JUN
02
2003
Dr.
Penny
Hunst
Regulatory
Manager
Mycogen
Seeds
c/
o
Dow
AgroSciences
LLC
9330
Zionsville
Road
Indianapolis,
IN
46268­
1054
Dear
Dr.
Hunst:

Subject:
Bacillus
thuringiensis
Cry1F
Protein
and
the
Genetic
Material
Necessary
for
its
Production
(
From
the
Insert
of
Plasmid
PHP12537)
in
Corn
/
Your
April
28,
2003
Application
and
Amended
Experimental
Program
Section
G
Which
Removes
Certain
States
from
Areas
of
Testing
and
Corrects
Arithmetic
Errors;
Your
May
19,
2003
Letter
and
Associated
Revised
Participant
and
Cooperator
Lists
EPA
Experimental
Use
Permit
No.
68467­
EUP­
4
Effective
Dates:
Plantings
Through
March
2004
and
Associated
Activities
Such
as
Collection
of
Field
Data;
Harvesting
&
Processing
of
Seed
After
Last
Planting
On
the
basis
of
the
information
furnished
by
the
applicant
and
the
annexed
program,
an
experimental
use
permit
(
EUP)
under
§
5
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
is
hereby
amended
for
Bacillus
thuringiensis
Cry1F
protein
and
the
genetic
material
necessary
for
its
production
(
from
the
insert
of
plasmid
PHP12537)
in
corn
[
moCry1F
corn].
The
total
acreage
allowed
remains
at
290.5.
However,
arithmetic
errors
in
acreage
totals
and
acreage
distributions
among
trials
have
been
amended
and
corrected.

The
states
of
California,
Colorado,
Georgia,
Kansas,
Maryland,
Michigan,
Missouri,
New
York,
North
Carolina,
Oklahoma,
Pennsylvania,
Texas,
and
Virginia
have
been
removed
from
the
program.
Illinois
acreage
has
been
reduced
from
51
to
21
acres;
Iowa
acreage
has
been
reduced
from
45.5
to
34.5
acres;
Minnesota
acreage
has
been
reduced
from
31
to
19
acres;
Nebraska
acreage
has
been
reduced
from
26
to
16
acres,
and
Wisconsin
acreage
has
been
reduced
from
26
to
16
acres.
Breeding
and
Observation
Nursery
Trials
have
gone
from
44
to
144
acres;
Maize
Agronomic
Observation
Trials
have
gone
from
172
to
79
acres;
Liberty
Herbicide
Tolerance
Trials
have
gone
from
7
to
8
acres;
Maize
Efficacy
Trials
have
gone
from
53
to
46
acres;
Maize
Demonstration
Trials
have
gone
from
10.5
acres
to
9.5
acres;
and
IRM
Trial
acres
remain
the
same
at
4
acres.

Although
your
program
requires
the
destruction
of
seed
or
plant
material
resulting
from
this
permit
that
are
not
saved
for
future
research,
analysis,
or
future
plantings;
we
note
that
moCry1F
corn
is
included
in
the
tolerance
exemption
listed
under
40
CFR
§
180.1217
that
permits
the
use
of
Cry1F
corn
in
food
or
feed.
2
Prior
to
shipment
and/
or
use
of
moCry1F
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
label,
as
well
as
the
non­
confidential
portion
of
the
April
28,
2003
Section
G
to
all
cooperators,
participants,
and
users
prior
to
the
pesticide
applications
made
in
accordance
with
this
EUP
amendment.
The
Agency
is
also
notifying
the
relevant
EPA
Region(
s),
by
sending
them
copies
of
this
EUP.

Conditions
under
which
the
EUP
is
being
amended/
extended
are
as
follows.

1.
The
total
amount
of
moCry1F
corn
seed
to
be
used
will
not
exceed
the
quantity
authorized
by
the
EUP
amendment.

2.
The
permittee
will
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).
We
note
that
the
acreage
listed
in
your
experimental
program
did
not
include
isolation
distances
or
non­
moCry1F
plants
receiving
moCry1F
pollen.
Future
experimental
use
permit
application
requests
and
the
final
report
for
this
permit
amendment
must
include
or
report
on
the
area
of
the
field
planted
to
moCry1F
corn
and
any
plants
intended
to
receive
pollen
from
moCry1F
corn
plants
through
cross
pollination.
A
perimeter
drawn
around
the
circumference
of
such
a
plot
will
serve
as
the
defining
measure
of
what
is
contained
within
the
experimental
plot.
This
must
include
border
row
plantings
where
required.
The
disposition
of
all
planted
moCry1F
corn
and
any
plants
intended
to
receive
pollen
from
moCry1F
corn
plants
must
also
be
reported.

4.
This
experimental
use
permit
is
not
a
limited
seed
increase
registration
under
§
3
of
FIFRA
and
plantings
solely
for
commercial
seed
increase
are
prohibited
3
5.
The
labeling
approved
by
EPA
on
April
11,
2003
must
be
used
for
all
shipments
of
seed
and
be
in
possession
of
the
user
under
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:

STATE
or
COMMONWEALTH
ACREAGE
Hawaii
104
Illinois
21
Indiana
41
Iowa
34.5
Kentucky
1
Louisiana
1
Minnesota
19
Mississippi
1
Nebraska
16
North
Dakota
7
Ohio
7
Puerto
Rico
14
South
Dakota
8
Wisconsin
16
Total
290.5
Sincerely,

/
s/

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