Document ID: EPA-HQ-OPP-2003-0212-0001
Agency: epa
Document Type: Notice
Title: Indoxacarb; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-07-02T04:00Z

39541
Federal
Register
/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Notices
for
public
viewing
in
EDOCKET.
For
further
information
about
the
electronic
docket,
see
EPA's
notice
describing
the
electronic
docket
at
67
FR
38102
(
May
31,
2002),
or
go
to
www.
epa.
gov/
edocket.
Title:
NSPS
for
Flexible
Vinyl
and
Urethane
Coating
and
Printing
(
40
CFR
part
60,
subpart
FFF),
OMB
Control
Number
2060
 
0073,
EPA
ICR
Number
1157.07.
This
is
a
request
to
renew
an
existing,
approved
collection
that
is
scheduled
to
expire
on
June
30,
2003.
Under
OMB
regulations,
the
Agency
may
continue
to
conduct
or
sponsor
the
collection
of
information
while
this
submission
is
pending
at
OMB.
Abstract:
The
NSPS
for
Flexible
Vinyl
and
Urethane
Coating
and
Printing,
published
at
40
CFR
part
60,
subpart
FFF,
were
proposed
on
January
18,
1983,
and
promulgated
on
June
29,
1984.
These
standards
of
performance
for
this
category
of
new
stationary
sources
of
hazardous
air
pollutants
are
required
by
section
111
of
the
Clean
Air
Act.
Facilities
may
meet
the
standards
by
using
materials
with
a
low
concentration
of
Volatile
Organic
Compounds
(
VOCs),
or
by
installing
emission
control
devices.
The
information
that
is
required
to
be
submitted
to
the
Agency
or
kept
at
the
facility
is
needed
to
insure
compliance
with
the
regulation.
These
include
initial
one­
time
notifications,
performance
tests
plans
and
reports
and
records
of
maintenance
and
shutdown,
startup,
and
malfunctions.
For
facilities
that
install
continuous
monitoring
system
(
CMS)
there
are
performance
tests,
and
maintenance
reports.
Excess
emissions
reports
are
submitted
semiannually.
Responses
to
the
collection
of
information
are
mandatory
(
40
CFR
part
60,
subpart
FFF).
An
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to,
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
Control
Number.
The
OMB
Control
Numbers
for
EPA's
regulations
are
listed
in
40
CFR
part
9
and
48
CFR
chapter
15,
and
are
identified
on
the
form
and/
or
instrument,
if
applicable.
Burden
Statement:
The
annual
public
reporting
and
recordkeeping
burden
for
this
collection
of
information
are
estimated
to
average
14
(
rounded)
hours
per
response.
Burden
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
This
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
Respondents/
Affected
Entities:
Flexible
Vinyl
and
Urethane
Coating
and
Printing
Manufacturers.
Estimated
Number
of
Respondents:
20.
Frequency
of
Response:
Semiannually,
initially.
Estimated
Total
Annual
Hour
Burden:
593.
Estimated
Total
Capital
and
Operations
&
Maintenance
(
O
&
M)
Annual
Costs:
$
61,000.
Changes
in
the
Estimates:
There
is
an
increase
of
78
hours
in
the
total
estimated
burden
currently
identified
in
the
OMB
Inventory
of
Approved
ICR
Burdens.
This
increase
in
burden
from
the
most
recently
approved
ICR
is
due
to
more
accurate
estimates
of
existing
sources.
We
have
assumed
that
there
will
be
one
new
source
(
respondent)
over
the
three
years
period
of
this
ICR.
The
change
in
respondent
cost
is
also
due
to
a
labor
rate
change
where
the
rate
has
increased
over
the
three
years
period
of
this
ICR.

Dated:
June
24,
2003.
Doreen
Sterling,
Acting
Director,
Collection
Strategies
Division.
[
FR
Doc.
03
 
16734
Filed
7
 
1
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0212;
FRL
 
7312
 
9]

Indoxacarb;
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
 
0212,
must
be
received
on
or
before
August
1,
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:
Rita
Kumar,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8291;
e­
mail
address:
kumar.
rita@
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.
EPA
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
ID
number
OPP
 
2003
 
0212.
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
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16:
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39542
Federal
Register
/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Notices
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
 
0212.
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
 
0212.
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
 
0212.
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
 
0212.
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
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02JYN1.
SGM
02JYN1
39543
Federal
Register
/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Notices
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:
June
19,
2003.
Peter
Caulkins,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner's
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
E.
I.
Du
Pont
de
Nemours
and
Company,
Du
Pont
Crop
Protection,
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.

E.
I.
Du
Pont
de
Nemours
and
Company
Du
Pont
Crop
Protection
PP
3F6576
EPA
has
received
a
pesticide
petition
(
PP
3F6576)
from
E.
I.
Du
Pont
de
Nemours
and
Company,
Du
Pont
Crop
Protection,
Wilmington,
Delaware,
proposing
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug
and
Cosmetic
Act,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180,
by
establishing
a
tolerance
for
combined
residues
of
Indoxacarb,
[(
S)­
methyl
7­
chloro­
2,5­
dihydro­
2­
[(
methoxycarbonyl)[
4­
(
trifluoromethoxy)
phenyl]
amino]
carbonyl]
indeno[
1,2e]
[
1,3,4]
oxadiazine­
4a(
3H)­
carboxylate]
and
its
R­
enantiomer
[(
R)­
methyl
7­
chloro­
2,5­
dihydro­
2­
[[(
methoxycarbonyl)[
4­
(
trifluoromethoxy)
phenyl]
amino]
carbonyl]
indeno
[
1,2­
e]
[
1,3,4]
oxadiazine­
4a(
3H)­
carboxylate]
in
a
75:
25
mixture
(
DPX
MP062),
respectively,
in
or
on
the
raw
agricultural
commodity
as
follows:
grape,
2
ppm
and
raisin,
6
ppm.
An
analytical
enforcement
method
(
LC
 
UV)
is
available
for
determining
plant
residues.
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
The
active
ingredient
in
the
end­
use
formulation,
AvauntO 
,
is
a
75:
25
mixture
of
two
isomers,
indoxacarb
(
DPX
 
KN128)
and
IN
 
KN127.
Only
one
of
the
isomers,
indoxacarb
(
DPX
 
KN128),
has
insecticidal
activity.
Since
the
insecticidal
efficacy
is
based
on
the
concentration
of
indoxacarb
(
DPX
 
KN128),
the
application
rates
have
been
normalized
on
an
indoxacarb
(
DPX
 
KN128)
basis.
The
proposed
tolerance
expression
includes
both
indoxacarb
(
DPX
 
KN128)
and
IN
 
KN127
and
the
residue
method
does
not
distinguish
between
the
enantiomers,
therefore,
residues
are
reported
as
the
sum
of
indoxacarb
(
DPX
 
KN128)
combined
with
IN
 
KN127.
Residues
of
indoxacarb
(
DPX
 
KN128)
combined
with
IN
 
KN127
will
be
referred
to
as
``
KN128/
KN127''.
1.
Plant
metabolism
The
metabolism
of
indoxacarb
in
plants
is
adequately
understood
to
support
these
tolerances.
Plant
metabolism
studies
in
cotton,
lettuce,
and
tomatoes
showed
no
significant
metabolites.
The
only
significant
residue
was
parent
compound.
2.
Analytical
method.
The
plant
residue
enforcement
method
detects
and
quantitates
indoxacarb
in
various
matrices
including
sweet
corn,
lettuce,
tomato,
broccoli,
apple,
grape,
cottonseed,
tomato,
peanut
and
soybean
commodity
samples
by
HPLC
 
UV.
The
limit
of
quantitation
in
the
method
allows
monitoring
of
crops
with
indoxacarb
residues
at
or
above
the
levels
proposed
in
these
tolerances.
3.
Magnitude
of
residues
 
a.
Grapes.
Residue
studies
were
conducted
at
a
total
of
13
field
sites.
All
studies
were
done
using
Avaunt
 
Insecticide
containing
30%
active
ingredient
(
300
grams
(
g)
DPX
 
KN128
per
kilogram
(
kg),
weight/
weight
(
w/
w).
Four
broadcast
applications
of
Avaunt
 
.
Insecticide
were
made
at
each
test
site
at
a
maximum
rate
of
0.11
lb.
active
ingredient
(
a.
i.)
DPX
 
KN128/
acre/
application
(
maximum
seasonal
use
rate
of
0.44
lb
DPX
 
KN128/
acre).
Applications
were
made
approximately
5
days
apart.
Residues
were
measured
as
the
combination
of
DPX­
KN128
and
IN
 
KN127
(
enantiomers
not
resolved
by
the
analytical
method).
Maximum
residues
of
KN128/
KN127
in
individual
duplicate
samples
were
1.72parts
per
million
(
ppm)
at
a
pre­
harvest
interval
(
PHI)
of
7
days
(
range
0.066
to
1.72
ppm.
b.
Grape
processing.
A
grape
processing
study
was
also
performed
in
California.
Grapes
received
four
applications
of
an
exaggerated
rate
of
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No.
127
/
Wednesday,
July
2,
2003
/
Notices
0.555
lb.
of
indoxacarb
per
acre,
5X
the
labeled
rate.
Samples
were
collected
from
control
and
treated
plots
7
days
after
the
last
application.
The
grape
samples
were
then
processed
using
standard
grape
processing
procedures.
Samples
collected
at
the
processing
facility
were
whole
fruit,
raisins
and
grape
juice.
The
mean
KN128/
KN127
residues
in
whole
fruit,
raisins
and
grape
juice
treated
with
the
exaggerated
rate
were
1.34
ppm,
3.66
ppm
and
<
0.01
ppm,
respectively.

B.
Toxicological
Profile
1.
Acute
toxicity.
Based
on
EPA
criteria,
indoxacarb
is
classified
as
follows
for
toxicity
categories:

Guideline
Title
Results
Category
81
 
1
Acute
oral
toxicity
LD50:
1,730
milligrams/
kilogram
(
mg/
kg)
(
M
Rat)
LD50:
268
mg/
kg/(
F
Rat)
Category
II
81
 
2
Acute
dermal
toxicity
LD50:
>
5,000
mg/
kg
(
Rat)
Category
IV
81
 
3
Acute
inhalation
toxicity
LC50:>
5.5
(
milligrams/
per
Liter
(
mg/
L)
(
M
Rat)
(
70%
MUP)
Category
IV
81
 
4
Primary
eye
irritation
Effects
reversed
within
72
hours
(
Rabbit)
Category
III
81
 
5
Primary
dermal
irritation
No
irritation
(
Rabbit)
Category
IV
81
 
6
Skin
sensitization
Sensitizer
(
Guinea
Pig)

Formulated
products
are
slightly
less
acutely
toxic
than
indoxacarb.
In
an
acute
neurotoxicity
study,
indoxacarb
exhibited
decreased
forelimb
grip
strength,
decreased
foot
splay,
and
some
evidence
of
slightly
reduced
motor
activity,
but
only
at
the
highest
doses
tested.
The
no
adverse
effects
level
(
NOAEL)
was
100
mg/
kg
for
males
and
12.5
mg/
kg
for
females
based
on
body
weight
effects
in
females
>
50
mg/
kg.
2.
Genotoxicty.
Indoxacarb
has
shown
no
genotoxic
activity
in
the
following
listed
in­
vitroand
in­
vivotests:
i.
Ames
 
Negative
ii.
In­
vitro
mammalian
gene
mutation
(
CHO/
HGPRT)
 
Negative
iii.
In­
vitro
unscheduled
DNA
synthesis
 
Negative
iv.
In­
vitro
chromosomal
aberration
 
Negative
v.
In­
vivo
mouse
micronucleus
 
Negative
3.
Reproductive
and
developmental
toxicity.
The
results
of
a
series
of
studies
indicated
that
there
were
no
reproductive,
developmental
or
teratogenic
hazards
associated
with
the
use
of
indoxacarb.
In
a
2­
generation
rat
reproduction
study,
the
parental
NOAEL
was
1.5
mg/
kg/
day.
The
parental
NOAEL
was
based
on
observations
of
reduced
weight
gain
and
food
consumption
for
the
higher
concentration
groups
of
the
F0
generation,
and
potential
treatmentrelated
changes
in
spleen
weights
for
the
higher
groups
of
the
F1
generation.
There
was
no
effect
on
mating
or
fertility.
The
NOAEL
for
fertility
and
reproduction
was
6.4
mg/
kg/
day.
The
offspring
NOAEL
was
1.5
mg/
kg/
day,
and
was
based
on
the
reduced
mean
pup
weights
noted
for
the
F1
litters
of
the
higher
concentration
groups.
The
effects
on
pup
weights
occurred
only
at
a
maternal
effect
level
and
may
have
been
due
to
altered
growth
and
nutrition
in
the
dams.
In
studies
conducted
to
evaluate
developmental
toxicity
potential,
indoxacarb
was
neither
teratogenic
nor
uniquely
toxic
to
the
conceptus
(
i.
e.,
not
considered
a
developmental
toxin).
Developmental
studies
conducted
in
rats
and
rabbits
demonstrated
that
the
rat
was
more
susceptible
than
the
rabbit
to
the
maternal
and
fetal
effects
of
DPX
 
MP062.
Developmental
toxicity
was
observed
only
in
the
presence
of
maternal
toxicity.
The
NOAEL
for
maternal
and
fetal
effects
in
rats
was
2
mg/
kg/
day
based
on
body
weight
effects
and
decreased
food
consumption
at
4
mg/
kg/
day.
The
NOAEL
for
developmental
effects
in
fetuses
was
>
4
mg/
kg/
day.
In
rabbits,
the
maternal
and
fetal
NOAELS
were
500
mg/
kg/
day
based
on
body
weight
effects,
decreased
food
consumption
in
dams
and
decreased
weight
and
delayed
ossification
in
fetuses
at
1,000
mg/
kg/
day.
4.
Subchronic
toxicity.
Subchronic
(
90­
day)
feeding
studies
were
conducted
with
rats,
mice,
and
dogs.
In
a
90­
day
feeding
study
in
rats,
the
NOAEL
was
3.1
and
2.1
mg/
kg/
day
for
males
and
females,
respectively.
In
male
rats,
the
NOAEL
was
based
on
decreased
body
weight
and
nutritional
parameters,
mild
hemolytic
anemia
and
decreased
total
protein
and
globulin
concentration.
In
female
rats,
the
NOAEL
was
based
on
decreased
body
weight
and
food
efficiency.
In
a
subchronic
neurotoxicity
study
in
rats,
there
was
no
evidence
of
neurotoxicity
at
11.9
and
6.09
mg/
kg/
day,
the
highest
dose
tested
for
males
and
females,
respectively.
The
subchronic
NOAEL
in
dogs
(
5.0
mg/
kg/
day,
M/
F)
was
based
on
hemolytic
anemia.
Erythrocyte
values
for
most
dogs
were
within
a
range
that
would
be
considered
normal
for
dogs
in
a
clinical
setting.
Mice
were
less
sensitive
to
indoxacarb
than
the
rats
or
dogs.
NOAELs
(
23
mg/
kg/
day,
males,
16
mg/
kg/
day,
females)
were
based
on
mortality
(
males
only);
increased
reticulocytes
and
Heinz
bodies
and
decreased
body
weight,
weight
gain,
food
consumption,
food
efficiency;
and
increased
clinical
signs
(
leaning
to
one
side
and/
or
with
abnormal
gait
or
mobility)
(
females
only).
In
a
28­
day
repeated
dose
dermal
study,
the
NOAEL
was
50
mg/
kg/
day
based
on
decreased
body
weights,
body
weight
gains,
food
consumption,
and
food
efficiency
in
females,
and
changes
in
hematology
parameters,
the
spleen
and
clinical
signs
of
toxicity
in
both
sexes
in
rats.
5.
Chronic
toxicity.
Chronic
studies
with
indoxacarb
were
conducted
on
rats,
mice,
and
dogs
to
determine
oncogenic
potential
and/
or
chronic
toxicity
of
the
compound.
Effects
generally
similar
to
those
observed
in
the
90­
day
studies
were
seen
in
the
chronic
studies.
Indoxacarb
was
not
oncogenic
in
rats
or
mice.
The
chronic
NOAEL
in
male
rats
was
5
mg/
kg/
day
based
on
body
weight
and
nutritional
effects.
In
females,
the
NOAEL
of
2.1
mg/
kg/
day
was
based
on
body
weight
and
nutritional
changes,
as
well
as
biologically
significant
hematologic
changes
at
3.6
mg/
kg/
day
and
above.

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2,
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Notices
Hemolytic
effects
were
present
only
through
the
6­
month
evaluation
and
only
in
females.
The
regenerative
nature
of
indoxacarb­
induced
hemolytic
anemia
was
demonstrated
by
the
absence
of
significant
changes
in
indicators
of
circulating
erythrocyte
mass
at
later
evaluations.
In
mice,
the
chronic
NOAEL
of
2.6
mg/
kg/
day
for
males
was
based
on
deceased
body
weight
and
weight
gain
effects
and
food
efficiency
at
13.8
mg/
kg/
day
and
above.
The
NOAEL
for
females
was
4.0
mg/
kg/
day
based
on
body
weight
nutritional
effects,
neurotoxicity,
and
clinical
signs
at
20
mg/
kg/
day.
In
dogs,
the
chronic
NOAEL
was
about
2.3
and
2.4
mg/
kg/
day
in
males
and
females,
respectively
based
on
hemolytic
effects
similar
to
those
seen
in
the
subchronic
dog
study.
6.
Animal
metabolism
 
i.
Livestock
animal
metabolism.
Animal
metabolism
has
been
studied
in
the
rat,
hen,
and
cow
and
is
well
understood.
In
contrast
to
crops,
indoxacarb
is
extensively
metabolized
in
animals.
ii
Poultry.
In
poultry,
hens
were
fed
at
10
ppm/
day
for
5
days,
87
 
88%
of
the
total
administered
dose
was
excreted;
parent
comprised
51
 
54%
of
the
total
dose
in
excreta.
Concentration
of
residues
in
eggs
were
low,
0.3
 
0.4
of
the
total
dose,
as
was
the
concentration
of
residues
in
muscle,
0.2%
of
the
total
dose.
Parent
and
metabolite
IN
 
JT333
were
not
detected
in
egg
whites;
only
insecticidally
inactive
metabolites
were
identified.
Parent
and
IN
 
JT333
were
found
in
egg
yolks;
however,
their
concentrations
were
very
low­
0.01­
0.02
ppm.
Concentrations
of
parent
and
IN
 
JT333
in
muscle
were
at
or
below
the
limit
of
quantitation,
(
LOQ)
(
0.01
ppm).
iii.
Cattle.
For
the
cow
study,
the
cattle
were
fed
at
10
ppm/
day
for
5
days;
approximately
20%
of
the
total
administered
dose
was
excreted
in
urine
and
53
 
60%
was
excreted
in
feces
in
5
days.
Four­
tenths
to
1.2%
of
the
total
dose
in
urine
was
parent
indicating
extensive
metabolism;
parent
represented
46
 
68%
of
the
fecal
activity.
Thus,
most
residues
were
not
absorbed;
those
residues
that
were
absorbed
were
extensively
metabolized.
Less
than
1%
of
the
total
administered
dose
was
in
milk,
most
of
which
was
parent
compound.
The
insecticidally
active
metabolite
IN
 
JT333
was
not
found
in
milk.
Residues
in
muscle
represented
less
than
0.01%
of
the
total
administered
dose
most
of
which
was
parent.
IN
 
JT333
was
not
detected
in
muscle.
No
other
metabolites
were
seen
above
10%
of
the
dose,
thus
only
parent
and
IN
 
JT333
were
monitored
in
the
cattle
feeding
study.
iv.
Cattle
feeding
study.
A
cattle
feeding
study
was
conducted
with
indoxacarb
at
doses
of
7.5
ppm,
22.5
and
75
ppm.
The
mean
KN128/
KN127
concentrations
were
proportional
to
the
dosing
level
in
whole
milk,
skim
milk,
cream,
muscle,
fat,
liver
and
kidney.
Based
on
final
residue
values
for
the
respective
commodities
contributing
to
the
cattle
diet,
the
anticipated
dietary
burden
in
dairy
cattle
is
51.7
ppm
and
the
anticipated
dietary
burden
in
beef
cattle
is
49.1
ppm.
The
proposed
grape
use
will
not
increase
the
animal
dietary
burden.
Based
on
standard
curves
constructed
from
data
in
the
cattle
feeding
study,
KN128/
KN127
concentrations
at
the
51.7
ppm
feeding
level
are
0.123
ppm
for
whole
milk,
0.033
ppm
for
skim
milk
and
1.46
ppm
for
cream.
The
KN128/
KN127
concentrations
at
the
49.1
ppm
feeding
level
are
0.046
ppm
for
muscle,
1.37
ppm
for
fat,
0.012
ppm
for
liver
and
0.026
ppm
for
kidney.
Tolerances
have
been
established
at
1.5
ppm
in
fat
(
cattle,
goat,
horse,
sheep
and
hog),
0.05
ppm
in
meat,
0.03
ppm
in
meat
byproducts
0.15
ppm
in
milk
and
4.0
ppm
in
milk
fat.
7.
Metabolite
toxicology.
In
rats,
indoxacarb
was
readily
absorbed
at
low
dose
(
5
mg/
kg),
but
saturated
at
the
high
dose
(
150
mg/
kg).
Indoxacarb
was
metabolized
extensively,
based
on
very
low
excretion
of
parent
compound
in
bile
and
extensive
excretion
of
metabolized
dose
in
the
urine
and
feces.
Some
parent
compound
remained
unabsorbed
and
was
excreted
in
the
feces.
No
parent
compound
was
excreted
in
the
urine.
The
retention
and
elimination
of
the
metabolite
IN­
JT333
from
fat
appeared
to
be
the
overall
rate
determining
process
for
elimination
of
radioactive
residues
from
the
body.
Metabolites
in
urine
were
cleaved
products
(
containing
only
one
radiolabel),
while
the
major
metabolites
in
the
feces
retained
both
radiolabels.
Major
metabolic
reactions
included
hydroxylation
of
the
indanone
ring,
hydrolysis
of
the
carboxylmethyl
group
from
the
amino
nitrogen
and
the
opening
of
the
oxadiazine
ring,
which
gave
rise
to
cleaved
products.
Metabolites
were
identified
by
mass
spectral
analysis,
NMR,
ultraviolet
(
UV),
and/
or
by
comparison
to
standards
chemically
synthesized
or
produced
by
microsomal
enzymes.
8.
Endocrine
disruption.
Lifespan,
and
multigenerational
bioassays
in
mammals,
and
acute
and
subchronic
studies
on
aquatic
organisms
and
wildlife
did
not
reveal
endocrine
effects.
Any
endocrine
related
effects
would
have
been
detected
in
this
definitive
array
of
required
tests.
The
probability
of
any
such
effect
due
to
agricultural
uses
of
indoxacarb
is
negligible.
C.
Aggregate
Exposure
Tolerances
for
indoxacarb
are
proposed
to
support
agricultural
use
on
grapes.
There
are
residential
uses
of
indoxacarb
pending
(
fire
ant
bait),
however,
the
risk
from
that
use
has
been
found
to
be
negligible.
1.
Dietary
exposure.
The
chronic
reference
dose
(
RfD)
of
0.02
mg/
kg
bwt/
day
is
based
on
a
NOAEL
of
2.0
mg/
kg
bwt/
day
from
the
subchronic
rat
feeding
study,
the
subchronic
rat
neurotoxicity
study,
and
the
chronic/
carcinogenicity
study,
using
an
uncertainty
factor
of
100.
The
acute
RfD
for
the
general
population
is
0.12
mg/
kg/
day,
based
on
the
NOAEL
of
12.5
mg/
kg
in
the
acute
neurotoxicity
study
and
an
uncertainty
factor
of
100.
The
acute
RfD
for
females
13
 
50
years
of
age
is
0.02
mg/
kg/
day,
based
on
the
NOAEL
of
2
mg/
kg/
day
observed
in
the
developmental
rat
toxicity
study
and
using
an
uncertainty
factor
of
100.
i.
Food.
Chronic
dietary
exposure
assessment.
Chronic
dietary
exposure
resulting
from
the
currently
approved
use
of
indoxacarb
on
apples,
Crop
group
5
(
brassica
vegetables),
cotton,
pears,
peppers,
sweet
corn,
tomatoes,
eggplant,
alfalfa,
head
and
leaf
lettuce,
peanuts,
potatoes,
soybeans,
cranberries
(
current
Section
18
use)
and
the
proposed
use
on
grapes
are
well
within
acceptable
limits
for
all
sectors
of
the
population.
The
Chronic
Module
of
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM,
Exponent,
Inc.,
formerly
Novigen
Sciences,
Inc.,
Version
7.76)
was
used
to
conduct
the
assessment
with
the
reference
dose
(
RfD)
of
0.02
mg/
kg/
day.
The
analysis
used
overall
mean
field
trial
values,
processing
factors
and
projected
peak
percent
crop
treated
values.
Secondary
residues
in
milk,
meat
and
poultry
products
were
also
included
in
the
analysis.
The
chronic
dietary
exposure
to
indoxacarb
is
0.000089
mg/
kg/
day,
and
utilizes
0.4%
of
the
RfD
for
the
overall
U.
S.
population.
The
exposure
of
the
most
highly
exposed
subgroup
in
the
population,
children
age
1
 
6
years,
is
0.000238
mg/
kg/
day,
and
utilizes
1.2%
of
the
RfD.
The
table
below
lists
the
results
of
this
analysis,
which
indicate
large
margins
of
safety
for
each
population
subgroup
and
very
low
probability
of
effects
resulting
from
chronic
exposure
to
indoxacarb.

Subgroup
Maximum
Dietary
Exposure
(
mg/
kg/
day)
%
RfD
U.
S
Population
0.000089
0.4
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2003
/
Notices
Subgroup
Maximum
Dietary
Exposure
(
mg/
kg/
day)
%
RfD
Non­
Nursing
Infants
(<
1
year
old)
0.000063
0.3
Children
(
1
 
6
years)
0.000238
1.2
Children
(
7
 
12
years)
0.000126
0.6
Females
(
13+,
nursing)
0.000073
0.4
Males
(
13
 
19
years)
0.000090
0.5
ii.
Acute
dietary
exposure.
Acute
dietary
exposure
resulting
from
the
currently
approved
use
of
indoxacarb
on
apples,
Crop
Group
5
(
brassica
vegetables),
cotton,
pears,
peppers,
sweet
corn,
tomatoes,
eggplant,
alfalfa,
head
and
leaf
lettuce,
peanuts,
soybeans,
potatoes,
cranberries
(
current
Section
18
use)
and
the
proposed
use
on
grapes
are
well
within
acceptable
limits
for
all
sectors
of
the
population.
The
Dietary
Exposure
Evaluation
Model
(
DEEMTM,
Exponent,
Inc.,
formerly
Novigen
Sciences,
Inc.,
Version
7.76)
was
used
to
conduct
the
assessment.
Margins
of
exposure
(
MOE)
were
calculated
based
on
an
acute
NOAEL
of
2
mg/
kg/
day
for
women
of
childbearing
age
and
a
NOAEL
of
12
mg/
kg/
day
for
children
and
the
general
population
(
Pesticide
Fact
Sheet
for
Indoxacarb).
The
Tier
3
analysis
used
distributions
of
field
trial
residue
data
adjusted
for
projected
peak
percent
crop
treated.
Secondary
residues
in
milk,
meat
and
poultry
products
were
also
included
in
the
analysis.
The
results
of
this
analysis
are
given
in
the
table
below.
The
percent
of
the
acute
population
adjusted
dose
(
a
PAD)
for
all
population
subgroups
shows
that
an
adequate
margin
of
safety
exists
in
each
case.
Thus,
the
acute
dietary
safety
of
indoxacarb
for
established
and
the
follow­
on
use
clearly
meets
the
Food
Quality
Protection
Act
(
FQPA)
standard
of
reasonable
certainty
of
no
harm
and
presents
acceptable
acute
dietary
risk.

Subgroup
99.9th
Percentile
of
exposure
Exposure
(
mg/
kg/
day)
%
Acute
population
adjusted
dose
(
aPAD)

U.
S.
population
0.008795
7.3
Subgroup
99.9th
Percentile
of
exposure
Exposure
(
mg/
kg/
day)
%
Acute
population
adjusted
dose
(
aPAD)

All
infants
0.024729
20.6
Non­
nursing
(<
1
year)
0.026036
21.7
Children
(
1
 
6
years)
0.013973
11.6
Children
(
7
 
12
years)
0.006882
5.7
Females
(
13
 
19
years)
0.005119
25.6
Females
(
20+,
not
pregnant
or
nursing)
0.005358
26.8
Females
(
13
 
50
years)
0.005307
26.5
iii.
Drinking
water.
Indoxacarb
is
highly
unlikely
to
contaminate
groundwater
resources
due
to
its
immobility
in
soil,
low
water
solubility,
high
soil
sorption,
and
moderate
soil
half­
life.
Based
on
the
PRZM/
EXAMS
and
SCI
 
GROW
models
the
estimated
environmental
concentrations
(
EECs)
of
indoxacarb
and
its
R­
enantiomer
for
acute
exposures
are
estimated
to
be
6.84
parts
per
billion
(
ppb)
for
surface
water
and
0.0025
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
0.316
ppb
for
surface
water
and
0.0025
ppb
for
ground
water.
Drinking
water
levels
of
comparisons
(
DWLOCs),
theoretical
upper
allowable
limits
on
the
pesticide's
concentration
in
drinking
water,
were
calculated
to
be
much
higher
than
the
EEC's.
The
chronic
DWLOC's
ranged
from
198
to
697
ppb.
The
acute
DWLOC's
ranged
from
440
to
3,890
ppb.
Thus,
exposure
via
drinking
water
is
acceptable.
2.
Non­
dietary
exposure.
Indoxacarb
product
registrations
for
residential
nonfood
uses
are
pending.
Nonoccupational
non­
dietary
exposure
for
DPX
 
MP062
has
been
estimated
to
be
extremely
small.
Therefore,
the
potential
for
non­
dietary
exposure
is
insignificant.

D.
Cumulative
Effects
EPA's
consideration
of
a
common
mechanism
of
toxicity
is
not
necessary
at
this
time
because
there
is
no
indication
that
toxic
effects
of
indoxacarb
would
be
cumulative
with
those
of
any
other
chemical
compounds.
Oxadiazine
chemistry
is
new,
and
indoxacarb
has
a
novel
mode
of
action
compared
to
currently
registered
active
ingredients.

E.
Safety
Determination
1.
U.
S.
population.
Dietary
and
occupational
exposure
will
be
the
major
routes
of
exposure
to
the
U.
S.
population,
and
ample
margins
of
safety
have
been
demonstrated
for
both
situations.
The
chronic
dietary
exposure
to
indoxacarb
is
0.000089
mg/
kg/
day,
which
utilizes
0.4%
of
the
RfD
for
the
overall
U.
S.
population,
using
mean
field
trial
values,
processing
factors
and
projected
peak
percent
crop
treated
values.
The
percent
of
the
acute
population
adjusted
dose
(
7.3%
aPAD)
for
the
overall
U.
S.
population
shows
that
an
adequate
margin
of
safety
exists.
Using
only
pesticide
handlers
exposure
data
base
(
PHED)
data
levels
A
and
B
(
those
with
a
high
level
of
confidence),
margin
of
exposure
(
MOEs)
for
occupational
exposure
are
650
for
mixer/
loaders
and
1,351
for
airblast
applicators
(
worst­
case).
Based
on
the
completeness
and
reliability
of
the
toxicity
data
and
the
conservative
exposure
assessments,
there
is
a
reasonable
certainty
that
no
harm
will
result
from
the
aggregate
exposure
of
residues
of
indoxacarb
including
all
anticipated
dietary
exposure
and
all
other
non­
occupational
exposures.
2.
Infants
and
children.
Chronic
dietary
exposure
of
the
most
highly
exposed
subgroup
in
the
population,
children
age
1
 
6
years,
is
0.000238
mg/
kg/
day
or
1.2%
of
the
RfD.
For
infants
(
non­
nursing,
<
1
yr.),
the
exposure
accounts
for
0.3%
of
the
RfD.
For
acute
exposure
at
the
99.9th
percentile
(
based
on
a
Tier
3
assessment)
the
exposure
was
0.013973
mg/
kg/
day
(
11.6%
a
PAD)
for
children
1
 
6
and
0.026036
mg/
kg/
day
(
21.7%
a
PAD)
for
non­
nursing
infants.
There
are
residential
uses
of
indoxa
carb
pending,
but
exposure
is
calculated
to
be
extremely
minimal.
The
estimated
levels
of
indoxa
carb
in
drinking
water
are
well
below
the
below
the
DWLOC.
Based
on
the
completeness
and
reliability
of
the
toxicity
data,
the
lack
of
toxicological
endpoints
of
special
concern,
the
lack
of
any
indication
that
children
are
more
sensitive
than
adults
to
indoxa
carb,
and
the
conservative
exposure
assessment,
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
the
aggregate
exposure
of
residues
of
indoxa
carb,
including
all
anticipated
dietary
exposure
and
all
other
nonoccupational
exposures.
Accordingly,
there
is
no
need
to
apply
an
additional
safety
factor
for
infants
and
children.

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Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Notices
F.
International
Tolerances
To
date,
no
international
tolerances
exist
for
indoxacarb.
[
FR
Doc.
03
 
16739
Filed
7
 
1
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0211;
FRL
 
7312
 
8]

Dinotefuran;
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
 
0211,
must
be
received
on
or
before
August
1,
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:
Rita
Kumar,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8291;
e­
mail
address:
kumar.
rita@
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
 
0211.
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
EPA's
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
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