Document ID: EPA-HQ-OPP-2013-0477-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-07-19T04:00Z

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 ([----------]) 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 amending the established 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: [Fruit, stone, group 12] at
[3.0] parts per million (ppm).  EPA has determined that the petition
contains data or information regarding the elements set forth in section
408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.

A. Residue Chemistry

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

	2. Analytical method. [Independently validated analytical methods have
been submitted for analyzing residues of parent fluxapyroxad (BAS 700 F)
plus metabolites M700F008, M700F048 and M700F002 with appropriate
sensitivity in/on stone fruits (group 12) crops, represented by cherry,
peach, and plum for which tolerances have been established.]    

	3. Magnitude of residues. [Field trials were carried out to determine
the magnitude of the residue in/on Cherry, Peach, and Plums. The data
were used to establish a tolerance of 2 ppm for fluxapyroxad (BAS 700 F)
residues in/on the stonefruit crop group 12 commodities.  For the
European Union (EU) import MRL application for cherries, two (2)
additional residue trials were conducted to complete the requirements. 
However, over-tolerance fluxapyroxad residues were confirmed in some
cherry samples which require amendment of the established tolerance for
the stonefruit crop group 12. 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
fluxapyroxad.  Detected residues of fluxapyroxad in all crops support
the proposed tolerance based on parent fluxapyroxad. The impact of the
amended tolerance on the animal Maximum Reasonably Balanced Diets was
insignificant, and thus no changes in tolerances in animal commodities
are proposed.]

B. Toxicological Profile

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

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

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

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

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

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

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

The neurotoxic potential of fluxapyroxad (BAS 700 F) was studied
following both acute and subchronic oral administration in the rat. In
the acute study, 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 fluxapyroxad.
Under the conditions of the present study the no observed adverse effect
level (NOAEL) for neurotoxicity was 5000 ppm (approximately 320 mg/kg
bw/d), the highest dose tested.]

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

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

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

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

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

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

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

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

C. Aggregate Exposure 

	1. Dietary exposure. [The tolerance expression for dietary risk
assessment is fluxapyroxad (BAS 700 F) and M700F008 in plant and animal
commodities except milk, for which M700F010 is also included.  Exposure
assessments were conducted to evaluate the potential risk due to acute
and chronic dietary exposure of the U.S. population and all
sub-populations. The assessments included all current established
tolerances, pending tolerances, the crop commodities proposed for
tolerances, 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 for which tolerances are pending, and crops
included in this submission. 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 pending
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 fluxapyroxad (BAS 700 F) uses were examined at
maximum use rates, maximum number of applications, and all proposed
application methods to determine which use would result in the highest
water concentrations. The highest acute 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 pending 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 fluxapyroxad
(BAS 700 F) acute Population Adjusted Dose (aPAD) of 1.25 mg/kg b.w./day
for all populations. The endpoint is based on the NOAEL of 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 fluxapyroxad (BAS 700 F) Acute Dietary Exposure
(Food and Water) Considering all Current and Proposed Tolerances using
DEEM-FCID at the 95th Percentile

Population	Exposure Estimate	% aPAD

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

	U.S. Population	0.047194	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 fluxapyroxad (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 fluxapyroxad (BAS 700 F) uses were examined at
maximum use rates, maximum number of applications, and all proposed
application methods to determine which use would result in the highest
water concentrations. The highest chronic 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 fluxapyroxad (BAS 700 F) Chronic Dietary Exposure
(Food and Water) Considering All  Commodities using DEEM-FCID

Population	Exposure Estimate	% cPAD

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

	U.S. Population	0.005725	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 fluxapyroxad (BAS 700 F)
residues in drinking water was included in the dietary assessments
above. For drinking water all fluxapyroxad uses were examined at maximum
use rates, maximum number of applications, and all proposed application
methods to determine which use would result in the highest water
concentrations. The highest acute and chronic water concentration
occurred from the rice use scenario.  The highest acute Estimated
Drinking Water Concentrations (EDWC) for fluxapyroxad 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 fluxapyroxad (BAS 700 F) 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.  Fluxapyroxad (BAS 700 F) i\hss
been proposed for registration for use on residential 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. 

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 fluxapyroxad (BAS
700 F)

Sub-Populations	Short-term Aggregate 

 	Food + water exp. (mg/kg bw/day)	Residential exp (mg/kg bw/day)	Total
exp (mg/kg bw/day)	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 (BAS 700 F) products for
disease control in turf. Because no dermal hazard of concern was
identified for fluxapyroxad, only inhalation exposure was assessed for
residential handlers, and incidental ingestion was assessed for
activities of children on treated turf. In all exposure scenarios, the
MOEs for residential use of fluxapyroxad were well above EPA’s level
of concern (MOE < 100) indicating that these exposures are not of
concern.

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 fluxapyroxad (BAS 700 F). For the purposes of this
tolerance action, therefore, BASF has not assumed that fluxapyroxad has
a common mechanism of toxicity with other substances.]

E. Safety Determination

	1. U.S. population. [Based on this risk assessment, BASF concludes that
there is a reasonable certainty that no harm will result to the general
population from the aggregate exposure to fluxapyroxad (BAS 700 F) from
the proposed increase in tolerance for the stonefruit crops, group 12.]

	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 fluxapyroxad (BAS 700 F) from
the proposed increase in tolerance for stonefruit crops, group 12.]

F. International Tolerances

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

Health Canada Pest Management Regulatory Agency (PMRA) has published
Maximum Residue Limits (MRL) for fluxapyroxad residues on multiple crop
commodities. A complete list can be found on the Maximum Residue Limits
for Pesticides webpage in the Pesticides and Pest Management section of
Health Canada’s website.

The Australian Pesticides and Veterinary Medicines Authority (APVMA)
established an MRL of 0.1 ppm on barley and all other crops grown in
Australia. The Food Standards Australia New Zealand also proposed an MRL
of 2 mg/kg (ppm) on stone fruits [except plums (including prunes)] for
the purpose of harmonizing MRLs with the U.S.

There are no CODEX maximum residue levels established for residues of
fluxapyroxad (BAS 700 F) in/on stone fruits (group 12). Several crops,
including stonefruits, were nominated for inclusion on the 2011
tentative CODEX evaluation schedule and the Data Directory for
fluxapyroxad was submitted for the 2012 Joint Meeting on Pesticide
Residues (JMPR). 

 PAGE   

 PAGE   2 

B*

B*

B*

 

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

 

?

D

E

Ì

Í

Ï

Ð

Ý

æ

é

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

	

-

"

U

W

í

î

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

h	

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

h	

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

摧䣾f	㜀$␸䠀$摧ᱻ[Ѐ1摧尼ùЀ1摧宖aЀ1摧畨ÇЀ1摧㹲

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

>*B*

B*

B*

B*

B*

h1

B*

B*

B*

B*

B*

h	

B*

B*

B*

B*

B*

B*

B*

B*

h1

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

h1

B*

B*

B*

B*

h1

h1

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

h	

B*

B*

B*

éÿ+

y €&B

éÿ+

y €&B

>*B*

>*B*

B*

B*

B*

B*

B*

B*

B*

B*

h	

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

h	

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

h1

B*

 h1

B*

B*

B*

B*

B*

B*

B*

B*

hç

B*

hç

B*

hç

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*