Event
MON
863
Bt
Cry3Bb1
Corn
Response
to
Comments
Document
September
2005
Response
to
Comments
Document
Bacillus
thuringiensis
Cry3Bb1
Protein
and
the
Genetic
Material
Necessary
for
its
Production
(
Vector
ZMIR13L)
in
Event
MON
863
Corn
U.
S.
Environmental
Protection
Agency
Office
of
Pesticide
Programs
Biopesticide
and
Pollution
Prevention
Division
Event
MON
863
Bt
Cry3Bb1
Corn
Response
to
Comments
Document
September
2005
ii
Table
of
Contents
Introduction
..........................................................................................................
iii
1
­
Insect
Resistance
Management
(
IRM)
.............................................................
1­
1
1.1
­
Refuges
1.2
­
Resistance
Defined
1.3
­
IRM
Plan
1.4
­
Data
Needs
and
Methods
1.5
­
Expression
Levels
2
­
Health
Effects
..................................................................................................
2­
1
2.1
­
Human
Health
2.2
­
Molecular
Biology/
Product
Characterization
2.3
­
Data
Needs
and
Methods
2.4
­
Expression
Levels
3
­
Environmental
Assessment
.............................................................................
3­
1
3.1
­
Non­
target
Organism
Effects
3.2
­
Environmental
Fate/
Persistence/
Indirect
Effects
on
Soil
Biota
4
­
Gene
Flow
and
Weediness
..............................................................................
4­
1
5
­
Benefits
............................................................................................................
5­
1
5.1
­
Efficacy
5.2
­
Decreased
Pesticide
Use
5.3
­
Alternatives
to
MON
863
6
­
The
Corn
Rootworm
Problem
(
background)
...................................................
6­
1
7
­
Registration/
Approval
­
General
......................................................................
7­
1
Event
MON
863
Bt
Cry3Bb1
Corn
Response
to
Comments
Document
September
2005
1Currently
with
the
USDA/
APHIS.

2Currently
with
the
USDA/
CSREES.

iii
Event
MON
863
Bt
Cry3Bb1
Corn
Response
to
Comments
Document
Team
Insect
Resistance
Management
(
IRM)
Robyn
Rose,
Ph.
D.
1
Health
Effects
John
Kough,
Ph.
D.

Environmental
Assessment
Zigfridas
Vaituzis.
Ph.
D.

Gene
Flow
and
Weediness
Chris
Wozniak,
Ph.
D.
2
Benefits
Edward
Brandt,
M.
A.

The
Corn
Rootworm
Problem
(
background)
Mike
Mendelsohn
Registration/
Approval
­
General
Mike
Mendelsohn
Legal
Counsel
Keith
Matthews,
J.
D.
Office
of
General
Counsel
Contract
Work
Assignment
Manager
Ibrahim
Barsoum,
Ph.
D.

Event
MON
863
Bt
Cry3Bb1
Corn
Response
to
Comments
Document
Team
Leader
Mike
Mendelsohn
Event
MON
863
Bt
Cry3Bb1
Corn
Response
to
Comments
Document
September
2005
3The
ICF
Consulting
project
manager
for
this
project
was
William
B.
Baird,
wbaird@
icfconsulting.
com.

iv
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).
Finally,
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.

This
document
presents
the
combined
set
of
comments
received
by
these
three
dockets
and
EPA's
response
based
on
EPA's
judgement
at
the
time
of
it's
registration
decision
(
with
the
exception
of
gene
stacking
comments
which
were
addressed
in
the
YieldGard
Plus
&
MON863
Gene
Stacking
Response
to
Comments
Document).

Approximately
937
comments
were
received
by
EPA
in
response
to
these
announcements.
Comments
were
received
from
private
citizens,
independent
farmers,
farming
cooperatives,
farm
industry
representatives,
trade
organizations,
advocacy
groups,
academic
researchers,
and
government
officials.
Comments
included
handwritten
letters,
typed
letters,
e­
mails,
faxes,
and
slide
presentations
from
the
SAP
meeting.

EPA
contracted
with
ICF
Consulting
of
Fairfax,
Virginia3
to
provide
technical
assistance
in
the
categorization
and
summary
of
these
public
comments
using
CommentWorks,
ICF's
proprietary
comment
analysis
and
response
development
software.
ICF
assisted
EPA
in
scanning
and
importing
letters
from
all
three
of
the
dockets
into
CommentWorks,
identifying
excerpts,
and
coding
them
to
key
issues
identified
by
EPA.

Several
organizations
interested
in
the
registration
of
MON
863
sponsored
letter­
writing
campaigns
to
promote
their
interests
and
provided
form
letters
for
members
or
other
interested
citizens
to
submit
to
EPA.
ICF
reviewed
all
of
the
substantive
comments
provided
by
EPA
to
Event
MON
863
Bt
Cry3Bb1
Corn
Response
to
Comments
Document
September
2005
v
identify
such
form
letters.
A
number
of
non­
substantive
letters
were
also
received
by
EPA,
but
not
provided
to
ICF.
ICF
identified
six
master
form
letters.
The
originating
organizations
for
these
campaign
letters
were
not
apparent,
and
the
master
letters
were
identified
on
the
basis
of
the
most
consistently
copied
text.
Most
of
the
937
comments
received
were
form
letters
(
81
percent).
In
some
cases
the
form
letters
were
signed
and
mailed
without
alteration.
However,
many
commenters
added
personalized
comments
or
edited
the
form
letters
to
better
express
their
individual
views.
ICF
imported
into
CommentWorks
only
the
unique
and
substantive
text
from
master
form
letters
and
from
altered
form
letters
in
order
to
avoid
repetition.
However,
for
each
master
form
letter,
ICF
tracked
the
total
number
of
both
altered
and
unaltered
form
letters
received.
In
total,
221
unique,
substantive
comments
were
imported
into
CommentWorks
for
detailed
analysis.

About
88
percent
of
the
937
comments
were
received
from
private
citizens.
This
number
includes
non­
substantive
comments
not
provided
to
ICF.
Comments
submitted
by
independent
farmers
were
not
differentiated
from
private
citizen
comments,
so
the
number
of
independent
farmers
submitting
comments
is
not
included
here.
Support
or
opposition
of
the
registration
was
not
tracked
for
individual
commenters,
however,
all
six
of
the
master
form
letters
expressed
support
for
the
registration
of
MON
863.
Based
on
the
large
number
of
form
letters
received
and
the
large
number
of
letters
received
from
private
citizens,
we
conclude
that
most
of
the
private
citizens
who
commented
on
the
application
generally
support
registration.

Some
of
the
major
environmental
or
public
interest
groups
included
the
Center
for
Science
in
the
Public
Interest,
Foundation
E.
A.
R.
T.
H.,
Greenpeace,
The
Sierra
Club,
The
Xerces
Society,
and
Union
of
Concerned
Scientists.
The
Center
for
Science
in
the
Public
Interest
did
not
express
strong
support
or
opposition
to
the
registration
of
MON
863,
but
did
provide
a
detailed
analysis
identifying
what
they
viewed
as
flaws
in
the
current
Insect
Resistance
Management
(
IRM)
plan.
Foundation
E.
A.
R.
T.
H.,
an
environmental
organization
focusing
on
agriculture,
supported
approval
of
the
registration
based
on
an
impact
survey
of
300
corn
growers
who,
by
and
large,
were
interested
in
reducing
pesticide
use
and
using
a
seed
product
like
MON
863.
Greenpeace,
The
Sierra
Club,
and
The
Xerces
Society,
all
environmental
advocacy
groups,
along
with
Union
of
Concerned
Scientists,
a
public
interest
group,
opposed
approval
of
the
application,
claiming
that
insufficient
scientific
data
are
available.
Each
of
these
groups
provided
lengthy
comments
and/
or
independent
evaluations
of
the
application
materials
submitted
by
Monsanto.

Agricultural
trade
associations
generally
supported
approval
of
registration
of
MON
863.
Among
these
trade
associations
were
the
American
Seed
Trade
Association,
the
Agribusiness
Association
of
Iowa,
the
Illinois
Corn
Growers
Association,
the
Iowa
Corn
Growers
Association,
the
Nebraska
Corn
Growers
Association,
the
Iowa
Seed
Association,
the
National
Grain
and
Feed
Association,
and
the
National
Wild
Turkey
Federation.
A
representative
of
the
National
Corn
Growers
Association
supported
the
registration
and
expressed
the
importance
of
a
workable
IRM
plan.
The
Illinois
Corn
Growers
Association
expressed
concerns
about
handling
and
marketing
the
product.
Event
MON
863
Bt
Cry3Bb1
Corn
Response
to
Comments
Document
September
2005
vi
Approximately
20
seed
and
grain
companies
submitted
comments
in
support
of
registration
of
MON
863.
Entomologists
from
research
and
academic
organizations
including
the
NCR­
46
committee
(
a
technical
committee
of
research
and
extension
entomologists),
Iowa
State
University,
Kansas
State
University,
Michigan
State
University,
Pennsylvania
State
University,
and
the
University
of
Delaware
also
expressed
support
of
the
registration.
Government
representatives
of
the
Illinois
Department
of
Agriculture,
Illinois
State
Senate,
Iowa
Department
of
Agriculture,
Nebraska
Department
of
Agriculture,
Ohio
Department
of
Agriculture,
Texas
House
of
Representatives,
Texas
Senate,
and
U.
S.
Department
of
Agriculture
all
supported
registration
of
MON
863.

The
remainder
of
this
report
presents
relevant
summaries
or
excerpts
from
all
the
unique,
substantive
comments
received
on
the
application.
This
report
is
organized
according
to
the
issues
addressed
by
commenters
(
see
Table
of
Contents
following
this
introduction).
The
first
section
addresses
comments
dealing
with
Insect
Resistance
Management
(
IRM).
Due
to
the
large
volume
of
comments
addressing
the
same
issues
on
IRM,
EPA
summarized
the
public
comments
in
this
section
and
provided
responses
following
the
comment
summaries.
The
other
sections
of
this
document
contain
verbatim
excerpts
from
public
comments.
In
these
sections,
EPA
responded
to
comments
in
two
different
ways.
In
cases
where
a
commenter
raised
unique
substantive
points,
EPA
provided
a
response
to
a
single
comment
excerpt.
In
other
cases,
the
issues
raised
in
different
comment
excerpts
were
similar
enough
to
allow
EPA
to
provide
one
response
for
a
group
of
excerpts.
