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Risk Assessment generated by a regulatory process
(RA)
last updated: 11 Mar 2023
Determination for the Safety Assessment of Soybean FG72 x A5547-127 for Direct Use as Food, Feed and for Processing
EN
11 Apr 2017
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- Competent National Authority: | BCH-CNA-PH-46524-5 This document has been updated. This is not the latest published version. Click here to view the latest version of the record.Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: +632 920-3986, +632 924-1278 local 2802,Fax: +632 920-3986,Email: osec.da@gmail.com,Website: http://www.da.gov.ph,
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MST-FGØ72-2 × ACS-GMØØ6-4 - Soybean modified for herbicide tolerance| Bayer CropScience | HPPD Herbicides, Resistance to herbicides (Glufosinate, Glyphosate)
- http://biotech.da.gov.ph [ English ]
Possibility of interactions of the three (3) proteins that will produce new allergens and new toxins
The possibility of the occurrence of interaction among the three (3) enzymes is NIL because they catalyze different reactions in their metabolic pathways. The three proteins have specific enzymatic activities using different substrates and via different metabolic pathways.
The likelihood of interaction might affect the stability and protein expression levels of either one of the three genes involved.
Soybean FG72 x A5547-127 contains hppdPf W336 gene encoding HPPD W336 protein, 2mepsps gene encoding 2mEPSPS protein and pat gene encoding PAT protein. Both HPPD W336 protein and PAT protein accumulates in the cytoplasm while 2mEPSPS protein are designed to accumulate in the plastids. However, the gene products are not likely to interact to produce new allergen or toxins due to their different mode of actions, metabolic pathways and enzymatic activities.
The molecular data established that the transformation events stacked in soybean FG72 9 A5547-127 retained their integrity. Comparison of the levels of the newly expressed proteins between the stack and the respective single events did not reveal an interaction that manifests at protein expression level. From the molecular characterization, no indications of interactions between the events based on the biological functions of the newly expressed proteins were identified.
The proteins newly expressed in soybean FG72 9 A5547-127 do not raise safety concerns for human and animal health, since no adverse effects were observed, no structural similarities to known toxins were detected, and no reasons were identified that the presence of the three proteins in combination would result in effects different from those of the individual proteins. Similarly, the technical experts did not identify indications of safety concerns regarding allergenicity with the individual newly expressed proteins or their mixture in soybean FG72 9 A5547-127, or regarding potential changes of its overall allergenicity. Soybean FG72 9 A5547-127 is expected to be as nutritious as the non-GM comparator and non-GM soybean reference varieties.
Based on the agronomic and phenotypic characteristics of soybean FG72 9 A5547-127, some differences were observed in soybean FG72 9 A5547-127 compared with the non-GM comparator. These differences were further assessed and found not to affect the ability of soybean FG72 9 A5547-127 to survive until subsequent seasons, or to establish occasional feral plants under in the Philippines. It was concluded that none of the differences identified in seed composition and agronomic/phenotypic characteristics between soybean FG72 9 A5547-127 and the non-GM comparator needs further assessment regarding food and feed safety.
The application concerns importation for direct use as food, feed or for processing of soybean line FG72xA5547-127. In case of spillage, FG72xA5547-127 soybean seed may be released into the environment. Soybean seeds rarely display dormancy and poorly survive in soil. Soybean volunteers are not often observed throughout the world and do not effectively compete with other cultivated plants, or weeds. In addition, volunteers are easily controlled mechanically or chemically. Modern soybean cultivars do not possess any of the characteristics commonly associated with problematic weeds.
There are no indications that the introduced genes in soybean line FG72xA5547-127 increase the potential to survive or attribute to the establishment of feral populations in case of incidental spillage. Wild relatives of soybean are not present in the Philippines and therefore introgression of the inserted sequences into closely related species cannot occur
Event-specific method using real-time PCR
No
Soybean FG72 x A5547-127 will be imported from outside the Philippines and will be handled in the same way as other imported soybean and derived products. Therefore, no specific conditions for use or handling are foreseen for FG72 x A5547-127.
