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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 MIR604 x TC1507 x 5307 x GA21 for Direct Use as Food, Feed and for Processing
EN
01 Dec 2016
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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 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 - Agrisure® Duracade™ 5222| Syngenta Seeds GmbH | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate)
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SYN-Ø53Ø7-1 - Agrisure® Duracade™ Maize| Syngenta Seeds GmbH | Resistance to diseases and pests (Insects, Coleoptera (beetles), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi))
- DA-BPI Biotechnology Office [ English ]
Interaction of the proteins involved in the combined trait product
Cry1Ab, Vip3Aa20, mCry3A, Cry1F, eCry3.1Ab, mEPSPS, PAT and PMI, are highly unlikely to produce any known allergen or toxins to human and animals because of the difference on their mode of action. There is no known mechanism of interaction among the RNA-based suppression and the proteins that could lead to adverse effects in human, animals or environment.
The Bt11 x MIR162 x MIR604 x TC1507 x 5307 x GA21 (SYN-BTØ11-1 x SYN-IR162-4 x SYN-IR6Ø4-5 x DAS-Ø15Ø7-1 x SYN-Ø53Ø7-1 x MON-ØØØ21-9) stacked maize event was produced by conventional breeding of Bt11, MIR162, MIR604, TC1507, 5307 and GA21 single events. The stacked maize event provides herbicide tolerance and insect resistance. All the 6 single parent events have been previously approved in the Philippines for food, feed and processing uses. Molecular analyses showed that the integrity of the transgenic inserts from each single event was preserved during the conventional breeding to produce the stacked maize event. The trait proteins - Bt11 (Cry1Ab, PAT), MIR162 (Vip3Aa20; PMI), MIR604 (mCry3A, PMI), TC1507 (Cry1F, PAT), 5307 (eCry3.1Ab, PMI) and GA21 (mEPSPS) have well defined modes of action and are functionally distinct. The distinct functions of all these proteins support that it is unlikely that they would interact to produce unintended effects. The levels of Cry1Ab, Vip3Aa20, mCry3A, Cry1F, eCry3.1Ab, mEPSPS, PAT and PMI proteins were similar to the levels measured in the single events. The compositional analyses showed that the nutrient composition of forage and grain of the stacked maize event is similar to conventional maize. Food derived from Bt11 x MIR162 x MIR604 x TC1507 x 5307 x GA21 stacked maize event is as safe as food derived from conventional maize varieties.
The likelihood of interaction of the proteins involved in the combined trait product: Cry1Ab, Vip3Aa20, mCry3A, Cry1F, eCry3.1Ab, mEPSPS, PAT and PMI, is highly unlikely to produce any known allergen or toxins to human and animals because of the difference on their mode of action. There is no known mechanism of interaction among the RNA-based suppression and the proteins that could lead to adverse effects in human, animals or environment which is not likely to interact. Furthermore, there are no possible unintended effects of stacked genes on the metabolism of the plant based on the previous assessments of individual transformation events. In addition, stability and expression of the gene will never be affected since molecular analyses also indicated the absence of any marker gene in Bt11 x MIR162 x MIR604 x TC1507 x 5307 x GA21 genome.
An ERA has been conducted for corn Bt11 x MIR162 x MIR604 x 1507 x 5307 x GA21 as recommended in the JDC#1 s2016 for risk assessment of food and feed from genetically modified plants.
Due to the absence of a specified Environmental Management Plan (EMP) by the traders/importers, it was suggested that the concern regulatory agency ensure the following: a) development of guidelines on the EMP in coordination with the Department of Environment and Natural Resources (DENR); b) implementation of the EMP by the traders/importers involved in the import, handling, processing and transport of viable corn Bt11 x MIR162 x MIR604 x TC1507 x 5307 x GA21 commodity products; and c) strict monitoring of the regulated article from port of entry to the trader's/importer's storage/warehouse.
Corn is a common source of food and feed and has a long history of safe use. Bt11 x MIR162 x MIR604 x 1507 x 5307 x GA21 corn has been modified to produce the Cry1Ab, Vip3Aa20, mCry3A, Cry1F, eCry3.1Ab, PAT, PMI, MIR604 PMI and mEPSPS proteins. No other new constituents apart from these proteins are expected to be produced in corn Bt11 x MIR162 x MIR604 x 1507 x 5307 x GA21 and compositional analyses have confirmed the compositional equivalence of corn Bt11 x MIR162 x MIR604 x 1507 x 5307 x GA21 to conventional corn. Therefore, no testing of any other constituent is considered necessary.
The scope of this application does not include cultivation of corn Bt11 x MIR162 x MIR604 x 1507 x 5307 x GA21 in the Philippines. In the unlikely event that small amounts of grain from Bt11 x MIR162 x MIR604 x 1507 x 5307 x GA21 corn accidentally found their way into the environment, this would represent extremely low levels of exposure and the survival of this grain to produce flowering plants would be very unlikely. In addition, volunteers could be easily controlled using any of the current agronomic measures taken to control other commercially available maize.
The proposed methods are real-time quantitative TaqMan® PCR based on specific detection of the genomic DNA of these events.
Yes
Yes
Yes
Yes
Yes
There are no anticipated changes to the intake/extent of use of maize as a result of the introduction of corn Bt11 x MIR162 x MIR604 x 1507 x 5307 x GA21 to the conventional corn supply. It is anticipated that the introduction of corn Bt11 x MIR162 x MIR604 x 1507 x 5307 x GA21 will replace some of the corn in existing food and feed products. However, the genetic modification was not intended to change any of the compositional parameters in food and feed as confirmed by the results obtained from the extensive compositional assessment.
- FAO: Bt11xMIR162xMIR605xTC1507x5307xGA21 maize [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
