Document ID: EPA-HQ-OPP-2003-0145-0001
Agency: epa
Document Type: Notice
Title: Fenpyroximate; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-07-11T04:00Z

41345
Federal
Register
/
Vol.
68,
No.
133
/
Friday,
July
11,
2003
/
Notices
after
the
effective
date
of
the
cancellation.
Although
in
its
original
voluntary
cancellation
letter,
Bayer
requested
18
months
to
address
any
remaining
stocks,
in
subsequent
communication
with
the
Agency,
Bayer
accepted
a
12
 
month
period
for
sale
and
distribution
of
the
existing
stocks.
Existing
stocks
are
those
stocks
of
registered
pesticide
products
which
are
currently
in
the
United
States
and
which
have
been
packaged,
labeled,
and
released
for
shipment
prior
to
the
effective
date
of
the
cancellation
action.
Unless
the
provisions
of
an
earlier
order
apply,
existing
stocks
already
in
the
hands
of
dealers
or
users
can
be
distributed,
sold,
or
used
legally
until
they
are
exhausted,
provided
that
such
further
sale
and
use
comply
with
the
EPA­
approved
label
and
labeling
of
the
affected
product.
Exception
to
these
general
rules
will
be
made
in
specific
cases
when
more
stringent
restrictions
on
sale,
distribution,
or
use
of
the
products
or
their
ingredients
have
already
been
imposed,
as
in
a
Special
Review
action,
or
where
the
Agency
has
identified
significant
potential
risk
concerns
associated
with
a
particular
chemical.
In
this
case,
the
Agency
does
not
see
a
need
to
deviate
from
these
general
rules.
Unless
the
Agency
receives
substantive
comments
during
the
comment
period
that
would
merit
further
review
of
this
matter,
the
Agency
intends
to
permit
existing
stocks
already
in
the
hands
of
dealers
or
users
to
be
distributed,
sold,
or
used
until
they
are
exhausted,
provided
that
such
further
sale
and
use
comply
with
the
EPAapproved
label
and
labeling
of
the
affected
product.

List
of
Subjects
Environmental
protection,
Pesticides
and
pests.

Dated:
June
30,
2003.
Richard
P.
Keigwin,
Jr.,
Acting
Director,
Special
Review
and
Reregistration
Division,
Office
of
Pesticide
Programs.

[
FR
Doc.
03
 
17509
Filed
7
 
10
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0145;
FRL
 
7314
 
8]

Fenpyroximate;
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
 
0145,
must
be
received
on
or
before
August
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:
 
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
 
0145.
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
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41346
Federal
Register
/
Vol.
68,
No.
133
/
Friday,
July
11,
2003
/
Notices
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
 
0145.
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
 
0145.
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
 
0145.
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
 
0145.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.
D.
How
Should
I
Submit
CBI
to
the
Agency?

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

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

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

II.
What
Action
is
the
Agency
Taking?

EPA
has
received
pesticide
petitions
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
VerDate
Jan<
31>
2003
15:
20
Jul
10,
2003
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200001
PO
00000
Frm
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Fmt
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4703
E:\
FR\
FM\
11JYN1.
SGM
11JYN1
41347
Federal
Register
/
Vol.
68,
No.
133
/
Friday,
July
11,
2003
/
Notices
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:
June
30,
2003.
Debra
Edwards,
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
petitioner
and
represent
the
views
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
4
(
IR­
4)

PP
3E6519
EPA
has
received
a
pesticide
petition
(
3E6519)
from
IR­
4,
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390
proposing,
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
by
establishing
a
tolerance
for
residues
of
combined
residues
of
fenpyroximate
benzoic
acid,
4­[[[(
E)­(
1,3­
dimethyl­
5­
phenoxy­
1H­
pyrazol­
4­
yl)
methylene]
amino]
oxy]
methyl]­,
1,1­
dimethylethyl
ester]
and
its
z­
isomer
benzoic
acid,
4­[[[[(
Z)­(
1,3­
dimethyl­
5­
phenoxy­
1H­
pyrazol­
4­
yl)
methylene]
amino]
oxy]
methyl]­,
1,1­
dimethylethyl
ester)]]
in
or
on
the
raw
agricultural
commodity
fruit,
pome,
group
11
at
0.3
parts
per
million
(
ppm).
Nichino
America,
Incorporated.

PP
2F6437
EPA
has
also
received
a
pesticide
petition
(
2F6437)
from
Nichino
America,
Inc.,
4550
New
Linden
Hill
Road,
Wilmington,
DE
19808
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
combined
residues
of
fenpyroximate
benzoic
acid,
4­[[[(
E)­
(
1,3­
dimethyl­
5­
phenoxy­
1H­
pyrazol­
4­
yl)
methylene]
amino]
oxy]
methyl]­,
1,1­
dimethylethyl
ester]
and
its
z­
isomer
benzoic
acid,
4­[[[[(
Z)­(
1,3­
dimethyl­
5­
phenoxy­
1H­
pyrazol­
4­
yl)
methylene]
amino]
oxy]
methyl]­,
1,1­
dimethylethyl
ester)]]
in
or
on
the
following
raw
agricultural
commodities:
Cotton,
undelinted
seed
at
0.1
ppm,
cotton,
gin
byproducts
at
9.0
ppm,
apple,
fruit
at
0.08
ppm,
and
grape
at
0.3
ppm.
Additionally,
EPA
has
received
request
for
tolerances
for
the
combined
residues
of
fenpyroximate
benzoic
acid,
4­[[[(
E)­(
1,3­
dimethyl­
5­
phenoxy­
1Hpyrazol
4­
yl)
methylene]
amino]
oxy]
methyl]­,
1,1­
dimethylethyl
ester]
and
its
z­
isomer
benzoic
acid,
4­[[[[(
Z)­
(
1,3­
dimethyl­
5­
phenoxy­
1H­
pyrazol­
4­
yl)
methylene]
amino]
oxy]
methyl]­,
1,1­
dimethylethyl
ester)]
and
the
acid
metabolite
((
E)­
4­[(
1,3­
dimethyl­
5­
phenoxypyrazol­
4­
yl)­
methyleneamino
oxymethyl
benzoic
acid
(
M­
3)],
all
expressed
as
fenpyroximate
in
or
on
milk
at
0.01
ppm;
meat
at
0.02
ppm;
fat
at
0.8
ppm;
kidney
at
0.5
ppm;
liver
at
0.5
ppm;
and
meat
byproducts
at
0.01
ppm
of
cattle,
goats,
hogs,
horses
and
sheep.
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
summary
has
been
prepared
by
the
Nichino
American,
Inc.,
Wilmington,
DE
19808,
the
registrant.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
metabolism
of
fenpyroximate
and
z­
isomer
has
been
studied
in
cotton,
apples,
grapes,
and
citrus
and
is
adequately
understood.
2.
Analytical
method.
As
a
result
an
enforcement
method
has
been
developed
which
involves
extraction
of
fenpyroximate
from
crops
with
acetone,
filtration,
partitioning
and
cleanup,
and
analysis
by
gas
chromatography
using
a
nitrogen/
phosphorous
detector.
This
method
allows
detection
of
residues
at
or
above
the
proposed
tolerances.
The
method
has
undergone
independent
laboratory
validation
as
required
by
PR
Notices
88
 
5
and
96
 
1.
3.
Magnitude
of
residues
 
i.
Magnitude
of
residues
in
crops
field
residue
trials
meeting.
EPA
study
requirements
have
been
conducted
at
the
maximum
label
rate
for
cotton,
grapes,
and
pome
fruit.
Results
from
these
trials
demonstrate
that
the
highest
fenpyroximate
and
z­
isomer
residues
found
will
not
exceed
the
proposed
tolerances
when
the
product
is
applied
following
the
proposed
use
directions.
ii.
Magnitude
of
the
residue
in
animals
 
a.
Ruminants.
Maximum
residues
of
fenpyroximate,
z­
isomer,
and
acid
metabolite
in
a
cattle
feeding
study
demonstrate
that
the
highest
fenpyroximate,
z­
isomer,
and
acid
metabolite,
combined
as
fenpyroximate,
will
not
exceed
the
proposed
tolerances
in
or
on
milk
(
0.01
ppm);
meat
(
0.02
ppm),
fat
(
0.8)
ppm,
kidneys
and
liver
(
0.5)
ppm,
and
meat
byproducts
(
0.01)
ppm
in
cattle,
goats,
hogs,
horses,
sheep.
b.
Poultry.
The
maximum
poultry
dietary
burden
results
from
a
diet
composed
of
cotton
meal
for
a
total
dietary
burden
that
is
significantly
lower
than
the
levels
that
would
require
the
proposal
of
tolerances
in
poultry.
This
conclusion
is
based
on
the
exaggerated
rate
field
crop
studies
carried
out
on
fenpyroximate
and
the
zisomer
Therefore,
an
exemption
from
tolerances
in
poultry
meat,
poultry
meat
by­
products,
fat
and
eggs
under
40
CFR
180.6(
a)(
3)
and
(
b)
is
proposed
as
it
is
not
possible
to
establish
with
certainty
whether
finite
residues
will
be
incurred,
but
there
is
no
reasonable
expectation
of
finite
residues.

B.
Toxicological
Profile
A
full
description
of
the
studies
describing
the
toxicity
of
fenpyroximate
can
be
found
in
the
posting
for
the
import
tolerances
on
hops
and
wine
grapes
in
the
Federal
Register
of
April
10,
2001
(
66
FR
18561)
(
FRL
 
6773
 
2).
1.
Animal
metabolism.
The
qualitative
nature
of
the
residues
of
fenpyroximate
and
z­
isomer
and
acid
metabolite,
in
animals
is
adequately
understood.
Fenpyroximate
was
not
metabolized
to
volatiles
to
any
significant
degree.
The
majority
of
either
benzyl
or
pyrazole
labels
(
approximately
70%
to
92%)
is
excreted
in
the
feces.
Urinary
excretion
accounts
for
less
(
approximately
9%
to
18%)
of
the
label.
Thus,
feces
and
urine
are
the
major
routes
of
excretion
for
fenpyroximate.
Tissue
did
not
accumulate
fenpyroximate
or
its
metabolites
to
any
great
extent.
The
greatest
levels
of
label
were
in
liver,
kidneys,
adrenals,
and
fat
(
to
a
lesser
degree).
In
blood,
nearly
all
the
label
is
in
the
plasma.
2.
Endocrine
disruption.
Chronic,
lifespan,
and
multigenerational
bioassays
in
mammals
and
acute
and
subchronic
studies
on
aquatic
organisms
and
wildlife
did
not
reveal
any
endocrine
effects
for
fenpyroximate.
Any
endocrine­
related
effects
would
have
been
detected
in
this
VerDate
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Federal
Register
/
Vol.
68,
No.
133
/
Friday,
July
11,
2003
/
Notices
comprehensive
series
of
required
tests.
The
probability
of
any
such
effect
due
to
agricultural
uses
of
fenpyroximate
is
negligible.

C.
Aggregate
Exposure
1.
Dietary
exposure.
The
potential
dietary
exposure
to
fenpyroximate
has
been
calculated
from
the
proposed
tolerances
for
use
on
cotton,
grapes,
and
pome
fruit.
These
very
conservative
chronic
dietary
exposure
estimates
used
the
tolerance
value
for
all
the
raw
agricultural
commodities.
In
addition,
these
estimates
assume
that
100%
of
the
crops
contain
fenpyroximate
residues.
i.
Food.
Chronic
dietary
exposure
to
fenpyroximate
was
estimated
on
the
basis
of
100%
crop
treatment
for
cotton,
grapes,
and
pome
fruit
and
assuming
tolerance
level
residues
on
these
crops.
These
estimated
exposures
were
compared
to
the
chronic
dietary
RfD
for
fenpyroximate,
which
has
already
been
established
by
EPA
at
0.010
milligrams/
kilogram/
day
(
mg/
kg/
day),
in
connection
with
the
import
tolerance
on
wine
grapes
and
hops.
ii.
Drinking
water.
Laboratory
and
field
data
have
demonstrated
that
fenpyroximate
is
immobile
in
soil
and
will
not
leach
into
ground
water.
Other
data
show
that
fenpyroximate
is
virtually
insoluble
in
water.
As
a
result,
NAI
concludes
that
residues
reaching
surface
waters
from
field
runoff
will
quickly
adsorb
to
sediment
particles
and
be
partitioned
from
the
water
column.
Further,
a
screening
evaluation
of
leaching
potential
for
other
miticides
was
conducted
using
EPA's
Pesticide
Root
Zone
Model
(
PRZM)
and
Screening
Concentration
in
Ground
Water
(
SCIGROW
Based
on
this
screening
assessment,
the
potential
concentrations
of
fenpyroximate
and
z­
isomer
in
water
at
depths
of
1
and
2
meters
are
essentially
zero
(<
1
part
per
trillion
(
ppt)).
Surface
water
concentrations
using
PRZM
and
EXAMS
were
predicted
in
the
simulated
pond
of
0.0242
part
per
billion
(
ppb).
2.
Non­
dietary
exposure.
There
are
no
registered
or
proposed
residential
uses
of
fenpyroximate.
Thus,
a
residential
exposure
assessment
is
not
required.
Exposure
to
fenpyroximate
for
the
mixer/
loader/
ground
boom
applicator
was
calculated
using
the
Pesticides
Handlers
Exposure
Data
base
(
PHED).
These
PHED
assessments
were
based
on
a
70
kg
operator
treating
<
50
acres
per
day
using
ground
boom
equipment
on
both
apples
and
grapes
and
80
acres
per
day
on
cotton
by
ground
application
with
an
operator
treating
at
a
maximum
use
rate
of
0.1
lb
active
ingredient
per
acre.
All
mixer/
loaders
and
workers/
operators
were
assumed
to
be
wearing
gloves,
long
pants
and
long­
sleeved
shirts.

D.
Cumulative
Effects
In
consideration
of
potential
cumulative
effects
of
fenpyroximate
and
other
substances
that
may
have
a
common
mechanism
of
toxicity,
to
our
knowledge
there
are
no
currently
available
data
or
other
reliable
information
indicating
that
any
toxic
effects
produced
by
fenpyroximate
would
be
cumulative
with
those
of
other
chemical
compounds;
thus
only
the
potential
risks
of
fenpyroximate
have
been
considered
in
this
assessment
of
its
aggregate
exposure.

E.
Safety
Determination
1.
U.
S.
population
 
i.
Acute.
Using
the
100%
crop
treatment
scenario
the
acute
population
adjusted
dose
(
aPAD)
for
the
general
population
is
0.002309
mg/
kg/
day.
Of
the
standard
subgroups
which
are
analyzed
by
the
Dietary
Exposure
Evaluation
Model
(
DEEM),
the
subgroup
with
the
highest
exposures
is
infants
(<
1
year)
with
an
acute
dietary
exposure
estimated
at
0.006368
mg/
kg/
day
(
12.74%
of
the
acute
reference
aRfD).
For
children
in
the
age
brackets
1
 
6
years
and
7
 
12
years,
the
dietary
exposures
are
approximately
0.004716
mg/
kg/
day
(
9.43%
of
the
aRfD)
and
0.002581
mg/
kg/
day
(
5.16%
of
the
aRfD),
respectively.
Males
and
females
aged
13
and
older
have
an
estimated
acute
dietary
exposure
of
0.001054
and
0.000911
mg/
kg/
day,
respectively
(
2.11%
and
1.82%
of
the
aRfD,
respectively).
Even
applying
the
Food
Quality
Protection
Act
(
FQPA)
factor
of
10X
to
females
aged
13
and
older
the
percent
aRfD
utilization
is
only
a
modest
11.82%.
All
values
for
percentage
utilization
of
the
aRfD
are
well
below
100%
and
no
value
exceeds
12.74%.
ii.
Chronic.
Of
the
standard
subgroups
which
are
analyzed
by
the
DEEM,
and
using
the
conservative
estimates,
of
100%
crop
treatment
scenario,
the
chronic
population
adjusted
dose
(
cPAD)
for
the
general
population,
is
approximately
0.0002579
mg/
kg/
day
(
which
is
2.58%
of
the
RfD).
This
value
is
based
on
the
no
observed
adverse
effect
level
(
NOAEL)
of
0.97
mg/
kg/
day
observed
in
the
chronic
rat
feeding
study,
the
worse
case
estimate
of
chronic
dietary
exposure
of
fenpyroximate
from
cotton,
grape,
and
pome
fruit
and
a
safety
(
uncertainty)
factor
of
100.
2.
Non­
dietary
exposure
 
i.
Acute.
The
margins
of
exposure
relative
to
the
acute
dietary
endpoint
(
5
mg/
kg/
day)
are
all
in
excess
of
1,000.
Therefore,
there
is
a
reasonable
certainty
that
no
harm
will
occur
from
acute
exposure
to
crops
treated
at
the
maximum
labeled
use
rates
and
minimum
preharvest
intervals
for
fenpyroximate.
Worker
exposure
(
mixer/
loader
and
applicator)
estimates
provide
for
margins
of
safety
of
>
100
in
all
scenarios.
Worker
exposure
is
therefore
expected,
to
a
reasonable
degree
of
scientific
certainty,
to
be
without
harm.
Based
on
the
above,
exposures
of
the
U.
S.
population
to
fenpyroximate
associated
with
the
uses
addressed
in
this
reduced
risk
submission
are
expected,
to
a
reasonable
degree
of
scientific
certainty,
to
be
without
harm.
ii.
Chronic.
The
margins
of
exposure
relative
to
the
chronic
dietary
endpoint
are
all
in
excess
of
1,700.
Therefore,
there
is
a
reasonable
certainty
that
no
harm
will
occur
from
chronic
exposure
to
crops
treated
at
the
maximum
labeled
use
rates
and
minimum
preharvest
intervals
for
fenpyroximate.
3.
Infants
and
children
 
i.
Acute.
Using
the
100%
crop
treatment
scenario,
the
subgroup
with
the
highest
exposures
is
infants
(<
1
year)
with
an
acute
dietary
exposure
estimated
at
0.006368
mg/
kg/
day
(
12.74%
of
the
aRfD).
For
children
in
the
age
brackets
1
 
6
years
and
7
 
12
years,
the
acute
dietary
exposures
are
approximately
0.004716
mg/
kg/
day
(
9.43%
of
the
aRfD)
and
0.002581
mg/
kg/
day
(
5.16%
of
the
aRfD),
respectively.
Acute
dietary
exposure
of
infants
and
children
is
therefore
expected,
to
a
reasonable
degree
of
scientific
certainty,
to
be
without
harm.
Based
on
the
above,
exposures
of
infants
and
children
to
fenpyroximate
associated
with
the
uses
addressed
in
this
reduced
risk
submission
are
expected,
to
a
reasonable
degree
of
scientific
certainty,
to
be
without
harm.
ii.
Chronic.
Using
the
100%
crop
treatment
scenario,
infants
(
less
than
1
year)
have
the
highest
chronic
exposure
(
0.0009228
mg/
kg/
day,
which
is
9.23
%
of
the
RfD).
For
children
in
the
age
brackets
1
 
6
years
and
7
 
12
years,
the
dietary
exposures
are
approximately
0.0005244
mg/
kg/
day
(
5.24%
of
the
RfD)
and
0.0002733
mg/
kg/
day
(
2.73%
of
the
RfD),
respectively.
Chronic
dietary
exposure
of
the
infants
and
children
is
therefore
expected,
to
a
reasonable
degree
of
scientific
certainty,
to
be
without
harm.
iii.
Conclusion.
There
is
a
complete
toxicity
data
base
for
fenpyroximate
and
exposure
data
are
conservatively
estimated
based
on
data
that
reasonably
account
for
potential
exposures.
Based
on
these
risk
assessments,
Nichino
America,
Inc.
concludes
that,
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
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41349
Federal
Register
/
Vol.
68,
No.
133
/
Friday,
July
11,
2003
/
Notices
aggregate
exposure
to
combined
residues
of
fenpyroximate.

F.
International
Tolerances
Codex
Maximum
Residue
Levels
(
MRLs)
have
been
established
for
residues
of
fenpyroximate
and
z­
isomer
on
apples
in
Brazil
at
0.1
ppm,
France
0.2
ppm,
Japan
1.0
ppm,
Spain
(
pome
fruits)
0.3
ppm,
and
Switzerland
0.2
ppm.
Codex
MRLs
have
been
established
on
grapes
in
France
at
0.2
ppm,
Japan
2.0
ppm,
Spain
0.3
ppm,
and
Switzerland
0.2
ppm.

[
FR
Doc.
03
 
17617
Filed
7
 
10
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0230;
FRL
 
7316
 
1]

2­
Ethylhexyl­
L­
Lactate;
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
identification
(
ID)
number
OPP
 
2003
 
0230,
must
be
received
on
or
before
August
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:
Kathryn
Boyle,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6304;
e­
mail
address:
boyle.
kathryn@
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
 
0230.
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.
1.
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
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