Document ID: EPA-HQ-OPP-2005-0122-0007
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
MEMORANDUM
SUBJECT:
Review
of
materials
submitted
by
Pioneer
in
support
of
proposed
amendments
to
the
Section
G
Experimental
Use
Permit
(
EUP
No:
029964­
EUP­
5)
for
Cry34/
35Ab1
corn.
Submission
dated
January
18,
2005.

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
This
request
to
extend
the
duration
and
increase
the
acreage
of
the
existing
Cry34/
35
EUP
is
acceptable.
It
is
recommended
that
the
full
request
of
5,115
EUP
acres
should
be
granted.

RECOMMENDATIONS
 
The
final
Section
G
submission
addressed
most
deficiencies
identified
by
the
Agency.
However,
state­
by­
state
breakdowns
of
acreage
and
locations
needed
per
protocol,
as
well
as
experiment
descriptions
for
each
protocol,
were
not
included.
It
is
recommended
that
these
details
should
be
provided
in
the
final
report
(
see
Final
Report
and
Future
Submissions
section).
 
See
EUP
review
completed
January
6,
2005
for
full
program
evaluation.

BACKGROUND
2
This
is
a
request
to
extend
the
duration
and
increase
the
allowable
acreage
permitted
under
the
EUP
granted
for
Pioneer's
Cry34/
35Ab11
corn.
The
EUP
also
includes
acreage
for
stacked
events,
containing
Cry34/
35Ab1
and
Cry1F
insecticidal
proteins,
which
provide
combined
protection
against
corn
rootworm
and
lepidopteran
pests.
The
present
EUP
(
last
amended
April
29,
2004)
permits
test
plant
cultivation
on
4,690
acres
in
27
states
and
Puerto
Rico
and
is
slated
to
expire
April
30,
2005.
The
Agency
completed
a
review
of
the
proposed
2005­
2006
program
on
January
6,
2005.
Upon
receiving
notification
of
deficiencies,
the
registrant
submitted
an
amended
Section
G
proposal
to
the
Agency.
The
present
review
evaluates
the
amended
proposal,
focusing
on
changes
made
since
completion
of
the
prior
review.
Refer
to
the
January
6,
2005
review
for
further
details
on
the
proposed
EUP.

PROGRAM
REVIEW
Specific
trial
protocols
proposed
for
the
period
March
2005­
April
2006
are
listed
below.
The
first
table
presents
acreage
requested
by
the
registrant
and
justified
by
the
Agency,
as
indicated
in
the
January
6th
review.
The
second
table
presents
acreage
requested
in
the
amended
Section
G,
which
generally
corresponds
with
acreage
justified
in
the
previous
review.
Acreage
will
be
divided
among
24
states
and
Puerto
Rico
(
see
attachment).

March
2004­
April
2005
EUP
Acres
EUP
Protocols
Requested
(
12­
15­
04)
Justified
(
1­
6­
04)
Breeding
and
observation
nursery
515
515
Agronomic
observation
trials
750
750
Herbicide
tolerance
study
100
100
Efficacy
trial
100
100
Insect
resistance
management
studies
3,950
2,500
Non­
target
organism
studies
100
100
Regulatory
studies
150
150
Research
seed
production
100
100
Inbred
seed
increase
800
800
Demonstration
trials
100
0
Total
Acreage
6,665
5,115
March
2004­
April
2005
1
The
EUP
covers
corn
containing
the
Cry34/
35Ab1
Insecticidal
Crystal
Protein
(
ICP)
produced
by
construct
(
event
DAS­
59122­
7,
plasmid
insert
PHP17662)
and
could
include
corn
produced
by
traditional
breeding
of
the
rootworm­
protected
corn
with
lepidopteran­
protected
Bt
corn
(
e.
g.
Herculex
1
Corn
(
Bt
Cry1F,
event
1507).
3
EUP
Protocols
EUP
Acres
Requested/
Justified
(
1­
18­
05)
Breeding
and
observation
nursery
750
Agronomic
observation
trials
515
Herbicide
tolerance
study
100
Efficacy
trial
100
Insect
resistance
management
studies
2,500
Non­
target
organism
studies
100
Regulatory
studies
150
Research
seed
production
100
Inbred
seed
increase
800
Total
Acreage
5,115
BPPD
Review
Proposed
acreages
are
justified.
However,
it
is
recommended
that
future
submissions
should
include
more
detailed
discussions
of
all
protocols
(
see
Future
Submissions
section
below).
Outstanding
deficiencies
should
be
addressed
in
the
final
report
(
see
January
6,
2005
review
and
Final
Report
section).

Final
Report
The
final
Section
G
submission
addressed
most
deficiencies
identified
by
the
Agency.
However,
state­
by­
state
breakdowns
of
acreage
and
locations
needed
per
protocol
were
not
included.
Consequently,
it
is
recommended
that
these
details
should
be
provided
in
the
final
report.
Specifically,
the
final
report
should
include:
 
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
Submissions
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).
4
 
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.