EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

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

 

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.

TEMPLATE:              

[BASF Corporation]

[Insert petition number]

	EPA has received a pesticide petition ([----------]) from [BASF
Corporation], [26 Davis Drive, P.O. Box 13528, Research Triangle Park,
North Carolina 27709-3528] proposing, pursuant to section 408(d) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to
amend 40 CFR part 180 by establishing a tolerance for residues of the
fungicide [Fluxapyroxad, (BAS 700 F);
1H-Pyrazole-4-carboxamide,3-(difluoromethyl)-1-methyl-N-(3',4',5'-triflu
oro[1,1'-biphenyl]-2-yl)-, its metabolites, and degradates] in or on the
following raw agricultural commodities[almond] at [0.05] parts per
million (ppm); [almond, hulls] at [4.0] ppm; [berry, low growing,
subgroup 13-07G] at [4.0] ppm; [bushberry, subgroup 13-07B] at [6.0]
ppm; [caneberry, subgroup 13-07A] at [6.0] ppm; [fruit, small, vine
climbing, except fuzzy kiwifruit, subgroup 13-07F] at [2.0] ppm;
[grapes] at [2.0] ppm; [grapes, raisin] at [5.7] ppm; [pecans] at [0.05]
ppm; [rice, bran] at [8.5] ppm; [rice, grain] at [5.0] ppm; [rice,
hulls] at [15.0] ppm; [rice, straw] at [20.0] ppm; [strawberry] at [4.0]
ppm; [sugarcane, cane] at [3.0] ppm; [vegetable, brassica leafy, group
5] at [3.0] ppm; [vegetable, bulb, group 3-07] at [0.8] ppm; [vegetable,
cucurbit, group 9] at [0.4] ppm; [vegetable, leafy, except brassica,
group 4] at [15.0] ppm; [vegetable, root, except sugarbeet, subgroup 1B]
at [0.7] ppm.  EPA has determined that the petition contains data or
information regarding the elements set forth in section 408 (d)(2) of 
FDDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data supports granting of the
petition. Additional data may be needed before EPA rules on the
petition.

A. Residue Chemistry

	1. Plant metabolism.[Nature of the residue studies were conducted in
wheat, soybean and tomato as representative crops in order to
characterize the fate of BAS 700 F (fluxapyroxad) in all crop matrices.
Two radiocarbon labels were studied in each crop, with 14-C labels
positioned in aniline and pyrazole ring structures. BAS 700 F was the
predominant residue in most crops.  In all crops the BAS 700 F Residues
of Concern (ROC) were characterized as parent BAS 700 F plus metabolites
M700F048 and M700F002. A confined rotational crop study added metabolite
M700F008 and confirmed that parent BAS 700 F plus metabolites M700F008,
M700F048 and M700F002 were the residues of concern in the representative
rotational crops of wheat, radish, and spinach.]

	2. Analytical method. [Independently validated analytical methods have
been submitted for analyzing residues of parent BAS 700 F (fluxapyroxad)
plus metabolites M700F008, M700F048 and M700F002 with appropriate
sensitivity in all the crop and processed commodities for root and tuber
vegetables (subgroups 1A, 1C, D), sugar beet tops,  legume vegetables
including soybean (group 6), foliage of legume vegetables (group 7),
fruiting vegetables (group 8), pome fruits (group 11), stone fruits
(group 12), cereal grains (group 15), forage, fodder and straw of cereal
grains (group 16), cotton, canola (rapeseed), sunflower and peanut and
in animal meat, fat, liver and kidney matrices, poultry meat, fat, liver
and skin, milk, cream and eggs for which tolerances have been
established.]    

	3. Magnitude of residues. [Field trials were carried out to determine
the magnitude of the residue in/on Blueberry, Raspberry, Broccoli,
Cabbage, Mustard greens, Green onion, Bulb onion, Cucumbers, Cantaloupe,
Summer squash, Grapes, Head lettuce, Leaf lettuce, Celery, Spinach, Rice
grain and straw, Carrot, roots, Radish, roots and tops, Sugarcane,
Almond, nuts and hulls and Pecans, and a field accumulation study was
performed in Crayfish. The number and locations of field trials are in
accordance with OPPTS Guideline 860.1500. Field trials were carried out
using the maximum label rates, the maximum number of applications, and
the minimum pre-harvest interval (PHI) for all the crops. Residues of
M700F048 and M700F002 were generally less than the limit of quantitation
and often less than the limit of detection. Residues of M700F008 were
significantly less than residues of BAS 700 F.  Detected residues of BAS
700 F in all crops support the proposed tolerances based on parent BAS
700 F.

Residues of BAS 700 F and M700F008 were monitored in the field
accumulation study in crayfish, and residues of each were <10 ppb at all
time points in crayfish tissue. The impact of the new commodities on the
animal Maximum Reasonably Balanced Diets was minimal, and thus no
changes in tolerances in animal commodities are proposed.]

B. Toxicological Profile

	1. Acute toxicity.  [BAS 700 F displayed low acute toxicity via the
oral, dermal and inhalation routes of exposure.  It was not irritating
to the eyes, only slightly irritating to the skin, and not a dermal
sensitizer. The acute toxicity studies place technical BAS 700 F in
toxicity category III for acute oral and dermal and category IV for
acute inhalation, eye and skin irritation.  BAS 700 F is not a dermal
sensitizer.]

	2. Genotoxicty. [BAS 700 F was not genotoxic in a battery of assays.
BAS 700 F was negative for inducing mutations in bacterial and mammalian
cell assays. No evidence of a clastogenic effect was observed in vitro
or in vivo, and BAS 700 F did not cause unscheduled DNA synthesis in
hepatocytes of treated rats.]

	3. Reproductive and developmental toxicity. [The reproductive and
developmental toxicity of BAS 700 F was investigated in a 2-generation
rat reproduction study as well as in rat and rabbit developmental
toxicity studies. In the reproduction study, there were no effects on
fertility, up to the highest dose tested of 300 mg/kg bw/d. At the high-
and mid- (50 mg/kg bw/d) doses tested, BAS 700 F administration resulted
in decreased food consumption, impaired body weight development,
clinical chemistry and select organ weight changes and histopathology.
Impairment of pup body weight development was also seen at these doses.
The NOAEL for systemic and developmental toxicity was 10 mg/kg bw/day.  

In the rat developmental toxicity study, slight maternal toxicity was
observed at the high dose level of 1000 mg/kg bw/d, in the form of
limited clinical chemistry, liver and thyroid weight effects, and
thyroid histopathology. No evidence of developmental toxicity was
observed in the rat up to the highest dose tested of 1000 mg/kg bw/d.

At the highest dose tested in the rabbit teratology study (60 mg/kg
bw/d), maternal toxicity consisted of clinical signs, abortion, reduced
food consumption, and impaired body weight development. The only
developmental effect at the high dose, which caused substantial maternal
toxicity, consisted of a commonly observed, reversible external
variation, paw hyperflexion. Based on the effects described, the
maternal and developmental NOAEL in rabbits was 25 mg/kg bw/d.]

	4. Subchronic toxicity. [The principal target organ in all studies in
rats, mice and dogs was the liver, as indicated by organ weight changes
and altered clinical chemistry parameters, which were consistent with
liver enzyme induction. Histopathological changes in the liver were only
evident in rats. The thyroid was also identified as a target organ in
rats, as indicated by organ weight changes, histopathology and thyroid
hormone changes. The lowest NOAEL in subchronic oral toxicity studies
was approximately 7.3 mg/kg bw/day in the rat 90-day study.

No systemic toxicity was observed in a 28-day repeat dose dermal
toxicity study at doses as high as 1000 mg/kg bw/day. 

The neurotoxic potential of BAS 700 F was studied following both acute
and subchronic oral administration in the rat. In the acute study,
treatment-related neurobehavioral effects were noted in mid and high
dose animals on the day of treatment. These consisted of slight
increases of the landing foot-splay in high dose males, reduction in the
number of rearings in males, and impaired motor activity in high and mid
dose males and females. No effects on these parameters were observed on
study days 7 and 14. Additionally, no treatment-related
neuropathological findings (brain weight changes, neurohistopathological
findings) were observed. Therefore, the affected parameters indicated a
neuropharmacological effect rather than neuronal damage. Based on the
results of this study the NOAEL for acute neurotoxicity was 125 mg/kg
bw/d in male and female rats.

There was no indication of clinical (general clinical observation, FOB
and motor activity) or neurohistopathological neurotoxicity in a
subchronic neurotoxicity study. Systemic signs of toxicity were
consistent with those seen in repeated dose studies with BAS 700 F.
Under the conditions of the present study the no observed adverse effect
level (NOAEL) for neurotoxicity was 5000 ppm (approximately 320 mg/kg
bw/d), the highest dose tested.]

	5. Chronic toxicity. [Systemic toxicity in long term oral exposure
studies in dogs, mice and rats included effects on food consumption,
body weight development and clinical chemistry changes. The liver was
identified as the main target organ in all species tested, as indicated
by liver weight changes and non-neoplastic lesions. Additional target
organs in the rat included the thyroid and bones. The spleen, gall
bladder and prostate were affected in dogs.

BAS 700 F was not carcinogenic in C57BL mice following continuous
dietary administration for 18 months at dietary concentrations up to
6000 ppm (approximately 1000 mg/kg bw/d). Treatment of BAS 700 F for 2
years in rats resulted in the induction of hepatocellular tumors in
males at dose levels ≥ 250 ppm and in females at ≥ 1500 ppm. A
mitogenic, Phenobarbital-like mechanism is proposed as the probable mode
of action for liver tumor development in rats. This was supported by
mechanistic studies on enzyme induction and S-Phase response in the
liver, and indicates there is a threshold for tumor development and a
margin of exposure cancer risk assessment is appropriate.

In the rat chronic/oncogenicity study, the NOAEL in males and females
was 50 ppm (2.1 and 2.7 mg/kg bw/day, respectively). NOAEL’s in the
mouse oncogenicity study were 150 ppm in males (21 mg/kg bw/day) and in
females (33 mg/kg bw/day).  In a chronic dog study, the NOAEL was 300
ppm (approximately 8 mg/kg bw/day).]

	6. Animal metabolism. [The rat, goat and hen metabolism studies were
conducted to determine the nature of the BAS 700 F residues in animals.
Studies were conducted with radiolabeled BAS 700 F with 14-C labels
positioned in aniline and pyrazole ring structures (hen metabolism,
aniline ring label only). BAS 700 F was either excreted rapidly in urine
and feces or transformed to a number of metabolites after administration
to animals. All relevant metabolites were identified. Unchanged parent
compound was found as the predominant component in most animal matrices.
The metabolism of BAS 700 F in the animals is well understood.
Degradation proceeds via N-demethylation of the pyrazole ring and/or
hyroxylation of the biphenyl ring followed by subsequent O- and
N-conjugation reactions to produce metabolites that are rapidly
excreted, along with parent, and do not readily accumulate in tissues or
milk. Residues in milk and most edible tissues are low. The same
metabolic reactions were observed in each of the animals studied, so
there is a consistent metabolic pathway for BAS 700 F in animals.  Rat,
goat and hen metabolism studies were also conducted with radiolabeled
M700F048, a N-glucoside of N-desmethyl BAS 700F, a plant metabolite,
seen at levels >10 TRR in soybean seed in the plant metabolism study. 
In all animals, the glucoside was readily hydrolyzed to generate
M700F008, a key intermediate in the metabolism of BAS 700 F in animals.
The radiolabeled residue was rapidly excreted with little uptake in
tissue, following a metabolic pathway in all animals like that for BAS
700 F.  Rat. goat and hen metabolism studies were also conducted with
radiolabeled M700F002, a carboxylic acid attached to the pyrazole-ring
formed by cleavage of the BAS 700 F carboxamide bond.  M700F002 was seen
at levels >10 TRR in soybean seed in the plant metabolism and was
present only at low levels in the rat urine.  In all animal studies,
M700F002 was not metabolized and was almost completely and rapidly
excreted unchanged, with no uptake in tissue.]

	7. Metabolite toxicology. [The metabolism of BAS 700 F is similar in
plants and mammals.  The metabolism of BAS 700 F, both in plants and
animals, is largely based on two key transformation reactions,
N-demethylation of the pyrazole moiety and hydroxylation of the biphenyl
moiety.  Both reactions, combinations thereof, and subsequent
conjugation reactions (e.g. glucose, glucuronic acid, cysteine) result
in a range of common and structurally related compounds.  Due to the
similar structural nature of most metabolites, the toxicity of most
plant metabolites is adequately estimated from the results of studies
performed with BAS 700 F in animals. In addition, the metabolism of
metabolites M700F002, and M700F048 were each investigated in rat, goat
and hen. Animal metabolism studies were performed with M700F002  since
the plant metabolite was seen in the rat metabolism only at low levels
in urine. In rat, goat and hen, M700F002 is rapidly and almost
completely excreted unchanged with almost no uptake in tissue, milk or
eggs.  M700F002 is not metabolized in animal to any significant extent. 


Animal metabolism studies were performed with M700F048, a glucoside
conjugate since the plant metabolite would not be formed in animal
metabolism. In animal metabolism studies, M700F048 was rapidly
hydrolyzed to metabolite M700F008, a key metabolite in the metabolic
pathway of BAS 700 F.  Unchanged M700F048 was not detected in edible
animal commodities.

Toxicology studies (Acute oral toxicity, Ames test, in vitro
mutagenicity test in mammalian cells, in vitro chromosome aberration
test, in vivo mouse micronucleus, 28/90-day rat feeding and
developmental toxicity in rabbits) were conducted on three metabolites.
Overall, M700F001, M700F002 and M700F048 are of low acute and subchronic
toxicity in rats. The metabolites showed no genotoxic potential in a
battery of genotoxicity studies. In addition, no adverse effects were
observed up to the highest doses tested in developmental toxicity study
with rabbits.]

	8. Endocrine disruption. [No specific tests have been conducted with
BAS 700 F to determine whether the chemical may have an effect in humans
that is similar to an effect produced by a naturally occurring estrogen
or other endocrine effects.  However, there were no significant findings
in other relevant toxicity studies (e.g., sub-chronic and chronic
toxicity, developmental toxicity and multi-generation reproductive
studies) which would suggest that BAS 700 F produces any endocrine
disruption.]

C. Aggregate Exposure 

	1. Dietary exposure. [The tolerance expression for dietary risk
assessment is BAS 700 F and M700F008 in plant and animal commodities
except milk, for which M700F010 is also included.  Exposure assessments
were conducted to evaluate the potential risk due to acute and chronic
dietary exposure of the U.S. population and all sub-populations. The
assessments included all current established tolerances and the
commodities proposed for tolerances and root and tuber vegetables
(subgroups 1A, 1C, D), legume vegetables including soybean (group 06),
fruiting vegetables (group 8), pome fruits (group 11), stone fruits
(group 12), cereal grains (group 15), cotton, canola, sunflower (group
20), peanut and animal matrices including egg, milk and cream.]

	i. Food. [Acute Dietary Exposure Assessment

Acute dietary exposure estimates were based on a) tolerance values on
crops approved as of May 14, 2012 with the factor of 1.5 that was used
in the acute dietary assessment conducted as part of the evaluation by
EPA (a few input values were changed as discussed below)  b) proposed
tolerance values for crops included in this submission and processing
factors for sugarcane refined sugar (0.04) and molasses (0.16) and c)
current tolerances for animal commodities.  A 1.5 factor was not used to
adjust the tolerances for the new commodities used in the assessment
since the levels of metabolite M700F008 were always much less than 50%
of the tolerance.  The analysis assumed 100% of all crops treated. 
Values changed from the EPA dietary analysis of February 2012 are
soybean seed commodities changed from 0.75 mg/kg to 0.15 mg/kg, sweet
corn changed from 0.015 to 0.15 mg/kg and rice commodities to reflect
new rice use. The impact of the new commodities on the animal Maximum
Reasonably Balanced Diets was minimal and thus no changes in tolerances
in animal commodities are proposed.  

For drinking water all BAS 700 F uses were examined at maximum use
rates, maximum number of applications, and all proposed application
methods to determine which use would result in the highest water
concentrations. The highest acute water concentration occurred from the
rice use scenario.  The highest acute Estimated Drinking Water
Concentrations (EDWC) for BAS 700 F were estimated to be 26.1 µg/L
(ppb) in surface water.   The consumption of water was included in the
analysis, and the residue concentration in water was set at 0.0261 mg/L
based on the surface water concentration determined for the use in rice.

The consumption data was from the NHANES 2-day food consumption data for
2003 to 2008 and the assessment was performed using the Dietary Exposure
Evaluation Module (DEEM-FCID) software. 

The resulting exposure estimates were compared against the BAS 700 F
acute Population Adjusted Dose (aPAD) of 1.25 mg/kg b.w./day for all
populations. The endpoint is based on the NOAEL of 125 mg/kg/day with an
FQPA safety factor of 1.  The most highly exposed sub-population was
children 1-2 years old with 8.9 % utilization of the aPAD. The results
of the acute dietary assessment are presented in Table 1.

Table 1. Results for BAS 700 F Acute Dietary Exposure (Food and Water)
Considering all Current and Proposed Tolerances using DEEM-FCID at the
95th Percentile

Population	Exposure Estimate	% aPAD

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

	U.S. Population	0.047194	3.8

All Infants (< 1 year old)	0.090603	7.2

Children (1-2 years old)	0.111309	8.9

Children (3-5 years old)	0.090178	7.2

Children (6-12 years old)	0.047793	3.8

Youth (13-19 years old)	0.031709	2.5

Adults (20-49 years old)	0.039777	3.2

Adults (50+ years old)	0.03779	3.0

Females (13-49 years old)	0.039958	3.2



The results of the analysis show that for all populations, the estimated
exposures are well below the Agency's level of concern (< 100% aPAD).
Additional refinements in the dietary risk assessment (i.e. utilizing
anticipated residue values, percent crop treated values) would further
reduce the estimated exposure values.

Chronic Dietary Exposure Assessment 

The chronic dietary exposure estimates were based on combined residues
of the highest average field trial (HAFT) values for parent and HAFT
values for residues of M700F008 for all registered raw agricultural
commodities and all newly proposed raw agricultural commodities except
for the use of the mean residue values of BAS 700 F and HAFT values for
residues of M700F008 for the commodities of barley, buckwheat, millet,
oat, and rice.  Processing factors for apple juice (0.2), apple sauce
(0.25), potato dry granules (1.17),  sugarcane refined sugar (0.04) and
molasses (0.16) as determined in processing studies were used.  Some
other changes were made to values used in the EPA evaluation of February
2012 in that apricot and nectarine residues were set equal to peach
residues, rye and triticale residues were set equal to wheat residues
and sweet corn was set to 0.15 mg/kg rather than 0.01 mg/kg.

For drinking water all BAS 700 F uses were examined at maximum use
rates, maximum number of applications, and all proposed application
methods to determine which use would result in the highest water
concentrations. The highest chronic water concentration occurred from
the use in paddy rice scenario.  The highest chronic EDWC’s for BAS
700F were estimated to be 23.623 µg/L in surface water. The consumption
of water was included in the analysis, and the residue concentration in
water was set at 0.0236 mg/L based on the surface water concentration
determined for the use in paddy rice.

The consumption data was from the NHANES 2-day food consumption data for
2003 to 2008 and the assessment was performed using the Dietary Exposure
Evaluation Module (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 70.3% cPAD.  The results of the chronic dietary
assessment are presented in Table 2.

Table 2.  Results for BAS 700 F Chronic Dietary Exposure (Food and
Water) Considering All  Commodities using DEEM-FCID

Population	Exposure Estimate	% cPAD

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

	U.S. Population	0.005725	27.3

All Infants (< 1 year old)	0.009033	43.0

Children (1-2 years old)	0.014769	70.3

Children (3-5 years old)	0.011421	54.4

Children (6-12 years old)	0.006514	31.0

Youth (13-19 years old)	0.003794	18.1

Adults (20-49 years old)	0.004983	23.7

Adults (50+ years old)	0.005376	25.6

Females (13-49 years old)	0.005047	24.0



The results of the risk assessment show that for all populations the
exposures are below a level of concern (< 100% cPAD). Additional
refinements in the dietary risk assessment (i.e. utilizing anticipated
residue values, percent crop treated values) would further reduce the
estimated exposure values.]

	ii. Drinking water. [The consumption of BAS 700 F residues in drinking
water was included in the dietary assessments above. For drinking water
all BAS 700 F uses were examined at maximum use rates, maximum number of
applications, and all proposed application methods to determine which
use would result in the highest water concentrations. The highest acute
and chronic water concentration occurred from the rice use scenario. 
The highest acute Estimated Drinking Water Concentrations (EDWC) for BAS
700 F were estimated to be 26.1 µg/L (ppb) in surface water.  The
consumption of water was included in the analysis, and the residue
concentration in water was set at 0.0261 mg/L based on the surface water
concentration determined for the use in rice.

The highest chronic water concentration occurred from the use in paddy
rice. The     highest chronic EDWC’s for BAS 700F were estimated to be
23.623 µg/L in surface water. The consumption of water was included in
the analysis, and the residue concentration in water was set at 0.0236
mg/L based on the surface water concentration determined for the use in
paddy rice.

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

Short- and intermediate-term aggregate risk assessments include exposure
from food, water, and residential uses.  BAS 700 F is registered for use
on residential turf.  Because no dermal hazard of concern was identified
for BAS 700 F (fluxapyroxad), only inhalation exposure was assessed for
residential handlers, and incidental ingestion was assessed for
activities of children on treated turf. 

The short-term oral NOAEL is 9.0 mg/kg bw/day and the intermediate-term
NOAEL is 7.3 mg/kg bw/day.  The short-term aggregate risk assessment is
presented in Table 3 and the intermediate-term aggregate risk assessment
is presented in Table 4.  

Table 3:  Short-Term Aggregate Exposure and Risk for BAS 700 F

Sub-Populations	Short-term Aggregate 

 	Food + water exp. (mg/kg bw/day)	Residential exp (mg/kg bw/day)	Total
exp (mg/kg bw/day)	MOE

US Population	0.005725	0.000000	0.005725	1572

Children 1-2 years old	0.014769	0.021385	0.036154	249



Table 4:  Intermediate-Term Aggregate Exposure and Risk for BAS 700 F

Sub-Populations	Intermediate-Term Aggregate

 	Food + water Exp. (mg/kg bw/day)	Residential Exp. (mg/kg bw/day)
Total Exp. (mg/kg bw/day)	MOE

US Population	0.005725	0.000000	0.005725	1275

Children 1-2 years old	0.014769	0.021385	0.036154	202



The aggregate MOEs for dietary (food + water) and residential exposures
are 202 and 249 for children 1-2 years old and 1275 and 1572 for the
general US population.  These MOE values indicate that aggregate risk
from the use of BAS 700 F is not a concern.    ]   

	2. Non-dietary exposure. 

[A residential exposure and risk assessment was conducted for the
proposed residential use of fluxapyroxad products for disease control in
turf. Because no dermal hazard of concern was identified for
fluxapyroxad, only inhalation exposure was assessed for residential
handlers, and incidental ingestion was assessed for activities of
children on treated turf. In all exposure scenarios, the MOEs for
residential use of fluxapyroxad were well above EPA’s level of concern
(MOE < 100) indicating that these exposures are not of concern.

The combined post-application exposure for children 1 to <2 years old
was estimated using highly conservative assumptions including: a) basing
the transferable residue on the seasonal maximum application rate; b)
combining all sources of incidental exposure; c) using EPA default
values for children’s activities. With these highly conservative
assumptions the incidental exposure was calculated to be 0.021385
mg/kg/day, resulting in short- and intermediate-term MOEs of 420 and
341, respectively.]

D. Cumulative Effects ["Section 408(b)(2)(D)(v) requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider “available information'' concerning the cumulative
effects of a particular pesticide's residues and “other substances
that have a common mechanism of toxicity." Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, EPA has not made a common mechanism of toxicity
finding as to BAS 700 F. For the purposes of this tolerance action,
therefore, BASF has not assumed that BAS 700 F has a common mechanism of
toxicity with other substances.]

E. Safety Determination

	1. U.S. population. [Based on this risk assessment, BASF concludes that
there is a reasonable certainty that no harm will result to the general
population from the aggregate exposure to BAS 700 F from the proposed
uses.]

	2. Infants and children. [Based on this risk assessment, BASF concludes
that there is a reasonable certainty that no harm will result to infants
or children from the aggregate exposure to BAS 700 F from the proposed
uses.]

F. International Tolerances

	[European Maximum Residue Limits (MRL) were established for
fluxapyroxad on multiple crops in October 2011 [Commission Regulation
(EU) No 978/2011 of 3 October 2011; MRLs for fluxapyroxad (BAS 700 F)
in various commodities of plant and animal origin. EFSA Journal 2011;
9(6):2196 [68 pp.].]

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rectory for fluxapyroxad has been submitted for the 2012 Joint Meeting
on Pesticide Residues (JMPR).

 PAGE   

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