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Risk Assessment
Record information and status
Record ID
111736
Status
Published
Date of creation
2017-03-01 01:52 UTC (estaciojulietafe@gmail.com)
Date of publication
2017-03-01 01:52 UTC (estaciojulietafe@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination of Safety of Monsanto's Stacked Trait Product Corn: MON89034 x NK603 for Commercial Propagation
Date of the risk assessment
2016-09-30
Institution responsible for the risk assessment
Department of Agriculture
Elliptical Road, Diliman
Quezon City
Philippines, 1100
Phone:+632 920-3986,+632 924-1278 local 2802
Fax:+632 920-3986
Email:osec.da@gmail.com
Url:DA
Department of Health
San Lazaro Compound, Sta. Cruz
Manila
Philippines
Phone:+632 651 7801; +623 651 7800
Fax:+632 743 1829
Email:etona@co.doh.gov.ph
Url:DOH Website
Department of Environment and Natural Resources
Visayas Avenue
Quezon City
Philippines, 1100
Phone:+632 925-2329, +632 920-4352
Fax:+632 920-4301
Email:osec@denr.gov.ph
Url:DENR,PAWB
Contact details of the main responsible risk assessor
Ms. Ma. Lorelei U. Agbagala
Supervising Agriculturist
Post Entry Quarantine
Bureau of Plant Industry (BPI)
Economic Garden
Los Banos, Laguna
Philippines, 4030
Phone:+63 49 536 1678
Fax:+63 49 536 1678
Email:lorelieu5@gmail.com
Url:Bureau of Plant Industry
Mr. Ariel J. Bayot
Officer-In-Charge Chief
National Plant Quarantine Services Division
Bureau of Plant Industry (BPI)
San Andres
Malate, Manila
Philippines
Phone:+63 2 404-0409
Fax:+63 2 404-0409
Email:ajbayot@yahoo.com
Risk assessment details
Living modified organism
MON-89Ø34-3 x MON-ØØ6Ø3-6 - Genuity® VT Double Pro™ Maize
Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glyphosate
Show detection method(s)
Scope of the risk assessment
  • Environmental Assessment
  • Socio-Economic, Ethical and Cultural Considerations
Risk assessment report / Summary
Methodology and points to consider
Likelihood that the potential adverse effects will be realized
The Cry proteins and EPSPS belong to very different classes of proteins. As such they have varying structures, functions, belong to different metabolic pathways, and have dissimilar modes of action. They can then be considered to be independent of each other. The genes have been found to be completely expressed and the proteins functional in MON89304 x NK603. Having the genes encoding for these different proteins and having the proteins fully functional in the same plant did not cause any adverse effect on the metabolism of the plant.  Furthermore, the Cry proteins and the CP4 EPSPS are structurally and functionally independent of each other. Any likely possible interaction between them may be considered to be insignificant and will not affect the stability and expression level of either one of the genes.
Possible consequences:
Few anti-nutrients have been established to occur in corn, which has no relevance to its food use. Though trypsin inhibitor, phytic acid, and secondary metabolites such as raffinose, ferulic acid and p-coumaric acid have been established as anti-nutrients in corn, they are present in very low amount and are below the thresholds considered to raise a food safety concern. The amount of anti-nutrients present in MON89034 and NK603 fell within the range found in non-transgenic corn.
Estimation of the overall risk
Stacked Trait Corn MON89034 x NK603 is found substantially equivalent to its conventional counterpart and does not pose any significant risks to animal, human health and the environment.
Recommendation(s)
After reviewing the scientific data and information relevant to the combined traits product Corn MON89034 x NK603 application of Monsanto Philippines Inc., it is concluded that no interaction was found between/among the combined traits as well as serious socio-economic, ethical and cultural issues. Hence, this plant product was found to be as safe as the conventional corn and can substitute for its traditional counterpart for commercial propagation, and is therefore approved for commercial propagation.  Monsanto is hereby notified that it may proceed with the activities for the above propagation following all existing rules and regulations consistent with JDC No.1 Series of 2016.
Need(s) for further information on specific issues of concern
Stacked Trait Corn MON89034 x NK603 is found substantially equivalent to its conventional counterpart and does not pose any significant risk to animal, human health and the environment.
Receiving environment(s) considered
This application is for commercial propagation of the MON89034 x NK603. This LMO is likewise evaluated for its safety for food, feed or for processing.
LMO detection and identification methods proposed
Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes.  For higher sensitivity, real-time PCR may be used.
Additional Information
Additional Information
Corn MON89034 x NK603 is intended for commercial propagation.

All information and relevant references in support of their application were submitted by the technology developer to  the Scientific and Technical Review Panel (STRP) members,  the DA, DOH and DENR  for use during the the evaluation of this event.
Other relevant website address or attached documents