Document ID: EPA-HQ-OPP-2005-0122-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-07-26T04:00Z

FEB
18
2005
Dr.
Ravinder
S.
Sidhu
Regulatory
Affairs
Manager
Monsanto
Company
800
North
Lindbergh
Blvd.
St.
Louis,
MO
63167
Dear
Dr.
Sidhu:

Subject:
Your
Application,
Administrative
Material,
and
Section
G
Dated
July
28,
2004
to
Test
ZMIR39
x
MON810
Combined
Insecticidal
Trait
Stacked
Corn
Along
with
ZMIR39
and
MON810
Corn.
EPA
Experimental
Use
Permit
No.
524­
EUP­
96
Effective
Dates:
Plantings
Through
March
1,
2006
and
Associated
Activities
Such
as
Collection
of
Field
Data;
Harvesting
&
Processing
of
Seed
After
Last
Planting;
Etc.
Quantity
Authorized:
60,457
lb
seed
(
3.63
lb
active
ingredient)

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
amended/
extended
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
180.117[
3]*
and
180.1214
apply
to
these
plant­
incorporated
protectants
in
corn
to
be
tested
under
this
permit.

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,
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
also
provide
a
copy
of
this
authorization
letter
and
stamped
labels,
as
well
as
the
non­
confidential
portion
of
the
Administrative
Material
and
Section
G
dated
July
28,
2004
to
all
cooperators,
participants,
and
users
prior
to
the
initial
pesticide
application
made
in
accordance
with
the
EUP
2
amendment/
extension.
The
Agency
is
also
notifying
the
relevant
EPA
Region(
s),
by
sending
them
copies
of
this
EUP.

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.
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)
and
must
include
the
following
items.

 
A
state­
by­
state
breakdown
of
acreage
per
protocol.
 
A
state­
by­
state
breakdown
of
locations
per
protocol.
 
A
listing
of
experiments
conducted
within
each
protocol.
 
Average
acreage
per
location
for
each
experiment
included
within
each
protocol
(
ideally
this
would
be
presented
on
a
state­
by­
state
basis).

4.
Per
40
CFR
§
17[
2]*.
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
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.

6.
This
experimental
use
permit
is
not
a
limited
seed
increase
registration
under
§
3
of
FIFRA
and
plantings
solely
for
commercial
seed
increase
are
prohibited
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;
provided
that
the
protocol
specific
acreage
is
not
exceeded,
that
the
States
agree
to
the
trials,
and
all
other
requirements
of
the
USDA/
APHIS
have
been
met
as
they
apply
to
the
testing.
We
note
that
3,023
acres
of
ZMIR39
containing
seed
are
included.

States
Acres
AL
3.75
CA
268
CO
113.20
3
States
cont.
Acres
cont.

HI
843.44
IA
737.75
IL
490.50
IN
272.25
KS
157.55
KY
35
MD
12
MI
73.60
MN
149.35
MO
108.25
MS
3.75
NC
2.40
ND
6.45
NE
382.10
NM
2.40
NY
12
OH
101.20
OK
4.00
PA
35.45
PR
245.93
SD
100.95
TN
40.35
TX
75
VA
2.40
WA
276
WI
127.85
Total
4682.87
4
Acreage
Protocol
Type
ZMIR39
MON810
ZMIR39
x
MON810
Border
Rows
Total
Breeding
and
observation
410.65
159.00
297.20
175.32
1,042.17
Inbred
seed
increase
production
808.50
97.30
396.50
158.05
1,460.35
Line
per
se,
hybrid
yield
and
herbicide
tolerance
trials
457.50
332.00
374.00
451.40
1,614.90
Insect
efficacy
trials
91.55
79.15
86.55
198.60
455.85
Product
characterization
and
performance
trials
1.00
1.00
1.00
1.00
4.00
Insect
resistance
management
trials
5.20
2.60
5.20
2.60
15.60
Nontarget
organisms
and
benefit
trials
2.00
0.50
2.00
0.50
5.00
Seed
treatment
trials
2.00
0.50
2.00
0.50
5.00
Swine
growth
and
feed
efficiency
trials
8.00
0
0
0
8.00
Dairy
cattle
feed
efficiency
trials
4.00
0
0
0
4.00
Beef
cattle
growth
and
feed
efficiency
trials
36.00
0
0
0
36.00
Cattle
grazing
feed
efficiency
trials
32.00
0
0
0
32.00
Total
1,858.4
672.05
1,164.45
987.97
4,682.87
We
note
that
future
EUP
submissions
should
include
the
following
information.

 
Protocols
to
be
conducted.
 
Experiments
to
be
included
within
each
protocol.
 
Estimated
state­
by­
state
breakdown
of
acreage
per
protocol.
 
Estimated
state­
by­
state
breakdown
of
locations
per
protocol.
 
Estimate
of
acreage
and
locations
required
for
each
experiment
included
within
protocols
(
ideally
this
would
be
presented
on
a
state­
by­
state
basis).
 
If
an
acreage
increase
is
requested
for
one
or
more
protocols,
justification
should
be
provided
for
those
increases
(
justification
should
be
provided
on
a
protocol
by
protocol
basis).
 
Objective
and
brief
description
of
each
experiment
included
within
protocols.
Approximate
number
of
hybrids/
inbreds/
isolines
to
be
tested
should
also
be
included
(
may
be
presented
as
average
number
of
lines
per
location).
 
Clear
explanation
of
acreage
calculation,
including
a
breakdown
of
EUP
acreage
designated
for
test
plants,
non­
test
plants,
and
border
rows
included
within
experimental
blocks.
 
It
should
be
noted
that
EUP
acreage
designated
for
demonstration
trials
is
generally
considered
inappropriate.

Sincerely,

/
s/

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