Document ID: EPA-HQ-OPP-2003-0086-0001
Agency: epa
Document Type: Notice
Title: Methoxyfenozide; Notice of Filing Pesticide Petitions to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-03-21T05:00Z

13917
Federal
Register
/
Vol.
68,
No.
55
/
Friday,
March
21,
2003
/
Notices
In
this
meeting,
the
EC
plans
to
review
a
report
from
its
Science
and
Technology
Review
Panel
(
S&
TRP)
(
EC)
­
Review
of
the
FY2004
Science
and
Technology
(
S&
T)
Budget:
An
SAB
Report.
The
background
materials
used
by
the
Review
Panel
in
its
original
deliberations
are
available
from
the
originating
EPA
Office,
(
for
further
information
see
67
FR
79912,
December
31,
2002,
http://
www.
epa.
gov/
fedrgstr/
EPA
 
MEETINGS/
2002/
December/
Day­
31/
m32987.
htm.)
General
information
about
the
EPA
Science
Advisory
Board,
may
be
found
on
the
SAB
Web
site
(
http://
www.
epa.
gov/
sab).
2.
Requests
for
Comment:
Requests
for
oral
comments
must
be
in
writing
(
email
fax
or
mail)
and
received
by
Mr.
Flaak
no
later
than
noon
eastern
standard
time
on
April
4,
2003.
Written
comments
should
also
be
sent
to
Mr.
Flaak
prior
to
the
meeting.
Submission
of
written
comments
by
e­
mail
to
Mr.
Flaak
will
maximize
the
time
available
for
review
by
the
EC.
3.
Availability
of
Review
Materials:
A
draft
of
the
SAB
report
listed
above
will
be
available
to
the
public
at
the
SAB
Web
site
under
the
heading
for
the
EC
Public
Teleconference,
April
10,
2003,
(
http://
www.
epa.
gov/
sab/
whatsnew.
htm)
approximately
one
week
prior
to
the
meeting.
4.
Charge
to
the
Executive
Committee:
The
focus
of
the
EC
review
of
this
report
will
be
on
the
following
questions:
(
a)
Has
the
SAB
adequately
responded
to
the
questions
posed
in
the
charge?
(
b)
Are
the
statements
and/
or
responses
in
the
draft
report
clear?
And
(
c)
are
there
any
errors
of
fact
in
the
report?
5.
General
Guidance
on
Providing
Oral
or
Written
Comments
at
SAB
Meetings:
It
is
the
policy
of
the
EPA
Science
Advisory
Board
to
accept
written
public
comments
of
any
length,
and
to
accommodate
oral
public
comments
whenever
possible.
The
EPA
Science
Advisory
Board
expects
that
public
statements
presented
at
its
meetings
will
not
be
repetitive
of
previously
submitted
oral
or
written
statements.
Oral
Comments:
In
general,
each
individual
or
group
requesting
an
oral
presentation
at
a
face­
to­
face
meeting
will
be
limited
to
a
total
time
of
10
minutes
(
unless
otherwise
indicated
above).
For
teleconference
meetings,
opportunities
for
oral
comment
will
usually
be
limited
to
no
more
than
three
minutes
per
speaker
and
no
more
than
15
minutes
total.
Deadlines
for
getting
on
the
public
speaker
list
for
a
meeting
are
given
above.
Speakers
should
bring
at
least
35
copies
of
their
comments
and
presentation
slides
for
distribution
to
the
reviewers
and
public
at
the
face­
toface
meetings.
Written
Comments:
Although
the
SAB
accepts
written
comments
until
the
date
of
the
meeting
(
unless
otherwise
stated),
written
comments
should
be
received
in
the
SAB
Staff
Office
at
least
one
week
prior
to
the
meeting
date
so
that
the
comments
may
be
made
available
to
the
committee
for
their
consideration.
Comments
should
be
supplied
to
the
appropriate
DFO
at
the
address/
contact
information
noted
above
in
the
following
formats:
one
hard
copy
with
original
signature,
and
one
electronic
copy
via
e­
mail
(
acceptable
file
format:
WordPerfect,
Word,
or
Rich
Text
files
(
in
IBM­
PC/
Windows
95/
98
format).
Those
providing
written
comments
and
who
attend
face­
to­
face
meeting
are
also
asked
to
bring
35
copies
of
their
comments
for
public
distribution.

Dated:
March
17,
2003.
Vanessa
T.
Vu,
Director,
EPA
Science
Advisory
Board
Staff
Office.
[
FR
Doc.
03
 
6819
Filed
3
 
20
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0086;
FRL
 
7297
 
1]

Methoxyfenozide;
Notice
of
Filing
Pesticide
Petitions
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
 
0086,
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:
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:
 
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
identification
(
ID)
number
OPP
 
2003
 
0086.
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
VerDate
Jan<
31>
2003
18:
05
Mar
20,
2003
Jkt
200001
PO
00000
Frm
00026
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
21MRN1.
SGM
21MRN1
13918
Federal
Register
/
Vol.
68,
No.
55
/
Friday,
March
21,
2003
/
Notices
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
 
0086.
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
 
0086.
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
 
0086.
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
 
0086.
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
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Federal
Register
/
Vol.
68,
No.
55
/
Friday,
March
21,
2003
/
Notices
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
13,
2003.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summaries
of
Petitions
The
petitioner
summaries
of
the
pesticide
petitions
are
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summaries
of
the
petitions
were
prepared
by
the
petitioners
and
represent
the
views
of
the
petitioners.
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
4
(
IR­
4)

PP
3E6527,
3E6528,
and
3E6533
EPA
has
received
pesticide
petitions
3E6527,
3E6528,
and
3E6533
from
the
Interregional
Research
Project
Number
4
(
IR­
4),
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390
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
methoxyfenozide
in
or
on
the
raw
agricultural
commodities
(
RAC):
Vegetable,
cucurbit,
group
9
at
0.3
parts
per
million
(
ppm)
(
3E6527),
pea,
blackeyed,
seed
and
pea,
southern,
seed
at
4.0
ppm
(
3E6528),
okra
at
2.0
ppm
(
3E6533),
and
turnip,
greens
at
30
ppm
(
3E6533).
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
a
summary
of
the
petitions
prepared
by
Rohm
and
Haas
Company,
100
Independence
Mall
West,
Philadelphia,
PA
19106
 
2399.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
qualitative
nature
of
methoxyfenozide
residues
in
plants
and
animals
is
adequately
understood
and
was
previously
published
in
the
Federal
Register
of
July
5,
2000
(
65
FR
41355)
(
FRL
 
6497
 
5).
2.
Analytical
method.
Adequate
enforcement
methods
are
available
for
determination
of
methoxyfenozide
residues
in
plant
commodities.
The
available
Analytical
Enforcement
Methodology
was
previously
reviewed
in
the
Federal
Register
of
(
September
20,
2002
67
FR
59193).
3.
Magnitude
of
residues.
Complete
residue
data
for
methoxyfenozide
on
okra;
turnip
greens;
cucurbit
vegetables;
pea,
blackeyed;
and
pea,
southern
have
been
submitted.
The
requested
tolerances
are
adequately
supported.
B.
Toxicological
profile
The
toxicological
profile
and
endpoints
for
methoxyfenozide
which
supports
this
petition
to
establish
tolerances
were
previously
published
in
the
Federal
Register
of
September
20,
2002
(
67
FR
59193)
(
FRL
 
7198­
5).

C.
Aggregate
Exposure
1.
Dietary
exposure.
Assessments
were
conducted
to
evaluate
potential
risks
due
to
chronic
and
acute
dietary
exposure
of
the
U.
S.
population
subgroups
to
residues
of
methoxyfenozide.
These
analysis
cover
all
registered
crops,
as
well
as,
uses
pending
with
the
Agency,
active
and
proposed
section
18
uses,
and
proposed
IR­
4
minor
uses.
There
are
no
registered
residential
nonfood
uses
of
methoxyfenozide.
i.
Food
 
a.
Acute
exposure.
No
appropriate
toxicological
endpoint
attributable
to
a
single
exposure
was
identified
in
the
available
toxicology
studies
on
methoxyfenozide
including
the
acute
neurotoxicity
study
in
rats,
the
developmental
toxicity
study
in
rats
and
the
developmental
toxicity
study
in
rabbits.
Since
no
acute
toxicological
endpoints
were
established,
Dow
AgroSciences
considers
acute
aggregate
risk
to
be
negligible.
b.
Chronic
exposure.
Dow
AgroSciences
assumed
100%
of
crops
would
be
treated
and
contain
methoxyfenozide
residues
at
the
tolerance
level.
Dow
AgroSciences
used
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM,
Novigen
Sciences,
Washington,
DC)
software
for
conducting
a
chronic
dietary
(
food)
risk
analysis.
DEEMTM
is
a
dietary
exposure
analysis
system
that
is
used
to
estimate
exposure
to
a
pesticide
chemical
in
foods
comprising
the
diets
of
the
U.
S.
population,
including
population
subgroups.
DEEMTM
contains
food
consumption
data
as
reported
by
respondents
in
the
Department
of
Agriculture
(
USDA)
continuing
surveys
of
food
intake
by
individuals
conducted
in
1994
 
1996.
ii.
Drinking
water
 
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.
ii.
Chronic
exposure.
Tier
II
screening­
level
assessments
can
be
conducted
suing
the
simulation
models
screening
constration
in
ground
water
(
SCI­
GROW)
and
EPA's
pesticide
root
zone
model/
exposure
analysis
modeling
system
(
PRZM/
EXAMS)
to
generate
estimated
environmental
concentrations
(
EECs)
for
ground
water
and
surface
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55
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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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