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Risk Assessment
Record information and status
Record ID
115896
Status
Published
Date of creation
2021-02-19 06:50 UTC (lorelieu5@gmail.com)
Date of publication
2021-02-19 06:50 UTC (lorelieu5@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination for the Safety Assessment of Product Corn MON 87411 for Direct Use as Food, Feed and for Processing
Date of the risk assessment
Date not available
Competent National Authority(ies) 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
Risk assessment details
Living modified organism
MON-87411-9 - Maize modified for herbicide tolerance and insect resistance
Monsanto Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera) Resistance to herbicides - Glyphosate
Scope of the risk assessment
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Methodology and points to consider
Potential adverse effects identified in the risk assessment
Corn is a source of energy due to its high carbohydrate and oil contents. The host organism provides essential and non-essential amino acids needed by swine, poultry and cattle. As the world's third leading cereal crop corn and its products are used as food, feed, oil, grits, meal, syrup and starch among others. It also contains antinutrients such as trypsin inhibitor, phytic acid, cerullic acid and raffinose. The crop is not known to be a source of toxicants and allergens.
Likelihood that the potential adverse effects will be realized
The two novel proteins are independently expressed and their functional activities maintained. They are expressed in different organelles with Cry3Bb1 expected to accumulate in the cytoplasm while the CP4 EPSPS protein is expected to be expressed in the chloroplast, as directed by a transit peptide. The two proteins are not expected to interact in a metabolic pathway.
Possible consequences:
Expression levels of Cry3b1 and CP4 EPSPS were determined in several plant parts and was validated by ELISA. Cry3Bb1 protein is not an enzyme and does not affect the metabolism of the plant while CP4 EPSPS protein. 
Estimation of the overall risk
Enough evidences indicated the substantial equivalence of the genetically modified crop in terms of nutritional composition and food safety with the conventional corn, other than the resistance against corn rootworm (CRW) (Diabrotica spp.) and tolerance to glyphosate herbicides.
Recommendation(s)
After a thorough scientific review and evaluation of documents, it was concluded that Corn MON87411 will not pose any significant risk to the health and environment and that any hazards could be managed by the measures set by the department. A biosafety permit can be issued to applicant for the said event.
Need(s) for further information on specific issues of concern
Corn MON 87411 is found to be as safe as its conventional counterpart and does not pose any significant risk to human and animal health.
Receiving environment(s) considered
Corn MON 87411 is not for propagation. This LMO will be directly used for food, feed and for processing
LMO detection and identification methods proposed
Diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR methods may be used.
Additional Information
Additional Information
Corn MON 87411 is intended for direct use as food, feed and for processing.

All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of this combined trait product.