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Risk Assessment generated by a regulatory process
(RA)
published: 11 Mar 2023
last updated: 25 Mar 2025
Determination for the Safety Assessment of CORN BT11 x MIR162 x MON89034 x GA21 for Commercial Propagation
EN
29 Nov 2018
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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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SYN-BTØ11-1 × SYN-IR162-4 × MON-89Ø34-3 × MON-ØØØ21-9 - Maize modified for insect resistance and herbicide tolerance| Monsanto, Syngenta Seeds GmbH | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate), Selectable marker genes and reporter genes
- DA-BPI Biotechnology Office [ English ]
Likelihood of interaction among the single events; potential of the combination to give rise to food and feed safety concerns
The proteins (Cry1Ab, PAT, Vip3Aa20, PMI, Cry1A.105, Cry2Ab2 and mEPSPS) show no homology to any known mammalian allergen or toxin. There is no evidence suggesting that the seven (7) proteins will interact to form some new allergens or toxin since each has a distinct mode of action and are not likely to interact.
Potential interactions may result to changes in protein expression levels. Upon review of data presented, the concentrations of Cry1Ab, PAT, Vip3Aa20, PMI, Cry1A.105, Cry2Ab2 and mEPSPS in tissues of the Bt11 x MIR162 x MON 89034 x GA21 corn hybrid were similar to those of the corresponding single-event corn hybrids namely: Bt11, MIR162 MON 89034 and GA21.
For Bt 11, the cry1AB and par gene expression are both driven by the 35S promoter, no cellular localization sequences are present, so the cytoplasm is the location for accumulation.
For MIR162, the vip3Aa20 and pmi gene expressions are both driven by ZmUbilnt promoter; no cellular localization sequences are present, so the cytoplasm is the location for accumulation.
For MON 89034, the Cry1A.105 protein is likely to accumulate in the cytoplasm of corn cells while the Cry2Ab2 protein is expected to accumulate in the chloroplasts of corn cells. This is because the gene construct encoding the Bt protein, Cry1A.105, does not include a sequence for targeting its transport to a specific sub-cellular location like organelle and would thus accumulate in the cytoplasm of corn cells. The Cry2Ab2 protein is targeted to the plastids by the addition of a chloroplast transit peptide (CTP).
The modified EPSPS enzyme,whether modified (as in GA21) or otherwise, is known to be directed in the chloroplast using the CTP. This transit peptide is cleaved off of the protein when it is imported into the chloroplast. When isolated from the plant, only the cleaved version of the protein can be found indicating that all of the protein is immediately imported into the chloroplast upon synthesis.
The molecular data established that the stacked events in the stacked maize have retained their integrity. Protein expression analyses show that the levels of the newly expressed proteins are similar in the stacked corn and the single events.
The incorporation of gene stacked event through conventional breeding is regarded as innocuous for its long history of safe use. Furthermore, the method of crossing individual transgenic parents is similar with that of non-transgenic parents. This method does not introduce any greater variation in the genome beyond what is obtained
The agricultural management for CORN BT11 x MIR162 x MON89034 x GA21 is essentially the same as its conventional counterpart, except for its built-in resistance against certain lepidopteran insect pests and glyphosate and glufosinate tolerances. Except for these intended changes, planting of Bt11 x MIR162 x MON 89034 x GA21 corn would not change the cultural management practices in corn that could affect adversely the environment.
Event-specific method using real-time PCR
Yes
Yes
Yes
Yes
Yes
The individual events of the gene stacked Corn Bt11 x MIR162 x MON89034 x GA21 have biosafety permits for commercial propagation, which were previously issued. Therefore, each event has undergone rigorous safety assessment, and is considered safe to the environment, biodiversity, and non-target organisms. Similarly, it is less likely to pose any significant adverse effect on the environment
