Document ID: EPA-HQ-OPP-2003-0173-0001
Agency: epa
Document Type: Rule
Title: Indoxacarb; Time-Limited Pesticide Tolerance
Posted Date: 2003-05-14T04:00Z

25824
Federal
Register
/
Vol.
68,
No.
93
/
Wednesday,
May
14,
2003
/
Rules
and
Regulations
Constitution
Avenue,
NW.,
Washington
DC.
The
EPA
Docket
Center
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
except
on
government
holidays.
You
can
reach
the
Reading
Room
by
telephone
at
(
202)
566
 
1742,
and
by
facsimile
at
(
202)
566
 
1741.
The
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number
for
the
Air
Docket
is
(
202)
566
 
1742.
You
may
be
charged
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reasonable
fee
for
photocopying
docket
materials,
as
provided
in
40
CFR
part
2.
FOR
FURTHER
INFORMATION
CONTACT:
Robert
Larson,
U.
S.
EPA,
National
Vehicle
and
Fuel
Emissions
Laboratory,
Transportation
and
Regional
Programs
Division,
2000
Traverwood
Drive,
Ann
Arbor,
MI
48105;
telephone
(
734)
214
 
4277,
fax
(
734)
214
 
4956,
e­
mail
larson.
robert@
epa.
gov.

SUPPLEMENTARY
INFORMATION:
We
stated
in
the
direct
final
rule
published
at
68
FR
17741
(
April
11,
2003)
that
if
we
received
adverse
comment
on
the
amendment,
by
May
12,
2003,
we
would
publish
a
timely
withdrawal
in
the
Federal
Register.
We
have
received
adverse
comments
on
the
amendments
to
40
CFR
89.2.
As
a
result
of
the
adverse
comments
received,
we
are
withdrawing
the
amendment
to
§
89.2.
We
intend
to
consider
the
issues
raised
by
the
comments
in
a
final
action
based
on
the
concurrent
notice
of
proposed
rulemaking
(
68
FR
17763).

List
of
Subjects
in
40
CFR
Part
89
Environmental
protection,
Administrative
practice
and
procedure,
Motor
vehicle
pollution.

Jeffrey
R.
Holmstead,
Assistant
Administrator
for
Office
of
Air
and
Radiation.
[
FR
Doc.
03
 
12021
Filed
5
 
13
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0173;
FRL
 
7307
 
6]

Indoxacarb;
Time­
Limited
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
time­
limited
tolerance
for
residues/
combined
residues
of
Indoxacarb,
(
S)­
methyl
7­
chloro­
2,5­
dihydro­
2­
[[(
methoxycarbonyl)
[
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
(
trifluoromethoxy)
phenyl]
amino]
carbonyl]
indeno[
1,2­
e]
[
1,3,4]
oxadiazine­
4a
(
3H)­
carboxylate
in
or
on
peaches.
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
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
establishes
a
maximum
permissible
level
for
residues
of
Indoxacarb
in
this
food
commodity
pursuant
to
section
408(
e)
of
Federal
Food
Drug
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
The
tolerance
will
expire
on
May
15,
2006.
DATES:
This
regulation
is
effective
May
14,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0173,
must
be
received
on
or
before
July
14,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
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
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
 
0173.
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.
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.

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25825
Federal
Register
/
Vol.
68,
No.
93
/
Wednesday,
May
14,
2003
/
Rules
and
Regulations
II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
April
16,
2003
(
68
FR
18582)
(
FRL
 
7302
 
3),
EPA
issued
a
proposed
rule
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
the
FQPA
(
Public
Law
104
 
170),
EPA,
in
cooperation
with
university
extension
specialists,
and
DuPont
Pont
Crop
Protection,
pursuant
to
sections
408(
e)
and
(
r)
of
FFDCA,
proposed
to
establish
a
tolerance
for
combined
residues
of
the
reduced
risk
pesticide,
Indoxacarb
in
or
on
peaches.
This
temporary
tolerance
supports
a
non­
crop
destruct
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
time­
limited
tolerances
for
pesticide
residues
from
FIFRA
experimental
use
permits.
The
proposed
rule
requested
that
40
CFR
180.564
be
amended
by
establishing
a
tolerance
for
combined
residues
of
the
insecticide,
Indoxacarb,
(
S)­
methyl
7­
chloro­
2,5­
dihydro­
2­
[[(
methoxycarbonyl)
[
4­
(
trifluoromethoxy)
phenyl]
amino]
carbonyl]
indeno[
1,2­
e]
[
1,3,4]
oxadiazine­
4a(
3H)­
carboxylate]
+
its
Renantiomer
[(
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
or
on
peaches
at
10.0
parts
per
million
(
ppm).
The
tolerance
will
expire
on
May
15,
2006.
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)
(
FRL
 
5754
 
7).

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,
(
S)­
methyl
7­
chloro­
2,5­
dihydro­
2­
[[(
methoxycarbonyl)
[
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
(
trifluoromethoxy)
phenyl]
amino]
carbonyl]
indeno[
1,2­
e]
[
1,3,4]
oxadiazine­
4a(
3H)­
carboxylate
on
peaches
at
10
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
the
proposed
rule,
as
well
as
the
no
observed
adverse
effect
level
(
NOAEL)
and
the
lowest
observed
adverse
effect
level
(
LOAEL)
from
the
toxicity
studies
reviewed.
Refer
to
the
April
16,
2003,
Federal
Register
document
(
68
FR,
18582)
for
a
detailed
discussion
of
the
aggregate
risk
assessments
and
determination
of
safety.
EPA
relies
upon
that
risk
assessment
and
the
findings
made
in
the
Federal
Register
document
in
support
of
this
action.
Below
is
a
brief
summary
of
the
aggregate
risk
assessment,
including
this
use
on
peaches.
B.
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:
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
0.75
ppm,
cattle,
goat,
horse,
sheep,
and
hog
meat
at
0.03
ppm,
cattle,
goat,
horse,
sheep,
and
hog
meat
byproducts
at
0.02
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,
leaf
at
10.0
ppm,
milk
at
0.10
ppm,
and
milk,
fat
at
3.0
ppm,
pear
at
0.20
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:
An
acute
dietary
endpoint
for
females
13
years
and
older
and
for
the
general
population,
including
infants
and
children
has
been
identified.
The
acute
population
adjusted
dose
(
aPAD)
for
females
is
0.02
milligrams/
kilogram/
day
(
mg/
kg/
day).
The
acute
dietary
endpoint
for
the
general
population
including
infants
and
children
is
0.12
mg/
kg/
day.
The
chronic
population
adjusted
dose
(
cPAD)
for
all
populations
is
0.02
mg/
kg/
day.
Indoxacarb
has
been
classified
as
a
``
not
likely''
to
be
carcinogenic
to
humans.
It
has
been
determined
that
the
FQPA
safety
factor
could
be
reduced
to
1X
for
Indoxacarb.
There
is
no
indication
of
quantitative
or
qualitative
increased
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure.
Currently,
indoxacarb
is
not
registered
for
use
in
residential
settings.
For
the
chronic
exposure
estimates,
it
was
assumed
that
all
commodities
had
tolerance
level
residues
and
100%
of
all
RACs
were
treated
with
indoxacarb.
Refined
processing
factors
were
used
in
the
chronic
analysis
for
several
commodities,
in
place
of
the
Dietary
Exposure
Evaluation
Model
(
DEEM
 
)
default
processing
factors.
The
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS)
and
Screening
Concentration
in
Ground
Water
(
SCIGROW
models
provided
the
estimated
environmental
concentrations
(
EECs)
of
indoxacarb.
The
EECs
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
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Rules
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3.7
ppb
for
surface
water
and
0.02
ppb
for
ground
water.
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
1
 
day
or
single
exposure.
The
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
II
(
partially
refined
analysis)
dietary
assessment
was
performed
with
use
of
anticipated
residues
(
ARs)
from
field
trial
data,
processing
factors
(
where
applicable),
assumed
100%
crop
treated
(
CT)
for
all
crops
other
than
peaches,
and
1%
CT
for
the
peach
EUP
(
300
acres).
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
USDA
1989
 
 
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
body
weight
(
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
I).
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.
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
ARs
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
percent
crop
treated
(
PCT)
as
required
by
section
408(
b)(
2)(
F)
of
the
FFDCA,
EPA
may
require
registrants
to
submit
data
on
PCT.
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
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
PRZM/
EXAMS
to
estimate
pesticide
concentrations
in
surface
water
and
SCI­
GROW,
which
predicts
pesticide
concentrations
in
ground
water.
In
general,
EPA
will
use
GENEEC
(
a
Tier
I
model)
before
using
PRZM/
EXAMS
(
a
Tier
II
model)
for
a
screening­
level
assessment
for
surface
water.
The
GENEEC
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
high­
end
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
EECs
from
these
models
to
quantify
drinking
water
exposure
and
risk
as
a
%
RfD
or
%
PAD.
Instead
drinking
water
levels
of
comparison
(
DWLOCs)
are
calculated
and
used
as
a
point
of
comparison
against
the
model
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/
Rules
and
Regulations
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
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)
(
FRL
 
5754
 
7).

C.
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:
i.
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;
ii.
Range
finding
studies
in
the
rat
comparing
indoxacarb
and
JW062
indicate
that
the
maternal
and
external
developmental
toxicity
are
comparable;
iii.
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:
iv.
Systemic
toxicity
is
at
similar
doses
and
of
similar
magnitude
to
that
observed
in
subchronic
feeding
studies
with
both
indoxacarb
and
JW062;
v.
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;
 
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
studymouse
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.

D.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
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
EPAs
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).
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and
Regulations
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
ground
water
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,
64%
of
the
aPAD
for
females
13
years
and
older,
67%
of
the
aPAD
for
infants
less
than
1
year
old
and
79%
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
1
of
this
Unit:

TABLE
1.
 
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
12
13.7
0.02
3,700
Females
13+
........................................................................................
0.12
64
13.7
0.02
218
All
infants
less
than
1
year
..................................................................
0.12
67
13.7
0.02
400
Children
1
to
2
.....................................................................................
0.12
79
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
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
on
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
2
of
this
unit:

TABLE
2.
 
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
65
Children
1
to
2
.....................................................................................
0.02
79
3.7
0.02
30
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
rat
or
mouse.
Indoxacarb
has
been
classified
as
``
not
likely
to
be
carcinogenic
in
humans''
by
the
Agency;
therefore
Indoxacarb
is
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,
PIRIB,
IRSD
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Avenue.,
NW,
Washington
D.
C.
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
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14,
2003
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Rules
and
Regulations
harmonization
is
not
an
issue
at
this
time.

V.
Conclusion
Therefore,
the
time­
limited
tolerance
is
established
for
combined
residues
of
Indoxacarb,
(
S)­
methyl
7­
chloro­
2,5­
dihydro­
2­
[[(
methoxycarbonyl)
[
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
(
trifluoromethoxy)
phenyl]
amino]
carbonyl]
indeno[
1,2­
e][
1,3,4]
oxadiazine­
4a(
3H)­
carboxylate,
in
or
on
peaches
at
10
ppm.
This
tolerance
will
expire
and
is
revoked
on
May
15,
2006.

VI.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
of
the
FFDCA
provides
essentially
the
same
process
for
persons
to
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d),
as
was
provided
in
the
old
sections
408
and
409
of
the
FFDCA.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?
You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2003
 
0173
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
July
14,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VI.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0173,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

B.
When
Will
the
Agency
Grant
a
Request
for
a
Hearing?
A
request
for
a
hearing
will
be
granted
if
the
Administrator
determines
that
the
material
submitted
shows
the
following:
There
is
a
genuine
and
substantial
issue
of
fact;
there
is
a
reasonable
possibility
that
available
evidence
identified
by
the
requestor
would,
if
established
resolve
one
or
more
of
such
issues
in
favor
of
the
requestor,
taking
into
account
uncontested
claims
or
facts
to
the
contrary;
and
resolution
of
the
factual
issues(
s)
in
the
manner
sought
by
the
requestor
would
be
adequate
to
justify
the
action
requested
(
40
CFR
178.32).

VII.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
a
tolerance
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
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
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
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
final
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
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Register
/
Vol.
68,
No.
93
/
Wednesday,
May
14,
2003
/
Rules
and
Regulations
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
final
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
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
final
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
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
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
rule.

VIII.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
this
final
rule
in
the
Federal
Register.
This
final
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

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
30,
2003.
Debra
Edwards
Director,
Registration
Division,
Office
of
Pesticide
Programs.


Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
 
[
AMENDED]


1.
The
authority
citation
for
part
180
continues
to
read
as
follows:

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
371.


2.
Section
180.564
is
amended
by
redesignating
the
existing
text
in
paragraph
(
a)
following
the
heading
``
General''
as
paragraph
(
a)(
1)
and
by
adding
a
new
paragraph
(
a)(
2)
to
read
as
follows:

§
180.564
Indoxacarb;
tolerances
for
residues.

(
a)
*
*
*
(
1)
*
*
*
(
2)
Time­
limited
tolerances
are
established
for
combined
residues
of
Indoxacarb,
(
S)­
methyl
7­
chloro­
2,5­
dihydro­
2­[[(
methoxycarbonyl)
[
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
(
trifluoromethoxy)
phenyl]
amino]
carbonyl]
indeno[
1,2­
e]
[
1,3,4]
oxadiazine­
4a(
3H)­
carboxylate,
in
connection
with
use
of
the
pesticide
under
FIFRA
section
5
experimental
use
permit
granted
by
EPA.
The
tolerances
are
specified
in
the
following
table,
and
will
expire
and
are
revoked
on
the
dates
specified.

Commodity
Parts
per
million
Expiration/
revocation
date
Peach
...........................................................................................................................................................
10
May
15,
2006
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93
/
Wednesday,
May
14,
2003
/
Rules
and
Regulations
[
FR
Doc.
03
 
11758
Filed
5
 
13
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0109;
FRL
 
7305
 
9]

Pyriproxyfen;
Pesticide
Tolerances
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
tolerance
for
residues
of
pyriproxyfen
in
or
on
atemoya,
biriba,
cherimoya,
custard
apple,
ilama,
soursop,
and
sugar
apple
at
0.20
parts
per
million
(
ppm);
avocado,
black
sapote,
canistel,
mamey
sapote,
mango,
papaya,
sapodilla
and
star
apple
at
1.0
ppm;
okra
at
0.02
ppm;
fig
at
0.30
ppm;
and
fig,
dried
at
1.0
ppm.
The
Interregional
Research
Project
Number
4
(
IR­
4)
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
May
14,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0109,
must
be
received
on
or
before
July
14,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Hoyt
Jamerson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9368;
e­
mail
address:
jamerson.
hoyt@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

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

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0109.
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.
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.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
March
7,
2003
(
68
FR
11093)
(
FRL
 
7289
 
8),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
pesticide
petitions
(
PP)
2E6416,
2E6425,
2E6428,
and
2E6436)
by
IR­
4,
681
US
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390.
That
notice
included
a
summary
of
the
petitions
prepared
by
Valent
U.
S.
A.
Corporation,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.510
be
amended
by
establishing
tolerances
for
residues
of
the
insecticide
pyriproxyfen,
2­[
1­
methyl­
2­(
4­
phenoxyphenoxy)
ethoxy]
pyridine,
in
or
on
atemoya,
biriba,
cherimoya,
custard
apple,
ilama,
soursop,
and
sugar
apple
at
0.20
ppm
(
PP
2E6416);
avocado,
black
sapote,
canistel,
mamey
sapote,
mango,
papaya,
sapodilla
and
star
apple
at
1.0
ppm
(
PP
2E6428);
okra
at
0.02
ppm
(
PP
2E6436);
fig
at
0.30
ppm
(
PP
2E6425);
and
fig,
dried
at
1.0
ppm
(
2E6425).
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)
(
FRL
 
5754
 
7).

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