Loading...
This record has been deleted. Since it is linked to a published record, it is available here for reference purposes only.
Click here to view the deleted recordThis document has been updated. This is not the latest published version. Click here to view the latest version of the record.
Risk Assessment generated by a regulatory process
(RA)
published: 11 Mar 2023
last updated: 27 Feb 2025
Determination for the Safety Assessment of Corn 5307 for Direct Use as Food, Feed and for Processing
EN
21 Jun 2019
-
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,
-
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 ]
Regulatory assessors, including the Scientific and Technical Review Panel (STRP), the Bureau of Plant Industry-Plant Products Safety Services Division (BPI-PPSSD), and the Bureau of Animal Industry-Biotechnology Team (BAI-BT), concluded that corn 5307 is as safe as its conventional counterpart for human food and animal feed. The Department of Environment and Natural Resources - Biosafety Committee (DENR-BC) recommended issuing a biosafety permit, provided environmental conditions are met. The Department of Health - Biosafety Committee (DOH-BC) found no significant health or environmental risks and supported permit issuance. Additionally, experts on socio-economic, ethical, and cultural considerations endorsed approval after evaluating its potential impact.
4o
The ability of corn 5307 to transfer genetic material to other organisms when compared to conventional maize.
There is no change in the ability of corn 5307 maize to transfer genetic material to other organisms when compared to conventional corn. The horizontal gene transfer from GM plants to bacteria with subsequent expression of the transgenes is regarded as highly unlikely under natural conditions, especially in the absence of selective pressure. Gene transfer from corn 5307 to other sexually compatible plant species is not possible since there are no wild relatives of corn in the Philippines.
Existing data on the safety of the Cry and PMI proteins have been taken into account in the assessment to demonstrate the safety of each protein. The assessment confirms that both of the newly expressed proteins, eCry3.1Ab and PMI, are not structurally or functionally related to proteins which have the potential to adversely affect human or animal health. They are rapidly degraded in simulated gastric fluid. Neither of the proteins showed any sequence homology with known mammalian toxins. The acute oral toxicity studies conducted with eCry3.1Ab and PMI, confirmed that these proteins are not acutely toxic to mice at the highest dose tested and there is no evidence to suggest that protein digestion is altered as a result of repeated exposure to the protein or to expect accumulation of protein with repeated exposure.
Corn 5307 is a genetically modified maize which expresses two transgenes:
1. an engineered ecry3.1Ab gene encoding the eCry3.1Ab protein for control of certain coleopteran pests. The eCry3.1Ab protein is based on mCry3A, a protein derived from the native Cry3A protein from B. thuringiensis subsp. tenebrionis, and on the Cry1Ab protein from B. thuringiensis subsp. kurstaki HD-1.
2. a pmi gene from E. coli encoding the PMI protein which serves as a selectable marker that allows transformed corn cells to utilize mannose as the only primary carbon source. There are no toxic effects of PMI on any organism.
The mechanism of interaction and mode of action of the protein eCry3.1Ab with the target organisms has been characterized and found to be similar to that of other coleopteran-active toxins.
In any case, the scope of this application does not include cultivation of corn 5307 in the Philippines. Therefore, any direct or indirect interactions between plants of corn 5307 and target organisms are highly unlikely.
The scope of this application does not include cultivation of corn 5307 in the Philippines. Environmental exposure to corn 5307 could only occur in the event that small amounts of grain of corn 5307 accidentally found their way into the environment. However, the survival of this grain would be very unlikely as corn is a highly domesticated plant and cannot survive without human intervention, especially under normal Philippine climatic conditions. This grain, if germinated, could be easily controlled using any of the current agronomic measures taken to control other commercially available maize.
The conclusion of the ERA is that the effects to the environment arising from the import and use of corn 5307 can be considered as negligible as those from any other commercial corn.
Compositional analysis corn 5307 have confirmed that the corn 5307 is equivalent in composition to conventional corn and as safe and nutritious as its conventional counterpart.
There is no reason to anticipate that corn 5307 would result in a product that differs in toxicity or allergenic potential to humans. None of the proteins produced by corn 5307 are known to be toxic or allergenic to humans and there are no known precedents where interactions between non-toxic proteins lead to toxic effects.
In summary, no adverse effects on human health are expected following consumption of food products consisting or containing corn 5307.
The possible effects on the use of the GM crop for food, feed and processing on specific ethnic or cultural groups should be best understood in the context of engagement and participation. Evaluation of Applicant’s response should be done alongside results of the procedures for Public Participation for Direct Use under Sec. 22 of JDC 1-2006.
Taking into account the results obtained in agronomic comparisons and the fact that the scope of this application does not include cultivation of corn 5307, which means that environmental exposure in the Philippines would be very low and localized, it can be concluded that: The genetic modification introduced in corn 5307 has not altered agronomic and phenotypic characters of corn 5307 associated with persistence or invasiveness potential compared to conventional corn. In addition, the genes introduced in corn 5307 will not confer any selective advantage or disadvantage compared to conventional corn.
Corn 5307 event is detectable using the event-specific real-time quantitative PCR-based method
Yes
Yes
Yes
Yes
Yes
Corn 5307 will be produced and processed in the same way as any non-GM corn and there is no evidence to suggest that the expression of the newly expressed proteins produced by this maize (eCry3.1Ab and PMI) will influence this processing in any way.
- CropLife Europe [ English ]
- InfoGM [ English ]
