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Risk Assessment generated by a regulatory process
(RA)
last updated: 05 Apr 2025
Determination for the Safety Assessment of Corn Bt11 × MIR162 for Direct Use as Food and Feed, or for Processing
EN
Date not available
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Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: (02) 8928-8741 to 64 local 2118, 2214, 2215, 2240,Fax:Website: http://www.da.gov.ph,
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Organization:Bureau of Plant Industry (BPI)San Andres, MalateManila, Metro Manila
1004, PhilippinesPhone: 8524-9588 local 230,Fax:Email: bpibiotech@buplant.da.gov.ph,Website: https://biotech.buplant.da.com.ph/,
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SYN-BTØ11-1 × SYN-IR162-4 - Insect Resistant Maize| Syngenta Seeds GmbH | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate), Selectable marker genes and reporter genes
The single corn events of Bt11 and MIR162 have been previously approved and granted biosafety permits. As such, the risk assessment focused on the possibility of gene interactions between the novel proteins expressed in the stacked corn line Bt11 × MIR162. The Scientific and Technical Review Panel (STRP), the Bureau of Plant Industry Plant Products Safety Services Division (BPI-PPSSD), the Bureau of Animal Industry (BAI), the Department of Environment and Natural Resources Biosafety Committee (DENR-BC), and the Department of Health Biosafety Committee (DOST-BC)- concurred that (1) Corn Bt11 × MIR162 is as safe for human food and animal feed as its conventional counterpart and (2) will not pose any significant risk to health and the environment.
The stacking of corn transformation events Bt11 and MIR162 may cause unintended interaction(s) and bring about new allergens or toxins.
The likelihood of potential adverse effects being realized is dependent upon the modes of action of the novel proteins expressed in Corn Bt11 × MIR162. These proteins— Cry1Ab, PAT, Vip3Aa20, and PMI— are not involved in similar metabolic pathways. In fact, Cry1Ab and Vip3Aa20 have no enzymatic activities and are not involved in any metabolic pathway in the corn plant. PAT and PMI, on the other hand, are involved in distinct biochemical processes.
The levels of expression of the novel proteins in Corn Bt11 × MIR162 were similar with that of the single-event corn lines, based on enzyme-linked immunosorbent assay (ELISA) results. The assessors concurred that no possible interaction between the novel proteins could affect the stability and expression level of each gene.
Considering that the novel proteins Cry1Ab, PAT, Vip3Aa20, and PMI have no possible interaction within the corn plan, the assessors concluded that the unintended effects of stacking the transformation events Bt11 and MIR162 through conventional breeding is negligible.
The assessors have recommended for the approval and issuance of a biosafety permit for the direct use as food and feed, or for processing of Corn Bt11 × MIR1628.
EN
Corn is a highly domesticated crop that is unable to persist unattended and in unmanaged settings. As such, the chances of the unintended release of the regulated article is improbable.
Event-specific real-time qPCR
Yes
Yes
Yes
Yes
Yes
EN
