Document ID: EPA-HQ-OPP-2005-0122-0005
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
January
6,
2005
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,
DP#
310099)
for
Cry34/
35Ab1
corn.
Submission
dated
July
28,
2004
and
revised
December
22,
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
This
request
to
extend
the
duration
and
increase
the
acreage
of
the
existing
Cry34/
35
EUP
is
acceptable.
It
is
recommended
that
5,115
EUP
acres
should
be
granted
(
6,665
acres
requested).

RECOMMENDATIONS
 
The
registrant
requested
100
acres
for
demonstration
trials.
However,
section
5
of
FIFRA
states,
"
the
Administrator
may
issue
an
experimental
use
permit
only
if
the
Administrator
determines
that
the
applicant
needs
such
permit
in
order
to
accumulate
information
necessary
to
register
a
pesticide "
Since
demonstration
trials
do
not
provide
information
required
for
pesticide
registration,
inclusion
of
demonstration
trials
in
EUP
acreage
is
inappropriate.
It
is
recommended
that
EUP
acreage
should
not
be
granted
for
demonstration
trials.
2
 
Based
on
available
information,
it
is
recommended
that
2,500
EUP
acres
(
3,950
acres
requested)
should
be
granted
for
insect
resistance
management
trials.
This
acreage
is
agronomically
justified,
because
the
protocol
includes
a
variety
of
trials,
of
which
the
largest
may
require
as
many
as
500
acres
per
location.

 
Proposed
acreages
for
Cry34/
35Ab1
corn
breeding
and
observation
nurseries,
agronomic
observation
trials,
herbicide
tolerance
studies,
efficacy
trials,
nontarget
organism
studies,
regulatory
experiments,
research
seed
production,
and
inbred
seed
increase
are
acceptable.
However,
it
is
recommended
that
all
protocol
descriptions
should
be
expanded
for
future
submissions.

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

 
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.
It
is
recommended
that
these
details
should
be
provided
in
the
final
report.

BACKGROUND
This
is
a
request
to
extend
the
duration
and
increase
the
allowable
acreage
permitted
under
the
EUP
granted
for
Pioneer's
Cry34/
35Ab11
corn,
which
protects
against
western
corn
rootworm
(
WCRW;
D.
virgifera
virgifera),
northern
corn
rootworm
(
NCRW;
D.
berberi),
and
Mexican
corn
rootworm
(
D.
virgifera
zea).
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.
Cry34Ab1
and
Cry35Ab1
proteins
are
temporarily
exempted
(
exemption
will
expire
April
30,
2006)
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
(
CFR
2004,
§
180.1242).
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.
It
should
be
noted,
however,
that
a
Scientific
Advisory
Panel
is
scheduled
to
meet
on
March
1­
2,
2005
"
to
consider
and
review
human
health
issues
associated
with
the
Cry34Ab1
protein".

PROGRAM
REVIEW
The
submission
requests
that
the
present
EUP
be
extended
until
April
30,
2006,
so
that
the
registrant
can
"
fully
evaluate
this
product
and
its
benefits."
The
registrant
also
requests
that
the
allowable
acreage
be
increased
to
6,665
acres
for
the
2005
growing
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
season.
The
attached
EUP
spreadsheet
(
Appendix
A)
describes
the
proposed
acreages
for
each
state.
It
should
be
noted
that
the
product's
temporary
exemption
from
tolerance
expires
April
30,
2006
and
thus,
corresponds
with
the
proposed
expiration
date
of
the
existing
EUP.

Participant/
Collaborator
Information
The
names,
telephone
numbers,
and
mailing
addresses
of
participants
who
will
supervise
experimental
work
covered
under
this
EUP
are
provided
in
the
submission.
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
Participant/
collaborator
information
is
sufficient
provided
that
undisclosed
collaborator
names
and
contact
information
are
submitted
prior
to
experiment
initiation.

Acreage
Calculation
Total
EUP
acreage
is
equivalent
to
the
sum
of
the
acreage
comprised
in
each
EUP
test
block.
This
calculation
would
include
all
Cry34/
35
corn
plants
(
includes
stacked
plants),
non­
Cry34/
35
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.

Field
Trial
Containment/
Disposition
Procedures
Field
trial
containment
is
said
to
comply
with
the
USDA­
APHIS
performance
standards
for
regulated
corn
trials.
Six
approaches
to
gene
flow
containment
are
listed
(
e.
g.
bagging,
660
ft.
isolation,
temporal
isolation,
etc.),
of
which
one
or
more
will
be
used
in
the
proposed
trials.

Sections
covering
plant
sampling,
harvest
procedures,
final
disposition,
and
volunteer
plant
monitoring,
include
brief
(
from
one
to
several
sentences)
descriptions
of
containment
procedures
that
may
be
implemented
during
these
phases.

BPPD
Review
The
isolation
methods
presented
are
acceptable.

Specific
Trial
Protocols
Specific
trial
protocols
implemented
for
the
period
March
2004­
March
2005
and
proposed
for
the
period
March
2005­
April
2006
are
listed
below.
Two
tables
are
presented
for
2005­
2006,
because
the
initial
request
(
submitted
7­
28­
04)
was
replaced
by
a
revised
submission
dated
12­
22­
04.
It
should
be
noted
that
the
revised
Section
G
was
submitted
in
response
the
Agency's
request
for
a
breakdown
of
acreage
per
protocol,
4
followed
by
a
request
for
more
information
on
the
insect
resistance
management
protocol.

March
2004­
April
2005
EUP
Acres
EUP
Protocols
Requested
Granted
Breeding
and
observation
nursery
?
?
Agronomic
observation
trials
?
?
Herbicide
tolerance
study
?
?
Efficacy
trial
?
?
Insect
resistance
management
studies
?
?
Non­
target
organism
studies
?
?
Regulatory
studies
?
?
Research
seed
production
?
?
Inbred
seed
increase
?
?
Demonstration
trials
?
?
Total
9,050
4,690
March
2004­
April
2005
Requested
(
7­
28­
04)
EUP
Protocols
EUP
Acres
Lbs.
of
Seed
Breeding
and
observation
nursery
?
?
Agronomic
observation
trials
?
?
Herbicide
tolerance
study
?
?
Efficacy
trial
?
?
Insect
resistance
management
studies
?
?
Non­
target
organism
studies
?
?
Regulatory
studies
?
?
Research
seed
production
?
?
Inbred
seed
increase
?
?
Demonstration
trials
?
?
Total
13,050
217,543
March
2005­
April
2006
Requested
(
12­
22­
04)
EUP
Protocols
EUP
Acres
Lbs.
of
Seed
Breeding
and
observation
nursery
515
8,583
Agronomic
observation
trials
750
12,500
Herbicide
tolerance
study
100
1,667
Efficacy
trial
100
1,667
Insect
resistance
management
studies
3,950
65,834
Non­
target
organism
studies
100
1,667
Regulatory
studies
150
2,500
Research
seed
production
100
1,667
Inbred
seed
increase
800
13,333
Demonstration
trials
100
1,667
Total
6,665
111,084
5
Protocol
descriptions
include
general
information
on
the
objective,
experimental
design,
plot
treatments,
genotypes
and
vectors,
and
estimated
planting
and
harvest
schedules
for
each
trial.
Protocol
objectives
are
listed
below:

Protocol:
Breeding
and
observation
nursery
Objective:
Convert
maize
lines
to
contain
the
Bt
Cry34/
35Ab1
genes.

Protocol:
Agronomic
observation
trials
Objective:
Assess
the
agronomic
and
phenotypic
properties
of
Bt
Cry34/
35Ab1
maize
lines.

Protocol:
Herbicide
tolerance
studies
Objective:
Evaluate
the
effect
of
herbicide
applications
on
Bt
Cry34/
35Ab1
maize
lines.

Protocol:
Efficacy
trials
Objective:
Assess
the
efficacy
of
Bt
Cry34/
35Ab1
maize
lines
in
controlling
western
corn
rootworm,
northern
corn
rootworm,
Mexican
corn
rootworm
and/
or
other
coleopteran
insects
Protocol:
Insect
resistance
management
studies
Objective:
Studies
will
provide
information
for
the
refinement
of
IRM
strategies
for
Bt
Cry34/
35Ab1
maize
lines.

Protocol:
Non­
target
organism
studies
Objective:
Provide
information
on
the
effect
of
Bt
Cry34/
35Ab1
plants
on
non­
target
arthropod
populations
commonly
found
in
maize
fields.

Protocol:
Regulatory
studies
Objective:
To
produce
grain
and
plant
material
for
composition
and
expression
analyses,
product
characterization,
herbicide
residue
analysis,
further
regulatory
or
stewardship
studies,
and/
or
benefit
studies.
Often
these
studies
are
done
under
GLP
and
are
submitted
to
domestic
or
international
regulatory
agencies.

Protocol:
Research
seed
production
Objective:
To
produce
seed
for
use
in
research
and/
or
regulatory
testing.

Protocol:
Inbred
seed
increase
Objective:
Increase
inbred
seed
for
further
testing
and
product
development.

Protocol:
Demonstration
trials
Objective:
Demonstrate
the
efficacy
of
Bt
Cry34/
35Ab1
maize
plants
in
controlling
western
corn
rootworm,
northern
corn
rootworm,
Mexican
corn
rootworm
and/
or
other
coleopteran
pests.
6
In
preparation
for
the
2005
growing
season,
the
registrant
requested
that
EUP
acreage
be
increased
from
the
4,690
acres
granted
in
2004,
to
6,665
acres
for
2005.
Since
a
breakdown
of
acreage
per
protocol
was
not
provided
in
the
2004
and
initial
2005
EUP
submissions,
it
is
unclear
which
protocols
are
affected
by
the
1,975
acre
increase
and
which
were
reduced
in
the
revised
2005
submission.
Consequently,
useful
year­
by­
year
and
submission­
by­
submission
comparisons
can
not
be
made.

Requested
acreage
for
individual
protocols
(
revised
2005
submission)
are
generally
in
line
with
past
EUP
acreage
requests
for
insect
protected
corn
products.
However,
the
acreage
for
insect
resistance
management
studies
is
considerably
larger
than
that
requested
and
granted
for
most
EUPs.
Consequently,
the
Agency
recommended
that
a
more
detailed
protocol
description
should
be
submitted
for
this
study
area.
Information
requested
by
the
Agency
included:
descriptions
of
specific
experimental
protocols,
experimental
objectives
and
expected
outcomes
for
each
trial,
experimental
design,
number
of
hybrids
to
be
used,
number
of
locations
required,
acreage
per
location,
and
a
table
showing
required
acreage
and
number
of
experimental
locations
per
state.

The
revised
Section
G,
dated
December
22,
2004,
provided
additional
information
on
experiments
that
would
be
included
within
the
insect
resistance
management
protocol.
Brief
descriptions
of
these
trials
are
listed
below.

1.
Monitoring
large
acreages
of
Cry34/
35
inbreds
for
corn
rootworm
larval
injury.
Large­
scale
testing
(
50
to
550
acres
per
location)
is
important
because
evaluations
will
rely
on
natural
pest
populations,
which
vary
considerably
throughout
a
field
and
from
location
to
location.

Multiple
replicate
trials
will
examine
three
to
five
different
Cry34/
35
inbreds,
with
several
different
genetic
backgrounds
(
number
of
hybrids
tested
is
subject
to
change).
Rows
of
corn
plants
containing
the
Cry34/
35
protein
(
inbreds
and
hybrids)
will
alternate
with
rows
containing
non­
Cry34/
35
corn
(
e.
g.
row
1
=
Cry34/
35
corn,
row
2
=
non­
Cry34/
35
corn,
etc.)

Following
peak
larval
feeding,
plants
from
the
non­
Cry34/
35
rows
will
be
inspected
for
root
lodging.
If
root
lodging
for
the
non­
Cry34/
35
line
reaches
a
certain
threshold,
researchers
will
dig
up
roots
from
a
representative
sample
of
Cry34/
35
and
non­
Cry34/
35
plants.
Roots
will
be
washed
to
remove
soil
and
the
level
of
rootworm
damage
will
be
visually
scored.

Data
generated
from
these
experiments
will
be
used
to
improve
scientific
understanding
of
trait
performance
(
corn
rootworm
protection),
as
well
as
performance
correlations
between
inbred
parent
lines
and
hybrid
crosses.
Ultimately,
this
information
would
be
used
to
set
thresholds
for
trait
performance,
an
important
component
in
the
development
of
unexpected
damage
guidelines.

2.
Investigations
of
rootworm
population
dynamics
in
Cry34/
35
fields.
Research
will
be
conducted
to
improve
understandings
of
how
Cry34/
35
corn
may
7
influence
the
number
of
emerging
rootworm
adults,
the
timing
of
adult
emergence,
gender
ratios,
dry
weight
of
newly
emerged
adults,
and
root
injury.

3.
Cry34/
35
dose
studies.
These
investigations
will
provide
insight
into
target
pest
adaptation
to
Cry34/
35,
by
identifying
the
expected
level
of
mortality
inflicted
by
the
insecticidal
protein
on
rootworm
larvae.

4.
Cry34/
35
efficacy
studies.
This
research
will
improve
the
registrant's
ability
to
establish
reliable
unexpected
damage
guidelines
for
rootworm
resistance
monitoring.

BPPD
Review
Present
Submission
Proposed
acreages
for
Cry34/
35Ab1
corn
breeding
and
observation
nurseries,
agronomic
observation
trials,
herbicide
tolerance
studies,
efficacy
trials,
non­
target
organism
studies,
regulatory
experiments,
research
seed
production,
and
inbred
seed
increase
are
acceptable.
However,
it
is
recommended
that
future
submissions
should
include
more
detailed
discussions
of
all
protocols
(
see
Future
Submissions
section
below).

The
registrant
has
requested
100
acres
for
demonstration
trials.
However,
section
5
of
FIFRA
states,
"
the
Administrator
may
issue
an
experimental
use
permit
only
if
the
Administrator
determines
that
the
applicant
needs
such
permit
in
order
to
accumulate
information
necessary
to
register
a
pesticide "
Since
demonstration
trials
do
not
provide
information
required
for
pesticide
registration,
inclusion
of
demonstration
trials
in
EUP
acreage
is
inappropriate.
It
is
recommended
that
EUP
acreage
should
not
be
granted
for
demonstration
trials.

The
registrant's
original
submission
(
July
2004)
did
not
include
sufficient
justification
for
the
unusually
large
(
most
PIP
EUP
submissions
request
100
acres
or
less
for
this
protocol)
acreage
request
associated
with
insect
resistance
management
trials.
However,
following
the
Agency's
request,
the
registrant
submitted
supplemental
information
(
revised
submission)
which
addressed
the
majority
of
identified
deficiencies.
Available
information
is
sufficient
to
recommend
acreage
for
the
2005
season,
however
it
is
recommended
that
outstanding
deficiencies
should
be
addressed
in
the
final
report
(
see
Final
Report
section
below).

Based
on
available
information,
it
is
recommended
that
2,500
EUP
acres
(
3,950
acres
requested)
should
be
granted
for
insect
resistance
management
trials.
This
acreage
is
agronomically
justified
because
the
protocol
includes
a
variety
of
trials,
the
largest
(
monitoring
experiment)
requiring
50
to
500
acres
per
location
if
useful
results
are
to
be
gathered.

March
2004­
April
2005
EUP
Acres
EUP
Protocols
Requested
Agronomically
Justified
Breeding
and
observation
nursery
515
515
8
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
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).
 
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.