Document ID: EPA-HQ-OPP-2010-0421-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-06-23T04:00Z

<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'-triflu
oro[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
[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
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. 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.

 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 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 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.]>

	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 sub-population 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

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 (DEEM-FCID)
software.  

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

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 

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

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)

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

]>

<	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>

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