Document ID: EPA-HQ-OPP-2003-0308-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-10-29T05:00Z

JUL
2
2003
Dr.
Russell
P.
Schneider
Technical
Director,
Registration
Regulatory
Affairs
Monsanto
Company
700
14th
Street,
N.
W.,
Suite
1100
Washington,
DC
20005
Dear
Dr.
Schneider:

Subject:
Your
Applications
and
Subsequent
Revisions
to
Test
ZMIR39
x
MON810
Combined
Insecticidal
Trait
Stacked
Corn
Hybrids
Along
with
ZMIR39
and
MON810
Corn
Hybrids
Dated
November
11,
2002;
May
19,
2003;
and
June
26,
2003.
EPA
Experimental
Use
Permit
No.
524­
EUP­
96
Effective
Dates:
Plantings
Through
December
31,
2003
and
Associated
Activities
Such
as
Collection
of
Field
Data;
Harvesting
&
Processing
of
Seed
After
Last
Planting;
Etc.

Quantity
Authorized:
11b
Cry3Bb1
Protein
In
Seeds
Shipped
On
the
basis
of
the
information
furnished
by
the
applicant
and
the
annexed
program,
this
experimental
use
permit
(
EUP)
under
§
5
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
is
hereby
granted
to
test
ZMIR39
x
MON810
combined
insecticidal
trait
stacked
corn
hybrids
along
with
ZMIR39
and
MON810
corn
hybrids;
Bacillus
thuringiensis
Cry3Bb1
Protein
and
the
genetic
material
necessary
for
its
production
(
vector
ZMIR39)
in
corn
[
ZMIR39]
and
Bacillus
thuringiensis
Cry1Ab
delta­
endotoxin
and
the
genetic
material
necessary
for
its
production
(
vector
PV­
ZMCT01)
in
corn
[
MON810].
Shipment
and/
or
use
under
this
Permit
is
subject
to
the
provisions
of
40
CFR
Part
172.
Tolerance
exemptions
under
40
CFR
180.1174
and
180.1214
apply
to
these
plant­
incorporated
protectants
in
corn
to
be
tested
under
this
permit
in
the
Bt.
Although
plantings
are
currently
only
approved
through
December
31,
2003,
provided
the
40
CFR
180.1214
time­
limited
tolerance
exemption
is
amended
so
that
its
expiration
date
is
removed;
the
Agency
anticipates
extending
this
EUP.

Prior
to
shipment
and/
or
use
of
the
subject
corn,
you
must
consult
with
the
pesticide
regulatory
officials
and,
if
applicable,
the
biotechnology
regulatory
officials
of
the
State(
s)
in
which
your
experimental
program
will
be
conducted,
and
obtain
a
State
permit
or
license
if
such
is
required.
(
Note
Hawaii's
reporting
requirement
for
genetically
modified
organisms
under
section
321­
11.6
of
the
Hawaii
revised
statutes.)
Issuance
of
this
Federal
permit
does
not
negate
the
need
for
permission
from
individual
States.
Prior
to
initiating
this
experimental
program
in
any
State,
2
you
are
to
notify
the
lead
Agency
of
the
State(
s)
in
which
your
experimental
program
will
be
conducted
of
the
specific
testing
program
(
when,
where,
how
much,
etc.).
Failure
to
do
so
may
result
in
revocation
or
modification
of
this
EUP.
You
must
comply
with
all
requirements
of
the
USDA/
APHIS
as
they
apply
to
the
proposed
testing.

You
must
provide
notice
to
the
State
pesticide
regulatory
Agency
at
least
72
hours
before
you
begin
to
apply
the
experimental
use
product.
You
must
modify
your
November
11,
2002
Section
G
and
its
May
19,
2003
supplement
and
submit
a
copy
for
the
record
so
that
it
agrees
with
your
labels
and
the
information
presented
in
your
June
26,
2003
submission;
namely
that
you
will
be
testing
ZMIR39
x
MON810
combined
insecticidal
trait
stacked
corn
hybrids
along
with
ZMIR39
and
MON810
corn
hybrids
under
this
EUP.
You
must
also
provide
a
copy
of
this
authorization
letter
and
approved
label,
as
well
as
the
non­
confidential
portion
of
the
revised
Section
G
mentioned
above
to
all
cooperators,
participants,
and
users
prior
to
the
initial
pesticide
application
made
in
accordance
with
the
EUP.
The
Agency
is
also
notifying
the
relevant
EPA
Region(
s),
by
sending
them
copies
of
this
EUP.

Based
upon
the
submitted
experimental
program,
the
subject
corn
seed
may
be
shipped
for
use
under
this
permit
to
the
following
State(
s)
and
be
planted
on
the
following
acreage
and
crops,
provided
that
the
States
agree
to
the
trials
and
all
other
requirements
of
the
USDA/
APHIS
have
been
met
as
they
apply
to
the
testing:

States
Acres
AL
2.5
CA
50
CO
10
HI
266
IA
101.2
IL
116.5
IN
38.3
KS
19
KY
0.5
MD
1.3
MI
2.5
MN
31.6
States
cont.
Acres
cont.

MO
20.3
3
MS
2.5
NC
0.5
NE
50.3
NM
0.5
NY
0.5
OH
29.6
PA
3.3
PR
29
SD
20
TN
12.5
TX
5.5
VA
0.5
WI
15.3
Total
829.7
Conditions
under
which
the
EUP
is
being
issued
are
as
follows.

1.
The
total
amount
of
corn
seed
to
be
used
will
not
exceed
the
quantity
authorized
by
the
EUP
and
its
planting
acres.

2.
Although
the
Agency
is
not
requiring
Monsanto
to
modify
its
experimental
program
as
requested
by
the
Sierra
Club
in
their
comments
to
OPP
Docket
No.
OPP­
2002­
0352,
the
permittee
must
immediately
notify
the
Environmental
Protection
Agency
of
any
findings
from
the
experimental
uses
that
have
a
bearing
on
safety
(
i.
e.,
reporting
to
the
Agency
of
any
adverse
effects
from
the
use
of,
or
exposure
to,
the
pesticide
is
required).
The
permittee
will
also
keep
records
of
production,
distribution
and
performance,
and,
on
request,
make
the
records
available
to
any
authorized
officer
or
employee
of
the
Environmental
Protection
Agency.

3.
You
must
provide
a
final
report
within180
days
of
the
expiration
of
the
permit.
The
final
report
must
include
all
of
the
items
set
forth
in
40
CFR
§
172.8(
b).

4.
Per
40
CFR
§
174.4(
b)(
v),
you
must
provide
the
name
and
street
address
of
all
cooperators
as
soon
as
available
and
prior
to
planting.

5.
The
labeling
submitted
in
connection
with
your
application
is
acceptable
subject
to
the
following
comments
and
must
be
used
for
all
shipments
of
seed
subsequent
to
receiving
this
approval
and
be
in
possession
of
the
user
under
this
EUP
amendment.
4
°
Modify
the
EUP
number
from
"
524­
EUP­
OA"
to
"
524­
EUP­
96
on
all
labels.

°
Each
label
must
have
the
EPA
Establishment
Number
listed
and
have
the
statement
"
Cooperators
must
have
at
least
one
copy
of
each
applicable
protocol..."
modified
to
state
"
Cooperators
and
participants
must
have
at
least
one
copy
of
each
applicable
protocol..."

°
Delete
the
"
EPA
Registration
Number
524­
489"
and
add
a
net
contents
statement
to
the
MON810
label
and
provide
the
active
ingredient
percentage
based
on
the
wt/
wt
of
dry
grain.

A
stamped
copy
of
the
master
label
which
includes
labels
for
ZMIR39,
MON810,
and
ZMIR39xMON810
hybrids
is
enclosed
for
your
records.
Within
30
days,
submit
an
updated
label
that
includes
these
changes
for
the
record.

6.
Submit
an
updated
Confidential
Statement
of
Formula
that
incorporates
the
changes
indicated
for
the
ingredients
statements
in
item
5
above.

7.
This
experimental
use
permit
is
not
a
limited
seed
increase
registration
under
§
3
of
FIFRA
and
plantings
solely
for
commercial
seed
increase
are
prohibited
Sincerely,

/
s/

Janet
L.
Andersen,
Ph.
D.,
Director
Biopesticides
and
Pollution
Prevention
Division
(
7511C)
Enclosure