Document ID: EPA-HQ-OPP-2005-0122-0013
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-07-26T04:00Z

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1
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UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,

FEB
23
2005
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
SUBJECT:
Addendum
No.
2
to
Product
Characterization
and
Expression
Analysis
for
Modified
Cry3A
(
mCry3A)
Bacillus
thuringiensis
insecticidal
protein
and
the
genetic
material
necessary
for
their
production
(
via
pZM26)
in
transgenic
maize
(
corn)
plants
derived
from
Syngenta
Seeds'
transformation
Event
MIR604,
EPA
Reg.
No.
67979­
EUP­
U
TO:
Mike
Mendelsohn,
Regulatory
Action
Leader
Microbial
Pesticides
Branch,
Biopesticides
and
Pollution
Prevention
Division
(
7511C)

FROM:
Annabel
Fellman,
Environmental
Protection
Specialist
Microbial
Pesticides
Branch,
Biopesticides
and
[
signed]
Pollution
Prevention
Division
(
7511C)

ACTION
REQUESTED:
To
confirm
that
the
formal
submission
of
responses
to
data
deficiencies
noted
in
the
initial
review
of
Modified
Cry3A
insect
control
protein
and
maize
(
Corn)
Plants
Derived
from
Event
MIR604
is
identical
to
the
data
sent
via
email
[
see
memorandum
from
A.
Fellman
to
M.
Mendelsohn,
02/
11/
05],
submitted
by
Syngenta
Seeds,
Inc.­
Field
Crops
 
NAFTA.
Confirmation
of
the
MRID
No.
for
the
data
submitted
in
response
to
data
deficiencies
is
also
presented
in
this
report.

CONCLUSION:
The
MRID
No.
for
the
data
submitted
in
response
to
data
deficiencies
is
464667­
01
and
the
formal
submission
represents
an
identical
compilation
of
the
supplemental
data
that
was
provided
earlier
via
email.
This
report
completes
the
data
required
in
support
for
an
EUP
as
well
as
the
petition
for
a
temporary
exemption
from
tolerances
for
the
mCry3A
protein
as
expressed
in
Event
MIR604
corn
plants.

*
THIS
REVIEW
DOES
NOT
CONTAIN
CONFIDENTIAL
BUSINESS
INFORMATION*
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2
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DATA
REVIEW
RECORD:
Active
Ingredient:
Modified
Cry3A
(
mCry3A)
Bacillus
thuringiensis
insecticidal
protein
and
the
genetic
material
necessary
for
their
production
(
via
pZM26)
in
transgenic
maize
(
corn)
plants
derived
from
Syngenta
Seeds'
transformation
Event
MIR604.
Product
Name:
Event
MIR604
Maize
Plants
Expressing
Modified
Cry3A
Bacillus
thuringiensis
Protein
Company
Name:
Syngenta
Seeds,
Inc.
 
Field
Corps­
NAFTA
ID
No:
67979
Chemical
Number:
006509
Decision
Number:
339682
DP
Barcode:
300338
MRID
No.
464667­
01
Syngenta
Seeds'
Responses
to
Questions
Raised
Jan.
5,
2005
during
the
Review
of
mCry3A
protein
as
expressed
in
Event
MIR604
Maize
BACKGROUND:
During
the
course
of
the
agency's
review
of
the
studies
submitted
in
support
for
a
EUP
application
and
temporary
tolerance
exemption
for
Modified
Cry3A
protein
as
expressed
in
Event
MIR604
Maize,
several
data
deficiencies
were
identified
and
required
further
clarification,
justification,
and
corrections
for
them
to
be
considered
complete
and
acceptable.
These
deficiencies
were
presented
to
the
registrant
by
the
agency
on
January
5,
2005
via
conference
call.
As
per
the
agency,
the
registrant
submitted
each
data
clarification/
explanation
requested
via
electronic
mail.
However,
the
formal
submission,
which
represented
a
compilation
of
the
requested
data,
was
submitted
to
the
agency
after
the
electronic
data
was
reviewed
[
see
memorandum
from
A.
Fellman
to
M.
Mendelsohn,
02/
11/
05].
In
addition,
the
MRID
No.
was
not
yet
assigned.
Therefore,
the
purpose
of
this
report
is
to
confirm
the
MRID
No.
and
that
the
data
send
electronically
is
identical
to
the
formal
submission.

SUMMARY
OF
DATA:
As
per
the
agency,
the
registrant
has
submitted
a
single
compilation
of
each
data
deficiency
on
February
2,
2005.
The
submission
included
explanations
for
data
discrepancies
as
well
as
supplemental
scientific
information
(
such
as
corrected
figures,
Standard
Operating
Procedures,
and
full
text
articles)
for
MRID
Nos.
461556
­
02
thru
­
07,
and
­
09
as
well
as
MRID
No.
464252­
02.
After
close
examination
and
comparative
evaluations
of
the
data
sent
via
email
and
the
formal
submission
(
which
was
assigned
MRID
No.
464667­
01),
the
reviewer
has
determined
that
the
formal
submission
represents
an
identical
compilation
of
the
supplemental
data
that
was
provided
earlier
via
email.

RECOMMENDATION:
ACCEPTABLE.
The
MRID
No.
for
the
data
submitted
in
response
to
data
deficiencies
is
464667­
01
and
the
formal
submission
represents
an
identical
compilation
of
the
supplemental
data
that
was
provided
earlier
via
email.
This
report
completes
the
data
required
in
support
for
an
EUP
as
well
as
the
petition
for
a
temporary
exemption
from
tolerances
for
the
mCry3A
protein
as
expressed
in
Event
MIR604
corn
plants.
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