Document ID: EPA-HQ-OPP-2003-0129-0001
Agency: epa
Document Type: Notice
Title: Fluoxastrobin; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-04-23T04:00Z

19991
Federal
Register
/
Vol.
68,
No.
78
/
Wednesday,
April
23,
2003
/
Notices
C.
How
and
To
Whom
Do
I
Submit
Comments?
To
submit
comments,
or
access
the
official
public
docket,
please
follow
the
detailed
instructions
as
provided
in
Unit
I.
C.
of
the
Federal
Register
of
the
January
29,
2003
document.
If
you
have
questions,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

II.
What
Action
is
EPA
Taking?
This
document
reopens
the
public
comment
period
established
in
the
Federal
Register
of
January
29,
2003.
In
that
document,
EPA
announced
the
availability
of
the
preliminary
comparative
ecological
assessment
for
nine
rodenticides
and
invited
comment
on
issues
directly
associated
with
the
nine
rodenticides
that
were
included
in
the
assessment.
Due
to
the
many
requests
received
for
additional
time
to
comment,
EPA
is
hereby
reopening
the
comment
period,
which
was
set
to
end
on
March
31,
2003,
to
May
30,
2003.

List
of
Subjects
Environmental
protection,
Pesticides
and
pests.

Dated:
April
8,
2003.
Lois
A.
Rossi,
Director,
Special
Review
and
Reregistration
Division,
Office
of
Pesticide
Programs.
[
FR
Doc.
03
 
10070
Filed
4
 
22
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0129;
FRL
 
7303
 
1]

Fluoxastrobin;
Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0129,
must
be
received
on
or
before
May
23,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Dennis
McNeilly,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
6742;
e­
mail
address:
mcneilly.
dennis@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
This
Action
Apply
to
Me?

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
This
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0129.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
VerDate
Jan<
31>
2003
14:
42
Apr
22,
2003
Jkt
200001
PO
00000
Frm
00024
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
23APN1.
SGM
23APN1
19992
Federal
Register
/
Vol.
68,
No.
78
/
Wednesday,
April
23,
2003
/
Notices
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2003
 
0129.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
opp­
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP
 
2003
 
0129.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001,
Attention:
Docket
ID
Number
OPP
 
2003
 
0129.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP
 
2003
 
0129.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

D.
How
Should
I
Submit
CBI
to
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
What
Action
is
the
Agency
Taking?

EPA
has
received
a
pesticide
petition
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
data
or
information
regarding
the
elements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

VerDate
Jan<
31>
2003
14:
42
Apr
22,
2003
Jkt
200001
PO
00000
Frm
00025
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
23APN1.
SGM
23APN1
19993
Federal
Register
/
Vol.
68,
No.
78
/
Wednesday,
April
23,
2003
/
Notices
Dated:
April
15,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
the
petitioner
and
represents
the
view
of
the
petitioner.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

Bayer
CropScience
PP
3F6556
EPA
has
received
a
pesticide
petition
(
3F6556)
from
Bayer
CropScience,
2
T.
W.
Alexander
Drive,
Research
Triangle
Park,
NC
27709
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
fluoxastrobin;
2­[[
6­(
2­
chlorophenoxy)­
5­
fluoro­
4­
pyrimidinyl]
oxy]
phenyl
(
5,6­
dihydro­
1,4,2­
dioxazin­
3­
yl)
methanone­
Omethyloxime
in
or
on
the
raw
agricultural
commodities
(
RACs)
alfalfa,
forage
at
0.05
parts
per
million
(
ppm),
alfalfa,
hay
at
1.0
ppm,
cotton,
gin
byproducts
at
0.02
ppm,
grain,
cereal,
forage
at
0.10
ppm,
grain,
cereal,
hay
at
0.10
ppm,
grain,
cereal,
straw
at
0.10
ppm,
grain,
cereal,
stover
at
0.10
ppm,
grass,
forage
at
0.10
ppm,
grass,
hay
at
0.50
ppm,
legume,
seed
at
0.01
ppm,
legume,
forage
at
0.05
ppm,
legume,
hay
at
0.05
ppm,
peanut
at
0.01
ppm,
peanut,
hay
at
20
ppm,
peanut,
refined
oil
at
0.10
ppm,
tomato,
paste
at
2.0
ppm,
vegetable,
fruiting,
group
at
1.0
ppm,
vegetable,
leafy,
petioles,
except
brassica,
subgroup
at
5.0
ppm,
and
vegetable,
tuberous
and
corm,
subgroup
at
0.01
ppm.
Fluoxastrobin;
2­[[
6­(
2­
chlorophenoxy)­
5­
fluoro­
4­
pyrimidinyl]
oxy]
phenyl
(
5,6­
dihydro­
1,4,2­
dioxazin­
3­
yl)
methanone­
Omethyloxime
and
its
phenoxyhydroxypyrimidine
metabolite;
6­(
2­
chlorophenoxy)­
5­
fluoro­
4­
pyrimidinol
in
or
on
the
RACs
cattle,
fat
at
0.10
ppm,
cattle,
meat
at
0.05
ppm,
cattle,
meat
byproducts
at
0.20
ppm,
milk
at
0.01
ppm,
and
milk,
fat
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
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
metabolism
of
fluoxastrobin
in
plants
is
adequately
understood.
Studies
have
been
conducted
to
delineate
the
metabolism
of
radiolabeled
fluoxastrobin
in
peanut,
tomato,
spring
wheat,
and
various
representative
rotational
crops,
all
showing
similar
results.
The
residue
of
concern
is
parent
fluoxastrobin
(
sum
of
E
and
Z
isomers).
2.
Analytical
method.
Adequate
analytical
methodology
using
liquid
chromatography/
mass
spectrometer/
mass
spectromer
(
LC/
MS/
MS)
detection
is
available
for
enforcement
purposes.
3.
Magnitude
of
residues.
Complete
residue
data
exists
for
fluoxastrobin
on
these
crops
and
crop
groupings.
Magnitude
of
residue
trials
were
conducted
on
peanut,
potato,
celery,
tomato,
pepper,
and
the
rotational
crops
of
alfalfa,
cotton,
cereal
grains
(
corn,
rice,
sorghum
and
wheat),
soybeans,
other
legume
vegetables,
and
grasses.
A
cattle
feeding
study
was
performed
in
order
to
determine
residues
in
meat
and
milk
commodities.
The
data
support
the
proposed
tolerances.

B.
Toxicological
Profile
1.
Acute
toxicity.
Oral
and
dermal
lethal
dose
(
LD)
50
values
were
>
2,000
milligrams/
kilogram
bodyweight
(
mg/
kg)
(
bwt).
Inhalation
lethal
concentrations
(
LC)
50
values
were
>
4,998
milligrams/
meters
(
mg/
m3)
air.
Fluoxastrobin
technical
was
not
irritating
to
rabbit
skin,
was
moderately
irritating
to
eyes
in
rabbits,
and
was
non­
sensitizing
dermally
in
the
Magnusson/
Kligman
maximization
test
in
guinea
pigs.
Acute
toxicity
studies
for
fluoxastrobin
support
an
overall
Toxicity
Category
III.
2.
Genotoxicity.
Several
genotoxicity
tests
were
conducted
to
test
for
pointmutagenic
activity,
chromosome
aberration
in
vitro
and
in
vivo,
and
for
DNA
repair.
All
tests
conducted
were
negative,
indicating
no
evidence
of
mutagenic
or
genotoxic
potential.
3.
Reproductive
and
developmental
toxicity.
An
oral
developmental
toxicity
study
in
rat
did
not
reveal
any
evidence
of
teratogenic
potential.
The
maternal
no
observed
adverse
effect
level
(
NOAEL)
was
300
mg/
kg
and
the
developmental
NOAEL
was
1,000
mg/
kg
bwt/
day.
An
oral
developmental
toxicity
study
in
rabbits
demonstrated
a
maternal
NOAEL
of
25
mg/
kg
bwt/
day,
a
developmental
NOAEL
of
100
mg/
kg
bwt/
day
and
did
not
reveal
any
teratogenic
potential.
A
2­
generation
study
in
rats,
with
a
parental
toxicity
NOAEL
of
73.7
mg/
kg
bwt/
day
for
males
and
86.7
mg/
kg
bwt/
day
for
females,
did
not
reveal
evidence
of
a
primary
reproductive
toxicity
potential.
The
reproductive
NOAEL
was
763.6
mg/
kg
bwt/
day
for
males
and
806.5
mg/
kg
bwt/
day
in
females.
4.
Subchronic
toxicity.
A
subchronic
toxicity
feeding
study
with
rats
over
90
days
demonstrated
a
NOAEL
of
7.3
and
18.3
mg/
kg
bwt/
day
for
males
and
females,
respectively,
based
on
reduced
body
weights
and
alterations
in
several
urinary
tract­
related
clinical
chemistry
parameters,
at
the
higher
dose
levels.
In
a
subchronic
feeding
study
in
mice
over
14
weeks,
a
NOAEL
was
not
established
based
on
decreased
alanine
aminotransferase
(
ALAT)
and
increased
absolute
and
relative
liver
weights
at
the
low
dose
level
(
21.7
and
35.3
mg/
kg
bwt/
day
for
males
and
females
respectively).
A
14­
week
feeding
study
in
dogs
demonstrated
a
NOAEL
of
3.0
mg/
kg
bwt/
day
based
on
decreased
body
weights
and
food
consumption,
and
liver
effects
(
enzyme
induction,
increased
liver
weights,
cytoplasmic
change),
and
thyroid
effects
(
decreased
T3)
5.
Chronic
toxicity.
A
24­
month
chronic/
oncogenicity
feeding
study
in
rats
demonstrated
a
NOAEL
of
53.0
and
35.2
mg/
kg
bwt/
day
for
males
and
females,
respectively.
An
oncogenicity
study
in
the
mouse
revealed
a
NOAEL
of
18.5
and
29.5
mg/
kg
bwt/
day
for
males
and
females,
respectively
based
on
liver
effects.
There
was
no
indication
in
the
rat
or
mouse
for
an
oncogenic
effect
of
fluoxastrobin.
A
1­
year
feeding
study
with
dogs
demonstrated
a
NOAEL
of
1.7
and
1.5
mg/
kg
bwt/
day
for
males
and
females,
respectively
based
on
decreased
body
weights
and
slight
liver
effects
(
increased
alkaline
phosphatase
(
Aph)
and
liver
weights).
6.
Animal
metabolism.
Metabolism
and
pharmacokinetic
studies
in
the
rats,
lactating
goats,
and
laying
hens
demonstrate
that
fluoxastrobin
residues
are
rapidly
absorbed,
metabolized,
and
eliminated.
There
was
no
evidence
of
accumulation
of
residues
in
any
tissues
or
organs.
The
metabolic
pattern
was
always
complex
and
numerous
metabolites
were
identified.
The
main
metabolic
reactions,
however,
are
very
comparable
for
all
tested
animal
species
and
most
metabolites
were
present
at
low
levels.
Based
on
the
available
metabolism
data,
fluoxastrobin
and
phenoxy­
hydroxypyrimidine
are
the
proposed
residues
of
concern
in
animals.
7.
Metabolite
toxicology.
The
residues
of
concern
are
fluoxastrobin
its
VerDate
Jan<
31>
2003
14:
42
Apr
22,
2003
Jkt
200001
PO
00000
Frm
00026
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
23APN1.
SGM
23APN1
19994
Federal
Register
/
Vol.
68,
No.
78
/
Wednesday,
April
23,
2003
/
Notices
phenoxy­
hydroxypyrimidine
metabolite.
This
metabolite
was
investigated
for
acute
oral
toxicity
and
point
mutagenic
activity
in
a
bacterial
reverse
mutation
assay.
The
phenoxyhydroxypyrimidine
metabolite
did
not
show
mutagenic
activity
in
the
reverse
mutation
assay
and
the
oral
LD50
was
>
300
<
500
mg/
kg
body
weight.
8.
Endocrine
disruption.
There
is
no
evidence
to
suggest
that
fluoxastrobin
has
any
primary
endocrine
disruptive
potential.
Reproductive
and
developmental
findings
provided
no
evidence
of
an
enhanced
sensitivity
of
the
young.

C.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food.
Acute
and
chronic
dietary
analyses
were
conducted
to
estimate
exposure
to
potential
fluoxastrobin
residues
in/
on
the
following
crops
and
crop
groups:
celery,
fruiting
vegetables,
peanuts,
and
potatoes.
Rotational
crops
included
in
the
analysis
are
alfalfa,
grasses,
legume
vegetables,
foliage
of
legume
vegetables,
cereal
grains,
and
cotton.
Tier
I
analysis
were
conducted
for
both
the
acute
and
chronic
scenarios
using
the
Dietary
Exposure
Evaluation
Model
(
DEEM)
(
Exponent,
Inc.)
software.
The
acute
dietary
exposure
estimates
at
the
95th
percentile
of
exposure
for
the
U.
S.
population
was
1.4%
of
the
acute
reference
dose
(
RfD).
The
population
subgroup
with
the
highest
exposure
was
children
1
to
6
at
2.7%
of
the
acute
RfD.
Chronic
dietary
exposure
estimates
from
potential
residues
of
fluoxastrobin
for
the
U.
S.
population
was
6.5%
of
the
chronic
RfD.
The
subpopulation
with
the
highest
exposure
was
children
1
to
6
with
12.7%
of
the
chronic
RfD
used.
Tier
I
assessments
use
tolerance
residue
values
and
100%
crop
treated.
These
can
be
considered
very
conservative
values.
ii.
Drinking
water.
EPA's
Standard
Operating
Procedure
(
SOP)
for
Drinking
Water
Exposure
and
Risk
Assessments
was
used
to
perform
the
drinking
water
analysis
for
fluoxastrobin.
This
SOP
utilizes
a
variety
of
tools
to
conduct
drinking
water
assessment.
These
tools
include
water
models
such
as
Screening
Concentration
in
Groundwater
(
SCIGROW
Generic
Estimate
Exposure
Concentration
(
GENEEC),
Pesticide
Root
Zone
Model­
Exposure
Analysis
Modeling
Systems
(
PRZM/
EXAMS),
and
monitoring
data.
If
monitoring
data
are
not
available
then
the
models
are
used
to
predict
potential
residues
in
surface
water
and
ground
water.
In
the
case
of
fluoxastrobin,
monitoring
data
do
not
exist,
therefore,
PRZMS/
EXAMS
and
SCI­
GROW
models
were
used
to
estimate
a
drinking
water
residue.
The
calculated
drinking
water
levels
of
comparison
(
DWLOC)
for
acute
and
chronic
exposures
for
all
adults
and
children
exceed
the
modeled
fluoxastrobin
drinking
water
estimated
concentrations
(
DWECs).
The
acute
DWLOC
values
are
8,624
parts
per
billion
(
ppb)
for
adults
and
2,433
ppb
for
children.
The
worst­
case
DWEC
for
acute
scenarios
is
calculated
to
be
58
ppb
using
the
PRZMS/
EXAMS
surface
water
model.
The
chronic
DWLOC
values
are
491
ppb
for
adults
and
131
ppb
for
children.
The
DWEC
for
the
worst­
case
chronic
scenario
is
28
ppb
PRZM/
EXAMS.
2.
Non­
dietary
exposure.
Residential
(
non­
dietary)
exposure
is
limited
to
post­
application
exposure
of
fluoxastrobin
from
professional
applications
to
residential
turf
and
golf
courses.
Using
the
very
conservative
EPA
SOPs
for
residential
exposure
a
margin
of
exposure
(
MOE)
of
7,143
was
calculated
for
the
youth
golfer
scenario.
Adult
and
toddler
reentry
to
treated
turf
MOEs
were
784
and
468
respectively.
Aggregate
exposure
considers
all
exposures
from
food,
drinking
water,
and
residential
uses
together.
Probabilistic
models
and
methods
as
well
as
refined
data
for
these
scenarios
are
under
development.
In
the
interim,
as
a
screening
level
analysis
a
worstcase
deterministic
calculation
can
be
considered.
For
fluoxastrobin
this
would
consist
of
a
child
(
1
to
6)
who
has
a
chronic
dietary
exposure
to
potential
residues
in
food
and
also
plays
on
a
maximally
treated
lawn
(
after
4
applications)
on
a
particular
day.
The
childs
lawn
exposure
includes
estimates
of
dermal
exposure
and
oral
exposure
from
hand
to
mouth,
object
to
mouth
and
soil
ingestion
SOP
scenarios.
The
childs
estimated
dose
from
the
lawn
exposure
is
0.0194
mg/
kg
bwt/
day.
The
child
1
to
6
chronic
dietary
exposure
estimate
is
0.001907
mg/
kg
bwt/
day.
The
total
dose
for
a
child
1
to
6
with
this
worst­
case
exposure
is
0.0213
mg/
kg
bwt/
day
or
8.5%
of
the
acute
RfD.
The
resulting
aggregate
acute
DWLOC
is
2,287
ppb
still
well
above
the
acute
DWEC
of
58
ppb.
Total
adult
exposure
(
average
dietary
and
dermal
lawn)
is
0.004804
mg/
kg
bwt/
day
or
1.9%
of
the
acute
RfD.
The
resulting
aggregate
acute
DWLOC
for
adults
is
17,164
ppb.

D.
Cumulative
Effects
Fluoxastrobin
is
a
novel
strobilurin
analog.
Bayer
will
submit
information,
if
necessary,
for
EPA
to
consider
concerning
potential
cumulative
effects
of
fluoxastrobin
consistent
with
the
schedule
established
by
EPA
in
the
Federal
Register
of
August
4,
1997
(
62
FR
42020)
(
FRL
 
5734
 
6),
and
other
EPA
publications
pursuant
to
the
Food
Quality
Protection
Act
(
FQPA).

E.
Safety
Determination
1.
U.
S.
population.
Using
the
conservative
assumptions
described
above,
based
on
the
completeness
and
reliability
of
the
toxicity
data
it
is
concluded
that
aggregate
exposure
to
the
proposed
uses
of
fluoxastrobin
will
utilize
at
most
1.9%
of
the
RfD
for
the
U.
S.
population,
and
is
likely
to
be
much
less
as
more
realistic
data
and
models
are
developed.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
RfD
because
the
RfD
represents
the
level
at
or
below
which
daily
aggregate
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
DWLOC
based
on
this
exposure
are
much
greater
than
conservative
estimated
concentrations,
and
would
be
expected
to
be
well
below
the
100%
level,
if
they
occur
at
all.
Therefore,
there
is
a
reasonable
certainty
that
no
harm
will
occur
to
the
U.
S.
population
from
aggregate
exposure
to
fluoxastrobin.

2.
Infants
and
children.
Consideration
of
the
toxicology
data
base
as
described
above
leads
to
no
additional
concerns
for
infants
and
children.
Therefore
the
FQPA
safety
factor
can
be
established
at
1X.
Using
the
conservative
exposure
assumptions
described
in
the
exposure
section
above,
the
percent
of
the
RfD
that
will
be
used
for
short­
term
aggregate
exposure
to
residues
of
fluoxastrobin
will
be
8.5%
for
children
1
to
6
(
the
most
highly
exposed
subgroup
This
value
is
based
on
a
worstcase
aggregate
exposure
calculation
of
a
child
1
to
6
who
has
a
background
dietary
exposure
to
potential
residues
and
plays
on
a
maximally
treated
lawn.
As
in
the
adult
situation,
DWLOC
are
much
higher
than
the
worst­
case
DWECs
and
would
be
expected
to
use
well
below
100%
of
the
RfD,
if
they
occur
at
all.
Therefore,
there
is
a
reasonable
certainty
that
no
harm
will
occur
to
infants
and
children
from
aggregate
exposure
to
residues
of
fluoxastrobin.

F.
International
Tolerances
Codex
maximum
residue
levels
are
not
yet
established
for
fluoxastrobin.
[
FR
Doc.
03
 
9746
Filed
4
 
22
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
VerDate
Jan<
31>
2003
14:
42
Apr
22,
2003
Jkt
200001
PO
00000
Frm
00027
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
23APN1.
SGM
23APN1