Document ID: EPA-HQ-OPP-2003-0102-0001
Agency: epa
Document Type: Notice
Title: Fludioxonil; Notice of Filing Pesticide Petitions to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-04-02T05:00Z

16046
Federal
Register
/
Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Notices
b.
Chronic
drinking
water
risk.
Chronic
DWLOCs
were
calculated
based
on
a
cPAD
of
0.0006
mg/
kg/
day.
For
the
chronic
assessment,
the
non­
nursing
infants
subpopulation
generated
the
lowest
chronic
DWLOC
of
approximately
5.5
ppb.
EPA
has
determined
that
the
surface
water
chronic
EEC
is
0.77
ppb
and
the
ground
water
EEC
is
1.9
ppb.
Since
the
ground
water
value
is
greater
than
the
surface
water
value,
the
ground
water
value
will
be
used
for
comparison
purposes
and
will
protect
for
any
concerns
for
surface
water
concentrations.
Since
the
chronic
DWLOC
of
5.5
ppb
is
higher
than
the
chronic
EEC
of
1.9
ppb,
Syngenta
believes
that
EPA
should
not
have
a
concern
for
chronic
risk
to
either
surface
or
ground
water.
c.
Lifetime
drinking
water
risk.
Based
on
currently
registered
and
proposed
uses
for
thiamethoxam,
Syngenta
has
determined
a
DWLOC
of
2.0
ppb.
At
the
currently
registered
maximum
use
rate
of
0.125
lbs.
a.
i.
per
acre
per
growing
season,
EPA
has
used
the
SCI­
GROW
model
to
predict
a
ground
water
EEC
of
1.9
ppb.
Thus,
the
ground
water
EEC
is
below
the
lifetime
DWLOC
for
the
general
population.
The
Agency
used
a
screening
level
model
designed
to
estimate
pesticide
concentrations
in
shallow
ground
water.
A
number
of
factors
demonstrate
that
the
actual
lifetime
exposure
through
drinking
water
will
be
less
than
the
lifetime
DWLOC.
These
reasons
are
as
follows:
 
Thiamethoxam
is
a
systemic
pesticide.
EPA's
Tier
I
ground
water
model
assumes
that
all
of
the
product
that
is
applied
to
the
crop
is
available
for
run
off.
Syngenta
has
submitted
data
to
show
that
a
percentage
(
15
 
25%)
of
the
product
is
absorbed
by
the
plant,
resulting
in
that
much
less
product
available
to
leach
into
ground
water.
Although,
data
submitted
is
on
only
two
crops
(
beans
and
cucumbers),
it
is
likely
that
the
total
amount
of
thiamethoxam
available
for
ground
water
leaching
is
less
than
the
amount
EPA
uses
as
a
model
input.
 
Although,
the
Agency
model
is
based
on
aerobic
soil
half
lives,
EPA's
lifetime
risk
assessment
is
for
lifetime
exposure.
Data
indicate
the
anaerobic
aquatic
half­
life
for
thiamethoxam
is
shorter
than
the
aerobic
soil
half­
life
and
longer
than
the
aerobic
aquatic
halflife
Although,
EPA
is
unable
to
predict,
with
a
high
degree
of
certainty,
what
happens
to
thiamethoxam
ground
water
over
time,
this
does
provide
some
support
for
the
expectation
that
concentrations
in
ground
water
will
decline
between
annual
applications.
 
Shallow
ground
water
modeling
is
not
the
perfect
model
for
representing
all
drinking
water
from
ground
water
sources.
It
is
likely
to
be
an
over
estimate
of
most
drinking
water
concentrations,
which
tend
to
originate
from
deeper
sources.
EPA's
experience
is
that
the
model
is
reasonably
accurate
for
shallow
drinking
water,
but
it
is
less
accurate
for
estimating
concentrations
in
drinking
water
from
deeper
sources.
 
The
Agency
has
established
conditions
of
registration
for
the
previous
uses
that
include
two
prospective
ground
water
studies
and
a
retrospective
monitoring
study,
so
that
the
reasonable
certainty
of
no
harm
finding
will
be
sustained.
Preliminary
results
have
indicated
no
detections
of
thiamethoxam
in
ground
water.
 
The
dietary
food
risk
is
based
on
residue
data
derived
from
the
average
of
field
trials,
which
were
performed
at
a
higher
application
rate
than
what
was
accepted
by
EPA.
It
is
not
unusual
in
the
Agency's
experience
for
field
trial
data
to
be
an
order
of
magnitude
above
actual
monitoring.
Since
thiamethoxam
has
only
recently
been
registered,
actual
monitoring
data
are
not
yet
available.
It
is
likely
that
the
actual
risk
contribution
from
food
will
be
much
lower
than
current
data
indicate,
which
would
result
in
a
larger
lifetime
DWLOC.
Syngenta
expects
that
this
refined
lifetime
DWLOC
would
be
larger
than
the
EECs
for
the
proposed
uses.
Based
on
the
previous
points,
Syngenta
does
not
expect
that
the
general
population
would
be
exposed
to
levels
exceeding
the
lifetime
DWLOC.
2.
Non­
dietary
exposure.
Thiamethoxam
is
not
currently
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.

D.
Cumulative
Effects
The
potential
for
cumulative
effects
of
thiamethoxam
and
other
substances
that
have
a
common
mechanism
of
toxicity
has
also
been
considered.
Thiamethoxam
belongs
to
a
new
pesticide
chemical
class
known
as
the
neonicotinoids.
There
is
no
reliable
information
to
indicate
that
toxic
effects
produced
by
thiamethoxam
would
be
cumulative
with
those
of
any
other
chemical
including
another
pesticide.
Therefore,
Syngenta
believes
it
is
appropriate
to
consider
only
the
potential
risks
of
thiamethoxam
in
an
aggregate
risk
assessment.

E.
Safety
Determination
Syngenta
concludes,
as
described
above,
that
there
is
reasonable
certainty
that
no
harm
to
the
U.
S.
population
will
result
from
aggregate
acute
or
chronic
dietary
exposure
to
thiamethoxam
residues
including
the
proposed
commodities.
F.
International
Tolerances
There
are
no
codex
MRLs
established
for
residues
of
thiamethoxam.
[
FR
Doc.
03
 
7803
Filed
4
 
1
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0102;
FRL
 
7299
 
6]

Fludioxonil;
Notice
of
Filing
Pesticide
Petitions
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
 
0102,
must
be
received
on
or
before
May
2,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Sidney
Jackson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
7610;
e­
mail
address:
jackson.
sidney@
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.
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.
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
VerDate
Jan<
31>
2003
15:
59
Apr
01,
2003
Jkt
200001
PO
00000
Frm
00067
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
02APN1.
SGM
02APN1
16047
Federal
Register
/
Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Notices
entities
not
listed
in
this
unit
could
also
be
affected.
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
 
0102.
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
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
 
0102.
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
 
0102.
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
VerDate
Jan<
31>
2003
15:
59
Apr
01,
2003
Jkt
200001
PO
00000
Frm
00068
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
02APN1.
SGM
02APN1
16048
Federal
Register
/
Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Notices
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001,
Attention:
Docket
ID
number
OPP
 
2003
 
0102.
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
 
0102.
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:
March
25,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petitions
The
petitioner's
summary
of
the
pesticide
petitions
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petitions
was
prepared
by
the
petitioner
and
represents
the
views
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.
The
Interregional
Research
Project
Number
4
(
IR­
4)
prepared
and
submitted
the
pesticide
petitions
to
EPA
on
behalf
of
Syngenta
Crop
Protection,
Inc.,
the
registrant.

Interregional
Research
Project
Number
4
PP
2E6486,
2E6462,
3E6526,
and
2E6448
EPA
has
received
pesticide
petitions
2E6486,
2E6462,
3E6526,
and
2E6448,
from
the
IR­
4
Project,
Center
for
Minor
Crop
Pest
Management,
Rutgers,
The
State
University
of
New
Jersey,
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
180.516
by
establishing
tolerances
for
residues
of
fludioxonil,
4­(
2,2­
difluoro­
1,3­
benzodioxol­
4­
yl)­
H­
pyrrole­
3­
carbonitrile,
in
or
on
the
following
raw
agricultural
commodities:
1.
PP
2E6486
proposes
tolerances
as
follows:
 
Brassica,
head
and
stem
subgroup
5a
at
1.5
parts
per
million
(
ppm).
 
Brassica,
leafy
greens
subgroup
5b
at
9.0
ppm.
 
Turnip,
greens
at
9.0
ppm.
2.
PP
2E6462
proposes
a
tolerance
for
carrot
at
0.5
ppm.
3.
PP
3E6526
proposes
a
tolerance
for
herb
subgroup
19a
at
33.0
ppm.
4.
PP
2E6448
proposes
a
tolerance
for
the
following:
 
Longan
at
2.0
ppm.
 
Lychee
at
2.0
ppm.
 
Pulasan
at
2.0
ppm.
 
Rambutan
at
2.0
ppm.
 
Spanish
lime
at
2.0
ppm.
Pending
PP
3E6526
proposes
a
tolerance
for
herb
subgroup
19a
at
33.0
ppm.
A
tolerance
currently
exist
for
fludioxonil
on
herbs
and
spices
at
0.02
ppm
(
40
CFR
180.516).
This
notice
proposes
amending
40
CFR
180.516
as
follows:
1.
Delete
existing
herbs
and
spices
tolerance
of
0.02
ppm
and
establish
a
seperate
herb
subgroup
19a
tolerance
at
33.0
ppm.
2.
Establish
a
seperate
spice
subgroup
19b
tolerance
at
0.02
ppm.
As
the
result
of
this
proposed
amendment,
the
pending
herb
subgroup
19a
tolerance
at
33.0
ppm
precludes
the
need
for
the
existing
herbs
tolerance
of
0.02
ppm.
Moreover,
the
existing
spices
tolerance
of
0.02
ppm
is
changed
to
spice
subgroup
19b
at
0.02
ppm.
Additional
data
may
be
needed
before
EPA
rules
on
the
petitions.
Syngenta
Crop
Protection,
Inc.,
Greensboro,
NC
27409
is
the
manufacturer
of
the
chemical
pesticide,
fludioxinil.
Syngenta
prepared
and
submitted
the
following
summary
of
information,
data,
and
arguments
in
support
of
the
pesticide
petitions.
This
summary
does
not
necessarily
reflect
the
findings
of
EPA.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
metabolism
of
fludioxonil
is
adequately
understood
for
the
purpose
of
the
proposed
tolerances.
2.
Analytical
method.
Syngenta
has
developed
and
validated
analytical
methodology
for
enforcement
purposes.
This
method
(
Syngenta
Crop
Protection
VerDate
Jan<
31>
2003
15:
59
Apr
01,
2003
Jkt
200001
PO
00000
Frm
00069
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
02APN1.
SGM
02APN1
16049
Federal
Register
/
Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Notices
Method
AG­
597B)
has
passed
an
Agency
petition
method
validation
for
several
commodities
and
is
currently
the
enforcement
method
for
fludioxonil.
This
method
has
also
been
forwarded
to
the
Food
and
Drug
Administration
for
inclusion
into
PAM
II.
An
extensive
data
base
of
method
validation
data
using
this
method
on
various
crop
commodities
is
available.
3.
Magnitude
of
residues.
Complete
residue
data
for
Brassica,
head
and
stem
(
subgroup
5e.
c.),
Brassica
leafy
greens
(
subgroup
5e.
c.),
turnip,
greens,
herb
(
subgroup
19e.
c.),
and
lychee,
longan,
rambutan,
pulasan,
and
Spanish
lime
have
been
submitted.
The
requested
tolerances
are
adequately
supported
by
field
research
data.

B.
Toxicological
Profile
An
assessment
of
toxic
effects
caused
by
fludioxonil
is
discussed
in
Unit
III.
A.
and
Unit
III.
B.
of
the
Federal
Register
of
August
2,
2002
(
67
FR
50354)
(
FRL
 
7188
 
7).
1.
Animal
metabolism.
The
metabolism
of
fludioxonil
in
rats
is
adequately
understood.
2.
Metabolite
toxicology.
The
residues
of
concern
for
tolerance
setting
purposes
is
fludioxonil,
the
parent
compound.
Consequently,
there
is
no
additional
concern
for
toxicity
of
metabolites.
3.
Endocrine
disruption.
Fludioxonil
does
not
belong
to
a
class
of
chemicals
known
for
having
adverse
effects
on
the
endocrine
system.
No
estrogenic
effects
have
been
observed
in
the
various
shortterm
and
long­
term
studies
conducted
with
various
mammalian
species.

C.
Aggregate
Exposure
1.
Dietary
exposure.
A
Tier
III
acute
and
chronic
dietary
exposure
evaluation
was
made
using
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM),
version
7.76
from
exponent.
Empirically
derived
processing
studies
for
apple
juice
(
0.09X),
apple
pomace
(
6.77X),
and
grape
juice
(
0.36X)
were
used
in
these
assessments.
The
apple
juice
processing
factor
was
used
as
a
surrogate
for
pear
juice
and
all
other
processing
factors
used
DEEMTM
defaults.
All
consumption
data
for
these
assessments
were
taken
from
the
U.
S.
Department
Agriculture
(
USDA)
Continuing
Survey
of
Food
Intake
by
Individuals
(
CSFII)
with
the
1994
 
96
consumption
data
base
and
the
Supplemental
CSFII
children's
survey
(
1998)
consumption
data
base.
These
exposure
assessments
included
all
registered
uses
and
uses
proposed
in
this
submission:
Brassica,
head
and
stem
(
subgroup
5e.
c.),
Brassica,
leafy
greens
(
subgroup
5e.
c.),
turnip,
greens,
carrot,
herbs
(
subgroup
19e.
c.),
lychee,
longan,
and
Spanish
lime.
Secondary
residues
in
animal
commodities
were
estimated
based
on
theoretical
worst­
case,
yet
nutritionally
adequate
animal
diets
and
transfer
information
from
feeding
studies.
i.
Food.
For
the
purposes
of
assessing
the
potential
dietary
exposure
under
the
proposed
tolerances,
Syngenta
Crop
Protection
has
estimated
aggregate
exposure
from
all
crops
for
which
tolerances
are
established
or
proposed.
These
assessments
utilized
residue
data
from
field
trials
where
fludioxonil
was
applied
at
the
maximum
intended
use
rate
and
samples
were
harvested
at
the
minimum
pre­
harvest
interval
(
PHI)
to
obtain
maximum
residues.
Percent
of
crop
treated
(
PCT)
values
were
estimated
based
upon
economic,
pest
and
competitive
pressures.
The
values
used
in
these
assessments
were:
All
seed
treatment
uses,
100%;
apricots
and
pistachios,
10%;
cherries,
16%;
nectarines,
49%;
onions,
9%;
peaches,
22%;
plums,
25%;
other
stone
fruit,
20%;
strawberries,
42%;
watercress,
95%;
berries,
13%;
salal,
13%;
herbs,
80%;
crop
group
5e.
c.
and
5e.
c.,
carrots,
and
lychee,
turnips
and
longan
10%.
ii.
Acute
exposure.
An
acute
reference
dose
(
aRfD)
of
1.0
milligram/
kilogram
body
weight
(
mg/
kg/
bwt)
day
for
the
females
13
 
50
years
subpopulation
only
was
based
on
a
no
observed
adverse
effect
level
(
NOAEL)
of
100
mg/
kg/
bwt
day
from
a
rat
teratology
study
and
an
uncertainty
factor
of
100X.
No
additional
FQPA
safety
factor
was
applied.
For
the
purpose
of
aggregate
risk
assessment,
the
exposure
value
was
expressed
in
terms
of
margin
of
exposure
(
MOE)
which
was
calculated
by
dividing
the
NOAEL
by
the
exposure
for
each
population
subgroup.
In
addition,
exposure
was
expressed
as
a
percent
of
the
aRfD.
Acute
exposure
to
the
females
13
 
50
years
subpopulation
resulted
in
a
MOE
of
9,933
(
1.01%)
of
the
aRfD
of
the
1.0
mg/
kg
bwt/
day.
Since
the
benchmark
MOE
for
the
assessment
was
100
and
since
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
RfD,
Syngenta
believes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
dietary
(
food)
exposure
to
residues
arising
from
the
current
and
proposed
uses
for
fludioxonil.
iii.
Chronic
exposure.
The
chronic
reference
dose
(
cRfD)
for
fludioxonil
is
0.033
mg/
kg
bwt/
day
and
is
based
on
a
1
 
year
study
in
dogs
with
a
NOAEL
of
3.3
mg/
kg
bwt/
day
and
an
Uncertainty
Factor
(
UF)
of
100X.
No
additional
Food
Quality
Protection
Act
(
FQPA)
safety
factor
was
applied.
The
fludioxonil
Tier
III
chronic
dietary
exposure
assessment
was
based
upon
residue
field
trial
results.
For
the
purpose
of
aggregate
risk
assessment,
the
exposure
values
were
expressed
in
terms
of
MOE
which
was
calculated
by
dividing
the
NOAEL
by
the
exposure
for
each
population
subgroup.
In
addition,
exposure
was
expressed
as
a
percent
of
the
RfD.
Chronic
exposure
to
the
most
exposed
subpopulation
(
children
1
and
2
years
old)
resulted
in
a
MOE
of
2,668
(
3.75%)
of
the
cRfD
of
0.033
mg/
kg
bwt/
day.
Since
the
benchmark
MOE
for
this
assessment
was
100
and
since
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
RfD,
Syngenta
believes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
dietary
(
food)
exposure
to
residues
arising
from
the
current
and
proposed
uses
for
fludioxonil.
iv.
Drinking
water.
Another
potential
source
of
exposure
of
the
general
population
to
residues
of
fludioxonil
are
residues
in
drinking
water.
Fludioxonil
rapidly
degrades
via
photolysis
on
the
soil
surface
and
in
water.
The
half­
lives
are
1
day
and
10
days,
respectively.
This
potential
for
rapid
degradation
reduces
the
potential
for
ground
water
or
surface
water
exposure.
Fludioxonil
soil/
solution
partition
coefficients
vary
from
991
to
2,440
indicating
a
relatively
high
affinity
for
binding
to
soil.
Estimated
Environmental
Concentrations
(
EECs)
of
fludioxonil
in
drinking
water
were
determined
for
the
highest
use
rate
of
fludioxonil
(
turfgrass
use).
Sceening
Concentration
in
Ground
Water
(
SCIGROW
(
Version
2.2)
was
used
to
determine
acute
and
chronic
ECCs
in
ground
water
and
FQPA
Index
Reservior
Screening
Tool
(
FIRST)
(
Version
1.0)
was
used
to
determine
acute
and
chronic
estimated
environmental
concentrations
in
surface
water.
Based
on
the
model
outputs,
the
ECCs
of
fludioxonil
are
0.174
parts
per
billion
(
ppb)
for
acute
and
chronic
exposure
to
ground
water
and
70
ppb
and
33
ppb
for
acute
and
chronic
exposure,
respectively,
to
surface
water.
Acute
Drinking
Water
Levels
of
Comparison
(
DWLOC)
were
calculated
based
on
an
acute
Populated
Adjusted
Dose
(
aPAD)
of
1
mg/
kg/
day.
For
the
acute
assessment,
the
females
(
13
 
50
years)
subpopulation
generated
an
acute
DWLOC
of
approximately
30,000
ppb.
Thus,
the
acute
DWLOC
of
30,000
ppb
is
considerably
higher
than
the
acute
EEC
of
70
ppb.
Chronic
DWLOC
were
calculated
based
on
a
cRfD
of
0.033
mg/
kg/
day.
For
the
chronic
assessment,
the
children
1
and
2
years
old
subpopulation
generated
the
lowest
chronic
DWLOC
of
approximately
320
ppb.
Thus,
the
chronic
DWLOC
of
320
ppb
is
considerably
higher
than
the
chronic
EEC
of
33
ppb.

VerDate
Jan<
31>
2003
15:
59
Apr
01,
2003
Jkt
200001
PO
00000
Frm
00070
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
02APN1.
SGM
02APN1
16050
Federal
Register
/
Vol.
68,
No.
63
/
Wednesday,
April
2,
2003
/
Notices
2.
Non­
dietary
exposure.
There
is
a
potential
residential
post­
application
exposure
to
adults
and
children
entering
residential
areas
treated
with
fludioxonil.
Since
the
Agency
did
not
select
a
short­
term
endpoint
for
dermal
exposure,
only
intermediate
dermal
exposures
were
considered.
Based
on
the
residential
use
pattern,
Syngenta
believes
that
no
long­
term
postapplication
residential
exposure
is
expected.
3.
Chronic
aggregate
exposure.
Based
on
the
completeness
and
reliability
of
the
toxicity
data
supporting
these
petitions,
Syngenta
believes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
residues
arising
from
all
current
and
proposed
fludioxonil
uses,
including
anticipated
dietary
exposure
from
food,
water,
and
all
other
types
of
nonoccupational
exposures.

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.''
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
fludioxonil
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
For
the
purposes
of
this
tolerance
action,
EPA
has
not
assumed
that
fludioxonil
has
a
common
mechanism
of
toxicity
with
other
substances.

E.
Safety
Determination
The
chronic
dietary
exposure
analysis
(
food
only)
showed
that
exposure
from
all
established
and
proposed
fludioxonil
uses
would
be
3.75%
of
the
cRfD
for
the
most
sensitive
subpopulation,
children
1
and
2
years
old.
Additionally,
for
females
13
 
50
years
old,
the
acute
dietary
exposure
analysis
(
food
only)
showed
that
exposure
from
all
established
and
proposed
fludioxonil
uses
would
be
1.01%
of
the
aPAD.
EPA
has
determined
that
reliable
data
support
using
the
standard
MOE
and
uncertainty
factor
(
100
for
combined
interspecies
and
intraspecies
variability)
for
fludioxonil
and
that
an
additional
safety
factor
of
10
is
not
necessary
to
be
protective
of
infants
and
children.
Acute
DWLOCs
were
calculated
based
on
an
aPAD
of
1
mg/
kg/
day.
For
the
acute
assessment,
the
females
(
13
 
50
years)
subpopulation
generated
an
acute
DWLOC
of
approximately
30,000
ppb.
The
acute
EEC
of
70
ppb
is
considerably
less
than
30,000
ppb.
For
the
chronic
assessment,
the
children
1
and
2
years
old
subpopulation
generated
the
lowest
chronic
DWLOC
of
approximately
320
ppb.
Thus,
the
chronic
DWLOC
of
320
ppb
is
considerably
higher
than
the
chronic
EEC
of
33
ppb.
Syngenta
has
considered
the
potential
aggregate
exposure
from
food,
water
and
nonoccupational
exposure
routes
and
concluded
that
aggregate
exposure
is
not
expected
to
exceed
100%
of
the
cRfD
and
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
the
aggregate
exposure
to
fludioxonil.

F.
International
Tolerances
There
are
no
Codex
maximum
residue
levels
established
for
fludioxonil.
[
FR
Doc.
03
 
7977
Filed
4
 
1
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0352;
FRL
 
7286
 
2]

Experimental
Use
Permit;
Receipt
of
Application
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
receipt
of
an
application
524
 
EUP
 
OA
from
Monsanto
Company
requesting
an
experimental
use
permit
(
EUP)
for
the
Bacillus
thuringiensis
Cry3Bb1
protein
and
the
genetic
material
necessary
for
its
production
(
vector
ZMIR39)
in
corn.
The
Agency
has
determined
that
the
application
may
be
of
regional
and
national
significance.
Therefore,
in
accordance
with
40
CFR
172.11(
a),
the
Agency
is
soliciting
comments
on
this
application.

DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2002
 
0352,
must
be
received
on
or
before
May
2,
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:
Mike
Mendelsohn,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8715;
e­
mail
address:
mendelsohn.
mike@
epa.
gov.

SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
This
action
may,
however,
be
of
interest
to
those
persons
who
are
interested
in
agricultural
biotechnology
or
may
be
required
to
conduct
testing
of
chemical
substances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
or
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA).
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
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
 
2002
 
0352.
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.
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
VerDate
Jan<
31>
2003
15:
59
Apr
01,
2003
Jkt
200001
PO
00000
Frm
00071
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
02APN1.
SGM
02APN1