EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: [Mark Suarez, (703) 305-0120]

INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In 

cases where the outline element does not apply, please insert “NA-Remove” and 

maintain the outline. Please do not change the margins, font, or format in your 

pesticide petition. Simply replace the instructions that appear in green, i.e., “[insert 

company name],” with the information specific to your action.

TEMPLATE:

[BASF Corporation]

[Insert petition number]

EPA has received a pesticide petition ([insert petition number]) from [BASF 

Corporation], [26 Davis Drive, P.O. Box 13528, Research Triangle Park, North 

Carolina 27709-3528] proposing, pursuant to section 408(d) of the Federal Food, Drug, 

and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by

establishing a tolerance for residues of [Fluxapyroxad, (BAS 700 F); 1H-Pyrazole-4-

carboxamide,3-(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-biphenyl]-2-yl)-)

in or on the following raw agricultural commodities [apple, wet pomace] at [3.5] parts 

per million (ppm); [barley, bran] at [6.0] ppm; [beet, sugar, tops] at [4.0] ppm; [beet,

sugar, dried pulp] at [0.16] ppm; [corn, field, grain] at [0.01] ppm; [corn, oil, refined] 

at [0.05] ppm; [cotton, gin byproducts] at [0.01] ppm; [cotton, undelinted seed] at

[0.01] ppm; [fruit, pome, group 11] at [0.7] ppm; [fruit, stone, group 12] at [1.4] ppm;

[grain, aspirated fractions] at [16.0] ppm; [grain, cereal, group 15, except field corn

grain] at [2.5] ppm; [grain, cereal, forage, fodder and straw, group 16)] at [25.0] ppm;

[peanut] at [0.02] ppm; [peanut, meal] at [0.03] ppm; [peanut, refined oil] at [0.06]

ppm; [plum, prune at [4.0] ppm; [potato, wet peel] at [0.2] ppm; [rapeseed,

(cultivars/varieties and/or hybrids including canola and crambe)] at [0.60] ppm;

[rice, hulls] at [10.0] ppm; [soybean, hulls] at [6.5] ppm; [soybean, seed] at [0.20] ppm;

[sunflower, seed] at [0.60] ppm; [vegetable, foliage of legume, group 7] at [18.0] ppm;

[vegetable, fruiting, group 8] at [0.60] ppm; [vegetable, legume, dried shelled pea and 

bean (except soybean), subgroup 6C] at [0.35] ppm; [vegetable, legume, edible 

podded, subgroup 6A] at [1.40] ppm; [vegetable, legume, succulent shelled pea and 

bean, subgroup 6B] at [0.45] ppm; [vegetable, root, subgroup 1A) at [0.10] ppm;

[vegetable, tuberous and corm, subgroup 1C] at [0.04] ppm; [vegetable, tuberous and 

corm, (except potato), subgroup 1D] at [0.04] ppm; [wheat, bran] at [6.0] ppm;

[wheat, germ] at [3.0] ppm; and in or on the following food commodities [cattle, fat] at

[0.1] ppm; [cattle, kidney] at [0.01] ppm; [cattle, liver] at [0.10] ppm; [cattle, meat] at
2

[0.01] ppm; [cattle, meat byproducts] at [0.10] ppm; [egg] at [0.01] ppm; [goat, fat] at

[0.1] ppm; [goat, kidney] at [0.01] ppm; [goat, liver] at [0.10] ppm; [goat, meat] at

[0.01] ppm; [goat, meat byproducts] at [0.10] ppm; [hog, fat] at [0.01] ppm; [hog, 

liver] at [0.01] ppm; [hog, meat] at [0.01] ppm; [hog, meat byproducts] at [0.01] ppm;

[horse, fat] at [0.1] ppm; [horse kidney] at [0.01] ppm; [horse, liver] at [0.10] ppm;

[horse, meat] at [0.01] ppm; [horse, meat byproducts] at [0.10] ppm; [milk] at [0.02]

ppm; [milk, fat] at [0.2] ppm; [egg] at [0.01] ppm; [poultry, byproducts ] at [0.01] ppm;

[poultry, fat] at [0.01] ppm; [poultry, liver] at [0.01] ppm; [poultry, meat] at [0.01]

ppm; [poultry, skin ] at [0.01] ppm; [sheep, fat] at [0.1] ppm; [sheep, kidney] at [0.01]

ppm; [sheep, liver] at [0.10] ppm; [sheep, meat] at [0.01] ppm; [sheep, meat 

byproducts] at [0.10] ppm. EPA has determined that the petition contains data or

information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, 

EPA has not fully evaluated the sufficiency of the submitted data at this time or whether 

the data supports granting of the petition. Additional data may be needed before EPA 

rules on the 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 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 crops of wheat, radish, 

and spinach.]

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

submitted for analyzing residues of parent BAS 700 F plus metabolites M700F008, 

M700F048 and M700F002 with appropriate sensitivity in all the crop and processed 

commodities for root and tuber vegetables (subgroups 1A, 1C, D), sugar beet tops, 

legume vegetables including soybean (group 6), foliage 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 which 

tolerances are being requested.]

3. Magnitude of residues. [Field trials were carried out to determine the 

magnitude of the residue in/on root and tuber vegetables (subgroups 1A, 1C], 

legumes vegetables (crop group 6 and 7 including soybean), fruiting vegetables (crop 

group 8), pome fruits (crop group 11), stone fruits (crop group 12), cereal grains 

(crop groups 15 and 16), canola (rapeseed), sunflower, peanut, and cotton. The 

number and locations of field trials are in accordance with OPPTS Guideline 

860.1500. Field trials were carried out using the maximum label rates, the maximum 
3

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, therefore, these residues are 

not proposed for monitoring. Residues of M700F008 were significantly less than

residues of BAS 700 F unless both were close to the limit of quantitation and thus 

M700F008 residues are not proposed for monitoring. Detected residues of BAS 700 

F in all crops support the proposed tolerances based on parent only.]

B. Toxicological Profile

1. Acute toxicity. [BAS 700 F displayed low acute toxicity via the oral, dermal 

and inhalation routes of exposure. It was not irritating to the eyes, only slightly 

irritating to the skin, and not a dermal sensitizer. The acute toxicity studies place 

technical BAS 700 F in toxicity category III for acute oral and dermal and category 

IV for acute inhalation, eye and skin irritation. BAS 700 F is not a dermal 

sensitizer.]

2. Genotoxicty. [BAS 700 F was not genotoxic in a battery of assays. BAS 700 

F was negative for inducing mutations in bacterial and mammalian cell assays. No 

evidence of a clastogenic effect was observed in vitro or in vivo, and BAS 700 F did 

not cause unscheduled DNA synthesis in hepatocytes of treated rats.]

3. Reproductive and developmental toxicity. [The reproductive and 

developmental toxicity of BAS 700 F was investigated in a 2-generation rat 

reproduction study as well as in rat and rabbit developmental toxicity studies. In the 

reproduction study, there were no effects on fertility, up to the highest dose tested of 

300 mg/kg bw/d. At the high- and mid- (50 mg/kg bw/d) doses tested, BAS 700 F 

administration resulted in decreased food consumption, impaired body weight 

development, clinical chemistry and select organ weight changes and 

histopathology. Impairment of pup body weight development was also seen at these 

doses. The NOAEL for systemic and developmental toxicity was 10 mg/kg bw/day. 

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

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

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

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

mg/kg bw/d.

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

toxicity consisted of clinical signs, abortion, reduced food 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

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 6 mg/kg bw/day in the rat 90-day study.

No systemic toxicity was observed in a 28-day repeat dose dermal toxicity study at 

doses as high as 1000 mg/kg bw/day. 

The neurotoxic 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.]

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.
5

In the rat chronic/oncogenicity study, the NOAEL in males and females was 50 ppm 

(2.1 and 2.7 mg/kg bw/day, respectively). NOAEL’s in the mouse oncogenicity study 

were 150 ppm in males (21 mg/kg bw/day) and in females (33 mg/kg bw/day). In a 

chronic dog study, the NOAEL was 300 ppm (approximately 8 mg/kg bw/day).]

6. Animal metabolism. [The rat, goat and hen metabolism studies were 

conducted to determine the nature of the BAS 700 F residues in animals. 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 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 
6

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 all 

three metabolites. Overall, M700F001, M700F002 and M700F048 are of low acute 

and subchronic toxicity in rats. The metabolites showed no genotoxic potential in a 

battery of genotoxicity studies. In addition, no adverse effects were observed up to 

the highest doses tested in developmental toxicity study with rabbits.]

8. Endocrine disruption. [No specific tests have been conducted with BAS 700 

F to determine whether the chemical may have an effect in humans that is similar to 

an effect produced by a naturally occurring estrogen or other endocrine effects. 

However, there were no significant findings in other relevant toxicity studies (e.g., 

sub-chronic and chronic toxicity, developmental toxicity and multi-generation 

reproductive studies) which would suggest that BAS 700 F produces any endocrine 

disruption.]

C. Aggregate Exposure

1. Dietary exposure. [The tolerance expression for BAS 700 F has not been 

finalized. Based on the results of field trials, animal transfer studies and exposure 

analysis, BASF is proposing that the tolerance expression for monitoring should be 

BAS 700 F only. 

Exposure assessments were conducted to evaluate the potential risk due to acute and 

chronic dietary exposure of the U.S. population and all sub-populations for two 

scenarios 1) BAS 700 F only and 2) BAS 700 F and metabolites M700F008,

M700F002 and M700F048 (expressed as parent equivalents). For assessments with 

combined residues of BAS 700 F and metabolites the analysis included tolerance 

values based on combined residues of BAS 700 F, M700F008, M700F002 and 

M700F048. For assessments with residues of BAS 700 F parent only, the analysis 

included proposed tolerance values for BAS 700 F only. The assessments included 

root and tuber vegetables (subgroups 1A, 1C, D), legume vegetables including 

soybean (group 06), fruiting vegetables (group 8), pome fruits (group 11), stone 

fruits (group 12), cereal grains (group 15), cotton, canola, sunflower, peanut,

anticipated residues in succeeding crops and animal matrices including egg, milk 

and cream.]
7

i. Food. [Acute Dietary Exposure Assessment

Acute dietary exposure estimates were based on tolerance values for combined 

residues of BAS 700 F, M700F008, M700F002 and M700F048 or proposed tolerance 

values (based on parent only), anticipated residues in succeeding crops based on the 

limited field rotational study, process factors from processing studies and 100% of 

all crops treated. The consumption data was from the USDA Continuing Survey of 

Food Intake by Individuals (CSFII 1994 - 1996, 1998) and the EPA Food 

Commodity Ingredient Database (FCID) using Exponent's Dietary Exposure 

Evaluation Module (DEEM-FCID) software. 

The resulting exposure estimates were compared against the BAS 700 F acute 

Population Adjusted Dose (aPAD) of 0.25 mg/kg b.w./day for females ages 13-49 and 

1.25 mg/kg b.w./day for all other populations. The endpoint for women of

childbearing age is based on the NOAEL of 25 mg/kg/day with an FQPA safety 

factor of 1, and the endpoint for remaining populations is based on the NOAEL of 

125 mg/kg/day with an FQPA safety factor of 1. The most highly exposed subpopulation was females 13 - 49 years old with 3.4% utilization of the aPAD. The 

results of the acute dietary assessment are presented in Tables 1 and 2 for the 

assessments using tolerances based on combined residues or parent only, 

respectively.

Table 1. Results for BAS 700 F Acute Dietary Exposure Analysis Considering 

All Tolerances (combined residues of BAS 700 F, M700F008 M700F002 and 

M700F048) using DEEM-FCID at the 95th Percentile 

Population Exposure Estimate %aPAD

Subgroups (mg/kg b.w./day)

U.S. Population 0.013314 1.1

All Infants (< 1 year old) 0.028796 2.3

Children (1-2 years old) 0.031371 2.5

Children (3-5 years old) 0.026442 2.1

Children (6-12 years old) 0.017246 1.4

Youth (13-19 years old) 0.009071 0.73

Adults (20-49 years old) 0.008572 0.69

Adults (50+ years old) 0.008688 0.70

Females (13 – 49 years old) 0.008382 3.4
8

Table 2. Results for BAS 700 F Acute Dietary Exposure Analysis Considering all 

Proposed Tolerances (parent only) using DEEM-FCID at the 95th Percentile

Population Exposure Estimate % aRfD

Subgroups (mg/kg b.w./day)

U.S. Population 0.011951 0.96

All Infants (< 1 year old) 0.024050 1.92

Children (1-2 years old) 0.027721 2.22

Children (3-5 years old) 0.023857 1.91

Children (6-12 years old) 0.015875 1.27

Youth (13-19 years old) 0.008342 0.67

Adults (20-49 years old) 0.007935 0.63

Adults (50+ years old) 0.007804 0.62

Females (13-49 years old) 0.007810 3.12

The results of the analysis show that a risk assessment using proposed tolerances 

based on parent only provides results comparable to that based on tolerances that 

take into account combined residues of BAS 700 F and metabolites M700F008, 

M700F002 and M700F048. 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 initial chronic dietary exposure estimates were based on tolerance values for 

combined residues of BAS 700 F, M700F008, M700F002 and M700F048, or 

proposed tolerance values (based on parent only), and anticipated residues in 

succeeding crops based on the limited field rotational study, process factors

determined in processing studies and 100% crop treated values for all commodities. 

The consumption data was from the USDA Continuing Survey of Food Intake by 

Individuals (CSFII 1994 - 1996, 1998) and the EPA Food Commodity Ingredient 

Database (FCID) using Exponent's Dietary Exposure Evaluation Module (DEEMFCID) software. 

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

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

population sub-group was children 1-2 years of age which utilized 66.5% cPAD. 

The results of the chronic dietary assessment are presented in Tables 3 and 4 for the 

assessments using tolerances based on combined residues or parent only, 

respectively. 
9

Table 3. Results for BAS 700 F Chronic Dietary Exposure Analysis Considering all 

Tolerances (combined residues of BAS 700 F, M700F008, M700F002 and 

M700F048) using DEEM-FCID 

Population Exposure Estimate %cPAD

Subgroups (mg/kg b.w./day)

U.S. Population 0.004629 22.0

All Infants (< 1 year old) 0.007719 36.8

Children (1-2 years old) 0.013962 66.5

Children (3-5 years old) 0.011420 54.4

Children (6-12 years old) 0.007017 33.4

Youth (13-19 years old) 0.003662 17.4

Adults (20-49 years old) 0.003432 16.3

Adults (50+ years old) 0.003564 17.0

Females (13-49 years old) 0.003317 15.8

Table 4. Results for BAS 700 F Chronic Dietary Exposure Analysis Considering all 

Proposed Tolerances (parent only) using DEEM-FCID

Population Exposure Estimate % cPAD

Subgroups (mg/kg b.w./day)

U.S. Population 0.004117 19.6

All Infants (< 1 year old) 0.006564 31.3

Children (1-2 years old) 0.012184 58.0

Children (3-5 years old) 0.010104 48.1

Children (6-12 years old) 0.006197 29.5

Youth (13-19 years old) 0.003243 15.4

Adults (20-49 years old) 0.003088 14.7

Adults (50+ years old) 0.003189 15.2

Females (13-49 years old) 0.002974 14.2

The results of the analysis show that a risk assessment using proposed tolerances 

based on parent only provides results comparable to that based on tolerances that 

take into account combined residues. The results of the analysis show that for all 

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. [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 

water concentrations occurred from the North Carolina apple crop scenario based 

on an aerial application at 0.1 lb/AC rate x 4 at a 7 day interval. Based on results 

from the PRZM/EXAMS and SCI-GROW models estimates, the highest acute 
10

Estimated Drinking Water Concentrations (EDWC) for BAS 700 F were estimated 

to be 15.0 ug/L (ppb) in surface water and 0.19 ug/L in ground water. The highest 

chronic EDWC’s for BAS 700F were estimated to be 5.1 ug/L in surface water and 

0.19 ug/L in ground water 

Drinking water exposure contributions were assessed based on the maximum 

estimated BAS 700 F water concentrations (acute 15 ug/L, chronic 5.07 ug/L), and 

water consumption and body weights reported in CSFII, using DEEM-FCID 

software. The acute and chronic estimated water exposure values are summarized 

in Tables 5 and 6, respectively. Drinking water exposure accounts for less than 

0.29% of the aPAD and 1.7% of the cPAD for all populations.

Table 5. Results for BAS 700 F Acute Water Exposure Analysis Considering the 

Maximum Estimated Acute Drinking Water Concentration using DEEM-FCID at 

the 95th Percentile

Population Water Exposure Estimate % aPAD

Subgroups (mg/kg b.w./day)

U.S. Population 0.000784 0.06

All Infants (< 1 year old) 0.002954 0.24

Children (1-2 years old) 0.001230 0.10

Children (3-5 years old) 0.001123 0.09

Children (6-12 years old) 0.000782 0.06

Youth (13-19 years old) 0.000636 0.05

Adults (20-49 years old) 0.000726 0.06

Adults (50+ years old) 0.000656 0.05

Females (13-49 years old) 0.000730 0.29

Table 6. Results for BAS 700 F Chronic Water Exposure Analysis Considering the 

Maximum Estimated Chronic Drinking Water Concentration using DEEM-FCID 

Population Water Exposure Estimate %cPAD

Subgroups (mg/kg b.w./day)

U.S. Population 0.000107 0.5

All Infants (< 1 year old) 0.000350 1.7

Children (1-2 years old) 0.000159 0.8

Children (3-5 years old) 0.000149 0.7

Children (6-12 years old) 0.000102 0.5

Youth (13-19 years old) 0.000077 0.4

Adults (20-49 years old) 0.000100 0.5

Adults (50+ years old) 0.000105 0.5

Females (13-49 years old) 0.000099 0.5
11

Acute Aggregate Exposure and Risk (food and water)

The aggregate acute risk includes exposure of BAS 700 F from food and water 

(Tables 7 and 8). The results of the analysis show that a risk assessment using

proposed tolerances based on BAS 700 F only provides results comparable to that 

based on tolerances that take into account combined residues of BAS 700 F, 

M700F008, M700F002 and M700F048. The results demonstrate that there are no 

safety concerns for any subpopulation based on the proposed uses and the results 

meet the FQPA standard of reasonable certainty of no harm. 

Table 7. Estimated Acute Aggregate Exposure and Risk of BAS 700 F (considering 

tolerances for combined residues of BAS 700 F, M700F0008, M700F002 and 

M700F048) using DEEM-FCID at the 95th Percentile 

Population Subgroup aPAD 

(mg/kg/day)

Food 

Exposure 

(mg/kg/day)

Water 

Exposure 

(mg/kg/day)

Total 

Exposure 

(mg/kg/day)

% 

aPAD

U.S. Population 1.25 0.013314 0.000784 0.013610 1.1

All Infants (< 1 yr old) 1.25 0.028796 0.002954 0.029960 2.4

Children 1-2 years 1.25 0.031371 0.001230 0.031943 2.6

Children 3-5 years 1.25 0.026442 0.001123 0.026878 2.2

Children 6 – 12 years 1.25 0.017246 0.000782 0.017455 1.4

Youth 13-19 years 1.25 0.009071 0.000636 0.009418 0.75

Adults 20-49 years 1.25 0.008572 0.000726 0.008917 0.71

Adults + 50 1.25 0.008688 0.000656 0.009021 0.72

Females 13-49 years 0.25 0.008382 0.000730 0.008744 3.5

Table 8. Estimated Acute Aggregate Exposure and Risk of BAS 700 F (considering 

proposed tolerances for parent only) using DEEM-FCID at the 95th Percentile

Population Subgroup aPAD 

(mg/kg/day)

Food 

Exposure 

(mg/kg/day)

Water 

Exposure 

(mg/kg/day)

Total 

Exposure 

(mg/kg/day)

% 

aPAD

U.S. Population 1.25 0.011951 0.000784 0.012317 0.99

All Infants (< 1 yr old) 1.25 0.024050 0.002954 0.024850 1.99

Children 1-2 years 1.25 0.027721 0.001230 0.028505 2.28

Children 3-5 years 1.25 0.023857 0.001123 0.024254 1.94

Children 6 – 12 years 1.25 0.015875 0.000782 0.016071 1.29

Youth 13-19 years 1.25 0.008342 0.000636 0.008567 0.69

Adults 20-49 years 1.25 0.007935 0.000726 0.008268 0.66

Adults + 50 1.25 0.007804 0.000656 0.008173 0.65

Females 13-49 years 0.25 0.007810 0.000730 0.008118 3.25

Short- and Intermediate-Term Aggregate Exposure and Risk (food, water, and 

residential)
12

Short- and intermediate-term aggregate risk assessments include exposure from 

food, water, and residential uses. There are no residential uses for BAS 700 F, 

therefore, a short- and intermediate-term aggregate risk assessment is not required. 

Chronic Aggregate Exposure and Risk (food and water)

The aggregate chronic risk includes exposure of BAS 700 F from food and water 

(Tables 9 and 10 ). The results of the analysis show that a risk assessment using

proposed tolerances based on parent only provides results comparable to that based 

on tolerances that take into account combined residues. The results demonstrate 

there are no safety concerns for any subpopulation based on the proposed uses and 

the results meet the FQPA standard of reasonable certainty of no harm. 

Table 9. Estimated Chronic Aggregate Exposure and Risk of BAS 700 F considering 

tolerances for combined residues of BAS 700 F, M700F0008 and M700F048

Population Subgroup cPAD 

(mg/kg/day)

Food 

Exposure 

(mg/kg/day)

Water Exposure 

(mg/kg/day)

Total 

Exposure 

(mg/kg/day)

% 

cPAD

U.S. Population 0.021 0.004629 0.000107 0.004736 22.6

All Infants (< 1 yr 

old)

0.021

0.007719 0.000350 0.008069 38.4

Children 1-2 years 0.021 0.013962 0.000159 0.014121 67.2

Children 3-5 years 0.021 0.011420 0.000149 0.011568 55.1

Children 6 – 12 years 0.021 0.007017 0.000102 0.007120 33.9

Youth 13-19 years 0.021 0.003662 0.000077 0.003729 17.8

Adults 20-49 years 0.021 0.003432 0.000100 0.003532 16.8

Adults + 50 0.021 0.003564 0.000105 0.003669 17.5

Females 13-49 years 0.021 0.003317 0.000099 0.003416 16.3

Table 10. Estimated Chronic Aggregate Exposure and Risk of BAS 700 F 

considering proposed tolerances for parent only

Population Subgroup cPAD 

(mg/kg/day)

Food 

Exposure 

(mg/kg/day)

Water Exposure 

(mg/kg/day)

Total 

Exposure 

(mg/kg/day)

% 

cPAD

U.S. Population 0.021 0.004117 0.000107 0.004214 20.1

All Infants (< 1 yr 

old)

0.021

0.006564 0.000350 0.006915 32.9

Children 1-2 years 0.021 0.012184 0.000159 0.012343 58.8

Children 3-5 years 0.021 0.010104 0.000149 0.010253 48.8

Children 6 – 12 years 0.021 0.006197 0.000102 0.006299 30.0

Youth 13-19 years 0.021 0.003243 0.000077 0.003320 15.8

Adults 20-49 years 0.021 0.003088 0.000100 0.003188 15.2

Adults + 50 0.021 0.003189 0.000105 0.003294 15.7

Females 13-49 years 0.021 0.002974 0.000099 0.003073 14.6

]
13

2. Non-dietary exposure. [There are no current or proposed residential uses 

for BAS 700 F. Therefore, a residential exposure and risk evaluation was not 

conducted.]

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

[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.]