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Risk Assessment
Record information and status
Record ID
115891
Status
Published
Date of creation
2021-02-18 06:50 UTC (lorelieu5@gmail.com)
Date of publication
2021-02-18 06:50 UTC (lorelieu5@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination for the Safety Assessment of CORN BT11 x MIR162 x MON89034 x GA21 for Propagation
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
SYN-BTØ11-1 x SYN-IR162-4 x MON-89Ø34-3 x MON-ØØØ21-9 - Maize modified for insect resistance and herbicide tolerance
Mannose tolerance Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths) Resistance to herbicides - Glufosinate, Glyphosate Selectable marker genes and reporter genes
Show detection method(s)
Scope of the risk assessment
  • LMOs for Propagation
Methodology and points to consider
Potential adverse effects identified in the risk assessment
No interaction of the resulting products such that a new allergen or a new toxin could be produced. 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.
Likelihood that the potential adverse effects will be realized
No interaction of the resulting products such that a new allergen or a new toxin could be produced. 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 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.

Gene products will not accumulate in the same or different subcellular compartments of the plant parts.
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-cellularlocation 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.
Possible consequences:
The protein expression in single events is similar to that in the stack product implying that there have been no detectable unexpected effects on the corn plant's metabolism. 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. This shows that the proteins mentioned are expressed and they are functioning properly in the stacked trait corn as in the corresponding single-event corn hybrids.
Estimation of the overall risk
Combined trait product corn Bt11 x MIR162 x MON89034 x GA21 applied for commercial propagation is as safe for human and animal health, and the environment as its conventional counterpart. 

Recommendation(s)
Corn Bt11 x MIR162 x MON89034 x GA21 applied for commercial propagation has no evidence of interaction on the resulting gene products. It is considered substantially equivalent to its conventional counterpart for its history of safe use as food in twelve countries namely Argentina, Brazil, Colombia, European Union, Japan, Mexico, Paraguay, Philippines, South Africa, South Korea, Taiwan, and Uruguay and as feed in nine countries namely Argentina, Brazil, Colombia, European Union, Japan, Paraguay, Philippines, South Africa, and South Korea. It has also been previously approved for commercial propagation in six countries namely Argentina, Brazil, Canada, Japan, Paraguay and Uruguay.

Further, 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.

A biosafety permit for propagation can be issued for the said event.
Need(s) for further information on specific issues of concern
The agricultural management for the corn hybrid is essentially the same as its conventional counterpart, except for its built-in resistance against certain lepidopteran insect pests and glyphosate and glufosinate tolerances. Therefore, 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.
Receiving environment(s) considered
The application of Bt11 x MIR162 x MON 89034 x GA21 corn is for propagation. This LMO will not be used for food, feed or 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
Bt11 x MIR162 x MON 89034 x GA21 corn is intended for propagation.

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.