Document ID: EPA-HQ-OPP-2003-0049-0001
Agency: epa
Document Type: Notice
Title: Tralkoxydim; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-03-21T05:00Z

13920
Federal
Register
/
Vol.
68,
No.
55
/
Friday,
March
21,
2003
/
Notices
water,
respectively.
The
modeling
was
conducted
based
on
the
environmental
profile
and
the
maximum
seasonal
application
rate
proposed
for
methoxyfenozide
(
1.0
lb
active
ingredient/
acre/
season).
PRZM/
EXAMS
was
used
to
generate
the
surface
water
EECs,
because
it
can
factor
the
persistent
nature
of
the
chemical
into
the
estimates.
The
EECs
for
assessing
chronic
aggregate
dietary
risk
used
by
the
Agency
are
6
parts
per
billion
(
ppb)
in
ground
water,
based
on
SCI­
GROW
and
98.5
ppb
in
surface
water,
based
on
the
PRZM/
EXAMS,
long­
term
mean.
2.
Non­
dietary
exposure.
Methoxyfenozide
is
not
currently
registered
for
use
on
any
residential
non­
food
sites.
Therefore,
there
is
no
non­
dietary
acute,
chronic,
short­
term
or
intermediate­
term
exposure.

D.
Cumulative
Effects
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
methoxyfenozide
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
methoxyfenozide
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
it
is
assumed
that
methoxyfenozide
does
not
have
a
common
mechanism
of
toxicity
with
other
substances.

E.
Safety
Determination
1.
U.
S.
population.
Using
the
DEEMTM
exposure
assumptions
described
in
this
unit,
Dow
AgroSciences
has
concluded
that
aggregate
exposure
to
methoxyfenozide
from
the
proposed
new
tolerances
will
utilize
18.9%
of
the
chronic
pollution
adjusted
dose
(
cPAD)
for
the
U.
S.
population.
The
major
identifiable
subgroup
with
the
highest
aggregate
exposure
is
children
1
 
6
years
old
at
37.6%
of
the
cPAD
and
is
discussed
below.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
cPAD
because
the
cPAD
represents
the
level
at
or
below
which
daily
aggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
Despite
the
potential
for
exposure
to
methoxyfenozide
in
drinking
water,
the
aggregate
exposure
is
not
expected
to
exceed
100%
of
the
cPAD.
Dow
AgroSciences
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
methoxyfenozide
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
(
UF)
usually
100
for
combine
inter­
species
and
intra­
species
variability
and
not
the
additional
tenfold
MOE/
UF
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.
The
toxicology
data
base
for
methoxyfenozide
included
acceptable
developmental
toxicity
studies
in
both
rats
and
rabbits
as
well
as
a
2­
generation
reproductive
toxicity
study
in
rats.
The
data
provided
no
indication
of
increased
sensitivity
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure
to
methoxyfenozide.
There
is
a
complete
toxicity
data
base
for
methoxyfenozide
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
Based
on
the
completeness
of
the
data
base
and
the
lack
of
prenatal
and
postnatal
toxicity,
EPA
determined
that
an
additional
safety
factor
was
not
needed
for
the
protection
of
infants
and
children.
Since
no
toxicological
endpoints
were
established,
acute
aggregate
risk
is
considered
to
be
negligible.
Using
the
exposure
assumptions
described
in
this
unit,
Dow
AgroSciences
has
concluded
that
aggregate
exposure
to
methoxyfenozide
from
the
proposed
new
tolerances
will
utilize
37.6%
of
the
cPAD
for
infants
and
children.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
cPAD
because
the
cPAD
represents
the
level
at
or
below
which
daily
aggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
Drinking
water.
The
back­
calculated
drinking
water
levels
of
concern
(
DWLOCs)
for
assessing
chronic
aggregate
dietary
risk
range
from
624
ppb
for
the
most
highly
exposed
population
subgroup
children
(
1
to
6)
years
old
to
2,839
ppb
for
the
U.
S.
population
(
48
contiguous
States)
(
all
seasons).
Despite
the
potential
for
exposure
to
methoxyfenozide
in
drinking
water,
Dow
AgroSciences
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD.
Short­
term
and
intermediate­
term
risks
are
judged
to
be
negligible
due
to
the
lack
of
significant
toxicological
effects
observed.
Based
on
these
risk
assessments,
Dow
AgroSciences
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
methoxyfenozide
residues.

F.
International
Tolerances
There
are
no
Codex
or
Canadian
maximum
residue
levels
(
MRL's)
established
for
residues
of
methoxyfenozide.
Mexican
MRL's
are
established
for
residues
of
methoxyfenozide
in
cottonseed
0.05
ppm
and
maize
0.01
ppm.
The
U.
S.
tolerances
on
these
commodities
are
2.0
ppm
and
0.05
ppm,
respectively.
Based
on
the
current
use
patterns,
the
U.
S.
tolerance
levels
cannot
be
reduced
to
harmonize
with
the
Mexican
MRL's,
so
incompatibility
will
exist.
[
FR
Doc.
03
 
6821
Filed
3
 
20
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0049;
FRL
 
7295
 
5]

Tralkoxydim;
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
 
0049,
must
be
received
on
or
before
April
21,
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.

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13921
Federal
Register
/
Vol.
68,
No.
55
/
Friday,
March
21,
2003
/
Notices
FOR
FURTHER
INFORMATION
CONTACT:
Jim
Tompkins,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5697;
e­
mail
address:
tompkins.
jim@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

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

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

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0049.
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
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SGM
21MRN1
13922
Federal
Register
/
Vol.
68,
No.
55
/
Friday,
March
21,
2003
/
Notices
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2003
 
0049.
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
 
0049.
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
 
0049.
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
 
0049.
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
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
record
keeping
requirements.

Dated:
March
13,
2003.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner's
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
the
petitioner
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.

Syngenta
Crop
Protection,
Inc.

PP
6F4631
EPA
has
received
a
pesticide
petition
(
6F4631)
from
Syngenta
Crop
Protection,
Inc.,
P.
O.
Box
18300,
Greensboro,
NC,
27419
 
8300
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
by
establishing
a
tolerance
for
residues
of
tralkoxydim,
2­
Cyclohexen­
1­
one,
2­[
1­
(
ethoxyimino)
propyl]­
3­
hydroxy­
5­
(
2,4,6­
trimethylphenyl)­(
9Cl),
in
or
on
the
raw
agricultural
commodity
(
RAC)
barley
grain,
barley
hay,
wheat
grain,
and
wheat
hay
at
0.02
parts
per
million
(
ppm)
and
barley
straw,
wheat
forage,
and
wheat
straw
at
0.05
ppm.
EPA
has
determined
that
the
petition
contains
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
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
nature
of
the
residue
in
barley,
wheat,
rotational
crops,
and
livestock
is
adequately
understood.
The
residues
of
concern
for
the
tolerance
expression
are
parent
per
se.
Based
on
the
results
of
animal
metabolism
studies
it
is
unlikely
that
secondary
residues
would
occur
in
animal
commodities
from
the
use
of
tralkoxydim
on
wheat
and
barley.
Tralkoxydim
rapidly
metabolizes
in
plants,
and
no
residues
of
parent
are
detected
at
harvest.
Extensive
metabolism
in
grain,
forage
and
straw
occurs,
with
none
of
the
individual
metabolites
exceeding
3.6%
total
radioactive
residue
(
TRR).

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E:\
FR\
FM\
21MRN1.
SGM
21MRN1
13923
Federal
Register
/
Vol.
68,
No.
55
/
Friday,
March
21,
2003
/
Notices
2.
Analytical
method.
An
adequate
analytical
method,
gas
chromatography/
mass
spectrometry
(
GC/
MS)
with
selected
ion
monitoring,
is
available
for
enforcement
purposes.
3.
Magnitude
of
residues.
Magnitude
of
the
residue
trials
conducted
on
spring
wheat,
winter
wheat,
and
barley
showed
no
residues
above
the
limit
of
quantification
((
LOQ)
=
0.02
ppm)
on
wheat
grain,
straw,
hay,
or
processed
commodities
at
the
harvest
timing
prescribed
by
the
label.
Residues
in
forage
ranged
from
<
0.02
ppm
to
0.03
ppm
at
28
days
posttreatment.
Based
on
the
results
of
animal
metabolism
studies,
it
is
unlikely
that
significant
residues
would
occur
in
secondary
animal
commodities
from
the
use
of
tralkoxydim
on
wheat
and
barley.
The
nature
of
the
residue
in
plants
is
adequately
understood.

B.
Toxicological
Profile
1.
Acute
toxicity.
EPA
has
established
an
acute
reference
dose
(
RfD)
for
tralkoxydim
of
0.3
milligrams/
kilogram/
day
(
mg/
kg/
day).
This
RfD
is
based
on
the
no
observed
adversed
effect
level
(
NOAEL)
of
30
mg/
kg/
day
established
in
the
rat
developmental
study
and
using
an
uncertainty
factor
(
UF)
of
100
based
on
10X
for
inter­
species
extrapolation
and
10X
for
intra­
species
variation.
2.
Genotoxicity.
Tralkoxydim
was
negative
for
mutagenic/
genotoxic
effects
in
a
gene
mutation
Ames
Assay
in
bacteria,
a
forward
gene
mutation
in
mouse
lymphoma
cells
in
culture,
chromosome
damage/
in
vitro
assay
in
human
lymphocyte
cells,
deoxyribonucleic
acid
(
DNA)
damage
repair
in
vivo
assay
in
rat
hepatocytes,
and
chromosome
damage
in
vivo
mouse
micronuclei.
3.
Reproductive
and
developmental
toxicity.
The
developmental
and
reproductive
toxicity
data
do
not
indicate
increased
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure
to
tralkoxydim.
A
3
 
generation
rat
reproduction
study
indicated
a
parental
systemic
NOAEL
of
200
ppm,
20
mg/
kg/
day
and
a
systemic
lowest
observed
averse
effect
level
(
LOAEL)
of
1,000
ppm,
100
mg/
kg/
day
based
on
reduced
body
weights
and
body
weight
gains
in
females.
No
reproductive
toxicity
was
observed.
A
rat
developmental
study
with
a
maternal
NOAEL
of
30
mg/
kg/
day
and
with
a
maternal
LOAEL
of
200
mg/
kg/
day
based
on
maternal
mortality,
reduced
body
weights,
and
reduced
food
consumption
and
a
developmental
NOAEL
of
30
mg/
kg/
day
and
a
developmental
LOAEL
of
200
mg/
kg/
day
based
on
reduced
ossification
of
the
centrum
and
hemicentrum,
centrum
bipartite,
misshapen
centra
and
fused
centra.
A
rabbit
developmental
study
with
a
maternal
NOAEL
of
20
mg/
kg/
day
and
a
maternal
LOAEL
of
100
mg/
kg/
day
based
on
reduced
food
consumption
and
a
developmental
NOAEL
of
20
mg/
kg/
day
and
a
developmental
LOAEL
of
100
mg/
kg/
day
based
on
abortions
and
increases
in
late
resorptions.
4.
Subchronic
toxicity.
Tralkoxydim
is
of
low
subchronic
toxicity
in
21
 
day
dermal
testing.
5.
Chronic
toxicity.
EPA
has
established
the
RfD
for
tralkoxydim
at
0.005
mg/
kg/
day.
This
RfD
is
based
on
NOAEL
of
0.5
mg/
kg/
day
in
the
chronic
toxicity
study
in
dogs
with
a
100
 
fold
UF
to
account
for
interspecies
extrapolation
(
10x)
and
intraspecies
variability
(
10x).
The
Health
Effects
Division
(
HED)
Cancer
Assessment
Review
Committee
(
CARC)
has
classified
tralkoxydim
in
accordance
with
the
Agency's
Proposed
Guidelines
for
Carcinogen
Risk
Assessment
(
April
10,
1996),
``
likely
to
being
human
carcinogen.''
This
classification
is
based
on
the
following
factors:
 
Occurrence
of
benign
Leydig
cell
tumors
at
all
dose
levels
with
the
incidences
at
the
high
dose
exceeding
the
concurrent
and
historical
control
range.
 
Lack
of
an
acceptable
carcinogenicity
study
in
a
second
species
as
required
by
OPPTS
Harmonized
Guidelines.
 
The
relevance
of
the
testicular
tumors
to
human
exposure
can
not
be
discounted.
6.
Animal
metabolism.
Based
on
the
results
of
animal
metabolism
studies
it
is
unlikely
that
significant
residues
would
occur
in
secondary
animal
commodities
from
the
use
of
tralkoxydim
on
wheat
and
barley.
7.
Metabolite
toxicology.
The
nature
of
the
residue
in
barley,
wheat,
rotational
crops,
and
livestock
is
adequately
understood.
The
residues
of
concern
for
the
tolerance
expression
are
parent
per
se.
8.
Endocrine
disruption.
There
has
been
no
evidence
of
endocrine
disruption
concerns
with
resulting
from
tralkoxydim
use
on
wheat
and
barley.

C.
Aggregate
Exposure
1.
Dietary
exposure.
The
proposed
tolerances
in
or
on
RACs:
Barley
grain,
barley
hay,
wheat
grain,
and
wheat
hay
at
0.02
ppm,
and
barley
straw,
wheat
forage,
and
wheat
straw
at
0.05
ppm
are
the
first
to
be
established
for
tralkoxydim.
There
is
no
reasonable
expectation
of
residues
of
tralkoxydim
occurring
in
meat,
milk,
poultry,
or
eggs
from
its
use
on
wheat
and
barley.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
tralkoxydim
as
follows:
i.
Acute
exposure
and
risk.
Acute
dietary
risk
assessments
are
performed
for
a
food­
use
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
1
 
day
or
single
exposure.
An
acute
dietary
risk
assessment
was
conducted
for
tralkoxydim
based
on
the
NOAEL
of
30
milligram/
kilogram/
day
(
mg/
kg/
day)
from
the
rat
developmental
study.
The
acute
dietary
analysis
using
the
dietary
exposure
evaluation
model
(
DEEM)
computer
program
estimates
that
the
distribution
of
single­
day
exposures
utilizes
0.02%
of
acute
RfD.
ii.
Chronic
exposure
and
risk.
The
RfD
for
tralkoxydim
is
0.005
mg/
kg/
day.
This
value
is
based
on
the
systemic
NOAEL
of
0.5
mg/
kg/
day
in
the
dog
chronic
feeding
study
with
a
100
 
fold
safety
factor
to
account
for
interspecies
extrapolation
(
10x)
and
intraspecies
variability
(
10x).
iii.
Food.
A
DEEM
chronic
exposure
analysis
was
conducted
using
tolerance
levels
for
wheat
and
barley
and
assuming
that
100%
of
the
crop
is
treated
to
estimate
dietary
exposure
for
the
general
population
and
22
subgroups.
The
chronic
analysis
showed
that
exposures
from
the
tolerance
level
residues
in
or
on
wheat,
and
barley
for
children
1
to
6
years
old
(
the
subgroup
with
the
highest
exposure)
would
be
1.4%
of
the
RfD.
The
exposure
for
the
general
U.
S.
population
would
be
less
than
1%
of
the
RfD.
A
lifetime
dietary
carcinogenicity
exposure
analysis
was
conducted
for
tralkoxydim
using
the
proposed
tolerances
along
with
the
assumption
of
100%
of
the
crop
treated
and
a
Q*
of
1.68
x
10­
2
(
mg/
kg/
day)­
1.
A
lifetime
risk
exposure
analysis
was
also
conducted
using
the
DEEM
computer
analysis.
The
estimated
cancer
risk
(
5
x
10­
7)
is
less
than
the
level
that
the
Agency
usually
considers
for
negligible
cancer
risk
estimates.
iv.
Drinking
water.
Drinking
water
estimated
concentrations
(
DWECs)
for
surface
water
(
parent
tralkoxydim)
were
calculated
by
EPA's
pesticide
root
zone
model
(
PRIZM)
computer
models
to
be
an
average
of
9.1
parts
per
billion
(
ppb).
the
DWECs
for
ground
water
based
on
the
computer
model
screening
concentration
in
ground
water
(
SCIGROW2
were
calculated
to
be
an
average
of
.016
ppb.
2.
Non­
dietary
exposure.
There
are
no
non­
food
uses
of
tralkoxydim
currently
registered
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA),
as
amended.
No
non­
dietary
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Federal
Register
/
Vol.
68,
No.
55
/
Friday,
March
21,
2003
/
Notices
exposures
are
expected
for
the
general
population.

D.
Cumulative
Effects
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
tralkoxydim
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Tralkoxydim
is
structurally
a
cyclohexanedione.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
tralkoxydim
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
these
tolerances
action,
therefore,
EPA
has
not
assumed
that
tralkoxydim
has
a
common
mechanism
of
toxicity
with
other
substances.

E.
Safety
Determination
1.
U.
S.
population
 
i.
Acute
risk.
The
acute
dietary
analysis
based
on
the
NOAEL
of
30
mg/
kg/
day
from
the
rat
developmental
study
using
the
DEEM
computer
program
estimates
that
the
distribution
of
single­
day
exposures
utilizes
0.02%
of
acute
RfD.
The
drinking
water
level
of
comparisons
(
DWLOCs)
for
acute
exposure
to
tralkoxydim
in
drinking
water
calculated
for
females
13
+
years
old
was
9,000
ppb.
The
estimated
average
concentration
in
surface
water
for
tralkoxydim
is
9
ppb.
EPA's
acute
DWLOC
is
well
above
the
estimated
exposures
for
tralkoxydim
in
water
for
the
subgroup
of
concern.
For
ground
water,
the
estimated
environmental
concentrations
(
EEC's)
using
the
SCIGROW
model
were
all
less
than
1
ppb.
ii.
Chronic
risk.
A
DEEM
chronic
exposure
analysis
showed
that
exposure
from
tolerance
level
residues
in
or
on
wheat,
and
barley
for
children
1
to
6
years
old
(
the
subgroup
with
the
highest
exposure)
would
be
1.4%
of
the
RfD.
The
exposure
for
the
general
U.
S.
population
would
be
less
than
1%
of
the
RfD.
The
DWLOCs
for
chronic
exposure
to
tralkoxydim
in
drinking
water
calculated
for
U.
S.
population
was
150
ppb
and
for
children
(
1
to
6
years
old)
the
DWLOC
was
50
ppb.
The
estimated
average
concentration
in
surface
water
for
tralkoxydim
is
9
ppb.
EPA's
chronic
DWLOC
is
above
the
estimated
exposures
for
tralkoxydim
in
water
for
the
U.
S.
population
and
the
subgroup
of
concern.
Conservative
model
estimates
SCI­
GROW
of
the
concentrations
of
tralkoxydim
in
ground
water
indicate
that
exposure
will
be
minimal.
iii.
Cancer
risk.
A
DWLOC
for
cancer
was
calculated
as
1
ppb.
The
estimated
concentration
in
surface
water
and
ground
water
for
tralkoxydim
for
chronic
exposure
are
0.9
ppb,
2.8
ppb,
(
the
56
 
day
concentration)/
3,
and
0.1
ppb,
respectively.
The
model
exposure
estimates
are
less
than
the
cancer
DWLOC.
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
tralkoxydim
residues.
2.
Infants
and
children.
The
Agency
concluded
that
an
extra
safety
factor
to
protect
infants
and
children
is
not
needed
based
on
the
following
considerations:
The
toxicology
data
base
is
complete
for
the
assessment
of
special
sensitivity
of
infants
and
children.
The
developmental
and
reproductive
toxicity
data
do
not
indicate
increased
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure.
The
NOAEL
used
in
deriving
the
RfD
is
based
on
changes
in
liver
function
and
morphology
in
male
adult
dogs
(
not
developmental
or
neurotoxic
effects)
after
chronic
exposure
and
thus
are
not
relevant
for
enhanced
sensitivity
to
infants
and
children.
Unrefined
dietary
exposure
estimates
(
assuming
all
commodities
contain
tolerance
level
residues)
overestimate
dietary
exposure.
Model
data
used
for
ground
water
and
surface
water
source
drinking
water
exposure
assessments
result
in
estimates
considered
to
be
upper­
bound
concentrations.
There
are
no
registered
uses
for
tralkoxydim
that
could
result
in
residential
exposures.
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
children
from
aggregate
exposure
to
tralkoxydim
residues.

F.
International
Tolerances
There
are
no
codex
Alimentarius
Commission
(
Codex)
or
Mexican
maximum
residue
levels
for
tralkoxydim
at
this
time.
[
FR
Doc.
03
 
6823
Filed
3
 
20
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0057;
FRL
 
7296
 
6]

Trifloxysulfuron­
sodium;
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
 
0057,
must
be
received
on
or
before
April
21,
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:
James
A.
Tompkins,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5697;
e­
mail
address:
tompkins.
jim@
epa.
gov.
SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?
You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
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
 
0057.
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
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