Document ID: EPA-HQ-OPP-2005-0540-0012
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-08-23T04:00Z

Azoxystrobin
Summary
of
Analytical
Chemistry
and
Residue
Data
DP
Num:
328984
1
of
14
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
Date:
6/
19/
06
Subject:
Azoxystrobin.
Uses
on
Foliage
of
Legume
Vegetables,
Group
7;
Fruiting
Vegetables,
Group
8
(
Except
Tomato);
Pea
and
Bean,
Succulent
and
Dried
Shelled
(
Except
Soybeans),
Subroups
6B
and
6C;
and
Nongrass
Animal
Feeds,
Group
18.
Summary
of
Analytical
Chemistry
and
Residue
Data.
Petition
Number
4E6823.

DP
Num:
328984
Decision
Number:
355347
PC
Code:
128810
MRID
Numbers:
NA
40
CFR
180.507
Chemical
Class:
Strobilurin
Fungicide
From:
W.
Cutchin,
Chemist
ARIA/
TRB
Registration
Division
(
7509P)

Through:
L.
Cheng,
Chemist
RAB3
Health
Effects
Division
(
7509P)

And
Chemistry
Science
Advisory
Council
Health
Effects
Division
(
7509P)

To:
S.
Jackson/
D.
Rosenblatt
RM05
RIMUERB
Registration
Division
(
7509P)

Executive
Summary
The
Interregional
Research
Project
#
4
(
IR­
4)
is
requesting
the
following
tolerances
for
the
residues
of
azoxystrobin
(
methyl(
E)­
2­(
2­(
6­(
2­
cyanophenoxy)
pyrimidin­
4­
yloxy)
phenyl)­
3­
methoxyacrylate)
and
the
Z­
isomer
of
azoxystrobin,
[
methyl(
Z)­
2­(
2­(
6­
(
2­
cyanophenoxy)
pyrimidin­
4­
yloxy)
phenyl)­
3­
methoxyacrylate]
(
R230310):
Azoxystrobin
Summary
of
Analytical
Chemistry
and
Residue
Data
DP
Num:
328984
2
of
14
Commodity
Proposed
Tolerance
(
ppm)

vegetables,
foliage
of
legume,
Group
7
30.0
vegetables,
fruit,
Group
8
(
except
tomato)
2.0
pea
and
bean,
succulent
shelled,
Group
6B
0.5
pea
and
bean,
dried
shelled,
except
soybean,
Group
6C
0.5
animal
feed,
nongrass,
Group
18
forage
30.0
animal
feed,
nongrass,
Group
18
hay
55.0
Azoxystrobin
is
a
broad
spectrum
fungicide
for
control
of
many
plant
diseases.
It
has
the
same
biochemical
mode
of
action
as
the
naturally
occurring
strobilurins
and
is
structurally
related
to
them.
It
is
in
the
same
chemical
class
as
trifloxystrobin.

Permanent
tolerances
are
currently
established
(
40
CFR
§
180.507)
for
the
combined
residues
of
azoxystrobin
and
the
Z­
isomer
in/
on
various
raw
and
processed
plant
commodities
ranging
from
0.01
ppm
in/
on
pecans
to
260
ppm
in/
on
the
Herb
Subgroup
19A,
dried,
except
chive,
vegetable,
leafy,
except
brassica,
group
4
at
30.0
ppm,
and
including
soybean,
forage
at
25.0
ppm,
soybean,
hay
at
55.0
ppm,
soybean,
hulls
at
1.0
ppm,
and
soybean,
seed
at
0.5
ppm.
Tolerances
are
also
established
[
40
CFR
§
180.507(
a)(
2)]
for
residues
of
azoxystrobin
per
se
in
milk
at
0.006
ppm
and
the
fat,
meat,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep
at
levels
ranging
from
0.01
­
0.07
ppm.

Azoxystrobin
is
formulated
as
Abound
®
Flowable
Fungicide
(
EPA
Reg.
No.:
100­
1098),
a
flowable
suspension
concentrate
(
SC)
with
22.9%
active
ingredient
(
ai).
The
product
is
to
be
applied
to
vegetables,
fruiting,
Group
8
(
except
tomato);
pea
and
bean,
succulent
and
dried,
except
soybean,
Subgroups
6B
and
6C;
and
nongrass
animal
feeds,
Group
18.
The
product
will
be
applied
prior
to
disease
development,
by
ground,
air,
or
chemigation
four
times
with
7­
14
day
intervals
at
0.10­
0.25
lb
ai/
A
(
1.0
lb
ai/
A/
season)
and
a
0­
day
PHI.

Adequate
plant
metabolism
studies
on
azoxystrobin
have
been
previously
conducted
using
grapes,
peanuts,
and
wheat.
Adequate
livestock
metabolism
studies
for
azoxystrobin
have
also
been
submitted.
The
HED
Metabolism
Assessment
Review
Committee
(
MARC)
has
determined
that
the
residues
of
concern
in/
on
plants
for
the
tolerance
expression
and
risk
assessment
are
azoxystrobin
and
its
Z­
isomer.
The
MARC
determined
that
the
residue
of
concern
in/
on
livestock
for
the
tolerance
expression
and
risk
assessment
is
azoxystrobin
only.

Previously
submitted
storage
stability
data
indicate
that
residues
of
azoxystrobin
and
the
Z­
isomer
are
stable
in
oil
seed
rape,
soybean
meal,
corn
grits,
carrot
root,
leaf
lettuce,
wheat
forage,
orange
oil,
orange
juice,
and
orange
pulp
for
at
least
two
years
under
frozen
storage.
The
information
is
adequate
for
the
purpose
of
supporting
the
proposed
tolerances.
Azoxystrobin
Summary
of
Analytical
Chemistry
and
Residue
Data
DP
Num:
328984
3
of
14
Adequate
methodology
is
available
for
enforcement
of
the
established
tolerances
on
plants.
The
gas
chromatography
with
nitrogen
phosphorus
detector
(
GC/
NPD)
method,
RAM
243/
04,
has
undergone
a
method
validation
by
the
EPA
analytical
laboratory.
EPA
comments
have
been
incorporated
and
the
revised
method,
designated
RAM
243,
has
been
submitted
to
FDA
for
inclusion
in
the
Pesticide
Analytical
Manual
(
PAM),
Volume
II
as
an
enforcement
method.
Adequate
methodology
is
available
for
enforcement
of
the
established
tolerances
on
livestock.
The
GC
method
255/
01
has
been
validated
by
the
EPA
analytical
laboratory
for
the
analysis
of
milk
and
livestock
tissues.
The
EPA
laboratory's
written
report
with
an
EPA
addendum
to
accompany
the
method,
and
the
method,
will
be
submitted
to
FDA
for
inclusion
in
PAM,
Vol.
II.
Data
pertaining
to
the
multiresidue
methods
testing
of
azoxystrobin
in
conjunction
with
the
grape
tolerance
petition
have
previously
been
submitted.
The
data
indicate
that
azoxystrobin
could
not
be
recovered
through
application
of
the
multiresidue
protocols.

No
new
residue
field
trial
data
were
submitted
for
the
foliage
of
legume
vegetables,
Crop
Group
7,
pea
and
bean,
succulent
and
dried,
except
soybean,
Subgroups
6B
and
6C,
or
nongrass
animal
feeds,
Group
18.
The
representative
commodities
for
Group
7
are
foliar
portions
of
any
cultivar
of
bean,
field
pea,
and
soybean.
RAB2
previously
stated
that
as
long
as
the
use
pattern
is
similar
and
the
proposed
field
trial
residue
data
supporting
a
tolerance
for
Group
4
are
submitted
and
deemed
adequate,
it
will
be
appropriate
to
request
a
tolerance
for
Group
7
at
the
same
level
as
Group
4.
The
requirements
set
forth
by
RAB2
for
the
establishment
of
an
azoxystrobin
tolerance
on
the
foliage
of
legume
vegetables,
Group
7
have
been
satisfied.
TRB
recommends
for
the
establishment
of
a
tolerance
at
30.0
ppm
for
the
residues
of
azoxystrobin
on
vegetables,
foliage
of
legume,
Group
7.
Since
the
proposed
tolerance
on
Group
7
will
include
soybean
hay
and
forage,
the
existing
tolerances
on
those
commodities
should
be
removed
(
minutes,
ChemSAC,
5/
10/
06).

There
are
tolerances
established
for
members
of
Group
8:
peppers,
okra,
and
eggplant
at
2.0
ppm,
and
tomato
at
0.2
ppm
(
CFR
§
180.507).
Although
all
the
existing
residue
data
on
the
Group
8
representative
commodities
were
determined
to
be
sufficient
to
establish
a
crop
group
tolerance,
risk
cup
issues
at
the
time
precluded
increasing
the
tomato
tolerance
and
separate
tolerances
were
requested
on
okra
and
eggplant.
Since
the
existing
data
were
determined
to
be
adequate
for
a
crop
group
tolerance,
there
is
sufficient
data
to
support
the
petition
for
the
requested
subgroup.
However,
the
commodity
definition
presented
by
the
petitioner
is
incorrect.
A
new
Section
F
should
be
submitted
requesting
a
tolerance
for
the
residues
of
azoxystrobin
at
2.0
ppm
on
vegetables,
fruiting,
Group
8
(
except
tomato).
The
existing
separate
tolerances
on
pepper,
okra,
and
eggplant
should
be
removed.

The
existing
tolerance
commodity
definitions
are:
pea
and
bean,
dried
shelled,
except
soybean,
subgroup,
except
cowpea,
and
field
pea;
and
pea
and
bean,
succulent
shelled,
subgroup,
except
cowpea.
The
subgroup
tolerances
excluded
cowpea
and
field
pea
because
there
was
no
residue
field
data
for
forage,
hay,
and/
or
silage
as
livestock
feeds.
In
order
to
satisfy
the
data
requirements,
RAB3
previously
indicated
that
residue
data
on
the
representative
crops
of
Group
7
were
required.
However,
as
stated
above,
the
requirements
set
forth
by
RAB2
for
the
establishment
of
an
azoxystrobin
tolerance
on
vegetables,
foliage
of
legume,
Group
7
have
been
Azoxystrobin
Summary
of
Analytical
Chemistry
and
Residue
Data
DP
Num:
328984
4
of
14
satisfied.
Therefore,
no
further
residue
field
trial
data
is
required.
TRB
recommends
for
the
establishment
of
tolerances
at
0.5
ppm
for
the
residues
of
azoxystrobin
on
pea
and
bean,
succulent
shelled,
Subgroup
6B;
and
pea
and
bean,
dried
shelled,
except
soybean,
Subgroup
6C.

IR­
4
requested
that
the
Agency
use
data
supporting
the
tolerances
for
vegetable,
leafy,
except
Brassica,
Group
4
at
30.0
ppm,
Brassica,
leafy
greens,
Subgroup
5B
at
25
ppm,
and
soybean,
hay
at
55.0
ppm
to
support
the
establishment
of
tolerances
for
animal
feed,
nongrass,
Group
18,
forage
at
30.0
ppm
and
animal
feed,
nongrass,
Group
18,
hay
at
55.0
ppm.
ChemSAC
has
determined
that
the
existing
data
cited
by
the
petitioner
is
not
sufficient
to
support
the
requested
tolerance.
TRB
recommends
against
the
proposed
tolerances
on
animal
feed,
nongrass,
Group
18,
forage
and
hay.
However,
based
on
the
existing
use
on
soybeans,
which
has
the
same
use
pattern
as
that
proposed
for
animal
feed,
nongrass,
Group
18,
a
reduced
number
of
residue
field
trials
would
be
appropriate.
Six
residue
field
trials
each
with
the
appropriate
geographic
distribution
on
the
two
representative
crops
for
animal
feed,
nongrass,
Group
18
(
alfalfa
and
clover)
are
required
to
support
a
proposed
azoxystrobin
tolerance.

There
are
no
processed
commodities
associated
with
the
uses
of
azoxystrobin
on
foliage
of
legume
vegetables,
Group
7;
vegetables,
fruiting,
Group
8
(
except
tomato);
and
pea
and
bean,
succulent
and
dried
shelled,
except
soybean,
Subgroups
6B
and
6C.
The
livestock
feed
items
of
regulatory
interest
for
the
current
action
are
cowpea
seed
at
0.05
ppm,
cowpea
hay
and
forage
at
30.0
ppm;
and
soybean,
forage
and
hay,
for
which
the
tolerance
will
be
raised
to
30
ppm.
Since
the
worst
case
cattle
and
swine
diets
using
existing
and
proposed
tolerances
will
not
exceed
the
level
of
the
ruminant
feeding
study
used
to
establish
the
current
tolerances,
no
increase
in
tolerances
for
ruminant
and
swine
commodities
are
required.
None
of
the
commodities
for
which
tolerances
are
proposed
have
poultry
feed
items
of
regulatory
interest;
therefore,
no
change
in
azoxystrobin
poultry
tolerances
is
required.

The
label
indicates
that
only
crops
with
registered
uses
may
be
planted
within
12
months
of
application.
This
plantback
interval
is
adequate.

Regulatory
Recommendations
and
Residue
Chemistry
Deficiencies
Provided
a
revised
Section
F
is
received
and
pending
the
results
of
the
forthcoming
human
health
risk
assessment,
TRB
recommends
for
the
following
tolerances
for
the
residues
of
azoxystrobin:

Commodity
Tolerance
(
ppm)

vegetables,
foliage
of
legume,
Group
7
30.0
vegetables,
fruiting,
Group
8
(
except
tomato)
2.0
pea
and
bean,
succulent
shelled,
Subgroup
6B
0.5
pea
and
bean,
dried
shelled,
except
soybean,
Subgroup
6C
0.5
Azoxystrobin
Summary
of
Analytical
Chemistry
and
Residue
Data
DP
Num:
328984
5
of
14
TRB
recommends
against
the
requested
tolerance
on
animal
feed,
nongrass,
Group
18.
The
residue
chemistry
data
base
is
not
adequate
to
support
the
requested
use,
additional
residue
field
trial
data
is
required.

Note
to
PM:
The
existing
tolerances
on
soybean
hay
and
forage,
pepper,
okra,
and
eggplant
should
be
removed.

Background
Azoxystrobin
is
a
broad
spectrum
fungicide
for
control
of
many
plant
diseases.
It
has
the
same
biochemical
mode
of
action
as
the
naturally
occurring
strobilurins
and
is
structurally
related
to
them.
Azoxystrobin
is
a
 ­
methoxyacrylate.
It
is
in
the
same
chemical
class
as
trifloxystrobin.
Azoxystrobin
acts
by
inhibiting
electron
transport.

TABLE
1.
Test
Compound
Nomenclature
Compound
Chemical
Structure
Common
name
azoxystrobin
Company
experimental
name
ICIA5504
IUPAC
name
methyl
(
E)­
2­{
2­[
6­(
2­
cyanophenoxy)
pyrimidin­
4­
yloxy]
phenyl}­
3­
methoxyacrylate
CAS
name
methyl
(
E)­
2­[[
6­(
2­
cyanophenoxy)­
4­
pyrimidinyl]
oxy]­
(
methoxymethylene)­
benzeneacetate
CAS
#
131860­
33­
8
End­
use
product/
EP
Amistar
 
(
EPA
Reg.
No.:
100­
1164),
Quadris
®
Flowable
(
EPA
Reg.
No.:
100­
1098),
Abound
®
Fungicide
(
EPA
Reg.
No.:
100­
1098)

TABLE
2.
Physicochemical
Properties
Azoxystrobin
Summary
of
Analytical
Chemistry
and
Residue
Data
DP
Num:
328984
6
of
14
Parameter
Value
Melting
point/
range
114­
116
°
C
pH
6.4
Density
1.25
g/
cm3
Water
solubility
(
mg/
L
at
20
°
C)
solvent
solubility
(
mg/
L)
water,
pH
5.2
6.7
water,
pH
7
6.7
water,
pH
9.2
5.9
Solvent
solubility
(
mg/
L
at
20
°
C)
solvent
solubility
(
mg/
mL)
n­
hexane
0.057
methanol
20
ethyl
acetate
130
toluene
55
acetone
86
dichloromethane
400
Vapor
pressure
at
25
°
C
1.1
x
10­
13
kPa
=
8.2
x
10­
13
mg
Hg
Dissociation
constant
(
pKa)
Not
dissociable
Octanol/
water
partition
coefficient
Log(
KOW)
log
POW
=
2.5
UV/
visible
absorption
spectrum
Not
available
860.1200
Directions
for
Use
TABLE
3.
Summary
of
Directions
for
Use
of
Azoxystrobin.

Applic.
Timing,
Type,
and
Equip.
Formulation
[
EPA
Reg.
No.]
Applic.
Rate
(
lb
ai/
A)
Max.
No.
Applic.
per
Season
Max.
Seasonal
Applic.
Rate
(
lb
ai/
A)
PHI
(
days)
Use
Directions
and
Limitations
Peppers
and
Other
Fruiting
Vegetables
(
Except
Cucurbits)

Apply
by
ground,
air,
or
chemigation
prior
to
disease
development.
Abound
®
Fungicide
[
100­
1098]
0.10­
0.25
4
1.0
0
Apply
on
a
7­
14
day
schedule.
Adjuvant
may
be
added.

Foliage
of
Legume
Vegetables
Apply
by
ground,
air,
or
chemigation
prior
to
disease
development.
Abound
®
Fungicide
[
100­
1098]
0.10­
0.25
4
1.5
0
Apply
on
a
7­
14
day
schedule.
Adjuvant
may
be
added.

Dry
and
Succulent
Legume
Vegetables
Azoxystrobin
Summary
of
Analytical
Chemistry
and
Residue
Data
DP
Num:
328984
7
of
14
Apply
by
ground,
air,
or
chemigation
prior
to
disease
development.
Abound
®
Fungicide
[
100­
1098]
0.10­
0.25
4
1.5
0
Apply
on
a
7­
14
day
schedule.
Adjuvant
may
be
added.

Forage,
Fodder,
Straw
and
Hay
Grass
and
Nongrass
Apply
by
ground,
air,
or
chemigation
prior
to
disease
development.
Abound
®
Fungicide
[
100­
1098]
0.10­
0.25
4
Nongrass:
1.5
Mixed
Grass
and
Nongrass:
0.75
0
Apply
on
a
7­
14
day
schedule.
Adjuvant
may
be
added.

Conclusions.
The
label
is
adequate
to
allow
evaluation
of
the
residue
data
relative
to
the
proposed
use.

860.1300
Nature
of
the
Residue
­
Plants
PP#
5F4541,
DP
Num:
218318
and
218448,
J.
Garbus,
3/
19/
96
PP#
6F4762,
DP
Num:
230634,
230635,
230636,
and
230637,
L.
Kutney,
4/
25/
97
DP
Num:
251683,
W.
Wassell,
2/
30/
98
Adequate
metabolism
studies
on
grapes,
peanuts,
and
wheat
were
submitted
in
conjunction
with
earlier
petitions
(
PP#
5F4541,
DP
Num:
218318
and
218448,
J.
Garbus,
3/
19/
96;
and
PP#
6F4762,
DP
Num:
230634,
230635,
230636,
and
230637,
L.
Kutney,
4/
25/
97).
Azoxystrobin
undergoes
photochemical
isomerization
to
produce
the
Z­
isomer
and
is
extensively
metabolized
in
plants.
The
parent
compound
undergoes
cleavage
of
the
ether
linkages
between
the
phenylacrylate
and
pyrimidinyl
rings
and
the
cyanophenyl
and
pyrimidinyl
rings,
with
subsequent
oxidation,
hydrolysis,
and/
or
reduction
of
the
primary
metabolites
to
form
numerous
secondary
metabolites.
Azoxystrobin
is
systemic.
The
HED
MARC
has
determined
that
the
residues
of
concern
in/
on
plants
for
the
tolerance
expression
and
risk
assessment
purposes
are
azoxystrobin
and
its
Z­
isomer
(
DP
Num:
251683,
W.
Wassell,
2/
30/
98).

860.1300
Nature
of
the
Residue
­
Livestock
PP#
5F4541,
DP
Num:
218318
and
218448,
J.
Garbus,
3/
19/
96
PP#
6F4762,
DP
Num:
230634,
230635,
230636,
and
230637,
L.
Kutney,
4/
25/
97
DP
Num:
251683,
W.
Wassell,
2/
30/
98
Adequate
ruminant
and
poultry
metabolism
studies
were
submitted
in
conjunction
with
earlier
petitions
(
PP#
5F4541,
DP
Num:
218318
and
218448,
3/
19/
96,
J.
Garbus;
and
PP#
6F4762,
DP
Num:
230634,
230635,
230636,
and
230637,
4/
25/
97,
L.
Kutney).
The
HED
MARC
has
determined
that
the
residue
of
concern
in
livestock
is
parent
azoxystrobin
only
(
DP
Num:
251683,
12/
30/
98,
W.
Wassell).

860.1340
Residue
Analytical
Methods
PP#
5F4541
and
PP#
6F4762,
DP
Num:
235342,
C.
Stafford,
5/
30/
97
Azoxystrobin
Summary
of
Analytical
Chemistry
and
Residue
Data
DP
Num:
328984
8
of
14
DP
Num:
249657
and
249668,
D.
Dotson,
1/
25/
99
For
plant
commodities,
method
RAM
243/
04
has
undergone
method
validation
by
the
Analytical
Chemistry
Branch
(
ACB),
BEAD
(
PP#
5F4541
and
PP#
6F4762,
DP
Num:
235342,
C.
Stafford,
5/
30/
97).
BEAD
comments
have
been
incorporated
and
the
revised
method
(
designated
RAM
243,
dated
5/
15/
98;
MRID
44595105)
has
been
submitted
to
FDA
for
inclusion
in
PAM
II.

For
analysis
of
livestock
commodities,
the
petitioner
had
previously
proposed
GC
method
255/
01
for
the
enforcement
of
tolerances
for
residues
of
azoxystrobin
in
livestock
commodities.
This
method
has
been
validated
by
the
EPA
analytical
laboratory
for
the
analysis
of
milk
and
livestock
tissues
(
DP
Num:
249657
and
249668,
D.
Dotson,
1/
25/
99).
The
EPA
laboratory's
written
report
with
an
EPA
addendum
to
accompany
the
method,
and
the
method,
will
be
submitted
to
FDA
for
inclusion
in
PAM,
Vol.
II.
In
the
interim,
copies
are
available
from
PIRIB/
IRSD
(
7502P)
and
ACB/
BEAD
(
7503P).

860.1360
Multiresidue
Methods
PP#
5F4541,
DP
Num:
218318
and
218448,
J.
Garbus,
3/
19/
96
Data
have
previously
been
submitted
pertaining
to
the
multiresidue
methods
testing
of
azoxystrobin
in
conjunction
with
the
grape
tolerance
petition
(
PP#
5F4541;
DP
Num:
218318
and
218448,
J.
Garbus,
3/
19/
96).
The
data
indicate
that
azoxystrobin
could
not
be
recovered
through
application
of
the
multiresidue
protocols.
These
data
have
been
forwarded
to
FDA.

860.1380
Storage
Stability
PP#
9F06058
and
ID#
s
000100­
01098
and
000100­
01093,
DP
Num:
283588
&
287062,
MRID
45738101,
N.
Dodd,
2/
6/
03
Previously
submitted
storage
stability
data
indicates
that
residues
of
azoxystrobin
and
the
Z­
isomer
(
R230310)
are
stable
in
soybean
meal,
corn
grits,
carrot
root,
leaf
lettuce,
wheat
forage,
orange
oil,
orange
juice,
and
orange
pulp
for
at
least
two
years
under
frozen
storage
(
PP#
9F06058
and
ID#
s
000100­
01098
and
000100­
01093,
DP
Num:
283588
&
287062,
MRID
45738101,
N.
Dodd,
2/
6/
03).

860.1400
Water,
Fish,
and
Irrigated
Crops
As
no
water,
fish,
or
irrigated
crop
issues
are
associated
with
the
uses
of
azoxystrobin
on
foliage
of
legume
vegetables,
Crop
Group
7;
fruiting
vegetables,
Crop
Group
8
(
except
tomato);
pea
and
bean,
succulent
and
dried
shelled,
Crop
Groups
6B
and
6C,
this
guideline
requirement
is
not
relevant
to
the
current
petition.

860.1460
Food
Handling
Azoxystrobin
Summary
of
Analytical
Chemistry
and
Residue
Data
DP
Num:
328984
9
of
14
As
there
are
no
food
handling
uses
for
azoxystrobin,
this
guideline
requirement
is
not
relevant
to
the
current
petition.

860.1480
Meat,
Milk,
Poultry,
and
Eggs
PP#
9F06058,
DP
Num:
260134,
M.
Nelson,
9/
6/
00
The
livestock
feed
items
of
regulatory
interest
for
the
current
action
are
cowpea
seed
at
0.05
ppm,
cowpea
hay
and
forage
at
30.0
ppm;
and
soybean,
forage
and
hay,
for
which
the
tolerance
will
be
raised
to
30
ppm.
The
tolerances
for
beef
livestock
commodities
were
established
based
on
the
feed
items:
rice
grain
at
5.0
ppm,
turnip
tops
at
50.0
ppm
and
soybean
forage
at
25
ppm.
These
tolerance
levels
resulted
in
MTDBs
for
beef
cattle
of
105.6
ppm
and
dairy
cattle
of
73.7
ppm
(
PP#
9F06058,
DP
Num:
260134,
M.
Nelson,
9/
6/
00).
Changing
the
commodities
used
in
the
original
MTDB
calculation
to
cowpea
seed
at
0.05
ppm
would
not
result
in
an
increase
in
the
MTDBs
for
cattle.
However,
using
the
worst
case
for
the
pending
tolerances,
the
tolerance
level
for
cowpea,
forage
at
30.0
ppm
with
the
feeding
information
in
OPPTS
Test
Guidelines,
860.1000,
result
in
increases
in
the
MTDB
for
beef
and
dairy
cattle
to
123.9
and
110.6
ppm,
respectively.
The
current
tolerances
on
ruminant
commodities
were
established
based
on
a
feeding
study
at
5,
25,
75,
and
250
ppm.
Since
the
worst
case
cattle
diets
using
existing
and
proposed
tolerances
(
Table
4)
will
not
exceed
the
level
of
the
ruminant
feeding
study
used
to
establish
the
current
tolerances
(
250
ppm),
no
increase
in
tolerances
for
ruminant
commodities
are
required.

The
tolerances
for
swine
commodities
were
established
based
on
the
feed
items:
rice
grain
at
5.0
ppm,
canola,
meal
at
1.0
ppm,
and
aspirated
grain
fractions
at
30.0
ppm,
which
resulted
in
a
MTDB
on
swine
of
9.5
ppm
(
PP#
9F06058,
DP
Num:
260134,
M.
Nelson,
9/
6/
00).
The
tolerances
for
swine
commodities
were
established
using
the
same
feeding
study
as
that
used
for
ruminants.
Changing
the
commodities
used
in
the
MTDB
calculation
to
include
cowpea,
forage
at
30.0
ppm
with
the
feeding
information
in
OPPTS
Test
Guidelines,
860.1000,
result
in
an
increase
in
the
MTDB
for
swine
to
15.1
ppm.
Since
the
worst
case
swine
diet
using
existing
and
proposed
tolerances
(
Table
4)
will
not
exceed
the
level
of
the
ruminant
feeding
study
used
to
establish
the
current
tolerances
(
25
ppm),
no
increase
in
tolerances
for
swine
commodities
are
required.

The
tolerances
for
poultry
commodities
were
established
based
on
the
rice
feed
items:
grain
and
bran
at
5.0
ppm,
and
hulls
at
20.0
ppm
which
results
in
a
MTDB
on
poultry
of
7.3
ppm.
None
of
the
commodities
for
which
tolerances
are
proposed
have
poultry
feed
items
of
regulatory
interest;
therefore,
no
change
in
azoxystrobin
poultry
tolerances
is
required.

TABLE
4.
Azoxystrobin
Maximum
Theoretical
Daily
Dietary
Burdens
for
Livestock
Feed
Commodity
Tolerance,
ppm
%
Dry
Matter
%
of
Diet
Burden
(
ppm)*

Beef
cattle
Rice,
grain
5.0
88
10
0.6
Cowpea,
forage
30.0
30
40
40
Azoxystrobin
Summary
of
Analytical
Chemistry
and
Residue
Data
DP
Num:
328984
10
of
14
Turnip,
tops
50.0
30
50
83.3
TOTAL
100
123.9
Dairy
cattle
Rice,
grain
5.0
88
10
0.6
Cowpea,
forage
30.0
30
60
60
Turnip,
tops
50.0
30
30
50
TOTAL
100
110.6
Swine
Rice,
grain
5.0
NA**
60
3
Cowpea,
forage
30.0
NA
15
4.5
Canola,
meal
1.0
NA
10
0.1
Aspirated
grain
fractions
50
NA
15
7.5
TOTAL
100
15.1
*
Burden
=
Tolerance
x
(%
Diet/%
Dry
Matter)
**
NA
=
Not
applicable
to
swine
and
poultry
dietary
calculations,
per
OPPTS
Test
Guidelines,
860.1000,
Table
1,
Footnote
2.

860.1500
Crop
Field
Trials
DP
Num:
254140,
G.
Herndon,
3/
17/
99
PP#
9F06058,
DP
Num:
260134,
M.
Nelson,
9/
6/
00
PP#
9F06058
and
ID#
s
000100­
01098
and
000100­
01093,
DP
Num:
283588
&
287062,
MRID
45738101,
N.
Dodd,
2/
6/
03
PP#
1E6264,
MRID
45332502
DP
Num:
274312,
G.
Herndon,
4/
30/
01
PP#
0F6218,
DP
Num:
278801,
N.
Dodd,
7/
31/
02
Vegetables,
Foliage
of
Legume,
Group
7
No
new
residue
field
trial
data
were
submitted
for
the
foliage
of
legume
vegetables,
Crop
Group
7.
The
representative
commodities
for
Crop
Group
7
are
foliar
portions
of
any
cultivar
of
bean,
field
pea,
and
soybean.
RAB2
stated
in
their
3/
17/
99
memo:
"
As
long
as
the
use
pattern
is
similar,
RAB2
would
expect
residues
to
be
similar
for
Crop
Group
4
and
Crop
Group
7.
Provided
that
the
proposed
field
trial
residue
data
supporting
a
tolerance
for
Crop
Group
4
are
submitted
and
deemed
adequate,
RAB2
concludes
that
it
will
be
appropriate
for
IR­
4
to
request
a
tolerance
for
Crop
Group
7
at
the
same
level
as
Crop
Group
4"
(
DP
Num:
254140,
G.
Herndon,
3/
17/
99).
The
use
patterns
for
Crop
Group
4
and
Crop
Group
7
are
the
same:
0.10­
0.25
lb
ai/
A
per
application,
with
a
seasonal
maximum
of
1.5
lb/
A
and
0­
day
PHI.
A
tolerance
for
vegetable,
leafy,
except
Brassica,
Group
4
at
30.0
ppm
was
conditionally
recommended
upon
the
receipt
and
acceptance
of
additional
spinach
field
trials
(
PP#
9F06058,
DP
Num:
260134,
M.
Nelson,
9/
6/
00).
The
additional
trials
were
submitted
and
found
to
be
adequate
to
satisfy
the
conditional
registration
(
PP#
9F06058
and
ID#
s
000100­
01098
and
000100­
01093,
DP
Num:
283588
&
287062,
MRID
45738101,
N.
Dodd,
2/
6/
03).
Azoxystrobin
Summary
of
Analytical
Chemistry
and
Residue
Data
DP
Num:
328984
11
of
14
The
requirements
set
forth
by
RAB2
for
the
establishment
of
an
azoxystrobin
tolerance
on
the
foliage
of
legume
vegetables,
Crop
Group
7
have
been
satisfied.
TRB
recommends
for
the
establishment
of
a
tolerance
at
30.0
ppm
for
the
residues
of
azoxystrobin
on
vegetables,
foliage
of
legume,
Group
7.
The
proposed
tolerance
on
Group
7
will
include
a
soybean
hay
and
forage.

Note
to
PM:
The
existing
tolerances
on
soybean
hay
and
forage
should
be
removed.

Vegetables,
Fruiting,
Group
8
(
Except
Tomato)

No
new
residue
field
trial
data
were
submitted
for
vegetables,
Fruiting,
Group
8
(
except
tomato).
There
are
tolerances
established
for
members
of
Crop
Group
8:
peppers,
okra,
and
eggplant
at
2.0
ppm;
and
tomato
at
0.2
ppm
(
CFR
§
180.507).
Bell
and
non­
bell
pepper
data
(
PP#
1E6264,
MRID
45332502)
were
used
to
establish
the
okra
and
eggplant
tolerances
as
a
result
of
a
previous
request
from
IR­
4
(
DP
Num:
274312,
G.
Herndon,
4/
30/
01).
Although
all
the
existing
data
on
the
Crop
Group
8
representative
commodities
were
determined
to
be
sufficient
to
establish
a
crop
group
tolerance,
risk
cup
issues
at
the
time
precluded
increasing
the
tomato
tolerance
and
separate
tolerances
were
requested
on
okra
and
eggplant.
Since
the
existing
data
were
determined
to
be
adequate
for
a
crop
group
tolerance,
there
is
sufficient
data
to
support
the
petition
for
the
requested
subgroup.
The
commodity
definition
presented
by
the
petitioner
is
incorrect.
A
new
Section
F
should
be
submitted
requesting
a
tolerance
for
the
residues
of
azoxystrobin
at
2.0
ppm
on
vegetables,
fruiting,
Group
8
(
except
tomato).

Note
to
PM:
The
existing
separate
tolerances
on
pepper,
okra,
and
eggplant
should
be
removed.

Pea
and
Bean,
Succulent
and
Dried
Shelled
(
except
Soybean),
Subgroups
6B
and
6C
No
new
residue
field
trial
data
were
submitted
for
pea
and
bean,
succulent
and
dried,
except
soybean,
Subgroups
6B
and
6C.
The
existing
tolerance
commodity
definitions
are:
pea
and
bean,
dried
shelled,
except
soybean,
subgroup,
except
cowpea,
and
field
pea;
and
pea
and
bean,
succulent
shelled,
subgroup,
except
cowpea.
The
subgroup
tolerances
excluded
cowpea
and
field
pea
because
there
was
no
residue
field
data
for
forage,
hay,
and/
or
silage
as
livestock
feeds.
In
order
to
satisfy
the
data
requirements,
RAB3
indicated
that
"
the
petitioner
must
provide
residue
data
on
the
representative
crops
of
Crop
Group
7"
(
PP#
0F6218,
DP
Num:
278801,
N.
Dodd,
7/
31/
02).
However,
as
stated
above,
the
requirements
set
forth
by
RAB2
for
the
establishment
of
an
azoxystrobin
tolerance
on
vegetables,
foliage
of
legume,
Group
7
have
been
satisfied.
Therefore,
no
further
residue
field
trial
data
is
required.
TRB
recommends
for
the
establishment
of
tolerances
at
0.5
ppm
for
the
residues
of
azoxystrobin
on
pea
and
bean,
succulent
shelled,
Subgroup
6B;
and
pea
and
bean,
dried
shelled,
except
soybean,
Subgroup
6C.

Animal
Feed,
Nongrass,
Group
18
ChemSAC,
5/
10/
06
No
new
residue
field
trial
data
were
submitted
for
animal
feed,
nongrass,
Group
18.
IR­
4
requests
that
the
Agency
use
data
supporting
the
tolerances
for
vegetable,
leafy,
except
Brassica,
Azoxystrobin
Summary
of
Analytical
Chemistry
and
Residue
Data
DP
Num:
328984
12
of
14
Group
4
at
30.0
ppm,
Brassica,
leafy
greens,
Subgroup
5B
at
25
ppm,
and
soybean,
hay
at
55.0
ppm
as
adequate
support
for
the
establishment
of
tolerances
for
animal
feed,
nongrass,
Group
18,
forage
at
30.0
ppm
and
animal
feed,
nongrass,
Group
18,
hay
at
55.0
ppm.
ChemSAC
has
determined
that
the
existing
data
cited
by
the
petitioner
is
not
sufficient
to
support
the
requested
tolerance
(
ChemSAC,
5/
10/
06).
TRB
recommends
against
the
proposed
tolerances
on
animal
feed,
nongrass,
Group
18,
forage
and
hay.

However,
based
on
the
existing
use
on
soybeans,
which
has
the
same
use
pattern
as
that
proposed
for
animal
feed,
nongrass,
Group
18,
a
reduced
number
of
residue
field
trials
would
be
appropriate.
Six
residue
field
trials
with
the
appropriate
geographic
distribution
on
the
two
representative
crops
for
animal
feed,
nongrass,
Group
18,
alfalfa
and
clover
are
required
to
support
a
proposed
azoxystrobin
tolerance.

860.1520
Processed
Food
and
Feed
There
are
no
processed
commodities
associated
with
the
uses
of
azoxystrobin
on
foliage
of
legume
vegetables,
Group
7;
fruiting
vegetables,
Group
8
(
except
tomato);
and
pea
and
bean,
succulent
and
dried
shelled,
Subgroups
6B
and
6C;
therefore,
a
discussion
of
processed
food
and
feed
is
not
germane
to
this
action.

860.1650
Submittal
of
Analytical
Reference
Standards
The
analytical
reference
standards
for
both
azoxystrobin
(
7/
2000)
and
its
Z­
isomer
(
5/
2001)
have
been
submitted
to
the
EPA
National
Pesticide
Standards
Repository.

860.1850
Confined
Accumulation
in
Rotational
Crops
DP
Num:
230634,
230635,
230636,
and
230637,
L.
Kutney,
4/
25/
97
DP
Num:
260134,
M.
Nelson,
9/
6/
00
Adequate
confined
studies
have
previously
been
reviewed
(
DP
Num:
230634,
230635,
230636,
and
230637,
L.
Kutney,
4/
25/
97)
and
summarized
(
DP
Num:
260134,
M.
J.
Nelson,
9/
6/
00).
Azoxystrobin
was
identified
in
all
RACs
at
the
30­
DAT
interval.
In
30­
DAT
samples,
the
Z
isomer
was
only
identified
in
wheat
forage
and
straw.
Compound
42
was
the
major
metabolite
identified
in
30­
DAT
lettuce
and
wheat
forage
and
straw.
In
30­
DAT
radish
roots,
azoxystrobin
was
the
major
metabolite
and
in
30­
DAT
radish
tops,
metabolites
G2,
N1,
and
N2
were
the
major
metabolites.
In
30­
DAT
wheat
grain,
14C­
starch
was
found
to
account
for
the
largest
portion
of
radioactivity.
Several
conjugated
metabolites
(
compound
42
and
the
M,
N,
and
O
metabolites)
of
primary
crop
metabolites
were
identified,
indicating
that
azoxystrobin
is
more
extensively
metabolized
in
rotational
crops
than
in
primary
crops.
The
residues
of
concern
in
rotational
crops
are
parent
and
the
Z­
isomer.

860.1900
Field
Accumulation
in
Rotational
Crops
DP
Num:
230634,
230635,
230636,
and
230637,
L.
Kutney,
4/
25/
97
Azoxystrobin
Summary
of
Analytical
Chemistry
and
Residue
Data
DP
Num:
328984
13
of
14
DP
Num:
260134,
M.
Nelson,
9/
6/
00
Limited
field
rotational
crop
studies
were
previously
reviewed
(
DP
Num:
230634,
230635,
230636,
and
230637,
4/
25/
97,
L.
Kutney)
and
summarized
(
DP
Num:
260134,
9/
6/
00,
M.
J.
Nelson).
The
limited
field
accumulation
study
(
MRID
45640307)
is
adequate
to
indicate
that
residues
of
azoxystrobin
and
Z­
isomer
(
R230310)
will
not
occur
in
mustard
greens,
turnip
roots,
turnip
tops,
and
wheat
grain
planted
36
days
after
application
of
azoxystrobin,
as
an
80%
water
dispersible
granular
formulation,
to
a
primary
crop
at
a
rate
of
1.6
lb
ai/
A/
season.
This
study
also
indicates
that
small
residues
of
azoxystrobin
per
se
may
occur
in
wheat
matrices
other
than
grain
at
a
plantback
interval
of
approximately
60
days
after
treatment
(
DAT)
(
i.
e.,
0.02
ppm
in
wheat
forage
at
61
DAT;
0.01
ppm
in
wheat
hay
at
45
DAT;
0.04
ppm
in
wheat
straw
at
59
DAT).
No
residues
of
Z­
isomer
(
R230310)
were
found
in
any
matrix
at
any
plantback
interval.

The
label
indicates
that
only
crops
with
registered
uses
may
be
planted
within
12
months
of
application.
This
plantback
interval
is
adequate.

860.1550
Proposed
Tolerances
The
HED
MARC
has
determined
that
the
residues
of
concern
in/
on
plants
for
the
tolerance
expression
and
risk
assessment
purposes
are
azoxystrobin
and
its
Z­
isomer.
The
HED
MARC
has
determined
that
the
residue
of
concern
in
livestock
is
parent
azoxystrobin
only.
The
existing
azoxystrobin
tolerances
are
listed
in
40
CFR
§
180.507.
There
are
no
Codex
MRLs
for
azoxystrobin.
Canada
and
Mexico
have
an
MRL
for
tomato
at
0.2.
Mexico
also
has
an
MRL
for
chili
pepper
at
2.0
ppm.
These
existing
MRLs
match
those
proposed
by
the
petitioner.
There
are
no
other
Canadian
or
Mexican
MRLs
for
commodities
of
concern
in
this
action.
Therefore,
there
are
no
international
harmonization
issues
associated
with
this
action.

TABLE
5.
Tolerance
Summary
for
Azoxystrobin
Commodity
Established/
Proposed
Tolerance
(
ppm)
Recommended
Tolerance
(
ppm)
Comments
(
correct
commodity
definition)

vegetables,
foliage
of
legume,
Group
7
30.0
30.0
vegetables,
fruiting,
Group
8
(
except
tomato)
2.0
2.0
pea
and
bean,
succulent
shelled,
Subgroup
6B
0.5
0.5
pea
and
bean,
dried
shelled,
except
soybean,
Subgroup
6C
0.5
0.5
Azoxystrobin
Summary
of
Analytical
Chemistry
and
Residue
Data
DP
Num:
328984
14
of
14
INTERNATIONAL
RESIDUE
LIMIT
STATUS
Chemical
Name:
Common
Name:
Azoxystrobin
Proposed
tolerance
Reevaluated
tolerance
Other
Date:
5/
2/
06
Codex
Status
(
Maximum
Residue
Limits)
U
.
S.
Tolerances
X
No
Codex
proposal
step
6
or
above
No
Codex
proposal
step
6
or
above
for
the
crops
requested
Petition
Numbers:
4E68237
DP
Barcodes:
D312953
Other
Identifier:
128810
Reviewer/
Branch:
W.
Cutchin
Residue
definition
(
step
8/
CXL):
N/
A
Proposed
Residue
definition:
Combined
residues
of
azoxystrobin
and
its
Z­
isomer
Crop
(
s)
MRL
(
mg/
kg)
Crop(
s)
Tolerance
(
ppm)

foliage
of
legume
vegetables,
Crop
Group
7
30.0
fruiting
vegetables,
Crop
Group
8
(
except
tomato)
2.0
pea
and
bean,
succulent
shelled,
Crop
Group
6B
0.5
pea
and
bean,
dried
shelled,
Crop
Group
6C
0.5
nongrass
animal
feed,
forage,
Crop
Group
18
30.0
nongrass
animal
feed,
hay
Crop
Group
18
55.0
Limits
for
Canada
Limits
for
Mexico
No
Limits
No
Limits
for
the
crops
requested
No
Limits
No
Limits
for
the
crops
requested
Residue
definition:
(
 E)­
methyl
2­[[
6­(
2­
cyanophenoxy)­
4­
pyrimidinyl]
oxy]­
 
­
methoxymethylene)
benzeneacetate,
including
the
isomer
(
Z)­
methyl
2­[[
6­(
2­
cyanophenoxy)­
4­
pyrimidinyl]
oxy]­­
(
methoxymethylene)
benzeneacetate
Residue
definition:
Azoxistrobin
Crop(
s)
MRL
(
mg/
kg)
Crop(
s)
MRL
(
mg/
kg)

Tomato
0.2
Tomato
0.2
Chile
pepper
2.

Notes/
Special
Instructions:
S.
Funk,
05/
07/
2006