residue in/on the representative 

raw agricultural commodities and processed fractions. The data are being 

submitted to propose tolerances for the citrus group 10-10, grass forage, fodder and 

hay, group 17 and nongrass animal feeds, group 18. The petition does not seek 

pasture use but proposes a use rate with a 14 day preharvest interval for group 17 

and group 18 commodities. 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 preharvest interval (PHI). Residues of M700F002 were generally less than the limit of 

quantitation and often less than the limit of detection. Residues of M700F048 were 

generally less than the limit of quantitation and often less than the limit of detection 

in citrus and significantly less than residues of BAS 700 F in grass and nongrass 

commodities. Residues of M700F008 were significantly less than residues of BAS 

700 F. Detected residues of fluxapyroxad (BAS 700 F) in citrus crops, grasses and 

nongrass animal feed commodities support the proposed tolerances based on parent 

fluxapyroxad (BAS 700 F).

The impact of the new uses in animal feed items was evaluated, and an amended 

tolerance in egg and a new tolerance in poultry fat are proposed due to the increase 

in the poultry feed burden. The feed burdens for ruminant or swine did not change 

significantly from the values determined in the prior EPA evaluation, so no 

amended tolerances for ruminant or hog, meat, byproducts or new tolerances for 

hog commodities are proposed.]

B. Toxicological Profile

1. Acute toxicity. [Fluxapyroxad (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 fluxapyroxad in toxicity category III for acute oral and 

dermal and category IV for acute inhalation, eye and skin irritation. Fluxapyroxad

is not a dermal sensitizer.]
3

2. Genotoxicty. [Fluxapyroxad (BAS 700 F) was not genotoxic in a battery of 

assays. Fluxapyroxad 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 fluxapyroxad did not cause unscheduled DNA synthesis in hepatocytes 

of treated rats.]

3. Reproductive and developmental toxicity. [The reproductive and 

developmental toxicity of fluxapyroxad (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, fluxapyroxad administration resulted in decreased food consumption, 

impaired body weight development, clinical chemistry and select organ weight 

changes and histopathology. Impairment of pup body weight development was also 

seen at these doses. The NOAEL for systemic and developmental toxicity was 10 

mg/kg bw/day. 

In the rat developmental toxicity study, slight maternal toxicity was observed at the 

high dose level of 1000 mg/kg bw/d, in the form of limited clinical chemistry, liver 

and thyroid weight effects, and thyroid histopathology. No evidence of 

developmental toxicity was observed in the rat up to the highest dose tested of 1000 

mg/kg bw/d.

At the highest dose tested in the rabbit teratology study (60 mg/kg bw/d), maternal 

toxicity consisted of clinical signs, abortion, reduced food 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 fluxapyroxad (BAS 700 F) was studied following both 

acute and subchronic oral administration in the rat. In the acute study, treatmentrelated 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 
4

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 fluxapyroxad. 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 lesions. 

Additional target organs in the rat included the thyroid and bones. The spleen, gall 

bladder and prostate were affected in dogs.

Fluxapyroxad (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 fluxapyroxad 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 fluxapyroxad (BAS 700 F) residues in 

animals. Studies were conducted with radiolabeled fluxapyroxad 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 fluxapyroxad in the animals 

is well understood. Degradation proceeds via N-demethylation of the pyrazole ring 
5

and/or hyroxylation of the biphenyl ring followed by subsequent O- and Nconjugation 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 fluxapyroxad 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 fluxapyroxad in animals. The radiolabeled 

residue was rapidly excreted with little uptake in tissue, following a metabolic 

pathway in all animals like that for fluxapyroxad. 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 fluxapyroxad 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 lieu of a fish metabolism study, a 

justification was submitted to waive the data requirement for a metabolism study in 

fish. The justification was based on the relatively low BCF of 25 in edible tissues of 

bluegill sunfish and the negligible BCF of <1 in the crayfish field accumulation 

study. This was sufficient information to fulfill the requirements for the use in rice, 

including in paddy rice, an aquatic system. BASF does not believe that an additional 

metabolism study in a bottom feeder (catfish) or predator (bass) fish will provide 

any new information that would add value to the existing Fluxapyroxad data 

package. 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 fluxapyroxad (BAS 700 F) is 

similar in plants and mammals. The metabolism of fluxapyroxad, 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 fluxapyroxad 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 
6

key metabolite in the metabolic pathway of fluxapyroxad. 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.]

8. Endocrine disruption. [No specific tests have been conducted with 

fluxapyroxad (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 

fluxapyroxad produces any endocrine disruption.]

C. Aggregate Exposure

1. Dietary exposure. [The tolerance expression for dietary risk assessment is 

fluxapyroxad (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 uses for all current 

established tolerances (40 CFR 180.666), the pending increased tolerance for foliar 

treatment of cotton and the proposed uses in citrus, animal feed, nongrass and 

grass, forage, fodder and hay which have an impact on the animal feed burden and 

expected residues in animal commodities. The acute and chronic dietary exposure 

estimates were conducted using DEEM, version 3.18 which includes the 

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

2008.

]

i. Food. [Acute Dietary Exposure Assessment

For plant commodities, the residue levels were set as follows: (a) for crops approved 

as of May 14, 2012, tolerance values adjusted with a factor of 1.5 to account for 

metabolite M700F008 were used as was done in the acute dietary assessment 

conducted as part of the evaluation by EPA (a few input values were changed as 

discussed below); (b) for crops approved as of February 26, 2014, tolerance values 

plus the HAFT for any level of M700F008 greater than the LOQ were used (this is 

different from the EPA analysis performed in July 3013) c) for the proposed foliar 

use in cotton (submitted in January 2014) and the use in citrus, tolerance values plus 

the HAFT for any level of M700F008 greater than the LOQ were used. A 1.5 factor 

was not used to adjust the tolerances for the commodities evaluated in 2013 or for 
7

the new commodities used in the assessment since the levels of metabolite M700F008 

were generally much less than 50% of the tolerance. The 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 the proposed rice use. Processing factors including DEEM 

default and empirical processing factors used in the dietary assessment conducted as 

part of the evaluation by EPA in May 2012 were included. Study derived processing 

factors were used for citrus, grape, cottonseed, rice and sugarcane process 

commodities (see Part A). The analysis assumed 100% of all crops were treated. 

The residue levels used for ruminant and poultry commodities were derived by 

extrapolation from residue levels of parent and M700F008 measured in the feeding 

studies based on the newly calculated feed burdens (see part A). The metabolite

M700F010 was considered to be equal to fluxapyroxad levels in milk. The tolerances 

of 0.01 mg/kg were used for freshwater finfish, shellfish, crustacean and hog, meat, 

byproducts. 

The total exposure estimates are lower than those in the EPA evaluation of July 25, 

2013 since for commodities registered in 2014 and for newly proposed commodities, 

the calculation of the total residue is based on tolerance plus the actual measured 

HAFT for M700F008 levels rather than the tolerance multiplied by a factor, such as 

1.5, to set the metabolite levels in plant commodities.

For drinking water all fluxapyroxad (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 Estimated Drinking Water Concentrations (EDWC) was estimated to 

be 203 μg/L (ppb) for use in turf. The drinking water exposure was included in the 

dietary analysis in Table 1.

The resulting exposure estimates were compared against the fluxapyroxad (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 1.25 mg/kg/day with an FQPA 

safety factor of 1. The most highly exposed sub-population was children 1-2 years 

old with 10.0 % utilization of the aPAD. The results of the acute dietary assessment 

are presented in Table 1.

Table 1. Results for fluxapyroxad (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 0.070893 5.7

All Infants (< 1 year old) 0.096648 7.7

Children (1-2 years old) 0.125256 10.0
8

Children (3-5 years old) 0.110571 8.9

Children (6-12 years old) 0.065201 5.2

Youth (13-19 years old) 0.053369 4.3

Adults (20-49 years old) 0.067673 5.4

Adults (50+ years old) 0.066053 5.3

Females (13-49 years old) 0.070237 5.6

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

For plant commodities, the residue levels were set as follows: (a) for crops approved 

as of May 14, 2012, the combined highest average field trial values for parent plus 

metabolite M700F008 were used as was done in the acute dietary assessment 

conducted as part of the February 2012 evaluation by EPA (a few input values were 

changed as discussed below); (b) for crops approved as of February 26, 2014 and 

the pending use in foliar treatment in cotton and the newly proposed uses, the field 

trial average residue values for parent plus the HAFT for the metabolite M700F008 

(when greater than the LOQ) were used, similar to the EPA evaluation performed 

in July 3013. Processing factors including DEEM default and empirical processing 

factors used in the dietary assessment conducted as part of the evaluation by EPA in 

February 2012 were included. Study derived processing factors were used for citrus, 

grape, cottonseed, rice and sugarcane process commodities (see Part A). The 

analysis assumed 100% of all crops were treated. The residue levels used for 

ruminant and poultry commodities were derived by extrapolation from residue 

levels of parent and M700F008 measured in the feeding studies based on the newly 

calculated feed burdens (see part A). The metabolite M700F010 was considered to 

be equal to fluxapyroxad levels in milk. The tolerances of 0.01 mg/kg were used for 

freshwater finfish, shellfish, crustacean and hog, meat, byproducts. 

For drinking water all fluxapyroxad (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 Estimated Drinking Water Concentrations (EDWC) was estimated 

to be 184 μg/L (ppb). The drinking water exposure was included in the dietary 

analysis in Table 2.

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 (DEEM-FCID) software, version 3.18. 

The chronic Population Adjusted Dose (cPAD) used for U.S. population and all subpopulations is 0.021 mg/kg bw/day. This endpoint is based on the NOAEL value of 
9

2.1 mg/kg bw/day using a FQPA safety factor of 1. The most highly exposed

population sub-group was all infants (< 1 year old) which utilized 71.8% cPAD. The 

results of the chronic dietary assessment are presented in Table 2.

Table 2. Results for fluxapyroxad (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 0.007134 34.0

All Infants (< 1 year old) 0.015081 71.8

Children (1-2 years old) 0.014897 70.9

Children (3-5 years old) 0.011889 56.6

Children (6-12 years old) 0.007493 35.7

Youth (13-19 years old) 0.005143 24.5

Adults (20-49 years old) 0.006554 31.2

Adults (50+ years old) 0.006742 32.1

Females (13-49 years old) 0.006559 31.2

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 fluxapyroxad (BAS 700 F) residues in 

drinking water was included in the dietary assessments above. For drinking water 

all fluxapyroxad 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 Estimated Drinking 

Water Concentrations (EDWC) was estimated to be 203 μg/L (ppb). The highest 

chronic EDWC’s for fluxapyroxad (BAS 700 F) were estimated to be 184 μg/L 

(ppb). 

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. Fluxapyroxad (BAS 700 F) is registered for use on 

residential turf. The residential uses of Fluxapyroxad will result is short-term 

exposure. The residential uses will not result in intermediate and therefore, an 

intermediate-term aggregate risk assessment is not required. Because no dermal 

hazard of concern was identified for fluxapyroxad only inhalation exposure was 

assessed for residential handlers, and incidental oral exposure (hand to mouth) was

assessed for activities of children on treated turf. 
10

The short-term oral NOAEL is 9.0 mg/kg bw/day. The short-term aggregate risk 

assessment is presented in Table 3.

Table 3: Short-Term Aggregate Exposure and Risk for fluxapyroxad (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)

Aggregate 

MOE

US Population 0.007134 0.022000 0.029134 309

Children 1-2 years old 0.014897 0.003500 0.018397 489

The aggregate MOEs for dietary (food + water) and residential exposures are 489 

for children and 309 for adults. 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 (BAS 700 F) 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.]

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 fluxapyroxad (BAS 700 F). For the purposes of this tolerance action, 

therefore, BASF has not assumed that fluxapyroxad has a common mechanism of 

toxicity with other substances.]

E. Safety Determination

1. U.S. population. [Based on this risk assessment, BASF concludes that the 

aggregate exposure to fluxapyroxad (BAS 700 F) from the current tolerances and 

proposed new tolerances does not result in an unacceptable risk.]
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2. Infants and children. [Based on this risk assessment, BASF concludes that 

the aggregate exposure to fluxapyroxad (BAS 700 F) from the current tolerances 

and proposed new tolerances does not result in an unacceptable risk.]

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.]

Health Canada Pest Management Regulatory Agency (PMRA) has published 

Maximum Residue Limits (MRL) for fluxapyroxad residues on multiple crop 

commodities. A complete list can be found on the Maximum Residue Limits for 

Pesticides webpage in the Pesticides and Pest Management section of Health 

Canada’s website.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) 

established an MRL of 0.1 ppm on barley and all other crops grown in Australia. 

The Food Standards Australia New Zealand also proposed an MRL of 2 mg/kg

(ppm) on stone fruits [except plums (including prunes)] for the purpose of

harmonizing MRLs with the U.S.

CODEX maximum residue levels were proposed for residues of fluxapyroxad (BAS 

700 F) in/on raw agricultural commodities and processed fractions by the 2012 Joint 

Meeting on Pesticide Residues (JMPR) and approved by the Codex Committee on 

Pesticide Residues (CCPR) in May 2013 (Summary Report from the 2012 Joint 

FAO/WHO Meeting on Pesticide Residues (JMPR), Oct 2012).

Summary of International MRLs (ppm) as of December, 2014

Some commodities might not be covered due to differences in crop groups and extrapolations.

Parentheses indicate that the U. S. MRL is more critical than the country MRL.

Commodity US Codex EU Australia Brazil Canada Japan Korea

Apple 0.8 0.9 0.9 0.8 {0.5} 0.8 0.9 0.8

Apricot 3 {2} {1} {2} {2} {2} {2}

Barley, grain 3 {2} {2} {0.2} {0.3} 3 3 {2}

Bean, broad (fava), 

succulent 0.5 --- {0.09} {0.1} --- 0.5 7

Bean, snap, 

succulent (w pods) 2 2 2 2

Bean, snap, 

succulent, shelled 0.5 {0.09} {0.09} {0.1} {0.03}

Bean, dry 0.4 0.3 0.4

Beet, sugar, root 0.1 0.15 0.15 0.1 0.15 0.1 0.2 0.1

Blackberry 5 --- {0.01} {0.1} --- --- ---

Blueberry, highbush 7 --- {0.01} {0.1} --- --- ---

Broccoli 4 --- {0.07} {0.1} --- --- ---
12

Summary of International MRLs (ppm) as of December, 2014

Some commodities might not be covered due to differences in crop groups and extrapolations.

Parentheses indicate that the U. S. MRL is more critical than the country MRL.

Commodity US Codex EU Australia Brazil Canada Japan Korea

Brussels sprouts 4 --- {0.07} {0.1} --- --- ---

Buckwheat, grain 3 3 3

Cabbage 4 --- {0.07} {0.1} --- --- ---

Cantaloupe 0.5 --- {0.01} {0.1} {0.05} --- ---

Cardoon 30 --- {0.01} {0.1} --- --- --- ---

Carrot 0.9 --- {0.1} {0.1} {0.02} --- ---

Celery 30 --- {0.01} {0.1} --- --- ---

Cherry, sweet 3 {2} {0.01} {2} {2} {2} {2} {2}

Chickpea, dry 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4

Corn, grain 0.01 0.01 0.01 0.1 0.05 0.01 0.2 0.15

Corn, sweet 0.15 0.15 0.15 {0.1} 0.15 0.15 0.2 0.15

Cottonseed 0.01 0.01 0.01 0.1 0.5 0.01 0.01

Cowpea, dry 0.4 --- {0.3} 0.4 --- 0.4 0.4

Cucumber 0.5 --- {0.01} {0.1} {0.05} --- {0.02}

Eggplant 0.7 {0.6} {0.6} {0.1} {0.6} 0.7 0.7

Endive (escarole) 30 --- {0.03} {0.1} --- --- ---

Fennel, bulb 30 --- {0.01} {0.1} --- --- {2}

Flaxseed/Linseed 0.9 {0.8} 0.9 {0.1} {0.8} 0.9 0.9

Garlic, bulb 1.5 --- {0.1} {0.1} --- --- ---

Ginseng, root, fresh 0.9 --- {0.01} {0.1} --- --- 7

Gold of pleasure 0.9 --- 0.9 {0.1} --- 0.9 --- ---

Grape, table 2 --- {0.01} {0.1} --- --- ---

Jujube, Chinese 3 {2} {1.5} {0.1} {2} {2} {0.8}

Lentil, dry 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4

Loquat 0.8 0.9 0.9 0.8 0.9 0.8 --- ---

Lupin, dry 0.4 --- {0.3} 0.4 --- 0.4 0.4 ---

Mayhaw 0.8 0.9 0.9 {0.1} 0.9 0.8 --- ---

Melon, casaba 0.5 --- {0.01} {0.1} {0.05} --- --- 0.5

Muskmelon 0.5 --- {0.01} {0.1} {0.05} --- --- 0.5

Nectarine 3 {2} {1} {2} {2} {2} {2}

Nut, cashew 0.06 --- {0.01} 0.1 --- --- 0.8

Oat, grain 3 {2} {2} {0.1} {0.3} 3 3

Onion, bulb 1.5 --- {0.1} {0.1} {0.01} --- ---

Pea, dry (field) 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4

Peach 3 {2} {1} {2} {2} {2} --- {0.3}

Peanut 0.01 0.01 0.01 0.1 0.01 0.01 0.01 0.01

Pear 0.8 0.9 0.9 0.8 0.9 0.8 0.9 0.8

Pepino 0.7 {0.6} {0.6} {0.1} {0.6} 0.7 ---

Pepper, bell 0.7 {0.6} {0.6} {0.1} {0.05} 0.7 0.7 {0.3}

Pepper, non-bell 0.7 {0.6} {0.6} {0.1} {0.6} 0.7 0.7 {0.3}

Plum 3 {2} {1.5} {0.1} {2} {2} {2} ---

Plumcot 3 {2} {1.5} {0.1} {2} {2} {2} ---

Poppy, seed 0.9 {0.8} 0.9 {0.1} {0.8} 0.9 {0.9} ---

Potato 0.02 0.03 0.03 0.1 {0.01} 0.02 0.03 0.02

Pumpkin 0.5 --- {0.01} {0.1} --- --- ---
13

Summary of International MRLs (ppm) as of December, 2014

Some commodities might not be covered due to differences in crop groups and extrapolations.

Parentheses indicate that the U. S. MRL is more critical than the country MRL.

Commodity US Codex EU Australia Brazil Canada Japan Korea

Purslane, garden 30 --- {0.03} {0.1} --- --- {7}

Quince 0.8 0.9 0.9 0.8 0.9 0.8 0.9

Rape seed (canola) 0.9 {0.8} 0.9 {0.1} {0.8} 0.9 0.9 {0.4}

Raspberry, black/red 5 --- {0.01} {0.1} --- --- ---

Rhubarb 30 --- {0.01} {0.1} --- --- {0.6} ---

Rye, grain 3 {0.3} {0.4} {0.1} {0.3} 3 3

Safflower, seed 0.9 {0.8} 0.9 {0.1} {0.8} 0.9 0.9

Sesame, seed 0.9 {0.8} 0.9 {0.1} {0.8} 0.9 0.9

Sorghum, grain 3 --- {0.7} {0.1} {2} 3 3 {0.8}

Soybean 0.15 0.15 0.15 0.3 {0.05} 0.15 0.3 0.15

Strawberry 4 --- {0.01} {0.1} --- --- ---

Sugar cane 3 --- {0.01} {0.1} {0.03} --- --- ---

Sunflower, seed 0.9 {0.8} {0.8} {0.1} {0.2} 0.9 0.9 {0.2}

Sweet potato 0.02 --- {0.01} 0.1 --- 0.02 0.02

Swiss chard 30 --- {0.03} {0.1} --- --- {7}

Tomato 0.7 {0.6} {0.6} {0.1} {0.2} 0.7 0.7 {0.3}

Triticale, grain 0.3 0.3 0.4 {0.1} 0.3 3 3

Watermelon 0.5 --- {0.01} {0.1} --- --- --- {0.1}

Wheat, grain 0.3 0.3 0.4 {0.1} 0.5 0.3 0.3 0.3

Yam, true, tuber 0.02 --- {0.01} 0.1 --- 0.02 0.02