54818
Federal
Register
/
Vol.
68,
No.
182
/
Friday,
September
19,
2003
/
Rules
and
Regulations
*
*
*
*
*
[
FR
Doc.
03
 
23854
Filed
9
 
18
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0282;
FRL
 
7324
 
6]

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

SUMMARY:
This
regulation
establishes
a
tolerance
for
residues
of
butafenacil
(
1,1­
dimethyl­
2­
oxo­
2­(
2­
propenyloxy)
ethyl
2­
chloro­
5­[
3,6­
dihydro­
3­
methyl­
2,6­
dioxo­
4­
(
trifluoromethyl)­
1(
2H)­
pyrimidinyl]
benzoate)
in
or
on
cotton
and
livestock
commodities.
Syngenta
Crop
Protection,
Inc.
requested
this
tolerance
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
September
19,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0282,
must
be
received
on
or
before
November
18,
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:
Jim
Tompkins,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5697;
e­
mail
address:
Tompkins.
Jim@
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.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions
in
Unit
II.
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
 
0282.
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
February
26,
2003
(
68
FR
8896)
(
FRL
 
7293
 
9),
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
1F6309)
by
Syngenta
Crop
Protection,
Inc.,
P.
O.
Box
18300,
Greensboro,
NC
27419
 
8300.
That
notice
included
a
summary
of
the
petition
prepared
by
Syngenta
Crop
Protection,
Inc.,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
part
180
be
amended
by
establishing
a
tolerance
for
residues
of
the
herbicide
butafenacil,
the
[
2+
2]
cycloaddition
dimer
of
butafenacil,
and
CGA­
293731
in
or
on
cotton,
undelinted
seed
at
0.5
parts
per
million
(
ppm);
and
in
or
on
cotton,
gin
byproducts
at
13.0
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
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
VerDate
jul<
14>
2003
15:
30
Sep
18,
2003
Jkt
200001
PO
00000
Frm
00022
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
19SER1.
SGM
19SER1
54819
Federal
Register
/
Vol.
68,
No.
182
/
Friday,
September
19,
2003
/
Rules
and
Regulations
available
scientific
data
and
other
relevant
information
in
support
of
this
action.
EPA
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
a
tolerance
for
residues
of
butafenacil
and
CGA­
293731
on
cattle,
kidney;
goat,
kidney;
hog,
kidney;
horse,
kidney;
and
sheep,
kidney
at
0.05
parts
per
million
(
ppm);
in
or
on
cattle,
liver;
goat,
liver;
hog,
liver;
horse,
liver;
and
sheep,
liver
at
0.50
ppm;
and
tolerances
for
residues
of
butafenacil
in
or
on
cotton,
undelinted
seed
at
0.50
ppm;
and
in
or
on
cotton,
gin
byproducts
at
10
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
these
tolerances
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
butafenacil
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no
observed
adverse
effect
level
(
NOAEL)
and
the
lowest
observed
adverse
effect
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

TABLE
1.
 
ACUTE
TOXICITY
OF
BUTAFENACIL
Guideline
number
Study
Type
Results
Toxicity
Category
870.1100
Acute
oral
Lethal
dose
(
LD)
50
>
5,000
milligrams/
kilogram
(
mg/
kg)
male
and
female
(
M/
F)
IV
870.1200
Acute
dermal
LD50
>
2,000
mg/
kg
M/
F
III
870.1300
Acute
inhalation
Lethal
concentration
(
LC)
50
>
5.10
milligrams
per
Liter
(
mg/
L)
IV
870.2400
Primary
eye
irritation
Ocular
irritation
resolved
within
96
hours
III
870.2500
Primary
skin
irritation
Not
an
irritant
IV
870.2600
Dermal
sensitization
Not
a
sensitizer
Not
Applicable
(
NA)

TABLE
2.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
number
Study
Type
Results
870.3100
90
 
Day
oral
(
dietary)
toxicity
rodents
(
rat)
NOAEL
=
300
ppm
(
18.8/
20.6
mg/
kg/
day
M/
F)
LOAEL
=
1,000
ppm
(
62.3/
69.3
mg/
kg/
day
M/
F),
based
on
decreased
body
weight
gains,
decreased
hemoglobin,
hematocrit
mean
corpuscular
hemoglobin
(
MCH),
mean
corpuscular
volume
(
MCV),
increased
red
cell
volume,
increased
bone
marrow
hypercellularity;
increased
bilirubin
and
urobilinogen;
increased
alanine
aminotransferase;
hepatocyte
necrosis;
inflammatory
liver
cell
infiltration
870.3100
90
 
Day
oral
(
dietary)
toxicity
in
rodents
(
mouse)
NOAEL
=
30
ppm
(
4.11/
5.67
mg/
kg/
day
M/
F)
LOAEL
=
100
ppm
(
13.8/
20.1
mg/
kg/
day
M/
F),
based
on
hepatic
histopathology:
fatty
change,
glycogen
deposition,
and
hypertrophy
in
both
sexes
870.3150
90
 
Day
oral
(
capsule)
toxicity
in
non­
rodents
(
dog)
NOAEL
=
200
mg/
kg/
day
M/
F
LOAEL
=
1,000
mg/
kg/
day
M/
F,
based
on
decreases
in
MCV
and
MCH
in
males;
increases
in
RDW,
HDW,
platelets
and
triglycerides
in
males;
and
hemosiderosis
in
spleen
and
liver
and
extramedullary
hematopoiesis
the
spleen
in
males
870.3200
28
 
Day
dermal
toxicity
(
rat)
NOAEL
=
1,000
mg/
kg/
day
LOAEL
=
not
determined
870.3700
Prenatal
developmental
toxicity
in
rodents
(
rat)
Maternal
NOAEL
=
1,000
mg/
kg/
day
Maternal
LOAEL
=
not
determined
Developmental
NOAEL
=
1,000
mg/
kg/
day
Developmental
LOAEL
=
not
determined
870.3700
Prenatal
developmental
toxicity
in
non­
rodents
(
rabbit
Maternal
NOAEL
=
100
mg/
kg/
day
Maternal
LOAEL
=
1,000
mg/
kg/
day
based
on
decreased
body
weight
gains
and
food
consumption
during
the
treatment
period
and
on
blood­
stained
vaginal
discharge
(
related
to
total
litter
loss)
in
two
doses
Developmental
NOAEL
=
100
mg/
kg/
day
Developmental
LOAEL
=
1,000
mg/
kg/
day
based
on
increased
early
resorptions
and
post­
implantation
loss
VerDate
jul<
14>
2003
15:
30
Sep
18,
2003
Jkt
200001
PO
00000
Frm
00023
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
19SER1.
SGM
19SER1
54820
Federal
Register
/
Vol.
68,
No.
182
/
Friday,
September
19,
2003
/
Rules
and
Regulations
TABLE
2.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
number
Study
Type
Results
870.3800
2
 
Generation
reproduction
and
fertility
effects
Parental/
systemic
NOAEL
=
30
ppm
(
2.4/
2.5
mg/
kg/
day
M/
F)
Parental/
systemic
LOAEL
=
300
ppm
(
23.8/
25.2
mg/
kg/
day
M/
F),
based
on
decreased
body
weights
and
food
consumption
and
on
increased
incidences
of
bile
duct
hyperplasia
and
liver
necrosis
in
males
and
females
of
both
generations
Offspring
NOAEL
=
300
ppm
(
23.8/
25.2
mg/
kg/
day
M/
F)
Offspring
LOAEL
=
1,000
ppm
(
79.6/
83.8
M/
F),
based
on
decreased
pup
body
weight
and
body
weight
gain
in
both
generations
Reproductive
NOAEL
=
30
ppm
(
2.4/
2.5
mg/
kg/
day
M/
F)
Reproductive
LOAEL
=
300
ppm
(
23.8/
25.2
mg/
kg/
day
M/
F)
based
on
an
increase
in
the
number
of
days
to
mating
in
both
generations
870.4100
1
 
Year
chronic
oral
(
capsule
toxicity
(
dog)
NOAEL
=
500
mg/
kg/
day
M/
F
LOAEL
=
1,000
mg/
kg/
day
M/
F,
based
on
decreased
body
weight
gain
in
males,
decreased
MCV,
MCH,
and
mean
corpuscular
hemoglobin
concentration
(
MCHC);
increased
thrombocytes
and
red
cell
volume
distribution
width;
hepatic
histopathology:
glycogen
disposition,
inclusion
bodies
in
cytoplasm,
and
pigment
disposition
in
both
sexes,
and
focal
vaculolation
in
females
870.4200
18
 
Month
carcinogenicity
dietary
study
(
mouse)
NOAEL
=
10
ppm
(
1.17/
1.20
mg/
kg/
day
M/
F)
LOAEL
=
60
ppm
(
6.96/
6.59
mg/
kg/
day
M/
F),
based
on
enlarged
livers
with
increased
weights,
and
hepatic
microscopic
lesions
including
Kupffer
cell
hyperplasia,
inflammatory
cell
infiltration
and
single
cell
necrosis
in
both
sexes
and
on
deposits
of
lipofuscin
in
males
No
evidence
of
carcinogenicity
870.4300
Combined
2
 
Year
chronic/
carcinogenicity
dietary
study
(
rat)
NOAEL
=
100
ppm
(
3.76/
4.43
mg/
kg/
day
M/
F)
LOAEL
=
300
ppm
(
11.4/
13.0
mg/
kg/
day
M/
F),
based
on
minimal
hepatic
abnormalities
in
the
females,
including
a
fatty
change
and
increased
mitotic
activity
No
evidence
of
carcinogenicity
870.5100
In
vitro
bacterial
gene
mutation
Negative
in
a
reverse
gene
mutation
assay
in
strains
TA98,
TA100,
TA102,
TA1535,
TA1537
of
S.
typhimurium
and
strain
WP2(
uvrA)
of
E.
coli
in
the
presence
and
absence
of
mammalian
metabolic
activation
870.5300
In
vitro
mammalian
cells
in
culture
Evidence
of
borderline
induction
of
mutant
colonies
in
presence
of
S9
in
a
mammalian
cell
gene
mutation
assay
at
the
hypoxanthine
guanine
phophoribosyl
transferase
(
HGPRT)
locus
of
Chinese
hamster
V79
cells
870.5375
In
vitro
mammalian
cytogenetics
Negative.
No
evidence
of
increase
in
chromosome
aberrations
over
background
870.5395
In
vivo
mammalian
cytogenetics
­
micronucleus
assay
(
mouse)
Negative.
No
increase
in
frequency
of
micronucleated
polychromatic
erythrocytes
870.5550
Other
genotoxicity
­
unscheduled
DNA
synthesis
(
UDS)­
in
vivo/
in
vitro
Negative.
No
evidence
of
induction
of
UDS;
no
indications
of
induction
of
DNA
damage
870.5550
Other
genotoxicity
­
UDS
­
in
vitro
Negative.
No
evidence
of
induction
of
UDS;
no
indications
of
induction
of
DNA
damage
in
primary
rat
hepatocytes
in
culture
870.6200
Acute
neurotoxicity
screening
battery
(
rat)
NOAEL
=
2,000
mg/
kg
LOAEL
=
Not
determined
No
evidence
of
neurotoxicity
870.6200
Subchronic
neurotoxicity
screening
battery
(
rat)
NOAEL
=
300
ppm
21/
24
mg/
kg/
day
M/
F
LOAEL
=
1,000
ppm
72/
76
mg/
kg/
day
M/
F,
based
on
liver
histopathology
and
decreased
motor
activity
at
week
13
in
the
males
No
evidence
of
neurotoxicity
VerDate
jul<
14>
2003
15:
30
Sep
18,
2003
Jkt
200001
PO
00000
Frm
00024
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
19SER1.
SGM
19SER1
54821
Federal
Register
/
Vol.
68,
No.
182
/
Friday,
September
19,
2003
/
Rules
and
Regulations
TABLE
2.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
number
Study
Type
Results
870.7485
Metabolism
and
pharmacokinetics
(
rat)
Overall
recovery
of
administered
radioactivity
exceeded
95%,
most
(
74
 
93%)
of
which
was
eliminated
in
the
feces.
Approximately
4
 
15%
of
the
administered
radioactivity
was
excreted
in
the
urine
over
168
hours
while
tissue
residues
were
negligible
thereby
implying
limited
absorption.
No
radioactivity
was
detected
in
expired
air.
Excretion
of
radioactivity
was
>
90%
complete
by
48
hours.
Up
to
six
components
were
detected
in
the
urine
of
rats
from
both
dose
groups,
the
most
prevalent
being
an
hydrolysis
product,
CGA­
293731
which
represented
>
90%
of
urinary
radioactivity.
Urinary
elimination
of
metabolites
was
quantitatively
greater
in
female
rats
than
in
males.
Only
minor
amounts
(
near
detection
limits)
of
parent
compound
were
detected
in
the
urine
of
high­
dose
males.
Based
upon
biliary
elimination,
¥
74
 
79%
of
the
dose
entered
the
hepatobiliary
pathway
but
was
eliminated
via
the
feces.
An
increase
in
parent
compound
in
feces
of
the
high­
dose
group
was
indicative
of
saturated
absorption
and/
or
saturated
metabolism,
but
could
not
be
definitively
resolved
due
to
the
absence
of
biliary
elimination
studies
at
the
high
dose.
Biliary
elimination
studies
revealed
that
approximately
60
 
64%
of
the
administered
low
dose
was
detected
in
0
 
4
hour
pooled
bile
samples
and
that
the
majority
of
fecal
radioactivity
could
be
attributed
to
biliary
metabolites
870.7485
Mechanistic
studies
Effects
on
enzymes
of
cultured
mouse,
rat,
and/
or
human
hepatocytes
involved
with
heme
biosynthesis
870.7485
Mechanistic
studies
Effects
on
liver
microsomal
and
plasma
protox
activity
and
its
metabolic
conversion
870.7485
Mechanistic
studies
Effects
on
porphyrin
profile
in
rats;
treatment
induced
porphyria,
consisting
of
accumulation
of
selected
porphyrins
in
the
liver,
spleen,
and
plasma
and
increased
excretion
in
urine
and
feces
870.7485
Mechanistic
studies
Test
substance
interferes
with
heme
biosynthesis
in
rats,
as
evidenced
by
dose­
dependent,
pronounced
porphyria
in
the
liver,
spleen,
and
plasma;
increased
porphyrin
excretion,
and
decreased
activity
of
various
isoenzymes
of
the
hepatic
microsomal
cytochrome
P450
system
870.7485
Mechanistic
studies
Test
substance
interferes
with
heme
biosynthesis
in
mice,
as
evidenced
by
dose­
dependent,
pronounced
porphyria
in
the
liver,
spleen,
and
plasma;
increased
porphyrin
excretion,
and
decreased
activity
of
various
isoenzymes
of
the
hepatic
microsomal
cytochrome
P450
system
870.7485
Mechanistic
studies
Effects
on
porphyrin
profile
in
mice;
treatment
induced
porphyria,
consisting
of
accumulation
of
selected
porphyrins
in
the
tissue
and
plasma,
and
increased
excretion
of
heme
precursors
B.
Toxicological
Endpoints
The
dose
at
which
the
NOAEL
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
margin
of
exposure
(
MOE).
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.
A
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
level
of
concern
(
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.
A
summary
of
the
toxicological
endpoints
for
butafenacil
used
for
human
risk
assessment
is
shown
in
Table
3
of
this
unit:

VerDate
jul<
14>
2003
15:
30
Sep
18,
2003
Jkt
200001
PO
00000
Frm
00025
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
19SER1.
SGM
19SER1
54822
Federal
Register
/
Vol.
68,
No.
182
/
Friday,
September
19,
2003
/
Rules
and
Regulations
TABLE
3.
 
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
BUTAFENACIL
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
dietary
(
General
population
including
infants
and
children)
None
NA
An
endpoint
attributable
to
a
single
dose
is
not
available
in
the
data
base
Chronic
dietary
(
All
populations
NOAEL=
1.2
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.012
mg/
kg/
day
Special
FQPA
SF
=
1
cPAD
=
chronic
RfD
Special
FQPA
SF
=
0.012
mg/
kg/
day
Mouse
oncogenicity
study
The
LOAEL
is
6.96
mg/
kg/
day,
based
on
enlarged
livers
with
increased
weights,
and
hepatic
microscopic
lesions
including
Kupffer
cell
hyperplasia,
inflammatory
cell
infiltration,
and
single
cell
necrosis
in
both
sexes
and
on
deposits
of
lipofuscin
in
males
Short­
term
inhalation
(
1
to
30
days)
Oral
NOAEL
=
18.8
mg/
kg/
day
Residential
LOC
for
MOE
=
100
Occupational
=
100
90
 
day
rat
feeding
study
The
LOAEL
for
this
study
is
62.3
mg/
kg/
day
based
on
decreased
hemoglobin,
hematocrit,
mean
corpuscular
hemoglobin
mean
corpuscular
volume,
increased
red
cell
volume
distribution
width,
and
increased
incidence
of
bone
marrow
hypercellularity
Short­
term
incidental
oral
(
1
to
30
days)
NOAEL
=
18.8
mg/
kg/
day
Residential
LOC
for
MOE
=
100
Occupational
=
NA
90
 
day
rat
feeding
study
The
LOAEL
for
this
study
is
62.3
mg/
kg/
day,
based
on
decreased
hemoglobin,
hematocrit,
mean
corpuscular
hemoglobin
mean
corpuscular
volume,
increased
red
cell
volume
distribution
width,
and
increased
incidence
of
bone
marrow
hypercellularity
Intermediate­
term
incidental
oral
(
1
 
6
months)
NOAEL
=
18.8
mg/
kg/
day
Residential
LOC
for
MOE
=
100
Occupational
=
NA
90
 
day
rat
feeding
study
The
LOAEL
for
this
study
is
62.3
mg/
kg/
day,
based
on
decreased
hemoglobin,
hematocrit,
mean
corpuscular
hemoglobin
mean
corpuscular
volume,
increased
red
cell
volume
distribution
width,
and
increased
incidence
of
bone
marrow
hypercellularity
Dermal
(
All
durations)
NA
NA
Quantification
of
dermal
risk
assessment
is
not
required
due
to
lack
of
concern
for
dermal,
systemic
or
developmental
toxicity
Short­
term
inhalation
(
1
to
30
days)
Oral
NOAEL
=
18.8
mg/
kg/
day
Residential
LOC
for
MOE
=
100
Occupational
=
100
90
 
day
rat
feeding
study
The
LOAEL
for
this
study
is
62.3
mg/
kg/
day
based
on
decreased
hemoglobin,
hematocrit,
mean
corpuscular
hemoglobin
mean
corpuscular
volume,
increased
red
cell
volume
distribution
width,
and
increased
incidence
of
bone
marrow
hypercellularity
Intermediate­
term
inhalation
(
1
to
6
months)
Oral
NOAEL
=
18.8
mg/
kg/
day
Residential
LOC
for
MOE
=
100
Occupational
=
100
90
 
day
rat
feeding
study
The
LOAEL
for
this
study
is
62.3
mg/
kg/
day,
based
on
decreased
hemoglobin,
hematocrit,
mean
corpuscular
hemoglobin
mean
corpuscular
volume,
increased
red
cell
volume
distribution
width,
and
increased
incidence
of
bone
marrow
hypercellularity
VerDate
jul<
14>
2003
15:
30
Sep
18,
2003
Jkt
200001
PO
00000
Frm
00026
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
19SER1.
SGM
19SER1
54823
Federal
Register
/
Vol.
68,
No.
182
/
Friday,
September
19,
2003
/
Rules
and
Regulations
TABLE
3.
 
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
BUTAFENACIL
 
Continued
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Long­
term
inhalation
(>
6
months)
Oral
NOAEL
=
1.2
mg/
kg/
day
Residential
LOC
for
MOE
=
100
Occupational
=
100
Mouse
oncogenicity
study
The
LOAEL
is
6.96
mg/
kg/
day,
based
on
enlarged
livers
with
increased
weights,
and
hepatic
microscopic
lesions
including
Kupffer
cell
hyperplasia,
inflammatory
cell
infiltration,
and
single
cell
necrosis
in
both
sexes
and
on
deposits
of
lipofuscin
in
males
Cancer
(
oral,
dermal,
inhalation
NA
NA
Classified
as
``
not
likely
to
be
carcinogenic
to
humans''

*
The
reference
to
the
Special
FQPA
SF
refers
to
any
additional
SF
retained
due
to
concerns
unique
to
the
FQPA.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
No
tolerances
have
previously
been
established
for
butafenacil.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
butafenacil
in
food
as
follows:
i.
Acute
exposure.
Quantitative
acute
dietary
risk
assessments
are
performed
for
a
food­
use
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
1
 
day
or
single
exposure.
No
appropriate
endpoint
attributable
to
a
single
exposure
was
identified
for
butafenacil
in
either
the
general
population
or
to
the
subpopulation
of
females
13
 
50
years
old,
therefore
no
acute
exposure
assessment
was
performed.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment,
the
Dietary
Exposure
Evaluation
Model
Food
Commodity
Intake
Database
(
DEEM­
FCID
 
)
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:
The
dietary
exposure
analysis
assumed
100%
crop
treated
and
tolerance
level
residues
or
maximum
field
trial
residues.
Based
on
total
food
exposure
for
butafenacil,
all
population
subgroups
are
below
1%
cPAD.
iii.
Cancer.
Butafenacil
showed
no
evidence
of
carcinogenicity
in
animal
tests
in
two
different
species,
and
therefore,
a
quantitative
cancer
risk
assessment
was
not
performed.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
butafenacil
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
butafenacil.
The
Agency
uses
the
First
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS),
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.
The
screening
concentration
in
ground
water
(
SCI­
GROW)
model
is
used
to
predict
pesticide
concentrations
in
shallow
ground
water.
For
a
screeninglevel
assessment
for
surface
water
EPA
will
use
FIRST
(
a
Tier
I
model)
before
using
PRZM/
EXAMS
(
a
Tier
II
model).
The
FIRST
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
high­
end
runoff
scenario
for
pesticides.
While
both
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
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
LOC.
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
butafenacil
they
are
further
discussed
in
Unit
III.
E.
Based
on
the
FIRST
and
SCI­
GROW
models,
the
EECs
of
butafenacil
for
chronic
exposures
are
estimated
to
be
0.049
parts
per
billion
(
ppb)
for
surface
water
and
0.00095
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).
Butafenacil
is
not
proposed
for
registration
for
use
on
any
sites
that
would
result
in
residential
exposure.
4.
Cumulative
effects
from
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
butafenacil
has
a
common
mechanism
of
toxicity
with
other
substances.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
butafenacil
and
any
other
substances
VerDate
jul<
14>
2003
15:
30
Sep
18,
2003
Jkt
200001
PO
00000
Frm
00027
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
19SER1.
SGM
19SER1
54824
Federal
Register
/
Vol.
68,
No.
182
/
Friday,
September
19,
2003
/
Rules
and
Regulations
and
butafenacil
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
butafenacil
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
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
There
are
no
residual
concerns
regarding
prenatal
or
postnatal
toxicity
or
completeness
of
the
toxicity
or
exposure
data
base.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
butafenacil
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
EPA
determined
that
the
10X
SF
to
protect
infants
and
children
could
be
reduced
to
1X.
The
FQPA
factor
was
reduced
because:
 
There
is
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
of
rat
and
rabbit
fetuses
to
in
utero
exposure
in
developmental
studies
or
to
in
utero
and
postnatal
exposure
to
rats
in
the
2
 
generation
reproduction
study.
 
There
are
no
residential
uncertainties
for
prenatal
or
postnatal
toxicity.
 
The
toxicological
data
base
is
complete
for
the
assessment
of
toxicity
and
susceptibility
following
prenatal
and/
or
postnatal
exposures.
No
clinical
signs
of
neurotoxicity
or
neuropathology
were
observed
in
the
data
base,
and
the
developmental
neurotoxicity
study
was
not
required.
 
There
are
no
residual
concerns
regarding
prenatal
or
postnatal
toxicity
or
completeness
of
the
toxicity
or
exposure
data
base.
 
The
dietary
food
exposure
assessment
is
Tier
I,
screening
level,
which
is
based
on
tolerance
level
residues
or
maximum
field
trial
residues
and
assumes
100%
of
all
crops
will
be
treated
with
chemical.
By
using
these
screening
level
assessments,
actual
exposures/
risks
will
not
be
underestimated.
 
The
dietary
drinking
water
assessment
utilizes
water
concentration
values
generated
by
health
protective,
high­
end
estimates
of
water
concentrations
which
will
not
likely
be
exceeded.
 
There
are
currently
no
registered
residential
uses
of
butafenacil.
 
These
assessments
will
not
underestimate
the
exposure/
risks
posed
by
current
or
proposed
uses
of
butafenacil.

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
EPA's
Office
of
Water
are
used
to
calculate
DWLOCs:
2
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
ground
water
are
less
than
the
calculated
DWLOCs,
EPA
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
EPA
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
EPA
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
EPA
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
No
acute
risk
from
exposure
to
butafenacil
is
expected
because
there
were
no
toxic
effects
of
concern
attributable
to
a
single
dose
identified
in
available
data.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
butafenacil
from
food
will
utilize
<
1%
of
the
cPAD
for
the
U.
S.
population,
<
1%
of
the
cPAD
for
infants
ages
1
 
2,
and
<
1%
of
the
cPAD
for
children
ages
3
 
5.
There
are
no
proposed
residential
uses
for
butafenacil
that
result
in
chronic
residential
exposure
to
butafenacil.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
butafenacil
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
water
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
Table
4
of
this
unit:

VerDate
jul<
14>
2003
15:
30
Sep
18,
2003
Jkt
200001
PO
00000
Frm
00028
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
19SER1.
SGM
19SER1
54825
Federal
Register
/
Vol.
68,
No.
182
/
Friday,
September
19,
2003
/
Rules
and
Regulations
TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
BUTAFENACIL
Population
cPAD
(
mg/
kg/
day)
%
cPAD
(
mg/
kg/
day)
Chronic
Food
Exposure1
(
mg/
kg/
day)
Ground
Water
EEC2
(
ppb)
Surface
Water
EEC2
(
ppb)
Chronic
DWLOC3
(
ppb)

General
U.
S.
population
0.012
<
1%
0.000041
0.00095
0.049
420
All
infants
(<
1
year
old)
0.012
<
1%
0.000014
0.00095
0.049
120
Children
(
1
 
2
years
old)
0.012
<
1%
0.000097
0.00095
0.049
120
Children
(
3
 
5
years
old)
0.012
<
1%
0.000104
0.00095
0.049
120
Children
(
6
 
12
years
old)
0.012
<
1%
0.000069
0.00095
0.049
120
Youth
(
13
 
19
years
old)
0.012
<
1%
0.000036
0.00095
0.049
360
Adults
(
20
 
49
years
old)
0.012
<
1%
0.000033
0.00095
0.049
420
Females
(
13
 
49
years
old)
0.012
<
1%
0.000030
0.00095
0.049
360
Adults
(
50+
years
old)
0.012
<
1%
0.000031
0.00095
0.049
420
1
Maximum
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
(
mg/
kg/
day)
­
chronic
food
exposure
from
DEEM
(
mg/
kg/
day);
no
res.
exp.
2
Parent
plus
CGA­
293731;
cotton
application
scenario
­
1
x
0.141
lb
ai/
acre;
maximum
proposed
rate
3DWLOC(
µ
g/
L)
=
(
allowable
water
exposure
(
mg/
kg/
day)
x
body
weight
(
kg)
x
1,000
µ
g/
mg)
÷
(
water
consumption
(
liters))
Consumption
=
1
L/
day
for
populations
<
13
years
old
and
2
L/
day
for
populations
 
13
years
old.
Default
body
weights
=
70
kg
for
general
U.
S.
population
and
adult
males,
60
kg
for
youth
and
females
 
13
years
old,
and
10
kg
for
all
others.

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).
Butafenacil
is
not
proposed
for
registrations
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
LOC.
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).
Butafenacil
is
not
proposed
for
registrations
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
LOC.
5.
Aggregate
cancer
risk
for
U.
S.
population.
Butafenacil
is
not
expected
to
pose
a
cancer
risk
because
no
evidence
of
carcinogenicity
was
found
in
adequate
animal
tests
in
two
different
species,
therefore
no
aggregate
cancer
risk
assessment
was
performed.
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
butafenacil
residues.
IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Syngenta
Crop
Protection,
Inc.
proposed
Syngenta
Method
131
 
99
for
enforcement
of
the
proposed
cotton
tolerances
(
adequate
validation,
independent
laboratory
validation
(
ILV),
and
radiovalidation
data
have
been
submitted).
The
petitioner
did
not
propose
ruminant
liver
and
kidney
tolerances
and
therefore
did
not
propose
a
method
for
enforcement
of
the
recommended
ruminant
liver
and
kidney
tolerances.
The
petitioner
has
and
will
submit
an
enforcement
method,
adequate
validation,
ILV,
and
radiovalidation
for
enforcement
of
the
ruminant
liver
and
kidney
tolerances
as
a
condition
of
registration.

B.
International
Residue
Limits
Canada,
Codex,
and
Mexico
do
not
have
maximum
residue
limits
for
residues
of
butafenacil
in/
on
cotton.
Therefore,
harmonization
is
not
an
issue.

C.
Conditions
As
a
condition
of
registration,
the
petitioner
must
submit:
1.
A
ruminant
liver
and
kidney
enforcement
method
and
submit
adequate
validation,
ILV,
and
radiovalidation
data.
2.
Submit
confirmatory
data
on
the
frozen
storage
stability
of
residues
of
butafenacil
in
or
on
cottonseed,
cotton
gin
byproduct,
cotton
hull,
cotton
meal,
and
cotton
oil.
3.
Submit
a
ruminant
feeding
study
to
confirm
the
Agency's
estimate
of
maximum
residues
of
butafenacil
from
the
goat
metabolism
study.

V.
Conclusion
Therefore,
the
tolerance
is
established
for
residues
of
butafenacil,
in
or
on
cattle,
kidney;
goat,
kidney;
hog,
kidney;
horse,
kidney;
and
sheep,
kidney
at
0.05
ppm;
in
or
on
cattle,
liver;
goat,
liver;
hog,
liver;
horse,
liver;
and
sheep,
liver
at
0.50
ppm;
in
or
on
cotton,
undelinted
seed
at
0.50
ppm;
and
in
or
on
cotton,
gin
byproducts
at
10
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.

VerDate
jul<
14>
2003
15:
30
Sep
18,
2003
Jkt
200001
PO
00000
Frm
00029
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
19SER1.
SGM
19SER1
54826
Federal
Register
/
Vol.
68,
No.
182
/
Friday,
September
19,
2003
/
Rules
and
Regulations
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
 
0282
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
18,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VI.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0282,
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
VerDate
jul<
14>
2003
15:
30
Sep
18,
2003
Jkt
200001
PO
00000
Frm
00030
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
19SER1.
SGM
19SER1
54827
Federal
Register
/
Vol.
68,
No.
182
/
Friday,
September
19,
2003
/
Rules
and
Regulations
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

VIII.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
this
final
rule
in
the
Federal
Register.
This
final
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).
List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
September
10,
2003.
James
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
180.592
is
added
to
read
as
follows:

§
180.592
Butafenacil;
tolerances
for
residues.

(
a)
General.
(
1)
Tolerances
are
established
for
residues
of
the
herbicide
butafenacil,
(
1,1­
dimethyl­
2­
oxo­
2­(
2­
propenyloxy)
ethyl
2­
chloro­
5­[
3,6­
dihydro­
3­
methyl­
2,6­
dioxo­
4­
(
trifluoromethyl)­
1(
2H)­
pyrimidinyl]
benzoate)
in
or
on
the
following
raw
agricultural
commodities:

Commodity
Parts
per
million
Cotton,
gin
byproducts
...
10
Cotton,
undelinted
seed
0.50
(
2)
Tolerances
are
established
for
residues
of
the
herbicide
butafenacil,
(
1,1­
dimethyl­
2­
oxo­
2­(
2­
propenyloxy)
ethyl
2­
chloro­
5­[
3,6­
dihydro­
3­
methyl­
2,6­
dioxo­
4­
(
trifluoromethyl)­
1(
2H)­
pyrimidinyl]
benzoate)
and
its
metabolite
CGA­
293731
(
1­
carboxy­
1­
methylethyl
2­
chloro­
5­[
3,6­
dihydro­
3­
methyl­
2,6­
dioxo­
4­(
trifluoromethyl)­
1(
2H)­
pyrimidinyl]
benzoate),
in
or
on
the
following
livestock
commodities:

Commodity
Parts
per
million
Cattle,
kidney
..................
0.05
Cattle,
liver
......................
0.50
Goats,
kidney
..................
0.05
Goats,
liver
.....................
0.50
Hog,
kidney
.....................
0.05
Hog,
liver
........................
0.50
Horse,
kidney
..................
0.05
Horse,
liver
.....................
0.50
Sheep,
kidney
.................
0.05
Sheep,
liver
.....................
0.50
(
b)
Section
18
emergency
exemptions.
[
Reserved]
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
(
d)
Indirect
and
inadvertant
residues.
[
Reserved]
[
FR
Doc.
03
 
23853
Filed
9
 
18
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0300;
FRL
 
7324
 
9]

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

SUMMARY:
This
regulation
establishes
tolerances
for
combined
residues
of
the
herbicide
S­
metolachlor
and
its
metabolites
in
or
on
asparagus;
carrot,
roots;
horseradish;
onion,
green;
rhubarb;
and
swiss
chard.
The
Interregional
Research
Project
Number
4
(
IR­
4)
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
DATES:
This
regulation
is
effective
September
19,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0300,
must
be
received
on
or
before
November
18,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Hoyt
Jamerson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9368;
e­
mail
address:
jamerson.
hoyt@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturer
(
NAICS
311)
 
Pesticide
manufacturer
(
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
VerDate
jul<
14>
2003
15:
30
Sep
18,
2003
Jkt
200001
PO
00000
Frm
00031
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
19SER1.
SGM
19SER1
