Document ID: EPA-HQ-OPP-2003-0270-0001
Agency: epa
Document Type: Rule
Title: Sulfentrazone; Pesticide Tolerances
Posted Date: 2003-09-24T04:00Z

55269
Federal
Register
/
Vol.
68,
No.
185
/
Wednesday,
September
24,
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:
September
10,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.


Therefore,
40
CFR
part
180
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
180.414
is
amended
as
follows:


a.
By
revising
the
commodities
cattle,
goat,
hog,
horse,
and
sheep
meat
byproducts
in
the
table
in
paragraph
(
a).


b.
By
revising
the
commodities
onion,
dry
bulb
and
onion,
green
in
the
table
in
paragraph
(
a).


c.
By
alphabetically
adding
commodities
in
the
table
in
paragraph
(
a).


d.
By
removing
and
reserving
paragraph
(
c).

§
180.414
Cyromazine;
tolerances
for
residues.

(
a)
*
*
*

Commodity
Parts
per
million
*
*
*
*
*

Broccoli
.....................................
1.0
Cabbage,
abyssinian
................
10.0
Cabbage,
seakale
.....................
10.0
*
*
*
*
*

Cattle,
kidney
............................
0.2
Commodity
Parts
per
million
*
*
*
*
*

Cattle,
meat
byproducts,
except
kidney
....................................
0.05
*
*
*
*
*

Garlic,
bulb
...............................
0.2
Garlic,
great­
headed,
bulb
........
0.2
*
*
*
*
*

Goat,
kidney
.............................
0.2
*
*
*
*
*

Goat,
meat
byproducts,
except
kidney
....................................
0.05
Hanover
salad,
leaves
..............
10.0
*
*
*
*
*

Hog,
kidney
...............................
0.2
*
*
*
*
*

Hog,
meat
byproducts,
except
kidney
....................................
0.05
*
*
*
*
*

Horse,
kidney
............................
0.2
*
*
*
*
*

Horse,
meat
byproducts,
except
kidney
....................................
0.05
*
*
*
*
*

Leek
..........................................
3.0
*
*
*
*
*

Onion,
dry
bulb
.........................
0.2
Onion,
green
.............................
3.0
Onion,
potato
............................
3.0
Onion,
tree
................................
3.0
Onion,
welsh
.............................
3.0
*
*
*
*
*

Rakkyo,
bulb
.............................
0.2
Shallot,
bulb
..............................
0.2
Shallot,
fresh
leaves
.................
3.0
*
*
*
*
*

Sheep,
kidney
...........................
0.2
*
*
*
*
*

Sheep,
meat
byproducts,
except
kidney
............................
0.05
*
*
*
*
*

Turnip,
greens
..........................
10.0
Vegetable,
brassica,
leafy,
group
5,
except
broccoli
.......
10.0
*
*
*
*
*

*
*
*
*
*
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
*
*
*
*
*

[
FR
Doc.
03
 
24012
Filed
9
 
23
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0270;
FRL
 
7324
 
5]

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

SUMMARY:
This
regulation
establishes
tolerances
for
combined
residues
of
the
herbicide
sulfentrazone
and
its
metabolites
in
or
on
asparagus;
bean,
lima,
succulent;
cabbage;
corn,
field,
forage;
corn,
field,
grain;
corn,
field,
stover;
horseradish,
roots;
pea
and
bean,
dried
shelled,
except
soybean,
subgroup
6C;
peanut;
peanut,
meal;
peppermint,
tops;
potato;
spearmint,
tops;
sugarcane,
cane;
sugarcane,
molasses;
and
sunflower,
seed.
EPA
is
also
deleting
certain
sulfentrazone
tolerances
that
are
no
longer
needed
as
result
of
this
action.
The
Interregional
Research
Project
Number
4
and
FMC
Corporation
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
September
24,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0270,
must
be
received
on
or
before
November
24,
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
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
32532)

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/
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68,
No.
185
/
Wednesday,
September
24,
2003
/
Rules
and
Regulations
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
 
0270.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
March
7,
2003
(
68
FR
11096)
(
FRL
 
7290
 
1),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
pesticide
petitions
(
PP
0E6149,
1E6311,
2E6405,
2E6498,
and
2E6500)
by
the
Interregional
Research
Project
Number
4
(
IR­
4),
and
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902,
and
PP
0F6116
and
2F6391
by
FMC
Corporation,
Agricultural
Products
Group,
1735
Market
Street,
Philadelphia,
PA
19103.
That
notice
included
a
summary
of
the
petitions
prepared
by
FMC
Corporation,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petitions
requested
that
40
CFR
180.498
be
amended
by
establishing
tolerances
for
combined
residues
of
the
herbicide
sulfentrazone,
[
N­(
2,4­
dichloro­
5­(
4­(
difluoromethyl)­
4,5­
dihydro­
3­
methyl­
5­
oxo­
1H­
1,2,4­
triazol­
1­
ylphenylmethansulfonoamide
and
its
metabolites
HMS
(
N­(
2,4­
dichloro­
5­(
4­(
difluoromethyl)­
4,5­
dihydro­
3­
hydroxymethyl­
5­
oxo­
1H­
1,2,4­
triazol­
1­
yl)
phenyl)
methanesulfonamide)
and
DMS
(
N­(
2,4­
dichloro­
5­(
4­
(
difluoromethyl)­
4,5­
dihydro­
5­
oxo­
1H­
1,2,4­
triazol­
1­
yl)
phenyl)
methanesulfonamide),
in
or
on
food
commodities
as
follows:
Sunflower,
seed
at
0.2
parts
per
million
(
ppm)
(
PP
0E6149);
horseradish,
roots
at
0.2
ppm
(
PP
1E6311);
cabbage
at
0.2
ppm
(
PP
1E6311);
peppermint,
tops
and
spearmint,
tops
at
0.3
ppm
(
1E6311);
potato
at
0.1
ppm
(
PP
2E6405);
bean,
lima,
succulent
at
0.15
ppm
(
PP
2E6498);
asparagus
at
0.15
ppm
(
2E6500);
peanut
nutmeat
and
its
processed
parts
at
0.2
ppm
and
sugarcane
and
its
processed
parts
at
0.1
ppm
(
PP
0F6116);
corn,
field
forage
at
0.25
ppm
(
PP
2F6391);
corn,
field
stover
at
0.35
ppm
(
PP
2F6391);
pea
and
bean,
dried
shelled,
except
soybean,
subgroup
6C
at
0.15
ppm
(
PP
2F6391).
Pesticide
petitions
0F6116,
2F6391
and
2E6405
were
subsequently
amended
to
propose
tolerances
for
peanut
at
0.20
ppm;
peanut,
meal
at
0.40
ppm;
sugarcane,
cane
at
0.15
ppm;
sugarcane,
molasses
at
0.20
ppm;
corn,
field,
forage
at
0.20
ppm;
corn,
field,
grain
at
0.15
ppm;
corn,
field,
stover
at
0.30
ppm
and
potato
at
0.15
ppm.
EPA
is
also
deleting
several
time­
limited
tolerances
established
in
connection
with
section
18
emergency
exemption
under
40
CFR
180.498(
b)
that
are
no
longer
needed,
as
a
result
of
this
action.
The
deletions
to
40
CFR
180.498(
b)
are
as
follows:
1.
Delete
horseradish,
roots
at
0.1
ppm;
replace
with
horseradish,
roots
at
0.20
ppm.
2.
Delete
pea,
dry,
seed
at
0.10
ppm;
replace
with
pea
and
bean,
dried
shelled,
except
soybean,
subgroup
6C
at
0.15
ppm.
3.
Delete
potato
at
0.10
ppm;
potato,
granules/
flakes
at
0.20
ppm;
and
potato,
wet
peel
at
0.15
ppm;
replace
with
potato
at
0.15
ppm.
4.
Delete
sugarcane
at
0.05
ppm;
replace
with
sugarcane,
cane
0.15
ppm
and
sugarcane,
molasses
at
0.20
ppm.
5.
Delete
sunflower
at
0.1
ppm;
replace
with
sunflower,
seed
at
0.20
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
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
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/
Vol.
68,
No.
185
/
Wednesday,
September
24,
2003
/
Rules
and
Regulations
FFDCA,
for
tolerances
for
combined
residues
of
sulfentrazone
and
its
major
metabolites
on
asparagus
at
0.15
ppm;
bean,
lima,
succulent
at
0.15
ppm;
cabbage
at
0.20
ppm;
corn,
field,
forage
at
0.20
ppm;
corn,
field,
grain
at
0.15
ppm;
corn,
field,
stover
at
0.30
ppm;
horseradish,
roots
at
0.20
ppm;
pea
and
bean,
dried
shelled,
except
soybean,
subgroup
6C
at
0.15
ppm;
peanut
at
0.20
ppm;
peanut,
meal
at
0.40
ppm;
peppermint,
tops
at
0.30
ppm;
potato
at
0.15
ppm;
spearmint,
tops
at
0.30
ppm;
sugarcane,
cane
0.15
ppm;
sugarcane,
molasses
0.20
ppm;
and
sunflower,
seed
at
0.20
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
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
sulfentrazone
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.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90
 
Day
oral
toxicity
rodents
(
rats)
NOAEL
=
19.9
milligrams/
kilogram/
day
(
mg/
kg/
day)
for
males
and
23.1
mg/
kg/
day
for
females
LOAEL
=
65.8
mg/
kg/
day
for
males
and
78.1
mg/
kg/
day
for
females
based
on
clinical
signs
of
anemia
(
reduced
hematocrit,
hemoglobin,
mean
cell
volume,
and
mean
cell
hemoglobin
values
during
treatment)

870.3100
90
 
Day
oral
toxicity
rodents
(
mice)
NOAEL
=
60
mg/
kg/
day
for
males
and
79.8
mg/
kg/
day
for
females
LOAEL
=
108.4
mg/
kg/
day
for
males
and
143.6
mg/
kg/
day
for
females
based
on
decreased
body
weights,
body
weight
gains,
red
blood
cells,
hemoglobin
hematocrit,
and
severity
of
splenic
micropathology
(
increased
incidence
and
severity
of
extramedullary
hematopoiesis)

870.3150
90
 
Day
oral
toxicity
in
nonrodents
(
dogs)
NOAEL
=
28
mg/
kg/
day
LOAEL
=
57
mg/
kg/
day
for
males
and
73
mg/
kg/
day
for
females
based
on
decreased
body
weights
(
7­
10%)
and
body
weight
gains
during
first
5
weeks
of
study;
decreased
hemoglobin,
hematocrit,
mean
cell
volume,
mean
cell
hemoglobin
and
mean
cell
hemoglobin
concentration,
and
increased
absolute
liver
weights
and
alkaline
phosphatase
levels,
and
microscopic
changes
in
the
liver
and
spleen
(
pigmented
sinusoidal
microphages
in
the
liver,
swollen
centrilobular
hepatocytes
and
pigmented
reticuloendothelial
cells
in
the
spleen)

870.3200
21/
28
 
Day
dermal
toxicity
Systemic
and
dermal
NOAEL
=
1,000
mg/
kg/
day,
highest
dose
tested
(
HDT)

870.3700
Prenatal
developmental
in
rodents
(
rats)
Maternal
NOAEL
=
25
mg/
kg/
day
LOAEL
=
50
mg/
kg/
day
based
on
increased
relative
splenic
extramedullary
hematopoiesis
Developmental
NOAEL
=
10
mg/
kg/
day
LOAEL
=
25
mg/
kg/
day
based
on
decreased
mean
fetal
weights,
and
retardation
in
skeletal
development
evidenced
by
an
increased
number
of
litters
with
any
variation
and
by
decreased
number
of
caudal
vertebral
and
metacarpal
ossification
sites
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Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.3700
Prenatal
developmental
in
rodents
(
rats)
Maternal
NOAEL
=
250
mg/
kg/
day
LOAEL
was
not
established.
Developmental
NOAEL
=
100
mg/
kg/
day
LOAEL
=
250
mg/
kg/
day
based
on
decreased
fetal
body
weight;
increased
incidence
of
fetal
variations
hypoplastic
or
wavy
ribs,
incompletely
ossified
lumbar
vertebral
arches,
and
incompletely
ossified
ischia
or
pubis;
and
reduced
number
of
thoracic
vertebral
and
rib
ossification
sites
870.3700
Prenatal
developmental
in
nonrodents
(
rabbits)
Maternal
NOAEL
=
100
mg/
kg/
day
LOAEL
=
250
mg/
kg/
day
based
on
increased
abortions
clinical
signs
(
hematuria
and
decreased
feces),
and
reduced
body
weight
gain
Developmental
NOAEL
=
100
mg/
kg/
day
LOAEL
=
250
mg/
kg/
day
based
on
increased
resorptions
decreased
live
fetuses
per
litter,
and
decreased
fetal
weights
870.3800
2
 
Generation
reproduction
and
fertility
effects
(
rats)
Parental/
Systemic
NOAEL
=
14
mg/
kg/
day
for
males
and
16
mg/
kg/
day
for
females
LOAEL
=
33
mg/
kg/
day
for
males
and
40
mg/
kg/
day
for
females
based
on
decreased
maternal
body
weight/
body
weight
gain
during
gestation
in
both
generation
(
P
and
F1)
and
reduced
premating
body
weight
gain
in
second
generation
(
F1)
males
Reproductive
NOAEL
=
14
mg/
kg/
day
for
males
and
16
mg/
kg/
day
for
females
LOAEL
=
33
mg/
kg/
day
for
males
and
40
mg/
kg/
day
for
females
based
on
increased
duration
of
gestation
in
females
and
degeneration
and/
or
atrophy
of
the
germinal
epithelium
of
the
testes
and
oligospermia
and
intratubular
degenerated
seminal
material
in
the
epididymis
of
F1
males
Offspring
NOAEL
=
14
mg/
kg/
day
for
males
and
16
mg/
kg/
day
for
females
LOAEL
=
33
mg/
kg/
day
for
males
and
40
mg/
kg/
day
for
females
based
on
reduced
prenatal
viability
(
fetal
and
litter),
reduced
litter
size,
increased
number
of
stillborn
pups,
reduced
pup
and
litter
postnatal
survival
and
decreased
pup
body
weights
throughout
lactation
870.3800
Reproduction
and
fertility
effects
(
rat)
Nonguideline
Parental/
Systemic
NOAEL
=
20
mg/
kg/
day
LOAEL
=
51
mg/
kg/
day
(
F1
females)
based
on
decrease
in
pre­
mating
body
weight
gain
(
10%)
Offspring
and
Reproductive
NOAEL
=
16
mg/
kg/
day
LOAEL
=
40
mg/
kg/
day
based
on
reduced
gestation
day
20
fetal
weights;
decreased
postnatal
day
0,
4
and
7
pup
weights;
decreased
pup
survival;
delayed
vaginal
patency;
reduced
epididymal,
prostate
and
testicular
weights
Additional
information
supports
the
conclusions
reached
in
the
2­
generation
reproduction
study
in
rats
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24,
2003
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Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.4100
Chronic
toxicity
dogs
NOAEL
=
24.9
mg/
kg/
day
for
males
and
29.6
mg/
kg/
day
for
females
LOAEL
=
61.2
mg/
kg/
day
for
males
and
61.9
mg/
kg/
day
for
females
based
on
compensated
normochromic
microcytosis
870.4200
Carcinogenicity
mice
NOAEL
=
93.9
mg/
kg/
day
for
males
and
116.9
mg/
kg/
day
for
females
LOAEL
=
160.5
mg/
kg/
day
for
males
and
198.0
mg/
kg/
day
for
females
based
on
dose­
related
decreases
in
hemoglobin
and
hematocrit
by
study
termination
No
evidence
of
carcinogenicity
870.4300
Combined
chronic
toxicity/
carcinogenicity
rats
NOAEL
=
40
mg/
kg/
day
for
males
and
36.4
mg/
kg/
day
in
females
LOAEL
=
82.2
mg/
kg/
day
for
males
and
67
mg/
kg/
day
for
females
based
on
dose­
related
decreased
body
weights
(
11
and
19%),
body
weight
gains
(
13
and
26%),
food
consumption
(
13
and
19%),
hemoglobin,
hematocrit,
mean
cell
volume,
and
mean
cell
hemoglobin.
Increased
nucleated
red
blood
cells
and
reticulocytes
in
bone
of
females
at
124.7
mg/
kg/
day
No
evidence
of
carcinogenicity
870.5100
Gene
mutation
No
evidence
of
compound­
induced
cytotoxicity
was
evident
in
Salmonella
typhimurium
strains
TA1535,
TA1538,
TA1537,
TA98
and
TA100
either
in
presence
or
in
absence
of
S9
activation.
The
positive
controls
induced
the
expected
mutagenic
responses
in
the
appropriate
tester
strain.
Sulfentrazone
was
considered
not
mutagenic
under
any
test
condition.

870.5300
In
vitro
mammalian
cell
gene
mutation
assay
(
mouse
lymphoma)
In
a
forward
gene
mutation
assay,
sulfentrazone
at
precipitating
levels
was
equivocally
positive
in
the
absence
of
S9
activation.
This
response
was
not
repeated
at
doses
up
to
1,800
µ
g/
ml
in
the
presence
of
S9
activation.

870.5395
Mammalian
erythrocyte
micronucleus
test
The
test
was
negative
in
mice
administered
single
intraperitoneal
doses
of
85
to
340
mg/
kg.
The
340
mg/
kg
dose
was
estimated
to
be
approximately
80%
of
the
LD50.
No
evidence
of
a
cytotoxic
effect
on
the
target
organ
and
no
significant
increase
in
the
frequency
of
micronucleated
polychromatic
erythrocytes
in
bone
marrow
cells.

870.5450
Dominant
lethal
assay­
rodent
There
were
no
significant
difference
from
negative
controls
in
the
proportion
of
early
dead:
total
implants
and
(
total)
dead:
total
implants.
Based
on
the
results,
sulfentrazone
is
considered
negative
for
inducing
dominant
lethal
mutations
in
pre­
meiotic
meiotic,
and
post­
meiotic
germ
cells
of
male
rats
under
conditions
of
this
assay
up
to
the
estimated
MTD.

870.6200
Acute
neurotoxicity
screening
battery
NOAEL
=
250
mg/
kg/
day
LOAEL
=
750
mg/
kg/
day
based
on
increased
incidence
of
clinical
signs,
FOB
findings,
and
decreased
motor
activity
which
was
reversed
by
day
14
postdose.
No
evidence
of
neuropathology
at
any
dose
tested.

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Vol.
68,
No.
185
/
Wednesday,
September
24,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.6200
Subchronic
neurotoxicity
screening
battery
NOAEL
=
30
mg/
kg/
day
for
males
and
37
mg/
kg/
day
for
females
LOAEL
=
150
mg/
kg/
day
for
males
and
180
mg/
kg/
day
for
females
based
on
increased
incidence
of
clinical
signs;
decreased
body
weight,
body
weight
gains,
and
food
consumption
in
females;
and
increased
motor
activity
in
females.
At
5,000
ppm,
included
increased
mortality;
decreased
body
weights,
and
body
weight
gains
in
males;
decreased
hindlimb
grip
strength
and
increased
tail
flick
latency
in
males
at
week
8;
distended
bladders
with
red
fluid
and
enlarged
spleen.
No
evidence
of
neuropathology
at
2,500
and
5,000
ppm.

870.7485
Metabolism
and
pharmacokinetics
(
rats)
Sulfentrazone
(
Phenyl
­
14C
­
sulfentrazone)
was
readily
absorbed
and
84
to
104%
of
the
administered
dose
was
excreted
in
urine
and
feces
within
72
hours.
There
were
no
major
sex
differences
in
the
pattern
of
excretion.
Almost
all
the
radioactivity
in
the
urine
was
3­
hydroxy­
methyl­
F6285
(
84
­
104%
of
the
administered
dose).
In
the
feces,
HMS
accounted
for
1.26
to
2.55%
of
the
administered
dose.
The
proposed
metabolic
pathway
appeared
to
be
conversion
of
the
parent
compound
mainly
to
3­
hydroxymethyl­
F6285
(
excreted
in
the
urine).
A
small
amount
of
3­
hydroxymethyl­
F6285
was
also
converted
to
3­
carboxylic
acid­
F6285
(
excreted
in
the
urine
and
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
sulfentrazone
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

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24,
2003
/
Rules
and
Regulations
TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
SULFENTRAZONE
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
dietary
(
females
13­
50
years
of
age)
NOAEL
=
25
mg/
kg/
day
UF
=
100
Acute
RfD
=
0.25
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
acute
RfD/
FQPA
SF
=
0.25
mg/
kg/
day
Developmental
toxicity
study
in
rats
LOAEL
=
50
mg/
kg/
day
based
on
decreased
live
fetuses,
and
increased
early
resorptions
Acute
dietary
(
general
population
including
infants
and
children)
NOAEL
=
250
mg/
kg/
day
UF
=
100
Acute
RfD
=
2.5
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
acute
RfD/
FQPA
SF
=
2.5
mg/
kg/
day
Acute
neurotoxicity
study
in
rats
LOAEL
=
750
mg/
kg/
day
based
on
increased
incidence
of
clinical
signs
and
FOB
parameters
and
decreased
motor
activity.

Chronic
dietary
(
all
populations
NOAEL=
14
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.14
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
chronic
RfD/
FQPA
SF
=
0.14
mg/
kg/
day
2
 
Generation
reproduction
study
LOAEL
=
33
mg/
kg/
day
based
on
decreased
body
weight
and
body
weight
gains
Short­
term
(
1
to
30
days)
and
intermediate­
term
(
1
to
6
months)
incidental
oral
Offspring
NOAEL
=
14
mg/
kg/
day
LOC
for
MOE
=
100
(
Residential)
2
 
Generation
reproduction
study
LOAEL
=
33
mg/
kg/
day
based
on
decreased
pup
body
weights
during
lactation
in
both
generations
Short­
term
dermal
(
1
to
30
days),
intermediate­
term
dermal
(
1
to
6
months)
and
long­
term
dermal
(>
6
months)
Dermal
study
NOAEL=
100
mg/
kg/
day
(
dermal
absorption
rate
=
10%)
LOC
for
MOE
=
100
(
Residential)
Dermal
developmental
study
in
rats
LOAEL
=
250
mg/
kg/
day
based
on
decreased
fetal
body
weight;
increased
incidences
of
fetal
variations:
hypoplastic
or
wavy
ribs,
incompletely
ossified
lumbar
vertebral
arches,
and
incompletely
ossified
ischia
or
pubes;
and
reduced
number
of
thoracic
vertebral
and
rib
ossification
sites
Short­
term
inhalation
(
1
to
30
days),
intermdiate­
term
inhalation
(
1
to
6
months)
and
long­
term
inhalation
(>
6
months)
Oral
study
NOAEL
=
14
mg/
kg/
day
(
inhalation
rate
=
100%
LOC
for
MOE
=
100
(
Residential)
2
 
Generation
reproduction
study
LOAEL
=
33
mg/
kg/
day
based
on
decreased
body
weight
and
body
weight
gains
Cancer
(
oral,
dermal,
inhalation
Not
applicable
Not
applicable
No
evidence
of
carcinogenicity
in
rats
and
mice
*
The
reference
to
the
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.
Tolerances
have
been
established
(
40
CFR
180.498)
for
the
combined
residues
of
sulfentrazone,
in
or
on
soybean,
seed
at
0.05
ppm.
Timelimited
tolerances
(
set
to
expire
on
December
31,
2004)
are
established
in
connection
with
section
18
emergency
exemptions
for
bean,
succulent
seed
without
pod
at
0.1;
horseradish,
roots
at
0.1
ppm;
chickpea,
seed
at
0.10
ppm;
pea,
dry,
seed
0.10
ppm;
potato
at
0.10
ppm;
potato,
wet
peel
at
0.15;
flax,
seed
at
0.20
ppm;
potato,
granules/
flakes
at
0.20
ppm;
strawberry
at
0.60
ppm.
Time­
limited
tolerances
(
set
to
expire
on
December
31,
2005)
are
established
in
connection
with
section
18
emergency
exemptions
for
sugarcane
at
0.05
ppm
and
sunflower
at
0.1
ppm.
Tolerances
are
also
established
for
indirect
or
inadvertent
residues
in
or
on
cereal
grain
(
excluding
sweet
corn).
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
sulfentrazone
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
1
 
day
or
single
exposure.
In
conducting
the
acute
dietary
risk
assessment
EPA
used
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEMTM)
which
incorporates
food
consumption
data
as
reported
by
respondents
in
the
United
States
Department
of
Agriculture
(
USDA)
1994
 
1996
and
1998
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
Separate
Tier
I,
acute
dietary
exposure
assessments
were
performed
for
females
13
to
49
years
old
and
for
the
general
U.
S.
population
(
including
infants
and
children)
using
tolerance­
level
residues
and
100
percent
crop
treated
(
PCT).
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
EPA
used
the
DEEMTM
software
with
the
Food
Commodity
Intake
Database
which
incorporates
food
consumption
data
as
reported
by
respondents
in
the
USDA
1994
 
1996
and
1998
nationwide
CSFII
and
accumulated
exposure
to
the
chemical
for
each
commodity.
An
unrefined,
Tier
I
chronic
dietary
exposure
assessment
was
performed
using
tolerance­
level
residues
and
100
PCT.
2.
Dietary
exposure
from
drinking
water.
Sulfentrazone
and
the
degradate
3­
carboxylic
acid
sulfentrazone
are
the
residues
of
concern
for
the
drinkingwater
risk
assessment.
Environmental
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24,
2003
/
Rules
and
Regulations
fate
data
suggest
that
sulfentrazone
and
3­
carboxylic
acid
sulfentrazone
are
persistent
and
mobile.
Based
on
the
structure
similarity,
3­
carboxylic
acid
sulfentrazone
could
potentially
have
similar
toxicity
as
the
parent.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
sulfentrazone
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
sulfentrazone.
The
Agency
uses
the
FQPA
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone
Model/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS),
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.
The
Screening
Concentrations
in
Ground
Water
(
SCI­
GROW)
model
is
used
to
predict
pesticide
concentrations
in
shallow
ground
water.
For
a
screening­
level
assessment
for
surface
water
EPA
will
use
FIRST
(
a
Tier
1
model)
before
using
PRZM/
EXAMS
(
a
Tier
2
model).
The
FIRST
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
high­
end
runoff
scenario
for
pesticides.
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
and
both
models
include
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
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
sulfentrazone,
they
are
further
discussed
in
the
aggregate
risk
sections
in
Unit
E.
Based
on
the
FIRST
and
SCI­
GROW
models
the
EECs
of
sulfentrazone
plus
its
major
metabolite
3­
carboxylic
acid
for
acute
exposures
are
estimated
to
be
35.8
parts
per
billion
(
ppb)
for
surface
water
and
26.0
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
7.8
ppb
for
surface
water
and
26.0
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).
Sulfentrazone
is
proposed
for
use
on
use
on
turf
by
professional
lawn
care
operators
as
a
broadcast
spray
at
a
maximum
application
rate
of
0.03
lbs
active
ingredient.
Based
on
the
proposed
use
pattern,
potential
residential/
non­
occupational
postapplication
exposures
include
the
following:
Short­
term
oral
turfgrass
exposure
(
toddler
hand­
to­
mouth,
object­
to­
mouth);
short­
term
dermal
turfgrass
exposure
(
adult
and
toddler)
and
short­
term
dermal
golfer
exposure
(
adult
and
adolescent).
Incidental
ingestion
of
soil
is
assumed
to
be
negligible.
Exposure
over
intermediateterm
(
1­
6
months)
or
long­
term
(
chronic,
more
than
6
months)
exposure
is
not
expected.
Homeowner
handler
exposure
is
not
expected
since
sulfentrazone
will
be
applied
by
professional
lawn
care
operators.
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
sulfentrazone
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
sulfentrazone
and
any
other
substances
and
sulfentrazone
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
sulfentrazone
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
is
evidence
of
increased
quantitative
susceptibility
following
in
utero
exposure
in
the
developmentaltoxicity
studies
in
rats
via
the
oral
and
dermal
routes,
and
there
is
evidence
for
increased
qualitative
susceptibility
following
prenatal
and/
or
postnatal
exposure
in
the
2
 
generation
reproduction
study
in
rats.
A
Degree
of
Concern
Analysis
was
performed
by
EPA
and
it
was
concluded
that
concerns
are
low
for
the
quantitative
susceptibility
of
rat
fetuses
observed
following
oral
and
dermal
exposures,
the
qualitative
susceptibility
of
rabbit
fetuses
seen
via
the
oral
route,
and
the
qualitative
susceptibility
seen
in
the
1­
and
2­
generation
reproduction
studies.
The
conclusion
was
based
on
the
following:
 
The
dose­
response
was
well
characterized.
 
There
were
clear
NOAELs
and
LOAELs
for
developmental,
offspring,
maternal,
and
parental
toxicities.
 
The
developmental
effects
in
rabbits
and
the
offspring
effects
in
the
rats
were
seen
in
the
presence
of
maternal
and
parental
toxicities,
respectively.
 
The
parental
reproductive
and
offspring
effects
were
reproducible
between
the
two
reproductive
studies.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
sulfentrazone
and
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/
Vol.
68,
No.
185
/
Wednesday,
September
24,
2003
/
Rules
and
Regulations
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
EPA
determined
that
the
10X
safety
factor
to
protect
infants
and
children
should
be
reduced
to
1X
for
the
following
reasons:
1.
There
are
no
residual
uncertainties
for
prenatal
and/
or
postnatal
toxicities
via
the
oral
route
since
the
doses
selected
for
overall
risk
assessments
would
address
the
concerns
for
the
developmental
and
offspring
toxicities
seen
in
the
above
mentioned
studies.
2.
There
are
no
residual
uncertainties
for
prenatal
and/
or
postnatal
toxicities
via
the
dermal
route
since
the
dose/
endpoint/
study/
species
of
concern
was
used
for
dermal­
risk
assessment.
3.
The
toxicology
data
base
is
complete.
4.
The
dietary
(
food)
exposure
assessment
utilizes
existing
and
proposed
tolerance
level
residues
and
assumes
100%
of
crops
treated
with
sulfentrazone.
The
assessment
is
based
on
reliable
data
and
is
not
expected
to
underestimate
exposure/
risk.
5.
Conservative
assumptions
are
used
in
the
drinking
water
models.
The
drinking
water
exposure
assessment
is
not
expected
to
underestimate
exposure/
risk.
6.
The
residential
exposure
assessment
is
based
on
conservative
assumptions
and
is
not
expected
to
underestimate
risk.
E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
DWLOCs
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
(
EECs).
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure).
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
the
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
ground
water
are
less
than
the
calculated
DWLOCs,
EPA
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
EPA
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
EPA
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
EPA
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
sulfentrazone
will
occupy
<
1%
of
the
aPAD
for
the
U.
S.
population,
<
1%
of
the
aPAD
for
females
13
years
and
older,
and
<
1%
of
the
aPAD
for
children
1
to
2
years
old,
the
population
at
greatest
exposure.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
sulfentrazone
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
aPAD,
as
shown
in
Table
3
of
this
unit:

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

U.
S.
population
2.5
<
1
35.8
26
87,000
Children
(
1
to
2
years
old)
2.5
<
1
35.8
26
25,000
Females
(
13
to
49
years
old)
2.5
<
1
35.8
26
75,000
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
sulfentrazone
from
food
will
utilize
1%
of
the
cPAD
for
the
U.
S.
population,
1%
of
the
cPAD
for
females
13
to
49
years
old
and
1
%
of
the
cPAD
for
children,
3
to
5
years
old,
the
population
at
greatest
exposure.
Based
on
the
proposed
use
pattern
for
turf
grass,
chronic
residential
exposure
to
residues
of
sulfentrazone
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
sulfentrazone
and
its
degredate,
3­
carboxylic
acid
sulfentrazone,
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
Table
4
of
this
unit:

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

U.
S.
population
0.14
1
7.8
26
4,900
Children
(
3
to
5
years
old)
0.14
1
7.8
26
1,400
Females
(
13
to
49
years
old)
0.14
1
7.8
26
4,200
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).
Sulfentrazone
is
proposed
for
registration
for
use
that
could
result
in
short­
term
residential
exposure
and
the
Agency
has
determined
that
it
is
appropriate
to
aggregate
chronic
food
and
water
and
short­
term
exposures
for
sulfentrazone.
Using
the
exposure
assumptions
described
in
this
unit
for
short­
term
exposures,
EPA
has
concluded
that
food
and
residential
exposures
aggregated
result
in
aggregate
MOEs
ranging
from
6,900
for
the
U.
S.
population
to
3,200
for
children
3
to
5
years
old.
These
aggregate
MOEs
do
not
exceed
the
Agency's
level
of
concern
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
short­
term
DWLOCs
were
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
sulfentrazone
in
ground
water
and
surface
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
water
and
ground
water,
EPA
does
not
expect
short­
term
aggregate
exposure
to
exceed
the
Agency's
level
of
concern,
as
shown
in
Table
5
of
this
unit:

TABLE
5.
 
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
TERM
EXPOSURE
TO
SULFENTRAZONE
Population
Subgroup
Aggregate
MOE
(
Food
+
Residential)
Aggregate
Level
of
Concern
(
LOC)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Short­
Term
DWLOC
(
ppb)

U.
S.
population
6,900
100
7.8
26
4,900
Children
(
3
to
5
years
old)
3,200
100
7.8
26
1,400
Females
(
13
to
49
years)
7,600
100
7.8
26
4,200
5.
Aggregate
cancer
risk
for
U.
S.
population.
There
is
no
evidence
of
carcinogenicity
to
humans
based
on
carcinogenicity
studies
in
male
and
female
rats
and
mice.
The
Agency
concludes
that
pesticidal
uses
of
sulfentrazone
are
not
likely
to
pose
a
cancer
hazard
to
humans.
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
sulfentrazone
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
An
adequate
enforcement
method
using
gas
chromatography
(
GC)
for
the
determination
of
sulfentrazone,
DMS,
and
HMS
residues
is
available
for
enforcement.
The
method
was
forwarded
to
the
Food
and
Drug
Administration
(
FDA)
for
inclusion
in
Pesticide
Analytical
Method
Volume
II
(
PAM
II).
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
There
are
no
established
Codex,
Canadian
or
Mexican
maximum
residue
limits
(
MRLs)
for
residues
of
sulfentrazone
in/
on
the
subject
commodities.
Therefore,
no
compatibility
problems
exist
for
the
tolerances
established
by
this
rule.

V.
Conclusion
Therefore,
the
tolerance
is
established
for
combined
residues
of
sulfentrazone
and
its
metabolites
HMS
(
N­(
2,4­
dichloro­
5­(
4­(
difluoromethyl)­
4,5­
dihydro­
3­
hydroxymethyl­
5­
oxo­
1H­
1,2,4­
triazol­
1­
yl)
phenyl)
methanesulfonamide)
and
DMS
(
N­(
2,4­
dichloro­
5­(
4­
(
difluoromethyl)­
4,5­
dihydro­
5­
oxo­
1H­
1,2,4­
triazol­
1­
yl)
phenyl)
methanesulfonamide,
in
or
on
asparagus
at
0.15
ppm;
bean,
lima,
succulent
at
0.15
ppm;
cabbage
at
0.20
ppm;
corn,
field,
forage
at
0.20
ppm;
corn,
field,
grain
at
0.15
ppm;
corn,
field,
stover
at
0.30
ppm;
horseradish,
roots
at
0.20
ppm;
pea
and
bean,
dried
shelled,
except
soybean,
subgroup
6C
at
0.15
ppm;
peanut
at
0.20
ppm;
peanut,
meal
at
0.40
ppm;
peppermint,
tops
at
0.30
ppm;
potato
at
0.15
ppm;
spearmint,
tops
at
0.30
ppm;
sugarcane,
cane
0.15
ppm;
sugarcane,
molasses
0.20
ppm;
and
sunflower,
seed
at
0.20
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
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24,
2003
/
Rules
and
Regulations
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
 
0270
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
24,
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
 
0270,
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
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Federal
Register
/
Vol.
68,
No.
185
/
Wednesday,
September
24,
2003
/
Rules
and
Regulations
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

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

List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.
Dated:
September
10,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

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

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

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


2.
Section
180.498
is
amended
by
redesignating
existing
paragraph
(
a)
as
(
a)(
1),
by
adding
paragraph
(
a)(
2),
and
in
the
table
to
paragraph
(
b)
by
removing
the
entries
``
horseradish,
roots'';
``
pea,
dry,
seed'';
``
potato'';
``
potato,
granules/
flakes'';
``
potato,
wet
peel'';
``
sugarcane'';
and
``
sunflower,
seed.''

§
180.498
Sulfentrazone;
tolerances
for
residues.

(
a)
General.
(
1)
*
*
*
(
2)
Tolerances
are
established
for
combined
residues
of
the
herbicide
sulfentrazone
and
its
metabolites
HMS
(
N­(
2,4­
dichloro­
5­(
4­(
difluoromethyl)­
4,5­
dihydro­
3­
hydroxymethyl­
5­
oxo­
1H­
1,2,4­
triazol­
1­
yl)
phenyl)
methanesulfonamide)
and
DMS
(
N­(
2,4­
dichloro­
5­(
4­
(
difluoromethyl)­
4,5­
dihydro­
5­
oxo­
1H­
1,2,4­
triazol­
1­
yl)
phenyl)
methanesulfonamide
in
or
on
the
following
food
commodities:

Commodity
Parts
per
million
Asparagus
................................................................................................................
0.15
Bean,
lima,
succulent
..............................................................................................
0.15
Cabbage
..................................................................................................................
0.20
Corn,
field,
forage
....................................................................................................
0.20
Corn,
field,
grain
......................................................................................................
0.15
Corn,
field,
stover
....................................................................................................
0.30
Horseradish,
roots
...................................................................................................
0.20
Pea
and
bean,
dried
shelled,
except
soybean,
subgroup
6C
.................................
0.15
Peanut
......................................................................................................................
0.20
Peanut,
meal
............................................................................................................
0.40
Peppermint,
tops
......................................................................................................
0.30
Potato
.......................................................................................................................
0.15
Spearmint,
tops
........................................................................................................
0.30
Sugarcane,
cane
......................................................................................................
0.15
Sugarcane,
molasses
..............................................................................................
0.20
Sunflower,
seed
.......................................................................................................
0.20
*
*
*
*
*

[
FR
Doc.
03
 
24011
Filed
9
 
23
 
03;
8:
45
am]

BILLING
CODE
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