(3) 1507 PHL Propagation RAR-26June2013

8/12/2019 (3) 1507 PHL Propagation RAR-26June2013

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RISK ASSESSMENT REPORT FOR GENETICALLY MODIFIED PLANTFOR 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.24thF, Antel Global Corporate CenterDoa Julia Vargas Ave., Ortigas CenterPasig City 1600 Philippines

Nature/Identity of Transgene(s):

Maize (Zea maysL.) line, DAS-157-1 (herein referred to as 1507 maize), wasgenerated by the insertion of a synthetic truncated cry1F gene, which was isolatedfrom Bacillus thuringiensis(Bt)subspecies aizawai and a gene for phosphinothricinacetyltransferase (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 protectionagainst certain lepidopteran pests. In local field trials, 1507 maize providedprotection 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 patgene, confers tolerance to the herbicidalactive 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:[email protected]

Host Organism: Maize (Zea maysL.) Method of Transformation Used:

Microprojectile bombardment using biolisticsDonor Organism: Bacillus thuringiensis(Bt)var. aizawai and

Streptomyces viridochromogenes

Proposed Use: propagation/cultivation

Date Received: Status:

Annex IIa
mailto:[email protected]:[email protected]


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

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BYTHE ASSESSOR

Yes No Cross Reference ofDocument(s) Submitted

Remarks/Recommendations

1. Source of keynutrients? X

If yes, describe.

Maize grain is fed to animals as a source of energyfrom carbohydrates and oils and provides a source ofessential and nonessential amino acids. The kernelcontains about 83% carbohydrate that is in the formof starch, pentosans, dextrins, sugars, cellulose, andhemicellulose. Starch makes up the biggest part ofthe carbohydrate fraction and provides most of theenergy. The fiber portion includes the cellulose andhemicellulose portions that are generally unavailableto non-ruminants.

Maize grain is rich in linoleic acid, one of theessential fatty acids needed by swine and poultry.Maize also has a favorable content of essential aminoacids with the exception of lysine and tryptophan.Maize provides an important source of methioninewhich 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 ofphosphorus. Maize grain is a source ofvitamins A, E, thiamin, riboflavin, pantothenic acid,and pyridoxine.

OECD (2002) ConsensusDocument on CompositionalConsiderations for NewVarieties of Maize (Zea Mays):Key Food and Feed Nutrients,

Anti-Nutrients and SecondaryPlant Metabolites. Organisationfor Economic Co-operation andDevelopment,ENV/JM/MONO(2002)25. (pp:19-27; 31-35)


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2. Source ofantinutrients? X

If yes, describe.

Maize contains several anti-nutrients such as phyticacid, DIMBOA and raffinose. Phytic acid binds mostof the phosphorus in maize, which results in reducedbioavailability of phosphorus for non-ruminantanimals. DIMBOA belongs to a group of metabolites,hydroxamic acids and benzoxazinoids, commonlyfound in cereal plants. Raffinose is a low molecularweight carbohydrate that is non-digestible.Maize also contains low levels of trypsin andchymotrypsin inhibitors, neither of which is

considered nutritionally significant.

OECD (2002) ConsensusDocument on CompositionalConsiderations for NewVarieties of Maize (Zea Mays):Key Food and Feed Nutrients,Anti-Nutrients and SecondaryPlant Metabolites. Organisationfor Economic Co-operation andDevelopment,ENV/JM/MONO(2002)25.(pp: 28-29)

3. Source oftoxicants? X

If yes, describe.

There are no known toxicants in maize.4. Source ofallergens? X

If yes, describe.

Maize is not a common allergenic food.

OECD (2002) ConsensusDocument on CompositionalConsiderations for NewVarieties of Maize (Zea Mays):Key Food and Feed Nutrients,Anti-Nutrients and SecondaryPlant Metabolites. Organisationfor Economic Co-operation andDevelopment,ENV/JM/MONO(2002)25. (p29)


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TO BE FILLED UP BY THE APPLICANT TO BE FILLED UP BY THEASSESSOR

Cross Reference ofDocument(s) Submitted


5. Used as food?

YES

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

Maize products (starch, oil, grits, meal and flour) areused in many foods. Starch is mostly fermented tosweeteners (syrups) and ethanol. It is also used forfoods, such as bakery products, baby foods, sauces,dressings and soups. Maize oil is used in salad- andcooking oil, mayonnaise, margarine, baking and fryingfat and in sauces and soups. Grits are used to makecereals and snacks and also to produce alcoholicbeverages. Meal is used for bread and muffins, andflour is used for pancakes and snacks. Bran is used asa dietary source of fiber.

OECD (2002) ConsensusDocument on CompositionalConsiderations for NewVarieties of Maize (Zea Mays):Key Food and Feed Nutrients,Anti-Nutrients and SecondaryPlant Metabolites. Organisationfor Economic Co-operation and

Development,ENV/JM/MONO(2002)25. (p31)

6. Consumptionpatterns

What is the usual consumption pattern of the productby population subgroups?

About 66% of all the maize produced worldwide isused for animal feed and 17% for humanconsumption. In the developing countries, 30% of themaize produced was used for human consumptionand 57% for animal feed, whereas in Western Europe,North America and other high income countries, 4%

was used for human consumption and 76% for animalfeed. In the Philippines, about 64% of maize demandis for animal feed, 22% for food and 13% forprocessing.

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


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7. Used as feed?

YES

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

Maize raw and processed products are both used asfeedstuff in livestock production. Maize is preferredfeedstuff as a processed whole grain, as a by-productof the milling industry, or as whole plant silage. Wholecorn plant may be used for animal (primarilyruminant) feed. The material can be fed directly orpreserved as silage. Maize grain is usually ground orrolled when fed to swine and poultry.

OECD (2002) ConsensusDocument on CompositionalConsiderations for NewVarieties of Maize (Zea Mays):Key Food and Feed Nutrients,Anti-Nutrients and SecondaryPlant Metabolites. Organisationfor Economic Co-operation andDevelopment,ENV/JM/MONO(2002)25. (p17)

8. Any other concerns/

additional information

None

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


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II. THE TRANSGENIC PLANT




1. If used as food List countries that have approved the transgenicplant as food. Provide summary of existingdocuments, references or opinions of regulatorybodies.

1507 maize has been granted approval fordirect 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 foundthat 1507 maize is considered as safe as itsconventional counterpart when used as food.

2. Consumption patterns Will consumption patterns by populationsubgroups be changed as a result of introducingthe novel food?

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


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3. If used as feed List countries that have approved the transgenicplant as feed. Provide summary of existingdocuments, references or opinions of regulatorybodies.

1507 maize has been granted approval fordirect 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 assafe as its conventional maize when used asfeed.

4. Any other concerns/additional information

None



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




1. Have all protein-encoding sequencesfound in the originalgene construct beendescribed with respect

to source and potentialpathogenic or allergenicproperties?

Yes No If no, indicate deficiencies. PHPI (2003) Risk Analysis Report forGenetically Modified Plant for DirectUse as Food or Feed, or forProcessing. Pioneer Hi-BredPhilippines, Inc. (Sections C and D)

X

2. Have all potentiallyinserted regulatorysequences (promoters,enhancers, terminationsignals etc) beenadequately described?

Yes No If no, indicate deficiencies. PHPI (2003) Risk Analysis Report forGenetically Modified Plant for DirectUse as Food or Feed, or forProcessing. Pioneer Hi-BredPhilippines, Inc. (Sections C and D)

X

3. Enumerate allintroduced expressiblesequences, includingantisense.

1. truncated cry1Fgene2. phosphinothricinNacetyltransferase ( pat) gene

PHPI (2003) Risk Analysis Report forGenetically Modified Plant for DirectUse as Food or Feed, or forProcessing. Pioneer Hi-BredPhilippines, Inc. (Section C)


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4. List all donororganisms. Donor Organisms

Indicate if knownto be toxic:

Yes or No

Indicate if knownto be an allergen:

Yes or No

PHPI (2003) Risk AnalysisReport for Genetically ModifiedPlant for Direct Use as Food orFeed, or for Processing.Pioneer Hi-Bred Philippines,Inc. (Sections C and D)

Bacillusthuringiensissubspecies aizawai

No No

Streptomycesviridochromogenes

No No

5. List allproteinsencoded by theexpressiblesequences.

ProteinsIndicate if knownto be toxic:

Yes or No

Indicate if knownto be an allergen:

Yes or No

PHPI (2003) Risk AnalysisReport for Genetically ModifiedPlant for Direct Use as Food orFeed, or for Processing.Pioneer Hi-Bred Philippines,Inc. (Section H)

Cry1F No NophosphinothricinNacetyltransferase (PAT)

No No

6. Any other concerns/additional information. None



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IV. THE TRANSFORMATION SYSTEM


Yes No Cross Reference ofDocument(s) Submitted


1. Transformationmethod

Agrobacterium mediated? XParticle bombardment? X PHPI (2003) Risk Analysis

Report for Genetically ModifiedPlant for Direct Use as Food orFeed, or for Processing.Pioneer Hi-Bred Philippines,

Inc. (Section D.1)

If none of the above, describe method below.

Target of genetic

modification

NuclearDNA

ChloroplastDNA

Mitochondrial DNA

X

Complete experimental protocol provided?Yes No

X

2. List of allgeneticcomponents

This should include all coding and non-codingregions together with the recombinant plasmidmap and its components, description(s) orcitation(s) for isolation and source, descriptionand characterization for each region. Are theseincluded?

X

PHPI (2003) Risk AnalysisReport for Genetically ModifiedPlant for Direct Use as Food orFeed, or for Processing.Pioneer Hi-Bred Philippines,Inc. (Section D.2)

3. Map ofplasmid vector

This should include size, orientation, andlocation of all genetic elements, oligonucleotideprimers used for PCR analysis, and the sites ofany restriction endonucleases used in theanalysis of the inserted DNA. Are these

included?

X

PHPI (2003) Risk AnalysisReport for Genetically ModifiedPlant for Direct Use as Food orFeed, or for Processing.Pioneer Hi-Bred Philippines,Inc. (Section D.3)

4. Carrier DNAand/or helperplasmids

Where used, are these described?X




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V. THE INSERTED DNA


Cross Reference ofDocument(s)

Submitted


1. Numberof insertionsites

Number of insertion sites.

One insertion site containing the following. One full length copy ofcry1Fand pat genes and in addition a limited number of non-

functional fragments of the cry1F and pat genes. Partial copies ofthe cry1Fand pat genes are not expressed as unique transcripts in1507 maize.

PHPI (2003) Risk AnalysisReport for GeneticallyModified Plant for Direct Useas Food or Feed, or forProcessing. Pioneer Hi-Bred

Philippines, Inc. (Section E.1)

How was this demonstrated?

Demonstrated sufficiently based on Southern analysisacross andwithin generations and sequence summary.Is this sufficient? Yes

2. Integrityand orderof geneticelementswithin eachinsertionsite

How was integrity demonstrated?Southernblotting

PCR NucleotideSequencing

PHPI (2003) Risk AnalysisReport for GeneticallyModified Plant for Direct Useas Food or Feed, or forProcessing. Pioneer Hi-BredPhilippines, Inc. (Section E.2)

PHPI (2013) SupplementalMolecular Report: MolecularCharacterization of BtCry1FMaize 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 XIf yes, briefly describe below.

Partial copies of Cry1F and PAT and PAT rearrangements weredetected at the single insertion point. Northern analysis showed notranscription.

Was this satisfactorily demonstrated? Yes No

(a) Truncations X(b) Deletions

(c) Rearrangements X


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

An analysis of the cry1F and patcoding sequence for the presenceof potential ORFs identified no ORFs in the mRNA that is expressedand translated into Cry1F protein that could encode proteins ofgreater than 200 amino acids. This indicates that there is nosignificant concern associated with ORFs in Cry1F maize line 1507.


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 Cry1Fprotein. 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 Registryhttp://biotech.da.gov.ph/Approval_Registry.php

4. Plasmidbackbonesequences

Present?Yes No

X


How was this determined, and was this sufficient?

Sufficiently well demonstrated using Southern analysis withprobes developed using plasmid backbone sequences.


http://biotech.da.gov.ph/http://biotech.da.gov.ph/


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VI. GENETIC STABILITY




1. Multigenerationalstability ofintroduced trait

How was thisassessed?

ELISA WesternBlotting

Bioassay Others PHPI (2003) Risk AnalysisReport for Genetically ModifiedPlant for Direct Use as Food orFeed, 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) generationswere tested

2. Segregationanalysis

How was thisassessed?

ELISA WesternBlotting

Bioassay Others PHPI (2003) Risk AnalysisReport for Genetically ModifiedPlant for Direct Use as Food orFeed, 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 ofsegregation, describe and explain why such method was used.

Were the results from segregation analysisconsistent with reported inserted number?

Yes No

X

3. Any other concerns/other information. None



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VII. EXPRESSED MATERIAL




1. Level ofExpressionof NovelProtein inDifferentPlant 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 ProteinConcentration of Maize LinesContaining Events DAS-157-1,MON-81-6, MON-63-6,

and Combined Trait ProductDAS-157-1xMON-81-6xMON-63-6: U.S. TestSites. Pioneer Hi-BredInternational, Inc, Study No.2008-071/012.

Cry1FRange:Mean:

1.4-6.93.6

6.0-9.47.6

13-2919


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3. MetabolicRole of theNovelProtein

PAT enzyme detoxifies phosfinothricin by acetylation into an inactivecompound.

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




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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 manytimes as necessary to record all information.



1. NovelProtein 1;Identify:

Cry1F

Digestibility Results

Digestion in: EstimatedT50

< 1 minute PHPI (2003) Risk Analysis Reportfor Genetically Modified Plant forDirect Use as Food or Feed, orfor Processing. Pioneer Hi-BredPhilippines, Inc. (Section H.4)

SGF X

Other

Determined by: Largest sizefragments

remainingafterdigestion

NA

ELISA

Western BlotBioassay

Other

Heat InactivationResults: PHPI (2003) Risk Analysis Report

for Genetically Modified Plant forDirect Use as Food or Feed, orfor Processing. Pioneer Hi-BredPhilippines, Inc. (Section H.4)

Estimated T50Determined by:

ELISAWestern

Bioassay X

Other

Amino Acid Sequence ComparisonIs there homology with known toxins. Yes No PHPI (2003) Risk Analysis Report


X

If yes, which ones? NA

What is the percentage of sequence similarity? NA

Acute Oral Gavage

Performed? Yes No PHPI (2003) Risk Analysis Reportfor Genetically Modified Plant forDirect Use as Food or Feed, orfor Processing. Pioneer Hi-BredPhilippines, Inc. (Section H.1)

XIf yes, report NOEL (mg/Kg body weight) >576 mg/kg

Source of the Test Protein

Plant PHPI (2003) Risk Analysis Reportfor Genetically Modified Plant forDirect Use as Food or Feed, orfor Processing. Pioneer Hi-BredPhilippines, Inc. (Sections H.1and D.5)

Bacterial X

OtherIf not plant, was equivalencydemonstrated?

Yes No

X


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Complete this portion of the table for each novel protein as manytimes as necessary to record all information.




PAT

Digestibility Results

Digestion in: EstimatedT50

< 1 minute PHPI (2003) Risk Analysis Reportfor Genetically Modified Plant forDirect Use as Food or Feed, orfor Processing. Pioneer Hi-BredPhilippines, Inc. (Section H.4)

SGF X

OtherDetermined by: Largest size

fragmentsremaining

afterdigestion

ELISA

Western Blot

BioassayOther

Heat Inactivation

Results:Estimated T50

Determined by:

ELISA

Western

BioassayOther

Amino Acid Sequence ComparisonIs there homology with known toxins Yes No PHPI (2003) Risk Analysis Report


XIf yes, which ones?

What is the percentage of sequence similarity?

Acute Oral GavagePerformed? Yes No PHPI (2003) Risk Analysis Report


X

If yes, report NOEL (mg/Kg body weight) LD50 > 6,000 mg/kg

Source of the Test Protein

Plant PHPI (2003) Risk Analysis Reportfor Genetically Modified Plant forDirect Use as Food or Feed, orfor Processing. Pioneer Hi-BredPhilippines, Inc. (Sections H.2and D.5)

Bacterial XOtherIf not plant, was equivalencydemonstrated?

Yes No

X


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Cross Reference of

Document(s) Submitted

Remarks/

Recommendations

4. If thereare two ormore novelproteinsexpressed:

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

Since Cry1F and PAT differ in modes of action, these novel proteinsare expected to be expressed independently of each other.There isno known interaction between and cry1Fand patgenes and geneproducts that would affect the stability and expression level of theindividual genes. PAT was used as a selectable marker in thedevelopment process of 1507 maize. The gene sequences for bothpatand cry1Fwere 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 expressedthroughout 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 protectionagainst certain lepidoteran pests while PAT confers tolerance toglufosinate containing herbicides. The novel proteins expressed in1507 maize are not expected to interact to negatively affectexpressed 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 substrateaffinity for L-Phosphinothricin, the active ingredient in glufosinateammonium. Cry1F and PAT proteins are not expected to interact ina metabolic pathway.



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IX. ALLERGENICITY ASSESSMENT





Cry1F

DigestibilityEstimated T50: < 1 minute PHPI (2003) Risk Analysis Report

for Genetically Modified Plant forDirect Use as Food or Feed, or forProcessing. Pioneer Hi-BredPhilippines, Inc. (Section H.4)

Digestion in SGFDetermined by: Largest size fragments

remaining:ELISA

Western Blot

Bioassay

OtherDigestion in SIF

Determined by: Largest size fragmentsremaining:ELISA

Western BlotBioassay

Other

Heat InactivationEstimated T50:

Determined by:

ELISA

Western BlotBioassayOther


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1. NovelProtein 1(continuation)

Cry1F

Amino Acid Sequence Comparison

Performed? Yes No PHPI (2003) Risk Analysis Reportfor Genetically Modified Plant forDirect Use as Food or Feed, or forProcessing. Pioneer Hi-BredPhilippines, Inc. (Section H.4)

X

If yes, any homology with knownallergens?

Yes No

X

If yes, which ones? Indicate %sequence similarity.

NA

Physiochemical Properties? NA

Glycosylated? Yes No

X

Molecular weight within 10-70kDa range?

Yes (65 kDa) PHPI (2003) Risk Analysis Reportfor Genetically Modified Plant forDirect Use as Food or Feed, or forProcessing. Pioneer Hi-BredPhilippines, Inc. (Section D.5)

Prevalence in Food

Percent of Total Protein

0.01%

>1.0%

>5.0%

Serum ScreeningPerformed? Yes No

X

If yes, report results.

2. Other concerns/additional information. None


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3. NovelProtein 2(continuation)

PAT

Amino Acid Sequence Comparison

Performed? Yes No PHPI (2003) Risk Analysis Reportfor Genetically Modified Plant forDirect Use as Food or Feed, or forProcessing. Pioneer Hi-BredPhilippines, Inc. (Section H.4)

X

If yes, any homology with knownallergens?

Yes No

X

If yes, which ones? Indicate %sequence similarity.

NA

Physiochemical Properties? NA

Glycosylated? Yes No

Molecular weight within 10-70kDa range?

Yes (20.617 kDa) PHPI (2003) Risk Analysis Reportfor Genetically Modified Plant forDirect Use as Food or Feed, or forProcessing. Pioneer Hi-BredPhilippines, Inc. (Section D.5)

Prevalence in Food

Percent of Total Protein

0.01%>1.0%

>5.0%

Serum Screening

Performed? Yes NoX

If yes, report results.

4. Other concerns/additional information. None


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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 APPLICANTTO BE FILLED UP BY THE

ASSESSOR



Contain a newsubstance?

Yes No If yes, identify and give the chemicalstructureX

What is the purpose ofhaving the regulatedarticle produce thisnew substance? Whatis the benefit of thisnew substance?Explain.

Is the new substancefound in the edibleportion of the plant?

Yes No Which part/s of the plant?

Is the new substanceknown as

Nutrient? Yes No If yes, identify then proceed to SectionXa1

Pesticide? Yes No If yes, identify then proceed to SectionXa2

Biologically activecompound?

Yes No If yes, identify then proceed to SectionXa3.

Allergen? Yes No If yes, identify. Explain why thisallergenic substance is safe in theparticular use the regulated article wasintended for.

Toxin? Yes No If yes, identify. Explain why this toxicsubstance is safe in the particular usethe regulated article was intended for.


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

Others?

Identify. Explain whythis new substance issafe in the particularuse the regulated

article was intendedfor.

Any otherconcerns?



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Section Xa1. If new substance is a nutrient



ASSESSOR

Please fill out this form as many as there are new substances Cross Reference ofDocument(s) Submitted


What is the knownbiological function ofthis substance?

Describe the history ofits 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 substanceequivalent in structureto those found in thesefood 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 ineach food where this new substanceoccurs.If no, please indicate whether theamount is lower or higher compared toother food crops. Explain why the level

of the new substance in the regulatedarticle is safe.

How much is theaverage consumptionof the nativesubstance?What is the effect of

prolonged

consumption?


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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 newsubstance alter thelevel or concentrationof other relatedcompound(s)?

Yes No If yes, is there possible adverse effectof this alteration?How is this adverse effect managed?

How do the followingfactors affect thestability of the newsubstance and describethe method ofdetermination:

a) Heat

b) Digestion

c) Processing

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

Is the substance in the

regulated article being

used in foodfortification?

Yes No If yes,a) At what level is it used?

b) How does this level comparewith the level found in theregulatedarticle?

Is this substanceproduced by a newpathway in theregulated article?

Yes No If yes,a) How many new proteins have

been introduced to completethe pathway?


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b) Are these proteins expressedin the edible parts of theregulated article?

If yes,

b)1. At what levels are theypresent?

b)2. Have these expressedproteins been assessed fortoxicity and allergenicity

potential?

Are all the information requiredto answer b)1& b)2 entered inappropriate section of thisdocument?

Any other concerns



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



ASSESSOR


SubmittedRemarks/Recommendations

Describe the followingabout the non-proteinpesticide:

LD50 value, Minimumpesticide residue levelvalues, Target pest

Known adverse effectsto humans/animalsand non-targetorganisms

Concentration/level inthe edible portion ofthe plant

Is this new substancea natural componentof 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


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substance occur in the

regulated article in the

same amount as in

other foods?

each food where this new substanceoccurs.

If no, please indicate whether theamount is lower or higher compared toother food crops. Explain why the levelof the new substance in the regulatedarticle is safe.

How much is theaverage consumptionof the nativesubstance?

What is the effect ofprolongedconsumption?

What is the amount ofthe new substance inthe regulated article?

Is this substanceknown to be toxic orhave adverse healtheffects when ingestedin excess of theaverage consumption?

Yes No

Does the newsubstance alter thelevel or concentrationof other related

compound(s)?

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

How do the followingfactors affect stabilityof the substance anddescribe the methodof determination:

a) Heat

b) Digestion

c) Processing


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

Is this substanceproduced by a newpathway in theregulated article?

Yes No If yes,

a) How many new proteins havebeen introduced to complete thepathway?

b) Are these proteins expressed inthe edible parts of the regulated

article?

If yes,

b)1. At what levels are theypresent?

b).2 Have these expressedproteins been assessed fortoxicity and allergenicitypotential?

Are all the information requiredto answer b)1& b)2 entered inappropriate section of thisdocument?

Any other concerns



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Section Xa3.If new substance is a biologically active compound



ASSESSOR


Submitted


Is this new substance anatural component of otherfoods?

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 substanceoccur in the regulatedarticle in the same amountas in other foods?

Yes No If yes, enumerate the crops andcorresponding values.If no, please indicate whether theamount is lower or higher compared toother food crops.

How much is the averageconsumption of the nativesubstance?

At what concentration does

this compound cause

characteristic bio-chemicalor 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 ofconsumption of theregulated article berecommended for a person


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to achieve the desiredbiological function to thebody?

What is the effect ofprolonged consumption?

Is this substance known tobe toxic or have adversehealth effects wheningested in certainquantities or in overdose?Explain

Yes No

What measures arerecommended to preventoverdosing?How do the followingfactors affect stability of thesubstance and describe themethod of determination:

a) Heat

b) Digestion

c) Processing

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


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Is this substance producedby a new pathway in theregulated article?

Yes No If yes,

a) How many new proteins havebeen introduced to completethe pathway?

b) Are these proteins expressed inthe edible parts of the regulatedarticle?

If yes,

b)1 At what levels arethey present?

b)2 Have these expressedproteins been assessedfor toxicity andallergenicity potential?

Are all the informationrequired to answer b)1& b)2entered in appropriate sectionof this document?

Any other concerns



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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


1. Proximate Analysis(protein fiber, fat, ash, carbohydrates)

Indicate as Grain __X__, Forage_____, or Consumed Portion

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

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

No significant differences among biologicallyimportant parameters.

Yes NoX

If yes, in which parameters? NAComparison with Range of Commercial Varieties

If comparison included a range ofcommercial varieties: How many?

NA

Were these grown under the sameenvironmental conditions?

Yes No

Were the data derived from the test(transgenic) line within the observedrange?

Yes No

If not, which parameters were outside the range? NAComparison with Range of Literature Values

Were the data derived from the test(transgenic) line within the reportedrange?

Yes No PHPI (2003) Risk Analysis Report forGenetically Modified Plant for Direct Use asFood 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 theybiologically relevant? NA

Yes No

If yes, note concern:


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2. Key Nutrients (Supply the information for eachcomponent that significantly contributes to the foodvalue of the crop, e.g. fatty acid composition, proteinquality, vitamins, minerals, etc. Use as many forms asthere are key nutrients derived from the crop.)

Cross Reference of Document(s)Submitted


2a. Key Nutrient 1; Identify: Fatty Acid Composition

Indicate as Grain _X_, Forage_____, or Consumed Portion


Comparison with SE Comparator (i.e., non-modified control, or other principle

comparatorAny significant differences?

Yes No

X

If yes, in which parameters: NA

Comparison with Range of Commercial VarietiesIf comparison included a range ofcommercial varieties: How many?

NA


Yes No


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 reportedrange?


X




Yes No

If yes, note concern: NA


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2. Key Nutrients (Continuation) Cross Reference of Document(s)Submitted


2c. Key Nutrient 3; Identify:Vitamins

Indicate as Grain __X__, Forage_____, or Consumed Portion



Yes No

X


Comparison with Range of Commercial Varieties

If comparison included a range ofcommercial varieties: How many?

NA


Yes No


Yes No


Comparison with Range of Literature Values

Were the data derived from the test(transgenic) line within the reported

range?


X


Biological SignificanceFor any statistical difference, are theybiologically relevant? NA

Yes No



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3. Antinutrients (If there are 2 or more antinutrientsknown, use as many sheets as necessary.)

Cross Reference of Document(s)Submitted


3a. Antinutrient 1; Identify: Phytic Acid PHPI (2003) Risk Analysis Report forGenetically Modified Plant for Direct Use asFood or Feed, or for Processing. PioneerHi-Bred Philippines, Inc. (Section I.3)


Yes No

X


Effect of processing on level ofantinutrients None Increase Lower

Other notes:

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


Yes No


Yes No


Comparison with Range of Literature ValuesWere the data derived from the test(transgenic) line within the reportedrange?

Yes No PHPI (2003) Risk Analysis Report forGenetically Modified Plant for Direct Use asFood or Feed, or for Processing. PioneerHi-Bred Philippines, Inc. (Section I.3)

X


Biological SignificanceFor any statistical difference, are theybiologically relevant? NA

Yes No



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3. Antinutrients (Continuation) Cross Reference of Document(s)Submitted


3b. Antinutrient 2; Identify: Trypsin Inhibitor


Yes No PHPI (2003) Risk Analysis Report forGenetically Modified Plant for Direct Use asFood or Feed, or for Processing. PioneerHi-Bred Philippines, Inc. (Section I.3)

X

If yes, in which parameters:

Effect of processing on level ofantinutrients None Increase Lower

Other notes:Trypsin inhibitor levels in both 1507 and control maize werebelow 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


Yes No


Yes No


Comparison with Range of Literature Values- NAWere the data derived from the test(transgenic) line within the reportedrange? [ranges not available in publishedliterature]

Yes No




Yes No



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XII. THE HOST PLANT ENVIRONMENT




1. Reproduction BiologyIndicate self-pollinatedor cross pollinated

Zea maysis an allogamous plant that propagatesthrough 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 pollenis very promiscuous, lands on any silk, germinatesalmost immediately after pollination, and within 24 hcompletes fertilization. Thus all corns willinterpollinate, except for certain popcorn varietiesand hybrids that have one of the gametophytefactors of the allelic series Ga and ga onchromosome four (Kermicle, 1997 as cited in OECD,2003).

OECD (2003) ConsensusDocument on the Biology ofZea mays subsp. mays(Maize). Organisation for

Economic Co-operation andDevelopment,ENV/JM/MONO(2003)11.

Indicate any pollinators(bees, etc.)

Pollinators were one of the functional guildsmonitored during the conduct of 1507 and1507xMON810xNK603 non-target arthropod (NTA)study. Based on this study, the pollinators of maizeinclude the common syrphid and hover flies: thesyrphid fly, Ischiodon scutellaris; and the hover fly,

Metasyrphussp. Pollinators also include thepalynovores (pollen-feeders) represented by thestingless bee, Tetragonula sapiens which wereabundant in Tampakan, South Cotabato site,especially during the pollen shedding stage. Someother species sighted in the field include anundetermined Anthophoridae (carpenter bee), adultsof rat-tail maggots (Eristalis sp.) and bee flies(Bombyliidae).

Lit Jr. IL, et. al. (2012)Monitoring of Key Non-TargetArthropods in TransgenicMaize Lines Containing EventDAS-157-1 and theCombined Trait Product DAS-157-1xMON-81-6xMON-63-6: 2011Philippines Field Study. PioneerHi-Bred Philippines, Inc., StudyNo. 2011-247.


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Describe possibleformation of viableinterspecific and/orintergeneric hybrids

Cultivated maize is sexually compatible to varyingdegrees with other members of the genus Zeacollectively referred to as teosinte and to a muchlesser extent with members of the genus Tripsacum.

There is a great sexual compatibility between maizeand annual teosinte (Zea mayssubsp. mexicana) andit is known that they produce fertile hybrids (Wilkes,1977 as cited in OECD, 2003). In areas of Mexicoand Guatemala maize and teosinte freely hybridizewhen in proximity of each other. Kermicle and Allen(1990) as cited in OECD (2003) have shown that

maize can introgress to teosinte; however, there isincompatibility between some maize populations andcertain types of teosinte resulting in low fitness ofsome hybrids that prevents a high rate ofintrogression (Evans and Kermicle, 2001 as cited inOECD, 2003). However, Teosinte, the known closerelative, is not known to occur naturally in thePhilippines. Teosinte populations are normallyconfined to the tropical and subtropical regions ofMexico, Guatemala and Nicaragua.

The genus Tripsacumcontains several species, mostof which are native to Mexico, Central and South

America. Though some species may occur wherecorn might be cultivated, successful geneintrogression from corn under natural conditions is

highly unlikely.

OECD (2003) ConsensusDocument on the Biology ofZea mays subsp. mays(Maize). Organisation forEconomic Co-operation andDevelopment,ENV/JM/MONO(2003)11.

USDA-APHIS (2001) Approvalof Mycogen Seeds c/o DowAgroSciences LLC and PioneerHi-Bred International, Inc.,Request (00-136-01p) Seeking

a Determination of Non-regulated Status for Bt Cry1FInsect Resistant, GlufosinateTolerant Corn Line 1507:Environmental Assessment andFinding of No SignificantImpact. United StatesDepartment of Agriculture,Animal and Plant HealthInspection Service.

List any known sexuallycompatible cultivatedspecies in the country

None, annual tesosinte and Tripsacumspecies arenot known to be cultivated in the Philippines.

List any known sexuallycompatible wild speciesin the country

There are no known sexually compatible wildrelatives growing with corn in the Philippines.


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2. Agricultural Practices

Would one expect thewide adoption of thetransgenic plant inagriculture to result inchanged cultivationpractices that could haveadverse environmentalimpact? If yes, describe.

The introduction of biotech maize in the Philippines hasincreased every year since it was first introduced forcultivation in 2003. The area planted to biotech maize in2011 reached 644,000 hectares wherein about 85%have been planted with stacked traits of Bt andherbicide tolerant maize. Consistent with the experienceof other biotech maize growing countries the steadyincrease in adoption reflects the significant andconsistent benefits generated by biotech maize tofarmers in the Philippines such as productivity gains andreduction in pesticide use.

The 1507 maize has been shown under field conditionsin the Philippines to be highly efficacious against Asiancorn borer (Ostrinia furnacalis). Additionally, 1507maize is expected to provided effective protectionagainst common cutworm (Spodoptera litura), cornsemi-looper (Chrysodeixis eriosoma), and blackcutworm (Agrotis ipsilon); and suppression of cornearworm (Helicoverpa armigera). The approval of 1507maize for cultivation would create the opportunity tostack Bttraits and deploy products producing multipleBt proteins active against each target pest within asingle plant as well as broadening the spectrum oflepidopteran pest control.

In order to delay the potential evolution of resistance inthe target pests to BtCry proteins expressed in plants,an Insect Resistance Management (IRM) plan is beingimplemented by developers and as mandated by theBureau of Plant Industry. The IRM plan includesdeployment of non-Bt refuge, farmers education,monitoring for the development of resistance to ACB,and mitigation measures in the event that resistantpopulations are confirmed. 1507 maize can also providea new tool for managing target insects that mightbecome resistant to other insecticides currently used,including potentially other Bt-based insecticides.Cultivation of 1507 maize will also follow appropriateIRM regimes.

Samson JA, et.al. (2012) FieldVerification of the AgronomicPerformance of TransgenicMaize (Zea maysL.) Line DAS-157-1 and Hybrid Stacked(DAS-157-1xMON-81-6xMON-63-6) Expressingthe Bacillus thuringiensisProteins for Efficacy AgainstAsian Corn Borer and theProteins PAT and CP4-EPSPSfor 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 HybridStacked Product DAS-157-1xMON-81-6xMON-63-6 against SecondaryLepidopteran Insect Pests ofCorn - 2012 Philippines FieldStudy. Pioneer Hi-BredPhilippines, Inc., Study No.PHI-2012-181.

James, C. 2011. Global Statusof 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
http://www.isaaa.org/http://www.isaaa.org/http://www.isaaa.org/http://www.isaaa.org/


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Are there anyanticipated changes inhabitat or geographicdistribution? If yes,describe.

No changes in habitat or geographic distribution areanticipated with the introduction of 1507 maize. Btmaize and its stack trait with herbicide tolerant maize(e.g. glyphosate tolerant maize) are widely cultivatedin the Philippines. 1507 maize is expected to replaceor complement (by further stacking) existing insectand weed control technologies in maize.

3. Pests and Diseases

Has the geneticmodification resulted inan altered reaction to

pests and/or diseases? Ifyes, describe.

The phenotypic, agronomic and ecological interactionassessments indicate that 1507 maize is comparableto conventional maize and is unlikely to have an

increased plant pest risk. The response of 1507maize to economically important diseases of maize inthe Philippines was evaluated and compared to non-transgenic maize in six agricultural environments.The tolerance of 1507 maize to different diseaseswas generally similar to the non-transgenic maizeunder the conditions of the multi-location tests.

Several diseases which are known to be predisposedby insect feeding, such as bacterial and Fusariumstalk and ear rots, had lower incidence in 1507 maizecompared to non-Bt control maize in some trial sites.

1507 maize, genetically modified to express theCry1F protein, is expected to control populations ofcertain target lepidopteran insect pests. Non-

lepidopteran insect pests are not expected to beaffected by plant-expressed Btprotein in 1507 maize.

Samson JA, et.al. (2012) FieldVerification of the AgronomicPerformance of Transgenic

Maize (Zea maysL.) Line DAS-157-1 and Hybrid Stacked(DAS-157-1xMON-81-6xMON-63-6) Expressingthe Bacillus thuringiensisProteins for Efficacy AgainstAsian Corn Borer and theProteins PAT and CP4-EPSPSfor Tolerance to Glufosinateand Glyphosate Herbicides.Pioneer Hi-Bred Philippines,Inc., Study No. PHI-2011-246.


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List common associatedpests and diseases tothe crop.

The common diseases and insect pests associatedwith 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. Fusariumstalk rot (Fusarium moniliforme)11. Phythiumstalk rot (Phythium aphanidermatum)12. Bacterial ear rot (Erwinia chrysanthemi pv. zeae)13. Fusariumear rot (Fusarium moniliforme)14. Diplodiaear rot (Stenocarpella maydis)15. Giberellaear 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) FieldVerification of the AgronomicPerformance of TransgenicMaize (Zea maysL.) Line DAS-157-1 and Hybrid Stacked(DAS-157-1xMON-81-6xMON-63-6) Expressingthe Bacillus thuringiensisProteins for Efficacy AgainstAsian Corn Borer and theProteins PAT and CP4-EPSPSfor Tolerance to Glufosinateand 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 StackedProduct DAS-157-1xMON-81-6xMON-63-6 againsSecondary Lepidopteran InsectPests of Corn - 2012 PhilippinesField Study. Pioneer Hi-BredPhilippines, Inc., Study No. PHI-2012-181.

4. Any other concerns/other information. None.


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XIII. CONSEQUENCES OF OUTCROSSING




1. Out-crossing to related varietiesDescribe the possibleenvironmentalconsequences ofintrogression of theintroduced trait intorelated crop species

Since 1507 maize does not exhibit characteristics thatcauses it to be more competitive or weedy than othercultivated corn, the potential impact of gene introgressionto related varieties is not expected to be greatly differentfrom that of other varieties of cultivated maize bred forincreased resistance to lepidopteran pests or for herbicidetolerance.

USDA-APHIS (2001) Approvalof Mycogen Seeds c/o DowAgroSciences LLC and PioneerHi-Bred International, Inc.,Request (00-136-01p) Seeking

a Determination of Non-regulated Status for Bt Cry1FInsect Resistant, GlufosinateTolerant Corn Line 1507:Environmental Assessment andFinding of No SignificantImpact. United StatesDepartment of Agriculture,Animal and Plant HealthInspection Service.


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2. Out-crossing to wild (or weedy) speciesDescribe the possibleenvironmentalconsequences ofintrogression of theintroduced trait into relatedwild species. Indicate ifthere is any selectionadvantage that can beconferred by this trait to awild species.

The potential for 1507 maize outcrossing to sexuallycompatible species is unlikely in the Philippines. Althoughcorn and annual teosinte are genetically compatible, windpollinated and freely hybridize when in close proximity toeach other, teosinte is not present in the Philippines,except perhaps as an occasional botanical specimen.Differences in flowering time, geographic separation anddevelopment factors makes natural crosses unlikely. Incontrast with teosinte, special techniques are required tohybridize maize and Tripsacum. Maize-Tripsacumhybridshave not been observed under natural conditions.

It is also unlikely that the potential introgression of insectresistance or glufosinate traits from 1507 maize wouldcause wild relative species to become more weedy in theabsence of glufosinate herbicide selection. The unlikelyintrogression of the glufosinate herbicide tolerance traitfrom 1507 maize would not be expected to provide aselective advantage to these populations since theywould not be routinely subjected to herbicide treatments.

Therefore, the environmental consequence of pollentransfer from 1507 maize to other wild or weedy speciesis negligible.

USDA-APHIS (2001) Approvalof Mycogen Seeds c/o DowAgroSciences LLC and PioneerHi-Bred International, Inc.,Request (00-136-01p) Seekinga Determination of Non-regulated Status for Bt Cry1FInsect Resistant, GlufosinateTolerant Corn Line 1507:Environmental Assessment andFinding of No SignificantImpact. United States

Department of Agriculture,Animal and Plant HealthInspection Service.

3. Risk mitigation measures

Are there any measures that would

mitigate risks arising from out-crossing?

Not applicable



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XIV. WEEDINESS POTENTIAL




1. DisseminationDescribe known modes ofdissemination of the crop (seed,rhizomes, etc.).

Maize has lost the ability to survive in thewild due to its long process ofdomestication, and needs humanintervention to disseminate its seed. Maizecannot persist as a weed. Volunteers arecommon in many agronomic systems, butthey are easily controlled; however, maizeis incapable of sustained reproductionoutside of domestic cultivation. Maizeplants are non-invasive in natural habitats(Gould, 1968 as cited in OECD, 2003). Incontrast to weedy plants, maize has apistillate inflorescence (ear) with a cobenclosed with husks. Consequently seeddispersal of individual kernels does notoccur naturally.

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

2. Seed dormancy

Was seed dormancy/survival undernormal condition assessed?

Yes NoX

Were there any changes in seed

dormancy? If yes, describe them:

Yes No


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3. Seed germination/ survival

Was seed germination/survivalassessed?

Yes No Samson JA, et.al. (2012) FieldVerification of the AgronomicPerformance of Transgenic Maize (ZeamaysL.) Line DAS-157-1 andHybrid Stacked (DAS-157-1xMON-81-6xMON-63-6) Expressingthe Bacillus thuringiensisProteins forEfficacy Against Asian Corn Borer andthe Proteins PAT and CP4-EPSPS forTolerance to Glufosinate andGlyphosate Herbicides. Pioneer Hi-BredPhilippines, Inc., Study No. PHI-2011-

246.

X

Were there any changes in seedgermination/survival? If yes,describe them:

Yes No

X

4. Time to maturity

Was time to maturity assessed? If yes, describehow:

Silk and pollen shed dates of 1507 and controlmaize was evaluated. Harvest moisture was alsomeasured.

Yes No Samson JA, et.al. (2012) FieldVerification of the AgronomicPerformance of Transgenic Maize (ZeamaysL.) Line DAS-157-1 andHybrid Stacked (DAS-157-1xMON-81-6xMON-63-6) Expressingthe Bacillus thuringiensisProteins forEfficacy Against Asian Corn Borer andthe Proteins PAT and CP4-EPSPS forTolerance to Glufosinate andGlyphosate Herbicides. Pioneer Hi-BredPhilippines, Inc., Study No. PHI-2011-246.

X

Were there any changes in time to maturity? Ifyes, describe:

Yes NoX

5. Describe any changes in other agronomic characteristics (e.g. tolerance toabiotic stresses, or diseases, or competitiveness) that would increase the plant'spotential to become a weed.

Data collected from six field test sites in two cropping seasons demonstrate thatagro-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 risksassociated with cultivation of 1507 maize in the Philippines is very low.


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XV. SECONDARY AND NON-TARGET EFFECTS

TO BE FILLED UP BY THE APPLICANT TO BE FILLED UPBY THE ASSESSOR

Cross Referenceof Document(s)

Submitted


Laboratory Studies(Fill out for each combination of novel protein and sentinel/indicator species tested.)

Novel ProteinIdentify:

Cry1F

a. TestedSentinel/Indicator Species1:

Collembola(Folsomia candida)

Assay Description Study Results: BiologicalSignificance &/or

Other Observations

A 28-day study wasconducted to determinechronic effects ofpurified Cry1F proteinon survival andreproduction ofCollembola. Threetreatment levels wereassessed: 0.63, 3.1 and12.5 mg/kg of test diet

LC50:>12.5mg/kgsoil

Other:worst-caseexposure estimate inplant material is0.350 mg Cry1F/kgwhole plant material;worst-case exposureestimate in soil is0.063 mg Cry1F/kgdry soil

Collembola were notaffected by chronicexposure to Cry1F atthe treatment levels.Treatments used instudy exceededworst caseestimates, indicatingthat the risk tospringtails underfield conditions isnegligible.

Anderson J (2012)Environmental RiskAssessment for theCultivation of DAS-157-1 Maize in thePhilippines. PioneerHi-Bred International,Inc, Study No. PHI-2012-313.

b. TestedSentinel/Indicator Species

2:

Earthworm(Eisenia fetida)


Other Observations

A 14-day test wasconducted to determinethe effects of Cry1Fprotein on survival andof earthworm.

LC50:>2.5mgCry1F/kg dry soil

Other:testedconcentration is148X the worst-caseexposure estimate(incorporating 61,775senescent 1507plants in top 15 cm ofsoil)

No mortality wasobserved at testedconcentration overthe 14-day studyindicating thatearthworms are atnegligible risks tothe environment.



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Cry1F

e. TestedSentinel/Indicator Species5:

Ladybird Beetle(Hippodamiaconvergens)


Other Observations

A 29-day limit test wasconducted to determinethe dietary toxicity ofCry1F protein toladybird beetle.Hippodamia convergenswere fed an artificialhoney diet containing480 ppm Cry1F protein.

LD50:>480 gCry1F/g diet

Other:testedconcentration is 15Xthe concentration ofCry1F in 1507 maizepollen

No increasedmortality ortreatment-relatedeffects wereobserved at testedconcentration.


f. TestedSentinel/Indicator Species6:

Honeybee (Apismellifera)


Other Observations

A 6-day study wasconducted to determinethe dietary toxicity ofCry1F protein on larvalhoneybee development.Apis mellifera were feda diet containing: a)isoline pollen, b) pollenexpressing 32 ng/mgCry1F protein, c) isolinepollen plus potassiumarsenate as positivecontrol, and d) anartificial sucrose

solution containingCry1F protein (640 ngCry1F/larvae).

LD50:>640 ngCry1F/larvae

Other:testedconcentration is 10Xfield exposure (eitherin form of pollen orpurified protein)

No effects on larvalsurvival wereobserved inhoneybees fed Cry1Fprotein equivalent toa 10X fieldexposure.



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Cry1F

g. TestedSentinel/Indicator Species7:

Water Flea(Daphnia magna)


Other Observations

A 48-hour staticrenewal acute toxicitystudy was conducted todetermine the toxicity ofCry1F protein toneonate cladoceran.Daphnia magnawereexposed to 100 mgCry1F protein/ L water

or 100 mg pollen(expressing 32 ng/mgCry1F protein)/L water.

EC50:>100 mgCry1F pollen/L

No mortality ortreatment-relatedeffects wereobserved at the 100mg Cry1F pollentreatment. The EC50for D. magnaexceeds the worst-case environmental

exposure estimateby several ordermagnitudes,indicating that Cry1Fprotein poses nohazards to Daphniaat environmentallyrelevantconcentrations.



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Submitted


Field Studies(Fill out for each species observed.)

1. Arthropodspecies 1studied/observed;Identify:

Herbivores

Site Information SamplingProtocol

Results BiologicalSignificance/Other

Observations

1. Number ofsites: 2

Sweep netsampling;ocularinspection;sticky traps

wet season trials:

Abundance of herbivores,including chewing andsucking insects, did notdiffer significantlybetween 1507 and non-transgenic control maize.

dry season trials:The numbers of non-target herbivores did notdiffer significantlybetween 1507 andcontrol maize in bothsites and throughout themaize growth stagesexcept at flowering stage(55 DAP) whereinsecticide treated

control maize hadsignificantly lowernumber of herbivorescompared to 1507 maize.

The sucking herbivores

observed were the cornleaf aphid, Rhopalosiphummaidis; several cornleafhoppers: Dalbulussp.,Nephotettixspp., Nezaraviridula; corn planthoppers,Peregrinus maidisandStenocranus pacificus;andthe less common mothhopper, Ricaniasp.

Non-target chewingherbivores identified wereflea beetle, Phyllotretasp.;(Figure 27.B); squashbeetle; silk beetle; flowerbeetle; June beetle; hornedcoreid bug, Cletus trigonus;

rice bug, Leptocorisaoratorius; and apachyrrhynchid weevil,Metapocyrtus sp.

Lit Jr. IL, et. al.

(2012) Monitoring ofKey Non-TargetArthropods inTransgenic MaizeLines ContainingEvent DAS-157-1and the CombinedTrait Product DAS-157-1xMON-81-6xMON-63-6: 2011Philippines FieldStudy. Pioneer Hi-Bred Philippines, Inc.,Study No. 2011-247.

2. Locations:

Cauyan,Isabela (CA)

Tampakan,South Cotabato(TA)

3. Number ofYears:

2011-2012 wetand dry croppingseasons

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


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Submitted




Predators


Results Biological Significance/Other Observations


Sweep netsampling;ocularinspection;sticky traps;pitfalltrapping;proteinbaiting

wet season trials:

The number ofpredators did not differsignificantly between1507 and control maizethrough all growthstages except during 20and 40 DAP in CA. InCA site, there weremore predators in non-Bt plots at 20 DAP whileat 40 DAP predatorswere more abundant in1507 maize vs. controlmaize.

NTA species observed: Coccinellids or ladybird

beetles: Micraspis discolorand Chilomenessexmaculata

Predatory tiny blackbeetle, Phalacrussp.;orange lady beetle,Chilomenes sexmaculata;rove beetles; tiger beetle;net-winged beetle; hispineblack beetle; earwigs

Mirid bugs, Cyrtorhinuslividipennis; bigeyed bug,Geocorissp.; damsel and

Lit Jr. IL, et. al.

(2012) Monitoring ofKey Non-TargetArthropods inTransgenic MaizeLines ContainingEvent DAS-157-1and the CombinedTrait Product DAS-157-1xMON-81-6xMON-63-6: 2011Philippines FieldStudy. Pioneer Hi-Bred Philippines, Inc.,

2. Locations:

Cauyan,Isabela (CA)



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3. Number ofYears:

2011-2012 wetand dry croppingseasons

dry season trial:1507 and control maizedid not significantlydiffer in terms ofabundance of predatorsin both sites and in allsampling periods. Theinsecticide treatedcontrol maize hadnumerically lowernumber of predatorsthan other treatmentsduring the vegetative

stages in CA and at thevegetative andflowering stages in TA.

pentatomid bug. Predatory black cricket,

Metioche vittaticollisandthe long-legged flies.

Lacewings, Micromusigorotusand Malladabasalis

Syrphid fly, Ischiodonscutellaris

Dragonflies anddamselflies, Pseudagrionsp.; the slender skimmer,Orthetrum Sabina; and

common ground skimmer,Diplacodes trivialis.

Spiders: Lynx spiders;Lycosids, Pardosapseudoannulata; derbyspider, Neoscona spp;corn spider, Argiope sp.;and other spidersbelonging to at least sixfamilies.

Ants: Solenopsis geminateand Pheidologetondiversus

Study No. 2011-247.



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Submitted




Pollinators


Results BiologicalSignificance/Other

Observations


Sweep netsampling;ocularinspection;sticky traps

wet season trials:Pollinators were

generally not abundantduring the wet season.The numbers ofpollinators observed in1507 maize did not differsignificantly with thecontrol maize.

dry season trials:Results for pollinators didnot present clear trendsas to treatment effects.However, duringflowering stage in CA,there were no significantdifferences in abundanceamong treatments whilein TA, 1507 and non-

treated control maizehad higher number ofpollinators vs.insecticide-treatedcontrol maize.

Pollinators observed intrials include the syrphid

fly, Ischiodon scutellaris;and the hover fly,Metasyrphussp. Pollinatorsalso include thepalynovores (pollen-feeders) represented bythe stingless bee,Tetragonula sapienswhichwere abundant in TA,especially during the pollenshedding stage. Somespecies sighted in the fieldinclude an Anthophoridae(carpenter bee), adults ofrat-tail maggots (Eristalissp.) and bee flies(Bombyliidae).

Lit Jr. IL, et. al.(2012) Monitoring of

Key Non-TargetArthropods inTransgenic MaizeLines ContainingEvent DAS-157-1and the CombinedTrait Product DAS-157-1xMON-81-6xMON-63-6: 2011Philippines FieldStudy. Pioneer Hi-Bred Philippines, Inc.,Study No. 2011-247.

2. Locations:

Cauyan,Isabela (CA)


3. Number ofYears:

2011-2012 wet

and dry croppingseasons



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To be answered by the Assessor

Given the above risk assessment, summarize below the possible risks (if any) due to thetransgenic 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 ofPlant 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 safeas its conventional counterpart and is not expected to pose any significant risk tohuman and animal health.

Find sufficient evidence that the regulated article applied for propagation will not poseany significant risk to the environment as its conventional counterpart and that anyrisks 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 tovalidate the claims of the applicant that the regulated article applied for is safe for:

_____ food, _____ feed, ______ environment.

(3) 1507 PHL Propagation RAR-26June2013

Documents

Transcript of (3) 1507 PHL Propagation RAR-26June2013