39462
Federal
Register
/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Rules
and
Regulations
*
*
*
*
*
[
FR
Doc.
03
 
16622
Filed
7
 
1
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0130;
FRL
 
7310
 
9]

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

SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
famoxadone
(
3­
anilino­
5­
methyl­
5­(
4­
phenoxyphenyl)­
1,3­
oxazolidine­
2,4­
dione)
in
or
on
vegetables,
fruiting,
group
8
(
except
tomato)
at
4.0
parts
per
million
(
ppm),
tomato
at
1.0
ppm;
vegetables
cucurbit,
group
9
at
0.30
ppm;
lettuce,
head
at
10.0
ppm;
potato
at
0.02
ppm;
grape
at
2.50
ppm;
grape,
raisin
at
4.0
ppm;
fat
of
cattle,
horses,
goats,
sheep
at
0.02
ppm;
liver
of
cattle,
horses,
goats,
sheep
at
0.05
ppm;
and
milk
fat
(
reflecting
negligible
residues
in
whole
milk)
at
0.060
ppm.
E.
I.
Dupont
Nemours
and
Company
(
Dupont)
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
These
reflect
the
first
food
tolerances
for
this
fungicide
in
the
United
States.
DATES:
This
regulation
is
effective
July
2,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0130,
must
be
received
on
or
before
September
2,
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:
Dennis
M.
McNeilly,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
6742;
email
address:
mcneilly.
dennis@
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
 
0130.
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
January
10,
2001
(
66
FR
1981)
(
FRL
 
6760
 
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
a
pesticide
petition
(
PP
0F6070)
for
establishing
tolerances
for
potatoes
at
0.05
ppm,
curcurbit
vegetable
crop
group
(
cucumbers,
melon,
squash)
at
0.7
ppm;
fruiting
vegetable
crop
group
(
tomatoes,
and
peppers)
at
1.0
ppm;
and
head
lettuce
at
15
ppm
by
Dupont,
P.
O.
Box
80038,
Wilmington,
DE
19880
 
0038.
That
notice
included
a
summary
of
the
petition
prepared
by
Dupont,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
In
a
second
Federal
Register
of
August
1,
2001
(
66
FR
39762)
(
FRL
 
6789
 
2),
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
a
pesticide
petition
(
PP
7E4847)
for
establishing
a
tolerance
for
grapes
at
2.0
parts
per
million
by
Dupont,
P.
O.
Box
80038,
Wilmington,
DE
19880
 
0038.
That
notice
included
a
summary
of
the
petition
prepared
by
Dupont,
the
registrant.
The
Agency
received
a
written
comment
from
the
World
Wildlife
Fund
(
WWF)
dated
August
31,
2001.
The
Agency's
response
to
this
comment
can
be
found
at
Unit
III.
B.
The
initial
petitions
requested
that
40
CFR
180.587
be
amended
by
establishing
tolerances
for
residues
of
the
fungicide
famoxadone
(
3­
anilino­
5­
methyl­
5­(
4­
phenoxyphenyl)­
1,3­
oxazolidine­
2,4­
dione)
in
or
on
potatoes
at
0.05
ppm;
cucurbit
vegetable
crop
group
at
0.7
ppm;
fruiting
vegetable
crop
group
at
1.0
ppm;
head
lettuce
at
15
ppm;
grapes
at
2.0
ppm;
and
raisins
at
4.0
ppm.
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
VerDate
Jan<
31>
2003
16:
15
Jul
01,
2003
Jkt
200001
PO
00000
Frm
00016
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
02JYR1.
SGM
02JYR1
39463
Federal
Register
/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Rules
and
Regulations
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
tolerances
for
residues
of
famoxadone
on
vegetables,
fruiting,
group
8
(
except
tomato)
at
4.0
ppm;
tomato
at
1.0
ppm;
vegetables,
cucurbit,
group
9
at
0.30
ppm;
lettuce,
head
at
10.0
ppm;
potato
at
0.02
ppm;
grape
at
2.50
ppm;
grape,
raisin
at
4.0
ppm;
fat
of
cattle,
horses,
goats,
sheep
at
0.02
ppm;
liver
of
cattle,
horses,
goats,
sheep
at
0.05
ppm
and
milk,
fat
(
reflecting
negligible
residues
in
whole
milk)
at
0.060
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
famoxadone
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no­
observed­
adverse­
effect­
level
(
NOAEL)
and
the
lowest­
observedadverse
effect­
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90­
Day
oral
toxicity
in
rats
NOAEL
=
Male
(
M):
3.3
milligrams/
kilogram/
day
(
mg/
kg/
day);
Female
(
F):
4.2
mg/
kg/
day.
LOAEL
=
M:
13.0
mg/
kg/
day
based
on
mild
hemolytic
anemia
and
decreased
glucose
F:
16.6
mg/
kg/
day
based
on
decreased
body
weight
gain,
food
consumption
and
food
efficiency;
mild
hemolytic
anemia
and
decreased
globulin.

870.3100
90­
Day
oral
toxicity
in
mice
NOAEL
=
M:
62.4
mg/
kg/
day;
F:
79.7
mg/
kg/
day.
LOAEL
=
M:
534
mg/
kg/
day
based
on
mild
hemolytic
anemia
with
secondary
responses
in
spleen
and
mild
hepatotoxicity
in
the
liver.
F:
757
mg/
kg/
day
based
on
mild
hemolytic
anemia
with
secondary
responses
in
spleen
and
mild
hepatotoxicity
in
the
liver.

870.3150
90­
Day
oral
toxicity
in
nonrodents
(
dogs)
NOAEL
=
M:
1.3
mg/
kg/
day;
F:
1.4
mg/
kg/
day
LOAEL
=
M:
10.0
mg/
kg/
day
based
on
lens
cataracts
in
eyes.
At
23.8/
21.2
mg/
kg/
day,
also
myotonic
twitches
(
starting
on
day
21);
decreased
body
weight,
body
weight
gain,
food
consumption,
and
food
efficiency;
slight
anemia
and
hyperkalemia
F:
1.4
mg/
kg/
day
based
on
lens
cataracts
in
eyes.
At
10.1
mg/
kg/
day,
no
additional
effects.
At
23.3/
20.1
mg/
kg/
day,
same
effects
as
for
males
at
23.8/
21.2
mg/
kg/
day.

870.3200
28­
Day
dermal
toxicity
in
rats
NOAEL
=
M:
250
mg/
kg/
day;
F:
1,000
mg/
kg/
day
LOAEL
=
M:
500
mg/
kg/
day
based
on
increased
alkaline
phosphatase,
alanine
aminotransferase
and
sorbitol
dehydrogenase;
and
mild
hepatotoxicity
in
the
liver.
F:
none
(>
1,000
mg/
kg/
day).
No
dermal
irritation
in
M
or
F.

870.3700
Prenatal
developmental
in
rats
Maternal
NOAEL
=
250
mg/
kg/
day
LOAEL
=
500
mg/
kg/
day
based
on
transient
decreased
body
weight
gain
and
food
consumption.
Developmental
NOAEL
=
1,000
mg/
kg/
day
LOAEL
=
none
(>
1,000
mg/
kg/
day
870.3700
Prenatal
developmental
in
nonrodents
(
rabbits)
Maternal
NOAEL
=
350
mg/
kg/
day
LOAEL
=
1,000
mg/
kg/
day
based
on
abortions;
decreased
body
weight,
body
weight
gain,
and
food
consumption;
and
abnormal
stools.
Developmental
NOAEL
=
350
mg/
kg/
day
LOAEL
=
1,000
mg/
kg/
day
based
on
abortions
and
equivocal
increases
in
postimplantation
loss
and
mean
resorptions
per
dose.

VerDate
Jan<
31>
2003
16:
15
Jul
01,
2003
Jkt
200001
PO
00000
Frm
00017
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
02JYR1.
SGM
02JYR1
39464
Federal
Register
/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.3800
Reproduction
and
fertility
effects
(
rats)
Parental/
Systemic
NOAEL
=
M/
F:
11.3/
14.2
mg/
kg/
day
LOAEL
=
M/
F:
44.7/
53.3
mg/
kg/
day
based
on
decreased
body
weight,
body
weight
gain,
and
food
consumption;
and
hepatotoxicity
in
the
liver.
Reproductive
NOAEL
=
M/
F:
44.7/
53.3
mg/
kg/
day
LOAEL
=
M/
F:
none
(>
44.7/
53.3
mg/
kg/
day
Offspring
NOAEL
=
M/
F:
11.3/
14.2
mg/
kg/
day
LOAEL
=
M/
F:
44.7/
53.3
mg/
kg/
day
based
on
decreased
body
weights
for
F1
and
F2
pups
throughout
lactation.

870.4100
Chronic
toxicity
in
dogs
NOAEL
=
M:
1.2
mg/
kg/
day.
F:
1.2
mg/
kg/
day.
LOAEL
=
M:
8.8
mg/
kg/
day
based
on
lens
cataracts
in
eyes.
F:
9.3
mg/
kg/
day
based
on
lens
cataracts
in
eyes.
No
other
adverse
effects
were
observed
in
M
or
F.

870.4100
Chronic
toxicity
in
Cynomolgus
monkeys
NOAEL
=
M:
100
mg/
kg/
day.
F:
100
mg/
kg/
day.
LOAEL
=
M:
1,000
mg/
kg/
day
based
on
mild
hemolytic
anemia
with
secondary
responses
in
spleen,
liver
and
kidney;
and
sinus
dilatation
in
spleen.
F:
1,000
mg/
kg/
day
based
on
mild
hemolytic
anemia
with
secondary
responses
in
spleen,
liver
and
kidney;
and
sinus
dilatation
in
spleen.
No
evidence
of
lens
cataracts
in
eyes
of
M
or
F.

870.4200
Carcino­
genicity
in
mice
NOAEL
=
M:
96
mg/
kg/
day.
F:
130
mg/
kg/
day.
LOAEL
=
M:
274
mg/
kg/
day
based
on
slight
hepatotoxicity
in
the
liver;
no
anemia.
F:
392
mg/
kg/
day
based
on
amyloidosis
and
slight
hepatotoxicity
in
the
liver;
no
anemia.
No
evidence
of
carcinogenicity
in
M
or
F.

870.4300
Combined
chronic
toxicity/
carcinogenicity
in
rats
NOAEL
=
M:
8.4
mg/
kg/
day.
F:
2.2
mg/
kg/
day
LOAEL
=
M:
16.8
mg/
kg/
day
based
on
slight
hemolytic
anemia
with
compensatory
erythropoiesis
and
secondary
responses
in
spleen
and
bone
marrow;
and
mild
hepatotoxicity
in
the
liver.
F:
10.7
mg/
kg/
day
based
on
decreased
body
weight
gain
and
slight
hemolytic
anemia.
At
23.0
mg/
kg/
day,
also
secondary
responses
to
anemia
in
spleen,
bone
marrow
and/
or
liver;
and
mild
hepatotoxicity
in
the
liver.
No
evidence
of
carcinogenicity
M
or
F.

870.5100
Reverse
gene
mutation
Negative
without
and
with
S­
9
activation
up
to
limit
dose
of
5,000
µ
gram(
g)/
plate.

870.5300
Forward
gene
mutation
(
In
Vitro
Mammalian
Cell
Gene
Mutation
Test)
Negative
without
and
with
S­
9
activation
up
to
the
limit
of
solubility
(
in
DMSO)
of
30
µ
g/
mL.

870.5300
Forward
gene
mutation
(
CHO/
HGPRT
locus)
Negative
without
and
with
S­
9
activation
up
to
cytotoxic
concentrations
( 
200
µ
g/
mL
without
S­
9
and
 
150
µ
g/
mL
with
S­
9).

870.5375
Chromosome
aberration
(
human
lymphocytes)
Positive
(
weak
clastogenic
effect)
without
S­
9
activation.
Statistically
significant
increases
in
percentage
of
aberrant
cells
at
several
dose
levels
ranging
from
5
 
15
µ
g/
mL.
Cytotoxicity
was
observed
at
10
 
18
µ
g/
mL.
Negative
with
S­
9
activation.

870.5375
Chromosome
aberration
(
human
lymphocytes)
Positive
(
weak
clastogenic
effect)
without
S­
9
activation.
Statistically
significant
increases
in
percentage
of
aberrant
cells
at
several
dose
levels
ranging
from
15
 
30
µ
g/
mL.
Cytotoxicity
was
observed
at
20
 
30
µ
g/
mL.
Negative
with
S­
9
activation.

870.5395
Micronucleus
assay
(
mouse
bone
marrow)
Negative
at
single­
oral
doses
of
up
to
limit
dose
of
5,000
mg/
kg.

870.5550
Unscheduled
DNA
synthesis
(
rat
hepatocytes)
Positive
response
(
increased
net
nuclear
grain
counts)
observed
at
several
treatment
levels
ranging
from
0.05
 
10
µ
g/
mL.
Cytotoxicity
was
observed
at
10
µ
g/
mL.

870.5550
Unscheduled
DNA
synthesis
(
rat
hepatocytes)
Negative
at
treatment
levels
up
to
10
µ
g/
mL.
Cytotoxicity
was
observed
at
10
µ
g/
mL.

870.5550
Unscheduled
DNA
synthesis
(
prim.
rat
hepatocytes)
Negative
at
treatment
levels
up
to
5.0
µ
g/
mL.
Cytotoxicity
was
observed
at
2.5
and
5.0
µ
g/
mL.

870.5550
Unscheduled
DNA
synthesis
(
hepatocytes
derived
from
male
rats
given
Famoxadone)
Negative
at
single­
oral
doses
of
up
to
2,000
mg/
kg.
No
marked
increases
in
net
nuclear
grain
counts
or
percentage
of
cells
in
repair
in
hepatocyte
cultures.

VerDate
Jan<
31>
2003
16:
15
Jul
01,
2003
Jkt
200001
PO
00000
Frm
00018
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
02JYR1.
SGM
02JYR1
39465
Federal
Register
/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.6200
Acute
neurotoxicity
screening
battery
(
rats)
NOAEL
=
M:
1,000
mg/
kg
F:
2,000
mg/
kg.
LOAEL
=
M:
2,000
mg/
kg
based
on
decreased
body
weight
gain
and
food
consumption
(
on
days
1
 
2);
and
palpebral
(
eyelid)
closure
(
on
day
1
only).
F:
none
(>
2,000
mg/
kg).

870.6200
Subchronic
neurotoxicity
screening
battery
(
rats)
NOAEL
=
M:
11.7
mg/
kg/
day
F:
14.4
mg/
kg/
day.
LOAEL
=
M:
47
mg/
kg/
day
based
on
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency.
F:
59
mg/
kg/
day
based
on
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency.
No
evidence
of
neurotoxicity
in
M
or
F.

870.7800
Immunotoxicity
study,
rats
(
28­
days)
NOAEL
=
M:
14
mg/
kg/
day.
F:
16
mg/
kg/
day.
LOAEL
=
M:
55
mg/
kg/
day
based
on
decreased
body
weight,
body
weight
gain,
food
consumption,
and
food
efficiency;
and
increased
spleen
weights
(
probably
due
to
increased
pigment
in
spleen).
F:
57
mg/
kg/
day
based
on
decreased
body
weight,
body
weight
gain,
food
consumption,
and
food
efficiency;
and
increased
spleen
weights
(
probably
due
to
increased
pigment
in
spleen).
No
evidence
of
immunotoxicity
in
M
or
F.

870.7800
Immunotoxicity
study,
mice
(
28­
days)
NOAEL
=
M:
1186
mg/
kg/
day.
F:
417
mg/
kg/
day.
LOAEL
=
M:
none
(>
1,186
mg/
kg/
day).
F:
1,664
mg/
kg/
day
based
on
increased
spleen
weights
(
probably
due
to
increased
pigment
in
spleen).
No
evidence
of
immunotoxicity
in
M
or
F.

870.7485
Metabolism
and
pharmacokinetics
rats
Only
about
40%
of
the
administered
dose
was
absorbed.
Most
of
the
administered
dose
(
87
 
6%)
was
eliminated
in
the
feces
within
24
hours;
very
little
(
3
 
12%)
was
eliminated
in
the
urine.
Unchanged
parent
(
51
 
84%
of
administered
dose)
and
2
hydroxylated
metabolites
(
IN­
KZ534
and
IN­
KZ007)
were
the
major
components
recovered
in
the
feces.
No
significant
qualitative
or
quantitative
differences
were
observed
for
sex,
dose
level,
or
repeated
dosing.

870.7485
Metabolism
and
pharmacokinetics
dogs
(
males
only)
Absorption
was
limited.
Most
of
the
administered
dose
(
62%)
was
eliminated
in
the
feces
within
24
hours;
very
little
(
about
8%)
was
eliminated
in
the
urine.
Initially,
unchanged
parent
(
94
 
97%
of
radioactivity
in
feces)
was
recovered
in
the
feces,
but
later
(>
24
hrs)
unchanged
parent
(
12
 
35%
of
radioactivity
in
feces),
IN­
KZ007
(
21
 
3%
of
radioactivity
in
feces)
and
IN­
ML815
(
4
 
9%
of
radioactivity
in
feces)
were
recovered.
Even
later
(>
48
hrs),
trace
amounts
of
the
hydroxylated
metabolites
IN­
KZ532
and
IN­
KZ534
were
also
identified
in
the
feces.

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
intraspecies
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
factors
(
SF)
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
SF.
For
non­
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.
The
linear
default
risk
methodology
(
Q*)
is
the
primary
method
currently
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
famoxadone
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

VerDate
Jan<
31>
2003
16:
15
Jul
01,
2003
Jkt
200001
PO
00000
Frm
00019
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
02JYR1.
SGM
02JYR1
39466
Federal
Register
/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Rules
and
Regulations
TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
FAMOXADONE
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
Females
13
 
50
years
of
age)
Not
applicable
Not
applicable
No
appropriate
endpoint
attributable
to
a
single
oral
dose
was
identified
in
the
available
toxicology
studies
on
famoxadone.

Acute
Dietary
(
General
population
including
infants
and
children)
Not
applicable
Not
applicable
No
appropriate
endpoint
attributable
to
a
single
oral
dose
was
identified
in
the
available
toxicology
studies
on
famoxadone.

Chronic
Dietary
(
All
populations)
LOAEL=
1.4
mg/
kg/
day
UF
=
1,000a
Chronic
RfD
=
0.0014
mg/
kg/
day
FQPA
SF
=
1
cPAD
=
chronic
RfD/
FQPA
SF
Chronic
PAD
=
0.0014
mg/
kg/
day
13­
Week
feeding
study
in
dogs.
b
LOAEL
=
1.4
mg/
kg/
day
based
on
microscopic
lens
lesions
(
cataracts)
in
eyes
of
female
dogs.

Cancer
(
Oral,
dermal,
and
inhalation)
Not
applicable
Not
applicable
Classification:
Not
Likely
to
be
carcinogenic
to
humans.

*
The
reference
to
the
FQPA
SF
refers
to
any
additional
SF
retained
due
to
concerns
unique
to
the
FQPA.
a
The
UF
of
1,000
includes
the
conventional
100
and
an
additional
10
for
the
use
of
the
LOAEL
and
dose
from
a
subchronic
(
13­
week)
study
for
chronic
risk
assessment.
b
Regarding
the
chronic
RfD
for
famoxadone,
a
1­
year
chronic
feeding
study
in
dogs
is
available,
but
was
determined
to
not
be
an
appropriate
study
for
use
in
chronic
risk
assessment
at
this
time.
Although
the
testing
laboratory
reported
a
NOAEL
of
1.2
mg/
kg/
day
for
treatment­
related
lens
lesions
(
cataracts)
in
the
eyes
of
the
male
and
female
dogs,
a
subsequent
evaluation
by
a
consulting
pathologist
of
the
microscopic
sections
of
the
eyes
from
all
dogs
in
this
study
strongly
suggested
that
a
serious
fixation
artifact
affected
all
the
eye
sections
such
that
only
prominent
cataracts
were
detectable
and
as
a
consequence,
a
NOAEL
could
not
be
reliably
determined
with
any
degree
of
confidence.
Considering
this
second
evaluation,
the
Agency
concluded
that
this
fixation
artifact
may
have
had
a
profound
effect
on
the
interpretation
of
the
histopathological
findings
in
the
eyes
of
all
dogs
in
this
study.
In
view
of
the
considerable
uncertainty
relating
to
the
microscopic
findings
in
the
eyes
of
all
dogs
in
this
study
and
the
resulting
uncertainty
with
regard
to
determining
a
NOAEL
for
eye
effects,
the
Agency
decided
to
not
use
the
results
from
this
1­
year
study
for
the
purpose
of
determining
a
chronic
RfD
for
famoxadone
at
this
time.
Based
on
a
consideration
of
findings
in
the
eyes
of
dogs
in
both
the
13­
week
and
1­
year
feeding
studies,
it
was
determined
that
the
lowest
dose
at
which
evidence
of
cataracts
was
actually
observed
was
in
the
female
dogs
in
the
13­
week
study
at
the
lowest
dose
tested
of
1.4
mg/
kg/
day
(
the
LOAEL).
This
13­
week
study,
rather
than
the
1­
year
study,
was
selected
to
be
the
most
appropriate
study
for
chronic
risk
assessment
at
this
time.
Since
a
LOAEL,
rather
than
a
NOAEL,
and
a
subchronic
study,
rather
than
a
chronic
study,
were
used
to
determine
the
chronic
RfD,
an
additional
10x
UF
was
added
to
the
conventional
UF
of
100x.
The
chronic
RfD
(
LOAEL
of
1.4
mg/
kg/
day/
UF
of
1,000)
for
famoxadone
was
determined
to
be
0.0014
mg/
kg/
day.

The
comment
received
from
WWF
concerned
a
toxicity
issue
in
particular:
The
potential
for
famoxadone
to
be
an
endocrine
disruptor.
WWF
quoted
the
notice
of
filing
which
was
written
by
Dupont.
``
Chronic,
lifespan
and
multigenerational
bioassays
in
mammals
and
acute
and
subchronic
studies
on
aquatic
organisms
and
wildlife
did
not
reveal
endocrine
effects.
Any
endocrine
related
effects
would
have
to
have
been
detected
in
this
definitive
array
of
required
tests.
The
probability
of
any
such
effects
due
to
agricultural
uses
of
famoxadone
is
negligible.''
WWF
stated
that
pursuant
to
FQPA,
the
Agency
is
establishing
a
new
endocrine
disruptor
screening
and
testing
program
because
existing
toxicology
protocols
are
not
adequate
to
detect
endocrine
disruption.
Therefore,
Dupont's
evaluation
of
the
endocrine
disruptor
potential
is
incomplete
and
consequently
misleading.
WWF
also
urges
the
Agency
to
consider
not
only
evidence
of
increasedsusceptibility,
but
also
the
significance
of
endocrine
disruptor
data
gaps
when
determining
the
FQPA
SF
for
famoxadone.
In
response
to
the
WWF
the
Agency
notes
that
FQPA
requires
EPA
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
such
other
endocrine
effect...
EPA
has
been
working
with
interested
stakeholders
to
develop
a
screening
and
testing
program
as
well
as
a
priority­
setting
scheme.
In
the
available
toxicity
studies
on
famoxadone,
no
evidence
of
endocrinerelated
effects
was
observed.
However,
famoxadone
may
be
subjected
to
further
screening
and/
or
testing
to
better
characterize
potential
effects
related
to
endocrine
disruption
when
additional
appropriate
screening
and/
or
testing
protocols
have
been
developed
by
the
Agency's
Endocrine
Disruptor
and
Testing
Advisory
Committee
(
EDSTAC).

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
are
being
established
for
(
40
CFR
180.587)
for
the
residues
of
famoxadone,
in
or
on
a
variety
of
raw
agricultural
commodities.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
famoxadone
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
toxicological
endpoint
attributable
to
a
single­
oral
dose
was
identified
in
the
available
toxicology
studies
on
famoxadone
that
would
be
applicable
to
females
(
13
 
50
years)
or
to
the
general
population
(
including
infants
and
children).
Therefore,
famoxadone
is
not
expected
to
pose
an
acute
dietary
risk.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1994
 
1996
and
1998
 
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:
Anticipated
residues
based
upon
average
field
trial
values
and
assumptions
that
100%
of
each
crop
is
treated
with
famoxadone.
iii.
Cancer.
The
Agency
has
classified
famoxadone
as
not
likely
to
be
VerDate
Jan<
31>
2003
16:
15
Jul
01,
2003
Jkt
200001
PO
00000
Frm
00020
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
02JYR1.
SGM
02JYR1
39467
Federal
Register
/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Rules
and
Regulations
carcinogenic
to
humans.
As
such,
famoxadone
is
not
expected
to
pose
a
cancer
dietary
risk.
iv.
Anticipated
residue
and
percent
crop
treated
(
PCT)
information.
Section
408(
b)(
2)(
E)
of
the
FFDCA
authorizes
EPA
to
use
available
data
and
information
on
the
anticipated
residue
levels
of
pesticide
residues
in
food
and
the
actual
levels
of
pesticide
chemicals
that
have
been
measured
in
food.
If
EPA
relies
on
such
information,
EPA
must
require
that
data
be
provided
5
years
after
the
tolerance
is
established,
modified,
or
left
in
effect,
demonstrating
that
the
levels
in
food
are
not
above
the
levels
anticipated.
Following
the
initial
data
submission,
EPA
is
authorized
to
require
similar
data
on
a
time
frame
it
deems
appropriate.
No
PCT
information
was
used
in
the
risk
assessment.
The
Agency
used
100%
which
would
over
estimate
exposure.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
famoxadone
in
drinking
water
because
this
is
a
new
chemical.
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
famoxadone.
The
Agency
uses
the
FQPA
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS)
to
estimate
pesticide
concentrations
in
surface
water
and
SCI­
GROW,
which
predicts
pesticide
concentrations
in
groundwater.
In
general,
EPA
will
use
FIRST
(
a
tier
1
model)
before
using
PRZM/
EXAMS
(
a
tier
2
model)
for
a
screening­
level
assessment
for
surface
water.
The
FIRST
model
is
a
subset
or
meta­
model
of
the
PRZM/
EXAMS
model
that
uses
specific
high­
end
runoff
scenario
for
pesticides.
FIRST
incorporates
an
index
reservoir
environment
and
a
percent
crop
area
(
PCA),
while
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
PCA,
all
available
information
on
the
pesticide's
fate
and
use
pattern,
and
site­
specific
cropping
information.
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
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
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
famoxadone
they
are
further
discussed
in
the
aggregate
risk
sections
in
Unit
E.
Based
on
the
PRZM/
EXAMS
and
SCIGROW
models
the
EECs
of
famoxadone
for
chronic
exposures
are
estimated
to
be
0.47
parts
per
billion
(
ppb)
for
surface
water
and
0.23
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).
Famoxadone
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
famoxadone
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,
famoxadone
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
famoxadone
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
final
rule
for
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
The
Agency
concluded
that
there
is
not
a
concern
for
pre­
and/
or
postnatal
toxicity
resulting
from
exposure
to
famoxadone.
No
quantitative
or
qualitative
evidence
of
increased
susceptibility,
as
compared
to
adults,
of
rat
or
rabbit
fetuses
to
in
utero
exposure
to
famoxadone
was
observed
in
the
developmental
toxicity
studies.
No
quantitative
or
qualitative
evidence
of
increased
susceptibility,
as
compared
to
adults,
of
rat
fetuses
or
neonates
was
observed
in
the
2­
generation
reproduction
study.
In
the
rat
developmental
toxicity
study,
the
NOAEL
for
maternal
toxicity
was
250
mg/
kg/
day
and
the
LOAEL
was
500
mg/
kg/
day,
based
on
transient
decreases
in
body
weight
gain
and
food
consumption.
At
1,000
mg/
kg/
day,
no
additional
treatment­
related
effects
were
observed
in
the
dams.
No
developmental
toxicity
was
observed
in
the
rat
study.
The
NOAEL
for
developmental
toxicity
was
1,000
mg/
kg/
day,
the
highest
dose
tested.
In
the
rabbit
developmental
toxicity
study,
the
maternal
and
developmental
NOAELs
and
LOAELs
were
the
same.
The
NOAEL
for
maternal
toxicity
and
developmental
toxicity
was
350
mg/
kg/
day.
The
LOAEL
for
maternal
toxicity
was
1,000
mg/
kg/
day,
based
on
abortions
in
4
out
of
17
does;
markedly
decreased
body
weight,
reduced
body
weight
gain
and
reduced
food
consumption
in
the
same
4
does,
and
increased
number
of
does
with
abnormal
or
little
or
no
stools.
The
LOAEL
for
developmental
toxicity
was
1,000
mg/
kg/
day;
based
on
abortions
in
4
out
of
17
does;
and
equivocal
increases
in
percent
post
implantation
loss
and
mean
number
of
resorptions
VerDate
Jan<
31>
2003
16:
15
Jul
01,
2003
Jkt
200001
PO
00000
Frm
00021
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
02JYR1.
SGM
02JYR1
39468
Federal
Register
/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Rules
and
Regulations
per
doe.
In
the
rabbit
study,
maternal
toxicity
(
does)
and
developmental
toxicity
(
fetuses)
are
considered
to
be
equally
sensitive
to
the
test
material.
Therefore,
based
on
the
results
in
these
two
developmental
toxicity
studies
in
rats
and
rabbits,
no
increased
susceptibility
of
the
fetuses
(
as
compared
to
adults)
was
demonstrated
for
famoxadone.
In
the
2­
generation
reproduction
study
in
rats,
the
NOAEL
for
parental
toxicity
was
200
ppm
(
equal
to
11.3/
14.2
mg/
kg/
day,
M/
F)
and
the
LOAEL
was
800
ppm
(
44.7/
53.3
mg/
kg/
day,
M/
F),
based
on
decreased
body
weight,
body
weight
gain,
and
food
consumption;
and
heptotoxicity
in
the
liver.
Also,
at
800
ppm,
adaptive
hepatocellular
responses
indicating
enzyme
induction
were
observed.
No
reproductive
toxicity
was
observed
in
this
study.
The
NOAEL
for
reproductive
toxicity
was
800
ppm
(
44.7/
53.3
mg/
kg/
day,
M/
F),
the
highest
dose
tested.
In
this
same
study,
the
NOAEL
for
offspring
toxicity
was
200
ppm
(
equal
to
11.3/
14.2
mg/
kg/
day,
M/
F)
and
the
LOAEL
was
800
ppm
(
44.7/
53.3
mg/
kg/
day,
based
on
decreased
body
weights
for
F1
and
F2
pups
throughout
their
respective
lactation
periods.
3.
Neurotoxicity.
The
Agency
concluded
that
there
is
not
a
concern
for
developmental
neurotoxicity
resulting
from
exposure
to
famoxadone
and
that
a
developmental
neurotoxicity
study
is
not
required.
Although
clinical
signs
of
neurotoxicity
were
observed
in
dogs
in
the
13­
week
study
at
the
highest
dose
tested
(>
20
mg/
kg/
day),
this
effect
was
not
observed
at
lower
doses
of
about
10
mg/
kg/
day
in
the
same
13­
week
study
or
in
a
subsequently
performed
1­
year
feeding
study
in
dogs.
Also,
toxicologically
significant
signs
of
neurotoxicity
were
not
observed
in
any
of
the
other
studies
on
famoxadone
in
any
species
(
including
rats,
mice,
or
monkeys)
at
any
time.
In
addition,
pre­
and
postnatal
studies
in
rats
and
rabbits
demonstrated
no
increased
susceptibility
of
fetuses
or
neonates
to
famoxadone
as
compared
to
adults.
Toxicologically
significant
neurotoxic
effects
would
not
be
expected
to
occur
in
an
additional
study
in
rats.
The
clinical
signs
of
neurotoxicity
(
muscle
twitches)
observed
only
in
dogs,
only
in
males,
and
only
at
the
highest
dose
tested,
would
not
be
anticipated
to
occur
in
a
developmental
neurotoxicity
study
in
rats.
4.
Conclusion.
The
Agency
concluded
that
the
toxicology
database
was
complete
for
FQPA
purposes
and
that
there
are
no
residential
uncertainties
for
pre­/
postnatal
toxicity.
Based
on
the
hazard
data,
the
Agency
recommended
the
special
FQPA
SF
be
reduced
to
1x.
The
famoxadone
risk
assessment
team
evaluated
the
quality
of
the
exposure
data;
and,
based
on
these
data,
recommended
that
the
special
FQPA
SF
be
reduced
to
1x.
The
recommendation
is
based
on
the
following:
i.
There
is
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
of
rat
and
rabbit
fetuses
to
in
utero
exposure
in
developmental
studies.
There
is
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
of
rat
offspring
in
the
multi­
generation
reproduction
study.
ii.
The
chronic
dietary
food
exposure
assessment
utilizes
average
field
trial
residue
data
and
for
all
proposed
uses,
100%
crop
treated
is
assumed.
The
chronic
assessment
is
somewhat
refined
and
based
on
reliable
data
derived
from
studies
designed
to
produce
worst­
case
residues
and
unlikely
to
underestimate
exposure.

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.
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure).
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
the
USEPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
Acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
groundwater
are
less
than
the
calculated
DWLOCs,
OPP
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
OPP
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
OPP
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,
OPP
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
endpoint
attributable
to
a
single­
oral
dose
was
identified
in
the
available
toxicology
studies
on
famoxadone.
Therefore,
no
acute
risk
from
famoxadone
is
not
expected.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
famoxadone
from
food
will
utilize
36%
of
the
cPAD
for
the
U.
S.
population,
76%
of
the
cPAD
for
Children
ages
1
 
2
and
68%
of
the
cPAD
for
Children
ages
3
 
5.
Children
ages
1
 
2
are
expected
to
be
the
most
highly
exposed
subpopulation
to
famoxadone.
There
are
no
residential
uses
for
famoxadone.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
famoxadone
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
3
of
this
unit:

TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
FAMOXADONE
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
Population
0.0014
36%
0.47
0.23
31
VerDate
Jan<
31>
2003
16:
15
Jul
01,
2003
Jkt
200001
PO
00000
Frm
00022
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
02JYR1.
SGM
02JYR1
39469
Federal
Register
/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Rules
and
Regulations
TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
FAMOXADONE
 
Continued
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

Children
1
 
2
years
old
0.0014
76%
0.47
0.23
3.4
Children
3
 
5
years
old
0.0014
68%
0.47
0.23
4.5
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).
Famoxadone
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
backgroundexposure
level).
Famoxadone
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.
Famoxadone
is
classified
as
``
not
likely
to
be
carcinogenic
to
humans.''
As
such,
no
cancer
risk
is
expected.
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,
including
infants
and
children,
from
aggregate
exposure
to
famoxadone
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Famoxadone
was
screened
through
multi­
residue
methods
listed
in
the
Pesticide
Analytical
Manual
Volume
I
(
PAM
Vol.
I),
Third
Edition
(
January
1994),
using
Protocols
C
to
E.
Protocols
A
and
B
were
not
used
because
famoxadone
does
not
have
an
n­
methyl
carbamate
structure
(
Protocol
A),
nor
is
it
an
acid
or
phenol
(
Protocol
B).
Protocol
C
showed
good
analytical
response
using
the
electron­
capture
detector
(
ECD)
and
nitrogen­
phosphorus
detector
(
NPD).
Good
recoveries
were
obtained
for
the
analysis
of
wine,
grapes,
and
tomatoes
(
92
 
138%)
using
Protocol
D.
Food
commodities
can
be
analyzed
for
famoxadone
residues
using
the
appropriate
extraction
method
with
the
mixed
ether
elution
system,
resulting
in
recovery
values
of
92
to
108%.
The
multi­
residue
methods
testing
appears
to
be
scientifically
acceptable
and
has
been
sent
to
the
FDA
for
further
evaluation.
Preliminary
analysis
suggests
that
Protocol
D
may
be
appropriate
for
analysis
of
famoxadone
in
plant
matrices
and
has
the
potential
to
be
the
primary
enforcement
method.
Adequate
enforcement
methodology
is
available
to
enforce
the
tolerance
expression.
The
method
may
be
requested
from:
Chief,
Analytical
Chemistry
Branch,
Environmental
Science
Center,
701
Mapes
Rd.,
Ft.
Meade,
MD
20755
 
5350;
telephone
number:
(
410)
305
 
2905;
e­
mail
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
No
CODEX
maximum
residue
limits
currently
exist
for
famoxadone:
Maximum
Residue
Levels
(
MRLs)
have
been
established
for
potatoes
in
the
Netherlands
at
0.02
ppm
and
for
grapes
in
Germany
at
2.0
ppm.

V.
Conclusion
Therefore,
tolerances
are
established
for
residues
of
famoxadone
(
3­
anilino­
5­
methyl­
5­(
4­
phenoxyphenyl)­
1,3­
oxazolidine­
2,4­
dione)
in
or
on
vegetables,
fruiting,
group
8
(
except
tomato)
at
4.0
ppm;
tomato
at
1
ppm;
vegetables
cucurbit,
group
9
at
0.30
ppm;
lettuce,
head
at
10.0
ppm;
potato
at
0.02
ppm
grape
at
2.50
ppm
(
import
only);
raisin
at
4.0
ppm
(
import
only);
fat
of
cattle,
horses,
goats,
sheep
at
0.02
ppm;
liver
of
cattle,
horses,
goats,
sheep
at
0.05
ppm;
and
milk,
fat
(
reflecting
negligible
residues
in
whole
milk)
at
0.060
ppm.

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)
of
FFDCA,
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
 
0130
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
September
2,
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
VerDate
Jan<
31>
2003
16:
15
Jul
01,
2003
Jkt
200001
PO
00000
Frm
00023
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
02JYR1.
SGM
02JYR1
39470
Federal
Register
/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Rules
and
Regulations
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
 
0130,
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
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.

VerDate
Jan<
31>
2003
16:
15
Jul
01,
2003
Jkt
200001
PO
00000
Frm
00024
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
02JYR1.
SGM
02JYR1
39471
Federal
Register
/
Vol.
68,
No.
127
/
Wednesday,
July
2,
2003
/
Rules
and
Regulations
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:
June
20,
2003.
Jim
Jones,
Director,
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
180.587
is
added
to
read
as
follows:

§
180.587
Famoxadone.

(
a)
General.
Tolerances
are
established
for
residues
of
the
fungicide
famoxadone
(
3­
anilino­
5­
methyl­
5­(
4­
phenoxyphenyl)­
1,3­
oxazolidine­
2,4­
dione)
in
or
on
the
following
commodities:

Commodity
Parts
per
million
Cattle,
fat
..............
0.02
Cattle,
liver
............
0.05
Goat,
fat
................
0.02
Goat,
liver
.............
0.05
Grape1
..................
2.50
Grape,
raisin1
.......
4.0
Horse,
fat
..............
0.02
Horse,
liver
...........
0.05
Lettuce,
head
........
10.0
Milk,
fat
(
reflecting
negligible
residues
in
whole
milk)
...................
0.06
Potato
...................
0.02
Sheep,
fat
.............
0.02
Sheep,
liver
...........
0.05
Tomato
..................
1.0
Commodity
Parts
per
million
Vegetable,
cucurbits,
group
9
........................
0.30
Vegetable,
fruiting,
group
8
except
tomato
...............
4.0
1
There
are
no
U.
S.
registrations
as
of
May
15,
2003.

(
b)
Section
18
emergency
exemptions.
[
Reserved]
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
(
d)
Indirect
or
inadvertant
residues.
[
Reserved]

[
FR
Doc.
03
 
16736
Filed
7
 
1
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
FEDERAL
COMMUNICATIONS
COMMISSION
47
CFR
Parts
0
and
54
[
CC
Docket
No.
02
 
6;
FCC
03
 
101]

Schools
and
Libraries
Universal
Service
Support
Mechanism
AGENCY:
Federal
Communications
Commission.
ACTION:
Final
rule,
correction.

SUMMARY:
This
document
corrects
an
error
in
the
DATES
section
and
the
SUPPLEMENTARY
INFORMATION
portion
of
a
Federal
Register
document
regarding
the
Commission
taking
major
steps
to
simplify
and
streamline
the
operation
of
our
universal
service
mechanism
for
schools
and
libraries,
while
improving
our
oversight
over
the
support
mechanism.
In
addition,
the
Commission
adopts
a
number
of
rules
to
streamline
program
operation,
and
promote
the
Commission's
goal
of
reducing
the
likelihood
of
fraud,
waste,
and
abuse.
The
summary
was
published
in
the
Federal
Register
on
June
20,
2003.

DATES:
Effective
July
2,
2003.

FOR
FURTHER
INFORMATION
CONTACT:
Jonathan
Secrest
and
Katherine
Tofigh,
Attorneys,
Telecommunications
Access
Policy
Division,
Wireline
Competition
Bureau,
(
202)
418
 
7400.

SUPPLEMENTARY
INFORMATION:
This
summary
contains
a
correction
to
the
dates
section
and
the
SUPPLEMENTARY
INFORMATION
portion
of
a
Federal
Register
summary,
68
FR
36931
(
June
20,
2003).
The
full
text
of
the
Commission's
Second
Report
and
Order
in
CC
Docket
No.
02
 
6,
FCC
03
 
101
released
on
April
30,
2003
is
available
for
public
inspection
during
regular
business
hours
in
the
FCC
Reference
Center,
Room
CY
 
A257,
445
Twelfth
Street,
SW.,
Washington,
DC,
20554.
In
rule
FR
Doc.
03
 
14928
published
June
20,
2003
(
68
FR
36931)
make
the
following
corrections.
1.
On
page
36931,
in
the
third
column,
in
the
DATES
section,
remove
``
§
54.515(
b)''
and
add
``
§
54.514(
b)''
in
its
place.
2.
On
page
36941,
in
the
third
column,
in
paragraph
89,
seventh
line,
remove
``
§
54.515(
b)''
and
add
``
§
54.514(
b)''
in
its
place.

Federal
Communications
Commission.
Marlene
H.
Dortch,
Secretary.
[
FR
Doc.
03
 
16533
Filed
7
 
1
 
03;
8:
45
am]

BILLING
CODE
6712
 
01
 
P
DEPARTMENT
OF
TRANSPORTATION
National
Highway
Traffic
Safety
Administration
49
CFR
Part
541
[
Docket
No.
NHTSA
 
03
 
14450]

RIN
2127
 
AI99
Federal
Motor
Vehicle
Theft
Prevention
Standard;
Final
Listing
of
Model
Year
2004
High­
Theft
Vehicle
Lines
AGENCY:
National
Highway
Traffic
Safety
Administration
(
NHTSA),
Department
of
Transportation.
ACTION:
Final
rule.

SUMMARY:
This
final
rule
announces
NHTSA's
determination
for
model
year
(
MY)
2004
high­
theft
vehicle
lines
that
are
subject
to
the
parts­
marking
requirements
of
the
Federal
motor
vehicle
theft
prevention
standard,
and
high­
theft
MY
2004
lines
that
are
exempted
from
the
parts­
marking
requirements
because
the
vehicles
are
equipped
with
antitheft
devices
determined
to
meet
certain
statutory
criteria
pursuant
to
the
statute
relating
to
motor
vehicle
theft
prevention.
EFFECTIVE
DATE:
The
amendment
made
by
this
final
rule
is
effective
July
2,
2003.

FOR
FURTHER
INFORMATION
CONTACT:
Ms.
Rosalind
Proctor,
Consumer
Standards
Division,
Office
of
Planning
and
Consumer
Standards,
NHTSA,
400
Seventh
Street,
SW.,
Washington,
DC
20590.
Ms.
Proctor's
telephone
number
is
(
202)
366
 
0846.
Her
fax
number
is
(
202)
493
 
2290.
SUPPLEMENTARY
INFORMATION:
The
Anti
Car
Theft
Act
of
1992,
Pub.
L.
102
 
519,
amended
the
law
relating
to
the
partsmarking
of
major
component
parts
on
designated
high­
theft
vehicle
lines
and
VerDate
Jan<
31>
2003
16:
15
Jul
01,
2003
Jkt
200001
PO
00000
Frm
00025
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
02JYR1.
SGM
02JYR1
