48367
Federal
Register
/
Vol.
68,
No.
156
/
Wednesday,
August
13,
2003
/
Notices
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0259;
FRL
 
7320
 
6]

Pyraclostrobin;
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
 
0259,
must
be
received
on
or
before
September
12,
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:
Shaja
R.
Brothers,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
3194];
e­
mail
address:
brothers.
shaja@
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
ID
number
OPP
 
2003
 
0259.
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
on
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
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
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48368
Federal
Register
/
Vol.
68,
No.
156
/
Wednesday,
August
13,
2003
/
Notices
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
 
0259.
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
 
0259.
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
 
0259.
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
 
0259.
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.

Dated:
August
5,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petitions
The
petitioner's
summary
of
the
pesticide
petitions
are
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petitions
were
prepared
by
Interregional
Research
Project
Number
4
(
IR­
4)
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.

Interregional
Research
Project
Number
4
(
IR­
4)]

PP
2E6473,
PP
3E6548,
and
PP
3E6553
EPA
has
received
pesticide
petitions
[
PP
2E6473,
PP
3E6548,
and
PP
3E6553]
from
(
IR­
4),
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390
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
180.582
by
establishing
tolerances
for
combined
residues
of
the
fungicide
[
pyraclostrobin,
carbamic
acid,
[
2­[[[
1­
(
4­
chlorophenyl)­
1H­
pyrazol­
3­
yl]
oxy]
methyl]
phenyl]
methoxy­,
methyl
ester
and
its
desmethoxy
metabolite
methyl
2­[[[
1­(
4­
chlorophenyl)­

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E:\
FR\
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13AUN1.
SGM
13AUN1
48369
Federal
Register
/
Vol.
68,
No.
156
/
Wednesday,
August
13,
2003
/
Notices
pyrazol­
3­
yl]
oxy]
methyl]
phenyl
carbamate]
in
or
on
the
following
raw
agricultural
commodities:
[
lettuce,
leaf
and
lettuce,
head
at
22
parts
per
million
(
ppm)],
[
vegetable,
leaves
of
root
and
tuber,
group
2
at
16
ppm],
and
[
brassica,
head
and
stem,
subgroup
5A
at
5
ppm].
EPA
has
determined
that
the
petitions
contain
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
petitions.
Additional
data
may
be
needed
before
EPA
rules
on
the
petitions.
This
summary
has
been
prepared
by
Bayer
Corporation,
Research
Triangle
Park,
NC
27709.

A.
Residue
Chemistry
1.
Plant
metabolism.
Nature
of
the
residue
studies
(
OPPTS
860.1300)
were
conducted
in
grape,
potato
and
wheat
as
representative
crops
in
order
to
characterize
the
fate
of
pyraclostrobin
in
all
crop
matrices.
Pyraclostrobin
demonstrated
a
similar
pathway
and
fate
in
all
three
crops.
In
all
three
crops
the
pyraclostrobin
residues
of
concern
(
ROC)
of
were
characterized
as
parent
(
pyraclostrobin)
and
BAS
500­
3),
methyl­
N[[[
1­(
4­
chlorophenyl)
pyrazol­
3yl]
oxy]
o­
tolyl]
carbamate.
2.
Analytical
method.
In
plants
the
method
of
analysis
is
aqueous
organic
solvent
extraction,
column
clean
up
and
quantitation
by
LC/
MS/
MS.
In
animals
the
method
of
analysis
involves
base
hydrolysis,
organic
extraction,
column
clean
up
and
quantitation
by
LC/
MS/
MS
or
derivatization
(
methylation)
followed
by
quantitation
by
gas
chromatography/
mass
spectrometry
(
GC/
MS).
3.
Magnitude
of
residues.
Field
trials
were
carried
out
in
order
to
determine
the
magnitude
of
the
residue
in
the
following
crops:
Brassica,
head
and
stem;
lettuce,
head
and
leaf;
and
turnip
greens
to
satisfy
the
requirements
for
a
crop
group
tolerance
for
pyraclostrobin
in
leaves
of
root
and
tuber
vegetables.
Field
trials
were
carried
out
using
the
maximum
label
rate,
the
maximum
number
of
applications,
and
the
minimum
preharvest
interval
for
each
crop
or
crop
group.

B.
Toxicological
Profile
1.
Acute
toxicity.
Based
on
available
acute
toxicity
data
pyraclostrobin
and
its
formulated
products
do
not
pose
acute
toxicity
risks.
The
acute
toxicity
studies
place
technical
pyraclostrobin
in
toxicity
category
IV
for
acute
oral;
category
III
for
acute
dermal
and
category
II
for
acute
inhalation.
Pyraclostrobin
is
category
III
for
both
eye
and
skin
irritation,
and
it
is
not
a
dermal
sensitizer.
Two
formulated
end
use
products
are
proposed,
an
emulsifiable
concentrate
(
EC)
and
an
extruded
granule
(
EG).
The
EC
has
an
acute
oral
toxicity
category
of
II,
acute
dermal
of
III,
acute
inhalation
of
IV,
eye
and
skin
irritation
categories
of
III,
and
is
not
a
dermal
sensitizer.
The
WG
has
acute
oral
and
dermal
toxicity
categories
of
III,
acute
inhalation
of
IV,
eye
irritation
of
III,
skin
irritation
of
IV
and
is
not
a
dermal
sensitizer.
2.
Genotoxicity.
Ames
test
(
1
study;
point
mutation):
Negative;
in
vitro.
CHO/
HGPRT
Locus
Mammalian
Cell
Mutation
Assay
(
1
study;
point
mutation):
Negative;
in
vitro
V79
Cells
CHO
Cytogenetic
Assay
(
1
study;
chromosome
damage):
Negative;
in
vivo.
Mouse
micronucleus
(
1
study;
chromosome
damage):
Negative;
in
vitro
rat
hepatocyte
(
1
study;
DNA
damage
and
repair):
Negative;
pyraclostrobin
has
been
tested
in
a
total
of
5
genetic
toxicology
assays
consisting
of
in
vitro
and
in
vivo
studies.
It
can
be
stated
that
pyraclostrobin
did
not
show
any
mutagenic,
clastogenic
or
other
genotoxic
activity
when
tested
under
the
conditions
of
the
studies
mentioned
above.
Therefore,
pyraclostrobin
does
not
pose
a
genotoxic
hazard
to
humans.
3.
Reproductive
and
developmental
toxicity.
The
reproductive
and
developmental
toxicity
of
pyraclostrobin
was
investigated
in
a
2­
generation
rat
reproduction
study
as
well
as
in
rat
and
rabbit
teratology
studies.
There
were
no
adverse
effects
on
reproduction
in
the
two­
generation
study
so
the
no
observed
adverse
effect
level
(
NOAEL)
is
the
highest
dose
tested
(
HDT)
of
300
ppm
(
32.6
milligrams/
kilogram
body
weight/
day
(
mg/
kg
bwt/
day).
Parental
and
pup
toxicity
in
the
form
of
reduced
body
weight
gain
were
observed
at
the
HDT
only.
Therefore,
the
parental
systemic
and
developmental
toxicity
NOAEL's
are
the
same
at
75
ppm
(
8.2
mg/
kg
bwt).
No
teratogenic
effects
were
noted
in
either
the
rat
or
rabbit
developmental
studies.
In
the
rat
study,
maternal
toxicity
observed
at
the
mid
and
high
dose
consisted
of
decreased
food
consumption
and
body
weight
gain.
Developmental
changes
noted
at
the
high
dose
were
increased
incidences
of
dilated
renal
pelvis
and
cervical
ribs
with
no
cartilage.
The
maternal
NOAEL
was
10
mg/
kg
bwt
and
the
developmental
NOAEL
was
25
mg/
kg
bwt.
In
the
rabbit
teratology
study,
maternal
toxicity
observed
at
the
mid
and
high
doses
consisted
of
decreased
food
consumption
and
body
weight
gain
(
severe
at
the
high
dose).
An
increased
post­
implantation
loss
was
also
observed
at
the
mid
and
high
doses
due
to
an
increase
in
early
resorptions.
In
rabbits,
these
types
of
effects
are
often
observed
with
significant
stress
on
the
mothers
(
as
seen
by
the
body
weight
gain
decrease
in
this
study)
and
not
indicative
of
frank
developmental
toxicity.
The
NOAEL
for
both
maternal
and
developmental
toxicity
was
5
mg/
kg
bwt.
4.
Subchronic
toxicity.
The
subchronic
toxicity
of
pyraclostrobin
was
investigated
in
90
 
day
feeding
studies
with
rats,
mice,
and
dogs,
and
in
a
28
 
day
dermal
administration
study
in
rats.
A
90
 
day
neurotoxicity
study
in
rats
was
also
performed.
Generally,
mild
toxicity
was
observed.
At
high
dose
levels
in
feeding
studies,
general
findings
in
all
three
species
were
decreased
food
consumption
and
body
weight
gain
and
a
thickening
of
the
duodenum.
Anemia
occurred
at
high
dose
levels
in
both
rats
and
mice
with
accompanying
extramedullary
hematopoiesis
of
the
spleen
in
rats.
In
rats
only,
a
finding
of
liver
cell
hypertrophy
was
indicative
of
a
physiological
response
to
the
handling
of
the
chemical.
Overall,
only
mild
toxicity
was
observed
in
oral
subchronic
testing.
In
the
28
 
day
repeat
dose
dermal
study,
no
systemic
effects
were
noted
up
to
the
HDT
of
250
mg/
kg
bwt/
day.
In
a
90
 
day
rat
neurotoxicity
study,
a
direct
neurotoxic
effect
was
not
observed.
5.
Chronic
toxicity.
Pyraclostrobin
was
administered
to
groups
of
5
male
and
5
female
purebred
Beagle
dogs
in
the
diet
at
concentrations
of
0,
100,
200
and
400
ppm
over
a
period
of
12
months.
Signs
of
toxicity
were
observed
at
the
high
dose.
Diarrhea
was
observed
throughout
the
study
period
for
both
sexes.
High
dose
males
and
females
initially
lost
weight
and
body
weight
gain
was
decreased
for
the
entire
study
period
for
females.
Hematological
changes
observed
were
an
increase
in
white
blood
cells
in
males,
and
an
increase
in
platelets
in
both
sexes
at
the
high
dose.
Clinical
chemistry
demonstrated
a
decrease
in
serum
total
protein,
albumin,
globulins
and
cholesterol
in
high
dose
animals
of
both
sexes
possibly
due
to
the
diarrhea
and
reduced
nutritional
status
of
the
animals.
The
NOAEL
was
200
ppm
(
ca.
5.5
mg/
kg
bwt/
day
males;
5.4
mg/
kg
bwt/
day
females).
In
a
carcinogenicity
study,
pyraclostrobin
was
administered
to
groups
of
50
male
and
50
female
Wistar
rats
at
dietary
concentrations
of
0;
25;
75,
and
200
ppm
for
24
months.
In
a
companion
chronic
toxicity
study,
20
rats/
sex
were
used
at
the
same
dose
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Notices
levels
as
in
the
carcinogenicity
study.
A
body
weight
gain
depression
of
10
 
11%
in
males
and
14
 
22%
in
females
with
an
accompanying
decrease
in
food
efficiency
was
observed
at
the
high
dose.
The
only
other
effect
observed
was
a
decrease
in
serum
alkaline
phosphatase
in
both
sexes
at
the
high
dose
and
decreased
alanine
aminotransferase
in
high
dose
males.
There
was
no
evidence
that
pyraclostrobin
produced
a
carcinogenic
effect
in
rats.
The
NOAEL
for
the
chronic
rat
and
the
cancer
rat
study
is
75
ppm
(
ca.
3.4
mg/
kg
bwt/
day
males;
4.6
mg/
kg
bwt/
day
females).
Pyraclostrobin
was
administered
to
groups
of
50
male
and
50
female
B6C3F1
mice
at
dietary
concentrations
of
0,
10,
30,
120
and
180
ppm
(
females
only)
for
18
months.
Body
weights
were
reduced
at
the
HDT
in
both
males
and
females.
At
the
high
dose,
body
weight
gain
decreases
of
27%
in
females
and
29%
in
males
with
an
accompanying
decrease
in
food
efficiency
were
observed.
No
other
signs
of
toxicity
were
noted
at
any
dose
level.
The
NOAEL
was
found
to
be
120
ppm
(
ca.
20.5
mg/
kg
bwt/
day)
for
females
and
30
ppm
(
ca.
4.1
mg/
kg
bwt/
day)
for
males.
There
was
no
evidence
that
pyraclostrobin
produced
a
carcinogenic
effect
in
mice.
6.
Animal
metabolism.
In
a
rat
metabolism
study
with
pyraclostrobin,
10
 
13%
of
the
administered
dose
was
excreted
in
the
urine
and
74
 
91%
in
the
feces
within
48
hours.
Excretion
via
bile
was
significant
accounting
for
35­
38%
of
the
administered
dose.
By
120
hours
after
dosing,
very
little
radioactivity
remained
in
tissues.
Pyraclostrobin
was
rapidly
and
almost
completely
metabolized.
Very
little
unchanged
parent
was
detected.
The
phase
one
biotransformation
is
characterized
by
Ndemethoxylation
various
hydroxylations,
cleavage
of
the
ether
bond
and
further
oxidation
of
the
two
resulting
molecule
parts.
Conjugation
of
the
formed
hydroxyl
groups
by
glucuronic
acid
or
sulfate
also
occurred.
In
summary,
pyraclostrobin
is
extensively
metabolized
and
rapidly
eliminated
primarily
via
the
bile,
with
no
evidence
of
accumulation
in
tissues.
7.
Metabolite
toxicology.
A
comparison
of
the
rat
metabolism
results
with
the
plant
metabolism/
residue
results
indicates
that
toxicology
studies
performed
with
the
parent
pyraclostrobin
are
sufficient
to
cover
dietary
exposure.
Plant
residues
are
primarily
the
parent
compound
with
a
fraction
(
up
to
10­
20%
at
most)
being
the
demethoxylated
parent.
This
metabolite
is
referred
to
as
BF
500
 
3
in
the
plant
studies
and
as
500M07
in
the
rat
study.
This
metabolite
in
the
rat
is
the
first
step
in
the
major
biotransformation
process
leading
to
the
majority
of
the
metabolites
determined
in
the
major
excretion
pathway.
8.
Endocrine
disruption.
No
specific
test
has
been
conducted
with
pyraclostrobin
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
(
i.
e.,
subchronic
and
chronic
toxicity,
teratology
and
multigeneration
reproductive
studies)
which
would
suggest
that
pyraclostrobin
produces
endocrine
related
effects.
C.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food
Assessments
were
conducted
to
evaluate
the
potential
risk
due
to
chronic
and
acute
dietary
exposure
of
the
U.
S.
population
to
residues
of
pyraclostrobin
(
BAS
500
F).
This
fungicide
and
its
desmethoxy
metabolite
(
BAS
500­
3)
were
expressed
as
the
parent
compound
(
BAS
500
F).
Tolerance
values
have
previously
been
established
for
various
cereals,
vegetables,
fruits,
and
animal
products
and
are
listed
in
the
U.
S.
EPA
final
rule
published
in
the
Federal
Register
September
27,
2002
(
Vol
67,
No.
188,
p
60886
60902).
This
analysis
included
brassica
(
head
&
stem),
lettuce
(
head
&
leaf),
and
leaves
of
root
and
tuber
vegetables
as
the
target
crops.
The
dietary
assessment
analysis
followed
an
initial
tier
approach
with
only
one
refinement.
Default
processing
factors,
100%
crop
treated,
and
anticipated
residue
values
from
the
raw
agricultural
commodity
(
RAC)
field
studies
along
with
some
residue
tolerances
were
assumed
in
the
assessment.
The
CARES
1.1
model
with
the
CSFII/
FCID
consumption
data
were
used
to
calculated
acute
and
chronic
exposure
estimates.
Acute
dietary
exposure.
The
estimated
acute
dietary
exposure
estimates
for
the
crops
listed
were
well
under
100%
of
the
aPAD
at
the
95th
percentile
(
Table
2).
The
overall
general
population
and
the
most
sensitive
subpopulation
(
females
13
 
49
years)
utilized
<
0.15%
and
7.8%
of
the
aRfD,
respectively.
The
%
aPAD
ranged
from
0.1
to
22.9%
for
all
subpopulations.

Population
Exposure
Estimate
%
aRfD
%
aPAD
Subgroups
(
mg/
kg
bwt/
day)

Birth
to
1
year
>
0.00045
>.
02
>.
02
1
 
2
years
0.003053
0.10
0.10
3
 
5
years
0.003297
0.11
0.11
1
 
6
years
0.003215
0.11
0.11
6
 
12
years
0.002884
0.10
0.10
13
 
19
years
0.002515
0.08
0.08
Females
13
 
49
years
0.003888
7.78
22.87
Males
20
 
49
years
0.003405
0.11
0.11
Chronic:
Results
of
the
chronic
dietary
exposure
assessments
are
listed
below.
The
estimated
chronic
dietary
exposure
from
the
crops
listed
above
was
less
than
5.5%
and
16.5%
of
the
cRfD
and
cPAD
for
all
subpopulations,
respectively.

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13,
2003
/
Notices
Population
Exposure
Estimate
%
cRfD
%
cPAD
Subgroups
milligrams/
kilogram
body
weight/
day
(
mg/
kg
bwt/
day)

Birth
to
1
year
0.0002888
0.85
2.63
1
 
2
years
0.0013
3.82
11.82
3
 
5
years
0.001731
5.09
15.74
1
 
6
years
0.00161
4.74
14.64
6
 
12
years
0.001336
3.93
12.15
13
 
19
years
0.001788
5.26
16.25
Females
13
 
49
years
0.001788
5.26
16.25
Males
20
 
49
years
0.001577
4.64
14.34
Adults
50+
years
0.001647
4.84
14.97
Results
of
the
chronic
and
acute
dietary
exposure
analysis
demonstrate
a
reasonable
certainty
that
no
harm
to
the
general
U.
S.
population
or
any
subpopulation
would
results
from
the
use
of
pyraclostrobin
on
brassica
(
head
&
stem),
lettuce
(
head
&
leaf),
and
leaves
of
root
and
tuber
vegetables.
To
ensure
that
these
additional
uses
on
the
proposed
crops
fits
within
the
total
risk
cup,
a
dietary
exposure
assessment
(
as
described
above
considering
100%
CT
and
residue
values)
was
conducted
with
the
most
sensitive
subpopulation
(
females
13
 
49
years)
using
all
previously
registered
and
current
proposed
crops
for
pyraclostrobin.
The
dietary
risk
assessment
conducted
by
the
EPA
and
published
in
the
Federal
Register
(
Vol
67,
No.
188,
p
60886
60902)
showed
that
the
acute
dietary
exposure
for
all
subpopulation
groups
(
except
females
13
 
50
years
of
age)
was
<
1%
of
the
aPAD.
For
females
13
50
years
of
age,
the
acute
dietary
exposure
accounted
for
41%
of
the
aPAD.
The
EPA
dietary
assessment
was
considered
partially
refined
and
somewhat
conservative
since
the
percent
crop
treated
data,
some
concentration
factors,
and
tolerance
levels
were
used.
The
total
acute
dietary
exposure
for
females
13
 
49
years
of
age
from
currently
registered
and
proposed
new
uses
accounts
for
63.87%
(
22.87
+
41
=
63.87)
of
the
aPAD.
The
dietary
risk
assessment
conducted
by
the
EPA
and
published
in
the
Federal
Register
showed
that
the
highest
chronic
dietary
exposure
(
74%
of
the
cPAD)
occurred
in
children
1
 
6
years
of
age.
The
total
chronic
dietary
exposure
for
children
1
 
6
years
of
age
from
currently
registered
and
proposed
new
uses
accounts
for
88.64%
(
14.64
+
74
=
88.64)
of
the
cPAD.
2.
Drinking
Water
There
are
no
established
maximum
contaminant
levels
or
health
advisory
levels
for
residues
of
pyraclostrobin
(
BAS
500
F)
or
its
metabolite
in
drinking
water.
A
tier
1
drinking
water
modeling
assessment
for
pyraclostrobin
using
the
FIRST
model
(
for
surface
water)
and
SCI­
GROW
(
for
ground
water)
produced
estimated
maximum
concentrations
of
20.4
ppb
(
acute
surface
water),
0.74
parts
per
billion
(
ppb)
(
chronic
surface
water)
and
0.009
ppb
(
acute
and
chronic
groundwater).
These
estimated
concentrations
are
less
than
worst­
case
calculated
acceptable
drinking
water
levels
of
concern
(
DWLOC)
of
pyraclostrobin
residues
in
drinking
water
based
on
acute
and
chronic
aggregate
exposure
for
both
registered
and
pending
crops
(
see
table
below).

Child
Adult
female
Adult
male
(
1
 
6
years)
(
13
 
49
years)
(
20
 
49
years)

water
consumption
(
L)
1
2
2
weight
kilogram
(
kg)
10
60
70
cPAD
(
mg/
kg
bwt/
day)
0.011
0.011
0.011
food
exposure
(
mg/
kg
bwt/
day)
chronic
0.00981
0.00398
0.004377
Max.
water
exposure
(
mg/
kg
bwt/
day)­
chronic
0.00119
0.00702
0.006623
DWLOC
(
µ
g/
L)
chronic
11.9
210.6
231.8
aPAD
(
mg/
kg
bwt/
day)
3
0.017
3
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Child
Adult
female
Adult
male
Food
exposure
(
mg/
kg
bwt/
day)
­
acute
0.02521
0.01068
0.011705
max.
waterexposure
(
mg/
kg
bwt/
day)­
acute
2.97479
0.00632
2.988295
DWLOC
(
µ
g/
L)
­
acute
29747.9
189.6
104590
3.
Aggregate
Exposure
(
Diet
+
Water)

The
aggregate
exposure
of
pyraclostrobin
residues
is
summarized
in
the
table
below.
Although,
BASF
has
submitted
an
application
for
registration
of
pyraclostrobin
in
residential
turf
areas
(
March
2000),
this
particular
use
has
been
reserved
pending
the
outcome
of
EPA
reviews
of
additional
toxicology
studies
submitted
by
BASF,
and
therefore,
residential
exposure
was
not
included
in
the
aggregate
exposure
assessment.

Exposure
Infants
Children
Males
(
20
 
49
years)
Women
(
0­
1
years)
(
1
 
6
years)
(
13
 
50
years)

FOOD
(
mg/
kg
bwt/
day)

Acute
Exposure
(
registered
uses)
0.014
0.022
0.0083
0.0068
Acute
Exposure
(
new
uses)
0.00045
0.003215
0.003405
0.003888
Total
acute
exposure
0.01445
0.025215
0.011705
0.010688
Chronic
Exposure
(
registered
uses)
0.0034
0.0082
0.0028
0.0022
Chronic
Exposure
(
new
uses)
0.0002888
0.00161
0.001577
0.001788
Total
Chronic
Exposure
0.0036888
0.00981
0.004377
0.003988
%
aPAD
0.48
0.84
0.39
62.87
%
cPAD
33.53
89.18
39.79
36.25
WATER
Acute
Exposure
(
mg/
kg
b.
w./
day)
0.00204
0.00136
0.000583
0.000648
Chronic
Exposure
(
mg/
kg
b.
w./
day)
0.0000009
0.0000006
0.0000003
0.0000003
%
aPAD
0.07
0.05
0.02
3.81
%
aPAD
0.003
0.002
0.001
0.001
AGGREGATE
Acute
Exposure
(
mg/
kg
bwt/
day)
0.01649
0.026575
0.012288
0.011336
Chronic
Exposure
(
mg/
kg
bwt/
day)
0.0036897
0.0098106
0.0043773
0.0039883
%
aPAD
0.55
0.89
0.41
66.68
%
aPAD
33.54
89.19
39.79
36.26
These
results
indicate
the
aggregate
exposure
of
pyraclostrobin
(
registered
use
and
the
proposed
crops
in
this
document),
from
potential
residues
in
food
and
water,
will
not
exceed
the
U.
S.
EPA's
level
of
concern
(
100%
of
PAD).
Overall,
we
can
conclude
with
reasonable
certainty
that
no
harm
will
occur
from
either
acute
or
chronic
aggregate
exposure
of
pyraclostrobin
residues.
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.'
Pyraclostrobin
is
a
foliar
fungicide
which
belongs
to
the
new
class
of
strobilurin
chemistry.
It
is
a
synthetic
analog
of
strobilurin
A,
a
naturally
occurring
antifungal
metabolite
of
the
mushroom
Strobillurus
tenacellus
(
Anke
et.
al.,
1977).
The
active
ingredient
acts
in
the
fungal
cell
through
inhibition
of
electron
transport
in
the
mitochondrial
respiratory
chain
at
the
position
of
the
cytochrome­
bc1
complex.
The
protective
effect
is
due
to
the
resultant
death
of
the
fungal
cells
by
disorganization
of
the
fungal
membrane
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system.
Pyraclostrobin
also
acts
curatively
to
prevent
the
increase
and
spread
of
fungal
infections
by
inhibiting
mycelial
growth
and
sporulation
on
the
leaf
surface.
BAS
500F
inhibits
spore
germination,
germ
tube
growth
and
penetration
into
the
host
tissues.
The
EPA
is
currently
developing
methodology
to
perform
cumulative
risk
assessments.
At
this
time,
there
is
no
available
data
to
determine
whether
BAS
500F
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
pyraclostrobin
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.

E.
Safety
Determination.
U.
S.
population.
Adding
the
proposed
uses
to
those
crops
already
on
the
pyraclostrobin
label,
aggregate
exposure
to
adults
in
the
U.
S.
population
utilized
at
most
67%
of
the
aPAD
and
40%
of
the
cPAD.
Therefore,
no
harm
to
the
overall
U.
S.
population
would
result
from
the
use
of
pyraclostrobin
on
the
proposed
and
existing
label
crops.
Infants
and
children.
All
subpopulations
based
on
age
were
considered.
The
highest
potential
exposure
was
predicted
for
children
age
1­
6.
Using
the
FQPA
safety
factor
of
3X
when
appropriate,
the
addition
of
the
proposed
crops
to
those
on
the
label
would
use
less
than
1%
of
the
aPAD
and
use
89%
of
the
cPAD
for
children
age
1
 
6.
BASF
concludes
that
there
is
reasonable
certainty
that
no
harm
will
result
to
infants
or
children
from
aggregate
exposure
to
pyraclostrobin
residues
on
the
proposed
and
existing
label
crops.

F.
International
Tolerances.
Maximum
Residue
Levels
(
MRLs)
have
been
established
for
pyraclostrobin
in
Canada.
No
MRLs
have
been
established
by
the
Codex
Alimentarius
Commission.
[
FR
Doc.
03
 
20641
Filed
8
 
12
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0260];
FRL
 
7320
 
9]

S­
Metolachlor;
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
 
0260,
must
be
received
on
or
before
September
12,
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:
Hoyt
Jamerson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9368];
e­
mail
address:
jamerson.
hoyt@
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
ID
number
OPP
 
2003
 
0260.
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
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