Document ID: EPA-HQ-OPP-2003-0125-0001
Agency: epa
Document Type: Proposed Rule
Title: Indoxacarb; Proposed Pesticide Tolerance
Posted Date: 2003-04-16T04:00Z

18582
Federal
Register
/
Vol.
68,
No.
73
/
Wednesday,
April
16,
2003
/
Proposed
Rules
final
rule
will
be
withdrawn
and
all
public
comments
received
will
be
addressed
in
a
subsequent
final
rule
based
on
this
proposed
rule.
The
EPA
will
not
institute
a
second
comment
period.
Any
parties
interested
in
commenting
on
this
action
should
do
so
at
this
time.
DATES:
Comments
must
be
received
in
writing
by
May
16,
2003.
ADDRESSES:
Written
comments
should
be
mailed
to
Kristeen
Gaffney,
Acting
Chief,
Permits
and
Technical
Assessment
Branch,
Mailcode
3AP11,
U.
S.
Environmental
Protection
Agency,
Region
III,
1650
Arch
Street,
Philadelphia,
Pennsylvania
19103.
Copies
of
the
documents
relevant
to
this
action
are
available
for
public
inspection
during
normal
business
hours
at
the
Air
Protection
Division,
U.
S.
Environmental
Protection
Agency,
Region
III,
1650
Arch
Street,
Philadelphia,
Pennsylvania
19103
and
District
of
Columbia
Department
of
Public
Health,
Air
Quality
Division,
51
N
Street,
NE.,
Washington,
DC
20002.
FOR
FURTHER
INFORMATION
CONTACT:
Paresh
R.
Pandya,
(
215)
814
 
2167,
or
by
e­
mail
at
pandya.
perry@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
For
further
information,
please
see
the
information
provided
in
the
direct
final
action,
with
the
same
title,
that
is
located
in
the
``
Rules
and
Regulations''
section
of
this
Federal
Register
publication.

Dated:
April
9,
2003.
James
W.
Newsom,
Acting
Regional
Administrator,
Region
III.
[
FR
Doc.
03
 
9344
Filed
4
 
15
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0125;
FRL
 
7302
 
3]

Indoxacarb;
Proposed
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Proposed
rule.

SUMMARY:
This
document
proposes
to
establish
a
temporary
tolerance
for
combined
residues
of
Indoxacarb,
(
S)­
methyl
7­
chloro­
2,5­
dihydro­
2­
[[(
methoxy
carbonyl)
[
4­(
trifluor
omethoxy)
phenyl]
amino]
carbonyl]
indeno[
1,2­
e][
1,3,4]
oxadiazine­
4a(
3H)­
carboxylate
+
its
R­
enantiomer
[(
R)­
methyl
7­
chloro­
2,5­
dihydro­
2­
[[(
methoxycarbonyl)[
4­(
trifluoro
methoxy)
phenyl]
amino]
carbonyl]
indeno
[
1,2­
e][
1,3,4]
oxadiazine­
4a(
3H)­
carboxylate
in
or
on
peaches
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
This
action
is
in
response
to
university
extension
specialists,
DuPont
Crop
Protection,
and
EPA's
combined
efforts
to
generate
the
information
necessary
for
use
of
the
reduced
risk
pesticide,
Indoxacarb,
on
peaches
for
control
of
oriental
fruit
moth
and
plum
cuculio.
This
proposed
temporary
tolerance
supports
a
non­
crop
destruct
experimental
use
permit
(
EUP)
under
section
5
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
authorizing
use
of
Indoxacarb
on
peaches
in
Georgia,
Michigan,
New
Jersey,
Pennsylvania,
South
Carolina,
and
West
Virginia.
This
regulation
proposes
to
establish
a
maximum
permissible
level
for
residues
of
Indoxacarb
in
this
food
commodity
pursuant
to
section
408(
e)
of
FFDCA,
as
amended
by
FQPA.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0125,
must
be
received
on
or
before
May
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
Code
111)
 
Animal
production
(
NAICS
Code
112)
 
Food
manufacturing
(
NAICS
Code
311)
 
Pesticide
manufacturing
(
NAICS
Code
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
 
0125.
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/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
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
restricted
by
statute,
which
is
not
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16APP1.
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18583
Federal
Register
/
Vol.
68,
No.
73
/
Wednesday,
April
16,
2003
/
Proposed
Rules
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
e­
mail
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
 
0125.
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
 
0125.
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
 
0125.
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
 
0125.
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.

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FR\
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16APP1.
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16APP1
18584
Federal
Register
/
Vol.
68,
No.
73
/
Wednesday,
April
16,
2003
/
Proposed
Rules
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.
Offer
alternative
ways
to
improve
the
proposed
rule
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
document.
8.
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.
Background
and
Statutory
Findings
EPA,
in
cooperation
with
DuPont
Crop
Protection
and
university
extension
specialists,
under
section
408(
e)
of
the
FFDCA,
21
U.
S.
C.
346a,
is
proposing
to
establish
a
tolerance
for
combined
residues
of
the
insecticide
Indoxacarb,
in
or
on
peaches
at
10.0
parts
per
million
(
ppm).
This
action
is
in
response
to
university
extension
specialists,
DuPont,
and
EPA's
combined
efforts
to
generate
the
information
necessary
for
registration
of
the
reduced
risk
pesticide,
Indoxacarb,
on
peaches
for
control
of
oriental
fruit
moth
and
plum
cuculio.
This
proposed
temporary
tolerance
supports
a
noncrop
destruct
experimental
use
permit
(
EUP)
under
section
5
of
FIFRA
authorizing
use
of
Indoxacarb
on
peaches
in
Georgia,
Michigan,
New
Jersey,
Pennsylvania,
South
Carolina,
and
West
Virginia.
Section
5
of
FIFRA
authorizes
EPA
to
issue
an
experimental
use
permit
for
a
pesticide.
This
provision
was
not
amended
by
FQPA.
EPA
has
established
regulations
governing
such
experimental
use
permits
in
40
CFR
part
172.
Section
408(
r)
of
FFDCA
authorizes
EPA
to
issue
temporary
tolerances
for
pesticide
residues
from
FIFRA
experimental
use
permits.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue
*
*
*''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
of
the
FFDCA
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).

III.
Aggregate
Risk
Assessment
and
Determination
of
Safety
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action.
EPA
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
a
tolerance
for
combined
residues
of
Indoxacarb
on
peaches
at
10.0
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerance
follows.

A.
Toxicological
Profile
EPA
has
evaluated
the
available
toxicity
data
and
considered
its
validity,
completeness,
and
reliability
as
well
as
the
relationship
of
the
results
of
the
studies
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
The
nature
of
the
toxic
effects
caused
by
Indoxacarb
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no­
observed­
adverse­
effect­
level
(
NOAEL)
and
the
lowest­
observedadverse
effect­
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90
 
Day
oral
toxicity
rodents
DPX­
MP062
NOAEL
=
M
3.1
mg/
kg/
day
F
2.1
mg/
kg/
day
LOAEL
=
M
6.0
mg/
kg/
day,
F
3.8
mg/
kg/
day
based
on
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency.

870.3150
90
 
Day
oral
toxicity
in
nonrodents
DPX­
JW062
NOAEL
=
5.0
mg/
kg/
day
LOAEL
=
19
mg/
kg/
day
based
on
hemolytic
anemia,
as
indicated
by
decrease
in
HGB,
RBCs;
increases
in
platelets,
increased
reticulocytes;
and
secondary
histopathologic
findings
indicative
of
blood
breakdown
(
pigment
in
Kupffer
cells,
renal
tubular
epithelium,
and
spleen
and
bone
marrow
macrophages);
increase
in
splenic
EMH;
and
RBC
hyperplasia
in
bone
marrow
in
dogs.

870.3200
21/
28
 
Day
dermal
toxicity
DPX­
MP062
NOAEL
=
2,000
mg/
kg/
day
LOAEL
=
>
2,000
mg/
kg/
day
in
rats.
DPX­
MP062
NOAEL
=
50
mg/
kg/
day
LOAEL
=
500
mg/
kg/
day
based
on
decreased
body
weights,
body
weight
gains,
food
consumption,
and
food
efficiency
in
F*,
and
changes
in
hematology
parameters
(
increased
reticulocytes),
the
spleen
(
increased
absolute
and
relative
weight
M*
only,
gross
discoloration),
clinical
signs
of
toxicity
in
both
sexes
in
rats.

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73
/
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April
16,
2003
/
Proposed
Rules
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.3700
Prenatal
developmental
in
rodents
DPX­
MP062
Maternal
NOAEL
=
2.0
mg/
kg/
day
LOAEL
=
4.0
mg/
kg/
day
based
on
decreased
mean
body
weights,
body
weight
gains,
food
consumption.
Developmental
NOAEL
=
2.0
mg/
kg/
day
LOAEL
=
4.0
mg/
kg/
day
based
on
decreased
fetal
weights.
DPX­
JW062
Maternal
NOAEL
=
10
mg/
kg/
day
LOAEL
=
100
mg/
kg/
day
based
on
mortality,
clinical
signs,
and
decreased
mean
body
weights,
body
weight
gains,
and
food
consumption.
Developmental
NOAEL
=
10
mg/
kg/
day
LOAEL
=
100
mg/
kg/
day
based
on
decreased
numbers
of
live
fetuses/
litter.
DPX­
JW062
Maternal
NOAEL
=
1.1
mg/
kg/
day
LOAEL
=
2.2
mg/
kg/
day
based
on
decreased
mean
body
weights,
body
weight
gains,
food
consumption,
and
food
efficiency.
Developmental
NOAEL
=
1.1
kg/
day
LOAEL
=
2.2
mg/
kg/
day
based
on
decreased
fetal
body
weights.

870.3700
Prenatal
developmental
in
nonrodents
DPX­
JW062
­
rabbits
Maternal
NOAEL
=
500
mg/
kg/
day
LOAEL
=
1,000
mg/
kg/
day
based
on
slight
decreases
in
maternal
body
weight
gain
and
food
consumption.
Developmental
NOAEL
=
500
mg/
kg/
day
LOAEL
=
1,000
mg/
kg/
day
based
on
decreased
fetal
body
weights
and
reduced
ossification
of
the
sternebrae.

870.3800
Reproduction
and
fertility
effects
DPX­
JW062
Parental/
Systemic
NOAEL
=
1.5
mg/
kg/
day
LOAEL
=
4.4
mg/
kg/
day
based
on
decreased
body
weights,
body
weight
gains,
and
food
consumption
of
F0
females,
and
increased
spleen
weights
in
the
F0
and
F1
females
Reproductive
NOAEL
=
6.4
mg/
kg/
day
LOAEL
=
6.4
mg/
kg/
day
Offspring
NOAEL
=
1.5
mg/
kg/
day
LOAEL
=
4.4
mg/
kg/
day
based
on
decrease
in
the
body
weights
of
the
F1
pups
during
lactation.

870.4100
Chronic
toxicity
rodents
DPX­
JW062
NOAEL
=
M
5,
F
2.1
mg/
kg/
day
LOAEL
=
M
10,
F
3.6
mg/
kg/
day
based
on
decr.
body
weight,
body
weight
gain,
and
food
consumption
and
food
efficiency;
decreased
HCT,
HGB
and
RBC
at
6
months
in
F
only.
no
evidence
of
carcinogenic
potential
870.4100
Chronic
toxicity
dogs
DPX­
JW062
NOAEL
=
M
2.3,
F
2.4
mg/
kg/
day
LOAEL
=
M
18,
F
19
mg/
kg/
day
based
on
decr.
HCT,
HGB
and
RBC;
increased
Heinz
bodies
and
reticulocytes
and
associated
secondary
microscopic
changes
in
the
liver,
kidneys,
spleen,
and
bone
marrow;
increased
absolute
and
relative
liver
weights.

870.4200
Carcinogenicity
rats
DPX­
JW062
see
870.4100.
No
evidence
of
carcinogenicity
870.4300
Carcinogenicity
mice
DPX­
JW062
NOAEL
=
M
2.6,
F4.0
mg/
kg/
day
LOAEL
=
M
14,
F
20
mg/
kg/
day
based
on
decreased
body
weight,
body
weight
gain,
and
food
efficiency
and
clinical
signs
indicative
of
neurotoxicity.
No
evidence
of
carcinogenicity
870.5100
Gene
Mutation
DPX­
MP062
strains
TA97a,
TA98,
TA100
and
TA1535
of
S.
typhimurium
and
strain
WP2(
uvrA)
of
E.
coli
were
negative
for
mutagenic
activity
both
with
and
without
S9
activation
for
the
concentration
range
10
 
5,000
µ
g/
plate
DPX­
JW062
strains
TA97a,
TA98,
TA100
and
TA1535
of
S.
typhimurium
and
strain
WP2(
uvrA)
of
E.
coli
were
negative
for
mutagenic
activity
both
with
and
without
S9
activation
for
the
concentration
range
10
 
5,000
µ
g/
plate.

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FR\
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16APP1.
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16APP1
18586
Federal
Register
/
Vol.
68,
No.
73
/
Wednesday,
April
16,
2003
/
Proposed
Rules
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.5300
Gene
Mutation
DPX­
MP062
negative
for
mutagenic
activity
for
the
following
concentration
ranges:
3.1
 
250
µ
g/
mL
(­
S9);
3.1
 
250
µ
g/
mL
(+
S9)
DPX­
JW062
negative
for
mutagenic
activity
for
the
following
concentration
ranges:
Negative;
100
 
1,000
µ
g/
mL
(­
S9);
100
 
1,000
µ
g/
mL
(+
S9),
precipitate
 
1,000
µ
g/
mL
870.5375
Cytogenetics
DPX­
MP062
no
evidence
of
chromosomal
aberrations
induced
by
the
test
article
over
background
for
the
following
concentration
ranges:
15.7
 
1,000
µ
g/
mL
(
±
S9)
DPX­
JW062
no
evidence
of
chromosomal
aberrations
induced
by
the
test
article
over
background
for
the
following
concentration
ranges:
19
 
300
µ
g/
mL
(­
S9),
19
 
150
µ
g/
mL
(+
S9);
partial
insoluble
and
cytotoxicity
 
150
µ
g/
mL
870.5395
Cytogenetics
DPX­
MP062
no
evidence
of
mutagenicity
for
the
following
dose
ranges:
3,000
 
4,000
mg/
kg
­
males;
1,000
 
2,000
mg/
kg
­
females
DPX­
JW062
no
evidence
of
mutagenicity
at
2,500
or
5,000
mg/
kg
870.5550
Other
Effects
DPX­
MP062
no
evidence
of
mutagenic
activity
at
the
following
concentration
range:
1.56
 
200
µ
g/
mL;
cytotoxicity
was
seen
at
concentrations
of
 
100
µ
g/
mL
DPX­
JW062
No
evidence
of
mutagenic
activity
at
the
following
concentration
range:
0.1
 
50
µ
g/
mL,
cytotoxicity
observed
at
 
50
µ
g/
mL
870.6200
Acute
neurotoxicity
screening
battery
DPX­
MP062
NOAEL
=
M
100,
F
12.5
mg/
kg
LOAEL
=
M
200
mg/
kg
based
on
decreased
body
weight
gain,
decreased
food
consumption
decreased
forelimb
grip
strength,
and
decreased
foot
splay.
F
50
mg/
kg
based
on
decreased
body
weight,
body
weight
gain,
and
food
consumption
DPX­
JW062
NOAEL=
M
>
2,000
mg/
kg
=
F
<
500
mg/
kg
LOAEL
>
M
2,000
mg/
kg
F
<
500
mg/
kg
based
on
clinical
signs,
decreased
body
weight
gains
and
food
consumption
and
FOB
effects
870.6200
Subchronic
neurotoxicity
screening
battery
DPX­
MP062
NOAEL
=
M
0.57,
F
0.68
mg/
kg/
day
LOAEL
=
M
5.6,
F
3.3
mg/
kg/
day
based
on
decreased
body
weight
and
alopecia
870.7485
Metabolism
and
pharmacokinetics
Both
DPX­
MP062
and
DPX­
JW062
were
extensively
metabolized
and
the
metabolites
were
eliminated
in
urine,
feces,
and
bile.
The
metabolite
profile
for
DPX­
JW062
was
dose
dependent
and
varied
quantitatively
between
males
and
females.
Differences
in
metabolite
profiles
were
also
observed
for
the
different
label
positions
(
indanone
and
trifluoromethoxyphenyl
rings).
All
biliary
metabolites
undergo
further
biotransformation
in
the
gut.
The
proposed
metabolic
pathway
for
both
DPX­
MP062
and
DPX­
JW062
has
multiple
metabolites
bearing
one
of
the
two
ring
structures
(
see
870
 
4100
chronic
toxicity
rodents
above).

B.
Toxicological
Endpoints
The
dose
at
which
no
adverse
effects
are
observed
(
the
NOAEL)
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(
LOC).
However,
the
lowest
dose
at
which
adverse
effects
of
concern
are
identified
(
the
LOAEL)
is
sometimes
used
for
risk
assessment
if
no
NOAEL
was
achieved
in
the
toxicology
study
selected.
An
uncertainty
factor
(
UF)
is
applied
to
reflect
uncertainties
inherent
in
the
extrapolation
from
laboratory
animal
data
to
humans
and
in
the
variations
in
sensitivity
among
members
of
the
human
population
as
well
as
other
unknowns.
An
UF
of
100
is
routinely
used,
10X
to
account
for
interspecies
differences
and
10X
for
intra
species
differences.
For
dietary
risk
assessment
(
other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(
acute
RfD
or
chronic
RfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
factor
is
retained
due
to
concerns
unique
to
the
FQPA,
this
additional
factor
is
applied
to
the
RfD
by
dividing
the
RfD
by
such
additional
factor.
The
acute
or
chronic
Population
Adjusted
Dose
(
aPAD
or
cPAD)
is
a
modification
of
the
RfD
to
accommodate
this
type
of
FQPA
Safety
Factor
(
SF).
For
non­
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.
The
linear
default
risk
methodology
(
Q*)
is
the
primary
method
currently
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used
by
the
Agency
to
quantify
carcinogenic
risk.
The
Q*
approach
assumes
that
any
amount
of
exposure
will
lead
to
some
degree
of
cancer
risk.
A
Q*
is
calculated
and
used
to
estimate
risk
which
represents
a
probability
of
occurrence
of
additional
cancer
cases
(
e.
g.,
risk
is
expressed
as
1
x
10­
6
or
one
in
a
million).
Under
certain
specific
circumstances,
MOE
calculations
will
be
used
for
the
carcinogenic
risk
assessment.
In
this
non­
linear
approach,
a
``
point
of
departure''
is
identified
below
which
carcinogenic
effects
are
not
expected.
The
point
of
departure
is
typically
a
NOAEL
based
on
an
endpoint
related
to
cancer
effects
though
it
may
be
a
different
value
derived
from
the
dose
response
curve.
To
estimate
risk,
a
ratio
of
the
point
of
departure
to
exposure
(
MOEcancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
Indoxacarb
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
INDOXACARB
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
females
13
 
50
years
of
age)
NOAEL
=
2.0
mg/
kg/
day
UF
=
100
Acute
RfD
=
0.02
mg/
kg
FQPA
SF
=
1
aPAD
=
acute
RfD
÷
FQPA
SF
=
0.02
mg/
kg/
day
Developmental
rat
toxicity
study.
developmental
LOAEL
=
4.0
mg/
kg/
day
based
on
decreased
fetal
body
weight.

Acute
Dietary
general
population
including
infants
and
children
NOAEL
=
12.5
mg/
kg
UF
=
100
Acute
RfD
=
0.12
mg/
kg
FQPA
SF
=
1
aPAD
=
acute
RfD
÷
FQPA
SF
=
0.12
mg/
kg/
day
Acute
oral
rat
neurotoxicity
study.
LOAEL
=
50
mg/
kg
based
on
decreased
body
weight
and
body
weight
gain
in
females.

Chronic
Dietary
all
populations
NOAEL
=
2.0
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.02
mg/
kg/
day
FQPA
SF
=
1
cPAD
=
chronic
RfD
÷
FQPA
SF
=
0.02
mg/
kg/
day
90
 
day
rat
subchronic
toxicity
study,
90
 
day
rat
neurotoxicity
study,
chronic/
carcinogenicity
rat
study.
LOAEL
=
3.3
mg/
kg/
day
based
on
decreased
body
weight,
alopecia,
body
weight
gain,
food
consumption
and
food
efficiency;
decreased
hematocrit,
hemoglobin
and
red
blood
cells
only
at
6
months.
3.3
mg/
kg/
day
is
the
lowest
LOAEL
of
the
three
studies.

Short­
Term
Oral
(
1
 
7
days)
(
Residential)
oral
study
NOAEL=
2.0
mg/
kg/
day
LOC
for
MOE
=
100
(
Residential
includes
the
FQPA
SF)
Developmental
rat
toxicity
study.
Maternal
LOAEL
=
4.0
mg/
kg/
day
based
on
decreased
mean
maternal
body
weights,
body
weight
gains,
and
food
consumption.

Intermediate­
Term
Oral
(
1
week
­
several
months)
(
Residential)
oral
study
NOAEL=
2.0
mg/
kg/
day
LOC
for
MOE
=
100
(
Residential
includes
the
FQPA
SF)
90
 
day
rat
subchronic
toxicity
study.
LOAEL
=
3.8
mg/
kg/
day
based
on
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency.

Short­
(
1
 
7
days),
Intermediate­
(
1
week
­
several
months),
and
Long­(
several
months
­
lifetime)
Term
Dermal
(
Occupational
Residential)
dermal
study
NOAEL=
50
mg/
kg/
day
LOC
for
MOE
=
100
(
Occupational)
LOC
for
MOE
=
100
(
Residential
includes
the
FQPA
SF)
28
 
day
rat
dermal
toxicity
study.
LOAEL
=
500
mg/
kg/
day
based
on
decreased
body
weights,
body
weight
gains,
food
consumption
and
food
efficiency
in
females,
and
changes
in
hematology
parameters
(
increased
reticulocytes),
the
spleen
(
increased
absolute
and
relative
weight
males
only,
gross
discoloration),
and
clinical
signs
of
toxicity
in
both
sexes.

Short­
Term
Inhalation
(
1
 
7
days)
(
Occupational/
Residential)
oral
study
NOAEL=
2.0
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Occupational)
LOC
for
MOE
=
100
(
Residential
includes
the
FQPA
SF)
Rat
developmental
toxicity
study.
Maternal
LOAEL
=
4.0
mg/
kg/
day
based
on
decreased
mean
maternal
body
weights,
body
weight
gains,
and
food
consumption.

Intermediate­
Term
Inhalation
(
1
week
­
several
months)
(
Occupational
Residential)
oral
study
NOAEL=
2.0
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Occupational)
LOC
for
MOE
=
100
(
Residential
includes
the
FQPA
SF)
90
 
day
rat
subchronic
toxicity
study.
LOAEL
=
3.8
mg/
kg/
day
based
on
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency.

Long­
Term
Inhalation
(
several
months
­
lifetime)
(
Occupational
Residential)
oral
study
NOAEL=
2.0
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Occupational)
LOC
for
MOE
=
100
(
Residential
includes
the
FQPA
SF)
90
 
day
rat
subchronic
toxicity
study,
90
 
day
rat
neurotoxicity
study,
chronic/
carcinogenicity
rat
study.
LOAEL
=
3.3
mg/
kg/
day
based
on
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency;
decreased
hematocrit,
hemoglobin
and
red
blood
cells
only
at
6
months.

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Vol.
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No.
73
/
Wednesday,
April
16,
2003
/
Proposed
Rules
TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
INDOXACARB
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
 
Continued
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Cancer
(
oral,
dermal,
inhalation)
``
not
likely''
to
be
carcinogenic
to
humans
N/
A
no
evidence
of
carcinogenicity
in
either
the
rat
or
mouse
in
acceptable
carcinogenicity
studies
and
no
evidence
of
mutagenicity.

*
The
reference
to
the
FQPA
Safety
Factor
refers
to
any
additional
safety
factor
retained
due
to
concerns
unique
to
the
FQPA.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.564)
for
the
combined
residues
of
Indoxacarb,
in
or
on
a
variety
of
raw
agricultural
commodities.
Including
tolerances
already
established
for:
alfalfa,
forage
at
10
ppm;
alfalfa,
hay
at
50
ppm;
apple
at
1.0
ppm;
apple,
wet
pomace
at
3.0
ppm;
brassica,
head
and
stem,
subgroup
at
5.0
ppm;
cattle,
goat,
horse,
sheep,
and
hog
fat
at
1.5
ppm;
cattle,
goat,
horse,
sheep,
and
hog
meat
at
0.05
ppm;
cattle,
goat,
horse,
sheep
,
and
hog
meat
byproducts
at
0.03
ppm;
corn,
sweet,
forage
at
10
ppm;
corn,
sweet,
kernel
plus
cob
with
husk
removed
at
0.02
ppm;
corn,
sweet
stover
at
15
ppm;
cotton
gin
byproducts
at
15
ppm;
cotton,
undelinted
seed
at
2.0
ppm;
lettuce,
head
at
4.0
ppm;
lettuce,
head
at
5.0
ppm;
lettuce,
leaf
at
10.0
ppm;
milk
at
0.15
ppm;
and
milk,
fat
at
4.0
ppm;
peanut
at
0.01
ppm;
peanut,
hay
at
40
ppm;
pear
at
0.20
ppm;
potato
at
0.01
ppm;
soybean,
seed
at
0.8
ppm;
soybean,
aspirated
grain
fractions
at
45
ppm;
and
vegetables,
fruiting,
group
at
0.50
ppm.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
Indoxacarb
in
food
as
follows:
i.
Acute
exposure.
Acute
dietary
risk
assessments
are
performed
for
a
fooduse
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
one
day
or
single
exposure.
The
Dietary
Exposure
Evaluation
Model
(
DEEM
 
)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1989
 
1992
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
acute
exposure
assessments:
An
acute
Tier
2
(
partially
refined
analysis)
dietary
assessment
was
performed
with
use
of
anticipated
residues
(
ARs)
from
field
trial
data,
processing
factors
(
where
applicable),
and
assumed
100%
crop
treated
(
CT)
for
all
crops.
ARs
for
meat,
milk,
poultry,
and
eggs
(
MMPE)
raw
agricultural
commodities
(
RACs)
were
calculated
also.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
DEEM
 
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA1989
 
1992
nationwide
CSFII
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
Chronic
exposure
estimates
are
expressed
in
mg/
kg
bw/
day
and
as
a
percent
of
the
cPAD.
The
chronic
dietary
assessment
assumed
tolerance
level
residues,
DEEM
 
default
processing
factors,
assumed
100%
CT
for
all
crops
other
than
peaches,
and
1%
CT
for
the
peach
EUP
(
300
acres)(
Tier
1).
iii.
Cancer.
There
is
no
evidence
for
mutagenicity
and
there
is
no
evidence
of
carcinogenicity
in
either
the
rat
or
mouse.
Indoxacarb
has
been
classified
as
``
not
likely
to
be
carcinogenic
in
humans''
by
the
Agency;
therefore,
no
carcinogenic
dietary
risk
analysis
was
performed.
iv.
Anticipated
residue
and
percent
crop
treated
(
PCT)
information.
Section
408(
b)(
2)(
E)
of
the
FFDCA
authorizes
EPA
to
use
available
data
and
information
on
the
anticipated
residue
levels
of
pesticide
residues
in
food
and
the
actual
levels
of
pesticide
chemicals
that
have
been
measured
in
food.
If
EPA
relies
on
such
information,
EPA
must
require
that
data
be
provided
5
years
after
the
tolerance
is
established,
modified,
or
left
in
effect,
demonstrating
that
the
levels
in
food
are
not
above
the
levels
anticipated.
Following
the
initial
data
submission,
EPA
is
authorized
to
require
similar
data
on
a
time
frame
it
deems
appropriate.
As
required
by
section
408(
b)(
2)(
E)
of
the
FFDCA,
EPA
will
issue
a
data
call­
in
for
information
relating
to
anticipated
residues
to
be
submitted
no
later
than
5
years
from
the
date
of
issuance
of
this
tolerance.
Section
408(
b)(
2)(
F)
of
the
FFDCA
states
that
the
Agency
may
use
data
on
the
actual
percent
of
food
treated
for
assessing
chronic
dietary
risk
only
if
the
Agency
can
make
the
following
findings:
Condition
1,
that
the
data
used
are
reliable
and
provide
a
valid
basis
to
show
what
percentage
of
the
food
derived
from
such
crop
is
likely
to
contain
such
pesticide
residue;
Condition
2,
that
the
exposure
estimate
does
not
underestimate
exposure
for
any
significant
subpopulation
group;
and
Condition
3,
if
data
are
available
on
pesticide
use
and
food
consumption
in
a
particular
area,
the
exposure
estimate
does
not
understate
exposure
for
the
population
in
such
area.
In
addition,
the
Agency
must
provide
for
periodic
evaluation
of
any
estimates
used.
To
provide
for
the
periodic
evaluation
of
the
estimate
of
PCT
as
required
by
section
408(
b)(
2)(
F)
of
the
FFDCA,
EPA
may
require
registrants
to
submit
data
on
PCT.
The
Agency
used
PCT
information
as
follows:
Dietary
exposure
estimates
were
based
on
1%
PCT
for
peaches.
This
PCT
of
1%
was
based
on
the
fact
that
the
2
 
year
experimental
use
permit
was
issued
for
only
300
acres
of
peaches
to
be
treated
annually,
which
amounts
to
0.2%
of
the
total
peach
acreage
in
the
United
States.
The
reason
for
using
1%
instead
of
0.2%
is
to
allow
for
any
uncertainties
in
the
residue
evaluation.
Before
making
this
tolerance
permanent,
reevaluation
of
dietary
exposure
will
be
performed
using
all
available
information.
Other
commodities
were
assumed
to
be
100%
treated.
The
Agency
believes
that
the
three
conditions
previously
discussed
have
been
met.
With
respect
to
Condition
1,
EPA
finds
that
the
PCT
information
described
1%
for
Indoxacarb
used
on
peaches
is
reliable
and
has
a
valid
basis.
A
2
 
year
EUP
has
been
issued
for
this
use,
which
will
allow
for
use
of
Indoxacarb
on
300
acres
of
peaches
in
some
eastern
states.
Before
the
use
can
be
expanded
for
treatment
of
greater
than
300
acres
per
year,
permission
from
the
Agency
must
be
obtained.
As
to
Conditions
2
and
3,
regional
consumption
information
and
consumption
information
for
significant
subpopulations
is
taken
into
account
through
EPA's
computer­
based
model
for
evaluating
the
exposure
of
significant
subpopulations
including
several
regional
groups.
Use
of
this
consumption
information
in
EPA's
risk
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/
Vol.
68,
No.
73
/
Wednesday,
April
16,
2003
/
Proposed
Rules
assessment
process
ensures
that
EPA's
exposure
estimate
does
not
understate
exposure
for
any
significant
subpopulation
group
and
allows
the
Agency
to
be
reasonably
certain
that
no
regional
population
is
exposed
to
residue
levels
higher
than
those
estimated
by
the
Agency.
Other
than
the
data
available
through
national
food
consumption
surveys,
EPA
does
not
have
available
information
on
the
regional
consumption
of
food
to
which
Indoxacarb
may
be
applied
in
a
particular
area.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
Indoxacarb
in
drinking
water.
Because
the
Agency
does
not
have
comprehensive
monitoring
data,
drinking
water
concentration
estimates
are
made
by
reliance
on
simulation
or
modeling
taking
into
account
data
on
the
physical
characteristics
of
Indoxacarb.
The
Agency
uses
the
Generic
Estimated
Environmental
Concentration
(
GENEEC)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS)
to
estimate
pesticide
concentrations
in
surface
water
and
SCIGROW
(
screening
concentration
in
ground
water),
which
predicts
pesticide
concentrations
in
groundwater.
In
general,
EPA
will
use
GENEEC
(
a
tier
1
model)
before
using
PRZM/
EXAMS
(
a
tier
2
model)
for
a
screening­
level
assessment
for
surface
water.
The
GENEEC
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
highend
runoff
scenario
for
pesticides.
GENEEC
incorporates
a
farm
pond
scenario,
while
PRZM/
EXAMS
incorporate
an
index
reservoir
environment
in
place
of
the
previous
pond
scenario.
The
PRZM/
EXAMS
model
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
as
drinking
water
would
likely
have
on
the
removal
of
pesticides
from
the
source
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
a
coarse
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
ever
exceed
human
health
levels
of
concern.
Since
the
models
used
are
considered
to
be
screening
tools
in
the
risk
assessment
process,
the
Agency
does
not
use
estimated
environmental
concentrations
(
EECs)
from
these
models
to
quantify
drinking
water
exposure
and
risk
as
a
percent
reference
dose
(%
RfD)
or
percent
population
adjusted
dose
(%
PAD).
Instead,
drinking
water
levels
of
comparison
(
DWLOCs)
are
calculated
and
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food,
and
from
residential
uses.
Since
DWLOCs
address
total
aggregate
exposure
to
Indoxacarb
they
are
further
discussed
in
the
aggregate
risk
sections
below.
Based
on
the
PRZM/
EXAMS
and
SCIGROW
models
the
estimated
environmental
concentrations
(
EECs)
of
Indoxacarb
for
acute
exposures
are
estimated
to
be
13.7
parts
per
billion
(
ppb)
for
surface
water
and
0.02
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
3.7
ppb
for
surface
water
and
0.02
ppb
for
ground
water.
3.
From
non­
dietary
exposure.
The
term
``
residential
exposure''
is
used
in
this
document
to
refer
to
nonoccupational
non­
dietary
exposure
(
e.
g.,
for
lawn
and
garden
pest
control,
indoor
pest
control,
termiticides,
and
flea
and
tick
control
on
pets).
Indoxacarb
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
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
Indoxacarb
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,
Indoxacarb
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
Indoxacarb
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
final
rule
for
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
There
is
no
evidence
for
either
qualitative
or
quantitative
susceptibility.
In
all
developmental
studies,
the
developmental
endpoint
occurs
at
the
maternal
LOAEL
or
above.
Although
there
is
no
rabbit
developmental
toxicity
study
with
indoxacarb,
a
study
is
not
required
since:
(
1)
studies
both
using
methyl
cellulose
comparing
JW062
in
the
rabbit
and
rat
demonstrate
that
the
toxicity
profiles
for
the
rat
and
rabbit
are
similar
and
that
the
rat
is
the
more
sensitive
species;
(
2)
range
finding
studies
in
the
rat
comparing
indoxacarb
and
JW062
indicate
that
the
maternal
and
external
developmental
toxicity
are
comparable;
(
3)
a
dietary
developmental
toxicity
study
in
the
rat
with
JW062
had
comparable
toxicity
to
the
gavage
indoxacarb
rat
developmental
toxicity
study.
Developmental
toxicity
only
occurred
at
levels
at
or
above
maternal
toxicity.
The
reproduction
toxicity
study
with
JW062
can
be
used
to
satisfy
the
requirement
for
an
indoxacarb
study
because:
1)
systemic
toxicity
is
at
similar
doses
and
of
similar
magnitude
to
that
observed
in
subchronic
feeding
studies
with
both
indoxacarb
and
JW062;
2)
based
on
the
data
base,
the
HIARC
determined
that
there
was
support
for
using
data
from
dietary
studies
conducted
with
JW062
to
satisfy
the
data
requirements
for
indoxacarb.
The
Agency
has
required
a
developmental
neurotoxicity
study
as
confirmatory
data
due
to:
 
Clinical
signs
of
neurotoxicity
in
several
studies,
males
and
females,
mice
and
rats,
at
some
doses
that
do
not
cause
mortality;
 
Signs
of
neurotoxicity
in
the
acute
neurotoxicity
study
rat
with
indoxacarb
(
males
and
females),
no
mortality
in
males
at
neurotoxic
doses;

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Clinical
signs
of
neurotoxicity
in
the
90
 
day
toxicity
study
rat
indoxacarb
(
females),
mortality;
 
Clinical
signs
of
neurotoxicity
in
the
90
 
day
toxicity
study
mouse
with
the
racemic
mixture,
JW062
(
males
and
females),
no
mortality
in
females
at
neurotoxic
doses,
mortality
in
males;
 
Clinical
signs
of
neurotoxicity
in
the
18
month
carcinogenicity
study
mouse
with
JW062
(
males
and
females)
high
and
mid
dose,
mortality
at
the
high
but
no
mortality
at
the
mid
dose;
and
 
Clinical
signs
of
neurotoxicity
in
the
developmental
toxicity
study
rat
with
JW062
(
using
methyl
cellulose
as
the
vehicle),
at
doses
causing
mortality.
3.
Conclusion.
The
Agency
concluded
that
the
FQPA
safety
factor
could
be
reducecd
to
1X
for
Indoxacarb
because:
 
There
is
no
indication
of
quantitative
or
qualitative
increased
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure;
 
The
requirement
of
a
developmental
neurotoxicity
study
is
not
based
on
the
criteria
reflecting
special
concern
for
the
developing
fetuses
or
young
which
are
generally
used
for
requiring
a
DNT
study
­
and
a
safety
factor
(
e.
g.:
neuropathy
in
adult
animals;
CNS
malformations
following
prenatal
exposure;
brain
weight
or
sexual
maturation
changes
in
offspring;
and/
or
functional
changes
in
offspring)
­
and
therefore
does
not
warrant
an
FQPA
safety
factor;
and
 
The
dietary
(
food
and
drinking
water)
exposure
assessments
will
not
underestimate
the
potential
exposures
for
infants
and
children
 
There
are
no
registered
residential
uses
at
the
current
time.
E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
drinking
water
level
of
comparison
(
DWLOCs)
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
(
EECs).
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
[
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure)].
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
the
USEPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
groundwater
are
less
than
the
calculated
DWLOCs,
EPA
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
EPA
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
EPA
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
EPA
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
Indoxacarb
will
occupy
12%
of
the
aPAD
for
the
U.
S.
population,
69%
of
the
aPAD
for
females
13
years
and
older,
67%
of
the
aPAD
for
infants
less
than
1
year
old
and
36%
of
the
aPAD
for
children
1
to
2
years
old.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
Indoxacarb
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
aPad,
as
shown
in
Table
3
of
this
unit:

TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
INDOXACARB
Population
Subgroup
aPAD
(
mg/
kg)
%
aPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Acute
DWLOC
(
ppb)

U.
S.
Population
0.12
7
13.7
0.02
3,700
Females
13
+
0.02
69
13.7
0.02
180
All
infants
less
than
1
year
0.12
67
13.7
0.02
400
Children
1
to
2
0.12
36
13.7
0.02
760
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
Indoxacarb
from
food
will
utilize
30%
of
the
cPAD
for
the
U.
S.
population,
29%
of
the
cPAD
for
infants
less
than
1
year
old
and
79%
of
the
cPAD
for
children
1
to
2
years
old.
There
are
no
residential
uses
for
Indoxacarb
that
result
in
chronic
residential
exposure
to
Indoxacarb.
Based
the
use
pattern,
chronic
residential
exposure
to
residues
of
Indoxacarb
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
Indoxacarb
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
Table
4
of
this
unit:

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Proposed
Rules
TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
INDOXACARB
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
Population
0.02
30
3.7
0.02
490
All
infants
less
than
1
year
old
0.02
29
3.7
0.02
140
Children
1
to
2
0.02
79
3.7
0.02
43
3.
Short­
term
risk.
Short­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Indoxacarb
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
the
aggregate
risk
is
the
sum
of
the
risk
from
food
and
water,
which
do
not
exceed
the
Agency's
level
of
concern.
4.
Intermediate­
term
risk.
Intermediate­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Indoxacarb
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
the
aggregate
risk
is
the
sum
of
the
risk
from
food
and
water,
which
do
not
exceed
the
Agency's
level
of
concern.
5.
Aggregate
cancer
risk
for
U.
S.
population.
There
is
no
evidence
for
mutagenicity
and
there
is
no
evidence
of
carcinogenicity
in
either
the
rat
or
mouse.
Indoxacarb
has
been
classified
as
``
not
likely
to
be
carcinogenic
in
humans''
by
the
Agency;
therefore,
Indoxacarb
is
not
expected
to
pose
carcinogenic
risk
when
used
as
directed.
6.
Determination
of
safety.
Based
on
these
risk
assessments,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
and
to
infants
and
children
from
aggregate
exposure
to
Indoxacarb
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methodology
(
high
performance
liquid
chromatography
HPLC/
UV
Method
AMR
2712
 
93)
is
available
to
enforce
the
tolerance
expression.
The
method
may
be
requested
from:
Calvin
Furlow,
PRRIB,
IRSD
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW,
Washington,
DC
20460;
telephone
number:
(
703)
305
 
5229;
e­
mail
address:
furlow.
calvin@
epa.
gov.
B.
International
Residue
Limits
There
are
no
established
or
proposed
Codex,
Canadian,
or
Mexican
maximum
residue
limits
(
MRLs)
for
residues
of
indoxacarb;
therefore,
international
harmonization
is
not
an
issue
at
this
time.

V.
Conclusion
A
15
 
day
comment
period
is
being
allowed
for
this
proposed
rule
because
of
the
speed
of
growth
and
the
pest
pressure,
and
the
Agency's
desire
to
be
suportive
of
efforts
by
peach
growers
and
researchers
to
find
alternatives
to
organophosphates
for
control
of
oriental
fruit
moth
and
plum
curculio
in
peaches.
Additionally,
the
Agency
feels
that
there
is
strong
evidence
in
support
of
the
safety
of
this
proposed
action.
Therefore,
a
temporary
tolerance
for
3
years
is
proposed
for
combined
residues
of
Indoxacarb,
(
S)­
methyl
7­
chloro­
2,5­
dihydro­
2­[[(
methoxy
carbonyl)
[
4­
(
trifluoromethoxy)
phenyl]
amino]
carbonyl]
indeno[
1,2­
e][
1,3,4]
oxadiazine­
4a(
3H)­
carboxylate
+
its
R­
enantiomer]
(
R)­
methyl
7­
chloro­
2,5­
dihydro­
2­
[[(
methoxycarbonyl)[
4­(
trifluoro
methoxy)
phenyl]
amino]
carbonyl]
indeno
[
1,2­
e][
1,3,4]
oxadiazine­
4a(
3H)­
carboxylate
in
peaches
at
10.0
ppm.

VI.
Statutory
and
Executive
Order
Reviews
This
proposed
rule
is
establishing
a
tolerance
under
section
408(
d)
of
the
FFDCA.
EPA
is
proposing
this
regulation
in
cooperation
with
Research
Extension
Specialists
at
the
University
of
Georgia,
Rutgers
University,
Clemson
University,
Pennsylvania
State
University,
Michigan
State
University,
University
of
West
Virginia,
and
DuPont
de
Nemours
and
Company.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
proposed
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
proposed
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
proposed
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
tolerance
in
this
proposed
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
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/
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68,
No.
73
/
Wednesday,
April
16,
2003
/
Proposed
Rules
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
proposed
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
proposed
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
proposed
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
proposed
rule.

List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
April
10,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.
[
FR
Doc.
03
 
9340
Filed
4
 
15
 
03;
8:
45
a.
m.]

BILLING
CODE
6560
 
50
 
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