FIFRA
SCIENTIFIC
ADVISORY
PANEL
(
SAP)
OPEN
MEETING
March
14
­
15,
2006
FIFRA
SAP
WEB
SITE
http://
www.
epa.
gov/
scipoly/
sap/
OPP
Docket
Telephone:
(
703)
305­
5805
Docket
Number:
OPP­
2006­
0035
Holiday
Inn
­
National
Airport
2650
Jefferson
Davis
Highway
Arlington,
VA
22202
Telephone:
(
703)
684­
7200
EVENT
MIR604
MODIFIED
Cry3A
PROTEIN
Bt
CORN
­
PLANTINCORPORATED
PROTECTANT
Tuesday,
March
14,
2006
C
8:
30
A.
M.
Introduction
and
Identification
of
Panel
Members
­
Kenneth
M.
Portier,
Ph.
D.
(
FIFRA
SAP
Session
Chair)

C
8:
40
A.
M.
Administrative
Procedures
by
Designated
Federal
Official
­
Mr.
Joseph
E.
Bailey
C
8:
50
A.
M.
Welcome
and
Opening
Remarks
 
Janet
Andersen,
Ph.
D.
(
Director,
Biopesticide
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs,
EPA)

C
9:
00
A.
M.
Introduction
and
Background
­
Mr.
Mike
Mendelsohn
(
Senior
Regulatory
Specialist,
Biopesticides
and
Pollution
Prevention),
Office
of
Pesticide
Programs,
EPA)

C
9:
30
A.
M
Overview
of
Ecological
Risk
Assessment
­
Tessa
Milofsky,
M.
S.
(
Biopesticide
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs,
EPA).

C
10:
30
A.
M.
BREAK
C
10:
45
A.
M
Overview
of
Human
Health
Risk
Assessment
­
Ms.
Annabel
Fellman,
(
Biopesticide
and
Pollution
Prevention
d
Division,
Office
of
Pesticide
Programs,
EPA).

C
11:
45
A.
M.
LUNCH
C
1:
00
P.
M.
Public
Comments
C
2:
00
P.
M.
Question
to
the
Panel
on
Ecological
Risk
Assessment
The
weight
of
evidence
from
the
reviewed
data
indicates
that
therewill
not
be
a
hazard
to
wildlife
from
the
commercialization
of
Event
MIR604
corn.
Although
the
mCry3A
protein
expressed
by
Event
MIR604
corn
is
known
to
affect
only
coleopteran
insect
species,
EPA
assessed
the
potential
risks,
to
a
wide
variety
of
non­
target
organisms
(
i.
e.
mammals,
birds,
fish,
invertebrates
and
plants),
that
could
potentially
result
from
exposure
to
this
Bt
protein.
The
emphasis
of
this
non­
target
risk
assessment,
however,
was
on
invertebrate
species
that
dominate
corn
agroecosystems.
The
Agency
also
evaluated
a
soil
fate
study
that
was
intended
to
provide
information
on
the
persistence
and
rate
of
degradation
of
mCry3A
protein
in
the
soil
environment.
After
reviewing
data
submitted
in
support
of
the
Event
MIR604
Bt
corn
registration,
EPA
concluded
that
aquatic
and
terrestrial
wildlife,
including
soil
organisms,
were
not
likely
to
be
adversely
affected
and
that
this
Bt
corn
product
is
not
likely
to
threaten
the
long­
term
survival
of
any
non­
target
wildlife
populations.

The
Panel
is
requested
to
comment
on
the
Agency's
analysis
of
the
currently
available
data
on
the
potential
impacts
of
Event
MIR604
corn
on
non­
target
species.

C
3:
30
P.
M.
BREAK
C
3:
45
P.
M.
Question
to
Panel
on
Human
Health
Risk
Assessment
(
1)
Previously
submitted
studies
for
Event
MIR604
demonstrated
the
equivalence
of
the
plantand
bacterial­
produced
test
substances
by
showing
similar
molecular
weights,
purity
of
90.3%,
a
lack
of
post­
translational
glycosylation
of
mCry3A
from
either
source,
and
comparable
toxicities
toward
western
corn
rootworm
(
WCRW).
However,
two
forms
of
mCry3A
(
designated
as
mCry3A­
sf
and
mCry3A­
lf)
were
found
in
the
bacterial­
produced
test
material
(
MCRY3A­
0102).
The
molecular
weights
of
the
short
and
long
form
of
mCry3A
were
67.5
kDa
and
69.1
kDa,
respectively,
determined
via
SDS­
PAGE
and
MALDI­
TOF
Mass
spectrometry.
The
lesser
of
the
two
components,
with
the
lower
molecular
weight,
corresponded
to
the
intended
mCry3A
protein
with
598
amino
acids.
The
other
component
contained
the
same
598
amino
acids
as
the
first
component
but
also
contained
an
additional
16
amino
acids
at
the
N 
terminal
end
of
the
protein.
Both
mCry3A
forms
were
insecticidally
active
against
WCRW.
On
this
basis,
and
taking
into
account
the
high
degree
of
structural
homology
(
97.4%
amino
acid
identity),
the
two
forms
of
mCry3A
in
test
material
MCRY3A­
0102
were
considered
to
be
equivalent.

Please
comment
on
the
Agency's
conclusion
that
the
mCry3A
proteins
from
corn
event
MIR604
and
from
recombinant
E.
coli
are
substantially
the
same
for
the
purpose
of
the
Agency's
risk
assessment;
and
that
the
equivalence
is
confirmed
for
the
two
forms
of
the
bacterial­
produced
mCry3A
test
material
(
MCRY3A­
0102).

C
5:
00
P.
M.
Adjournment
Please
be
advised
that
agenda
times
are
approximate;
when
the
discussion
for
one
topic
is
completed,
discussions
for
the
next
topic
will
begin.
For
further
information,
please
contact
the
Designated
Federal
Official
for
this
meeting,
Mr.
Joseph
Bailey,
via
telephone:
(
202)
564­
2045;
fax:
(
202)
564­
8382;
or
email:
bailey.
joseph@
epa.
gov
FIFRA
SCIENTIFIC
ADVISORY
PANEL
(
SAP)
OPEN
MEETING
March
14
­
15,
2006
FIFRA
SAP
WEB
SITE
http://
www.
epa.
gov/
scipoly/
sap/
OPP
Docket
Telephone:
(
703)
305­
5805
Docket
Number:
OPP­
2006­
0035
Holiday
Inn
­
National
Airport
2650
Jefferson
Davis
Highway
Arlington,
VA
22202
Telephone:
(
703)
684­
7200
EVENT
MIR604
MODIFIED
Cry3A
PROTEIN
Bt
CORN
­
PLANTINCORPORATED
PROTECTANT
Wednesday,
March
15,
2006
C
8:
30
A.
M.
Introduction
and
Identification
of
Panel
Members
­
Kenneth
M.
Portier,
Ph.
D.
(
FIFRA
SAP
Session
Chair)

C
8:
40
A.
M.
Administrative
Procedures
by
Designated
Federal
Official
­
Mr.
Joseph
E.
Bailey
C
8:
45
A.
M.
Continuation
of
Questions
to
the
Panel
on
Human
Health
Risk
Assessment
Previously
submitted
studies
demonstrated
the
lack
of
toxicity
of
the
mCry3A
protein
following
acute
oral
high­
dose
exposure
to
mice,
rapid
degradation
of
mCry3A
upon
exposure
to
simulated
mammalian
gastric
fluid,
and
the
lack
of
significant
amino
acid
sequence
homology
of
the
mCry3A
protein
to
proteins
known
to
be
mammalian
toxins
or
human
allergens.
Moreover,
little
to
no
human
dietary
exposure
to
mCry3A
protein
is
expected
to
occur
via
transformed
corn.
Therefore,
dietary
exposure
to
mCry3A
is
not
anticipated
to
pose
any
dietary
risk
to
the
U.
S.
population.

Please
comment
on
the
Agency's
conclusions
regarding
the
lack
of
mammalian
toxicity
and
allergenicity
of
mCry3A.

C10:
30
A.
M.
Adjournment
Please
be
advised
that
agenda
times
are
approximate;
when
the
discussion
for
one
topic
is
completed,
discussions
for
the
next
topic
will
begin.
For
further
information,
please
contact
the
Designated
Federal
Official
for
this
meeting,
Mr.
Joseph
Bailey,
via
telephone:
(
202)
564­
2045;
fax:
(
202)
564­
8382;
or
email:
bailey.
joseph@
epa.
gov
