Document ID: EPA-HQ-OPP-2003-0052-0001
Agency: epa
Document Type: Notice
Title: Tebufenozide; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide       Chemical in or on Food
Posted Date: 2003-03-12T05:00Z

11846
Federal
Register
/
Vol.
68,
No.
48
/
Wednesday,
March
12,
2003
/
Notices
strains
each
of
Salmonella
typhimurium
and
Escherichia
coli.
These
tests
showed
ultramarine
to
be
non­
toxic
and
non­
mutagenic
to
the
four
strains.
3.
Reproductive
and
developmental
toxicity.
Female
rats
were
fed
with
diets
containing
up
to
100,000
ppm
ultramarine
before
and
during
pregnancy.
There
were
no
maternal
deaths
and
the
test
report
concluded
that
ultramarine
had
no
teratogenic
activity
at
levels
from
100
to
100,000
ppm
in
the
diet.
4.
Subchronic
toxicity
 
i.
Fifteen
 
Day
test.
Ultramarine
was
administered
to
male
mice
and
female
rats
at
increasing
dose
levels
up
to
the
maximum
that
could
be
given
in
a
single
dose.
No
deaths
were
observed
in
either
species
over
a
period
of
15
days.
The
LD50
is
greater
than
10,000
mg/
kg
(
rats).
ii.
Ninety­
Day
test.
In
feeding
trials
on
rats
and
mice,
after
90
days
at
levels
of
100,000
part
per
million
(
ppm)
in
the
diet
the
effect
of
ultramarine
was
very
much
like
that
of
inert
clay
with
(
LD50)
greater
than
10,000
milligrams/
kilograms
(
mg/
kg).
5.
Chronic
toxicity.
There
are
no
reported
studies
on
chronic
toxicity
but
ultramarine
has
a
history
of
well
over
100
years
of
safe
manufacture
and
use
with
no
reports
of
ill
effects
of
any
kind.
In
the
early
years
of
industrial
production
the
work
force
was
subjected
to
conditions
which
would
be
totally
unacceptable
today.
Large
amounts
of
fine
ultramarine
dust
were
inhaled
and
ingested
without
any
reported
ill
effects.
In
addition
ultramarine
was
used
as
a
whitening
agent
for
sugar
in
many
parts
of
the
world,
again
with
no
reported
ill
effects.
In
Europe,
the
use
of
ultramarine
in
lipsticks
has
been
permitted
for
over
50
years.
Its
use
at
levels
up
to
0.5%
for
coloring
cattle
salt
licks
where
it
is
clearly
ingested
by
the
cattle,
has
been
permitted
for
many
years.
Ultramarine
is
also
permitted
world­
wide
for
use
in
toys
and
children's
paints
including
powder
and
finger
paints.

C.
Aggregate
Exposure
1.
Dietary
exposure.
In
the
proposed
use
of
ultramarine
as
a
seed
coating
it
will
not
come
into
contact
with
the
grown
and
harvested
crop.
As
ultramarine
is
insoluble,
it
will
not
be
metabolized
by
the
plants
grown
from
the
treated
seed.
There
is
therefore
no
risk
of
dietary
exposure.
i.
Food.
For
the
reasons
stated
above
there
is
no
risk
that
food
produced
from
the
treated
seed
will
contain
any
ultramarine.
ii.
Drinking
water.
As
ultramarine
and
any
of
its
decomposition
products
are
insoluble
in
water
there
is
no
danger
of
any
leaching
into
water
courses
used
for
production
of
drinking
water.
2.
Non­
dietary
exposure.
The
only
anticipated
human
exposure
to
ultramarine
used
for
seed
coating
will
be
during
the
coating
process
and
any
handling
of
the
coated
seed.
Good
practice
should
ensure
minimal
contact
and
in
any
case
there
is
no
evidence
of
adverse
health
effects
from
exposure
to
ultramarine
during
over
100
years
of
production
and
use.

D.
Cumulative
Effects
As
ultramarine
and
its
decomposition
products
are
totally
insoluble
and
not
metabolized
by
plants
or
animals
there
is
no
risk
of
any
cumulative
effect.
Also,
in
the
proposed
end
use
there
is
no
risk
of
long
term
exposure
to
humans.

E.
Safety
Determination
1.
U.
S.
population.
The
use
of
ultramarine
as
a
seed
coating
does
not
pose
a
safety
concern
for
the
U.
S.
population
due
to
its
non­
toxicity
and
the
absence
of
exposure.
2.
Infants
and
children.
Infants
and
children
will
not
be
exposed
to
ultramarine
from
its
use
in
seed
coating
applications.
In
any
case,
ultramarine
is
permitted
in
the
United
States
and
world­
wide
for
use
in
children's
toys,
modeling
clay,
and
finger
paints.

F.
International
Tolerances
There
is
no
listed
threshold
limit
value
or
maximum
exposure
limit
for
ultramarine.
Normal
practice
is
to
consider
it
as
a
nuisance
dust
with
threshold
limit
value
(
TLV)
10
mg/
m3.
The
pigment
is
not
listed
as
a
dangerous
substance
in
the
European
Community
or
any
similar
national
or
international
classification;
neither
is
it
classified
as
hazardous
for
disposal.

[
FR
Doc.
03
 
5751
Filed
3
 
11
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0052;
FRL
 
7295
 
4]

Tebufenozide;
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
 
2003
 
0052,
must
be
received
on
or
before
April
11,
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
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Industry
(
NAICS
111)
 
Crop
production
(
NAICS
112)
 
Animal
production
(
NAICS
311)
 
Food
manufacturing,
and
Pesticide
manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
ID
number
OPP
 
2003
 
0052.
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
VerDate
Jan<
31>
2003
15:
39
Mar
11,
2003
Jkt
200001
PO
00000
Frm
00047
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
12MRN1.
SGM
12MRN1
11847
Federal
Register
/
Vol.
68,
No.
48
/
Wednesday,
March
12,
2003
/
Notices
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
on
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
 
0052
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
 
0052.
In
contrast
to
EPA's
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
 
0052.
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
 
0052.
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
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Notices
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
a
pesticide
petition
as
follows
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
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
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
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

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

Dated:
March
4,
2003.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petitions
The
petitioner's
summary
of
the
pesticide
petitions
are
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petitions
was
prepared
by
Interregional
Research
Project
Number
4
(
IR­
4),
and
represents
the
view
of
the
petitioner.
The
petition
summary
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
(
IR­
4)

PP
2E6397
and
2E6413
EPA
has
received
pesticide
petitions
(
2E6397
and
2E6413)
from
the
Interregional
Research
Project
Number
4
(
IR­
4),
681
U.
S.
Highway.
#
1
South,
North
Brunswick,
NJ
08902
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
by
establishing
tolerances
for
residues
of
tebufenozide
in
or
on
the
raw
agricultural
commodities
vegetable,
tuberous
and
corn,
except
potato,
subgroup
at
0.01
parts
per
million
(
ppm)
(
2E6397)
and
grape
at
3.0
ppm
(
2E6413).
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.
Rohm
and
Haas
company
was
acquired
by
Dow
Agro
Sciences
LLC,
Indianapolis,
IN
46268
 
1054).

A.
Residue
Chemistry
1.
Plant
metabolism.
The
qualitative
nature
of
the
residue
in
plants
is
adequately
understood
based
upon
acceptable
apple,
sugar
beet,
and
rice
metabolism
studies.
The
Agency
has
concluded
that
the
residue
of
regulatory
concern
is
tebufenozide
per
se.
2.
Analytical
method.
High
performance
liquid
chromatographic
(
HPLC)
analytical
methods
using
ultraviolet
(
UV)
detection
have
been
validated
for
grape
and
sweet
potato.
The
methods
involve
extraction
by
blending
with
solvents,
purification
of
the
extracts
by
liquid­
liquid
partitions,
and
final
purification
of
the
residues
using
solid
phase
extraction
column
chromatography.
3.
Magnitude
of
residues.
Complete
residue
data
for
tebufenozide
on
grape
and
sweet
potato
have
been
submitted.
The
requested
tolerances
are
adequately
supported.

B.
Toxicological
Profile
1.
Acute
toxicity.
Acute
toxicity
studies
with
technical
grade:
Oral
lethal
dose
LD50
in
the
rat
is
>
5
grams
for
males
and
females
­
Toxicity
Category
IV;
dermal
LD50
in
the
rat
is
equal
to
5,000
milligrams/
kilogram
(
mg/
kg)
for
males
and
females
­
Toxicity
Category
III;
inhalation
LD50
in
the
rat
is
>
4.5
milligram/
liter
(
mg/
l)
­
Toxicity
Category
III;
primary
eye
irritation
study
in
the
rabbit
is
a
non­
irritant;
primary
skin
irritation
in
the
rabbit
>
5
mg
­
Toxicity
Category
IV.
Tebufenozide
is
not
a
sensitizer.
2.
Genotoxicty.
Several
mutagenicity
tests
were
all
negative.
These
include
an
Ames
assay
with
and
without
metabolic
activation,
an
in
vivo
cytogenetic
assay
in
rat
bone
marrow
cells,
and
in
vitro
chromosome
aberration
assay
in
Chinese
hampster
ovary
(
CHO)
cells,
a
CHO/
HGPRT
assay,
a
reverse
mutation
assay
with
E.
Coli,
and
an
unscheduled
DNA
synthesis
assay
(
UDS)
in
rat
hepatocytes.
3.
Reproductive
and
developmental
toxicity.
In
a
prenatal
developmental
toxicity
study
in
Sprague­
Dawley
rats
25/
group,
tebufenozide
was
administered
on
gestation
days
6
 
15
by
gavage
in
aqueous
methyl
cellulose
at
dose
levels
of
50,
250,
or
1,000
mg/
kg/
day
and
a
dose
volume
of
10
millilter/
kilogram
(
ml/
kg).
There
was
no
evidence
of
maternal
or
developmental
toxicity;
the
maternal
and
developmental
toxicity
no
observed
adverse
effect
level
(
NOAEL)
was
1,000
mg/
kg/
day.
In
a
prenatal
developmental
toxicity
study
conducted
in
New
Zealand
white
rabbits
20/
group,
tebufenozide
was
administered
in
5
ml/
kg
of
aqueous
methyl
cellulose
at
gavage
doses
of
50,
250,
or
1,000
mg/
kg/
day
on
gestation
days
7
 
19.
No
evidence
of
maternal
or
developmental
toxicity
was
observed;
the
maternal
and
developmental
toxicity
NOAEL
was
1,000
mg/
kg/
day.
4.
Subchronic
toxicity.
A
1
 
year
dog
feeding
study
with
a
lowest
observed
adverse
effect
level
(
LOAEL)
of
250
ppm,
9
mg/
kg/
day
for
male
and
female
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12,
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/
Notices
dogs
based
on
decreases
in
red
blood
cells
(
RBC),
hematocrit
(
HCT),
and
hemaglobin
(
HGB),
increases
in
heinz
bodies,
methemoglobin,
mean
corpuscuslar
volume
(
MCV),
mean
corpuscular
hematocrit
(
MCH),
reticulocytes,
platelets,
plasma
total
bilirubin,
spleen
weight,
and
spleen/
body
weight
ratio,
and
liver/
body
weight
ratio.
Hemotopoiesis
and
sinusoidal
engorgement
occurred
in
the
spleen,
and
hyperplasis
occurred
in
the
marrow
of
the
femur
and
sternum.
The
liver
showed
an
increased
pigment
in
the
Kupffer
cells.
The
NOAEL
for
systemic
toxicity
in
both
sexes
is
50
ppm
(
1.9
mg/
kg/
day).
5.
Chronic
toxicity.
An
18
 
month
mouse
carcinogenicity
study
with
no
carcinogenicity
observed
at
dosage
levels
up
to
and
including
1,000
ppm.
A
2
 
year
rat
carcinogenicity
with
no
carcinogenicity
observed
at
dosage
levels
up
to
and
including
2,000
ppm,
97
mg/
kg/
day
and
125
mg/
kg/
day
for
males
and
females,
respectively.
6.
Animal
metabolism.
The
pharmacokinetics
and
metabolism
of
tebufenozide
were
studied
in
female
Sprague­
Dawley
rats
(
3
 
6/
sex/
group)
receiving
a
single
oral
dose
of
3
or
250
mg/
kg
of
RH­
5992
14C
labeled
in
one
of
three
positions
(
A­
ring,
B­
ring
or
buryl
carbon).
The
extent
of
absorption
was
not
established.
The
majority
of
the
radio
labeled
material
was
eliminated
or
excreted
in
the
feces
within
48
hours;
small
amounts
(
1%
to
7%
of
the
administered
dose)
were
excreted
in
the
urine
and
only
traces
were
excreted
in
expired
air
or
remained
in
the
tissues.
There
was
no
tendency
for
bioaccumulation.
Absorption
and
excretion
were
rapid.
A
total
of
11
metabolites,
in
addition
to
the
parent
compound,
were
identified
in
the
feces;
the
parent
compound
accounted
for
96%
to
99%
of
the
administered
radioactivity
in
the
high
dose
group
and
35%
to
43%
in
the
low
dose
group.
No
parent
compound
was
found
in
the
urine;
urinary
metabolites
were
not
characterized.
The
absorption
and
metabolism
of
tebufenozide
were
studied
in
a
group
of
male
and
female
bile­
duct
cannulated
rats.
Over
a
72
hour
period,
biliary
excretion
accounted
for
30%
(
males)
to
34%
(
females)
of
the
administered
dose
while
urinary
excretion
accounted
for
about
5%
of
the
administered
dose
and
the
carcass
accounted
for
<
0.5%
of
the
administered
dose
for
both
males
and
females.
Thus
systemic
absorption
(
percent
of
dose
recovered
in
the
bile,
urine
and
carcass)
was
35%
male
to
39%
female.
The
majority
of
the
radioactivity
in
the
bile
(
20%
male
to
24%
female
of
the
administered
dose)
was
excreted
within
the
first
6
hours
post­
dosing
indicating
rapid
absorption.
Furthermore,
urinary
excretion
of
the
metabolites
was
essentially
complete
within
24
hours
post­
dosing.
A
large
amount
(
67%
female
to
70%
male)
of
the
administered
dose
was
unabsorbed
and
excreted
in
the
feces
by
72
hours.
Total
recovery
of
radioactivity
was
105%
of
the
administered
dose.
7.
Metabolite
toxicology.
A
total
of
13
metabolites
were
identified
in
the
bile;
the
parent
compound
was
not
identified,
i.
e.
unabsorbed
compound,
nor
were
the
primary
oxidation
products
seen
in
the
feces
in
the
pharmacokinetics
study.
The
proposed
metabolic
pathway
proceeded
primarily
by
oxidation
of
the
benzylic
carbons
to
alcohols,
aldehydes
or
acids.
Bile
contained
most
of
the
other
highly
oxidized
products
found
in
the
feces.
The
most
significant
individual
bile
metabolites
accounted
for
5%
to
18%
of
the
total
radioactivity
(
F
and/
or
M).
Bile
also
contained
the
previously
undetected
(
in
the
pharmacokinetics
study)
``
A''
Ring
ketone
and
the
``
B''
Ring
diol.
The
other
major
components
were
characterized
as
high
molecular
weight
conjugates.
No
individual
bile
metabolite
accounted
for
5%
of
the
total
administered
dose.
Total
bile
radioactivity
accounted
for
about
17%
of
the
total
administered
dose.
No
major
qualitative
differences
in
biliary
metabolites
were
observed
between
sexes.
The
metabolic
profile
in
the
bile
was
similar
to
the
metabolic
profile
in
the
feces
and
urine.
8.
Endocrine
disruption.
The
toxicology
profile
of
tebufenozide
shows
no
evidence
of
physiological
effects
characteristic
of
the
disruption
of
the
hormone
estrogen.
Based
on
structureactivity
information,
tebufenozide
is
unlikely
to
exhibit
estrogenic
activity.

C.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food.
Tolerances
have
been
established
(
40
CFR
180.482)
for
the
residues
of
tebufenozide,
in
or
on
a
variety
of
raw
agricultural
commodities.
The
current
petition
requests
establishment
of
tolerances
in
or
on
grape
at
3.0
ppm
and
vegetable,
tuberous
and
corn,
except
potato,
subgroup
at
0.01
ppm.
Risk
assessments
were
conducted
by
Dow
AgroSciences
to
assess
dietary
exposures
and
risks
from
tebufenozide,
benzoic
acid,
3,5­
dimethyl­
1­(
1,1­
dimethylethyl)­
2­(
4­
ethylbenzoyl)
hydrazide
as
follows:
a.
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.
Neither
neurotoxicity
nor
systemic
toxicity
was
observed
in
rats
given
a
single
oral
administration
of
tebufenozide
at
0,
500,
1,000
or
2,000
mg/
kg.
No
maternal
or
developmental
toxicity
was
observed
following
oral
administration
of
tebufenozide
at
1,000
mg/
kg/
day
(
limitdose
during
gestation
to
pregnant
rabbits.
This
risk
is
considered
to
be
negligible.
b.
Chronic
exposure.
The
reference
dose
(
RfD)
used
for
the
chronic
dietary
analysis
is
0.018
mg/
kg/
day.
In
conducting
the
dietary
exposure
evaluation
model
(
DEEM)
analysis
for
chronic
exposure
to
and
risk
from
tebufenozide
residues
in
food,
Dow
AgroSciences
used
tolerance
level
residues
for
all
crops
and
other
commodities
with
established
or
pending
tebufenozide
tolerances;
and
percent
crop­
treated
(
PCT)
information
for
some
of
these
crops.
ii.
Drinking
water
 
a.
Acute
exposure.
Because
no
acute
dietary
endpoint
was
determined,
Dow
AgroSciences
concludes
that
there
is
a
reasonable
certainty
of
no
harm
from
acute
exposure
from
drinking
water.
b.
Chronic
exposure.
The
Agency
calculated
the
Tier
I
Estimated
Environmental
Concentrations
(
EECs)
for
tebufenozide
using
generic
expected
environmental
concentration
(
GENEEC)
(
surface
water)
and
screening
concentration
in
ground
water
(
SCIGROW
(
ground
water)
models
for
use
in
the
human
health
risk
assessment.
For
chronic
exposure,
the
worst
case
EECs
for
surface
water
and
ground
water
were
16.5
parts
per
billion
(
ppb)
and
1.04
ppb,
respectively.
These
values
represent
upper­
bound
estimates
of
the
concentrations
that
might
be
found
in
surface
and
ground
water.
2.
Non­
dietary
exposure.
There
is
a
potential
for
occupational
exposure
to
tebufenozide
during
mixing,
loading
and
application
activities.
However
the
Agency
did
not
identify
dermal
or
inhalation
endpoints
for
tebufenozide
and
determined
that
risks
from
these
routes
of
exposure
are
negligible.

D.
Cumulative
Effects
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity,
Section
408(
b)(
2)(
D)(
v)
requires
that,
when
considering
whether
to
establish,
modify
or
revoke
a
tolerance,
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
tebufenozide
has
a
common
mechanism
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Federal
Register
/
Vol.
68,
No.
48
/
Wednesday,
March
12,
2003
/
Notices
of
toxicity
with
other
substances,
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
tebufenozide
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
petition,
Dow
AgroSciences
has
not
assumed
that
tebufenozide
has
a
common
mechanism
of
toxicity
with
other
substances.

E.
Safety
Determination
1.
U.
S.
population.
Using
the
exposure
assumptions
previously
described,
and
taking
into
account
the
completeness
and
reliability
of
the
toxicity
data,
Dow
AgroSciences
has
concluded
that
dietary
(
food
only)
exposure
to
tebufenozide
will
utilize
21%
of
the
chronic
population
adjusted
dose
(
cPAD)
for
the
U.
S.
population.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
cPAD.
Submitted
environmental
fate
studies
suggest
that
tebufenozide
is
moderately
persistent
to
persistent
and
mobile;
thus,
tebufenozide
could
potentially
leach
to
ground
water
and
runoff
to
surface
water
under
certain
environmental
conditions.
The
modeling
data
for
tebufenozide
indicate
levels
less
than
the
Agency's
DWLOCs.
There
are
no
chronic
non­
occupational/
residential
exposures
expected
for
tebufenozide.
Therefore,
Dow
AgroSciences
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
adults,
infants
and
children
from
chronic
aggregate
exposure
to
tebufenozide
residues.
2.
Infants
and
children.
FFDCA
section
408
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
margin
of
exposure
(
MOE)
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
EPA
believes
that
reliable
data
support
using
the
standard
uncertainty
factor
(
usually
100
for
combined
inter­
and
intra­
species
variability)
and
not
the
additional
tenfold
MOE/
uncertainty
factor
when
EPA
has
a
complete
data
base
under
existing
guidelines
and
when
the
severity
of
the
effect
in
infants
or
children
or
the
potency
or
unusual
toxic
properties
of
a
compound
do
not
raise
concerns
regarding
the
adequacy
of
the
standard
MOE/
safety
factor.
Using
the
exposure
assumptions
previously
described,
and
taking
into
account
the
completeness
and
reliability
of
the
toxicity
data,
the
dietary
(
food
only)
exposure
to
tebufenozide
will
utilize
51%
of
the
cPAD
for
the
most
highly
exposed
population
subgroup
(
children
1
 
6
years
old).
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
cPAD.
Despite
the
potential
for
exposure
to
tebufenozide
in
drinking
water
and
from
non­
dietary
nonoccupational
exposure,
Dow
AgroSciences
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
RfD.

F.
International
Tolerances
Codex
maximum
residue
levels
have
been
established
for
residues
of
tebufenozide
in/
on
pome
fruit
(
1.0
ppm),
husked
rice
(
0.1
ppm)
and
walnut
(
0.05
ppm).
Tebufenozide
is
registered
in
Canada,
and
a
tolerance
for
residues
in/
on
apples
is
established
at
1.0
ppm.
EPA
has
set
the
pome
fruit
tolerance
at
1.5
ppm
based
on
U.
S.
field
residue
trials.

[
FR
Doc.
03
 
5912
Filed
3
 
11
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0022;
FRL
 
7295
 
9]

Dimethenamid;
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
 
2003
 
0022,
must
be
received
on
or
before
April
11,
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:
Sidney
Jackson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
7610;
e­
mail
address:
jackson.
sidney@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Industry
(
NAICS
111),
e.
g.,
Crop
production.
 
Industry
(
NAICS
112),
e.
g.,
Animal
production.
 
Industry
(
NAICS
311),
e.
g.,
Food
manufacturing.
 
Industry
(
NAICS
32532),
e.
g.,
Pesticide
manufacturing.
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions
in
Unit
I.
A.
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
 
0022.
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
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