Document ID: EPA-HQ-OPP-2005-0122-0011
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-07-26T04:00Z

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
FEB
07
2005
MEMORANDUM
SUBJECT:
Review
of
materials
submitted
by
Syngenta
in
support
of
proposed
of
Section
G
Experimental
Use
Permit
(
EUP
No:
67979­
EUP­
X,
DP#
310094)
for
Cry3A
corn.
Submission
dated
December
15,
2003
and
revised
February
4,
2005.

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

FROM:
Tessa
Milofsky,
M.
S.
Agronomist
signed
2­
7­
05
Microbial
Pesticides
Branch,
Biopesticides
and
Pollution
Prevention
Division
(
7511C)

PEER
REVIEW:
Alan
Reynolds,
M.
S.
Entomologist
signed
2­
7­
05
Microbial
Pesticides
Branch,
Biopesticides
and
Pollution
Prevention
Division
(
7511C)

CONCLUSION
The
requested
EUP
and
corresponding
acreage
are
ACCEPTABLE.
It
is
recommended
that
the
registrant's
full
request
of
3,910
EUP
acres
should
be
granted.

RECOMMENDATIONS
 
The
participant/
collaborator
information
is
sufficient
provided
that
collaborator
names
and
contact
information
are
submitted
prior
to
experiment
initiation.
 
Containment
procedures
described
in
the
submission
are
adequate
provided
that
a
temporary
tolerance
exemption
is
approved
prior
to
granting
the
EUP.

BACKGROUND
Syngenta
has
submitted
materials
in
support
of
their
request
for
an
Experimental
Use
Permit
(
EUP),
covering
the
period
February
14,
2005
through
February
2006,
to
allow
field
testing
of
corn
rootworm
protected
mCry3A
corn
(
Event
MIR604­
derived
corn
plants).
The
product
is
said
to
protect
field
corn
against
western
corn
rootworm
(
Diabrotica
virgifera
virgifera),
northern
corn
rootworm
(
D.
longicornis
barveri),
southern
corn
rootworm
(
D.
undecimpunctata
howardi),
and
Mexican
corn
rootworm
(
D.
virgifera
zea).
Planting
proposed
under
the
EUP
will
take
place
in
17
states
and
Puerto
Rico,
and
will
not
exceed
3910
total
acres.
The
submission
was
accompanied
by
a
petition
for
a
temporary
exemption
from
tolerance
and
recommendations
provided
in
this
EUP
review
assume
that
this
tolerance
will
be
granted.
It
should
also
be
noted
that
a
different
formulation
of
the
Cry3A
protein,
used
to
control
coleopteran
pests
in
potato,
has
been
granted
a
permanent
exemption
from
food
and
feed
tolerances.

PROGRAM
OVERVIEW
Participant/
Collaborator
Information
The
names,
telephone
numbers,
and
mailing
addresses
of
participants
who
will
supervise
experimental
work
covered
under
this
EUP
are
listed
under
each
protocol.
Information
on
cooperators
was
not
included,
yet
the
registrant
states
that
this
listing
will
be
provided
prior
to
planting
or
initiation
of
the
research
trials.

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

Field
Trial
Containment
Syngenta'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
provided
that
a
temporary
tolerance
exemption
is
approved
prior
to
granting
the
EUP.

Acreage
Calculation
Total
EUP
acreage
is
equivalent
to
the
sum
of
the
acreage
comprised
in
each
EUP
test
block.
This
calculation
would
include
all
MIR604
corn
plants
(
includes
stacked
plants),
non­
MIR604
corn
plants
(
e.
g.
breeding
plants
or
isoline
control
plots),
and
associated
border
rows
contained
within
the
perimeter
of
the
test
block.
The
section
also
includes
field
plans
that
illustrate
how
blocks
of
EUP
corn
may
be
positioned
in
relation
to
non­
EUP
corn
fields,
providing
a
visual
representation
of
experimental
block
location.

BPPD
Review
This
approach
to
EUP
acreage
calculation
is
acceptable.

Trial
Protocols
Trial
protocols
proposed
for
the
period
March
15,
2005­
February,
2006
are
described
below.
The
submission
included
a
comprehensive
table
(
Appendix
A)
which
lists,
on
a
state
by
state
basis,
the
number
of
acres
and
locations
dedicated
to
each
protocol.

EUP
Acreage1
Protocol
Type
MIR604
Acreage
Non­
MIR604
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
nontarget
insect
field
trials,
etc.)
40
110
150
Total
575
3,335
3,910
Protocol
descriptions
include
information
on
the
test
sites
(
states
and
number
of
locations
per
state),
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.

1
EUP
acreage
is
the
sum
of
the
acreage
found
within
the
perimeter
of
all
associated
experimental
blocks.
This
includes
MIR604
plants,
non­
MIR604
plants,
and
border
rows
included
within
the
blocks.