Document ID: EPA-HQ-OPP-2003-0011-0001
Agency: epa
Document Type: Notice
Title: Sulfentrazone; Notice of Filing Pesticide Petitions to Establish Tolerances for a Certain Pesticide        Chemical in or on Food
Posted Date: 2003-03-07T05:00Z

11096
Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
aerosol
sprays,
emulsifiable
concentrates,
and
impregnated
materials
(
pet
collars).
With
the
exception
of
the
pet
collar
uses,
consumer
use
of
pyriproxyfen
typically
results
in
acute
and
short­
term
intermittent
exposures.

D.
Cumulative
Effects
There
are
no
other
pesticidal
compounds
that
are
structurally
related
to
pyriproxyfen
and
have
similar
effects
on
animals.
In
consideration
of
potential
cumulative
effects
of
pyriproxyfen
and
other
substances
that
may
have
a
common
mechanism
of
toxicity,
there
are
currently
no
available
data
or
other
reliable
information
indicating
that
any
toxic
effects
produced
by
pyriproxyfen
would
be
cumulative
with
those
of
other
chemical
compounds.
Thus,
only
the
potential
risks
of
pyriproxyfen
have
been
considered
in
this
assessment
of
aggregate
exposure
and
effects.
Valent
will
submit
information
for
EPA
to
consider
concerning
potential
cumulative
effects
of
pyriproxyfen
consistent
with
the
schedule
established
by
EPA
at
(
62
FR
42020
August
4,
1997)
and
other
subsequent
EPA
publications
pursuant
to
the
Food
Quality
Protection
Act.

E.
Safety
Determination
1.
U.
S.
population.
Chronic
exposure
to
the
overall
U.
S.
population
is
estimated
to
be
0.002984
mg/
kg/
bwt
day,
representing
0.9%
of
the
Reference
Dose
(
RfD).
The
results
of
the
chronic
dietary
exposure
assessment
demonstrate
that
estimates
of
chronic
dietary
exposure
for
all
existing,
pending
and
proposed
uses
of
pyriproxyfen
are
well
below
the
chronic
RfD
of
0.35
mg/
kg/
bwt
day.
The
estimated
chronic
dietary
exposure
from
food
for
the
overall
U.
S.
population
and
many
non­
child/
infant
subgroups
is
from
0.002123
to
0.003884
mg/
kg/
bwt
day,
0.607
to
1.100%
of
the
RfD.
Generally,
the
Agency
has
no
cause
for
concern
if
total
residue
contribution
is
less
than
100%
of
the
RfD.
Valent
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
overall
U.
S.
population
or
any
nonchild
infant
subgroups
from
aggregate,
chronic
dietary
exposure
to
pyriproxyfen
residues.
2.
Infants
and
children
 
i.
Safety
factor
for
infants
and
children.
In
assessing
the
potential
for
additional
sensitivity
of
infants
and
children
to
residues
of
pyriproxyfen,
FFDCA
section
408
provides
that
EPA
shall
apply
an
additional
margin
of
safety,
up
to
10­
fold,
for
added
protection
for
infants
and
children
in
the
case
of
threshold
effects
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
The
toxicological
data
base
for
evaluating
prenatal
and
postnatal
toxicity
for
pyriproxyfen
is
complete
with
respect
to
current
data
requirements.
There
are
no
special
prenatal
or
postnatal
toxicity
concerns
for
infants
and
children,
based
on
the
results
of
the
rat
and
rabbit
developmental
toxicity
studies
or
the
2­
generation
reproductive
toxicity
study
in
rats.
Valent
concludes
that
reliable
data
support
use
of
the
standard
100­
fold
uncertainty
factor
and
that
an
additional
uncertainty
factor
is
not
needed
for
pyriproxyfen
to
be
further
protective
of
infants
and
children.
ii.
Chronic
dietary
exposure
and
risk
infants
and
children.
For
the
most
highly
exposed
sub­
population,
children
1
to
6
years
of
age,
exposure
is
calculated
to
be
0.007438
mg/
kg/
bwt
day,
or
2.1%
of
the
RfD.
Using
the
conservative
exposure
assumptions,
the
percentage
of
the
RfD
that
will
be
utilized
by
chronic
dietary
(
food
only)
exposure
to
residues
of
pyriproxyfen
ranges
from
0.002601
mg/
kg/
bwt
day
for
nursing
infants,
up
to
0.007438
mg/
kg/
bwt
day
for
children
(
1
to
6
years
of
age),
0.743
to
2.125%
of
the
RfD,
respectively.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
RfD
because
the
RfD
represents
the
level
at
or
below
which
daily
aggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
Valent
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate,
chronic
dietary
exposure
to
pyriproxyfen
residues.
iii.
Drinking
water.
The
average
56
 
day
concentration
predicted
in
the
simulated
pond
water
was
0.16
parts
per
billion
(
ppb).
Using
standard
assumptions
about
body
weight
and
water
consumption,
the
chronic
exposure
to
pyriproxyfen
from
this
drinking
water
would
be
4.57
x
10­
6
and
1.6
x
10­
5
mg/
kg/
bwt
day
for
adults
and
children,
respectively;
0.0046%
of
the
RfD
0.35
mg/
kg/
day
for
children.
Based
on
this
worse
case
analysis,
the
contribution
of
water
to
the
dietary
risk
is
negligible.
iv.
Non­
dietary
exposure.
Chronic
residential
post­
application
exposure
and
risk
assessments
were
conducted
to
estimate
the
potential
risks
from
pet
collar
uses.
The
risk
assessment
was
conducted
using
the
following
assumptions:
Application
rate
of
0.58
mg
active
ingredient
day,
average
body
weight
for
a
1
 
6
year
old
child
of
10
kg,
the
active
ingredient
dissipates
uniformly
through
365
days
the
label
instruct
to
change
collar
(
once
a
year),
1%
of
the
active
ingredient
is
available
for
dermal
and
inhalation
exposure
per
day
assumption
from
Draft
EPA
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments
(
December
18,
1997).
The
assessment
also
assumes
an
absorption
rate
of
100%.
This
is
a
conservative
assumption
since
the
dermal
absorption
was
estimated
to
be
10%.
The
estimated
chronic
term
margin
of
exposure
(
MOE)
was
61,000
for
children,
and
430,000
for
adults.
The
risk
estimates
indicate
that
potential
risks
from
pet
collar
uses
do
not
exceed
the
Agency's
level
of
concern.

F.
International
Tolerances
There
are
no
presently
existing
Codex
maximum
residue
levels
for
pyriproxyfen.
[
FR
Doc.
03
 
5315
Filed
3
 
6
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0011;
FRL
 
7290
 
1]

Sulfentrazone;
Notice
of
Filing
Pesticide
Petitions
to
Establish
Tolerances
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0011,
must
be
received
on
or
before
April
7,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Shaja
R.
Brothers,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
3194;
e­
mail
address:
brothers.
shaja@
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
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17:
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2003
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11097
Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
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
insert
appropriate
cite
to
either
another
unit
in
the
preamble
or
a
section
in
a
rule.
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
 
0011.
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/.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2003
 
0011
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
opp­
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP
 
2003
 
0011.
In
contrast
to
EPA's
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Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001,
Attention:
Docket
ID
Number
OPP
 
2003
 
0011.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP
 
2003
 
0011.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

D.
How
Should
I
Submit
CBI
To
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
What
Action
is
the
Agency
Taking?

EPA
has
received
pesticide
petitions
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
FFDCA,
21
U.
S.
C.
346a.
EPA
has
determined
that
these
petitions
contain
data
or
information
regarding
the
elements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
these
petitions.
Additional
data
may
be
needed
before
EPA
rules
on
the
petitions.

List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
January
30,
2003.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summaries
of
Petitions
The
petitioner's
summaries
of
the
pesticide
petitions
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summaries
of
the
petitions
was
prepared
by
FMC
Corporation
and
represents
the
view
of
FMC
Corporation.
The
petitions
summaries
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

Interregional
Research
Project
Number
4
and
FMC
Corporation
PP
(
0E6149,
1E6311,
2E6405,
2E6498,
2E6500,
0F6116,
and
2F6391
EPA
has
received
pesticide
petitions
(
0E6149,
1E6311,
2E6405,
2E6498,
and
2E6500)
from
Interregional
Research
Project
Number
(
IR
 
4),
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902.
EPA
has
also
received
pesticide
petitions
(
0F6116
and
2F6391)
from
FMC
Corporation,
Agricultural
Products
Group,
1735
Market
Street,
Philadelphia,
PA
19103
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
180.498
by
establishing
tolerances
for
residues
of
sulfentrazone
(
N­
2,4­
dichloro­
5­[
4­(
difluoromethyl)­
4,5­
dihydro­
3­
methyl­
5­
oxo­
1H­
1,2,4­
triazol­
1­
yl]
phenylmethanesulfonamide
and
its
metabolites
3­
hydroxymethylsulfentrazone
(
N­
2,4­
dichloro­
5­[
4­
(
difluoromethyl)­
4,5­
dihydro­
3­
hydroxymethyl­
5­
oxo­
1H­
1,2,4­
triazol­
1­
yl]
phenyl]
methanesulfonamide)
and
3­
desmethyl
sulfentrazone
(
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
raw
agricultural
commodities:
1.
PP
0E6149
proposes
the
establishment
of
a
tolerance
for
sunflower,
seed
at
0.2
parts
per
million
(
ppm).
2.
PP
1E6311
proposes
the
establishment
of
tolerances
for
horseradish,
roots
at
0.2
ppm,
cabbage
at
0.2
ppm,
peppermint,
tops
at
0.3
ppm,
and
spearmint,
tops
at
0.3
ppm.
3.
PP
2E6405
proposes
the
establishment
of
a
tolerance
for
potato
at
0.1
ppm.
4.
PP
2E6498
proposes
the
establishment
of
a
tolerance
for
bean,
lima,
succulent
at
0.15
ppm.
5.
PP
2E6500
proposes
the
establishment
of
a
tolerance
for
asparagus
at
0.15
ppm.
6.
PP
0F6116
proposes
the
establishment
of
tolerances
for
peanut
nutmeat
and
its
processed
parts
at
0.2
ppm,
and
sugarcane
and
its
processed
parts
at
0.1
ppm.
7.
PP
2F6391
proposes
the
establishment
of
tolerances
for
corn,
field,
forage
at
0.25
ppm,
corn,
field,

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Federal
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/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
stover
at
0.35
ppm;
pea
and
bean,
dried
shelled,
except
soybean,
subgroup
6C
at
0.15
ppm.
EPA
has
determined
that
the
petitions
contain
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petitions.
Additional
data
may
be
needed
before
EPA
rules
on
the
petitions.
This
notice
includes
summaries
of
the
petitions
prepared
by
FMC
Corporation,
Philadelphia,
PA
19103.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
metabolism
of
sulfentrazone
in
plants
is
adequately
understood
for
the
existing
and
proposed
tolerances.
2.
Analytical
method.
The
proposed
analytical
method
for
determining
residues
of
sulfentrazone
is
hydrolysis
followed
by
gas
chromatographic
separation.
3.
Magnitude
of
residues.
The
magnitude
of
residues
is
adequately
understood
for
the
proposed
commodities.

B.
Toxicological
Profile
1.
Acute
toxicity.
A
battery
of
acute
toxicity
studies
placed
technical
sulfentrazone
in
toxicity
categories
III
and
IV.
No
evidence
of
sensitization
was
observed
following
dermal
application
in
guinea
pigs.
In
an
acute
neurotoxicity
study
in
rats
at
gavage
doses
of
0,
750,
or
2,000
milligrams/
kilogram
(
mg/
kg),
the
no
observable
adverse
effect
level
(
NOAEL)
of
250
mg/
kg
and
the
lowest
observable
adverse
effect
level
(
LOAEL)
of
750
mg/
kg
were
based
upon
increased
incidences
of
clinical
signs,
Functional
Observation
Battery
(
FOB)
findings,
and
decreased
motor
activity
which
were
reversed
by
day
14
post­
dose.
There
was
no
evidence
of
neuropathology.
2.
Genotoxicity.
A
reverse
gene
mutation
assay
(
salmonella
typhimurium)
yielded
negative
results,
both
with
and
without
metabolic
activation.
A
mouse
lymphoma
forward
gene
mutation
assay
yielded
negative
results
with
equivocal
results
without
activation.
A
mouse
micronucleus
assay
test
was
negative
following
intraperitoneal
injection
of
340
mg/
kg.
3.
Reproductive
and
developmental
toxicity.
In
a
dermal
developmental
study
in
the
rat
at
doses
of
0,
5,
25,
50,
100,
and
250
mg/
kg/
day,
a
maternal
(
systemic)
NOAEL
was
established
at
250
mg/
kg/
day.
Significant
treatmentrelated
increases
in
the
fetal
and
litter
incidences
of
incompletely
ossified
lumbar
vertebral
arches,
hypoplastic
or
wavy
ribs,
and
incompletely
ossified
or
nonossified
ischia
or
pubes
occurred
at
the
high­
dose
(
250
mg/
kg/
day).
An
additional
significant
increase
in
the
high­
dose
fetal
incidence
of
variations
in
the
sternebrae
(
incompletely
ossified
or
unossified)
was
not
judged
to
be
treatment­
related.
At
250
mg/
kg/
day,
the
mean
numbers
of
thoracic
vertebral
and
rib
ossification
sites
were
significantly
decreased,
a
high­
dose
effect
of
treatment
with
sulfentrazone
consistent
with
the
significant
treatment­
related
hypoplasia
observed
in
the
skeletal
evaluation
of
the
ribs.
Therefore,
the
developmental
(
fetal)
LOAEL
is
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.
The
developmental
(
fetal)
NOAEL
is
100
mg/
kg/
day.
A
developmental
toxicity
study
in
rabbits
was
conducted
at
gavage
dose
levels
of
0,
100,
250,
or
375
mg/
kg/
day.
Treatment­
related
incidences
of
decreased
feces
and
hematuria
were
noted
at
250
mg/
kg/
day
or
greater.
In
addition,
at
the
375
mg/
kg/
day
dose
level,
5
rabbits
aborted.
Significant
reductions
in
mean
body
weight
change
were
observed
for
the
dosing
period
(
GD
7
 
19)
and
for
the
study
duration
(
GD
0
 
29,
both
before
and
after
adjustment
for
gravid
uterine
weight)
at
the
250
and
375
mg/
kg/
day
dose
levels.
Therefore,
the
maternal
(
systemic)
LOAEL
is
250
mg/
kg/
day,
based
upon
increased
abortions,
clinical
signs
(
hematuria
and
decreased
feces),
and
reduced
body
weight
gain.
The
maternal
(
systemic)
NOAEL
is
100
mg/
kg/
day.
Skeletal
evaluation
in
fetuses
revealed
doserelated
and
treatment­
related
findings
at
the
375
mg/
kg/
day
dose
level.
These
included
significant
increases
in
both
the
fetal
and
litter
incidences
of
fused
caudal
vertebrae
(
a
malformation)
and
of
partially
fused
nasal
bones
(
a
variation).
In
addition,
at
375
mg/
kg/
day,
significant
treatment­
related
reductions
in
ossification
site
averages
were
observed
for
metacarpals
and
both
forepaw
and
hindpaw
phalanges.
Therefore,
the
developmental
(
fetal)
LOAEL
is
250
mg/
kg/
day,
based
upon
increased
resorptions,
decreased
live
fetuses
per
litter,
and
decreased
fetal
weight.
The
developmental
(
fetal)
NOAEL
is
100
mg/
kg/
day.
A
2
 
generation
reproduction
study
in
the
rat
at
dietary
levels
of
14,
33,
or
46
mg/
kg/
day
in
males
and
16,
40,
or
56
mg/
kg/
day
in
females
established
a
NOAEL
for
systemic
and
reproductive/
developmental
parameters
of
14
mg/
kg/
day
for
males
and
16
mg/
kg/
day
for
females.
The
LOAEL
for
systemic
and
reproductive/
development
parameters
was
33
mg/
kg/
day
for
males
and
40
mg/
kg/
day
for
females.
Systemic
effects
were
comprised
of
decreased
body
weight
gains,
while
reproductive/
developmental
effect
at
the
LOAEL
included
degeneration
and/
or
atrophy
in
the
testes,
with
epididymal
sperm
deficits,
in
the
second
(
F1)
generation
males.
Male
fertility
in
the
F1
generation
was
reduced
at
higher
doses;
litter
size,
pup
survival,
and
pup
body
weight
for
both
generations
were
also
effected
at
higher
doses.
4.
Subchronic
toxicity.
A
90
 
day
subchronic
toxicity
study
was
conducted
in
rats,
with
dietary
intake
levels
of
0,
3.3,
6.7,
19.9,
65.8,
199.3,
or
534.9
mg/
kg/
day
for
males
and
0,
4,
7.7,
23.1,
78.1,
230.5,
or
404.3
mg/
kg/
day
for
females
respectively.
NOAELs
of
19.9
mg/
kg/
day
in
males
and
23.1
mg/
kg/
day
in
females
were
based
on
clinical
anemia.
A
90
 
day
subchronic
feeding
study
was
conducted
in
mice
by
dietary
admix
at
doses
of
0,
10.3,
17.8,
60.0,
108.4,
or
194.4
mg/
kg/
day
for
males
and
0,
13.9,
29.0,
79.8,
143.6,
or
257.0
mg/
kg/
day
for
females,
respectively.
NOAELs
of
60
mg/
kg/
day
(
males)
and
79.8
mg/
kg/
day
(
females)
were
based
on
decreases
in
body
weights
and/
or
gains;
decreased
erythrocytes,
hemoglobin
(
Hgb)
and
hematocrit
(
HCT)
values;
and
splenic
microscopic
pathology.
In
a
90
 
day
subchronic
feeding
study
in
dogs
administered
by
dietary
admix
at
doses
of
0,
10,
28,
or
57
mg/
kg/
day
for
males
and
0,
10,
28,
or
73
mg/
kg/
day
for
females,
a
NOAEL
of
28
mg/
kg/
day
was
determined
for
both
males
and
females
based
on
decreases
in
Hgb
and
HCT,
elevated
alkaline
phosphatase
levels,
increased
liver
weights
and
microscopic
liver
as
well
as
splenic
changes.
A
90
 
day
subchronic
neurotoxicity
study
in
the
rat
was
conducted
at
dietary
levels
of
30,
150,
or
265
mg/
kg/
day
in
males,
and
37,
180,
or
292
mg/
kg/
day
in
females,
with
a
NOAEL
of
30
mg/
kg/
day
in
males
and
37
mg/
kg/
day
in
females.
The
LOAEL
was
150
mg/
kg/
day
for
males
and
180
mg/
kg/
day
for
females
based
on
increased
incidences
of
clinical
signs,
decreased
body
weights,
body
weight
gains,
and
food
consumption
in
females
and
increased
motor
activity
in
females
at
week
13.
There
were
no
neurohistopathological
effects
on
the
peripheral
or
central
nervous
system.
5.
Chronic
toxicity.
A
12
 
month
feeding
study
in
dogs
was
dosed
at
levels
of
0.0,
24.9,
or
61.2
mg/
kg/
day
for
male
dogs
and
0.0,
10.4,
29.6,
or
61.9
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Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
mg/
kg/
day
for
female
dogs
in
the
control
through
high­
dose
groups,
respectively,
with
a
NOAEL
of
24.9
mg/
kg/
day
for
males
and
29.6
mg/
kg/
day
for
females
based
on
hematology
effects
and
microscopic
liver
changes.
An
18
 
month
feeding/
carcinogenicity
study
in
mice
was
conducted
with
dietary
intake
of
0,
46.6,
93.9,
160.5,
or
337.6
mg/
kg/
day
for
males
and
0,
58.0,
116.9,
198.0,
or
407.1
mg/
kg/
day
for
females.
A
NOAEL
of
93.9
mg/
kg/
day
in
males
and
116.9
mg/
kg/
day
in
females
was
based
on
decreases
in
Hgb
and
HCT.
There
were
no
treatment­
related
increases
in
tumors
of
any
kind
observed
at
any
dose
level.
In
a
24
 
month
chronic
feeding/
carcinogenicity
study
in
rats
at
dietary
doses
of
0,
24.3,
40.0,
82.8,
or
123.5
mg/
kg/
day
for
males
and
20.0,
36.4,
67.0,
or
124.7
mg/
kg/
day
for
females,
an
overall
NOAEL
of
40.0
mg/
kg/
day
in
males
and
36.4
mg/
kg/
day
in
females
was
based
on
hematology
effects
and
reduced
body
weights.
There
was
no
evidence
of
a
carcinogenic
response.
6.
Animal
metabolism.
A
metabolism
study
in
rats
indicated
that
approximately
84
to
104%
of
the
orally
administered
dose
of
sulfentrazone
was
excreted
in
the
urine,
and
that
the
pooled
urinary
radioactivity
consisted
almost
entirely
of
3­
hydroxymethyl
sulfentrazone.
Pooled
fecal
radioactivity
showed
that
the
major
metabolite
consisted
of
3­
hydroxymethylsulfentrazone
(
1.26
to
2.55%
of
the
administered
dose).
The
proposed
metabolic
pathway
appeared
to
be
conversion
of
the
parent
compound
mainly
to
3­
hydroxymethylsulfentrazone
(
excreted
in
urine
and
feces).
7.
Endocrine
disruption.
An
evaluation
of
the
potential
effects
on
the
endocrine
systems
of
mammals
has
not
been
determined;
however,
no
evidence
of
such
effects
were
reported
in
the
chronic
or
reproductive
toxicology
studies
described
above.
There
was
no
observed
pathology
of
the
endocrine
organs
in
these
studies.
There
is
no
evidence
at
this
time
that
sulfentrazone
causes
endocrine
effects.

C.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food.
A
Tier
3
short­
term
exposure
analysis
has
been
performed
to
estimate
the
exposure
for
all
adults,
adult
females,
and
toddlers
(
3
to
4
years
of
age)
in
the
U.
S.
population
for
these
raw
commodities
and
processed
commodities.
This
analysis
utilized
Novigen's
(
Novigen
Sciences,
Inc.)
Dietary
Exposure
Evaluation
Model
(
DEEM)
software;
field
trial
data
for
registered
and
pending
crop
uses;
percent
crop
treated
information;
and
consumption
data
from
the
United
States
Department
of
Agriculture
(
USDA)
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFIIs),
conducted
from
1994
 
1996.
ii.
Drinking
water.
A
Tier
1
short­
term
drinking
water
exposure
assessment
was
conducted
to
determine
exposure
risk
of
sulfentrazone
residues
from
consumption
of
water.
This
analysis
was
performed
utilizing
EPA's
Standard
Operating
Procedure
(
SOP)
for
Drinking
Water
Exposure
Risk
Assessments
(
DUS
EPA,
1997b),
the
absorbed
(
systemic)
aggregate
exposure
estimates,
and
water
data
from
FMC
Corporation
ground
water
study
conducted
in
North
Carolina.
2.
Non­
dietary
exposure.
The
primary
source
for
human
non­
dietary
exposure
to
sulfentrazone
will
be
from
postapplication
exposure
to
treated
residential
turf
grass.
The
routes
of
sulfentrazone
exposure
were
dermal
post­
application
exposure
for
adults
and
toddlers,
and
post­
application
incidental
ingestion
of
sulfentrazone
due
to
the
hand­
to­
mouth
behavior
of
toddlers.
A
worst
case
short­
term
nondietary
exposure
analysis
was
conducted
using
algorithms
and
default
factors
published
in
EPA's
SOPs
for
Residential
Exposure
Assessments.

D.
Cumulative
Effects
Cumulative
exposure
to
substances
with
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
considers
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide
residue
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
In
the
case
of
sulfentrazone,
EPA
has
determined
that
it
does
not
have
the
capability
to
apply
the
information
in
its
files
to
a
resolution
of
common
mechanism
issues
in
a
manner
that
would
be
useful
in
a
risk
assessment.
This
tolerance
determination
therefore
does
not
take
into
account
common
mechanism
issues.
The
Agency
will
reexamine
the
tolerances
for
sulfentrazone,
if
reexamination
is
appropriate,
after
the
Agency
has
determined
how
to
apply
common
mechanism
issues
to
its
pesticide
risk
assessments.

E.
Safety
Determination
1.
U.
S.
population.
The
absorbed
(
systemic)
aggregate
exposure
estimates
for
all
adults,
and
adult
females
were
found
to
be
0.0015
mg/
kg/
day
and
0.0017
mg/
kg/
day,
respectively.
The
acute
dietary
(
99.9%),
non­
dietary,
and
aggregate
margin
of
exposure
(
MOE)
for
all
adults
were
found
to
be
12,353,
7,571,
and
6,726
respectively.
The
acute
dietary
(
99.9%),
non­
dietary
and
aggregate
MOE
for
adult
females
were
22,857,
6,327,
and
5,717
respectively.
The
MOE
from
the
limited
potential
for
short­
term
exposure
from
residential
uses
was
>
1,000.
Based
on
these
assessments,
it
can
be
concluded
that
there
is
reasonable
certainty
of
no
harm
to
the
U.
S.
population
from
exposure
to
sulfentrazone.
2.
Infants
and
children.
The
absorbed
(
systemic)
aggregate
exposure
estimates
for
toddlers
were
found
to
be
0.0054
mg/
kg/
day.
The
acute
dietary
(
99.9%),
non­
dietary,
and
aggregate
MOE
for
toddlers
were
found
to
be
6,721,
2,048,
and
1,869
respectively.
The
MOE
from
the
limited
potential
for
short­
term
exposure
from
residential
uses
was
>
1,000.
Based
on
these
assessments,
it
can
be
concluded
that
there
is
reasonable
certainty
of
no
harm
to
infants
and
children
from
exposure
to
sulfentrazone.
The
calculated
drinking
water
levels
of
concern
for
all
adults,
and
adult
females
were
estimated
to
be
298
parts
per
billion
(
ppb),
250
ppb,
respectively.
These
values
exceed
the
maximum
water­
monitoring
residue
of
42
ppb
(
from
the
North
Carolina
study).
Therefore,
the
data
indicate
a
low
risk
potential
due
to
the
aggregate
(
food,
water
and
residential)
exposures
to
sulfentrazone
residues.

F.
International
Tolerances
There
are
no
Codex
Alimentarius
Commission
(
Codex)
maximum
residue
levels
for
sulfentrazone.
[
FR
Doc.
03
 
5319
Filed
3
 
6
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0350;
FRL
 
7285
 
8]

Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2002
 
0350,
must
be
received
on
or
before
April
7,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
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