RISK ASSESSMENT REPORT FOR GENETICALLY MODIFIED PLANT

FOR PROPAGATION

BASIC INFORMATION

Applicant: Pioneer Hi-Bred Philippines, Inc.

Event Code/Identification: DAS-157-1
(also referred to as 1507 and TC1507 maize)
Official Address:

Pioneer Hi-Bred Philippines, Inc.
24
th
F, Antel Global Corporate Center
Doa Julia Vargas Ave., Ortigas Center
Pasig City 1600 Philippines

Nature/Identity of Transgene(s):

Maize (Zea mays L.) line, DAS-157-1 (herein referred to as 1507 maize), was
generated by the insertion of a synthetic truncated cry1F gene, which was isolated
from Bacillus thuringiensis (Bt) subspecies aizawai and a gene for phosphinothricin
acetyltransferase (pat), which was isolated from Streptomyces viridochromogenes.
Telephone No: +63 2 6371234

Brief Description of Phenotypic Effect(s) of the Transgene:

The Cry1F protein, encoded by the cry1F gene in 1507 maize, confers protection
against certain lepidopteran pests. In local field trials, 1507 maize provided
protection against Asian corn borer (Ostrinia furnacalis), corn semi-looper
(Chrysodeixis eriosoma), common cutworm (Spodoptera litura), black cutworm
(Agrotis ipsilon), and corn earworm (Helicoverpa armigera)

The PAT protein, encoded by the pat gene, confers tolerance to the herbicidal
active ingredient glufosinate-ammonium. The PAT enzyme catalyzes the
conversion of L- phosphinothricin, the active ingredient in glufosinate-ammonium,
to an inactive form and thereby detoxifies the glufosinate-ammonium herbicide.
The glufosinate tolerance trait in 1507 maize is utilized as a selectable marker.
Fax No: +63 2 6875114

Email Address: jan.samson@pioneer.com
Host Organism: Maize (Zea mays L.) Method of Transformation Used:

Microprojectile bombardment using biolistics
Donor Organism: Bacillus thuringiensis (Bt) var. aizawai and
Streptomyces viridochromogenes
Proposed Use: propagation/cultivation
Date Received:

Status:
Annex IIa


2
2

I. THE HOST ORGANISM (Scientific name: Maize (Zea mays L.)

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY
THE ASSESSOR
Yes No Cross Reference of
Document(s) Submitted
Remarks/
Recommendations
1. Source of key
nutrients?

X


If yes, describe.

Maize grain is fed to animals as a source of energy
from carbohydrates and oils and provides a source of
essential and nonessential amino acids. The kernel
contains about 83% carbohydrate that is in the form
of starch, pentosans, dextrins, sugars, cellulose, and
hemicellulose. Starch makes up the biggest part of
the carbohydrate fraction and provides most of the
energy. The fiber portion includes the cellulose and
hemicellulose portions that are generally unavailable
to non-ruminants.

Maize grain is rich in linoleic acid, one of the
essential fatty acids needed by swine and poultry.
Maize also has a favorable content of essential amino
acids with the exception of lysine and tryptophan.
Maize provides an important source of methionine
which is the most limiting amino acid in poultry.

Maize grain is extremely low in calcium, and thus,
not a big contributor to the calcium in animal diets.
Maize, on the other hand is a fair source of
phosphorus. Maize grain is a source of
vitamins A, E, thiamin, riboflavin, pantothenic acid,
and pyridoxine.

OECD (2002) Consensus
Document on Compositional
Considerations for New
Varieties of Maize (Zea Mays):
Key Food and Feed Nutrients,
Anti-Nutrients and Secondary
Plant Metabolites. Organisation
for Economic Co-operation and
Development,
ENV/JM/MONO(2002)25. (pp:
19-27; 31-35)



3
3
2. Source of
antinutrients?

X


If yes, describe.

Maize contains several anti-nutrients such as phytic
acid, DIMBOA and raffinose. Phytic acid binds most
of the phosphorus in maize, which results in reduced
bioavailability of phosphorus for non-ruminant
animals. DIMBOA belongs to a group of metabolites,
hydroxamic acids and benzoxazinoids, commonly
found in cereal plants. Raffinose is a low molecular
weight carbohydrate that is non-digestible.
Maize also contains low levels of trypsin and
chymotrypsin inhibitors, neither of which is
considered nutritionally significant.

OECD (2002) Consensus
Document on Compositional
Considerations for New
Varieties of Maize (Zea Mays):
Key Food and Feed Nutrients,
Anti-Nutrients and Secondary
Plant Metabolites. Organisation
for Economic Co-operation and
Development,
ENV/JM/MONO(2002)25.
(pp: 28-29)

3. Source of
toxicants?

X
If yes, describe.

There are no known toxicants in maize.

4. Source of
allergens?

X
If yes, describe.

Maize is not a common allergenic food.
OECD (2002) Consensus
Document on Compositional
Considerations for New
Varieties of Maize (Zea Mays):
Key Food and Feed Nutrients,
Anti-Nutrients and Secondary
Plant Metabolites. Organisation
for Economic Co-operation and
Development,
ENV/JM/MONO(2002)25. (p29)





4
4
TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY THE
ASSESSOR
Cross Reference of
Document(s) Submitted
Remarks/Recommendations
5. Used as food?

YES
If yes, describe the final form of the consumed food
product (raw vs. processed, etc).

Maize products (starch, oil, grits, meal and flour) are
used in many foods. Starch is mostly fermented to
sweeteners (syrups) and ethanol. It is also used for
foods, such as bakery products, baby foods, sauces,
dressings and soups. Maize oil is used in salad- and
cooking oil, mayonnaise, margarine, baking and frying
fat and in sauces and soups. Grits are used to make
cereals and snacks and also to produce alcoholic
beverages. Meal is used for bread and muffins, and
flour is used for pancakes and snacks. Bran is used as
a dietary source of fiber.

OECD (2002) Consensus
Document on Compositional
Considerations for New
Varieties of Maize (Zea Mays):
Key Food and Feed Nutrients,
Anti-Nutrients and Secondary
Plant Metabolites. Organisation
for Economic Co-operation and
Development,
ENV/JM/MONO(2002)25. (p31)


6. Consumption
patterns
What is the usual consumption pattern of the product
by population subgroups?

About 66% of all the maize produced worldwide is
used for animal feed and 17% for human
consumption. In the developing countries, 30% of the
maize produced was used for human consumption
and 57% for animal feed, whereas in Western Europe,
North America and other high income countries, 4%
was used for human consumption and 76% for animal
feed. In the Philippines, about 64% of maize demand
is for animal feed, 22% for food and 13% for
processing.
OECD (2003) Consensus
Document on the Biology of Zea
mays subsp. mays (Maize).
Organisation for Economic Co-
operation and Development,
ENV/JM/MONO(2003)11.



5
5
7. Used as feed?

YES
If yes, describe the final form of the consumed feed
product (raw vs. processed, etc).

Maize raw and processed products are both used as
feedstuff in livestock production. Maize is preferred
feedstuff as a processed whole grain, as a by-product
of the milling industry, or as whole plant silage. Whole
corn plant may be used for animal (primarily
ruminant) feed. The material can be fed directly or
preserved as silage. Maize grain is usually ground or
rolled when fed to swine and poultry.
OECD (2002) Consensus
Document on Compositional
Considerations for New
Varieties of Maize (Zea Mays):
Key Food and Feed Nutrients,
Anti-Nutrients and Secondary
Plant Metabolites. Organisation
for Economic Co-operation and
Development,
ENV/JM/MONO(2002)25. (p17)


8. Any other concerns/
additional information
None





To be Filled Up by the Assessor
Summarize significant deficiencies that need to be addressed by the applicant.









6
6
II. THE TRANSGENIC PLANT

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY THE
ASSESSOR
Cross Reference of
Document(s) Submitted
Remarks/Recommendations
1. If used as food List countries that have approved the transgenic
plant as food. Provide summary of existing
documents, references or opinions of regulatory
bodies.

1507 maize has been granted approval for
direct use as food in Argentina, Australia, Brazil,
Canada, China, Colombia, European Union,
Japan, Korea, Mexico, Philippines, Singapore,
South Africa, Taiwan, U.S. and Uruguay.

Regulatory agencies of these countries found
that 1507 maize is considered as safe as its
conventional counterpart when used as food.


2. Consumption patterns Will consumption patterns by population
subgroups be changed as a result of introducing
the novel food?

No, consumption and use are not expected to
change as a result of introducing 1507 maize.




7
7
3. If used as feed List countries that have approved the transgenic
plant as feed. Provide summary of existing
documents, references or opinions of regulatory
bodies.

1507 maize has been granted approval for
direct use as feed in Argentina, Australia, Brazil,
Canada, China, Colombia, European Union,
Japan, Korea, Mexico, Philippines, Singapore,
South Africa, Taiwan, U.S. and Uruguay.

Approving countries through their regulatory
bodies found that 1507 maize is considered as
safe as its conventional maize when used as
feed.


4. Any other concerns/
additional information
None



To be Filled Up by the Assessor
Summarize significant deficiencies that need to be addressed by the applicant.










8
8
III. THE DONOR ORGANISM (Scientific name: Bacillus thuringiensis (Bt) subspecies aizawai and Streptomyces viridochromogenes)

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY
THE ASSESSOR
Cross Reference of
Document(s) Submitted
Remarks/
Recommendations
1. Have all protein-
encoding sequences
found in the original
gene construct been
described with respect
to source and potential
pathogenic or allergenic
properties?
Yes No If no, indicate deficiencies. PHPI (2003) Risk Analysis Report for
Genetically Modified Plant for Direct
Use as Food or Feed, or for
Processing. Pioneer Hi-Bred
Philippines, Inc. (Sections C and D)





X

2. Have all potentially
inserted regulatory
sequences (promoters,
enhancers, termination
signals etc) been
adequately described?
Yes No If no, indicate deficiencies.






PHPI (2003) Risk Analysis Report for
Genetically Modified Plant for Direct
Use as Food or Feed, or for
Processing. Pioneer Hi-Bred
Philippines, Inc. (Sections C and D)





X

3. Enumerate all
introduced expressible
sequences, including
antisense.
1. truncated cry1F gene
2. phosphinothricinNacetyltransferase ( pat) gene


PHPI (2003) Risk Analysis Report for
Genetically Modified Plant for Direct
Use as Food or Feed, or for
Processing. Pioneer Hi-Bred
Philippines, Inc. (Section C)





9
9
TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY
THE ASSESSOR
Cross Reference of
Document(s) Submitted
Remarks/
Recommendations
4. List all donor
organisms.



Donor Organisms
Indicate if known
to be toxic:
Yes or No
Indicate if known
to be an allergen:
Yes or No
PHPI (2003) Risk Analysis
Report for Genetically Modified
Plant for Direct Use as Food or
Feed, or for Processing.
Pioneer Hi-Bred Philippines,
Inc. (Sections C and D)


Bacillus thuringiensis
subspecies aizawai
No No
Streptomyces
viridochromogenes
No No


5. List all
proteins
encoded by the
expressible
sequences.

Proteins
Indicate if known
to be toxic:
Yes or No
Indicate if known
to be an allergen:
Yes or No
PHPI (2003) Risk Analysis
Report for Genetically Modified
Plant for Direct Use as Food or
Feed, or for Processing.
Pioneer Hi-Bred Philippines,
Inc. (Section H)


Cry1F No No
phosphinothricinN
acetyltransferase (PAT)
No No



6. Any other concerns/additional information. None



To be Filled Up by the Assessor
Summarize significant deficiencies that need to be addressed by the applicant.










10
10
IV. THE TRANSFORMATION SYSTEM

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY THE
ASSESSOR
Yes No Cross Reference of
Document(s) Submitted
Remarks/
Recommendations
1. Transformation
method
Agrobacterium mediated? X
Particle bombardment? X PHPI (2003) Risk Analysis
Report for Genetically Modified
Plant for Direct Use as Food or
Feed, or for Processing.
Pioneer Hi-Bred Philippines,
Inc. (Section D.1)


If none of the above, describe method below.
Target of genetic
modification
Nuclear
DNA
Chloroplast
DNA
Mitochondria
l DNA

X

Complete experimental protocol provided?


Yes

No

X
2. List of all
genetic
components
This should include all coding and non-coding
regions together with the recombinant plasmid
map and its components, description(s) or
citation(s) for isolation and source, description
and characterization for each region. Are these
included?


X
PHPI (2003) Risk Analysis
Report for Genetically Modified
Plant for Direct Use as Food or
Feed, or for Processing.
Pioneer Hi-Bred Philippines,
Inc. (Section D.2)

3. Map of
plasmid vector
This should include size, orientation, and
location of all genetic elements, oligonucleotide
primers used for PCR analysis, and the sites of
any restriction endonucleases used in the
analysis of the inserted DNA. Are these
included?


X
PHPI (2003) Risk Analysis
Report for Genetically Modified
Plant for Direct Use as Food or
Feed, or for Processing.
Pioneer Hi-Bred Philippines,
Inc. (Section D.3)

4. Carrier DNA
and/or helper
plasmids
Where used, are these described?



X

5. Any other concerns/additional information. None


To be Filled Up by the Assessor
Summarize significant deficiencies that need to be addressed by the applicant.






11
11
V. THE INSERTED DNA

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY THE
ASSESSOR
Cross Reference of
Document(s)
Submitted
Remarks/Recommendations
1. Number
of insertion
sites
Number of insertion sites.

One insertion site containing the following. One full length copy of
cry1F and pat genes and in addition a limited number of non-
functional fragments of the cry1F and pat genes. Partial copies of
the cry1F and pat genes are not expressed as unique transcripts in
1507 maize.

PHPI (2003) Risk Analysis
Report for Genetically
Modified Plant for Direct Use
as Food or Feed, or for
Processing. Pioneer Hi-Bred
Philippines, Inc. (Section E.1)


How was this demonstrated?

Demonstrated sufficiently based on Southern analysis across and
within generations and sequence summary.

Is this sufficient? Yes
2. Integrity
and order
of genetic
elements
within each
insertion
site
How was integrity demonstrated?
Southern
blotting
PCR Nucleotide
Sequencing
PHPI (2003) Risk Analysis
Report for Genetically
Modified Plant for Direct Use
as Food or Feed, or for
Processing. Pioneer Hi-Bred
Philippines, Inc. (Section E.2)

PHPI (2013) Supplemental
Molecular Report: Molecular
Characterization of Bt Cry1F
Maize Line 1507


X X X
Other methods used.
Were any of the following identified/determined? Yes No
(a) Truncations X
(b) Deletions X
(c) Rearrangements X
If yes, briefly describe below.

Partial copies of Cry1F and PAT and PAT rearrangements were
detected at the single insertion point. Northern analysis showed no
transcription.


Was this satisfactorily demonstrated? Yes No
(a) Truncations X
(b) Deletions
(c) Rearrangements X


12
12
If truncations, deletions, or rearrangements occurred, how was the
potential for creating novel chimeric ORFs tested?

An analysis of the cry1F and pat coding sequence for the presence
of potential ORFs identified no ORFs in the mRNA that is expressed
and translated into Cry1F protein that could encode proteins of
greater than 200 amino acids. This indicates that there is no
significant concern associated with ORFs in Cry1F maize line 1507.

PHPI (2003) Risk Analysis
Report for Genetically
Modified Plant for Direct Use
as Food or Feed, or for
Processing. Pioneer Hi-Bred
Philippines, Inc. (Section E.2)


3. Has the main transgene been expressed in other approved GM crops? If yes,
please enumerate these crops.

No GM crop approved for propagation in the Philippines expresses the Cry1F
protein. On the other hand, PAT protein is expressed in Bt 11 (SYN-BT11-1)
maize which is approved for propagation in the Philippines.
BPI Approval Registry
http://biotech.da.gov.ph/
Approval_Registry.php

4. Plasmid
backbone
sequences
Present?
Yes No
X
PHPI (2003) Risk Analysis
Report for Genetically
Modified Plant for Direct Use
as Food or Feed, or for
Processing. Pioneer Hi-Bred
Philippines, Inc. (Section E.3)


How was this determined, and was this sufficient?

Sufficiently well demonstrated using Southern analysis with
probes developed using plasmid backbone sequences.


5. Any other concerns/additional information. None


To be Filled Up by the Assessor
Summarize significant deficiencies that need to be addressed by the applicant.









13
13
VI. GENETIC STABILITY

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY THE
ASSESSOR
Cross Reference of
Document(s) Submitted
Remarks/
Recommendations
1. Multigenerational
stability of
introduced trait
How was this
assessed?
ELISA Western
Blotting
Bioassay Others PHPI (2003) Risk Analysis
Report for Genetically Modified
Plant for Direct Use as Food or
Feed, or for Processing.
Pioneer Hi-Bred Philippines,
Inc. (Sections F.1 and F.2)


X
If others, describe.

Southern Analysis, DNA Probe/Hybridization


How many generations were tested? Three (3) generations
were tested


2. Segregation
analysis
How was this
assessed?
ELISA Western
Blotting
Bioassay Others PHPI (2003) Risk Analysis
Report for Genetically Modified
Plant for Direct Use as Food or
Feed, or for Processing.
Pioneer Hi-Bred Philippines,
Inc. (Section F.2)


X
If others, describe.


How many generations of backcrosses were tested? Three (3)
backcross generations were tested.

If any other method was used to show stability of
segregation, describe and explain why such method was used.


Were the results from segregation analysis
consistent with reported inserted number?

Yes No
X
3. Any other concerns/other information. None


To be Filled Up by the Assessor
Summarize significant deficiencies that need to be addressed by the applicant.








14
14
VII. EXPRESSED MATERIAL

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY
THE ASSESSOR
Cross Reference of
Document(s) Submitted
Remarks/
Recommendations
1. Level of
Expression
of Novel
Protein in
Different
Plant Parts


Plant Part Roots Stalk Leaf Grain Pollen Silk
Expression in 1507 maize measured by ELISA (ng/mg tissue dry weight) Buffington J, et. al. (2009)
Expressed Trait Protein
Concentration of Maize Lines
Containing Events DAS-157-1,
MON-81-6, MON-63-6,
and Combined Trait Product
DAS-157-1xMON-81-
6xMON-63-6: U.S. Test
Sites. Pioneer Hi-Bred
International, Inc, Study No.
2008-071/012.

Cry1F
Range:
Mean:

1.4-6.9
3.6

6.0-9.4
7.6

13-29
19

<0.069-6.9
3.7

20-35
26


PAT
Range:
Mean:

<0.069-0.60
0.16


<0.046-1.1
0.15

5.1-13
8.4

<0.069
<0.069

<0.28
<0.28



Expression in 1507 maize measured by ELISA (ng/mg tissue dry weight) Samson JA, et. al. (2012)
Expressed Cry1F Protein
Concentration of Maize Lines
Containing Events DAS-157-1
and Combined Trait Product
DAS-157-1xMON-81-
6xMON-63-6: 2011
Philippines Field Study. Pioneer
Hi-Bred Philippines, Inc., Study
No. PHI-2011-248.


Cry1F
Range:


1.1-9.3

1.3-10.0

7.2-14.5

1.7-5.0

14.0-24.0

1.0-2.0

2. Level of
Expression
of Novel
Protein in
Different
Plant Forms



Plant
Form
Grains
(ug/g fwt)
Forage
(ug/g fwt)
Stover
(ug/g fwt)
Flower
(ug/g fwt)
Other Forms Utilized
(ug/g fwt)

Expression measured by: NA
ELISA

Western

Others
(specify)


Expression measured by: NA
ELISA

Western

Others
(specify)




15
15
3. Metabolic
Role of the
Novel
Protein

PAT enzyme detoxifies phosfinothricin by acetylation into an inactive
compound.

Cry1F protein is not an enzyme and has no metabolic function.

3. Any other concerns/other information. None



To be Filled Up by the Assessor
Summarize significant deficiencies that need to be addressed by the applicant.















16
16
VIII. TOXICOLOGICAL ASSESSMENT

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY ASSESSOR
Complete this portion of the table for each novel protein as many
times as necessary to record all information.
Cross Reference of
Document(s) Submitted
Remarks/Recommendations
1. Novel
Protein 1;
Identify:

Cry1F
Digestibility Results
Digestion in: Estimated
T50
< 1 minute PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or
for Processing. Pioneer Hi-Bred
Philippines, Inc. (Section H.4)


SGF X
Other
Determined by: Largest size
fragments
remaining
after
digestion
NA
ELISA
Western Blot
Bioassay
Other
Heat Inactivation
Results: PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or
for Processing. Pioneer Hi-Bred
Philippines, Inc. (Section H.4)


Estimated T50
Determined by:
ELISA
Western
Bioassay X
Other
Amino Acid Sequence Comparison
Is there homology with known toxins. Yes No PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or
for Processing. Pioneer Hi-Bred
Philippines, Inc. (Section H.4)

X
If yes, which ones? NA
What is the percentage of sequence similarity? NA
Acute Oral Gavage
Performed? Yes No PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or
for Processing. Pioneer Hi-Bred
Philippines, Inc. (Section H.1)

X
If yes, report NOEL (mg/Kg body weight) >576 mg/kg
Source of the Test Protein
Plant PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or
for Processing. Pioneer Hi-Bred
Philippines, Inc. (Sections H.1
and D.5)

Bacterial X
Other
If not plant, was equivalency
demonstrated?
Yes No
X


17
17
TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY THE
ASSESSOR
Complete this portion of the table for each novel protein as many
times as necessary to record all information.
Cross Reference of
Document(s) Submitted
Remarks/Recommendations
2. Novel
Protein 2;
Identify:

PAT
Digestibility Results
Digestion in: Estimated
T50
< 1 minute PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or
for Processing. Pioneer Hi-Bred
Philippines, Inc. (Section H.4)


SGF X
Other
Determined by: Largest size
fragments
remaining
after
digestion

ELISA
Western Blot
Bioassay
Other
Heat Inactivation
Results:
Estimated T50
Determined by:
ELISA
Western
Bioassay
Other
Amino Acid Sequence Comparison
Is there homology with known toxins Yes No PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or
for Processing. Pioneer Hi-Bred
Philippines, Inc. (Section H.4)

X
If yes, which ones?
What is the percentage of sequence similarity?
Acute Oral Gavage
Performed? Yes No PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or
for Processing. Pioneer Hi-Bred
Philippines, Inc. (Section H.2)

X
If yes, report NOEL (mg/Kg body weight) LD50 > 6,000 mg/kg
Source of the Test Protein
Plant PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or
for Processing. Pioneer Hi-Bred
Philippines, Inc. (Sections H.2
and D.5)

Bacterial X
Other
If not plant, was equivalency
demonstrated?
Yes No
X



18
18
Cross Reference of
Document(s) Submitted
Remarks/
Recommendations
4. If there
are two or
more novel
proteins
expressed:





(a) are these proteins expressed independently of each other and is
the functional activity of these proteins maintained?

Since Cry1F and PAT differ in modes of action, these novel proteins
are expected to be expressed independently of each other. There is
no known interaction between and cry1F and pat genes and gene
products that would affect the stability and expression level of the
individual genes. PAT was used as a selectable marker in the
development process of 1507 maize. The gene sequences for both
pat and cry1F were optimized for improved expression in plants
without altering function or activity.

(b) describe, if these are expressed in the same cell organelle

The Cry1F and PAT proteins in 1507 maize are expressed
throughout the plant tissue and throughout the life of the plant.

(c) describe, if and how they interact to express the phenotype(s)

The Cry1F protein expressed in 1507 maize confers protection
against certain lepidoteran pests while PAT confers tolerance to
glufosinate containing herbicides. The novel proteins expressed in
1507 maize are not expected to interact to negatively affect
expressed phenotypes.


(d) describe, if they interact in a metabolic pathway

The Cry1F protein is not an enzyme, and therefore, is not expected
to affect plant metabolism. The PAT protein has high substrate
affinity for L-Phosphinothricin, the active ingredient in glufosinate
ammonium. Cry1F and PAT proteins are not expected to interact in
a metabolic pathway.


5. Any other concerns/other information. None







19
19
IX. ALLERGENICITY ASSESSMENT

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY THE
ASSESSOR
Cross Reference of
Document(s) Submitted
Remarks/Recommendations
1. Novel
Protein 1;
Identify:

Cry1F
Digestibility
Estimated T50:



< 1 minute PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or for
Processing. Pioneer Hi-Bred
Philippines, Inc. (Section H.4)


Digestion in SGF
Determined by: Largest size fragments
remaining:

ELISA
Western Blot
Bioassay
Other
Digestion in SIF
Determined by: Largest size fragments
remaining:

ELISA
Western Blot
Bioassay
Other
Heat Inactivation
Estimated T50:




Determined by:
ELISA
Western Blot
Bioassay
Other






20
20
1. Novel
Protein 1
(continuation)


Cry1F
Amino Acid Sequence Comparison
Performed? Yes No PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or for
Processing. Pioneer Hi-Bred
Philippines, Inc. (Section H.4)


X
If yes, any homology with known
allergens?
Yes No
X
If yes, which ones? Indicate %
sequence similarity.


NA
Physiochemical Properties?


NA
Glycosylated? Yes No
X
Molecular weight within 10-70
kDa range?
Yes (65 kDa) PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or for
Processing. Pioneer Hi-Bred
Philippines, Inc. (Section D.5)


Prevalence in Food
Percent of Total Protein
<=0.01% X PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or for
Processing. Pioneer Hi-Bred
Philippines, Inc. (Section H.3)

>0.01%
>1.0%
>5.0%
Serum Screening
Performed? Yes No
X
If yes, report results.



2. Other concerns/additional information. None









21
21

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY THE
ASSESSOR
Cross Reference of
Document(s) Submitted
Remarks/Recommendations
3. Novel
Protein 2;
Identify:


PAT
Digestibility
Estimated T50:



< 1 minute PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or for
Processing. Pioneer Hi-Bred
Philippines, Inc. (Section H.4)


Digestion in SGF
Determined by: Largest size fragments
remaining:

ELISA
Western Blot
Bioassay
Other
Digestion in SIF
Determined by: Largest size fragments
remaining:

ELISA
Western Blot
Bioassay
Other
Heat Inactivation
Estimated T50:




Determined by:
ELISA
Western Blot
Bioassay
Other







22
22
3. Novel
Protein 2
(continuation)


PAT
Amino Acid Sequence Comparison
Performed? Yes No PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or for
Processing. Pioneer Hi-Bred
Philippines, Inc. (Section H.4)


X
If yes, any homology with known
allergens?
Yes No
X
If yes, which ones? Indicate %
sequence similarity.


NA
Physiochemical Properties?


NA
Glycosylated? Yes No

Molecular weight within 10-70
kDa range?
Yes (20.617 kDa) PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or for
Processing. Pioneer Hi-Bred
Philippines, Inc. (Section D.5)

Prevalence in Food
Percent of Total Protein
<=0.01% X PHPI (2003) Risk Analysis Report
for Genetically Modified Plant for
Direct Use as Food or Feed, or for
Processing. Pioneer Hi-Bred
Philippines, Inc. (Section H.3)

>0.01%
>1.0%
>5.0%
Serum Screening
Performed? Yes No
X
If yes, report results.




4. Other concerns/additional information. None










23
23
Section X. IF REGULATED ARTICLE IS COMPOSITIONALLY ALTERED

[This section is not applicable to 1507 maize - 1507 maize is not compositionally altered]

TO BE FILLED UP BY THE APPLICANT
TO BE FILLED UP BY THE
ASSESSOR
Cross Reference of
Document(s) Submitted
Remarks/Recommendations

Contain a new
substance?
Yes No If yes, identify and give the chemical
structure





X
What is the purpose of
having the regulated
article produce this
new substance? What
is the benefit of this
new substance?
Explain.



Is the new substance
found in the edible
portion of the plant?
Yes No Which part/s of the plant?





Is the new substance
known as




Nutrient?

Yes No If yes, identify then proceed to Section
Xa1



Pesticide? Yes No If yes, identify then proceed to Section
Xa2



Biologically active
compound?
Yes No If yes, identify then proceed to Section
Xa3.



Allergen? Yes No If yes, identify. Explain why this
allergenic substance is safe in the
particular use the regulated article was
intended for.



Toxin?


Yes No If yes, identify. Explain why this toxic
substance is safe in the particular use
the regulated article was intended for.





24
24
Anti-nutrient?


Yes No If yes, identify. Explain why this anti-
nutrient is safe in the particular use the
regulated article was intended for.



Others?

Identify. Explain why
this new substance is
safe in the particular
use the regulated
article was intended
for.



Any other
concerns?

To be Filled Up by the Assessor
Summarize significant deficiencies that need to be addressed by the applicant.










25
25
Section Xa1. If new substance is a nutrient

[This section is not applicable to 1507 maize - 1507 maize is not compositionally altered]

TO BE FILLED UP BY THE APPLICANT
TO BE FILLED UP BY THE
ASSESSOR
Please fill out this form as many as there are new substances Cross Reference of
Document(s) Submitted
Remarks/Recommendations
What is the known
biological function of
this substance?

Describe the history of
its use as a nutrient.

Is this new substance a
natural component of
other food crops?
Yes No If yes, enumerate these crops.

Is the new substance
equivalent in structure
to those found in these
food crops?
Explain.
Yes No

Does this new
substance occur in the
regulated article in the
same amount as in
other foods?

Yes No If yes, indicate the range of values in
each food where this new substance
occurs.
If no, please indicate whether the
amount is lower or higher compared to
other food crops. Explain why the level
of the new substance in the regulated
article is safe.


How much is the
average consumption
of the native
substance?



What is the effect of
prolonged
consumption?



26
26
What is the amount of
the new substance in
the regulated article?

Is this substance
known to be toxic or
have adverse health
effects when ingested
in excess of the
average consumption?
Yes No

Does the new
substance alter the
level or concentration
of other related
compound(s)?
Yes No If yes, is there possible adverse effect
of this alteration?
How is this adverse effect managed?


How do the following
factors affect the
stability of the new
substance and describe
the method of
determination:


a) Heat


b) Digestion

c) Processing

d) Others (e.g. light, oxidation, storage, etc.)
Is the substance in the
regulated article being
used in food
fortification?
Yes No If yes,
a) At what level is it used?

b) How does this level compare
with the level found in the
regulated
article?


Is this substance
produced by a new
pathway in the
regulated article?
Yes No If yes,
a) How many new proteins have
been introduced to complete
the pathway?



27
27




a)

b) Are these proteins expressed
in the edible parts of the
regulated article?
b)
c) If yes,
d)
e) b)1. At what levels are they
f) present?
g)
b)2. Have these expressed
proteins been assessed for
toxicity and allergenicity
potential?

Are all the information required
to answer b)1& b)2 entered in
appropriate section of this
document?
Any other concerns



To be Filled Up by the Assessor
Summarize significant deficiencies that need to be addressed by the applicant.




28
28
Section Xa2 If new substance is a known non-protein pesticide

[This section is not applicable to 1507 maize - 1507 maize is not compositionally altered]

TO BE FILLED UP BY THE APPLICANT
TO BE FILLED UP BY THE
ASSESSOR
Cross Reference of
Document(s)
Submitted
Remarks/Recommendations
Describe the following
about the non-protein
pesticide:

LD50 value, Minimum
pesticide residue level
values, Target pest

Known adverse effects
to humans/animals
and non-target
organisms

Concentration/level in
the edible portion of
the plant


Is this new substance
a natural component
of other foods?

Yes No If yes, enumerate these foods.


Is the new substance
equivalent in structure
to those found in
these other foods?
If not, explain.
Yes No


Does this new Yes No If yes, indicate the range of values in


29
29
substance occur in the
regulated article in the
same amount as in
other foods?

each food where this new substance
occurs.

If no, please indicate whether the
amount is lower or higher compared to
other food crops. Explain why the level
of the new substance in the regulated
article is safe.
How much is the
average consumption
of the native
substance?


What is the effect of
prolonged
consumption?


What is the amount of
the new substance in
the regulated article?


Is this substance
known to be toxic or
have adverse health
effects when ingested
in excess of the
average consumption?
Yes No


Does the new
substance alter the
level or concentration
of other related
compound(s)?

Yes No If yes, is there possible adverse health
effect due to this alteration?



How do the following
factors affect stability
of the substance and
describe the method
of determination:


a) Heat


b) Digestion

c) Processing


30
30

d) Others (e.g. light, oxidation,
storage, etc.)
Is this substance
produced by a new
pathway in the
regulated article?


Yes No If yes,

a) How many new proteins have
been introduced to complete the
pathway?

b) Are these proteins expressed in
the edible parts of the regulated
article?

a) If yes,
b)
c) b)1. At what levels are they
d) present?
e)
b).2 Have these expressed
proteins been assessed for
toxicity and allergenicity
potential?
Are all the information required
to answer b)1& b)2 entered in
appropriate section of this
document?




Any other concerns


To be Filled Up by the Assessor
Summarize significant deficiencies that need to be addressed by the applicant.




31
31
Section Xa3.If new substance is a biologically active compound

[This section is not applicable to 1507 maize - 1507 maize is not compositionally altered]

TO BE FILLED UP BY THE APPLICANT
TO BE FILLED UP BY THE
ASSESSOR
Cross Reference of
Document(s)
Submitted
Remarks/Recommendatio
ns
Is this new substance a
natural component of other
foods?
Yes No If yes, enumerate these foods.




Is the new substance
equivalent in structure to
those found in these food
crops?
Yes No



Does this new substance
occur in the regulated
article in the same amount
as in other foods?
Yes No If yes, enumerate the crops and
corresponding values.
If no, please indicate whether the
amount is lower or higher compared to
other food crops.




How much is the average
consumption of the native
substance?


At what concentration does
this compound cause
characteristic bio-chemical
or physiological changes to
occur in humans and
animals?


What is the concentration
of this compound in the
edible portion of the plant?


At what levels of
consumption of the
regulated article be
recommended for a person




32
32
to achieve the desired
biological function to the
body?

What is the effect of
prolonged consumption?



Is this substance known to
be toxic or have adverse
health effects when
ingested in certain
quantities or in overdose?
Explain
Yes No



What measures are
recommended to prevent
overdosing?


How do the following
factors affect stability of the
substance and describe the
method of determination:


a) Heat

b) Digestion
c) Processing

d) Others (e.g. light, oxidation, storage, etc.)


33
33
Is this substance produced
by a new pathway in the
regulated article?



Yes




















No
























If yes,

a) How many new proteins have
been introduced to complete
the pathway?

b) Are these proteins expressed in
the edible parts of the regulated
article?

c) If yes,
d)
e) b)1 At what levels are
f) they present?
g)
b)2 Have these expressed
proteins been assessed
for toxicity and
allergenicity potential?

Are all the information
required to answer b)1& b)2
entered in appropriate section
of this document?


Any other concerns




To be Filled Up by the Assessor
Summarize significant deficiencies that need to be addressed by the applicant.










34
34

XI. NUTRITIONAL DATA

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY THE ASSESSOR
1. Proximate Analysis Cross Reference of Document(s)
Submitted
Remarks/Recommendations
1. Proximate Analysis
(protein fiber, fat, ash, carbohydrates)

Indicate as Grain __X__, Forage_____, or Consumed Portion

PHPI (2003) Risk Analysis Report for
Genetically Modified Plant for Direct Use as
Food or Feed, or for Processing. Pioneer Hi-
Bred Philippines, Inc. (Section I.1)


Comparison with SE Comparator (i.e., non-
modified control, or other principle
comparator Any significant differences?

No significant differences among biologically
important parameters.
Yes No
X
If yes, in which parameters? NA
Comparison with Range of Commercial Varieties
If comparison included a range of
commercial varieties: How many?
NA
Were these grown under the same
environmental conditions?
Yes No

Were the data derived from the test
(transgenic) line within the observed
range?
Yes No

If not, which parameters were outside the range? NA
Comparison with Range of Literature Values
Were the data derived from the test
(transgenic) line within the reported
range?
Yes No PHPI (2003) Risk Analysis Report for
Genetically Modified Plant for Direct Use as
Food or Feed, or for Processing. Pioneer Hi-
Bred Philippines, Inc. (Section I.1)


X
If not, which parameters were outside range: NA


Biological Significance
For any statistical difference, are they
biologically relevant? NA
Yes No



If yes, note concern:







35
35
TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY THE ASSESSOR
2. Key Nutrients (Supply the information for each
component that significantly contributes to the food
value of the crop, e.g. fatty acid composition, protein
quality, vitamins, minerals, etc. Use as many forms as
there are key nutrients derived from the crop.)
Cross Reference of Document(s)
Submitted
Remarks/Recommendations
2a. Key Nutrient 1; Identify: Fatty Acid Composition

Indicate as Grain _X_, Forage_____, or Consumed Portion

PHPI (2003) Risk Analysis Report for
Genetically Modified Plant for Direct Use as
Food or Feed, or for Processing. Pioneer Hi-
Bred Philippines, Inc. (Section I.2)


Comparison with SE Comparator (i.e., non-
modified control, or other principle
comparator Any significant differences?

Yes No
X
If yes, in which parameters: NA



Comparison with Range of Commercial Varieties
If comparison included a range of
commercial varieties: How many?
NA
Were these grown under the same
environmental conditions?
Yes No

Were the data derived from the test
(transgenic) line within the observed
range?
Yes No

If not, which parameters were outside range:


Comparison with Range of Literature Values
Were the data derived from the test
(transgenic) line within the reported
range?
Yes No PHPI (2003) Risk Analysis Report for
Genetically Modified Plant for Direct Use as
Food or Feed, or for Processing. Pioneer Hi-
Bred Philippines, Inc. (Section I.2)


X
If not, which parameters were outside range: NA


Biological Significance
For any statistical difference, are they
biologically relevant? NA
Yes No

If yes, note concern: NA






36
36
TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY THE ASSESSOR
2. Key Nutrients (Continuation) Cross Reference of Document(s)
Submitted
Remarks/Recommendations
2b. Key Nutrient 2; Identify: Amino Acid Composition

Indicate as Grain _X_, Forage______, or Consumed Portion

PHPI (2003) Risk Analysis Report for
Genetically Modified Plant for Direct Use as
Food or Feed, or for Processing. Pioneer Hi-
Bred Philippines, Inc. (Section I.4)


Comparison with SE Comparator (i.e., non-
modified control, or other principle
comparator Any significant differences?
Yes No
X
If yes, in which parameters: NA



Comparison with Range of Commercial Varieties
If comparison included a range of
commercial varieties: How many?
NA
Were these grown under the same
environmental conditions?
Yes No

Were the data derived from the test
(transgenic) line within the observed
range?
Yes No

If not, which parameters were outside range:


Comparison with Range of Literature Values
Were the data derived from the test
(transgenic) line within the reported
range?
Yes No PHPI (2003) Risk Analysis Report for
Genetically Modified Plant for Direct Use as
Food or Feed, or for Processing. Pioneer Hi-
Bred Philippines, Inc. (Section I.4)


X
If not, which parameters were outside range: Threonine
and Glutamic acid (both 1507 and control lines were
outside range of literature values)

Biological Significance
For any statistical difference, are they
biologically relevant?
Yes No
X
If yes, note concern:








37
37

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY THE ASSESSOR
2. Key Nutrients (Continuation) Cross Reference of Document(s)
Submitted
Remarks/Recommendations
2c. Key Nutrient 3; Identify: Vitamins

Indicate as Grain __X__, Forage_____, or Consumed Portion

PHPI (2003) Risk Analysis Report for
Genetically Modified Plant for Direct Use as
Food or Feed, or for Processing. Pioneer Hi-
Bred Philippines, Inc. (Section I.4)


Comparison with SE Comparator (i.e., non-
modified control, or other principle
comparator Any significant differences?
Yes No
X
If yes, in which parameters: NA



Comparison with Range of Commercial Varieties
If comparison included a range of
commercial varieties: How many?
NA
Were these grown under the same
environmental conditions?
Yes No

Were the data derived from the test
(transgenic) line within the observed
range?
Yes No

If not, which parameters were outside range:


Comparison with Range of Literature Values
Were the data derived from the test
(transgenic) line within the reported
range?
Yes No PHPI (2003) Risk Analysis Report for
Genetically Modified Plant for Direct Use as
Food or Feed, or for Processing. Pioneer Hi-
Bred Philippines, Inc. (Section I.4)


X
If not, which parameters were outside range: NA
Biological Significance
For any statistical difference, are they
biologically relevant? NA

Yes No

If yes, note concern: NA







38
38
TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY THE ASSESSOR
3. Antinutrients (If there are 2 or more antinutrients
known, use as many sheets as necessary.)
Cross Reference of Document(s)
Submitted
Remarks/
Recommendations
3a. Antinutrient 1; Identify: Phytic Acid

PHPI (2003) Risk Analysis Report for
Genetically Modified Plant for Direct Use as
Food or Feed, or for Processing. Pioneer
Hi-Bred Philippines, Inc. (Section I.3)


Comparison with SE Comparator (i.e., non-
modified control, or other principle
comparator Any significant differences?

Yes No
X
If yes, in which parameters: NA


Effect of processing on level of
antinutrients

None Increase Lower

Other notes:



Comparison with Range of Commercial Varieties
If comparison included a range of commercial varieties,
how many? NA

Were these grown under the same
environmental conditions?
Yes No

Were the data derived from the test
(transgenic) line within the observed
range?
Yes No

If not, which parameters were outside range:


Comparison with Range of Literature Values
Were the data derived from the test
(transgenic) line within the reported
range?
Yes No PHPI (2003) Risk Analysis Report for
Genetically Modified Plant for Direct Use as
Food or Feed, or for Processing. Pioneer
Hi-Bred Philippines, Inc. (Section I.3)


X
If not, which parameters were outside range: NA


Biological Significance
For any statistical difference, are they
biologically relevant? NA

Yes No

If yes, note concern: NA




39
39

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY THE ASSESSOR
3. Antinutrients (Continuation) Cross Reference of Document(s)
Submitted
Remarks/Recommendations
3b. Antinutrient 2; Identify: Trypsin Inhibitor


Comparison with SE Comparator (i.e., non-
modified control, or other principle
comparator Any significant differences?
Yes No PHPI (2003) Risk Analysis Report for
Genetically Modified Plant for Direct Use as
Food or Feed, or for Processing. Pioneer
Hi-Bred Philippines, Inc. (Section I.3)


X
If yes, in which parameters:


Effect of processing on level of
antinutrients
None Increase Lower

Other notes:
Trypsin inhibitor levels in both 1507 and control maize were
below the limit of quantitation (LLOQ=2,000 TIU/g).


Comparison with Range of Commercial Varieties
If comparison included a range of commercial varieties,
how many? NA

Were these grown under the same
environmental conditions?
Yes No

Were the data derived from the test
(transgenic) line within the observed
range?
Yes No

If not, which parameters were outside range:


Comparison with Range of Literature Values- NA
Were the data derived from the test
(transgenic) line within the reported
range? [ranges not available in published
literature]
Yes No

If not, which parameters were outside range:


Biological Significance
For any statistical difference, are they
biologically relevant? NA
Yes No

If yes, note concern: NA




40
40

XII. THE HOST PLANT ENVIRONMENT

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY
THE ASSESSOR
Cross Reference of
Document(s) Submitted
Remarks/
Recommendations
1. Reproduction Biology
Indicate self-pollinated
or cross pollinated
Zea mays is an allogamous plant that propagates
through seed produced predominantly by cross-
pollination and depends mainly on wind borne cross-
fertilization. Maize is essentially 100% open-
pollinated (cross-fertilizing) crop species. Corn pollen
is very promiscuous, lands on any silk, germinates
almost immediately after pollination, and within 24 h
completes fertilization. Thus all corns will
interpollinate, except for certain popcorn varieties
and hybrids that have one of the gametophyte
factors of the allelic series Ga and ga on
chromosome four (Kermicle, 1997 as cited in OECD,
2003).

OECD (2003) Consensus
Document on the Biology of
Zea mays subsp. mays
(Maize). Organisation for
Economic Co-operation and
Development,
ENV/JM/MONO(2003)11.

Indicate any pollinators
(bees, etc.)
Pollinators were one of the functional guilds
monitored during the conduct of 1507 and
1507xMON810xNK603 non-target arthropod (NTA)
study. Based on this study, the pollinators of maize
include the common syrphid and hover flies: the
syrphid fly, Ischiodon scutellaris; and the hover fly,
Metasyrphus sp. Pollinators also include the
palynovores (pollen-feeders) represented by the
stingless bee, Tetragonula sapiens which were
abundant in Tampakan, South Cotabato site,
especially during the pollen shedding stage. Some
other species sighted in the field include an
undetermined Anthophoridae (carpenter bee), adults
of rat-tail maggots (Eristalis sp.) and bee flies
(Bombyliidae).

Lit Jr. IL, et. al. (2012)
Monitoring of Key Non-Target
Arthropods in Transgenic
Maize Lines Containing Event
DAS-157-1 and the
Combined Trait Product DAS-
157-1xMON-81-
6xMON-63-6: 2011
Philippines Field Study. Pioneer
Hi-Bred Philippines, Inc., Study
No. 2011-247.



41
41
Describe possible
formation of viable
interspecific and/or
intergeneric hybrids
Cultivated maize is sexually compatible to varying
degrees with other members of the genus Zea
collectively referred to as teosinte and to a much
lesser extent with members of the genus Tripsacum.

There is a great sexual compatibility between maize
and annual teosinte (Zea mays subsp. mexicana) and
it is known that they produce fertile hybrids (Wilkes,
1977 as cited in OECD, 2003). In areas of Mexico
and Guatemala maize and teosinte freely hybridize
when in proximity of each other. Kermicle and Allen
(1990) as cited in OECD (2003) have shown that
maize can introgress to teosinte; however, there is
incompatibility between some maize populations and
certain types of teosinte resulting in low fitness of
some hybrids that prevents a high rate of
introgression (Evans and Kermicle, 2001 as cited in
OECD, 2003). However, Teosinte, the known close
relative, is not known to occur naturally in the
Philippines. Teosinte populations are normally
confined to the tropical and subtropical regions of
Mexico, Guatemala and Nicaragua.

The genus Tripsacum contains several species, most
of which are native to Mexico, Central and South
America. Though some species may occur where
corn might be cultivated, successful gene
introgression from corn under natural conditions is
highly unlikely.
OECD (2003) Consensus
Document on the Biology of
Zea mays subsp. mays
(Maize). Organisation for
Economic Co-operation and
Development,
ENV/JM/MONO(2003)11.

USDA-APHIS (2001) Approval
of Mycogen Seeds c/o Dow
AgroSciences LLC and Pioneer
Hi-Bred International, Inc.,
Request (00-136-01p) Seeking
a Determination of Non-
regulated Status for Bt Cry1F
Insect Resistant, Glufosinate
Tolerant Corn Line 1507:
Environmental Assessment and
Finding of No Significant
Impact. United States
Department of Agriculture,
Animal and Plant Health
Inspection Service.

List any known sexually
compatible cultivated
species in the country
None, annual tesosinte and Tripsacum species are
not known to be cultivated in the Philippines.

List any known sexually
compatible wild species
in the country
There are no known sexually compatible wild
relatives growing with corn in the Philippines.



42
42
2. Agricultural Practices
Would one expect the
wide adoption of the
transgenic plant in
agriculture to result in
changed cultivation
practices that could have
adverse environmental
impact? If yes, describe.
The introduction of biotech maize in the Philippines has
increased every year since it was first introduced for
cultivation in 2003. The area planted to biotech maize in
2011 reached 644,000 hectares wherein about 85%
have been planted with stacked traits of Bt and
herbicide tolerant maize. Consistent with the experience
of other biotech maize growing countries the steady
increase in adoption reflects the significant and
consistent benefits generated by biotech maize to
farmers in the Philippines such as productivity gains and
reduction in pesticide use.

The 1507 maize has been shown under field conditions
in the Philippines to be highly efficacious against Asian
corn borer (Ostrinia furnacalis). Additionally, 1507
maize is expected to provided effective protection
against common cutworm (Spodoptera litura), corn
semi-looper (Chrysodeixis eriosoma), and black
cutworm (Agrotis ipsilon); and suppression of corn
earworm (Helicoverpa armigera). The approval of 1507
maize for cultivation would create the opportunity to
stack Bt traits and deploy products producing multiple
Bt proteins active against each target pest within a
single plant as well as broadening the spectrum of
lepidopteran pest control.

In order to delay the potential evolution of resistance in
the target pests to Bt Cry proteins expressed in plants,
an Insect Resistance Management (IRM) plan is being
implemented by developers and as mandated by the
Bureau of Plant Industry. The IRM plan includes
deployment of non-Bt refuge, farmers education,
monitoring for the development of resistance to ACB,
and mitigation measures in the event that resistant
populations are confirmed. 1507 maize can also provide
a new tool for managing target insects that might
become resistant to other insecticides currently used,
including potentially other Bt-based insecticides.
Cultivation of 1507 maize will also follow appropriate
IRM regimes.
Samson JA, et.al. (2012) Field
Verification of the Agronomic
Performance of Transgenic
Maize (Zea mays L.) Line DAS-
157-1 and Hybrid Stacked
(DAS-157-1xMON-81-
6xMON-63-6) Expressing
the Bacillus thuringiensis
Proteins for Efficacy Against
Asian Corn Borer and the
Proteins PAT and CP4-EPSPS
for Tolerance to Glufosinate
and Glyphosate Herbicides.
Pioneer Hi-Bred Philippines,
Inc., Study No. PHI-2011-246.

Samson JA, et. al. (2012)
Efficacy of Corn Event DAS-
157-1 and the Hybrid
Stacked Product DAS-157-
1xMON-81-6xMON-
63-6 against Secondary
Lepidopteran Insect Pests of
Corn - 2012 Philippines Field
Study. Pioneer Hi-Bred
Philippines, Inc., Study No.
PHI-2012-181.

James, C. 2011. Global Status
of Commercialized Biotech/GM
Crops: 2011. ISAAA Brief 43-
2011. http://www.isaaa.org/
resources/publications/
biotech_country_facts
_and_trends/download
/Facts%20and%20Trends
%20-%20 Philippines.pdf




43
43
Are there any
anticipated changes in
habitat or geographic
distribution? If yes,
describe.
No changes in habitat or geographic distribution are
anticipated with the introduction of 1507 maize. Bt
maize and its stack trait with herbicide tolerant maize
(e.g. glyphosate tolerant maize) are widely cultivated
in the Philippines. 1507 maize is expected to replace
or complement (by further stacking) existing insect
and weed control technologies in maize.


3. Pests and Diseases
Has the genetic
modification resulted in
an altered reaction to
pests and/or diseases? If
yes, describe.
The phenotypic, agronomic and ecological interaction
assessments indicate that 1507 maize is comparable
to conventional maize and is unlikely to have an
increased plant pest risk. The response of 1507
maize to economically important diseases of maize in
the Philippines was evaluated and compared to non-
transgenic maize in six agricultural environments.
The tolerance of 1507 maize to different diseases
was generally similar to the non-transgenic maize
under the conditions of the multi-location tests.

Several diseases which are known to be predisposed
by insect feeding, such as bacterial and Fusarium
stalk and ear rots, had lower incidence in 1507 maize
compared to non-Bt control maize in some trial sites.

1507 maize, genetically modified to express the
Cry1F protein, is expected to control populations of
certain target lepidopteran insect pests. Non-
lepidopteran insect pests are not expected to be
affected by plant-expressed Bt protein in 1507 maize.
Samson JA, et.al. (2012) Field
Verification of the Agronomic
Performance of Transgenic
Maize (Zea mays L.) Line DAS-
157-1 and Hybrid Stacked
(DAS-157-1xMON-81-
6xMON-63-6) Expressing
the Bacillus thuringiensis
Proteins for Efficacy Against
Asian Corn Borer and the
Proteins PAT and CP4-EPSPS
for Tolerance to Glufosinate
and Glyphosate Herbicides.
Pioneer Hi-Bred Philippines,
Inc., Study No. PHI-2011-246.



44
44
List common associated
pests and diseases to
the crop.
The common diseases and insect pests associated
with maize in the Philippines are as follows:

A. Common corn diseases:
1. Downy mildew (Peronosclerospoa philippinensis)
2. Banded leaf and sheath blight (Rhizoctonia solani)
3. Northern leaf blight (Helminthosporium turcicum)
4. Southern leaf blight (Helminthosporium maydis)
5. Diplodia leaf blight (Diplodia macrospora)
6. Grey leaf spot (Cercospora zeae-maydis)
7. Maize rust (Puccinia polysora)
8. Physoderma brown spot (Physoderma maydis)
9. Bacterial stalk rot (Erwinia chrysanthemi pv. zeae)
10. Fusarium stalk rot (Fusarium moniliforme)
11. Phythium stalk rot (Phythium aphanidermatum)
12. Bacterial ear rot (Erwinia chrysanthemi pv. zeae)
13. Fusarium ear rot (Fusarium moniliforme)
14. Diplodia ear rot (Stenocarpella maydis)
15. Giberella ear rot (Giberella zeae)
16. Maize stripe virus

B. Common lepidopteran insect pests:
1. Asian corn borer (Ostrinia furnacalis)
2. Corn semi-looper (Chrysodeixis eriosoma)
3. Common cutworm (Spodoptera litura)
4. Corn earworm (Helicoverpa armigera)
5. True armyworm (Mythimna separata)
6. Black cutworm (Agrotis ipsilon)
7. Pink stemborer (Sesamia inferens)

C. Common non-lepidopteran insect pests:
1. Corn leaf aphid (Rhopalosiphum maidis)
2. Corn planthopper (Sternocranus pacificus)
3. Corn planthopper (Peregrinus maidis)
4. Corn thrips (Frankliniella williamsi)
5. Corn seedling maggot (Atherigona oriyzae)

Samson JA, et.al. (2012) Field
Verification of the Agronomic
Performance of Transgenic
Maize (Zea mays L.) Line DAS-
157-1 and Hybrid Stacked
(DAS-157-1xMON-81-
6xMON-63-6) Expressing
the Bacillus thuringiensis
Proteins for Efficacy Against
Asian Corn Borer and the
Proteins PAT and CP4-EPSPS
for Tolerance to Glufosinate
and Glyphosate Herbicides.
Pioneer Hi-Bred Philippines,
Inc., Study No. PHI-2011-246.

Samson JA, et. al. (2012)
Efficacy of Corn Event DAS-
157-1 and the Hybrid Stacked
Product DAS-157-1xMON-
81-6xMON-63-6 against
Secondary Lepidopteran Insect
Pests of Corn - 2012 Philippines
Field Study. Pioneer Hi-Bred
Philippines, Inc., Study No. PHI-
2012-181.


4. Any other concerns/other information. None.





45
45
XIII. CONSEQUENCES OF OUTCROSSING

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY
THE ASSESSOR
Cross Reference of
Document(s) Submitted
Remarks/
Recommendations
1. Out-crossing to related varieties
Describe the possible
environmental
consequences of
introgression of the
introduced trait into
related crop species

Since 1507 maize does not exhibit characteristics that
causes it to be more competitive or weedy than other
cultivated corn, the potential impact of gene introgression
to related varieties is not expected to be greatly different
from that of other varieties of cultivated maize bred for
increased resistance to lepidopteran pests or for herbicide
tolerance.

USDA-APHIS (2001) Approval
of Mycogen Seeds c/o Dow
AgroSciences LLC and Pioneer
Hi-Bred International, Inc.,
Request (00-136-01p) Seeking
a Determination of Non-
regulated Status for Bt Cry1F
Insect Resistant, Glufosinate
Tolerant Corn Line 1507:
Environmental Assessment and
Finding of No Significant
Impact. United States
Department of Agriculture,
Animal and Plant Health
Inspection Service.



46
46
2. Out-crossing to wild (or weedy) species
Describe the possible
environmental
consequences of
introgression of the
introduced trait into related
wild species. Indicate if
there is any selection
advantage that can be
conferred by this trait to a
wild species.
The potential for 1507 maize outcrossing to sexually
compatible species is unlikely in the Philippines. Although
corn and annual teosinte are genetically compatible, wind
pollinated and freely hybridize when in close proximity to
each other, teosinte is not present in the Philippines,
except perhaps as an occasional botanical specimen.
Differences in flowering time, geographic separation and
development factors makes natural crosses unlikely. In
contrast with teosinte, special techniques are required to
hybridize maize and Tripsacum. Maize-Tripsacum hybrids
have not been observed under natural conditions.

It is also unlikely that the potential introgression of insect
resistance or glufosinate traits from 1507 maize would
cause wild relative species to become more weedy in the
absence of glufosinate herbicide selection. The unlikely
introgression of the glufosinate herbicide tolerance trait
from 1507 maize would not be expected to provide a
selective advantage to these populations since they
would not be routinely subjected to herbicide treatments.

Therefore, the environmental consequence of pollen
transfer from 1507 maize to other wild or weedy species
is negligible.
USDA-APHIS (2001) Approval
of Mycogen Seeds c/o Dow
AgroSciences LLC and Pioneer
Hi-Bred International, Inc.,
Request (00-136-01p) Seeking
a Determination of Non-
regulated Status for Bt Cry1F
Insect Resistant, Glufosinate
Tolerant Corn Line 1507:
Environmental Assessment and
Finding of No Significant
Impact. United States
Department of Agriculture,
Animal and Plant Health
Inspection Service.

3. Risk mitigation measures


Are there any measures that would
mitigate risks arising from out-
crossing?

Not applicable
4. Any other concerns/other information. None






47
47
XIV. WEEDINESS POTENTIAL

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY
THE ASSESSOR
Cross Reference of
Document(s) Submitted
Remarks/
Recommendations
1. Dissemination
Describe known modes of
dissemination of the crop (seed,
rhizomes, etc.).

Maize has lost the ability to survive in the
wild due to its long process of
domestication, and needs human
intervention to disseminate its seed. Maize
cannot persist as a weed. Volunteers are
common in many agronomic systems, but
they are easily controlled; however, maize
is incapable of sustained reproduction
outside of domestic cultivation. Maize
plants are non-invasive in natural habitats
(Gould, 1968 as cited in OECD, 2003). In
contrast to weedy plants, maize has a
pistillate inflorescence (ear) with a cob
enclosed with husks. Consequently seed
dispersal of individual kernels does not
occur naturally.

OECD (2003) Consensus Document on
the Biology of Zea mays subsp. mays
(Maize). Organisation for Economic
Co-operation and Development,
ENV/JM/MONO(2003)11.

2. Seed dormancy
Was seed dormancy/survival under
normal condition assessed?
Yes No
X
Were there any changes in seed
dormancy? If yes, describe them:
Yes No
















48
48
3. Seed germination/ survival
Was seed germination/survival
assessed?
Yes No Samson JA, et.al. (2012) Field
Verification of the Agronomic
Performance of Transgenic Maize (Zea
mays L.) Line DAS-157-1 and
Hybrid Stacked (DAS-157-1xMON-
81-6xMON-63-6) Expressing
the Bacillus thuringiensis Proteins for
Efficacy Against Asian Corn Borer and
the Proteins PAT and CP4-EPSPS for
Tolerance to Glufosinate and
Glyphosate Herbicides. Pioneer Hi-Bred
Philippines, Inc., Study No. PHI-2011-
246.

X
Were there any changes in seed
germination/survival? If yes,
describe them:

Yes No
X
4. Time to maturity
Was time to maturity assessed? If yes, describe
how:

Silk and pollen shed dates of 1507 and control
maize was evaluated. Harvest moisture was also
measured.

Yes No Samson JA, et.al. (2012) Field
Verification of the Agronomic
Performance of Transgenic Maize (Zea
mays L.) Line DAS-157-1 and
Hybrid Stacked (DAS-157-1xMON-
81-6xMON-63-6) Expressing
the Bacillus thuringiensis Proteins for
Efficacy Against Asian Corn Borer and
the Proteins PAT and CP4-EPSPS for
Tolerance to Glufosinate and
Glyphosate Herbicides. Pioneer Hi-Bred
Philippines, Inc., Study No. PHI-2011-
246.


X
Were there any changes in time to maturity? If
yes, describe:

Yes No
X
5. Describe any changes in other agronomic characteristics (e.g. tolerance to
abiotic stresses, or diseases, or competitiveness) that would increase the plant's
potential to become a weed.

Data collected from six field test sites in two cropping seasons demonstrate that
agro-phenotypic characteristics, disease tolerance and abiotic stress response
(e.g., winds, drought conditions) of 1507 maize was generally similar to the non-
transgenic control maize. The results support the conclusion that the risks
associated with cultivation of 1507 maize in the Philippines is very low.





49
49
XV. SECONDARY AND NON-TARGET EFFECTS

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP
BY THE ASSESSOR
Cross Reference
of Document(s)
Submitted
Remarks/
Recommendations
Laboratory Studies
(Fill out for each combination of novel protein and sentinel/indicator species tested.)

Novel Protein
Identify:

Cry1F
a. Tested
Sentinel/
Indicator Species
1:

Collembola
(Folsomia candida)

Assay Description


Study Results:


Biological
Significance &/or
Other Observations

A 28-day study was
conducted to determine
chronic effects of
purified Cry1F protein
on survival and
reproduction of
Collembola. Three
treatment levels were
assessed: 0.63, 3.1 and
12.5 mg/kg of test diet

LC50: >12.5mg/kg
soil

Other: worst-case
exposure estimate in
plant material is
0.350 mg Cry1F/kg
whole plant material;
worst-case exposure
estimate in soil is
0.063 mg Cry1F/kg
dry soil

Collembola were not
affected by chronic
exposure to Cry1F at
the treatment levels.
Treatments used in
study exceeded
worst case
estimates, indicating
that the risk to
springtails under
field conditions is
negligible.
Anderson J (2012)
Environmental Risk
Assessment for the
Cultivation of DAS-
157-1 Maize in the
Philippines. Pioneer
Hi-Bred International,
Inc, Study No. PHI-
2012-313.


b. Tested
Sentinel/
Indicator Species
2:

Earthworm
(Eisenia fetida)


Assay Description


Study Results:


Biological
Significance &/or
Other Observations

A 14-day test was
conducted to determine
the effects of Cry1F
protein on survival and
of earthworm.

LC50: >2.5mg
Cry1F/kg dry soil

Other: tested
concentration is
148X the worst-case
exposure estimate
(incorporating 61,775
senescent 1507
plants in top 15 cm of
soil)

No mortality was
observed at tested
concentration over
the 14-day study
indicating that
earthworms are at
negligible risks to
the environment.
Anderson J (2012)
Environmental Risk
Assessment for the
Cultivation of DAS-
157-1 Maize in the
Philippines. Pioneer
Hi-Bred International,
Inc, Study No. PHI-
2012-313.






50
50


Novel Protein
Identify:

Cry1F
c. Tested
Sentinel/
Indicator Species
3:

Parasitic
Hymenoptera
(Nasonia
vitripennis)


Assay Description


Study Results:


Biological
Significance &/or
Other Observations

A 12-day limit test was
conducted to determine
the dietary toxicity of
Cry1F protein to
parasitic hymenoptera.
Nasonia vitripennis fed
with artificial honey diet
containing 320 ppm
Cry1F protein.

LD50: >320 g
Cry1F/g diet

Other: tested
concentration is 10X
the concentration of
Cry1F in 1507 maize
pollen

No increased
mortality or
treatment-related
effects were
observed at tested
concentration.
Anderson J (2012)
Environmental Risk
Assessment for the
Cultivation of DAS-
157-1 Maize in the
Philippines. Pioneer
Hi-Bred International,
Inc, Study No. PHI-
2012-313.


d. Tested
Sentinel/
Indicator Species
4:

Green Lacewing
(Chrysoperla
carnea)


Assay Description


Study Results:


Biological
Significance &/or
Other Observations

A 13-day limit test was
conducted to determine
the dietary toxicity of
Cry1F protein to green
lacewing larvae.
Chrysoperla carnea fed
an artificial diet
containing 480 ppm
Cry1F protein.

LD50: >480 g
Cry1F/g diet

Other: tested
concentration is 15X
the concentration of
Cry1F in 1507 maize
pollen

No increased
mortality was
observed at tested
concentration.
Anderson J (2012)
Environmental Risk
Assessment for the
Cultivation of DAS-
157-1 Maize in the
Philippines. Pioneer
Hi-Bred International,
Inc, Study No. PHI-
2012-313.






51
51
Novel Protein
Identify:

Cry1F
e. Tested
Sentinel/
Indicator Species
5:

Ladybird Beetle
(Hippodamia
convergens)


Assay Description


Study Results:


Biological
Significance &/or
Other Observations

A 29-day limit test was
conducted to determine
the dietary toxicity of
Cry1F protein to
ladybird beetle.
Hippodamia convergens
were fed an artificial
honey diet containing
480 ppm Cry1F protein.

LD50: >480 g
Cry1F/g diet

Other: tested
concentration is 15X
the concentration of
Cry1F in 1507 maize
pollen

No increased
mortality or
treatment-related
effects were
observed at tested
concentration.
Anderson J (2012)
Environmental Risk
Assessment for the
Cultivation of DAS-
157-1 Maize in the
Philippines. Pioneer
Hi-Bred International,
Inc, Study No. PHI-
2012-313.


f. Tested
Sentinel/
Indicator Species
6:

Honeybee (Apis
mellifera)


Assay Description


Study Results:


Biological
Significance &/or
Other Observations

A 6-day study was
conducted to determine
the dietary toxicity of
Cry1F protein on larval
honeybee development.
Apis mellifera were fed
a diet containing: a)
isoline pollen, b) pollen
expressing 32 ng/mg
Cry1F protein, c) isoline
pollen plus potassium
arsenate as positive
control, and d) an
artificial sucrose
solution containing
Cry1F protein (640 ng
Cry1F/larvae).

LD50: >640 ng
Cry1F/larvae

Other: tested
concentration is 10X
field exposure (either
in form of pollen or
purified protein)

No effects on larval
survival were
observed in
honeybees fed Cry1F
protein equivalent to
a 10X field
exposure.
Anderson J (2012)
Environmental Risk
Assessment for the
Cultivation of DAS-
157-1 Maize in the
Philippines. Pioneer
Hi-Bred International,
Inc, Study No. PHI-
2012-313.








52
52
Novel Protein
Identify:

Cry1F
g. Tested
Sentinel/
Indicator Species
7:

Water Flea
(Daphnia magna)


Assay Description


Study Results:


Biological
Significance &/or
Other Observations

A 48-hour static
renewal acute toxicity
study was conducted to
determine the toxicity of
Cry1F protein to
neonate cladoceran.
Daphnia magna were
exposed to 100 mg
Cry1F protein/ L water
or 100 mg pollen
(expressing 32 ng/mg
Cry1F protein)/L water.

EC50: >100 mg
Cry1F pollen/L


No mortality or
treatment-related
effects were
observed at the 100
mg Cry1F pollen
treatment. The EC50
for D. magna
exceeds the worst-
case environmental
exposure estimate
by several order
magnitudes,
indicating that Cry1F
protein poses no
hazards to Daphnia
at environmentally
relevant
concentrations.
Anderson J (2012)
Environmental Risk
Assessment for the
Cultivation of DAS-
157-1 Maize in the
Philippines. Pioneer
Hi-Bred International,
Inc, Study No. PHI-
2012-313.
























53
53

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP
BY THE ASSESSOR
Cross Reference
of Document(s)
Submitted
Remarks/
Recommendations
Field Studies
(Fill out for each species observed.)

1. Arthropod
species 1
studied/
observed;
Identify:

Herbivores
Site Information Sampling
Protocol
Results Biological
Significance/Other
Observations

1. Number of
sites: 2



Sweep net
sampling;
ocular
inspection;
sticky traps
wet season trials:
Abundance of herbivores,
including chewing and
sucking insects, did not
differ significantly
between 1507 and non-
transgenic control maize.

dry season trials:
The numbers of non-
target herbivores did not
differ significantly
between 1507 and
control maize in both
sites and throughout the
maize growth stages
except at flowering stage
(55 DAP) where
insecticide treated
control maize had
significantly lower
number of herbivores
compared to 1507 maize.
The sucking herbivores
observed were the corn
leaf aphid, Rhopalosiphum
maidis; several corn
leafhoppers: Dalbulus sp.,
Nephotettix spp., Nezara
viridula; corn planthoppers,
Peregrinus maidis and
Stenocranus pacificus; and
the less common moth
hopper, Ricania sp.

Non-target chewing
herbivores identified were
flea beetle, Phyllotreta sp.;
(Figure 27.B); squash
beetle; silk beetle; flower
beetle; June beetle; horned
coreid bug, Cletus trigonus;
rice bug, Leptocorisa
oratorius; and a
pachyrrhynchid weevil,
Metapocyrtus sp.
Lit Jr. IL, et. al.
(2012) Monitoring of
Key Non-Target
Arthropods in
Transgenic Maize
Lines Containing
Event DAS-157-1
and the Combined
Trait Product DAS-
157-1xMON-
81-6xMON-
63-6: 2011
Philippines Field
Study. Pioneer Hi-
Bred Philippines, Inc.,
Study No. 2011-247.

2. Locations:

Cauyan,
Isabela (CA)
Tampakan,
South Cotabato
(TA)



3. Number of
Years:

2011-2012 wet
and dry cropping
seasons





2. Any other concerns to non-target effects: none







54
54


TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP
BY THE ASSESSOR
Cross Reference
of Document(s)
Submitted
Remarks/
Recommendations
Field Studies
(Fill out for each species observed.)

3. Arthropod
species 1
studied/
observed;
Identify:

Predators
Site Information Sampling
Protocol
Results Biological Significance/
Other Observations

1. Number of
sites: 2



Sweep net
sampling;
ocular
inspection;
sticky traps;
pitfall
trapping;
protein
baiting
wet season trials:
The number of
predators did not differ
significantly between
1507 and control maize
through all growth
stages except during 20
and 40 DAP in CA. In
CA site, there were
more predators in non-
Bt plots at 20 DAP while
at 40 DAP predators
were more abundant in
1507 maize vs. control
maize.
NTA species observed:
Coccinellids or ladybird
beetles: Micraspis discolor
and Chilomenes
sexmaculata
Predatory tiny black
beetle, Phalacrus sp.;
orange lady beetle,
Chilomenes sexmaculata;
rove beetles; tiger beetle;
net-winged beetle; hispine
black beetle; earwigs
Mirid bugs, Cyrtorhinus
lividipennis; bigeyed bug,
Geocoris sp.; damsel and
Lit Jr. IL, et. al.
(2012) Monitoring of
Key Non-Target
Arthropods in
Transgenic Maize
Lines Containing
Event DAS-157-1
and the Combined
Trait Product DAS-
157-1xMON-
81-6xMON-
63-6: 2011
Philippines Field
Study. Pioneer Hi-
Bred Philippines, Inc.,

2. Locations:

Cauyan,
Isabela (CA)
Tampakan,
South Cotabato
(TA)





55
55
3. Number of
Years:

2011-2012 wet
and dry cropping
seasons




dry season trial:
1507 and control maize
did not significantly
differ in terms of
abundance of predators
in both sites and in all
sampling periods. The
insecticide treated
control maize had
numerically lower
number of predators
than other treatments
during the vegetative
stages in CA and at the
vegetative and
flowering stages in TA.
pentatomid bug.
Predatory black cricket,
Metioche vittaticollis and
the long-legged flies.
Lacewings, Micromus
igorotus and Mallada
basalis
Syrphid fly, Ischiodon
scutellaris
Dragonflies and
damselflies, Pseudagrion
sp.; the slender skimmer,
Orthetrum Sabina; and
common ground skimmer,
Diplacodes trivialis.
Spiders: Lynx spiders;
Lycosids, Pardosa
pseudoannulata; derby
spider, Neoscona spp;
corn spider, Argiope sp.;
and other spiders
belonging to at least six
families.
Ants: Solenopsis geminate
and Pheidologeton
diversus

Study No. 2011-247.
4. Any other concerns to non-target effects: none















56
56
TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP
BY THE ASSESSOR
Cross Reference
of Document(s)
Submitted
Remarks/
Recommendations
Field Studies
(Fill out for each species observed.)

5. Arthropod
species 1
studied/
observed;
Identify:

Pollinators
Site Information Sampling
Protocol
Results Biological
Significance/Other
Observations

1. Number of
sites: 2



Sweep net
sampling;
ocular
inspection;
sticky traps
wet season trials:
Pollinators were
generally not abundant
during the wet season.
The numbers of
pollinators observed in
1507 maize did not differ
significantly with the
control maize.

dry season trials:
Results for pollinators did
not present clear trends
as to treatment effects.
However, during
flowering stage in CA,
there were no significant
differences in abundance
among treatments while
in TA, 1507 and non-
treated control maize
had higher number of
pollinators vs.
insecticide-treated
control maize.

Pollinators observed in
trials include the syrphid
fly, Ischiodon scutellaris;
and the hover fly,
Metasyrphus sp. Pollinators
also include the
palynovores (pollen-
feeders) represented by
the stingless bee,
Tetragonula sapiens which
were abundant in TA,
especially during the pollen
shedding stage. Some
species sighted in the field
include an Anthophoridae
(carpenter bee), adults of
rat-tail maggots (Eristalis
sp.) and bee flies
(Bombyliidae).

Lit Jr. IL, et. al.
(2012) Monitoring of
Key Non-Target
Arthropods in
Transgenic Maize
Lines Containing
Event DAS-157-1
and the Combined
Trait Product DAS-
157-1xMON-
81-6xMON-
63-6: 2011
Philippines Field
Study. Pioneer Hi-
Bred Philippines, Inc.,
Study No. 2011-247.

2. Locations:

Cauyan,
Isabela (CA)
Tampakan,
South Cotabato
(TA)



3. Number of
Years:

2011-2012 wet
and dry cropping
seasons





6. Any other concerns to non-target effects: none







57
57
To be answered by the Assessor

Given the above risk assessment, summarize below the possible risks (if any) due to the
transgenic plant and indicate possible mitigating measures.

Source of the
Risk
Human Health Animal Health Environment Mitigating
Measures





























After a thorough scientific review and evaluation of the documents provided by the Bureau of
Plant Industry relevant to DAS-157-1 (1507 Maize) of Pioneer Hi-Bred Philippines, Inc., I

Find scientific evidence that the regulated article applied for propagation is as safe
as its conventional counterpart and is not expected to pose any significant risk to
human and animal health.

Find sufficient evidence that the regulated article applied for propagation will not pose
any significant risk to the environment as its conventional counterpart and that any
risks posed to the environment could be managed by the following measures:
1.
2.
3.
4.

Based on the above summary of possible risks identified, need additional information to
validate the claims of the applicant that the regulated article applied for is safe for:
_____ food, _____ feed, ______ environment.



Signature
STRP Member/Regulatory Agency
Date