Ecological
Group
(
of
SAP)
comments
(
presented
by
Dr.
Cobb)

Page
1
of
3
Study
Results
MRID
SAP
Conclusion
Review
of
Characterization
and
Safety
of
Modified
Cry3A
protein
and
maize
(
corn)

plants
derived
from
Event
MIR604
with
comparison
to
native
Cry3A
protein
Classification:

Acceptable
461556­
01
Part
of
Human
Health
Data
Package
Molecular
characterization
of
event
MIR604
maize
(
corn)
expressing
a
modified
Cry3A
bacillus
thuringiensis
protein
Classification:

Acceptable
461556­
02
Part
of
Human
Health
Data
Package
Characterization
of
modified
Cry3A
protein
produced
in
event
MIR604­
derived
maize
(
corn)
and
comparison
with
modified
Cry3A
protein
expressed
in
recombinant
Escherichia
coli
Classification:

Acceptable
461556­
03
Part
of
Human
Health
Data
Package
Wild
Mammal
Testing,
Tier
I
Limit
test
from
UP/
Down
N/
A
Six
of
seven
had
no
significant
concerns
One
minor
concern
that
doses
were
not
verified
(
Acceptable)

Avian
Acute
Oral
Toxicity
Test,
Tier
1
(
Northern
Bobwhite
quail,
Colinus
virginianus)
Classification:

Supplemental
461556­
16
4
of
seven
no
significant
concerns
Two
methodological
Concern
Two
statistical
concerns
(
Questionable)

Avian
Oral,
Tier
1
(
Broiler,
Gallus
domesticus)
Classification:

Acceptable
462656­
15
There
were
no
significant
concerns.

There
was
one
concern
that
Gallus
is
an
insenstitive
species
(
Acceptable)
Ecological
Group
(
of
SAP)
comments
(
presented
by
Dr.
Cobb)

Page
2
of
3
Study
Results
MRID
SAP
Conclusion
Freshwater
Fish
Testing,
Tier
1
(
Rainbow
trout,
Onchorhynchus
mykiss)
Classification:

Acceptable
461556­
17
462656­
02
5
of
seven
no
significant
concerns
One
significant
concern
One
concern
of
statistical
rigor
(
Possibly
acceptable)

Estuarine
&
Marine
Animal
Testing,
Tier
I
N/
A
Nontarget
Plant
Studies,
Tier
I
N/
A
Nontarget
Insect
Testing,
Tier
1
(
Lady
beetle,
Coccinella
septempunctata)
Classification:

Acceptable
462656­
03
462656­
04
Five
of
seven
no
significant
concerns
One
concern
of
Agral
effect
on
protein
There
was
concern
for
poor
statistical
rigor
(
Possibly
acceptable
pending
Agral
affect)

Nontarget
Insect
Testing,
Tier
1
(
Carabid
beetle,
Poecilus
cupreus)
Classification:

Acceptable
462656­
05
462656­
06
Five
of
seven
had
no
significant
concerns
Two
concerns
with
statistical
design
(
Possibly
acceptable)

Nontarget
Insect
Testing,
Tier
1
(
Rove
beetle,
Aleochara
bilineata)
Classification:

Acceptable
462656­
07
462656­
08
Five
of
seven
had
no
significant
concerns
Two
concerns
with
statistical
design
(
Possibly
acceptable)

Nontarget
Insect
Testing,
Tier
1
(
Insidious
flower
bug,
Orius.
insidiosis)
Classification:

Acceptable
462656­
09
462656­
10
There
were
no
significant
concerns
There
was
concern
for
poor
statistical
rigor
(
Acceptable)
Ecological
Group
(
of
SAP)
comments
(
presented
by
Dr.
Cobb)

Page
3
of
3
Study
Results
MRID
SAP
Conclusion
Honey
Bee
Testing,
Tier
1
(
Apis
mellifera)
Classification:

Acceptable
461556­
18
Five
of
six
no
concerns
One
concern
of
statistical
interpretation
One
concern
of
nominal
dose
and
the
possibility
that
CRY3
was
in
suspension
(
Possibly
acceptable)

Aquatic
Invertebrate
Acute
Toxicity
Test,

Tier
1
Classification:

Acceptable
Waiver
justification
Three
of
seven
had
no
significant
concerns
Four
had
significant
concerns
(
Possibly
unacceptable)

Earthworm
Subchronic
Toxicity
Study
(
Eisenia
fetida)
Supplemental
462656­
11
462656­
12
One
panelist
had
no
significant
concerns
Six
of
seven
had
significant
concerns
(
Likely
Unacceptable)

Insecticidal
Activity
Spectrum
Study
Classification:

Acceptable
461556­
01
461556­
03
Part
of
Human
Health
Data
Set
Expression
in
a
Terrestrial
Environment
(
Soil
Fate)
Classification:

Supplemental
462656­
14
Three
of
seven
had
no
significant
concerns
Four
of
seven
had
significant
concerns
(
Likely
Unacceptable)

Environmental
Fate
Assessment
Classification:

Supplemental
462656­
13
No
significant
concerns
at
this
level
Concerns
for
flow
to
algae
(
Acceptable)
