UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
December
8,
2004
MEMORANDUM
SUBJECT:
Review
of
materials
submitted
by
Monsanto
in
support
of
amendments
to
their
Section
G
Experimental
Use
Permit
(
EUP
No:
524­
EUP­
96,
DP#
310095)
for
Cry3Bb1
corn.
Submission
dated
July
30,
2004.

TO:
Michael
Mendelsohn
Senior
Regulatory
Action
Leader
Microbial
Pesticides
Branch,
Biopesticides
and
Pollution
Prevention
Division
(
7511C)

FROM:
Tessa
Milofsky,
M.
S.
Agronomist
Microbial
Pesticides
Branch,
Biopesticides
and
Pollution
Prevention
Division
(
7511C)

PEER
REVIEW:
Alan
Reynolds,
M.
S.
Entomologist
Microbial
Pesticides
Branch,
Biopesticides
and
Pollution
Prevention
Division
(
7511C)

CONCLUSION
The
requested
EUP
extension
and
corresponding
acreage
increase
are
acceptable.

RECOMMENDATION
 
The
participant/
collaborator
information
is
sufficient
provided
that
undisclosed
collaborator
names
and
contact
information
are
submitted
prior
to
experiment
initiation.
BACKGROUND
This
is
a
request
to
extend
the
duration
and
increase
the
allowable
acreage
permitted
under
the
existing
EUP
for
Cry3Bb1
corn
(
vector
ZMIR39).
EUP
acres
may
include
ZMIR39
corn
hybrids,
MON810
(
CryAb1)
corn
hybrids,
ZMIR39
x
MON810
stacked
corn
hybrids,
and
border
rows.
The
present
EUP
(
last
amended
April
27,
2004)
permits
test
plant
cultivation
on
2,529.13
acres
in
28
different
states
and
Puerto
Rico
and
is
slated
to
expire
February
28,
2005.
On
August
2,
1996
and
March
31,
2004,
respectively,
the
CryAb1
and
Cry3Bb1
proteins,
and
the
genetic
material
required
for
their
production,
were
exempted
from
the
requirement
of
a
tolerance
when
used
as
plant­
incorporated
protectants
in
the
food
and
feed
commodities
of
field
corn,
sweet
corn,
and
popcorn
(
40
CFR
2004,
§
180.1173
and
§
180.1214).
Consequently,
non­
crop
destruct
status
has
been
granted,
meaning
that
confinement
and
destruction
of
plant
material
(
e.
g.,
pollen,
seeds,
stalks,
etc.)
is
not
required
for
this
EUP.

PROGRAM
OVERVIEW
This
submission
requests
that
the
present
EUP
be
extended
until
March
1,
2006.
The
registrant
also
requests
that
the
allowable
EUP
acreage
be
increased
to
4,682.87
acres
for
the
2005
­
2006
growing
season.
The
attached
EUP
spreadsheet
(
Appendix
1)
lists
the
proposed
acreages
for
each
state.

EUP
Labels
Labels
were
provided
for
ZMIR39
corn,
MON810
corn,
and
the
ZMIR39
x
MON810
stack.

BPPD
Review
The
labels
are
acceptable.

Participant/
Collaborator
Information
The
names,
telephone
numbers,
and
mailing
addresses
of
participants
and
collaborators
(
partial
listing)
who
will
supervise
experimental
work
covered
under
this
EUP
are
listed
in
Sections
G.
1.
a.
and
G.
1.
b.,
respectively.

BPPD
Review
The
participant/
collaborator
information
is
sufficient
provided
that
undisclosed
collaborator
names
and
contact
information
are
submitted
to
the
Agency
prior
to
experiment
initiation.

Field
Trial
Containment
Monsanto's
proposed
field
trial
containment
program
complies
with
the
USDA­
APHIS
Performance
Standards
for
regulated
corn
trials.
The
USDA's
guidelines
are
general,
leaving
room
for
registrants
to
develop
containment
programs
that
are
appropriate
for
each
management
system.

BPPD
Review
Containment
procedures
described
in
the
submission
are
adequate.
Trial
Protocols
Trial
protocols
proposed
for
the
period
March
1,
2005
­
March
1,
2006
are
described
below.
The
submission
included
a
comprehensive
table
(
Appendix
1)
which
lists,
on
a
state
by
state
basis,
the
number
of
acres
dedicated
to
each
protocol.

Acreage
Protocol
Type
ZMIR39
MON810
ZMIR39
x
MON810
Border
Rows
Total
Breeding
and
observation
410.65
159.00
297.20
175.32
1,042.17
Inbred
seed
increase
production
808.50
97.30
396.50
158.05
1,460.35
Line
per
se,
hybrid
yield
and
herbicide
tolerance
trials
457.50
332.00
374.00
451.40
1,614.90
Insect
efficacy
trials
91.55
79.15
86.55
198.60
455.85
Product
characterization
and
performance
trials
1.00
1.00
1.00
1.00
4.00
Insect
resistance
management
trials
5.20
2.60
5.20
2.60
15.60
Nontarget
organisms
and
benefit
trials
2.00
0.50
2.00
0.50
5.00
Seed
treatment
trials
2.00
0.50
2.00
0.50
5.00
Swine
growth
and
feed
efficiency
trials
8.00
0
0
0
8.00
Dairy
cattle
feed
efficiency
trials
4.00
0
0
0
4.00
Beef
cattle
growth
and
feed
efficiency
trials
36.00
0
0
0
36.00
Cattle
grazing
feed
efficiency
trials
32.00
0
0
0
32.00
Total
1,858.4
672.05
1,164.45
987.97
4,682.87
Protocol
descriptions
include
information
on
the
objective,
experimental
design,
plot
treatments,
genotypes,
estimated
planting
and
harvest
schedules
for
each
trial,
and
containment
procedures
(
shipping,
pollen
flow,
and
post­
harvest).
Details
of
these
components
may
be
found
in
the
submission.

BPPD
Review
Acreage
requests
are
acceptable.

Acreage
Calculation
Acreage
was
presented
as
a
breakdown
between
ZMIR39
corn
hybrids,
MON810
corn
hybrids,
ZMIR39
x
MON810
stacked
corn
hybrids,
and
border
rows.
The
acreage
breakdown
presented
in
the
`
Trial
Protocol'
section
(
above)
presents
the
total
acreage
for
all
four
categories.

Some
states
and
territories
have
climates
which
allow
multiple
plantings
per
year.
Hawaii
and
Puerto
Rico
are
generally
considered
to
have
continuous
planting.
For
these
areas,
acres
are
counted
only
one
time.
Thus,
if
20
acres
is
listed
for
Hawaii
and
these
acres
are
planted
three
times
in
one
year,
the
acreage
is
still
listed
as
20.

BPPD
Review
This
approach
to
acreage
calculation
is
acceptable.
FUTURE
SUBMISSIONS
Below
are
recommendations
for
future
EUP
submissions.
These
recommendations
reflect
deficiencies
that
were
identified
in
2005
requests
for
EUP
acreage.

Final
Report
It
is
recommended
that
the
following
items
should
be
listed
in
final
reports:
 
A
state­
by­
state
breakdown
of
acreage
per
protocol.
 
A
state­
by­
state
breakdown
of
locations
per
protocol.
 
A
listing
of
experiments
conducted
within
each
protocol.
 
Average
acreage
per
location
for
each
experiment
included
within
each
protocol
(
ideally
this
would
be
presented
on
a
state­
by­
state
basis).

Future
Requests
for
EUP
Acreage
If
EUP
requests
are
to
be
objectively
evaluated,
it
is
strongly
recommended
that
future
submissions
should
include
the
following
information:
 
Protocols
to
be
conducted.
 
Experiments
to
be
included
within
each
protocol.
 
Estimated
state­
by­
state
breakdown
of
acreage
per
protocol.
 
Estimated
state­
by­
state
breakdown
of
locations
per
protocol.
 
Estimate
of
acreage
and
locations
required
for
each
experiment
included
within
protocols
(
ideally
this
would
be
presented
on
a
state­
by­
state
basis).
 
If
an
acreage
increase
is
requested
for
one
or
more
protocols,
justification
should
be
provided
for
those
increases
(
justification
should
be
provided
on
a
protocol
by
protocol
basis).
 
Objective
and
brief
description
of
each
experiment
included
within
protocols.
Approximate
number
of
hybrids/
inbreds/
isolines
to
be
tested
should
also
be
included
(
may
be
presented
as
average
number
of
lines
per
location).
 
Clear
explanation
of
acreage
calculation,
including
a
breakdown
of
EUP
acreage
designated
for
test
plants,
non­
test
plants,
and
border
rows
included
within
experimental
blocks.
 
It
should
be
noted
that
EUP
acreage
designated
for
demonstration
trials
is
generally
considered
inappropriate.
