Philippines | BCH-RA-PH-115896 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)

last updated: 19 Feb 2021
General Information
Determination for the Safety Assessment of Product Corn MON 87411 for Direct Use as Food, Feed and for Processing
Risk assessment details
  • 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), Northern corn rootworm (Diabrotica barberi)), Resistance to herbicides (Glyphosate)
Methodology and points to consider
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.
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.
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. 
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.
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.
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.
Corn MON 87411 is not for propagation. This LMO will be directly used for food, feed and for processing
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
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.
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