Document ID: EPA-HQ-OPP-2005-0122-0010
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-07-26T04:00Z

MAR
23
2005
Dr.
Demetra
Vlachos
Senior
Manager,
Regulatory
Affairs
Syngenta
Seeds,
Inc.
P.
O.
Box
12257
Research
Triangle
Park,
NC
27709­
2257
Dear
Dr.
Vlachos:

Subject:
Your
12/
15/
2003
Application
and
Revised
Section
G
Dated
2/
4/
2005
Modified
Cry3A
Corn
EPA
Experimental
Use
Permit
No.
67979­
EUP­
4
Effective
Dates:
Plantings
Through
February
28,
2006
and
Associated
Field
Operations
Through
October
15,
2006
Quantity
Authorized:
17,250,000
mCry3A
Corn
Plants
(
15.53
Grams
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
issued
to
test
modified
Cry3A
Bacillus
thuringiensis
protein
and
the
genetic
material
necessary
for
its
production
(
via
elements
of
pZM26)
in
Event
MIR604
corn
(
SYN­
IR6

4­
5).
Shipment
and/
or
use
under
this
Permit
is
subject
to
the
provisions
of
40
CFR
Part
172.
Tolerance
exemptions
currently
under
40
CFR
180.1252
and
being
issued
under
40
CFR
Part
174.456
apply
to
the
plant­
incorporated
protectant
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,
approved
label,
and
experimental
program
section
G
to
all
cooperators,
participants,
and
users
prior
to
the
initial
pesticide
application
made
in
accordance
with
this
EUP.
The
Agency
is
also
notifying
the
relevant
EPA
Region(
s),
by
sending
them
copies
of
this
EUP.
2
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
that
the
agronomically
justified
acreage
as
listed
below
is
not
exceeded
and
that
States
agree
to
the
trials
and
all
other
requirements
of
the
USDA/
APHIS
have
been
met
as
they
apply
to
the
testing.

States
Acres
of
Plants
Derived
From
mCry3A
Corn
Acres
of
Plants
from
Non­
mCry3A
Genotypes
that
are
Part
of
an
EUP
Field
Trial
Protocol,
Including:
Control/
Check
Plants
and
any
Plants
in
Border
Rows,
and
Other
NonmCry3A
Genotypes
Planted
Adjacent
to
the
EUP
Plot
CO
3
41
HI
46
62
IA
244
401
IL
48
762
IN
23
259
KS
4
52
KY
3
21
MD
10
20
MI
13
127
MN
39
327
MO
18
207
MS
1
7
NE
32
415
OH
18
206
PR
41
127
SD
10
91
TX
2
14
WI
20
196
Totals
575
3335
Protocol
Type
EUP
Acreage*
mCry3A
Acreage
Non­
mCry3A
Acreage
Total
EUP
Acreage
Breeding
and
observation
117
279
396
Efficacy
field
trials
94
1,320
1,414
Agronomic
observation
26
284
310
Inbred
and
hybrid
production
298
1,342
1,640
Regulatory
field
trials
(
e.
g.
IRM
and
non­
target
insect
field
trials,
etc.)
40
110
150
Total
575
3,335
3,910
*
EUP
acreage
is
the
sum
of
the
acreage
found
within
the
perimeter
of
all
associated
experimental
blocks.
This
includes
mCry3A
plants,
non­
mCry3A
plants,
and
border
rows
included
within
the
blocks.
3
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).

4.
Per
40
CFR
§
172.4(
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
modified
Cry3A
seed
subsequent
to
receiving
this
approval
and
be
in
possession
of
the
user
under
this
EUP.

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
Sincerely,

/
s/

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