Document ID: EPA-HQ-OPP-2003-0142-0001
Agency: epa
Document Type: Notice
Title: Fenhexamid; Notice of Filing Pesticide Petitions to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-05-21T04:00Z

27799
Federal
Register
/
Vol.
68,
No.
98
/
Wednesday,
May
21,
2003
/
Notices
amended
the
Federal
Food,
Drug,
and
Cosmetic
Act,
Congress
directed
EPA
to
develop
a
screening
program,
using
appropriate
validated
test
systems
and
other
scientifically
relevant
information,
to
determine
whether
certain
substances
may
have
hormonal
effects
in
humans.
In
1996,
EPA
chartered
a
scientific
advisory
committee,
the
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
under
the
authority
of
the
Federal
Advisory
Committee
Act
(
FACA
)
to
advise
it
on
establishing
a
program
to
carry
out
Congress'
directive.
EDSTAC
recommended
a
multi­
step
approach
including
a
series
of
screens
(
Tier
I
screens)
and
tests
(
Tier
II
tests)
for
determining
whether
a
chemical
substance
may
have
an
effect
in
humans
similar
to
that
produced
by
naturally
occurring
hormones.
EPA
adopted
almost
all
of
EDSTAC's
recommendations
in
the
program
that
it
developed,
the
Endocrine
Disruptor
Screening
Program
(
EDSP),
to
carry
out
Congress'
directive.
EDSTAC
also
recognized
that
there
currently
are
no
validated
test
systems
for
determining
whether
a
chemical
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
naturally
occurring
hormones.
Consequently,
EPA
is
in
the
process
of
developing
and
validating
the
screens
and
tests
that
EDSTAC
recommended
for
inclusion
in
the
EDSP.
In
carrying
out
this
validation
exercise,
EPA
is
working
closely
with,
and
adhering
to
the
principles
of
the
Interagency
Coordinating
Committee
for
the
Validation
of
Alternate
Methods
(
ICCVAM).
EPA
also
is
working
closely
with
the
Organization
for
Economic
Cooperation
and
Development's
(
OECD)
Endocrine
Testing
and
Assessment
Task
Force
to
validate
and
harmonize
endocrine
screening
tests
of
international
interest.
Finally,
to
ensure
that
EPA
has
the
best
and
most
up­
to­
date
advice
available
regarding
the
validation
of
the
screens
and
tests
in
the
EDSP,
EPA
formed
the
Endocrine
Disruptor
Methods
Validation
Subcommittee
(
EDMVS)
of
the
National
Advisory
Council
for
Environmental
Policy
and
Technology
(
NACEPT).
EDMVS
provides
independent
advice
and
counsel
to
the
Agency
through
NACEPT,
on
scientific
and
technical
issues
related
to
validation
of
the
EDSP
Tier
I
screens
and
Tier
II
tests,
including
advice
on
methods
for
reducing
animal
use,
refining
procedures
involving
animals
to
make
them
less
stressful,
and
replacing
animals
where
scientifically
appropriate.
The
EDMVS
has
held
six
meetings
since
its
establishment
in
September
2001.
The
objectives
of
the
first
meeting,
which
was
held
in
October
2001,
(
docket
control
number
OPPT
 
42212D)
were
for
EPA
to
provide:
1.
An
overview
of
EPA's
Endocrine
Disruptor
Program.
2.
Background
information
on
test
protocol
validation
and
approaches.
3.
For
the
EDMVS
to
develop
a
clear
understanding
of
their
scope,
purpose,
and
operating
procedures.
4.
The
EDMVS
and
the
EDSP
to
determine
the
next
steps.
The
objectives
of
the
December
2001
meeting
(
docket
control
number
OPPT
 
42212E)
were
for
the
EDMVS
to
provide
input
and
advice
on:
1.
EDMVS's
mission
statement
and
work
plan.
2.
The
in
utero
through
lactation
assay
detailed
review
paper.
3.
The
pubertal
assay
study
design
for
the
multi­
dose
and
chemical
array
protocols.
4.
The
mammalian
one­
generation
study
design.
The
objectives
of
the
March
2002
meeting
(
docket
control
number
42212F)
were
for
the
EDMVS
to
provide
input
and
advice
on:
1.
EPA's
implementation
process
and
practical
aspects
of
validation.
2.
The
in
utero
through
lactation
assay
protocol.
3.
The
fish
reproduction
assay
detailed
review
paper.
4.
Special
studies,
the
fathead
minnow
assays,
vitellogenin
assay,
and
avian
dosing
protocol.
5.
The
steroidogenesis
detailed
review
paper.
6.
The
aromatase
detailed
review
paper.
7.
A
proposed
standard
suite
of
chemicals
for
testing
in
the
Tier
I
screening
assays.
8.
The
current
efforts
related
to
evaluating
the
relevance
of
animal
data
to
human
health.
9.
EPA's
approach
to
addressing
low
dose
issues.
The
objective
of
the
June
2002
teleconference
meeting
(
docket
ID
number
OPPT
 
2002
 
0020)
was
for
the
EDMVS
to
provide
input
and
advice
on
the
steroidogenesis
detailed
review
paper.
The
objectives
of
the
July
2002
meeting
(
docket
ID
number
OPPT
 
2002
 
0029)
were:
1.
To
review
the
screening
criteria,
recommended
by
EDSTAC
and
adopted
by
EDSP
for
screens.
2.
To
receive
an
update
of
the
NICEATM
estrogen
and
androgen
receptor
binding
efforts.
3.
To
discuss
and
provide
advice
on
general
dose
setting
issues;
and
to
provide
comments
and
advice
on:
 
A
pubertal­­
special
study­­
restricted
feeding.
 
A
mammalian
2­
generation
draft
PTU
special
study.
 
An
amphibian
metamorphosis
detailed
review
paper.
 
An
invertebrate
detailed
review
paper.
The
objective
of
the
December
2002
teleconference
meeting
(
docket
ID
number
OPPT
 
2002
 
0059)
was
for
the
EDMVS
to
provide
input
and
advice
on
the
Tier
II
fish
life
cycle
assay
detailed
review
paper.

III.
Meeting
Objectives
for
the
June
5
 
6,
2003
Meeting
The
objectives
of
the
June
5
 
6,
2003
(
docket
ID
number
OPPT
 
2003
 
0016)
are
for
EDMVS
to
provide
input
and
advice
on:
1.
The
Tier
II
Mammalian
2­
generation
special
study
on
the
onegeneration
extension
results.
2.
The
Tier
I
steroidogenesis
(
sliced
testes)
study
results.
3.
To
provide
the
status
of
the
Tier
I
study
results
of
the
aromatase
placental
tissue
study.
A
list
of
the
EDMVS
members
and
meeting
materials
are
available
on
our
web
site
(
http://
www.
epa.
gov/
scipoly/
oscpendo/
edmvs.
htm)
and
in
the
public
docket.

List
of
Subjects
Environmental
protection,
Endocrine
system,
Endocrine
disruptors,
Endocrine
disruptor
screening
program.

Dated:
May
9,
2003.
Joseph
Merenda,
Director,
Office
of
Science
Coordination
and
Policy,
Office
of
Prevention,
Pesticides
and
Toxic
Substances.
[
FR
Doc.
03
 
12484
Filed
5
 
20
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0142;
FRL
 
7308
 
4]

Fenhexamid;
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
pesticide
petitions
proposing
the
establishment
of
regulations
for
residues
of
a
certain
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Federal
Register
/
Vol.
68,
No.
98
/
Wednesday,
May
21,
2003
/
Notices
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0142,
must
be
received
on
or
before
June
20,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Sidney
Jackson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
7610;
e­
mail
address:
jackson.
sidney@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
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.
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.
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
 
0142.
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
EPA's
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
EPA's
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
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/
Vol.
68,
No.
98
/
Wednesday,
May
21,
2003
/
Notices
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
 
0142.
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
 
0142.
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
 
0142.
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
 
0142.
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
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
these
petitions
contain
data
or
information
regarding
the
elements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petitions.
Additional
data
may
be
needed
before
EPA
rules
on
the
petitions.

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

Dated:
May
9,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petitions
The
petitioner's
summary
of
the
pesticide
petitions
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petitions
was
prepared
by
the
Arvesta
Corporation,
100
First
Street,
Suite
1700,
San
Francisco,
CA
94105
and
represents
the
view
of
Arvesta
Corporation.
The
petitions
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
PP
2E6463,
2E6496,
3E6532,
and
3E6541
EPA
has
received
pesticide
petitions
2E6463,
2E6496,
3E6532,
and
3E6541,
from
the
Interregional
Research
Project
Number
4
(
IR
 
4),
Center
for
Minor
Crop
Pest
Management,
Rutgers,
The
State
University
of
New
Jersey,
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
180.553
by
establishing
tolerances
for
residues
of
fenhexamid,
N­(
2,3­
dichloro­
4­
hydroxyphenyl)­
1­
methyl­
cyclohexane
carboxamide,
in
or
on
raw
agricultural
commodities
as
follows:
1.
PP
2E6463
proposes
a
tolerance
in
or
on
kiwifruit
(
post
harvest)
at
15.0
parts
per
million
(
ppm).
2.
PP
2E6496
proposes
to
establish
tolerances
in
or
on
cucumber
at
2.0
ppm,
and
vegetable,
fruiting,
group
8
at
2.0
ppm.
3.
PP
3E6532
proposes
a
tolerance
in
or
on
leafy
greens
subgroup
4A,
except
spinach,
at
30.0
ppm.
4.
PP
3E6541
proposes
a
tolerance
in
or
on
fruit,
stone,
group
12
(
post
harvest)
at
10
ppm.
This
action
also
proposes
to
further
amend
40
CFR
180.553
by
deleting
the
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Federal
Register
/
Vol.
68,
No.
98
/
Wednesday,
May
21,
2003
/
Notices
entry
for
stone
fruit,
except
plum
(
fresh
prune)
tolerance
at
6.0
ppm
as
a
higher
tolerance
of
10
ppm
for
fruit,
stone,
group
12
(
post
harvest)
is
proposed
herein.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
qualitative
nature
of
fenhexamid
residues
in
plants
is
adequately
understood.
2.
Analytical
method.
An
adequate
method
for
purposes
of
enforcement
of
the
proposed
fenhexamid
tolerances
in
plant
commodities
is
available.
3.
Magnitude
of
residues.
The
magnitude
of
residues
for
fenhexamid
on
the
proposed
commodities
is
adequately
understood.

B.
Toxicological
Profile
In
the
Federal
Register
of
February
8,
2002
(
67
FR
6028)
(
FRL
 
6821
 
2),
EPA
published
the
Notice
of
Filing
proposing
the
establishment
of
tolerances
for
residues
of
fenhexamid
on
a
number
of
raw
agricultural
commodities,
including
caneberry,
et.
al.
That
publication
summarizes
in
detail
the
current
state
of
knowledge
regarding
the
toxicological
profile
of
fenhexamid
including
aggregate
exposure
assessment
and
determination
of
safety.
Interested
readers
are
referred
to
that
document
for
specific
information
under
Unit
II.

C.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food.
Dietary
exposure
to
fenhexamid
is
limited
to
the
established
tolerances
for
residues
of
fenhexamid
on
grapes
(
at
4.0
ppm),
raisins
(
at
6.0
ppm),
strawberries
(
at
3.0
ppm),
almond
nutmeat
(
at
0.02
ppm),
almond
hulls
(
at
2.0
ppm),
stonefruit
(
pre­
harvest,
at
5.0
ppm),
pear
(
at
15
ppm),
bushberries
(
at
5.0
ppm),
caneberries
(
at
20
ppm),
and
pistachios
(
at
0.02
ppm);
the
proposed
tolerances
in
the
current
submission
which
are
as
follows:
Cucumber
(
at
2.0
ppm),
crop
group
8
(
fruiting
vegetables,
at
2.0
ppm),
kiwi
(
post­
harvest,
at
15.0
ppm),
lettuce
(
at
30.0
ppm),
and
crop
group
12
(
stonefruit,
pre­
harvest
and
post­
harvest,
at
10.0
ppm).
ii.
Drinking
water.
Review
of
the
environmental
fate
data
indicates
that
fenhexamid
is
relatively
immobile
and
rapidly
degrades
in
the
soil
and
water.
Fenhexamid
dissipates
in
the
environment
via
several
processes.
Therefore,
Arvesta
Corporation
believes
that
a
significant
contribution
to
aggregate
risk
from
fenhexamid
in
drinking
water
is
unlikely.
2.
Non­
dietary
exposure.
There
is
no
significant
potential
for
nonoccupational
exposure
to
the
general
public.
The
proposed
uses
are
limited
to
agricultural
and
horticultural
use.
D.
Cumulative
Effects
Consideration
of
a
common
mechanism
of
toxicity
is
not
appropriate
at
this
time
since
it
has
a
unique
mode
of
action.
Moreover,
there
is
no
significant
toxicity
observed
for
fenhexamid.
Even
at
toxicology
limit
doses,
only
minimal
toxicity
is
observed
for
fenhexamid.
Therefore,
Arvesta
Corporation
concludes
that
only
the
potential
risks
of
fenhexamid
are
considered
in
the
exposure
assessment.

E.
Safety
Determination
1.
U.
S.
population.
Considering
that
the
percent
of
the
chronic
population
adjusted
dose
(
cPAD)
utilized
by
all
current
uses
(
almonds,
bushberries,
caneberries,
grapes,
pear,
pistachios,
raisins,
pre­
harvest
stonefruit,
and
strawberry)
is
estimated
to
be
7%
in
the
Federal
Register
of
April
18,
2002
(
67
FR
19114)
(
FRL
 
6829
 
9);
considering
also
the
proposed
tolerances,
proportion
of
the
crops
treated
and
their
importance
in
the
diet,
the
percent
of
the
cPAD
utilized
by
the
proposed
uses
is
estimated
to
14%.
Therefore,
Arvesta
Corporation
believes
that
the
estimates
of
dietary
exposure
indicate
adequate
safety
margins
for
the
overall
U.
S.
population.
2.
Infants
and
children.
Considering
that
the
percent
of
the
cPAD
utilized
by
all
current
uses
(
almonds,
bushberries,
caneberries,
grapes,
pear,
pistachios,
raisins,
pre­
harvest
stonefruit,
and
strawberry)
is
estimated
to
be
66%
(
infants)
and
17%
(
children)
(
67
FR
19114,
April
18,
2002);
considering
also
the
proposed
tolerances,
proportion
of
the
crops
treated
and
their
importance
in
the
diet,
the
percent
of
the
cPAD
utilized
by
the
proposed
uses
is
estimated
to
11%
(
infants)
and
13%
(
children).
Therefore,
the
estimates
of
dietary
exposure
indicate
adequate
safety
margins
for
children.
In
assessing
the
potential
for
additional
sensitivity
of
infants
and
children
to
residues
of
fenhexamid,
the
available
developmental
toxicity
and
reproductive
toxicity
studies
and
the
potential
for
endocrine
modulation
by
fenhexamid
were
considered.
Developmental
toxicity
studies
in
two
species
indicate
that
fenhexamid
does
not
impose
additional
risks
to
developing
fetuses
and
is
not
a
teratogen.
The
2
 
generation
reproduction
study
in
rats
demonstrated
that
there
were
no
adverse
effects
on
reproductive
performance,
fertility,
fecundity,
pup
survival,
or
pup
development
at
non­
maternally
toxic
levels.
Maternal
and
developmental
no
observed
adverse
effect
levels
(
NOAELs)
and
lowest
observed
adverse
effect
levels
(
LOAELs)
were
comparable,
indicating
no
increase
in
susceptibility
of
developing
organisms.
No
evidence
of
endocrine
effects
was
noted
in
any
study.
It
is
therefore
concluded
by
Arvesta
Corporation
that
fenhexamid
poses
no
additional
risk
for
infants
and
children
and
no
additional
uncertainty
factor
is
warranted.

F.
International
Tolerances
International
tomato
tolerances
are
in
effect
in
France,
Germany,
Greece,
Italy,
Slovenia,
Spain,
Turkey
(
1
ppm),
and
other
European
countries
(
2
ppm).
Kiwi
tolerances
are
as
follows:
Greece,
Italy,
and
Slovenia
(
10
ppm).
Stonefruit
tolerances
already
exist
in
the
U.
S.
for
pre­
harvest
applications
as
well
as
in
Canada
(
6
ppm),
Austria
(
cherry,
5
ppm;
plum,
2
ppm);
Belgium
(
cherry,
5
ppm);
Germany
and
Slovenia
(
cherry,
5
ppm;
peach
and
plum,
2
ppm),
Italy
(
cherry,
5
ppm;
apricot,
peach,
and
plum
2
ppm);
Japan
(
peach,
1
ppm),
Switzerland
(
cherry,
2
ppm)
and
the
United
Kingdom
(
plum,
1
ppm),
and
other
European
countries
(
peach
and
plum,
1
ppm;
cherry,
5
ppm).
[
FR
Doc.
03
 
12485
Filed
5
 
20
 
03;
8:
45
am]

BILLING
CODE
6560
 
60
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0167;
FRL
 
7306
 
9]

Carbofuran;
Receipt
of
Applications
for
Emergency
Exemption,
Solicitation
of
Public
Comment
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
EPA
has
received
specific
exemption
requests
from
the
Texas
Department
of
Agriculture;
the
Oklahoma
Department
of
Agriculture,
Food,
and
Forestry;
and
the
Louisiana
Department
of
Agriculture
and
Forestry
to
use
the
pesticide
flowable
carbofuran
(
Furadan
4F
Insecticide/
Nematicide)
(
EPA
Reg.
No.
279
 
2876)
to
treat
up
to
1.8
million
acres
of
cotton
in
Texas;
100,000
acres
of
cotton
in
Oklahoma;
and
500,000
acres
of
cotton
in
Louisiana
to
control
cotton
aphid.
The
Applicants
propose
the
use
of
a
chemical
which
has
been
the
subject
of
a
Special
Review
within
EPA's
Office
of
Pesticide
Programs,
and
is
intended
for
a
use
that
could
pose
a
risk
similar
to
the
risk
posed
by
uses
evaluated
under
the
Special
Review.
The
granular
formulation
of
carbofuran
was
the
subject
of
a
Special
Review
between
the
years
of
1986
 
1991,
which
resulted
in
a
negotiated
settlement
whereby
most
of
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