Document ID: EPA-HQ-OPP-2004-0182-0010
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-10-11T04:00Z

Event
MON
863
Bt
Cry3Bb1
Corn
&
YieldGard
Plus
Gene
Stacking
September
2005
Response
to
Comments
Document
Response
to
Comments
Document
YieldGard
Plus
&
MON863
Gene
Stacking
U.
S.
Environmental
Protection
Agency
Office
of
Pesticide
Programs
Biopesticide
and
Pollution
Prevention
Division
Event
MON
863
Bt
Cry3Bb1
Corn
&
YieldGard
Plus
Gene
Stacking
September
2005
Response
to
Comments
Document
1Currently
with
the
USDA/
APHIS.

Page
2
of
9
Event
MON
863
Bt
Cry3Bb1
Corn
&
YieldGard
Plus
Gene
Stacking
Response
to
Comments
Team
Ibrahim
Barsoum,
Ph.
D.
John
Kough,
Ph.
D.
Keith
Matthews,
J.
D.
Mike
Mendelsohn
Robyn
Rose,
Ph.
D.
1
Zigfridas
Vaituzis.
Ph.
D.

Introduction
On
March
1,
2001,
the
U.
S.
Environmental
Protection
Agency
(
EPA)
announced
receipt
of
an
application
to
register
a
pesticide
product
containing
an
active
ingredient
not
included
in
any
previously
registered
product
pursuant
to
the
provisions
of
section
3(
c)(
4)
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
(
66
FR
15435).
The
applicant,
Monsanto
Company,
submitted
the
registration
application
to
register
the
product,
Event
MON
863:
Corn
Rootworm­
Protected
Corn.
Upon
receipt
of
the
application,
EPA
opened
docket
OPP­
30509
for
public
comment
on
registration
of
this
product.
On
March
13,
2002,
EPA
announced
receipt
of
a
revised
application
from
Monsanto,
and
accepted
comments
under
docket
OPP­
30509B
(
67
FR
11333).
On
July
24,
2002,
EPA
announced
a
meeting
of
the
FIFRA
Scientific
Advisory
Panel
(
SAP)
to
consider
and
review
corn
rootworm
plant­
incorporated
protectant,
insect
resistance
management
and
non­
target
insect
issues
(
67
FR
48461)
and
accepted
comments
under
docket
OPP­
2002­
0157.
Finally,
on
April
2,
2003,
EPA
announced
receipt
of
an
application
for
YieldGard
Plus
Corn,
and
accepted
comments
under
OPP­
2002­
0351
(
68
FR
16036).

This
document
provides
EPA's
responses
to
gene
stacking
comments
received
regarding
the
MON
863
Cry3Bb1
corn
application
for
full
commercial
registration,
as
well
as
all
comments
received
regarding
YieldGard
Plus
corn
(
a
cross
of
MON
863
and
MON
810
corn
that
stacks
the
cry1Ab
and
cry3Bb1
genes
to
provide
protection
against
both
European
corn
borers
and
corn
rootworms)
based
on
EPA's
judgement
at
the
time
of
its
registration
decisions.
Event
MON
863
Bt
Cry3Bb1
Corn
&
YieldGard
Plus
Gene
Stacking
September
2005
Response
to
Comments
Document
2The
ICF
Consulting
project
manager
for
this
project
was
William
B.
Baird,
wbaird@
icfconsulting.
com.

Page
3
of
9
EPA
contracted
with
ICF
Consulting
of
Fairfax,
Virginia2
to
provide
technical
assistance
in
the
categorization
and
summary
of
the
MON
863
public
comments
using
CommentWorks,
ICF's
proprietary
comment
analysis
and
response
development
software.
ICF
assisted
EPA
in
scanning
and
importing
letters
from
the
three
MON
863
dockets
into
CommentWorks,
identifying
excerpts,
and
coding
them
to
key
issues
identified
by
EPA.

The
format
differs
between
the
YieldGard
Plus
and
the
MON863
comment
responses
as
MON
863
excerpts
were
provided
by
ICF
and
the
YieldGard
Plus
comments
were
summarized
by
EPA
staff.

YieldGard
Plus
Comment
Summaries
and
EPA
Response
Thirteen
comments
were
received
in
response
to
the
Federal
Register
notice
that
announced
receipt
of
the
YieldGard
Plus
application
for
registation.
Comments
were
received
from
the
seed
industry,
farmer
groups,
academia,
and
one
public
interest
group.
Summaries
of
the
comments
a
and
BPPD's
responses
follow.

Seed
Companies
Five
seed
companies
or
related
organizations
provided
six
comments.
These
included
Mershman
Seeds,
Inc.,
Channel
Bio
Corp.(
a
holding
company
that
owns
Crow's
Hybrid
Corn
Company,
Midwest
Seed
Genetics,
and
Wilson
Seeds),
NC+
Hybrids,
J.
C.
Robinson
Seeds,
Beck's
Superior
Hybrids,
and
the
Michigan
Agri­
Business
Association.

All
seed
company
commenters
were
in
favor
of
registration.
They
stated
that
registration
of
the
Cry1Ab/
Cry3Bb1
corn
would:
provide
an
increase
in
farmer
income,
reduce
pressure
on
seed
businesses
regarding
the
time
needed
to
commercialize
new
lines
and
allow
production
of
YieldGard
Plus
seed
in
U.
S.
verses
outside
the
U.
S.;
reduce
the
use
of
conventional
chemical
pesticides
and
provide
a
safer
work
environment
for
farmers,
as
well
as
have
less
impact
on
nontarget
insects
and
the
environment;
provide
another
tool
for
farmers
that
will
control
different
types
of
pests,
have
increased
efficacy,
result
in
improvement
of
plant
health,
provide
increased
efficacy,
and
have
quick
market
acceptance.

Farmer
Groups
Three
farmer
groups
provided
comments.
These
included
the
Nebraska
Corn
Board,
the
Nebraska
Corn
Growers
Association,
and
the
Kansas
Corn
Growers
Association.
All
farmer
Event
MON
863
Bt
Cry3Bb1
Corn
&
YieldGard
Plus
Gene
Stacking
September
2005
Response
to
Comments
Document
Page
4
of
9
group
commenters
were
in
favor
of
registration.
They
stated
that
registration
of
the
Cry1Ab/
Cry3Bb1
corn
would:
reduce
pesticide
use
and
trips
across
the
field,
and
provide
agronomic,
economic,
and
environmental
benefits.
Further,
they
indicated
that
corn
producers
need
more
tools.

Academia
Gerald
Wilde
and
Phil
Sloderbeck,
both
of
Kansas
State
University,
commented.
Dr.
Wilde
commented
that
the
insect
resistant
management
plan
submitted
by
Monsanto
was
scientific
and
rational.
Dr.
Sloderbeck
commented
that
the
plan
was
generally
acceptable,
but
that
it
did
not
take
into
consideration
low
adoption
areas
and
rotational
practices.
He
further
commented
that
the
requirement
of
spraying
YieldGard
Plus
acreage
when
the
refuge
is
sprayed
for
adult
insects
when
adult
rootworms
are
present
is
contary
to
integrated
pest
management
and
that
community
refuges
should
be
considered.

UCS
UCS
urged
EPA
to
hold
an
SAP
mtg
prior
to
making
a
registration
decision
regarding
YieldGard
Plus.
Scientific
comments
submitted
were
already
submitted
for
the
MON863
(
YieldGard
Rootworm)
application
and
their
excerpts
and
EPA's
response
are
listed
in
the
MON863
section
of
this
document.

EPA
Response
In
its
October
31,
2003
Decision
Memorandum,
the
Agency
determined
that
Monsanto
provided
sufficient
data
to
characterize
the
incremental
risks
associated
with
the
stacking
of
Bacillus
thuringiensis
Cry3Bb1
protein
and
the
genetic
material
necessary
for
its
production
(
Vector
ZMIR13L)
in
event
MON863
corn
and
Bacillus
thuringiensis
Cry1A(
b)
delta
endotoxin
and
the
genetic
material
necessary
for
its
production
in
corn
via
conventional
breeding.
Accepting
the
new
use
application
proposed
by
Monsanto
Company
did
not
significantly
increase
the
risk
of
any
unreasonable
adverse
effect
on
man
or
the
environment.
The
Agency
was
able
to
come
to
this
conclusion
without
a
Scientific
Advisory
Panel
meeting.
The
Agency
recognizes
the
concerns
about
the
current
refuge
deployment
requirements
(
of
spraying
the
YieldGard
Plus
acreage
when
the
refuge
is
sprayed
and
corn
rootworm
adults
are
present.

While
the
separate
refuge
option
for
YieldGard
Plus
helps
prevent
unnecessary
spraying
of
YieldGard
Plus
acreage
for
areas
that
have
high
corn
borer
pressure,
an
option
that
allows
spraying
the
refuge
without
requiring
spraying
of
the
YieldGard
Plus
acreage
is
currently
not
available
for
low
adoption
areas.
The
requirement
of
spraying
the
YieldGard
Plus
acreage
if
the
refuge
is
sprayed
and
adult
corn
rootworms
are
present
was
deemed
necessary
to
delay
the
onset
Event
MON
863
Bt
Cry3Bb1
Corn
&
YieldGard
Plus
Gene
Stacking
September
2005
Response
to
Comments
Document
Page
5
of
9
of
corn
rootworm
resistance.
We
recognize
the
commentor's
concern
and
as
new
information
becomes
available
to
the
Agency,
will
consider
ways
of
minimizing
chemical
sprays
where
this
does
not
impact
the
development
of
resistance.

MON863
Gene
Stacking
Comment
Excerpts
and
EPA
Responses
Commenter
Name:
Charles
Benbrook
Commenter
Organization
Name:
Union
of
Concerned
Scientists
Comment
Number:
30509­
115000
Excerpt
Number:
40
Excerpt
Text:

Moreover,
we
believe
that
as
more
information
is
compiled
on
Cry
3Bb
corn
and
as
more
balanced,
independent
assessments
are
completed,
the
magnitude
of
the
projected
benefits
will
shrink
and
the
scope
and
severity
of
possible
risks
will
rise.
In
particular,
Monsanto's
plan
to
"
stack"
Cry
3Bb
and
Cry
1Ab
endotoxins
in
the
same
corn
varieties,
perhaps
in
conjunction
with
the
Roundup
Ready
trait,
will
raise
new
and
complex
risk
assessment
science
and
regulatory
policy
issues.

EPA
Response
In
its
October
31,
2003
Decision
Memorandum,
the
Agency
determined
that
Monsanto
provided
sufficient
data
to
characterize
the
incremental
risks
associated
with
the
stacking
of
Bacillus
thuringiensis
Cry3Bb1
protein
and
the
genetic
material
necessary
for
its
production
(
Vector
ZMIR13L)
in
event
MON863
corn
and
Bacillus
thuringiensis
Cry1A(
b)
delta
endotoxin
and
the
genetic
material
necessary
for
its
production
in
corn
via
conventional
breeding.
Accepting
the
new
use
application
proposed
by
Monsanto
Company
did
not
significantly
increase
the
risk
of
any
unreasonable
adverse
effect
on
man
or
the
environment.

Commenter
Name:
Lincoln
Brower
Commenter
Organization
Name:
Sweet
Briar
College
Comment
Number:
30509B­
084000
Excerpt
Number:
2
Excerpt
Text:
In
many
respects,
the
potential
for
biodiversity
damage
that
may
ensue
from
a
corn
varietal
that
secretes
Bt
toxins
in
its
roots­
seems
even
greater
to
me
.......
affecting
the
biological
integrity
of
the
soil
ecosystem
in
some
of
the
richest
and
most
biodiverse
soils
on
this
planet.
Gene
stacking
seems
particularly
troublesome
and
fraught
with
long
term
toxicological
uncertainty.

EPA
Response
Specific
terms
and
conditions
of
the
MON
863
registration
require
that
field
studies
be
conducted
on
fields
planted
with
YieldGard
Plus
corn
for
at
least
three
consecutive
years
to
evaluate
the
potential
effects
of
the
Cry1Ab/
Cry3Bb1
corn
on
biodiversity.
Also,
post­
registration
monitoring
is
required
to
ensure
that
insect
biodiversity
including
soil­
dwelling
organisms
will
not
be
adversely
effected
by
the
Cry1Ab/
Cry3Bb1
stacked
corn
product.
The
Yieldgard
Plus
Fact
Sheet
Event
MON
863
Bt
Cry3Bb1
Corn
&
YieldGard
Plus
Gene
Stacking
September
2005
Response
to
Comments
Document
Page
6
of
9
may
be
accessed
from
EPA's
webpage,
http://
www.
epa.
gov/
pesticides/
biopesticides/
ingredients/
factsheets/
factsheet_
006430­
006484.
htm.

Commenter
Name:
Rissler
Commenter
Organization
Name:
UCS
Comment
Number:
30509B­
089000
Excerpt
Number:
19
Excerpt
Text:

D.
Gene
Stacking
Raises
Risks
That
Have
Not
Been
Addressed.

As
more
novel
traits
are
introduced
into
the
corn
genome,
companies
will
increasingly
stack
two
or
more
genes
in
the
same
variety.
Some
commercial
varieties
already
contain
stacked
genes
including
herbicide­
tolerant
Bt­
corn
and
Bt­
cotton.
The
first
gene
likely
to
be
stacked
with
MON
863
will
confer
resistance
to
Roundup
(
glyphosate)
herbicide.
Next
will
probably
be
the
Cry
1Ab
gene
for
control
of
ECB,
and
then
dual
Bt­
corn
plus
the
Roundup
Ready
gene.
Other
companies
working
toward
commercialization
of
transgenic
corn
for
rootworm
control
will
follow
suit,
stacking
first
herbicide­
tolerant
genes
with
a
rootworm
toxin
gene,
then
one
of
several
ECB
Bt
genes,
and
last,
multiple
genes
for
ECB
and/
or
rootworm
control,
plus
herbicide
tolerance.

Stacking
two
genes
producing
different
Bt
toxins
raises
a
host
of
new
questions
and
concerns
that
will
take
considerable
time
and
effort
to
adequately
address.
These
include:

­
The
combined
impact
of
two
Bt
toxins
on
target
and
nontarget
organisms;

EPA
Response
The
combined
impact
of
Cry1Ab
and
Cry3Bb1
was
considered.
These
genes
are
expressed
in
the
stacked
YieldGard
Plus
corn
as
the
single
trait
Cry1Ab
and
Cry3Bb1
corn.
Laboratory
studies
were
conducted
that
demonstrated
no
evidence
of
a
change
in
efficacy
toward
susceptible
pests
between
the
stacked
and
single
trait
hybrids.
No
impact
is
expected
to
occur
for
non­
target
pests
that
are
not
susceptible
to
the
proteins
if
the
susceptible
pests
are
not
impacted.
To
verify
this
conclusion,
specific
terms
and
conditions
of
the
Yieldgard
plus
registration
require
that
field
studies
be
conducted
after
registration
to
monitor
for
changes
in
insect
abundance
and
diversity
after
exposure
to
Yieldgard
plus
corn.

­
Consequences
on
resistance
management
to
all
target
insects,
given
that
at
least
one
event
is
likely
to
be
expressed
at
sublethal
levels;

EPA
Response
Research
and
models
were
conducted
to
determine
an
appropriate
IRM
strategy
for
MON
810
and
MON
863.
IRM
strategies
and
grower
agreements
to
comply
with
IRM
requirements
are
Event
MON
863
Bt
Cry3Bb1
Corn
&
YieldGard
Plus
Gene
Stacking
September
2005
Response
to
Comments
Document
Page
7
of
9
required
for
MON
810,
MON
863
and
MON810/
MON863
stacked
hybrids.
The
registration
also
requires
Monsanto
to
develop,
implement,
and
report
to
EPA
on
monitoring
programs
to
evaluate
whether
there
are
statistically
significant
and
biologically
relevant
changes
in
target
insect
susceptibility
to
Cry3Bb1
or
Cry1Ab
proteins
in
the
target
insects.

­
Levels
in
roots
and
root
exudates,
environmental
fate
of
the
toxins
in
the
soil,
possible
synergistic
effects,
and
impacts
on
soil
food
webs
and
microbial
communities;

EPA
Response
The
DT50
was
determined
in
the
laboratory
for
single
trait
MON
810
and
MON
863
corn
as
well
as
the
stacked
hybrids.
Specific
terms
and
conditions
of
the
registrations
require
the
generation
of
field
data
for
the
single
trait
and
stacked
hybrids
on
cornfields
that
have
been
grown
with
the
Bt
Cry
protein
for
at
least
three
consecutive
years
to
evaluate
the
potential
accumulation
and
persistence
of
Bt
in
the
soil.
In
addition,
field
studies
monitoring
for
changes
in
insect
communities
including
soil­
dwelling
organisms
will
be
conducted
after
registration.
The
rapid
degradation
of
the
Bt
protein
in
soil
and
lack
of
persistence
or
accumulation
of
the
Bt
proteins
also
suggests
that
microbial
communities
will
not
be
adversely
affected.

­
Stability
of
the
transformation
event
given
the
presence
of
two,
and
possibly
more,
promoter
gene
sequences;

EPA
Response
Product
characterization
data
demonstrated
that
YieldGard
®
Plus
Corn,
which
resulted
from
the
conventional
cross
of
MON
810
and
MON
863,
contains
the
cry1Ab1
and
cry3Bb1
genes
and
that
there
have
been
no
major
alterations
or
rearrangements
in
the
conventional
cross
of
these
two
events
(
lines)
for
these
two
gene
inserts.

­
Potential
for
pleiotrophic
impacts,
especially
under
conditions
of
stress;
and
­
Energy
drag
on
the
plant
and
potential
reduction
of
yields.

EPA
Response
There
are
no
data
suggesting,
nor
does
EPA
have
any
reason
to
believe,
that
these
plants
will
be
subject
to
any
pleiotrophic
effects
that
will
constitute
an
unreasonable
adverse
effect
on
the
environment.
The
terms
and
conditions
of
the
registrations,
however,
require
substantial
monitoring
of
these
products
in
the
field.
We
fully
expect
that
such
required
monitoring
will
reveal
any
potential
pleiotrophic
effects
that
might
possibly
constitute
an
unreasonable
adverse
effect
on
the
environment.
Event
MON
863
Bt
Cry3Bb1
Corn
&
YieldGard
Plus
Gene
Stacking
September
2005
Response
to
Comments
Document
Page
8
of
9
Commenter
Name:
Rissler
Commenter
Organization
Name:
UCS
Comment
Number:
30509B­
089000
Excerpt
Number:
33
Excerpt
Text:

6.
Request
the
SAP
to
describe
the
risks
associated
with
gene
stacking
and
develop
a
research
agenda
to
assess
those
risks.

Commenter
Name:
Rissler
Commenter
Organization
Name:
UCS
Comment
Number:
30509B­
089000
Excerpt
Number:
41
Excerpt
Text:

7.
Prohibit
gene
stacking,
pending
the
outcome
of
credible
new
research
on
the
risks
associated
with
gene
stacking.

EPA
Response
In
its
October
31,
2003
Decision
Memorandum,
the
Agency
determined
that
Monsanto
provided
sufficient
data
to
characterize
the
incremental
risks
associated
with
the
stacking
of
Bacillus
thuringiensis
Cry3Bb1
protein
and
the
genetic
material
necessary
for
its
production
(
Vector
ZMIR13L)
in
event
MON863
corn
and
Bacillus
thuringiensis
Cry1A(
b)
delta
endotoxin
and
the
genetic
material
necessary
for
its
production
in
corn
via
conventional
breeding.
Accepting
the
new
use
application
proposed
by
Monsanto
Company
did
not
significantly
increase
the
risk
of
any
unreasonable
adverse
effect
on
man
or
the
environment.
The
Agency
was
able
to
come
to
this
conclusion
without
a
Scientific
Advisory
Panel
meeting.

Commenter
Name:
N/
A
Commenter
Organization
Name:
Center
for
Science
in
the
Public
Interest
Comment
Number:
OPP02­
0028
Excerpt
Number:
13
Excerpt
Text:

11.
Monsanto
has
not
considered
whether
stacking
MON
863
with
Cryl
or
herbicide
tolerance
genes
will
increase
the
acreage
of
corn
containing
Cry3Bb1
or
Cryl
compared
to
unstacked
varieties
alone.

The
greater
the
acreage
containing
Cry3Bbl
or
Cryl
genes,
the
greater
the
likely
hood
that
insect
resistance
will
develop
to
either
gene.
EPA
should
carefully
consider
the
potential
impacts
of
gene
stacking
of
Cry3Bb1
with
other
GE
products
on
IRM
for
CRW
protected
Bt
corn
and
Cryl
corn
borer
protected
corn.
Cry
gene
stacking
should
be
restricted
if
it
may
jeopardize
IRM
efficacy.
Event
MON
863
Bt
Cry3Bb1
Corn
&
YieldGard
Plus
Gene
Stacking
September
2005
Response
to
Comments
Document
Page
9
of
9
EPA
Response
EPA
believes
that
the
currently
available
information
supports
a
conclusion
that
it
is
not
relevant
that
additional
acres
of
Bt
corn
may
planted
because
of
the
availability
of
stacked
products
as
long
as
an
adequate
refuge
is
planted
to
ensure
mitigation
of
insect
resistance.
An
IRM
plan
is
required
for
the
stacked
as
well
as
the
single
trait
hybrids.

Commenter
Name:
N/
A
Commenter
Organization
Name:
Center
for
Science
in
the
Public
Interest
Comment
Number:
OPP02­
0028
Excerpt
Number:
27
Excerpt
Text:

D.
Gene
Stacking
and
Resistance
Management
Finally,
no
consideration
has
been
presented
concerning
the
possible
impact
of
stacked
transgenes
(
that
is,
several
transgenes
in
one
plant)
on
resistance
management.
Stacking
of
MON
863
with
MON
810
or
herbicide
tolerance
genes
may
increase
the
total
acreage
of
corn
containing
those
genes
either
alone
or
in
combination
compared
with
the
acreage
containing
those
genes
if
they
were
not
stacked.

Of
particular
concern
is
the
increased
possibility
of
resistance
to
MON
8
1
0.
In
particular,
MON
8
1
0
does
not
provide
a
sufficiently
high
dose
for
corn
earthworm/
cotton
bollworm
(
Helicoverpa
zea)
for
the
refuge
strategy
to
be
effective
if
a
high
percentage
of
corn
acres
contain
Cry1Ab.
Previous
evaluation
suggested
that
as
long
as
the
percentage
of
corn
in
a
region
containing
CrylAb
remained
low
enough
(
below
about
50%),
selection
pressure
may
be
low
enough
to
minimize
resistance
concerns.
If
stacking
of
MON
810
with
MON
863
significantly
increases
the
acreage
of
corn
containing
Cryl
genes,
the
likelihood
of
corn
earthworm
resistance
may
increase
substantially.

How
widely
stacked­
gene
varieties
are
grown
depends
on
a
number
of
factors,
including
how
Monsanto
and
other
companies
develop
and
market
CRW­
protected
Bt
varieties.
EPA
must
address
the
­
issue
of
stacking
to
assure
that
it
does
not
contribute
significantly
to
insect
resistance
to
Bt
products.
EPA
should
restrict
gene
stacking
unless
it
can
be
assured
that
stacking
will
not
threaten
IRM.

EPA
Response
Since
models
are
based
on
100%
adoption,
increasing
the
acreage
of
Bt
corn
due
to
stacking
genes
should
not
increase
the
risk
of
resistance.
Monitoring
for
insect
resistance
to
Bt
corn
is
required.
There
have
been
no
reports
of
any
insects
becoming
resistant
to
Bt
corn
in
the
field.
If
resistance
is
detected,
a
remedial
action
plan
to
mitigate
the
resistance
is
required.
In
addition,
a
50%
refuge
for
lepidopteran­
active
corn
is
required
in
southern
cotton­
growing
regions
to
prevent
CEW/
CBW
resistance.
Stacking
the
MON
810
and
MON
863
genes
will
not
threaten
insect
resistance
based
on
the
currently
required
IRM
strategy.