Document ID: EPA-HQ-OPP-2005-0122-0015
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-07-26T04:00Z

MAY
06
2004
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
Application
Dated
April
29,
2003
to
Test
Event
3243M
Corn
and
Confidential
Statement
of
Formula
Dated
May
4,
2004
EPA
Experimental
Use
Permit
No.
67979­
EUP­
3
Effective
Dates:
The
Date
of
this
Letter
Through
August
15,
2005
and
Associated
Activities
Such
as
Collection
of
Field
Data;
Harvesting
&
Processing
of
Seed
After
Last
Planting;
Etc.
Quantity
Authorized:
5,880
lbs
Corn
Seed
(
2.91
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
hereby
issued
to
test
Event
3243M
corn;
Bacillus
thuringiensis
Cry1Ab
protein
and
the
genetic
material
necessary
for
its
production
(
via
elements
of
p2062)
in
corn.
Shipment
and/
or
use
under
this
Permit
is
subject
to
the
provisions
of
40
CFR
Part
172.
Tolerance
exemptions
under
40
CFR
180.1173
and
to
be
issued
under
180.1252
apply
to
the
plant­
incorporated
protectant
and
plant­
incorporated
protectant
inert
ingredient
in
the
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
2
before
you
begin
to
apply
the
experimental
use
product.
You
must
also
provide
a
copy
of
this
authorization
letter
and
approved
label,
as
well
as
the
experimental
program
section
G
(
as
revised
in
item
2
below)
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
Regions,
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,
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
AR
2
AZ
2
CA
2
FL
2
HI
84
IA
39
IL
29
IN
10
KS
3
KY
4
LA
2
MI
5
MN
19
MO
7
MS
3
NC
2
NE
15
NM
2
OH
5
3
States
Acres
PR
37
SD
4
TX
2
WI
14
Total
Acres
294
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.
While
it
is
not
anticipated
that
test
plots
would
be
within
1/
4
mile
of
endangered
or
threatened
Lepidoptera,
your
experimental
program,
section
G,
must
be
modified
by
indicating
no
plantings
may
be
within
1/
4
mile
of
endangered
or
threatened
Lepidoptera
habitats.

3.
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.

4.
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).

5.
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.

6.
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.
A
stamped
copy
of
the
label
which
contains
the
correct
EUP
number,
67979­
EUP­
3,
is
enclosed
for
your
records.
4
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
Copies
of
relevant
reviews
are
enclosed
for
your
information.
Please
note
Carl
Etsitty's
April
21,
2004
review
and
the
comments
regarding
the
detection/
quantification
limits.
While
this
information
is
not
necessary
for
the
EUP,
it
should
be
submitted
prior
to
or
with
an
application
for
registration.

Sincerely,

/
s/

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