Document ID: EPA-HQ-OPP-2003-0117-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-04-03T05:00Z

TRANSMITTAL
DOCUMENT
SUBMITTED
BY
Monsanto
Company
600
13th
Street,
N.
W.
Suite
660
Washington,
DC
20005
REGULATORY
ACTION
IN
SUPPORT
OF
WHICH
THIS
PACKAGE
IS
SUBMITTED
Application
to
Amend
the
Experimental
Use
Permit
for
Event
MON
863,
Corn
Rootworm­
Protected
Corn
(
ZMIR13L),
Permit
No.
524­
EUP­
93
TRANSMITTAL
DATE
April
1,
2003
LIST
OF
SUBMITTED
DOCUMENTS
Volume
1
Administrative
Materials
in
Support
of
Application
to
Amend
the
Experimental
Use
Permit
for
Event
MON
863:
Corn
Rootworm­
Protected
Corn
(
ZMIR13L),
Permit
No.
524­
EUP­
93
Company
Official:
April
1,
2003
Dennis
P.
Ward,
Ph.
D.
Date
Regulatory
Affairs
Manager
Tel.
636­
737­
6631
Company
Name:
Monsanto
Company
Company
Contact:
Russell
P.
Schneider,
Ph.
D.
Regulatory
Affairs
Director
Tel.
202­
383­
2866
Monsanto
Company
00­
CR­
030E­
9
Page
1
of
1
Title
Administrative
Materials
in
Support
of
Application
to
Amend
the
Experimental
Use
Permit
for
Event
MON
863:
Corn
Rootworm­
Protected
Corn
(
ZMIR13L),
Permit
No.
524­
EUP­
93
[
Redacted
Copy]

Data
Requirement
40
CFR
Part
172
Authors
D.
P.
Ward,
Ph.
D.

Submission
Date
April
1,
2003
Registrant
Submitting
Monsanto
Company
600
13th
Street,
N.
W.
Suite
660
Washington,
DC
20005
Registrant
Document
No.

00­
CR­
030E­
9
Volume
1
of
1
Monsanto
Company
00­
CR­
030E­
9
Page
1
of
32
STATEMENT
OF
NO
DATA
CONFIDENTIALITY
CLAIM
No
claim
of
confidentiality
is
made
for
any
information
in
this
application
on
the
basis
of
its
falling
within
the
scope
of
FIFRA
10(
d)(
1)(
A),
(
B),
or
(
C).

Monsanto
submits
this
material
to
the
United
States
Environmental
Protection
Agency
specifically
under
provisions
contained
in
FIFRA
as
amended,
and
consents
to
use
and
disclosure
of
this
material
by
EPA
according
to
FIFRA.
In
submitting
this
material
to
EPA
according
to
method
and
format
requirements
contained
in
PR
Notice
86­
5
and
40
CFR
§
158.33,
we
do
not
waive
any
protection
of
rights
involving
this
material
that
would
have
been
claimed
by
the
company
if
this
material
had
not
been
submitted
to
the
EPA.

Company:
Monsanto
Company
Company
Agent:
_______________________________________
Dennis
P.
Ward,
Ph.
D.
Regulatory
Affairs
Manager
Date:
April
1,
2003
Monsanto
Company
00­
CR­
030E­
9
Page
2
of
32
VOLUME
1
TABLE
OF
CONTENTS
Page
No.

Title.....................................................................................................................
1
Statement
of
No
Data
Confidentiality
Claims....................................................
2
Table
of
Contents................................................................................................
3
Application
to
Amend
EUP
(
Form
8570­
17)......................................................
4
Section
A.
Confidential
Statement
of
Formula.............................................
5
Section
B.
Proposed
Experimental
Use
Permit
Label..................................
6
Section
C.
Reference
to
Available
Toxicity
Data........................................
8
Section
D.
Residue
Data...............................................................................
9
Section
E.
Effectiveness
Data....................................................................
10
Section
F.
Tolerance
if
Testing
Involves
Use
in
Food
or
Feed..................
11
Section
G.
Proposed
Experimental
Program..............................................
12
Section
G.
1.
a
Participants
in
the
Experimental
Program................................
12
Section
G.
1.
b
Cooperators
in
the
Experimental
Program................................
14
Section
G.
2
Acreage,
Seed
and
Active
Ingredient
Quantities
by
State
or
Possession
for
Corn
Event
MON
863
..................
15
Section
G.
3
Program
Details,
Including
Containment.................................
16
Section
G.
4
Program
Objectives...................................................................
31
Section
G.
5
Program
Quantities...................................................................
32
Section
G.
6
Proposed
Duration....................................................................
32
Section
G.
7
Method
of
Disposition
of
Plant
Materials.................................
32
Monsanto
Company
00­
CR­
030E­
9
Page
3
of
32
Please
read
instructions
on
reverse
before
completing
form.
Form
Approved.
OMB
No.
2070­
0040.

United
States
ENVIRONMENTAL
PROTECTION
AGENCY
Washington,
DC
20460
OPP
Identifier
Number
Office
of
Pesticide
Programs
(
7505C)
Application
for
Experimental
Use
Permit
to
Ship
and
Use
a
Pesticide
for
Experimental
Purposes
Only
1.
Type
of
Application
New

Amendment
(
See
No.
2)

Extension
(
Give
Permit
Number
below)
2.
Briefly
explain
(
attach
a
separate
sheet
if
necessary)

Application
to
renew
permit
524­
EUP­
93
for
continued
testing
of
Event
MON
863:
Corn
Rootworm­
Protected
Corn
(
vector
ZMIR13L)
for
the
2003
growing
season;
includes
trials
with
combined
trait
hybrids
Permit
Number
524­
EUP­
93
3.
Name
and
address
of
Firm/
Person
to
Whom
the
Experimental
Use
Permit
is
to
be
Issued
(
include
ZIP
Code)
(
Type
or
Print)
Monsanto
Company
600
13th
Street,
N.
W.,
Suite
660
Washington,
DC
20005
4.
Name
and
address
of
Shipper
only
if
shipment
is
intended
or
if
different
from
applicant's
name
and
address
(
include
Zip
Code)
(
Type
or
Print)

EPA
Company
Number
524
6.
Is
product
registered
with
EPA?

5.
Name
of
Product
Corn
Event
MON
863:
Rootworm­
Protected
Corn
(
Vector
ZMIR13L)
and
hybrids
derived
there
from
No

Yes
(
Give
Registration
Number
or
File
Symbol
below)

Registration
Number
524­
528
File
Symbol
524­
LEI
&
524­
LUL
.
Total
Quantity
of
Product
Proposed
for
Shipment/
Use
7
Pounds
of
formulated
product
36,864
lb
Pounds
of
active
ingredient
3.54
lb
8.
Acreage
or
Area
to
be
Treated
2,304
acres
9.
Proposed
Period
of
Shipment/
Use
May
15,
2003
 
June
30,
2004
10.
Places
from
which
shipped
Materials
present
on­
site
11.
Crops/
Site
to
be
Treated
Corn
12.
Specify
the
name
and
number
of
the
contact
person
most
familiar
with
this
application.
13.
Signature
of
Applicant
or
Authorized
Firm
Representative
Dennis
P.
Ward
Tel.
636­
737­
6631
14.
Title
Regulatory
Affairs
Manager
15.
Date
Signed
April
1,
2003
Certification
This
is
to
certify
that
food
and
feed
derived
from
the
experimental
program
will
not
be
used
or
offered
for
consumption
or
sale
for
consumption,
except
by
laboratory
or
experimental
animals,
if
illegal
residues
are
present
in
or
on
such
food
or
feed.
I
certify
that
the
statements
I
have
made
on
this
form
and
all
attachments
thereto
are
true,
accurate,
and
complete.
I
acknowledge
that
any
knowingly
false
or
misleading
statement
may
be
punishable
by
fine
or
imprisonment,
or
both,
under
applicable
law.

Below
for
EPA
Use
Only
In
any
correspondence
on
this
application,
refer
to
this
number
Received
by:
EPA­
OPP
Registration
Division
Washington,
DC
20460
Normal
review
time
indicates
that
processing
of
this
application
should
be
completed
by
(
date)

Name
of
EPA
Contact
Person
Telephone
Number
EPA
Form
8570­
17
(
Rev.
1­
94)
Previous
editions
are
obsolete
Monsanto
Company
00­
CR­
030E­
9
Page
4
of
32
Section
A.
Confidential
Statement
of
Formula
On
file
at
EPA,
refer
to
Transmittal
dated
February
20,
2003:
"
Amendment
of
the
Application
to
Register
a
Bacillus
thuringiensis
Cry3Bb1
Protein
and
the
Genetic
Material
Necessary
for
its
Production
(
Vector
ZMIR13L)
in
Event
MON
863
Corn".
EPA
File
Symbol
524­
LEI.
Registration
for
Event
MON
863
Corn
was
granted
on
February
24,
2003,
and
assigned
EPA
registration
number,
524­
528.

Monsanto
Company
00­
CR­
030E­
9
Page
5
of
32
Section
B.
Proposed
Experimental
Use
Permit
Label
On
May
11,
2001,
EPA
established
a
time­
limited
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
plant­
pesticide
Bacillus
thuringiensis
Cry3Bb1
protein
and
the
genetic
material
necessary
for
its
production
in
corn
on
field
corn,
sweet
corn
and
popcorn
(
66
FR
24061).
A
safety
and
nutritional
assessment
consultation
for
corn
event
MON
863
has
been
completed
with
the
U.
S.
Food
and
Drug
Administration
(
FDA).
This
consultation
established
that
corn
varieties
containing
event
MON
863
are
not
materially
different
in
composition,
safety
and
other
relevant
parameters
from
corn
currently
on
the
market
and
that
MON
863
does
not
raise
issues
that
would
require
premarket
review
or
approval
by
FDA1
.
Grain,
silage,
and/
or
forage
produced
under
this
EUP
may
be
released
into
commerce
and
used
as
food
or
feed.

On
October
8,
2002,
the
U.
S.
Department
of
Agriculture
(
USDA)
made
a
determination
of
nonregulated
status
for
corn
event
MON
863
(
67
FR
65087).
An
Environmental
Assessment
and
Finding
of
No
Significant
Impact
were
part
of
the
USDA
determination.

Other
transgenic
corn
events
that
will
be
crossed
to
MON
863
lines
for
purposes
of
creating
a
combined
trait
plant­
incorporated
protectant
will
also
have
received
a
determination
of
nonregulated
status
from
USDA.

1
FDA
letter
to
Monsanto;
http://
www.
cfsan.
fda.
gov/~
rdb/
bnfL075.
html
Monsanto
Company
00­
CR­
030E­
9
Page
6
of
32
FOR
EXPERIMENTAL
USE
ONLY
Not
for
sale
to
any
person
other
than
a
participant
or
cooperator
of
the
EPA­
approved
Experimental
Use
Program.

For
use
only
at
a
site
of
a
participant
or
cooperator
and
in
accordance
with
the
terms
and
conditions
of
the
Experimental
Use
Permit.
This
labeling
must
be
in
possession
of
the
user
at
the
time
of
planting.

EPA
EXPERIMENTAL
USE
PERMIT
NUMBER
524­
EUP­
93
Event
MON
863:
Corn
Rootworm­
Protected
Corn
Seed
This
package
contains
corn
rootworm­
protected
corn
seed
producing
Cry3Bb1,
an
insecticidal
protein
from
Bacillus
thuringiensis.
This
protein
is
effective
in
controlling
corn
rootworm
(
Diabrotica
spp.)
larvae.

Active
Ingredient:
Bacillus
thuringiensis
Cry3Bb1
protein
and
the
genetic
material
necessary
for
its
production
(
ZMIR13L)
in
event
MON
863
corn
.....................................
0.001
­
0.006
%*

Inert
Ingredients:
Substance
produced
by
a
marker
gene
and
the
genetic
material
necessary
for
its
production
(
ZMIR13L)
in
corn...........................................................
0.00002
­
0.00003
%

*
Maximum
percent
(
wt/
wt)
of
dry
grain.

Monsanto
Company
700
Chesterfield
Parkway
West
St.
Louis,
MO
63017
Keep
Out
Of
Reach
Of
Children.

CAUTION
DIRECTIONS
FOR
USE
Use
of
this
seed
in
a
manner
inconsistent
with
the
terms
of
this
Experimental
Use
Permit
is
a
violation
of
Federal
law.

The
contents
may
only
be
used
according
to
the
approved
EUP
program.
Cooperators
must
have
at
least
one
copy
of
each
applicable
protocol
prior
to
initiating
any
research
with
the
contents.

DISPOSAL
Any
seed
not
used
in
these
experiments
must
be
returned
to
Monsanto
Company
or
seed
company
partners
/
affiliates,
or
disposed
of
as
specified
in
the
field
protocols.

Monsanto
Company
00­
CR­
030E­
9
Page
7
of
32
Section
C.
Reference
to
Available
Toxicity
Data
Studies
conducted
to
evaluate
the
toxicity
of
Cry3Bb1
protein
have
been
previously
submitted
to
the
Agency
and
are
listed
by
MRID
number
below:

454240­
00
454240­
01
454240­
02
454240­
05
454240­
07
454240­
08
454240­
09
454240­
10
454240­
11
455382­
01
455382­
02
455382­
03
455382­
09
455770­
00
455770­
02
Monsanto
Company
00­
CR­
030E­
9
Page
8
of
32
Section
D.
Residue
Data
Refer
to
the
study
on
Cry3Bb1
and
NPTII
protein
levels
in
tissue
samples
collected
from
corn
event
MON
863
(
MRID
No.
454240­
01).
An
analytical
method
for
detection
of
Cry3Bb1
in
corn
grain
has
also
been
submitted
to
EPA
(
MRID
No.
453731­
01).
An
exemption
from
the
requirement
of
a
tolerance
has
been
established
for
both
Cry3Bb1
(
40
CFR
§
180.1214)
and
NPTII
(
40
CFR
§
180.1134).
Other
Bt
proteins
produced
in
a
combined
trait
hybrid
with
MON
863
will
also
have
received
an
exemption
from
the
requirement
of
a
tolerance
from
EPA
(
e.
g.
Cry1Ab).

Monsanto
Company
00­
CR­
030E­
9
Page
9
of
32
Section
E.
Effectiveness
Data
The
results
of
multiple
field
efficacy
trials
with
event
MON
863
have
been
previously
submitted
to
the
Agency.
Refer
to
the
Administrative
Volume
submitted
June
20,
2000
(
MRID
45156800),
the
data
volume
submitted
March
20,
2001
(
MRID
45361303),
and
the
data
volume
submitted
January
8,
2002
(
MRID
455770­
01).

Monsanto
Company
00­
CR­
030E­
9
Page
10
of
32
Section
F.
Tolerance
if
Testing
Involves
Use
in
Food
or
Feed
The
Agency
has
recently
established
a
time­
limited
exemption
from
the
requirement
of
a
tolerance
for
Cry3Bb1
protein
and
the
genetic
material
necessary
for
its
production
in
corn
on
field
corn,
sweet
corn
and
popcorn
(
40
CFR
§
180.1214).
).
Other
Bt
proteins
produced
in
a
combined
trait
hybrid
with
MON
863
will
also
have
received
an
exemption
from
the
requirement
of
a
tolerance
from
EPA
(
e.
g.
Cry1Ab).

Monsanto
Company
00­
CR­
030E­
9
Page
11
of
32
Section
G.
Proposed
Experimental
Program
G.
1.
a.
Experimental
Use
Permit:
Participants
in
the
Experimental
Program
Table
1.
List
of
Participants
who
will
supervise
experimental
work
conducted
under
this
EUP.
All
Participants
are
research
scientists
employed
by
Monsanto
Company.

{
CBI
Cross
Reference
Number
1}

Monsanto
Company
00­
CR­
030E­
9
Page
12
of
32
Table
1
(
cont.).
List
of
Participants
who
will
supervise
experimental
work
conducted
under
this
EUP.
All
Participants
are
research
scientists
employed
by
Monsanto
Company.

{
CBI
Cross
Reference
Number
1}

Monsanto
Company
00­
CR­
030E­
9
Page
13
of
32
G.
1.
b.
Experimental
Use
Permit:
Cooperators
in
the
Experimental
Program
Tables
2.
List
of
Cooperators
Involved
in
the
Experimental
Work
Conducted
under
this
EUP.

The
names,
addresses
and
telephone
numbers
of
the
Cooperators
in
this
program
will
be
provided
to
the
Agency
prior
to
planting
or
initiation
of
research
trials.

Monsanto
Company
00­
CR­
030E­
9
Page
14
of
32
G.
2.
Acreage,
Seed
and
Active
Ingredient
Quantities
by
State
or
Possession
for
Event
MON
863:
Corn
Rootworm­
Protected
Corn
(
ZMIR13L)

Table
3.
Tabulation
of
proposed
acreage
and
active
ingredient
quantities
for
each
state.

State
Acreage
Planting
Seed
(
lb)
Active
Ingredient
in
Planting
Seed
(
g)
AL
8
128
6
AR
8
128
6
CA
225
3,600
157
CO
74
1,184
52
DE
8
128
6
FL
8
128
6
GA
8
128
6
HI
400
6,400
229
IA
139
2,224
97
ID
8
128
6
IL
139
2,224
97
IN
139
2,224
97
KS
74
1,184
52
KY
8
128
6
LA
8
128
6
MD
8
128
6
MI
68
1,088
47
MN
139
2,224
97
MO
68
1,088
47
MS
8
128
6
MT
8
128
6
NC
8
128
6
ND
38
608
26
NE
139
2,224
97
NM
8
128
6
NY
68
1,088
47
OH
74
1,184
52
OK
38
608
26
PA
68
1,088
47
PR
100
1,600
70
SD
74
1,184
52
TN
8
128
6
TX
38
608
26
UT
8
128
6
VA
8
128
6
WI
74
1,184
52
Total
2,304
acres
36,864
lbs
1,606
grams
1Based
on
a
maximum
of
0.0096
%
Cry3Bb1
protein
by
dry
weight
in
corn
seed.

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G.
3
Program
Details,
Including
Containment
G.
3.
a.
Crop
Corn
(
Zea
mays)
Event
MON
863:
Corn
Rootworm­
Protected
Corn
(
Vector
ZMIR13L)
and
hybrids
thereof,
including
hybrids
created
by
crossing
MON
863
to
corn
lines
containing
other
registered
insect­
protected
traits
(
e.
g.
MON
810).

G.
3.
b.
Target
Pests
Corn
rootworm
species
(
Diabrotica
spp.).
Efficacy
against
lepidopteran
insects
will
also
be
evaluated
in
the
combined
trait
hybrids.

G.
3.
c.
Major
Geographic
Areas
35
States
and
Puerto
Rico,
representing
diverse
agronomic
zones
G.
3.
d.
Sites
Research
stations,
seed
production
fields,
privately
owned
farms,
and
University
farms.

G.
3.
e.
Season
of
Use
May
15,
2003
through
June
30,
2004
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G.
3.
f.
Trial
Types
G.
3.
f.
1.
Protocol
#
1
­
BREEDING
AND
OBSERVATION
NURSERY
Objective
Observe
the
phenotype
of
corn
expressing
the
cry3Bb1
gene
in
different
elite
corn
lines
derived
from
event
MON
863
(
vector
ZMIR13L)
and/
or
maintain
these
transgenic
lines
through
seed
production.

Description
Material
containing
the
cry3Bb1
gene
will
be
hand
pollinated,
either
self­
pollinated,
backcrossed
or
crossed
to
a
tester
line,
and/
or
be
sampled
for
various
types
of
laboratory
analyses
to
determine
phenotype
and/
or
genotype.
Some
or
all
lines
may
be
hand
pollinated
with
nontransgenic
or
other
transgenic
corn.

Genotypes
and
Vectors
Test
material
will
consist
of
corn
event
MON
863
(
vector
ZMIR13L)
in
different
corn
genetic
backgrounds.
Hybrids
containing
event
MON
863
in
combination
with
other
EPA­
registered
events
(
e.
g.,
MON
810,
Cry1F,
etc.)
will
also
be
evaluated.

Sampling
Plant
tissue
(
including
seed)
and/
or
whole
plant
samples
may
be
collected
during
the
growing
season
and
returned
to
Monsanto
or
other
laboratories
for
analysis.

Isolation
and
Containment
No
special
isolation
or
containment
procedures
are
required.

Schedule
Hawaii
and
Puerto
Rico:
Number
of
plantings
per
site:
continuous.
Continental
U.
S.:
Number
of
plantings
per
site:
up
to
two.

Approx.
Planting
Dates:
February
through
June
Approx.
Harvest
Dates:
August
through
November
Monsanto
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Final
Disposition
Unused
planting
seed
will
be
destroyed,
used
for
other
research
purposes,
used
as
food
or
feed,
or
returned
to
Monsanto
or
seed
company
partners
and
affiliates.
At
the
end
of
the
growing
season
the
corn
may
be
harvested.
Following
completion
of
data
collection
and/
or
harvest,
all
corn
plants
in
the
genetically
engineered
trial
will
be
destroyed
(
see
G.
7).
Harvested
materials
may
be
retained
for
use
in
further
research,
used
as
food
or
feed,
or
used
as
future
planting
seed.

Monsanto
Company
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G.
3.
f.
2.
Protocol
#
2
­
INBRED
SEED
INCREASE
PRODUCTION
Objective
Produce
quantities
of
seed
and
plant
material
for
further
testing
and
product
development.

Description
Various
elite
inbred
corn
lines
containing
the
cry3Bb1
gene
will
be
allowed
to
open
pollinate
in
isolation
to
generate
seed.

Genotypes
and
Vectors
Test
material
will
consist
of
corn
event
MON
863
(
vector
ZMIR13L)
in
different
corn
genetic
backgrounds.
Hybrids
containing
event
MON
863
in
combination
with
other
EPA­
registered
events
will
also
be
evaluated.

Sampling
Plant
tissue
(
including
seed)
and/
or
whole
plant
samples
may
be
collected
during
the
growing
season
and
returned
to
Monsanto
or
other
laboratories
for
analysis.

Isolation
No
special
isolation
or
containment
procedures
are
needed.

Schedule
Hawaii
and
Puerto
Rico:
Number
of
plantings
per
site:
continuous.
Continental
U.
S.:
Number
of
plantings
per
site:
up
to
two.
Approx.
Planting
Dates:
February
through
June
Approx.
Harvest
Dates:
August
through
November
Final
Disposition
Unused
planting
seed
will
be
destroyed,
used
for
further
research,
used
as
food
or
feed,
or
returned
to
Monsanto
or
seed
company
partners
/
affiliates.
At
the
end
of
the
growing
season
the
corn
may
be
harvested.
Following
completion
of
data
collection
and/
or
harvest,
all
corn
plants
in
the
genetically
engineered
trial
will
be
destroyed
(
see
G.
7).
Harvested
materials
may
be
retained
for
use
in
further
research,
used
as
food
or
feed,
or
used
as
future
planting
seed.

Monsanto
Company
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G.
3.
f.
3.
Protocol
#
3
­
LINE
PER
SE
AND
HYBRID
YIELD
TRIAL
Objective
Assess
any
agronomic
effects
of
the
genetic
insertion
in
corn
event
MON
863
(
vector
ZMIR13L)
in
different
corn
genetic
backgrounds.

Description
Corn
lines
will
be
planted
in
a
randomized
design
or
single
large
blocks.
Each
line
may
be
represented
by
a
segregant
without
the
cry3Bb1
gene
and
a
segregant
with
the
cry3Bb1
gene
in
inbred
and
hybrid
formats.
These
trials
could
include
up
to
100
different
lines
per
location.
Lines
will
be
evaluated
for
several
agronomic
characteristics,
such
as
early
vigor,
plant
color,
plant
height,
days
to
flowering,
days
to
maturity,
yield
and
test
weight.
At
some
sites,
multiple
sets
of
this
type
of
trial
may
be
conducted.
These
will
be
considered
as
unique
locations
for
computational
purposes.

Genotypes
and
Vectors
Test
material
will
consist
of
corn
event
MON
863
(
vector
ZMIR13L)
in
different
corn
genetic
backgrounds.
Hybrids
containing
event
MON
863
in
combination
with
other
EPA­
registered
events
will
also
be
evaluated.

Sampling
Plant
tissue
(
including
seed)
and/
or
whole
plant
samples
may
be
collected
during
the
growing
season
and
returned
to
Monsanto
or
other
laboratories
for
analysis.

Isolation
No
special
isolation
or
containment
procedures
are
needed.

Schedule
Hawaii:
Number
of
plantings
per
site:
continuous.
Continental
U.
S.:
Number
of
plantings
per
site:
up
to
two.
Approx.
Planting
Dates:
February
through
June
Approx.
Harvest
Dates:
August
through
November
Final
Disposition
Unused
planting
seed
will
be
destroyed,
used
for
further
research,
used
as
food
or
feed,
or
returned
to
Monsanto
or
seed
company
partners/
affiliates.
At
the
end
of
the
growing
season
the
corn
may
be
harvested.
Following
completion
of
data
collection
and/
or
harvest,
all
corn
plants
in
the
genetically
engineered
trial
will
be
destroyed
(
see
G.
7).
Harvested
materials
Monsanto
Company
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030E­
9
Page
20
of
32
may
be
retained
for
use
in
further
research,
used
as
food
or
feed,
or
used
as
future
planting
seed.

Monsanto
Company
00­
CR­
030E­
9
Page
21
of
32
G.
3.
f.
4.
Protocol
#
4
­
INSECT
EFFICACY
TRIALS
Objective
Assess
the
efficacy
of
corn
expressing
the
cry3Bb1
gene
in
different
corn
genetic
backgrounds
against
corn
rootworm
and
other
potential
soil
pests
of
corn.
Efficacy
against
a
number
of
lepidopteran
pests
will
be
evaluated
in
combined
trait
hybrids.

Description
Lines
will
be
planted
in
a
randomized
design
or
single
large
blocks.
Nontransgenic
negative
segregants
of
the
Cry3Bb1
corn
will
be
used
as
untreated
checks
and
treated
with
insecticide
standards.
Treatments
will
be
evaluated
for
efficacy
against
corn
rootworm,
several
other
insect
pests
and
yield.
At
some
sites,
multiple
sets
of
this
type
of
trial
may
be
conducted.
These
will
be
considered
as
unique
locations
for
computational
purposes.

Genotypes
and
Vectors
Test
material
will
consist
of
corn
event
MON
863
(
vector
ZMIR13L)
in
different
corn
genetic
backgrounds.
Hybrids
containing
event
MON
863
in
combination
with
other
EPA­
registered
events
will
also
be
evaluated.

Sampling
Plant
tissue
(
including
seed)
and/
or
whole
plant
samples
may
be
collected
during
the
growing
season
and
returned
to
Monsanto
or
other
laboratories
for
analysis.

Isolation
No
special
isolation
or
containment
procedures
are
required.

Schedule
Hawaii
and
Puerto
Rico:
Number
of
plantings
per
site:
continuous.
Continental
U.
S.:
Maximum
number
of
plantings
per
site:
up
to
two.
Approx.
Planting
Dates:
February
through
June
Approx.
Harvest
Dates:
August
through
November
Final
Disposition
Unused
planting
seed
will
be
destroyed,
used
for
other
research,
used
as
food
or
feed,
or
returned
to
Monsanto
or
seed
company
partners/
affiliates.
At
the
end
of
the
growing
season,
the
corn
may
be
harvested
for
further
research
purposes.
Following
completion
of
data
collection
and/
or
harvest,
all
corn
plants
in
the
genetically
engineered
trial
will
be
destroyed
Monsanto
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030E­
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of
32
(
see
G.
7).
Harvested
materials
may
be
retained
for
use
in
further
research,
used
as
food
or
feed,
or
used
as
future
planting
seed.

Monsanto
Company
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G.
3.
f.
5.
Protocol
#
5
­
PRODUCT
CHARACTERIZATION,
PERFORMANCE
AND
LABELING
TRIALS
Objective
To
produce
grain
and
plant
material
for
product
characterization,
further
regulatory
testing,
benefit
studies,
and
product
labeling
purposes.

Description
Material
expressing
the
cry3Bb1
gene
will
be
either
hand
pollinated
or
open
pollinated
to
generate
seed
and/
or
sampled
for
various
types
of
laboratory
analyses,
such
as
composition,
equivalency,
phenotype
and
molecular
characterization.
Some
or
all
lines
may
be
hand
pollinated
or
open
pollinated
with
nontransgenic
or
other
transgenic
corn.

Genotypes
and
Vectors
Test
material
will
consist
of
corn
event
MON
863
(
vector
ZMIR13L)
in
different
corn
genetic
backgrounds.
Hybrids
containing
event
MON
863
in
combination
with
other
EPA­
registered
events
will
also
be
evaluated.

Sampling
Plant
tissue
(
including
seed)
and/
or
whole
plant
samples
may
be
collected
during
the
growing
season
and
returned
to
Monsanto
or
other
laboratories
for
analysis.

Isolation
No
special
isolation
or
containment
procedures
are
required.

Schedule
Hawaii
and
Puerto
Rico:
Number
of
plantings
per
site:
continuous.
Continental
U.
S.:
Maximum
number
of
plantings
per
site:
up
to
two.
Approx.
Planting
Dates:
February
through
June
Approx.
Harvest
Dates:
August
through
November
Final
Disposition
Unused
planting
seed
will
be
destroyed,
used
for
other
research,
used
as
food
or
feed,
or
returned
to
Monsanto
or
seed
company
partners/
affiliates.
At
the
end
of
the
growing
season,
the
corn
may
be
harvested
for
further
research
purposes.
Following
completion
of
data
collection
and/
or
harvest,
all
corn
plants
in
the
genetically
engineered
trial
will
be
destroyed
(
see
G.
7).
Harvested
materials
may
be
retained
for
use
in
further
research,
used
as
food
or
feed,
or
used
as
future
planting
seed.

Monsanto
Company
00­
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030E­
9
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32
G.
3.
f.
6.
Protocol
#
6
­
INSECT
RESISTANCE
MANAGEMENT
TRIALS
Objective
To
develop
additional
data
for
use
in
further
refining
a
corn
rootworm
insect
resistance
management
(
IRM)
plan.
Studies
include
characterizing
dose,
larval
movement,
adult
movement
and
mating
behavior,
and
effects
of
Cry3Bb1
protein
on
adult
fitness.

Description
Trials
will
be
planted
in
a
randomized
design
or
single
large
blocks.
Nontransgenic
negative
segregants
of
the
Cry3Bb1
corn
will
be
used
as
untreated
checks
and
treated
with
insecticide
standards.
Adult
emergence
studies
will
be
conducted
in
conjunction
with
efficacy
trials.
Larval
movement
studies
will
look
at
across
row
and
within
row
movement
from
both
transgenic
and
nontransgenic
corn.
Seed
mix
trials
will
include
several
ratios
of
transgenic
to
nontransgenic
plants.
Efficacy,
adult
emergence,
and
yield
from
each
treatment
will
be
evaluated.
Adults
collected
from
these
trials
will
be
evaluated
for
fitness.

Genotypes
and
Vectors
Test
material
will
consist
of
corn
event
MON
863
(
vector
ZMIR13L)
in
different
corn
genetic
backgrounds.

Sampling
Plant
tissue
(
including
seed)
and/
or
whole
plant
samples
may
be
collected
during
the
growing
season
and
returned
to
Monsanto
or
other
laboratories
for
analysis.

Isolation
No
special
isolation
or
containment
procedures
are
required.

Schedule
Hawaii
and
Puerto
Rico:
Number
of
plantings
per
site:
continuous.
Continental
U.
S.:
Number
of
plantings
per
site:
up
to
two.
Approx.
Planting
Dates:
February
through
June
Approx.
Harvest
Dates:
August
through
November
Final
Disposition
Unused
planting
seed
will
be
destroyed,
used
for
other
research,
used
as
food
or
feed,
or
returned
to
Monsanto
or
seed
company
partners
/
affiliates.
At
the
end
of
the
growing
season,
the
corn
may
be
harvested
for
further
research
purposes.
Following
completion
of
data
collection
and/
or
harvest,
all
corn
plants
in
the
genetically
engineered
trial
will
be
Monsanto
Company
00­
CR­
030E­
9
Page
25
of
32
destroyed
(
see
G.
7).
Harvested
seed
may
be
retained
for
use
in
further
research,
used
as
food
or
feed,
or
used
as
future
planting
seed.

Monsanto
Company
00­
CR­
030E­
9
Page
26
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32
G.
3.
f.
7.
Protocol
#
7
­
NONTARGET
ORGANISMS
AND
BENEFIT
TRIALS
Objective
Develop
additional
data
to
assess
the
impact
of
Cry3Bb1
protein
on
nontarget
organisms,
including
a
wide
variety
of
soil
and
surface­
dwelling
organisms.
The
potential
for
interactive
effects
of
multiple
Bt
proteins
on
nontarget
organisms
will
be
evaluated
in
the
combined
trait
hybrids.

Description
Trials
will
be
planted
in
a
randomized
design
or
single
large
blocks.
Observations
will
be
made
across
a
wide
variety
of
environments.
Nontransgenic
negative
segregants
of
the
Cry3Bb1
corn
will
be
used
as
untreated
checks
and
treated
with
insecticide
standards.
Cry3Bb1
protein
will
be
measured
in
the
soil
of
transgenic
and
nontransgenic
plots.
From
these
same
plots,
microbial
community
structure,
earthworm
populations,
terrestrial
invertebrates
on
and
below
the
soil
surface
will
be
measured.
The
potential
for
additive
or
synergistic
effects
between
Cry1
and
Cry3Bb
proteins
will
be
evaluated
in
combined
trait
hybrids.

Genotypes
and
Vectors
Test
material
will
consist
of
corn
event
MON
863
(
vector
ZMIR13L)
in
different
corn
genetic
backgrounds.
Hybrids
containing
event
MON
863
in
combination
with
other
EPA­
registered
events
will
also
be
evaluated.

Sampling
Plant
tissue
(
including
seed)
and/
or
whole
plant
samples
may
be
collected
during
the
growing
season
and
returned
to
Monsanto
or
other
laboratories
for
analysis.

Isolation
No
special
isolation
or
containment
procedures
are
required.

Schedule
Hawaii
and
Puerto
Rico:
Number
of
plantings:
continuous.
Continental
U.
S.:
Number
of
plantings
per
site:
up
to
two.
Approx.
Planting
Dates:
February
through
June
Approx.
Harvest
Dates:
August
through
November
Final
Disposition
Unused
planting
seed
will
be
destroyed,
used
for
other
research,
used
as
food
or
feed,
or
returned
to
Monsanto
or
seed
company
partners
/
affiliates.
At
the
end
of
the
growing
Monsanto
Company
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season,
the
corn
may
be
harvested
for
further
research
purposes.
Following
completion
of
data
collection
and/
or
harvest,
all
corn
plants
in
the
genetically
engineered
trial
will
be
destroyed
(
see
G.
7).
Harvested
materials
may
be
retained
for
use
in
further
research,
used
as
food
or
feed,
or
used
as
future
planting
seed.

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G.
3.
f.
8.
Protocol
#
8
­
SEED
TREATMENT
TRIALS
Objective
To
evaluate
effects
of
diverse
seed
treatments,
in
combination
with
transgenic
corn,
on
corn
rootworm
and
additional
insect
pests.

Description
Transgenic
and
nontransgenic
seed
will
be
coated
with
a
variety
of
seed
treatments
that
will
contain
an
array
of
soil
insecticides
and
other
insect
deterrents.
Trials
will
be
planted
in
a
randomized
design
or
single
large
blocks.
Nontransgenic
negative
segregants
of
the
Cry3Bb1
corn
will
be
used
as
untreated
checks
and
treated
with
insecticide
standards.
Treatments
will
be
evaluated
for
efficacy
against
corn
rootworm,
other
insect
pests,
and
effects
of
the
seed
treatment
on
agronomic
characteristics,
such
as
germination
and
seedling
vigor.

Genotypes
and
Vectors
Test
material
will
consist
of
corn
event
MON
863
(
vector
ZMIR13L)
in
different
corn
genetic
backgrounds.

Sampling
Plant
tissue
(
including
seed)
and/
or
whole
plant
samples
may
be
collected
during
the
growing
season
and
returned
to
Monsanto
or
other
laboratories
for
analysis.

Isolation
No
special
isolation
or
containment
procedures
are
required.

Schedule
Hawaii
and
Puerto
Rico:
Number
of
plantings:
continuous.
Continental
U.
S.:
Number
of
plantings
per
site:
up
to
two.
Approx.
Planting
Dates:
February
through
June
Approx.
Harvest
Dates:
August
through
November
Final
Disposition
Unused
planting
seed
will
be
destroyed,
used
for
further
research,
used
as
food
or
feed,
or
returned
to
Monsanto
or
seed
company
partners
/
affiliates.
At
the
end
of
the
growing
season,
the
corn
may
be
harvested
for
further
research
purposes.
Following
completion
of
data
collection
and/
or
harvest,
all
corn
plants
in
the
genetically
engineered
trial
will
be
destroyed
(
see
G.
7).
Harvested
materials
may
be
retained
for
use
in
further
research,
used
as
food
or
feed,
or
used
as
future
planting
seed.

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G.
3.
g.
Containment
Procedures
On
October
8,
2002,
the
USDA
granted
nonregulated
status
to
all
corn
lines
containing
event
MON
863.
Therefore,
no
special
containment
procedures
are
required
for
the
storage,
transportation
or
environmental
release
of
MON
863
corn
seed.

1.
Disposal
of
Leftover
Planting
Seed
Seed
unused
for
planting
will
be
either:
1)
destroyed
by
incineration,
autoclaving
or
buried
in
the
test
field,
or
2)
returned
to
a
secure
storage
location,
or
3)
returned
to
Monsanto
Company
or
seed
company
partners
/
affiliates,
or
4)
used
as
food
or
animal
feed
2.
Field
Operations
a.
Personnel
Workers
in
the
trial
site
area
will
be
informed
that
no
plant
material
is
to
be
removed
from
the
marked
trial
site
without
direct
authorization.
Where
trials
are
located
on
privately
owned
farms,
the
responsible
researcher
will
inform
the
owner
of
the
farm
as
to
the
nature
of
the
experiment
and
the
need
to
maintain
the
plants
and
seed
separate
from
other
plant
material
not
part
of
the
trial.

b.
Planting
These
trials
will
be
planted
only
at
locations
to
be
specified
in
the
EPA
Experimental
Use
Permit.

3.
Trial
completion
a.
Destruction
After
harvest
or
completion
of
data
collection,
all
corn
plants
in
the
trial,
including
MON
863
plants,
nontransgenic
controls,
and
nontransgenic
buffer
plants
will
be
destroyed.
Methods
standard
for
the
area
will
be
employed
(
brush­
hog;
shred
and
disk,
etc.),
in
compliance
with
any
local
plow
down
regulations.
Waste
plant
materials
may
be
plowed
under,
burned
in
the
field
(
subject
to
local
burning
ordinances),
or
otherwise
devitalized.

b.
Crop
rotation
In
the
continental
U.
S.,
the
trial
site
may
be
rotated
to
a
different
crop,
planted
with
corn
again,
or
left
fallow.

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Section
G.
4
Program
Objectives
This
application
for
amendment
of
Experimental
Use
Permit
524­
EUP­
93
will
allow
for
continued
field
testing
and
development
of
combined
insecticidal
trait
hybrids
formed
through
breeding
of
event
MON
863
with
other
EPA­
approved
Bt
corn
products
(
e.
g.,
Cry1Ab).
This
research
program
is
multi­
faceted
and
includes
both
hybrid
development
and
agronomic
tests
to
evaluate
how
corn
with
the
corn
rootworm­
protected
trait
can
be
utilized
by
growers.
Testing
is
separated
into
several
key
areas,
as
described
below:

Protocol
#
1
­
Breeding
and
Observation
Nursery
(
approximately
10%
of
requested
acres)

Observe
the
phenotype
of
corn
containing
the
cry3Bb1
gene
in
different
elite
lines
derived
from
event
MON
863
(
vector
ZMIR13L)
and/
or
maintain
these
transgenic
lines
through
seed
production.
Create
combined
trait
hybrids
containing
event
MON
863
and
other
EPA­
approved
Bt
events.

Protocol
#
2
­
Inbred
Seed
Increase
Production
(
approx.
19%
of
requested
acres)

Produce
quantities
of
seed
and
plant
material
for
further
testing
and
product
development.

Protocol
#
3
­
Line
Per
Se
and
Hybrid
Yield
Trial
(
approx.
48%
of
requested
acres)

Assess
any
agronomic
effects
of
the
cry3Bb1
gene
insertion
event
MON
863
(
vector
ZMIR13L)
in
different
corn
genetic
backgrounds.

Protocol
#
4
­
Insect
Efficacy
Trials
(
approx.
19%
of
requested
acres)

Assess
any
efficacy
of
corn
expressing
Cry3Bb1
protein
in
different
corn
genetic
backgrounds
against
corn
rootworm
and
other
potential
soil
pests
of
corn.
Assess
efficacy
of
combined
trait
hybrids
against
both
corn
rootworms
and
lepidopteran
pests.

Protocol
#
5
­
Product
Characterization,
Performance
and
Labeling
Trials
(
approx.
1%
of
requested
acres)

To
produce
grain
and
plant
material
for
product
characterization,
further
regulatory
testing,
benefit
studies,
and
product
labeling
purposes.

Protocol
#
6
­
Insect
Resistance
Management
Trials
(
approx.
1%
of
requested
acres)

To
develop
additional
data
in
support
of
further
refining
a
corn
rootworm
IRM
plan.
Studies
include
characterizing
dose,
CRW
larval
movement,
adult
movement
and
mating
behavior,
and
effects
of
Cry3Bb1
protein
exposure
on
adult
fitness.

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Protocol
#
7
­
Nontarget
Organisms
and
Benefit
Trials
(
approx.
1%
of
requested
acres)

Develop
additional
data
to
assess
the
impact
of
Cry3Bb1
protein
on
nontarget
organisms
including
a
wide
variety
of
soil
and
surface­
dwelling
organisms.
Also
evaluate
impact
of
combined
insecticidal
trait
hybrids
on
a
variety
of
nontarget
organisms.

Protocol
#
8
­
Seed
Treatment
Trials
(
approx.
1%
of
requested
acres)

To
evaluate
effects
of
diverse
seed
treatments,
in
combination
with
transgenic
corn,
on
corn
rootworm
and
additional
insect
pests.

Section
G.
5
Program
Quantities
 
A
maximum
of
2,304
acres
of
the
corn
rootworm­
protected
corn
event
MON
863
(
vector
ZMIR13L)
and
hybrids
thereof
will
be
planted
(
Section
G.
2).

 
This
acreage
is
necessary
to
adequately
meet
the
extensive
program
objectives,
varied
insect
species,
infestation
levels,
and
weather
conditions
found
in
U.
S.
corn
growing
regions.

 
In
the
development
of
insect
resistant
genetically
engineered
plants,
it
is
necessary
to
properly
characterize
the
crop
performance
on
a
large
scale
and
to
produce
sufficient
seed
to
continue
similar
research
and
development
in
subsequent
seasons.

Section
G.
6
Proposed
Duration
May
15,
2003
through
June
30,
2004
Section
G.
7
Method
of
Disposition
of
Plant
Materials
Disposition
of
plant
materials
at
the
conclusion
of
the
testing
program
will
be
as
follows:

Unused
seed
for
planting
will
be
either:
1)
returned
to
a
secure
storage
location
at
the
site,
or
2)
destroyed
by
incineration,
autoclaving
or
burial
in
the
test
field,
or
3)
returned
to
Monsanto
or
seed
company
partner
/
affiliate,
or
4)
used
as
food
or
animal
feed
Seed
and
other
plant
materials
may
be
harvested
for
further
research,
used
as
food
or
feed,
or
returned
to
Monsanto
or
its
seed
partners.
After
harvest
or
completion
if
data
collection,
all
corn
plants
in
the
trial
will
be
destroyed.
Standard
methods
for
the
area
will
be
employed
and
conducted
in
compliance
with
local
plow
down
regulations.
Waste
plant
materials
may
be
plowed
under,
burned
in
the
field
(
subject
to
local
burning
ordinances),
or
otherwise
devitalized.