Document ID: EPA-HQ-OPP-2002-0219-0001
Agency: epa
Document Type: Notice
Title: Methoxyfenozide; Pesticide Tolerance.
Posted Date: 2002-09-20T04:00Z

59193
Federal
Register
/
Vol.
67,
No.
183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
commodities
to
the
table
in
paragraph
(
a)(
2).
ii.
The
text
of
paragraph
(
b)
is
removed
and
reserved.

§
180.479
Halosulfuron­
methyl;
tolerances
for
residues.
(
a)
General.
*
*
*
(
2)
*
*
*

Commodity
Parts
per
million
*
*
*
*
*
Asparagus
.............................
0.8
Bean,
dry,
seed
....................
0.05
Bean,
snap,
succulent
..........
0.05
*
*
*
*
*
Vegetables,
fruiting
(
except
cucurbits),
group
...............
0.05
(
b)
Section
18
emergency
exemptions.
[
Reserved]
*
*
*
*
*

[
FR
Doc.
02
 
23995
Filed
9
 
19
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0219;
FRL
 
7198
 
5]

Methoxyfenozide;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
methoxyfenozide
and
the
combined
residues
of
methoxyfenozide
and
its
glucuronide
metabolite
on
various
agriculural
food
commodities.
This
regulation
also
establishes
tolerances
for
indirect
or
inadvertent
residues
for
methoxyfenozide
and
establishes
tolerances
for
indirect
or
inadvertent
combined
residues
for
methoxyfenozide
and
its
metabolites
on
various
food
commodities,
and
increases
the
already
established
tolerances
for
residues
of
methoxyfenozide
and
increases
the
already
established
tolerances
for
the
combined
residues
of
methoxyfenozide
and
its
glucuronide
metabolite
on
various
food
commodities.
Rohm
and
Haas
Company
and
the
Interregional
Research
Project
Number
4
(
IR
 
4),
Technology
Center
of
New
Jersey,
the
State
University
of
New
Jersey
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996.
The
chemical
was
subsequently
purchased
by
Dow
Agrosciences
from
Rohm
and
Haas
Company.
The
specific
food
commodities
affected
by
the
establishment
or
increase
of
these
tolerances
are
set
forth
in
the
preamble
to
this
document.

DATES:
This
regulation
is
effective
September
20,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0219,
must
be
received
on
or
before
November
19,
2002.

ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
ID
number
OPP
 
2002
 
0219
in
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Joseph
M.
Tavano,
Registration
Division
7505C,
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
305
 
6411;
e­
mail
address:
tavano.
joseph@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:

Categories
NAICS
Examples
of
Potentially
Affected
Entities
Industry
111
Crop
production
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
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
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?

1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
home
page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
home
page
select
``
Laws
and
Regulations'',
``
Regulations
and
Proposed
Rules,''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register
 
Environmental
Documents.''
You
can
also
go
directly
to
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.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP
 
2002
 
0219.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305
 
5805.

II.
Background
and
Statutory
Findings
In
the
Federal
Registers
of
January
10,
2000,
65
FR
1370
 
1381;
FRL
 
6394
 
6;
March
19,
2001,
66
FR
15432
 
15459;
FRL
 
6766
 
7;
May
23,
2001,
66
FR
28482
 
28487;
FRL
 
6782
 
5
and
August
24,
2001,
66
FR
44629
 
44634;
FRL
 
6796
 
2;
and
August
14,
2002,
67
FR
52996
 
53001;
FRL
 
7191
 
9.
EPA
issued
notices
pursuant
to
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA)
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
petitions
(
PP
9F6033;
9F6062;
0F6201;
0F6213;
1F
6259;
1F6287;
2E6382
and
VerDate
Sep<
04>
2002
17:
27
Sep
19,
2002
Jkt
197001
PO
00000
Frm
00059
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
20SER1.
SGM
20SER1
59194
Federal
Register
/
Vol.
67,
No.
183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
2E6408)
by
Rohm
and
Haas
Company,
100
Independence
Mall
West,
Philadelphia,
PA
19106
 
2399
and
the
Interregional
Research
Project
Number
4
(
IR
 
4),
Technology
Centre
of
New
Jersey,
the
State
University
of
New
Jersey,
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390.
These
notices
included
a
summary
of
the
petitions
prepared
by
Rohm
and
Haas
Company,
the
registrant
or
the
Interregional
Research
Project
Number
4
(
IR
 
4).
There
were
no
comments
received
in
response
to
these
notices
of
filing.
The
petitions
requested
that
40
CFR
180.544
be
amended
by
establishing
tolerances
for
residues
of
the
insecticide
methoxyfenozide
in
or
on
almond,
hulls;
artichoke,
globe;
field
corn
grain;
field
corn
forage;
field
corn
stover
(
fodder);
corn,
oil;
aspirated
grain
fractions;
sweet
corn
(
K
+
CWHR);
sweet
corn
forage;
sweet
corn
stover
(
fodder);
corn
silage;
stone
fruits
crop
group;
prunes;
grapes;
Spanish
lime;
longan;
lychee;
tree
nut
crop
group;
pulasan;
raisins;
rambutan;
fruiting
vegetables
(
except
cucurbits);
crop
subgroup
4A
leafy
green
vegetables;
4B
leaf
petioles;
head
and
stem
Brassica;
crop
subgroup
5B
leafy
Brassica
greens;
at
45.0,
3.0,
0.05,
15.0,
105,
0.2,
1.0,
0.05,
30,
60,
5.0,
5.0,
7.0,
1.0,
2.0,
2.0,
2.0,
0.1,
2.0,
1.5,
2.0,
2.0,
25.0,
10.0,
6.5,
20
parts
per
million
(
ppm)
respectively
and
an
increase
in
the
established
tolerance
for
residues
of
methoxyfenozide
to
0.1
ppm
in
milk
and
an
increase
in
the
established
tolerances
for
residues
of
methoxyfenozide
and
its
glucuronide
metabolite
in
the
fat
of
cattle,
goats,
horses,
hogs
and
sheep;
liver
of
cattle,
goats,
horses,
hogs
and
sheep;
and
meat
byproducts
(
except
liver)
of
cattle,
goats,
horses
hogs
and
sheep
to
0.5,
0.4
and
0.1
ppm
respectively.
These
petitions
also
requested
that
40
CFR
180.544
be
amended
by
establishing
time
limited
tolerances
for
the
indirect
or
inadvertent
residues
of
methoxyfenozide
and
its
metabolites
RH
 
117,236
free
phenol
of
methoxyfenozide;
3,5­
dimethylbenzoic
acid
N­
tert­
butyl­
N'­(
3­
hydroxy­
2­
methylbenzoyl)
hydrazide,
RH
 
151,055
glucose
conjugateof
RH
 
117,236;
3,5­
dimethylbenzoicacid
N­
tert­
butyl­
N­
[
3(
b­
D­
glucopyranosyloxy)­
2­
methylbenzoyl]­
hydrazide
and
RH
 
152,072
the
malonylglycosyl
conjugate
of
RH
117,236
in
or
on
root
and
tuber
vegetables;
leaves
of
root
and
tuber
vegetables;
bulb
vegetables;
leafy
vegetables
(
except
Brassica);
Brassica
vegetables;
legume
vegetables;
foliage
of
legume
vegetables;
forage,
fodder,
hay,
and
straw
of
cereal
grains;
grass
forage,
fodder
and
hay;
forage,
fodder,
straw
and
hay
of
non­
grass
animal
feeds;
and
herbs
and
spices
when
present
therein
as
a
result
of
application
of
methoxyfenozide
to
growing
crops
at
0.05,
0.1,
0.1,
0.2,
0.2,
0.05,
8.0,
7.0,
7.0,
8.0
and
8.0
ppm
respectively.
Based
on
the
residue
data
submitted,
EPA
has
determined
that
the
following
changes
to
the
requested
tolerances
listed
above
are
necessary.
A
higher
tolerance
of
125
ppm
is
required
for
field
corn
stover.
A
higher
tolerance
of
30.0
ppm
is
required
for
vegetable,
leafy
(
except
Brassica),
leafy
greens
subgroup.
A
higher
tolerance
of
25
ppm
is
required
for
vegetable,
leafy
(
except
Brassica),
leaf
petioles
subgroup.
A
higher
tolerance
of
7.0
ppm
is
required
for
vegetables,
leafy,
Brassica
(
cole),
head
and
stem
subgroup.
A
higher
tolerance
of
30.0
ppm
is
required
for
vegetables,
leafy,
Brassica
(
cole),
greens
subgroup.
A
separate
tolerance
of
0.30
is
needed
for
plums
(
fresh
prune).
A
lower
tolerance
of
25.0
ppm
is
required
for
almond
hulls.
A
higher
tolerance
of
2.0
ppm
is
required
for
aspirated
grain
fractions.
No
tolerance
is
required
for
corn
silage
since
residues
in
silage
are
covered
by
the
proposed
tolerance
for
field
corn
forage.
A
tolerance
for
processed
prunes
is
not
needed.
A
lower
tolerance
of
3.0
ppm
is
required
for
stone
fruit
(
except
plum,
fresh
prune).
The
proposed
higher
tolerances
for
hog
commodities
are
not
needed.
A
tolerance
of
0.02
ppm
is
required
for
poultry,
fat
and
0.02
for
poultry,
meat.
A
tolerance
of
0.02
ppm
is
required
for
eggs.
A
tolerance
of
0.10
ppm
is
required
for
poultry,
liver
and
0.02
ppm
for
poultry
meat
byproducts
(
mbyp)
(
except
liver).
Higher
tolerances
for
the
indirect
or
inadvertent
residues
of
methoxyfenozide
in
or
on
vegetable,
bulb,
group;
vegetable,
root
and
tuber,
group
and
vegetable,
root
and
tuber,
leaves,
group
at
0.20,
0.10,
and
0.20
ppm
respectively
are
required.
Tolerances
for
the
indirect
or
inadvertent
residues
of
methoxyfenozide
in
or
on
leafy
and
Brassica
vegetables
are
not
needed
since
direct
tolerances
are
being
established
for
them.
Higher
tolerances
for
the
indirect
or
inadvertent
combined
residues
of
methoxyfenozide
benzoic
acid,
3­
methoxy­
2­
methyl­,
2­(
3,5­
dimethylbenzoyl)­
2­(
1,1­
dimethylethyl)
hydrazide
and
its
metabolites
RH
 
117,236
free
phenol
of
methoxyfenozide;
3,5­
dimethylbenzoic
acid
N­
tert­
butyl­
N'­(
3­
hydroxy­
2­
methylbenzoyl)
hydrazide],
RH
 
151,055
[
glucose
conjugate
of
RH
 
117,236;
3,5­
dimethyl
benzoic
acid
N­
tert­
butyl­
N­[
3
(
b­
D­
glucopyranosyloxy)­
2­
methylbenzoyl]­
hydrazide
and
RH
 
152,072
the
malonylglycosyl
conjugate
of
RH
117,236
in
or
on
animal
feed,
non­
grass
(
forage,
fodder,
straw,
hay),
group;
grain,
cereal,
forage,
fodder,
and
straw,
group;
grass,
forage,
fodder,
and
hay,
group;
herbs
and
spices,
group;
vegetable,
legume,
group;
and
vegetable,
legume,
foliage,
group
at
10.0
ppm,
10.0
ppm,
10.0
ppm,
10.0
ppm,
0.10
ppm
and
10.0
ppm
respectively
are
needed.
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)
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)
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
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),
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),
for
tolerances
for
residues
of
the
insecticide
methoxyfenozide
in
or
on
almond,
hulls;
artichoke,
globe;
cattle,
fat;
corn,
field,
grain;
corn,
field,
forage;
corn,
field,
stover;
corn,
oil;
corn,
aspirated
grain
fractions;
corn,
sweet
(
K
+
CWHR);
corn,
sweet,
forage;
corn,
sweet,
stover;
fruit,
stone,
group
(
except
plum,
fresh
prune);
goat,
fat;
grape;
horse,
fat;
lime,
Spanish;
longan;
lychee;
milk;
nut,
tree,
group;
pistachio;
plum
(
fresh
prune);
poultry,
fat;
poultry,
meat;
pulasan;
raisin;
rambutan;
sheep,
fat;
vegetable,

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183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
fruiting
(
except
cucurbits),
group;
vegetable,
leafy
(
except
Brassica),
leafy
greens
subgroup;
vegetable,
leafy
(
except
Brassica),
leaf
petioles
subgroup;
vegetable,
leafy,
Brassica
(
cole),
head
and
stem
subgroup;
vegetable,
leafy,
Brassica
(
cole),
greens
subgroup
at
25.0,
3.0,
0.50,
0.05,
15.0,
125.0,
0.20,
2.0,
0.05,
30.0,
60.0,
3.0,
0.50,
1.0,
0.50,
2.0,
2.0,
2.0,
0.10,
0.10,
0.10,
0.30,
0.02,
0.02,
2.0,
1.5,
2.0,
0.5,
2.0,
30.0,
25.0,
7.0
and
30.0
ppm
respectively,
and
for
the
combined
residues
of
methoxyfenozide
and
its
glucuronide
metabolite
in
or
on
cattle,
liver;
cattle,
meat
byproducts
(
except
liver);
eggs;
goat,
liver;
goat
meat
byproducts
(
except
liver);
horse,
liver;
horse,
meat
byproducts
(
except
liver);
poultry,
liver;
poultry,
meat
byproducts
(
except
liver);
sheep,
liver;
and
sheep,
meat
byproducts
(
except
liver)
at
0.40,
0.10,
0.02,
0.40,
0.10,
0.40,
0.10,
0.10,
0.02,
0.40
and
0.10
ppm,
respectively.
EPA
also
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2),
for
time­
limited
tolerances
for
the
indirect
or
inadvertent
residues
for
methoxyfenozide
in
or
on
vegetable,
bulb,
group;
vegetable,
root
and
tuber,
group;
and
vegetable,
root
and
tuber,
leaves,
group
when
present
therein
as
a
result
of
the
application
of
methoxyfenozide
to
growing
crops
at
0.20,
0.10
and
0.20
ppm,
respectively
and
time­
limited
indirect
or
inadvertent
combined
residues
for
methoxyfenozide
and
its
metabolites
RH
 
117,236
free
phenol
of
methoxyfenozide;
3,5­
dimethylbenzoic
acid
N­
tert­
butyl­
N'­(
3­
hydroxy­
2­
methylbenzoyl)
hydrazide],
RH
 
151,055
glucose
conjugate
of
RH
 
117,236;
3,5­
dimethylbenzoicacid
Ntert
butyl­
N­[
3(
b­
D­
glucopyranosyloxy)­
2­
methylbenzoyl]­
hydrazide
and
RH
 
152,072
the
malonylglycosyl
conjugate
of
RH
 
117,236
in
or
on
animal
feed,
non­
grass
(
forage,
fodder,
straw,
hay),
group;
grain,
cereal,
forage,
fodder,
and
straw,
group;
grass,
forage,
fodder,
and
hay,
group;
herbs
and
spices,
group;
vegetable,
legume,
group;
and
vegetable,
legume,
foliage,
group
when
present
therein
as
a
result
of
the
application
of
methoxyfenozide
to
growing
crops
at
10.0,
10.0,
10.0,
10.0,
0.10
and
10.0
ppm,
respectively.
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
methoxyfenozide
are
discussed
below
as
well
as
the
no
observed
adverse
effect
level
(
NOAEL)
and
the
lowest
observed
adverse
effect
level
(
LOAEL)
from
the
toxicity
studies
reviewed.
In
an
acute
neurotoxicity
study
in
rats
(
MRID
44617802),
statistically
significant
decreased
hindlimb
grip
strength
was
observed
in
male
rats
at
3
hours
(
approximate
time
of
peak
effect)
following
a
single
oral
dose
of
2,000
milligrams/
kilogram
(
mg/
kg)
(
limit
dose)
of
methoxyfenozide.
Decreased
hindlimb
grip
strength
was
also
observed
in
the
male
rats
at
7
and
14
days,
but
was
not
statistically
significant.
No
other
systemic
or
neurotoxic
effects
were
observed
in
the
male
rats
or
in
the
female
rats
at
any
time
in
this
study.
Since
this
marginal
effect
occurred
only
in
one
sex,
was
statistically
significant
at
only
one
time,
was
observed
only
at
the
high
dose
(
limit
dose)
and
no
other
signs
of
toxicity
were
observed
in
the
rats
in
this
study,
this
possible
effect
is
not
considered
to
be
biologically
significant.
In
addition,
neither
decreased
hindlimb
grip
strength
nor
any
other
signs
of
neurotoxicity
were
observed
in
any
of
the
animals
at
any
time
in
a
90
 
day
subchronic
neurotoxicity
study
in
rats
(
MRID
44617803).
In
a
2
 
week
range­
finding
dietary
study
in
rats
(
MRID
44617722),
treatment­
related
effects
were
observed
at
 
5,000
ppm
in
the
liver
(
increased
liver
weights
and
hepatocellular
hypertrophy
in
males
and
females),
in
the
thyroid
gland
(
hypertrophy/
hyperplasia
of
follicular
cells
in
males
and
females),
and
in
the
adrenal
gland
(
increased
adrenal
weights
and/
or
hypertrophy
of
the
zona
fasciculata
in
females).
Hypertrophy/
hyperplasia
of
thyroid
follicular
cells
was
also
observed
in
males
and
females
at
1,000
ppm,
the
LOAEL
in
this
study.
The
NOAEL
was
250
ppm.
Treatmentrelated
hematological
changes
were
not
observed
in
the
rats
in
this
study.
In
a
3
 
month
feeding
study
in
rats
(
MRID
44617722),
the
predominant
treatment­
related
effects
were
increased
liver
weights
in
males
and
females
and
periportal
hepatocellular
hypertrophy
in
all
males
and
females
at
20,000
ppm
(
highest
dose
tested)
and
at
5,000
ppm.
In
addition,
at
20,000
ppm,
a
slightly
decreased
(
7
 
8%)
red
blood
cell
(
RBC)
count
and
slightly
decreased
(
7
 
8%)
hemoglobin
concentration,
compared
to
control
rats,
were
observed
in
the
females.
The
LOAEL
in
this
study
was
5,000
ppm
(
353
mg/
kg/
day
in
males
and
379
mg/
kg/
day
in
females).
The
NOAEL
was
1,000
ppm
(
69
mg/
kg/
day
in
males
and
72
mg/
kg/
day
in
females).
Although
observed
in
the
2
 
week
dietary
study
and
in
the
2
 
year
chronic
feeding/
carcinogenicity
study
in
rats,
treatmentrelated
effects
in
the
thyroid
and
adrenal
glands
were
not
observed
in
the
rats
in
this
3
 
month
study.
There
is
no
available
biological
explanation
for
this
difference
in
findings
in
the
studies.
In
a
2
 
year
combined
chronic
feeding/
carcinogenicity
study
in
rats
(
MRID
44617731),
the
following
treatment­
related
effects
were
observed
at
20,000
ppm
(
highest
dose
tested):
decreased
survival
in
males,
decreased
body
weight
and
food
efficiency
in
females
during
the
last
year
of
the
study,
hematological
changes
(
decreased
RBC
counts,
hemoglobin
concentrations,
and/
or
hematocrits;
methemoglobinemia;
and
increased
platelet
counts)
in
males
and
females,
increased
liver
weights
and
periportal
hepatocellular
hypertrophy
in
males
and
females,
thyroid
follicular
cell
hypertrophy
in
males,
altered
thyroid
colloid
in
males
and
females,
and
increased
adrenal
weights
in
males
and
females.
At
8,000
ppm,
the
following
treatment­
related
effects
were
observed:
hematological
changes
(
decreased
RBC
counts,
hemoglobin
concentrations,
and/
or
hematocrits
in
males
and
females),
liver
toxicity
(
increased
liver
weights
in
males
and
periportal
hepatocellular
hypertrophy
in
males
and
females),
histopathological
changes
in
the
thyroid
(
increased
follicular
cell
hypertrophy
in
males
and
altered
colloid
in
males)
and
possible
adrenal
toxicity
(
increased
adrenal
weights
in
males
and
females).
The
LOAEL
in
this
study
was
8,000
ppm
(
411
mg/
kg/
day
in
males
and
491
mg/
kg/
day
in
females),
based
on
the
effects
described
above.
The
NOAEL
was
200
ppm
(
10.2
mg/
kg/
day
in
males
and
11.9
mg/
kg/
day
in
females).
This
NOAEL
was
used
to
establish
the
RfD
for
methoxyfenozide.
Utilizing
an
uncertainty
factor
(
UF)
of
100
to
account
for
both
interspecies
extrapolation
(
10X)
and
intraspecies
variability
(
10X),
the
chronic
RfD
for
methoxyfenozide
was
calculated
to
be
0.10
mg/
kg/
day.
No
evidence
of
carcinogenicity
was
observed
in
this
study.
Dosing
was
considered
adequate
because
of
the
decreased
survival
in
males
and
the
decreased
body
weights
and
food
efficiency
in
females
at
20,000
ppm.
In
addition,
the
highest
dose
tested
for
both
males
and
females,
20,000
ppm
(
1,045
mg/
kg/
day
males
and
1,248
mg/
kg/
day
in
females),
is
higher
than
the
limit
dose
of
1,000
mg/
kg/
day.
In
a
2
 
week
range­
finding
study
in
dogs
(
MRID
44617724),
treatment­

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Federal
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/
Vol.
67,
No.
183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
related
hematological
changes
were
observed
in
both
males
and
females
at
3,500
ppm,
7,000
ppm,
15,000
ppm
and
30,000
ppm
(
highest
dose
tested).
These
changes
included
decreased
RBC
counts,
decreased
hemoglobin
concentrations,
decreased
hematocrits,
decreased
MCHC,
increased
MCV,
increased
MCH,
increased
Heinz
bodies,
methemoglobinemia,
changes
in
RBC
morphology
such
as
Howell­
Jolly
bodies
and
polychromasia,
increased
reticulocyte
counts,
increased
nucleated
RBC
and
increased
platelet
counts.
At
the
same
dose
levels
( 
3,500
ppm),
increased
spleen
weights
and/
or
enlarged
spleens
were
also
observed.
At
 
7,000
ppm,
plasma
total
bilirubin
was
increased.
The
LOAEL
in
this
study
was
3,500
ppm
(
90
 
184
mg/
kg/
day
in
males
and
females).
The
NOAEL
was
300
ppm
(
11
 
16
mg/
kg/
day
in
males
and
females).
In
a
3
 
month
feeding
study
in
dogs
(
MRID
44617724),
no
treatment­
related
effects
other
than
a
suggestion
of
decreased
body
weight
gains
in
males
and
females
were
observed
in
either
males
or
females
at
the
highest
dose
tested
viz.
5,000
ppm
(
198
mg/
kg/
day
in
males
and
209
mg/
kg/
day
in
females).
Although
hematological
effects
were
noted
in
dogs
in
the
2
 
week
rangefinding
study
at
 
3,500
ppm
(
90
 
184
mg/
kg/
day)
and
in
the
1
 
year
chronic
feeding
study
at
 
3,000
ppm
(
106
mg/
kg/
day
in
males
and
111
mg/
kg/
day
in
females),
hematological
changes
were
not
observed
in
this
3
 
month
study
at
5,000
ppm
(
198/
209
mg/
kg/
day).
There
is
no
available
biological
explanation
for
this
difference
in
findings
in
the
studies.
As
part
of
the
3
 
month
study
in
dogs
(
MRID
44617724),
some
male
and
female
dogs
were
given
15
ppm
(
0.6
mg/
kg/
day)
of
methoxyfenozide
in
the
diet
for
15
weeks
followed
by
an
increase
in
the
dietary
dose
to
15,000
ppm
(
422
mg/
kg/
day
in
males
and
460
mg/
kg/
day
in
females)
for
an
additional
6
weeks.
After
about
2
weeks
and
6
weeks
at
15,000
ppm,
hematological
examinations
were
conducted.
No
hematological
changes
in
these
dogs
were
observed.
Apparently,
pretreatment
of
the
dogs
at
15
ppm
for
15
weeks
prevented
the
occurrence
of
hematological
changes
which
would
have
been
expected
to
occur
based
on
results
in
the
2
 
week
and
1
 
year
feeding
studies.
One
possible
explanation
is
that
the
liver
microsomal
enzyme
system
may
have
been
stimulated
so
much
during
pretreatment
at
15
ppm
that
the
metabolic
(
detoxification
?)
rate
of
methoxyfenozide
was
increased
to
the
point
where
blood
levels
of
methoxyfenozide
may
have
remained
below
critical
effect
levels
at
15,000
ppm.
Another
possible
explanation
is
that
compensatory
mechanisms
for
replacing
damaged
RBC
in
pretreated
dogs
may
have
been
so
efficient
that
hematological
changes
were
not
observed
in
these
dogs
even
at
15,000
ppm.
Other
explanations
for
this
finding
are
also
possible.
In
a
1
 
year
chronic
feeding
study
in
dogs
(
MRID
44617728),
the
predominant
toxic
effects
were
anemia
and
signs
of
an
associated
compensatory
response.
At
30,000
ppm,
the
highest
dose
tested,
the
following
treatment­
related
effects
were
observed
in
both
males
and
females:
decreased
RBC
counts,
decreased
hemoglobin
concentrations,
decreased
hematocrits,
methemoglobinemia,
nucleated
RBC,
increased
platelets,
increased
serum
total
bilirubin,
bilirubinurea,
increased
hemosiderin
in
macrophages
in
liver
and
spleen,
and
increased
hyperplasia
in
bone
marrow
of
rib
and
sternum.
Increased
liver
weights
in
males
and
females
and
increased
thyroid
weights
in
males
were
also
observed
at
30,000
ppm.
Signs
of
anemia
were
also
noted
at
3,000
ppm
and
included
decreased
RBC
counts,
decreased
hemoglobin
concentrations,
decreased
hematocrits,
methemoglobinemia,
increased
platelets,
and
increased
serum
total
bilirubin
and
bilirubinurea.
The
LOAEL
in
this
study
was
3,000
ppm
(
106
mg/
kg/
day
in
males
and
111
mg/
kg/
day
in
females).
The
NOAEL
was
300
ppm
(
9.8
mg/
kg/
day
in
males
and
12.6
mg/
kg/
day
in
females).
In
a
3
 
month
feeding
study
in
mice
(
MRID
44617723),
the
only
treatmentrelated
effect
was
decreased
body
weight
gain
in
males
and
females
at
7,000
ppm,
the
highest
dose
tested.
The
LOAEL
in
this
study
was
7,000
ppm
(
1,149
mg/
kg/
day
in
males
and
1,742
mg/
kg/
day
in
females)
and
the
NOAEL
was
2,500
ppm
(
428
mg/
kg/
day
in
males
and
589
mg/
kg/
day
in
females).
In
an
18
 
month
carcinogenicity
study
in
mice
(
MRID
44617729),
no
treatment­
related
effects
were
observed
at
doses
up
to
and
including
the
limit
dose
of
7,000
ppm
(
1,020
mg/
kg/
day
in
males
and
1,354
mg/
kg/
day
in
females).
No
evidence
of
carcinogenicity
was
observed
in
this
study.
Dosing
was
considered
adequate
because
the
highest
dose
tested
for
both
males
and
females,
7,000
ppm
(
1,020
mg/
kg/
day
in
males
and
1,354
mg/
kg/
day
in
females,
respectively),
is
higher
than
the
limit
dose
of
1,000
mg/
kg/
day.
In
a
battery
of
four
mutagenicity
studies
(
with
and
without
metabolic
activation,
as
appropriate
for
the
specific
study),
technical
grade
methoxyfenozide
was
negative
for
genotoxicity
in
all
four
studies.
The
four
studies
satisfy
the
new
revised
mutagenicity
guideline
requirements
for
a
new
chemical
(
published
in
1991).
An
additional
mutagenicity
study,
performed
on
RH
 
117,236
(
Metabolite
M­
B),
a
metabolite
of
methoxyfenozide,
was
also
negative
for
genotoxicity.
Based
on
the
lack
of
evidence
of
carcinogenicity
in
male
and
female
rats
as
well
as
in
male
and
female
mice
and
on
the
lack
of
genotoxicity
in
an
acceptable
battery
of
mutagenicity
studies,
methoxyfenozide
is
classified
as
a
``
not
likely''
human
carcinogen
according
to
the
EPA
Proposed
Guidelines
for
Carcinogen
Risk
Assessment
(
April
10,
1996).
In
a
developmental
toxicity
study
in
rats
(
MRID
44638201),
no
signs
of
maternal
toxicity
in
dams
or
of
developmental
toxicity
in
fetuses
were
observed
at
the
limit
dose
of
1,000
mg/
kg/
day.
The
NOAEL
in
this
study
for
both
maternal
toxicity
and
developmental
toxicity
was
1,000
mg/
kg/
day.
The
LOAEL
was
>
1,000
mg/
kg/
day.
Similarly,
in
a
developmental
toxicity
study
in
rabbits
(
MRID
44617726),
no
signs
of
maternal
toxicity
or
of
developmental
toxicity
were
observed
at
the
limit
dose
of
1,000
mg/
kg/
day.
The
NOAEL
in
this
study
for
both
maternal
toxicity
and
developmental
toxicity
was
1,000
mg/
kg/
day.
The
LOAEL
was
>
1,000
mg/
kg/
day.
In
neither
the
developmental
toxicity
study
in
rats
nor
in
the
developmental
toxicity
study
in
rabbits
was
there
any
evidence
for
increased
susceptibility
of
fetuses
to
in
utero
exposure
to
methoxyfenozide.
In
these
studies,
methoxyfenozide
was
determined
not
to
be
a
developmental
toxicant.
In
a
2­
generation
(
1
litter/
generation)
reproduction
study
in
rats
(
MRID
44617727),
treatment­
related
parental
toxicity
was
observed
only
at
20,000
ppm,
the
highest
dose
tested.
At
this
dose,
increased
liver
weights
were
observed
in
males
and
females
of
both
generations
and
midzonal
to
periportal
hepatocellular
hypertrophy
was
observed
in
the
livers
of
all
males
and
females
of
both
generations.
The
LOAEL
for
parental
toxicity
was
20,000
ppm
(
1,552
mg/
kg/
day
for
males
and
1,821
mg/
kg/
day
for
females)
and
the
NOAEL
was
2,000
ppm
(
153
mg/
kg/
day
for
males
and
181
mg/
kg/
day
for
females).
There
were
no
treatment­
related
effects
on
reproductive
parameters
for
adult
(
parent)
animals.
The
NOAEL
for
reproductive
toxicity
was
20,000
ppm.
Since
no
treatment­
related
effects
were
observed
in
the
pups,
the
NOAEL
for
neonatal
toxicity
was
also
20,000
ppm.
The
NOAEL
for
parental
toxicity
in
this
reproduction
study
is
higher
than
the
NOAEL
for
the
2
 
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chronic
feeding/
carcinogenicity
study
in
rats
because
many
of
the
toxic
effects
observed
in
the
2
 
year
study
at
the
LOAEL
(
hematological
changes,
liver
toxicity,
histopathological
changes
in
the
thyroid
gland
and
increased
adrenal
weights)
were
not
examined
in
the
reproduction
study.
In
a
metabolism
study
in
rats
(
MRID
44617804),
14C­
methoxyfenozide
was
rapidly
absorbed,
distributed,
metabolized
and
almost
completely
excreted
within
48
hours.
The
major
route
of
excretion
was
feces
(
86
 
97%)
with
lesser
amounts
in
the
urine
(
5
 
13%).
An
enterohepatic
circulation
was
observed.
The
test
material
was
metabolized
principally
by
Odemethylation
of
the
A­
ring
methoxy
group
and
oxidative
hydroxylation
of
the
B­
ring
methyl
groups
followed
by
conjugation
with
glucuronic
acid.
No
significant
sex­
related
or
dosedependent
differences
in
metabolic
disposition
were
noted.
Seven
metabolites
and
the
parent
accounted
for
74
 
90%
of
the
administered
dose
in
all
groups.
The
glucuronide
conjugates
are
considered
to
be
less
toxic
than
the
parent
compound
because
glucuronide
conjugation
is
well
known
to
be
a
commonly
occurring
``
detoxification''
mechanism
in
mammalian
species
since
it
results
in
the
formation
of
more
polar,
more
water­
soluble
metabolites
which
are
readily
and
easily
excreted
from
the
body
(
in
this
case,
in
the
bile
and
urine).
Further,
based
on
similarities
of
chemical
structure,
the
non­
conjugated
metabolites
would
be
expected
to
be
no
more
toxic
than
the
parent
compound.
In
a
dermal
absorption
study
in
rats
(
MRID
44638201)
using
an
80%
wettable
powder
formulation
as
the
test
material,
the
cumulative
dermal
absorption
of
test
material
after
a
10
or
24
hour
dermal
exposure
was
determined
to
be
2%.
In
a
28
 
day
dermal
toxicity
study
in
rats
(
MRID
44617725),
no
treatmentrelated
systemic
or
skin
effects
were
observed
at
the
limit
dose
of
1,000
mg/
kg/
day
(
HDT).
Regarding
effects
on
endocrine
organs,
methoxyfenozide
affected
the
thyroid
gland
and
adrenal
gland
in
the
2
 
week
and
2
 
year
feeding
studies
in
rats.
In
the
thyroid
gland,
hypertrophy/
hyperplasia
of
follicular
cells
and
altered
colloid
were
observed
in
males
and
females
at
or
near
the
LOAEL
in
both
of
these
studies.
In
the
adrenal
gland,
increased
adrenal
weights
and
hypertrophy
of
the
zona
fasciculata
were
also
observed
in
males
and
females
at
or
near
the
LOAEL.
In
addition,
in
the
1
 
year
chronic
feeding
study
in
dogs,
increased
thyroid
weight
in
males
was
observed,
but
only
at
the
very
high
dose
of
30,000
ppm.
Other
than
the
morphological
changes
described
above,
there
were
no
signs
of
thyroid
or
adrenal
dysfunction
in
these
or
in
any
other
studies
on
methoxyfenozide.

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.
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
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
methoxyfenozide
used
for
human
risk
assessment
is
shown
in
the
following
Table
2:

TABLE
1.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
METHOXYFENOZIDE
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
(
mg/
kg/
day)
Endpoint
Study
Acute
Dietary
None
No
appropriate
endpoint
was
identified
in
the
oral
toxicity
studies
including
the
acute
neurotoxicity
study
in
rats
and
the
developmental
toxicity
studies
in
rats
and
rabbits.
None
UF
=
N/
A
Acute
RfD
=
Not
Applicable
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Friday,
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20,
2002
/
Rules
and
Regulations
TABLE
1.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
METHOXYFENOZIDE
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
 
Continued
Exposure
Scenario
Dose
(
mg/
kg/
day)
Endpoint
Study
Chronic
Dietary
(
Non
cancer)
All
Population
Subgroups
NOAEL
=
10.2
mg/
kg/
day
Hematological
changes
(
decreased
RBC,
hemoglobin
and/
or
hematocrit),
liver
toxicity
(
increased
weights,
hypertrophy),
histopathological
changes
in
thyroid
(
increased
follicular
cell
hypertrophy
altered
colloid
possible
adrenal
toxicity
(
increased
weights).
2
 
Year
combined
chronic
feeding/
carcinogenicity
rats
UF
=
100;
FQPA
=
1X
Chronic
RfD
=
0.10
mg/
kg/
day
Chronic
Population
Adjusted
Dose
(
cPAD)
=
0.10
mg/
kg/
day
This
cPAD
applies
to
All
population
subgroups.

Short­
Term,
Intermediate­
Term,
and
Long­
Term
(
Dermal)
None
No
systemic
toxicity
was
seen
at
the
limit
dose
following
repeated
dermal
application
to
rats.
None
Short­
Term­
Intermediate­
Term,
and
Long­
Term
(
Inhalation)
None
Based
on
low
vapor
pressure
the
low
acute
toxicity
of
both
the
technical
and
formulated
products
as
well
as
the
application
rate
and
application
method,
there
is
minimal
concern
for
inhalation
exposure
None
Cancer
None
None.
None
*
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
180.544)
for
the
residues
of
methoxyfenozide,
in
or
on
a
variety
of
raw
agricultural
commodities.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
methoxyfenozide
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.
No
appropriate
toxicological
endpoint
attributable
to
a
single
exposure
was
identified
in
the
available
toxicology
studies
on
methoxyfenozide.
Thus,
the
risk
from
acute
exposure
is
considered
negligible.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
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
chronic
exposure
assessments:
a.
A
tier
1(
assumptions:
tolerance
level
residues
and
100
percent
crop
treated
)
was
conducted.
b.
The
established
tolerances
of
40
CFR
180.544
and
the
new
tolerances
established
today
were
included
in
the
analysis.
c.
Anticipated
residues
and
percent
crop
treated
were
not
used
in
this
analysis.
d.
The
processing
factors
applied
were
the
DEEM
default
values.
As
shown
in
table
2
of
this
preamble,
the
resulting
dietary
food
exposures
occupy
up
to
34.3%
of
the
Chronic
PAD
for
the
most
highly
exposed
population
subgroup,
children,
1
 
6
years
old.
These
results
should
be
viewed
as
conservative
(
health
protective)
risk
estimates.
Refinements
such
as
use
of
percent
crop­
treated
information
and/
or
anticipated
residue
values
would
yield
even
lower
estimates
of
chronic
dietary
exposure.

TABLE
2.
 
SUMMARY:
CHRONIC
DIETARY
EXPOSURE
ANALYSIS
BY
DEEM
(
TIER
1)

Population
Subgroup1
Exposure
(
mg/
kg/
day)
%
of
Chronic
PAD2
U.
S.
Population
(
Total)
0.018704
18.7
All
infants
(<
1
year
old)
0.020335
20.3
Nursing
infants
0.010197
10.2
Non­
nursing
infants
0.024603
24.6
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Vol.
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183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
TABLE
2.
 
SUMMARY:
CHRONIC
DIETARY
EXPOSURE
ANALYSIS
BY
DEEM
(
TIER
1)
 
Continued
Population
Subgroup1
Exposure
(
mg/
kg/
day)
%
of
Chronic
PAD2
Children
(
1
 
6
years
old)
0.034286
34.3
Children
(
7
 
12
years
old)
0.024543
24.5
Females
13+
(
nursing)
0.021335
21.3
Non­
hispanic/
non­
white/
non­
black
0.021910
21.9
1
The
subgroups
listed
are:
(
1)
the
U.
S.
Population
(
total);
(
2)
those
for
infants
and
children;
(
3)
the
most
highly
exposed
of
the
females
subgroups
in
this
case
Females
13+
(
nursing),
and
(
4)
the
most
highly
exposed
of
the
remaining
subgroups,
in
this
case
Non­
hispanic/
non­
white/
non­
black.
2
Percent
Chronic
PAD
=
(
Exposure
÷
Chronic
PAD)
x
100.

iii.
Cancer.
Methoxyfenozide
is
classified
as
a
``
not
likely''
human
carcinogen.
Therefore
this
risk
is
considered
negligible.
iv.
Anticipated
residue
and
percent
crop
treated
information.
Anticipated
residue
and
percent
crop
treated
information
was
not
used
in
the
Agency's
assessment.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
methoxyfenozide
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
methoxyfenozide.
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
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
%
RfD
or
%
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
methoxyfenozide
they
are
further
discussed
in
the
aggregate
risk
sections.
Based
on
the
PRZM/
EXAMS
and
SCIGROW
models
the
estimated
environmental
concentrations
(
EECs)
of
methoxyfenozide
for
acute
exposures
are
estimated
to
be
290
parts
per
billion
(
ppb)
for
surface
water
and
12
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
197
ppb
for
surface
water
and
12
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).
Methoxyfenozide
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)
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
methoxyfenozide
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,
methoxyfenozide
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
methoxyfenozide
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.
FFDCA
section
408
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
database
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
margin
of
exposure
(
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.
The
toxicology
database
for
methoxyfenozide
included
acceptable
developmental
toxicity
studies
in
both
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rats
and
rabbits
as
well
as
a
2
 
generation
reproductive
toxicity
study
in
rats.
The
data
provided
no
indication
of
increased
sensitivity
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure
to
methoxyfenozide.
3.
Conclusion.
The
10X
safety
factor
for
the
protection
of
infants
and
children
(
as
required
by
FQPA)
has
been
removed
(
i.
e.
reduced
to
1x)
for
the
following
reasons:
 
The
toxicology
data
base
for
methoxyfenozide
is
complete
for
assessment
of
potential
hazard
to
infants
and
children.
 
Based
on
weight­
of­
the­
evidence
considerations,
the
HIARC
determined
that
a
developmental
neurotoxicity
study
in
rats
is
not
required
to
support
the
registration
of
methoxyfenozide.
 
In
developmental
toxicity
studies
in
rats
and
rabbits
(
MRID
44638201,
44617726),
no
increased
susceptibility
in
fetuses
as
compared
to
maternal
animals
was
observed
following
in
utero
exposures.
 
In
a
2­
generation
reproduction
study
in
rats
(
MRID
44617727),
no
increased
susceptibility
in
pups
as
compared
to
adults
was
observed
following
in
utero
and
post­
natal
exposures.
 
The
exposure
assessments
will
not
underestimate
the
potential
dietary
(
food
and
drinking
water)
or
non­
dietary
exposures
for
infants
and
children
from
the
use
of
methoxyfenozide.

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
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
EPA
are
used
to
calculate
DWLOCs:
2L/
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.
No
appropriate
toxicological
endpoint
attributable
to
a
single
(
acute)
dietary
exposure
was
identified.
No
acute
risk
is
expected
from
exposure
to
methoxyfenozide.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
methoxyfenozide
from
food
will
utilize
18.7%
of
the
cPAD
for
the
U.
S.
population,
24.6%
of
the
cPAD
for
non­
nursing
infants
and
34.3%
of
the
cPAD
for
children
(
1
 
6
years
old).
There
are
no
residential
uses
for
methoxyfenozide
that
result
in
chronic
residential
exposure
to
methoxyfenozide.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
methoxyfenozide
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
the
following
Table
3:

TABLE
3.
 
DWLOCS
FOR
CHRONIC
(
NON­
CANCER)
DIETARY
EXPOSURE
Population
Subgroup
Chronic
PAD
(
mg/
kg/
day)
Food
Exposure
(
mg/
kg/
day)
Max.
Water
Exposure
(
mg/
kg/
day)
1
SCI­
GROW
(
µ
g/
L)
GENEEC
56
 
day
avg
(
µ
g/
L)
DWLOC
(
µ
g/
L)
2,3,4
U.
S.
Population
(
total)
0.10
0.019
0.081
12
197
2,800
Females
13+
5
0.10
0.021
0.079
12
2,400
Infants/
Children5
0.10
0.034
0.066
12
197
660
Other5
0.10
0.022
0.078
12
197
2,700
1
Maximum
Water
Exposure
(
mg/
kg/
day)
=
Chronic
PAD
(
mg/
kg/
day)
­[
Chronic
Food
Exposure
+
Chronic
Residential
Exposure
(
mg/
kg/
day)].
Methoxyfenozide
has
no
registered
residential
uses.
2
DWLOC
(
µ
g/
L)
=
[
Maximum
water
Exposure
(
mg/
kg/
day)
x
body
wt
(
kg)]
÷
[(
10­
3
mg/
µ
g)
x
water
consumed
daily
(
L/
day)].
µ
g/
L
=
parts
per
billion.
3
EPA
default
body
weights
are:
General
U.
S.
Population,
70
kg;
Males
(
13+
years
old),
70
kg;
Females
(
13+
years
old),
60
kg;
Other
Adult
Populations,
70
kg;
and,
All
Infants/
Children,
10
kg.
4
EPA
default
daily
drinking
rates
are
2
L/
day
for
Adults
and
1
L/
day
for
Children.
5
Within
each
of
these
subgroups,
the
subpopulation
with
the
highest
(
chronic)
food
exposure
was
selected;
namely,
Females
(
13+/
nursing);
Children
1
 
6
yrs;
and,
Non­
hispanic/
non­
white/
non­
black,
respectively.

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).
Methoxyfenozide
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.

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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).
Methoxyfenozide
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.
Methoxyfenozide
is
classified
as
a
``
not
likely''
human
carcinogen.
Therefore,
exposure
to
methoxyfenozide
is
expected
to
create
at
most
a
negligible
risk
of
cancer.
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
methoxyfenozide
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
1.
Enforcement
methods
for
target
crops.
Adequate
enforcement
methods
are
available
for
determination
of
methoxyfenozide
residues
in
plant
commodities.
The
similar
methods
that
are
used
vary
depending
on
the
matrices
involved.
The
enforcement
method
for
cottonseed
is
TR
34
 
96
 
88
(
high
production
liquid
chromatography
using
ultraviolet
detection
(
HPLC/
UV);
MRID
44617821),
which
has
undergone
a
successful
petition
method
validation
(
PMV)
trial
conducted
by
EPA
(
D261663).
The
enforcement
method
for
pome
fruit
(
also
proposed
for
globe
artichoke
and
lychee)
is
TR
34
 
98
 
87
(
HPLC/
UV;
MRID
44626304),
which
has
also
undergone
a
successful
PMV
trial
conducted
by
EPA
(
D261664).
The
other
proposed
enforcement
methods
are
on:
corn,
TR
34
 
00
 
38
(
HPLC/
UV;
MRID
45213504);
tree
nuts,
TR
34
 
00
 
107
(
HPLC/
UV;
MRID
45373503);
stone
fruit,
TR
34
 
00
 
109
(
HPLC/
UV;
MRID
45313302);
leafy
and
Brassica
(
cole)
vegetables,
fruiting
vegetables,
grapes
and
raisins,
TR
34
 
99
 
74
(
HPLC/
UV
or
MS;
MRID
44873410).
Adequate
confirmatory
method
validation,
radiovalidation,
and
independent
laboratory
validation
(
ILV)
data
for
these
methods
have
been
provided.
2.
Enforcement
method
for
rotational
crops.
Method
TR
34
 
00
 
41(
MRID
45194701)
is
designated
as
the
enforcement
method
for
indirect
or
inadvertent
residues
in
rotational
crops
(
D269986).
The
method
determines
residues
of
methoxyfenozide
(
HPLC/
UV)
in
high
moisture
crops;
and
residues
of
methoxyfenozide
and
its
metabolites
RH
 
117,236,
RH
 
151,055,
and
RH
 
152,072
(
HPLC/
MS)
in
low
moisture
crops.
Adequate
confirmatory
method
validation,
radiovalidation,
and
ILV
data
have
been
submitted.
EPA
concluded
(
D274209)
a
PMV
trial
on
this
method
was
not
needed
because
of
its
similarity
to
TR
34
 
98
 
87.
3.
Enforcement
methods
for
animal
commodities.
The
tolerance
enforcement
method
for
animal
commodities
(
except
poultry)
is
TR
34
 
98
 
106
(
MRID
44626305),
which
has
undergone
a
successful
PMV
trial
conducted
by
EPA
(
D261665).
The
method
determines
residues
of
parent
methoxyfenozide
(
HPLC/
UV)
in
fat,
cream,
milk,
and
muscle;
and
residues
of
methoxyfenozide
and
its
metabolite
RH
 
141,518
(
HPLC/
MS)
in
liver
and
kidney
(
D249438).
A
similar
method,
TR
34
 
00
 
40
(
MRID
45213505),
will
be
the
enforcement
method
for
poultry
commodities.
TR
34
 
00
 
40
determines
methoxyfenozide
in
fat
(
HPLC/
UV)
and
muscle
(
HPLC/
MS);
and
methoxyfenozide
and
RH
 
141,518
(
HPLC/
MS)
in
eggs
and
liver
(
D269969).
EPA
concluded
(
D274209)
a
PMV
trial
on
this
method
was
not
needed
because
of
its
similarity
to
TR
34
 
98
 
106.
Adequate
confirmatory
method
validation,
radiovalidation,
and
ILV
data
have
been
submitted
for
both
methods.
4.
Multiresidue
methods
testing.
Methoxyfenozide
is
not
recoverable
by
the
Food
and
Drug
Administration
multiresidue
method
protocols
of
the
Pesticide
Analytical
Method,
Volume
I
(
D249438).
Test
data
for
metabolites
RH
 
141,518,
RH
 
117,236,
RH
 
151,055,
and
RH
 
152,072
are
also
required,
but
have
not
been
submitted.
Submission
of
such
test
data
will
be
made
a
condition
of
registration.
These
methods
may
be
requested
from:
Calvin
Furlow,
PIRIB,
Information
Resources
and
Services
Division
(
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
Codex
or
Canadian
MRLs
established
for
residues
of
methoxyfenozide.
Mexican
MRLs
are
established
for
residues
of
methoxyfenozide
in
cottonseed
(
0.05
ppm)
and
maize
(
0.01
ppm).
The
U.
S.
tolerances
on
these
commodities
are
2.0
ppm
and
0.05
ppm,
respectively.
Based
on
the
current
use
patterns,
the
U.
S.
tolerance
levels
can
not
be
reduced
to
harmonize
with
the
Mexican
MRLs,
so
incompatibility
will
exist.

C.
Conditions
Submission
of
test
data
showing
the
recovery
of
metabolites
RH
 
141,518,
RH
 
117,236,
RH
 
151,055,
and
RH
 
152,072
through
the
multiresidue
test
protocols
of
PAM,
Vol.
1.
Submission
of
additional
field
accumulation
trials
(
the
24
reportedly
in
progress).
In
the
interim
period,
only
time­
limited
tolerances
(
5
year)
should
be
established.
 
Submission
of
the
following
additional
field
trials,
conducted
per
their
respective
proposed
use
pattern:
 
Three
for
spinach
(
one
each
from
Regions
1,
2,
and
10)
 
Two
for
celery
(
both
from
Region
3,
preferably
using
Intrepid
2F)
 
Three
for
mustard
greens
(
one
each
from
Regions
2,
3,
and
10)
 
Two
for
plums
(
one
each
from
Regions
10
and
11)
Submission
of
the
following
additional
information
from
the
hen
feeding
study:
 
Results
of
analysis
(
to
be
conducted)
of
the
fat
and
meat
(
muscle)
samples
for
residues
of
RH
 
141,518;
 
Freezer
storage
stability
data
that
covers
the
period
of
time
these
poultry
fat
and
meat
(
muscle)
samples
have
been
maintained
in
storage;
and,
 
Revised
tolerances
and
tolerance
expression
(
to
include
RH
141,518)
for
these
matrices,
if
warranted.

V.
Conclusion
Therefore,
tolerances
are
established
for
residues
of
the
insecticide
methoxyfenozide
in
or
on
almond,
hulls;
artichoke,
globe;
cattle,
fat;
corn,
field,
grain;
corn,
field,
forage;
corn,
field,
stover;
corn,
oil;
corn,
aspirated
grain
fractions;
corn,
sweet
(
K
+
CWHR);
corn,
sweet,
forage;
corn,
sweet,
stover;
fruit,
stone,
group
(
except
plum,
fresh
prune);
goat,
fat;
grape;
horse,
fat;
lime,
Spanish;
longan;
lychee;
milk;
nut,
tree,
group;
pistachio;
plum
(
fresh
prune);
poultry,
fat;
poultry,
meat;
pulasan;
raisin;
rambutan;
sheep,
fat;
vegetable,
fruiting
(
except
cucurbits),
group;
vegetable,
leafy
(
except
Brassica),
leafy
greens
subgroup;
vegetable,
leafy
(
except
Brassica),
leaf
petioles
subgroup;
vegetable,
leafy,
Brassica
(
cole),
head
and
stem
subgroup;
vegetable,
leafy,
Brassica
(
cole),
greens
subgroup
at
25.0,
3.0,
0.50,0.05,
15.0,
125.0,
0.20,
2.0,
0.05,
30.0,
60.0,
3.0,
0.50,
1.0,0.50,
2.0,2.0,
2.0
0.10,
0.10,0.10,0.30,
0.02,
0.02,
2.0,
1.5,
2.0,
0.5,
2.0,
30.0,
25.0,
7.0
and
30.0
part
per
million
(
ppm)
respectively
and
for
the
combined
residues
of
methoxyfenozide
and
its
glucuronide
metabolite
in
or
on
cattle,

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20,
2002
/
Rules
and
Regulations
liver;
cattle,
meat
byproducts
(
except
liver);
eggs;
goat,
liver;
goat
meat
byproducts
(
except
liver);
horse,
liver;
horse,
meat
byproducts
(
except
liver);
poultry,
liver;
poultry,
meat
byproducts
(
except
liver);
sheep,
liver;
and
sheep,
meat
byproducts
(
except
liver)
at
0.40,
0.10,
0.02,
0.40,
0.10,
0.40,
0.10,
0.10,
0.02,
0.40
and
0.10
part
per
million
(
ppm)
respectively.
These
petitions
also
requested
that
40
CFR
180.544
be
amended
by
establishing
time
limited
tolerances
for
the
indirect
or
inadvertent
residues
for
methoxyfenozide
in
or
on
vegetable,
bulb,
group;
vegetable,
root
and
tuber,
group;
and
vegetable,
root
and
tuber,
leaves,
group
when
present
therein
as
a
result
of
the
application
of
methoxyfenozide
to
growing
crops
at
0.20,
0.10
and
0.20
part
per
million
(
ppm)
respectively
and
time
limited
indirect
or
inadvertent
combined
residues
for
methoxyfenozide
and
its
metabolites
RH
 
117,236
free
phenol
of
methoxyfenozide;
3,5­
dimethylbenzoic
acid
N­
tert­
butyl­
N'­(
3­
hydroxy­
2­
methylbenzoyl)
hydrazide,
RH
 
151,055
glucose
conjugate
of
RH
 
117,236;
3,5­
dimethylbenzoicacid
N­
tert­
butyl­
N­
[
3(
b­
D­
glucopyranosyloxy)­
2­
methylbenzoyl]­
hydrazide
and
RH
 
152,072
the
malonylglycosyl
conjugate
of
RH
117,236
in
or
on
animal
feed,
non­
grass
(
forage,
fodder,
straw,
hay),
group;
grain,
cereal,
forage,
fodder,
and
straw,
group;
grass,
forage,
fodder,
and
hay,
group;
herbs
and
spices,
group;
vegetable,
legume,
group;
and
vegetable,
legume,
foliage,
group
when
present
therein
as
a
result
of
the
application
of
methoxyfenozide
to
growing
crops
at
10.0,
10.0,
10.0,
10.0,
0.10
and
10.0
part
per
million
(
ppm)
respectively.

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
of
1996,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
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
FFDCA
sections
408
and
409.
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
 
2002
 
0219
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
November
19,
2002.
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.
You
may
also
deliver
your
written
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.
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.
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.
2.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2002
 
0219,
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.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
2.
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.
Regulatory
Assessment
Requirements
This
final
rule
establishes
a
tolerance
under
FFDCA
section
408(
d)
in
response
to
a
petition
submitted
to
the
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183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
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
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
FFDCA
section
408(
d),
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
FFDCA
section
408(
n)(
4).
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.
Submission
to
Congress
and
the
Comptroller
General
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:
September
16,
2002.
Peter
Caulkins,
Acting
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
180.544
is
revised
to
read
as
follows:

§
180.544
Methoxyfenozide;
tolerances
for
residues.
(
a)
General.
(
1)
Tolerances
are
established
for
residues
of
the
insecticide
methoxyfenozide
per
se;
benzoic
acid,
3­
methoxy­
2­
methyl­,
2­
(
3,5­
dimethylbenzoyl)­
2­(
1,1­
dimethylethyl)
hydrazide
in
or
on
the
following
food
commodities:

Commodity
Parts
per
million
Almond,
hulls
............................
25
Apple,
wet
pomace
...................
7.0
Artichoke,
globe
........................
3.0
Brassica,
head
and
stem,
subgroup
.....................................
7.0
Brassica,
leafy
greens,
subgroup
.....................................
30
Cattle,
fat
..................................
0.50
Cattle,
meat
..............................
0.02
Corn,
field,
forage
.....................
15
Corn,
field,
grain
.......................
0.05
Corn,
field,
refined
oil
...............
0.20
Corn,
field,
stover
.....................
125
Corn,
sweet,
forage
..................
30
Corn,
sweet,
kernal
plus
cob
with
husks
removed
..............
0.05
Corn,
sweet,
stover
..................
60
Cotton,
gin
byproducts
.............
35
Cotton,
undelinted
seed
...........
2.0
Fruit,
pome,
group
....................
1.5
Fruit,
stone,
group,
except
fresh
prune
plum
...................
3.0
Goat,
fat
....................................
0.50
Goat,
meat
................................
0.02
Grain,
aspirated
fractions
.........
2.0
Grape
........................................
1.0
Grape,
raisin
.............................
1.5
Hog,
fat
.....................................
0.1
Hog,
meat
.................................
0.02
Horse,
fat
..................................
0.50
Horse,
meat
..............................
0.02
Leaf
petioles
subgroup
.............
25
Leafy
greens
subgroup
.............
30
Longan
......................................
2.0
Lychee
......................................
2.0
Milk
...........................................
0.10
Nut,
tree,
group
........................
0.10
Pistachio
...................................
0.10
Plum,
prune,
fresh
....................
0.30
Poultry,
fat
................................
0.02
Poultry,
meat
............................
0.02
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Commodity
Parts
per
million
Pulasan
.....................................
2.0
Rambutan
.................................
2.0
Sheep,
fat
.................................
0.50
Sheep,
meat
.............................
0.02
Spanish
lime
.............................
2.0
Vegetable,
fruiting,
group
.........
2.0
(
2)
For
combined
residues
of
the
insecticide
methoxyfenozide;
benzoic
acid,
3­
methoxy­
2­
methyl­,
2­(
3,5­
dimethylbenzoyl)­
2­(
1,1­
dimethylethyl)
hydrazide
and
its
glucuronide
metabolite
RH­
141,518;
b­
DGlucopyranuronic
acid,
3­[
2­(
1,1­
dimethylethyl)­
2­(
3,5­
dimethylbenzoyl)­
hydrazino]
carbonyl­
2­
methylphenyl­]
in
the
following
commodities:

Commodity
Parts
per
million
Cattle,
liver
................................
0.40
Cattle,
meat
byproducts,
except
liver
........................................
0.10
Egg
...........................................
0.02
Goat,
liver
.................................
0.40
Goat,
meat
byproducts,
except
liver
........................................
0.10
Hog,
liver
..................................
0.1
Hog,
meat
byproducts,
except
liver
........................................
0.02
Horse,
liver
...............................
0.40
Horse,
meat
byproducts,
except
liver
........................................
0.10
Commodity
Parts
per
million
Poultry,
liver
..............................
0.10
Poultry,
meat
byproducts,
except
liver
................................
0.02
Sheep,
liver
...............................
0.40
Sheep,
meat
byproducts,
except
liver
................................
0.10
(
b)
Section
18
emergency
exemptions.
Time­
limited
tolerances
are
established
for
the
residues
of
the
insecticide
methoxyfenozide
in
connection
with
the
use
of
the
pesticide
under
section
18
emergency
exemption
granted
by
EPA.
The
tolerances
will
expire
on
the
dates
specified
in
the
following
tables.

Commodity
Parts
per
million
Expiration/
revocation
date
Corn,
field,
forage
..................................................................................................................................................
10
12/
31/
03
Corn,
field,
grain
....................................................................................................................................................
0.02
12/
31/
03
Corn,
field,
stover
..................................................................................................................................................
75
12/
31/
03
Corn,
oil
.................................................................................................................................................................
0.1
12/
31/
03
Soybean,
aspirated
grain
fractions
........................................................................................................................
20
12/
31/
03
Soybean,
forage
....................................................................................................................................................
10
12/
31/
03
Soybean,
hay
.........................................................................................................................................................
75
12/
31/
03
Soybean,
refined
oil
...............................................................................................................................................
1.0
12/
31/
03
Soybean,
seed
.......................................................................................................................................................
0.04
12/
31/
03
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
(
d)
Indirect
or
inadvertent
residues.
(
1)
Tolerances
are
established
for
the
indirect
or
inadvertent
residues
of
the
insecticide
methoxyfenozide
per
se;
benzoic
acid,
3­
methoxy­
2­
methyl­,
2­
(
3,5­
dimethylbenzoyl)­
2­(
1,1­
dimethylethyl)
hydrazide
in
or
on
the
following
raw
agricultural
commodities,
when
present
therein
as
a
result
of
the
application
of
methoxyfenozide
to
growing
crops
as
listed
in
paragraph
(
a)
of
this
section:

Commodity
Parts
per
million
Expiration/
Revocation
Date
Vegetable,
bulb,
group
..........................................................................................................................................
0.20
09/
30/
07
Vegetable,
root
and
tuber,
group
..........................................................................................................................
0.10
09/
30/
07
Vegetable,
leaves
of
root
and
tuber,
group
...........................................................................................................
0.20
09/
30/
07
(
2)
Tolerances
are
established
for
the
indirect
or
inadvertent
combined
residues
of
methoxyfenozide;
benzoic
acid,
3­
methoxy­
2­
methyl­,
2­(
3,5­
dimethylbenzoyl)­
2­(
1,1­
dimethylethyl)
hydrazide
and
its
metabolites
RH­
117,236
free
phenol
of
methoxyfenozide;
3,5­
dimethylbenzoic
acid
N­
tert­
butyl­
N'­(
3­
hydroxy­
2­
methylbenzoyl)
hydrazide,
RH­
151,055
glucose
conjugate
of
RH­
117,236;
3,5­
dimethyl
benzoic
acid
N­
tert­
butyl­
N­[
3
(
b­
D­
glucopyranosyloxy)­
2­
methylbenzoyl]­
hydrazide
and
RH­
152,072
the
malonylglycosyl
conjugate
of
RH
117,236
in
or
on
the
following
raw
agricultural
commodities,
when
present
therein
as
a
result
of
the
application
of
methoxyfenozide
to
growing
crops
as
listed
in
paragraph
(
a)
of
this
section:

Commodity
Parts
per
million
Expiration/
Revocation
Date
Animal
feed,
non­
grass,
group
..............................................................................................................................
10.0
09/
30/
07
Grain,
cereal,
forage,
fodder
and
straw,
group
.....................................................................................................
10.0
09/
30/
07
Grass,
forage,
fodder,
and
hay,
group
..................................................................................................................
10.0
09/
30/
07
Herb
and
spice,
group
...........................................................................................................................................
10.0
09/
30/
07
Vegetable,
legume,
group
.....................................................................................................................................
0.10
09/
30/
07
Vegetable,
foliage
of
legume,
group
.....................................................................................................................
10.0
09/
30/
07
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Rules
and
Regulations
[
FR
Doc.
02
 
23996
Filed
9
 
19
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
FEDERAL
COMMUNICATIONS
COMMISSION
47
CFR
Part
64
[
CC
Docket
Nos.
96
 
115,
96
 
149;
FCC
02
 
214]

Implementation
of
the
Telecommunications
Act
of
1996:
Telecommunications
Carriers'
Use
of
Customer
Proprietary
Network
Information
and
Other
Customer
Information;
Implementation
of
the
Non­
Accounting
Safeguards
of
Sections
271
and
272
of
the
Connumications
Act
of
1934,
as
Amended
AGENCY:
Federal
Communications
Commission.
ACTION:
Final
rule.

SUMMARY:
This
document
adopts
rules
to
implement
section
222
of
the
Communications
Act
of
1934
(
as
amended
by
the
Telecommunications
Act
of
1996),
which
governs
carriers'
use
and
disclosure
of
customer
proprietary
network
information
(
CPNI).
This
document
affirms
the
continued
use
of
the
total
service
approach
to
define
what
carriers
may
do
under
section
222(
c)(
1)
without
notice
to
customers,
and
allows
a
carrier
to
choose
whether
to
use
an
opt­
out
or
optin
approval
method
for
obtaining
customer
approval
for
a
carrier
to
use
its
customer's
individually
identifiable
CPNI
for
the
purpose
of
marketing
communications­
related
services
to
that
customer.
Specifically,
this
document
allows
the
use
of
CPNI
by
carriers
or
disclosure
to
their
affiliated
entities
providing
communications­
related
services,
as
well
as
third­
party
agents
and
joint
venture
partners
providing
communications­
related
services,
only
after
a
carrier
receives
a
customer's
knowing
consent
in
the
form
of
notice
and
``
opt­
out''
approval.
This
document
also
permits
disclosure
of
CPNI
to
unrelated
third
parties
or
to
carrier
affiliates
that
do
not
provide
communications­
related
services
requires
express
customer
consent,
described
as
``
opt­
in''
approval.
This
document
also
further
refines
the
rules
governing
the
process
by
which
carriers
provide
notification
to
customers
of
their
CPNI
rights.
Specifically,
it
clarifies
the
form,
content
and
frequency
of
carrier
notices.
Additionally,
this
document
affirms
the
Federal
Communications
Commission's
conclusion
that
customers'
preferred
carrier
(
PC)
freeze
information
constitutes
CPNI
and
thereby
warrants
privacy
protection
pursuant
to
section
222,
and
announces
the
Commission's
decision
to
forbear
from
imposing
the
express
consent
requirements
announced
in
this
document
with
respect
to
PC­
freezes.
This
document
also
reaffirms
existing
Commission
rules
addressing
winback
and
retention
marketing,
and
declines
to
adopt
further
rules
regarding
a
carrier's
denial
of
CPNI
to
another
carrier
with
customer
authorization.

DATES:
Effective
October
21,
2002,
except
§
§
64.2007,
64.2008,
and
64.2009,
which
contain
information
collection
requirements
that
are
not
effective
until
approved
by
the
Office
of
Management
and
Budget.
The
Federal
Communications
Commission
will
publish
a
document
in
the
Federal
Register
announcing
the
effective
date
of
these
rules.

FOR
FURTHER
INFORMATION
CONTACT:
Marcy
Greene,
Attorney­
Advisor,
Competition
Policy
Division,
Wireline
Competition
Bureau,
at
(
202)
418
 
2410,
or
via
the
Internet
at
mgreene@
fcc.
gov.

SUPPLEMENTARY
INFORMATION:
This
is
a
summary
of
the
Commission's
Third
Report
and
Order
in
CC
Docket
Nos.
96
 
115
and
96
 
149,
adopted
July
16,
2002,
and
released
July
25,
2002.
The
complete
text
of
this
Report
and
Order
is
available
for
inspection
and
copying
during
normal
business
hours
in
the
FCC
Reference
Information
Center,
Portals
II,
445
12th
Street,
SW.,
Room
CY­
A257,
Washington,
DC,
20554.
This
document
may
also
be
purchased
from
the
Commission's
duplicating
contractor,
Qualex
International,
Portals
II,
445
12th
Street,
SW.,
Room
CY­
A257,
Washington,
DC
20554,
telephone
202
 
863
 
2893,
facsimile
202
 
863
 
2898,
or
via
e­
mail
at
qualexint@
aol.
com.
It
is
also
available
on
the
Commission's
Web
site
at
http://
www.
fcc.
gov.

Synopsis
of
the
Report
and
Order
1.
The
Commission
resolves
in
this
Order
several
issues
in
connection
with
carriers'
use
of
customer
proprietary
network
information
(``
CPNI'')
pursuant
to
section
222
of
the
Telecommunications
Act
of
1996.
Through
section
222,
Congress
recognized
both
that
telecommunications
carriers
are
in
a
unique
position
to
collect
sensitive
personal
information
and
that
customers
maintain
an
important
privacy
interest
in
protecting
this
information
from
disclosure
and
dissemination.
The
rules
adopted
by
the
Commission
focus
on
the
nature
of
the
customer
approval
needed
before
a
carrier
can
use,
disclose
or
permit
access
to
CPNI.
2.
Background.
This
proceeding
was
initiated
in
1996
to
implement
section
222
of
the
Communications
Act
of
1934
(
as
amended),
which
governs
carriers'
use
and
disclosure
of
CPNI.
On
February
26,
1998,
the
Commission
adopted
regulations
implementing
section
222
in
its
CPNI
Order.
[
63
FR
20236,
April
24,
1998].
In
particular,
it
concluded
that
section
222(
c)(
1)
of
the
Act
allows
a
carrier
to
use
a
customer's
CPNI,
derived
from
the
complete
service
subscribed
to
from
that
carrier,
for
marketing
purposes
within
the
existing
service
relationship.
This
is
known
as
the
``
total
service
approach.''
The
Commission
also
concluded
that
carriers
must
notify
the
customer
of
the
customer's
rights
under
section
222
and
then
obtain
express
written,
oral
or
electronic
customer
approval
 
a
``
notice
and
opt­
in''
approach
 
before
a
carrier
may
use
CPNI
to
market
services
outside
the
customer's
existing
service
relationship
with
that
carrier.
On
September
3,
1999,
the
Commission
released
an
Order
on
Reconsideration
[
64
FR
53242,
Oct.
1,
1999]
that
affirmed
the
opt­
in
approach,
but
streamlined
the
CPNI
rules
so
that
carriers
could
use
CPNI
to
market
customer
premises
equipment
and
information
services
without
customer
approval,
and
lessened
carriers'
CPNI
record­
keeping
responsibilities.
It
also
eliminated
restrictions
on
a
carrier's
ability
to
use
CPNI
to
regain
customers
that
switched
to
another
carrier,
known
as
``
winbacks.''
3.
After
the
Commission
adopted
the
Order
on
Reconsideration,
but
prior
to
its
release,
the
Court
of
Appeals
for
the
Tenth
Circuit
vacated
portions
of
the
1998
CPNI
Order.
The
court
found
that
the
Commission
did
not
show
that
the
opt­
in
form
of
consent
protected
privacy
and
promoted
competition
in
a
manner
consistent
with
the
First
Amendment
of
the
U.
S.
Constitution.
4.
In
an
October
6,
2000
Order,
AT&
T
v.
Bell
Atlantic
(
denying
a
complaint
by
AT&
T
regarding
the
manner
in
which
Bell
Atlantic
markets
the
services
of
its
long
distance
affiliate
to
its
local
exchange
customers),
the
Commission
interpreted
the
Tenth
Circuit's
vacatur
as
applying
only
to
the
discrete
issue
that
was
before
the
court.
On
September
7,
2001,
the
Commission
released
a
Clarification
Order
and
Second
Further
Notice
of
Proposed
Rulemaking
[
66
FR
50140,
Oct.
2,
2001]
that
determined
that
all
CPNI
rules
except
those
relating
to
opt­
in
remained
in
effect,
and
that
carriers
may
choose
to
obtain
customer
approval
by
means
of
an
opt­
out
approach
until
the
Commission
adopted
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