Document ID: EPA-HQ-OPP-2003-0308-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-10-29T05:00Z

1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
Subject:
Review
of
Administrative
Materials
in
support
of
an
Application
to
Amend
and
Extend
the
Experimental
Use
Permit
for
Genetically
Modified
Corn
(
Vector
ZMIR13L)
Producing
a
Cry3Bb1
Protein
that
Provides
Control
of
Corn
Rootworm
(
Diabrotica
sp.).
EPA
Reg.
No.
524­
EUP­
93;
DP
Barcode
D290025;
Case
No.
065182;
Submission
No.
S632862;
Chemical
No.
6484.

From:
Robyn
Rose,
Entomologist
Biopesticides
and
Pollution
Prevention
Division,
7511C
Peer
Review:
Zigfridas
Vaituzis,
Ph.
D.,
Microbiologist
Biopesticides
and
Pollution
Prevention
Division,
7511C
To:
Mike
Mendelsohn,
Regulatory
Action
Leader
Biopesticides
and
Pollution
Prevention
Division,
7511C
Classification:
It
is
acceptable
to
plant
MON
863
corn.

Background:

Monsanto
has
requested
an
amendment
and
extension
to
their
application
for
the
Experimental
Use
Permit
(
EUP)
524­
EUP­
93
for
corn
event
MON
863
in
a
letter
dated
April
1,
2003
from
Dennis
Ward
(
Monsanto,
Regulatory
Affairs
Manager)
to
Dennis
Szuhay
(
EPA/
OPP/
BPPD
Microbial
Pesticides,
Acting
Branch
Chief).
The
previous
EUP
application
for
MON
863
corn
that
Monsanto
is
requesting
to
amend
was
submitted
on
December
11,
2002.
Event
MON
863
expressed
in
corn
has
been
granted
a
Section
3
registration
(
524­
LEI)
since
the
previous
submission
requesting
an
EUP.
Monsanto
is
requesting
this
amendment
and
extension
to
524­
EUP­
93
in
order
"
to
continue
development
work
on
combined
insecticidal
trait
hybrids
created
by
crossing
MON
863
corn
line
to
other
lines
containing
registered
plant­
incorporated
protectants."

Monsanto
intends
to
plant
a
total
of
2,304
acres
among
33
states
plus
Puerto
Rico
and
Hawaii
during
the
2003
growing
season
(
Table
1).
In
addition
to
the
acreage
planted
for
the
trials
2
described
below,
260
acres
planted
among
7
states
is
being
reserved
by
Monsanto
as
"
unassigned
acreage"
(
Table
2).
Event
MON
863
field
corn
hybrids
expressing
the
Cry3Bb1
protein
will
be
planted
in
addition
to
hybrids
containing
additional
Bt
events
(
e.
g.,
event
MON
810).
Cry3Bb1
is
a
coleopteran­
active
protein
that
is
labeled
to
control
corn
rootworm
species
(
Diabrotica
spp.)
except
for
southern
corn
rootworm.
Hybrids
will
be
evaluated
for
efficacy
against
corn
rootworms
as
well
as
lepidopteran
insects
in
the
combined
trait
hybrids.
MON
863
research
plots
will
be
planted
at
research
stations,
seed
production
fields,
privately
owned
and
University
farms
from
May
15,
2003
through
June
30,
2004.

A
"
time­
limited"
exemption
from
a
tolerance
for
Cry3Bb1
protein
and
the
genetic
material
necessary
for
its
production
in
field
corn,
sweet
corn
and
popcorn
is
published
in
the
40
CFR
§
180.1214.
Toxicity
studies
submitted
to
EPA
in
support
of
the
Cry3Bb1
registration
include
MRID
Nos.
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
and
455770­
02.
Efficacy
studies
submitted
to
EPA
include
MRID
Nos.
451568­
00,
453613­
03
and
455770­
01.

Table
1.
Proposed
Acreage
and
Active
Ingredient
Quantities
for
Each
State
and
Territory
State
Acreage
Planting
Seed
(
lbs)
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
State
Acreage
Planting
Seed
(
lbs)
Active
Ingredient
in
Planting
Seed
(
g)

3
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
2304
36,864
1,606
Table
2.
Acreage
to
be
planted
per
trial
Acreage
by
State
&
Protocol
Code
State
1
2
3
4
5
6
7
8
U**
(
Acres)
AL
0
0
4
2
0
0
0
2
0
8
AR
0
0
4
2
0
0
0
2
0
8
CA
50
175
0
0
0
0
0
0
0
225
CO
0
0
40
10
0
5
0
19
0
74
DE
2
0
5
1
0
0
0
0
0
8
FL
1
1
4
1
0
0
0
1
0
8
GA
1
1
4
1
0
0
0
1
0
8
HI
60
200
80
0
20
0
0
0
40
400
4
IA
10
10
33
16
10
5
10
5
40
139
ID
1
1
4
1
0
0
0
1
0
8
IL
10
10
33
16
10
5
10
5
40
139
IN
10
15
33
16
10
5
5
5
40
139
KS
0
0
30
10
0
5
10
19
0
74
KY
1
1
4
1
0
0
0
1
0
8
LA
1
1
4
1
0
0
0
1
0
8
MD
1
1
3
1
0
0
1
1
0
8
MI
4
0
36
15
0
0
0
13
0
68
MN
10
20
33
16
10
5
0
5
40
139
MO
4
0
31
15
0
5
0
13
0
68
MS
0
0
4
2
0
0
0
2
0
8
MT
0
0
4
2
0
0
0
2
0
8
NC
1
1
4
1
0
0
0
1
0
8
ND
4
10
10
6
0
0
0
8
0
38
NE
15
20
38
10
6
5
0
5
40
139
NM
0
0
4
2
0
0
0
2
0
8
NY
4
0
31
10
0
0
10
13
0
68
OH
1
4
30
15
0
5
0
19
0
74
OK
0
0
10
15
0
0
0
13
0
38
PA
4
0
36
15
0
0
0
13
0
68
PR
40
20
10
0
10
0
0
0
20
100
SD
1
4
35
15
0
0
0
19
0
74
TN
1
1
4
1
0
0
0
1
0
8
TX
1
2
8
7
0
5
0
15
0
38
UT
0
0
4
2
0
0
0
2
0
8
VA
1
1
4
1
0
0
0
1
0
8
WI
1
4
30
15
0
5
0
19
0
74
TOTA
240
503
651
244
76
55
46
229
260
2,304
*
Table
provided
by
Monsanto
**
Unassigned
acreage
at
this
time,
being
held
in
reserve
1
Breeding
and
Observation
Nursery
Trials
2
Inbred
Seed
Increase
Production
Trials
3
Line
Per
Se
and
Hybrid
Yield
Trials
4
Insect
Efficacy
Trials
5
Product
Characterization,
Performance
and
Labeling
Trials
6
Insect
Resistant
Management
Trials
7
Nontarget
Organisms
and
Benefit
Trials
8
Seed
Treatment
Trials
EUP
Label
Statements
Proposed
by
Monsanto:

°
"
FOR
EXPERIMENTAL
USE
ONLY"
°
"
Not
for
sale
to
any
person
other
than
a
participant
or
cooperator
of
the
EPA­
approved
Experimental
Use
Program."
5
°
"
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
package
contains
corn
rootworm­
protected
corn
seed
producing
Cry3Bb1,
and
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
(
vector
ZMIR13L)
in
event
MON
863
corn.....
0.001­
0.006%"
°
"
Inert
Ingredients:
Substance
produced
by
marker
gene
and
the
genetic
material
necessary
for
its
production
(
ZMIR13L)
in
corn...........
0.00002
­
0.00003%."
°
"
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."
°
"
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."

Experimental
Program
Summary:

Sampling
Samples
including
whole
corn
plants,
tissue
and/
or
seed
may
be
sent
to
Monsanto
or
other
laboratories
for
analysis.

Isolation
Research
plots
will
not
be
isolated
or
contained
since
it
is
not
required.

Schedule
There
will
be
continuos
plantings
in
Hawaii
and
Puerto
Rico
and
at
least
two
plantings
per
site
in
the
continental
U.
S.
Plantings
in
the
continental
U.
S.
will
occur
from
February
until
June
and
fields
will
be
harvested
from
August
to
November.

Final
Disposition
Seed
that
is
not
planted
under
this
EUP
may
be
used
for
other
research
purposes,
as
food
or
feed,
returned
to
Monsanto
or
seed
companies
or
destroyed.
Corn
plants
will
be
destroyed
after
data
collection
and
harvested
corn
may
be
used
in
additional
research,
for
future
plantings
or
as
food
or
feed.

1)
Breeding
and
Observation
Nursery
Trials
According
to
Monsanto,
these
trials
will
be
conducted
to
"[
o]
bserve
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."
Corn
plants
containing
event
MON
863
in
various
genetic
backgrounds
will
be
used
in
these
trials.
Hybrids
containing
MON
863
and
MON
810
will
be
planted
(
per
personal
communication
between
Russ
Schneider
and
Mike
Mendelsohn,
6­
19­
03).
A
total
of
240
acres
will
be
planted
among
27
states
for
these
trials
(
Table
2).
Plants
containing
the
cry3Bb1
gene
will
be
hand­
pollinated
with
non­
Bt
6
corn
or
other
Bt
corn
hybrids.
Hand
pollination
will
be
accomplished
by
selfing,
backcrossing
or
crossing
plants
to
a
tester
line.

2)
Inbred
Seed
Increase
Production
Trials
According
to
Monsanto,
these
trials
will
be
conducted
to
"[
p]
roduce
quantities
of
seed
and
plant
material
for
further
testing
and
product
development."
Seed
will
be
generated
by
allowing
inbred
corn
lines
containing
the
cry3Bb1
gene
to
open
pollinate.
Hybrids
containing
MON
863
and
MON
810
will
be
planted
A
total
of
503
acres
will
be
planted
among
22
states
for
these
trials
(
Table
2).

3)
Line
Per
Se
and
Hybrid
Yield
Trials
According
to
Monsanto,
these
trials
will
be
conducted
to
"[
a]
ssess
any
agronomic
effects
of
the
genetic
insertion
in
corn
event
MON
863
(
vector
ZMIR13L)
in
different
corn
genetic
backgrounds."
Up
to
100
inbred
and
hybrid
corn
lines
with
and
without
the
cry3Bb1
gene
will
be
planted
per
location
in
a
randomized
design
or
as
single
large
blocks.
Hybrids
containing
MON
863
and
MON
810
will
be
planted
Agronomic
characteristics
(
e.
g.,
early
vigor,
plant
color
and
height,
days
to
flowering
and
maturity,
yield,
test
weight)
will
be
evaluated.
A
total
of
651
acres
will
be
planted
among
35
states
for
these
trials
(
Table
2).

4)
Insect
Efficacy
Trials
According
to
Monsanto,
these
trials
will
be
conducted
to
"[
a]
ssess
the
efficacy
of
corn
expressing
the
cry3Bb1
gene
in
different
corn
genetic
backgrounds
against
corn
rootworms
and
other
potential
soil
pests
of
corn.
Efficacy
against
a
number
of
lepidopteran
pests
will
be
evaluated
in
combined
trait
hybrids."
Inbred
and
hybrid
corn
lines
with
and
without
the
cry3Bb1
gene
will
be
planted
per
location
in
a
randomized
design
or
as
single
large
blocks.
Hybrids
containing
MON
863
and
MON
810
will
be
planted.
Untreated
and
insecticide
treated
plots
will
serve
as
controls.
Yield
and
efficacy
against
insect
pests
particularly
the
corn
rootworm
will
be
evaluated.
A
total
of
244
acres
will
be
planted
among
33
states
for
these
trials
(
Table
2).

5)
Product
Characterization,
Performance
and
Labeling
Trials
According
to
Monsanto,
these
trials
will
be
conducted
"[
t]
o
produce
grain
and
plant
material
for
product
characterization,
further
regulatory
testing,
benefit
studies,
and
product
labeling
purposes."
Seed
will
be
generated
by
hand
pollinating
or
allowing
corn
lines
containing
the
cry3Bb1
gene
to
open
pollinate.
Plots
may
also
be
sampled
for
analyses
of
composition,
equivalency
phenotype
and
molecular
characterization
in
the
laboratory.
Hybrids
containing
MON
863
and
MON
810
will
be
planted.
Untreated
and
insecticide
treated
plots
will
serve
as
controls.
A
total
of
76
acres
will
be
planted
among
7
states
for
these
trials
(
Table
2).

6)
Insect
Resistant
Management
Trials
According
to
Monsanto,
these
trials
will
be
conducted
"[
t]
o
develop
addition
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."
Inbred
and
hybrid
corn
lines
with
and
without
the
cry3Bb1
7
gene
will
be
planted
per
location
in
a
randomized
design
or
as
single
large
blocks.
Hybrids
containing
MON
863
and
MON
810
will
be
planted.
Untreated
and
insecticide
treated
plots
will
serve
as
controls.
These
trials
will
include
studies
on
larval
movement
within
and
between
rows,
seed
mixes,
efficacy,
adult
emergence
and
yield.
Emerged
adults
will
also
be
evaluated
for
fitness
and
in
conjunction
with
efficacy
trials.
A
total
of
55
acres
will
be
planted
among
10
states
for
these
trials
(
Table
2).

7)
Nontarget
Organisms
and
Benefit
Trials
According
to
Monsanto,
these
trials
will
be
conducted
to
"[
d]
evelop
additional
data
to
assess
the
impact
of
Cry3Bb1
protein
on
nontarget
organisms,
including
a
wide
variety
of
soil
and
surfacedwelling
organisms.
The
potential
for
interactive
effects
of
multiple
Bt
proteins
on
nontarget
organisms
will
be
evaluated
in
the
combined
trait
hybrids."
Inbred
and
hybrid
corn
lines
with
and
without
the
cry3Bb1
gene
will
be
planted
per
location
in
a
randomized
design
or
as
single
large
blocks.
Hybrids
containing
MON
863
and
MON
810
will
be
planted.
Untreated
and
insecticide
treated
plots
will
serve
as
controls.
These
trials
will
be
conducted
to
assess
microbial
community
structure,
earthworm
populations,
and
terrestrial
invertebrates
at
the
soil
surface
and
below.
These
trials
will
also
evaluate
potential
synergistic
effects
in
the
Cry3Bb1/
Cry1
stacked
products.
A
total
of
46
acres
will
be
planted
among
6
states
for
these
trials
(
Table
2).

8)
Seed
Treatment
Trials
According
to
Monsanto,
these
trials
will
be
conducted
"[
t]
o
evaluate
effects
of
diverse
seed
treatments,
in
combination
with
transgenic
corn,
on
corn
rootworm
and
additional
insect
pests."
Transgenic
and
nontransgenic
corn
lines
with
and
without
the
cry3Bb1
gene
will
be
planted
per
location
in
a
randomized
design
or
as
single
large
blocks.
Hybrids
containing
MON
863
and
MON
810
will
be
planted.
Corn
seed
will
be
treated
with
a
variety
of
insecticides.
Untreated
and
insecticide
treated
plots
will
serve
as
controls.
Effects
on
agronomic
characteristics
(
e.
g.,
germination,
seedling
vigor)
and
efficacy
against
corn
rootworms
and
other
insect
pests
will
be
evaluated.
A
total
of
229
acres
will
be
planted
among
32
states
for
these
trials
(
Table
2).

ENVIRONMENTAL
EFFECTS
A.
Non­
target
species
effects
1.
Hazard
Assessment
for
Terrestrial
Animals
a.
Avian:
Data
already
on
file
at
EPA
for
Bt
crystal
proteins
and
published
data
show
that
consumption
of
Bacillus
thuringiensis
crystal
protein
containing
corn
has
no
measurable
deleterious
effects
on
avian
species.
This
indicates
that
the
proposed
limited
time/
acreage
EUP
is
not
likely
to
have
any
measurable
effects
on
avian
wildlife.

b.
Mammalian
Wildlife:
Many
different
Bacillus
thuringiensis
crystal
proteins
have
been
8
evaluated
in
mammalian
toxicology
tests
in
the
last
40
years.
In
addition,
eighty
percent
of
Bt
corn
produced
in
the
last
5
years
has
been
fed
to
poultry
and
livestock.
No
adverse
effects
have
been
observed
in
mammals
upon
oral
exposure
to
any
of
the
Bt
crystal
proteins.
The
mammalian
toxicology
data
already
on
file
at
EPA
for
Bt
crystal
proteins
and
published
data
also
indicate
that
there
is
no
significant
toxicity
to
rodents
from
acute
oral
testing
at
the
maximum
hazard
dose
levels.
In
light
of
the
above
toxicology
information,
risk
to
mammalian
wildlife
from
the
proposed
limited
time/
acreage
EUPs
is
expected
to
be
minimal
to
nonexistent.

c.
Non­
target
Plants:
Since
the
active
ingredient
in
this
product
is
an
insect
toxin
that
has
never
shown
any
toxicity
to
plants,
these
studies
have
been
waived
for
this
product.
The
pollen
outcrossing
issues
are
addressed
below.

d.
Non­
target
invertebrates:

1.
Honey
Bees:
Data
on
file
at
EPA
for
Bt
crystal
proteins
show
that
the
consumption
of
Bt
protein
containing
corn
pollen
has
no
measurable
deleterious
effects
on
adult
honey
bees
and
larvae.
In
addition,
since
corn
is
wind
pollinated,
few
honey
bees
are
expected
to
be
exposed.
As
a
result,
no
discernible
detrimental
effects
to
honey
bees
are
expected
from
the
proposed
limited
time/
acreage
EUPs
.

2.
Lady
beetle
predator:
Data
on
file
at
EPA
for
Bt
crystal
proteins,
including
Cry3Bb1,
show
that
no
adverse
effects
to
Hippodamia
convergens,
an
indicator
species
for
predatory
beetles,
are
expected.
Lady
beetles
may
feed
on
prey
or
pollen
in
the
EUP
fields,
however,
no
detectable
effects
of
reduction
in
the
abundance
of
beetles
is
expected
from
the
limited
duration
and
acreage
of
the
proposed
EUP
3.
Earthworm
and
Collembola:
Published
data,
and
data
on
file
at
EPA
for
Bt
crystal
proteins
show
that
the
consumption
of
Bacillus
thuringiensis
crystal
protein
has
no
measurable
deleterious
effects
on
earthworms
or
collembola
(
Folsomia
candida),
representative
beneficial
soil
invertebrate
species.
The
proposed
limited
time/
acreage
EUP
is
not
likely
to
have
any
measurable
effects
on
beneficial
soil
invertebrates.

4.
Non­
target
insects:
Published
data,
and
data
on
file
at
EPA
show
that
exposure
to
Bt
proteins
from
corn
plants
in
the
field
has
no
measurable
detrimental
effect
on
non­
target
insects.
Therefore,
the
proposed
limited
time/
acreage
EUP
is
not
likely
to
have
any
measurable
effects
on
non­
target
insects.
As
part
of
the
EUP
program,
trials
will
be
conducted
to
assess
microbial
community
structure,
earthworm
populations,
and
terrestrial
invertebrates
at
the
soil
surface
and
below.

2.
Hazard
Assessment
for
Aquatic
Animals
a.
Fish:
The
requirement
for
a
static
renewal
toxicity
study
is
normally
waived
based
on
a
lack
of
exposure
of
fish
to
the
Bt
protein
produced
in
corn.
Exposure
from
corn
pollen,
if
it
does
take
9
place,
will
be
of
a
very
short
duration
and
quantity
and
is
not
expected
to
have
any
detectable
effect
on
freshwater
fish.

b.
Aquatic
Invertebrates:
Published
and
in­
house
data
for
Bt
crystal
protein
containing
corn
show
that
Bt
crystal
proteins
have
no
measurable
deleterious
effects
on
Daphnia
magna,
a
sensitive
aquatic
invertebrate
species.
The
data
indicate
that
the
expected
environmental
concentration
of
corn
pollen
from
the
proposed
limited
time/
acreage
EUP
is
not
likely
to
have
any
measurable
effects
on
aquatic
invertebrates.

c.
Estuarine
and
Marine
Animals:
The
estuarine
fish
and
shrimp
studies
are
not
required
for
this
product
because
of
very
low
potential
for
exposure.

Non­
target
Effects
Summary:
Published
and
in­
house
data
for
Bt
crystal
protein
containing
corn
show
that
the
Cry
proteins
are
very
species
specific
in
their
activity,
therefore
no
measurable
or
irreversible
interactions
with
non­
target
organisms
are
anticipated
for
the
proposed
limited
duration
and
limited
acreage
EUP.
The
nature
of
the
EUP
programs
and
the
expression
of
the
active
ingredient
within
the
corn
plant
limits
exposure
to
non­
target
species.

B.
Outcrossing
and
Weediness
There
is
no
evidence
of
transfer
of
any
gene,
including
introduced
genes,
to
organisms
other
than
those
with
which
corn
is
sexually
compatible.
In
addition,
there
are
no
weedy
relatives
of
corn
in
the
areas
near
the
trial
sites.

C.
Environmental
fate
Numerous
studies,
when
performed
under
realistic
conditions,
have
shown
that
the
Bt
proteins
produced
in
Bt
crops
are
rapidly
degraded
in
the
soil.
This
was
confirmed
in
a
FIFRA
Scientific
Advisory
Panel
Report
(
December
8,
1999).
The
Panel
concluded
that
"
bioaccumulation
is
not
expected
to
occur
with
transgenic
proteins
because
biodegredation
mechanisms
for
proteins
are
ubiquitous."
The
degradation
of
Bt
protein
in
plant
tissue
has
been
evaluated
for
several
Bt
crops
that
has
been
approved
by
EPA
as
part
of
regulatory
requirements.
In
addition,
EPA
scientists
have
carried
out
independent
studies
which
have
evaluated
the
degradation
of
Bt
proteins
in
Bt
cotton
(
Cry1Ac
and
Cry1Ab)
and
Btt
potato
(
Cry3A)
in
soil.
All
of
these
studies
have
demonstrated
that
the
Bt
proteins
expressed
in
Bt
plants
are
degraded
at
rates
similar
to
microbial
Bt
products.
Thus
all
evidence
to
date
shows
that,
when
degradation
of
Bt
proteins
in
soil
are
assessed
under
realistic
conditions,
the
proteins
in
Bt
plants
readily
degrade,
as
expected
for
proteins.

D.
Insect
Resistance
Management
There
is
not
a
concern
of
widespread
corn
rootworm
resistance
occurring
from
the
limited
acreage
that
will
be
planted
under
this
EUP
program.
10
E.
Endangered
species
considerations
Based
on
the
previously
submitted
Cry
protein
toxicity
and
exposure
data
there
will
not
be
a
"
may
effect"
situation
for
endangered
mammals,
birds,
plants
and
aquatic
species.
In
addition,
because
there
are
no
sexually
compatible
wild
or
weedy
relatives
of
corn
(
Z.
mays)
in
the
United
States,
the
Cry
protein
genes
cannot
escape
into
plants
on
which
endangered/
threatened
species
feed
on
in
these
areas.
However,
all
endangered/
threatened
insect
species
(
notably
Coleoptera)
that
may
be
susceptible
to
the
Bacillus
thuringiensis
crystal
proteins
may
be
adversely
affected
if
exposed.
Therefore,
the
test
plots
for
the
proposed
EUP
program
must
not
be
near
the
habitats
of
endangered
beetle
{
Coleoptera)
species
since
it
has
not
been
determined
that
these
will
not
be
adversely
affected
if
exposed
to
the
Bt
protein
in
the
soil
or
through
pollen
consumption.
However,
exposure
of
endangered
beetles
to
toxic
levels
of
Cry
proteins
in
the
field
from
this
EUP
appears
to
be
highly
unlikely.
Nevertheless,
the
EUP
test
plots
must
not
be
located
near
the
habitats
of
endangered
coleopteran
species
in
the
following
counties:

American
burying
beetle
(
Nicrophorus
americanus)
in
Kansas
(
Doniphan,
Douglas,
Montgomery,
Pottawatomie,
Riley,
and
Saline
Counties),
in
Missouri
(
Bollinger,
Boone,
Franklin,
Howard,
Jefferson,
Mississippi,
Newton,
St.
Louis,
and
Wayne
counties).
and
in
South
Dakota
(
Brookings,
Haakon
and
Union
counties).
Nebraska
(
North
Platte
and
Lincoln,
Dawson
and
Cherry
counties).

Hungerford's
crawling
water
beetle
(
Brychius
hungerfordi)
only
along
the
East
Branch
of
the
Maple
River,
Emmet
County,
Michigan;
the
East
Branch
of
the
Black
River,
Montmorency
County,
Michigan;

HAZARD
ASSESSMENT
Adverse
effects
to
populations
of
nontarget
organisms
from
planting
MON
863
corn
are
not
expected
from
this
limited
acreage
EUP.
Based
on
published
information
and
previously
submitted
studies
for
registered
Bt
Cry
proteins,
including
Cry3Bb1,
no
detectable
or
irreversible
hazard
to
terrestrial
or
aquatic
nontarget
species
is
anticipated
from
this
short
duration
small
acreage
EUP.
Detectable
amounts
of
Cry
protein
are
not
expected
to
accumulate
and
persist
in
soil
in
these
experimental
plots.

BPPD
Conclusions:
No
significant
or
irreversible
hazards
to
non­
target
organisms
are
anticipated
for
the
short
duration
of
this
limited
acreage
experimental
use
providing
that
testing
does
not
take
place
in
the
vicinity
of
endangered
beetle
habitats.
Based
on
the
previously
submitted
Cry
protein
toxicity
and
exposure
data
there
will
not
be
a
"
may
effect"
situation
for
endangered
mammals,
birds,
plants
and
aquatic
species.
All
endangered/
threatened
insect
species
that
are
susceptible
to
Cry3Bb1
(
e.
g.,
coleopterans)
may
be
adversely
affected
if
exposed.
In
the
case
of
Cry3Bb1
protein,
the
test
plots
for
the
proposed
EUP
program
must
not
be
near
the
habitats
of
endangered
beetle
(
coleopteran)
species
since
these
may
be
adversely
affected
if
exposed
to
the
Bt
protein
in
the
soil
or
through
pollen
consumption.
11