Following the submission of application EFSA-GMO-NL-2010-85 under Regulation (EC) No 1829/2003 from Monsanto, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) was asked to deliver a scientific opinion on the safety of herbicide-tolerant, stearidonic acid (SDA)-producing genetically modified (GM) soybean MON 87769 × MON 89788 (Unique Identifier MON-87769-7 × MON-89788-1). The scope of application EFSA-GMO-NL-2010-85 is for food and feed uses, import and processing, but excludes cultivation within the European Union (EU).
Soybean containing the single events MON 87769 (expressing the Δ15 desaturase protein from Neurospora crassa (NcΔ15D) and the Δ6 desaturase protein from Primula juliae (PjΔ6D)) and MON 89788 (expressing the CP4 protein 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS)) were assessed previously and no concerns were identified for human and animal health or environmental safety. No safety concern was identified by updated bioinformatic analyses, or reported by the applicant with regard to the two single soybean events, since the publication of the corresponding scientific opinions. Consequently, the EFSA GMO Panel considers that its previous conclusions on the safety of the single soybean events remain valid.
The two-event stack soybean MON 87769 × MON 89788 was produced by conventional crossing of the soybean lines MON 87769 and MON 89788, combining the production of SDA and the tolerance to glyphosate-based herbicides. The EFSA GMO Panel evaluated soybean MON 87769 × MON 89788 with reference to the scope and appropriate principles described in its guidelines for the risk assessment of GM plants and derived food and feed, the environmental risk assessment of GM plants and the post-market environmental monitoring (PMEM) of GM plants. The scientific evaluation of the risk assessment included molecular characterisation of the inserted DNA and analysis of the expression of the corresponding proteins. An evaluation of the comparative analyses of the compositional, agronomic and phenotypic characteristics was undertaken, and the safety of the newly expressed protein and the whole food/feed was evaluated with respect to potential toxicity, allergenicity and nutritional wholesomeness. Evaluations of environmental impacts and the PMEM plan were also undertaken. In accordance with the EFSA GMO Panel guidance document applicable to this application (EFSA GMO Panel, 2011a), “For GM plants containing a combination of transformation events (stacked events) the primary concern for risk assessment is to establish that the combination of events is stable and that no interactions between the stacked events, that may raise safety concerns compared to the single events, occur. The risk assessment of GM plants containing stacked events focuses on issues related to: a) stability of the inserts, b) expression of the introduced genes and their products and c) potential synergistic or antagonistic effects resulting from the combination of the events”.
The molecular data establish that the transformation events stacked in soybean MON 87769 × MON 89788 have the same molecular properties and characteristics as the single transformation events. Comparison of the levels of the NcΔ15D, PjΔ6D and CP4 EPSPS proteins between the stack and the corresponding single events did not reveal an interaction that would affect protein or trait expression levels in a way that would give rise to safety concerns. The biological functions of the newly expressed proteins did not suggest the possibility of interactions between the events at a functional level.
The EFSA GMO Panel considered the compositional, phenotypic and agronomic data supplied and the observed statistically significant differences between soybean MON 87769 × MON 89788 and its comparator, in the light of the field trial design, measured biological variation and the level of the studied compounds in commercial non-GM soybean varieties. No relevant differences were identified in the compositional characteristics of soybean MON 87769 × MON 89788 in comparison with its comparator, except for the altered fatty acid composition (of SDA, g-linolenic acid and two trans-fatty acids) and a reduction in linoleic acid.
The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly expressed PjΔ6D, NcΔ15D and CP4 EPSPS proteins, and found no evidence that the genetic modification might significantly change the overall allergenicity of soybean MON 87769 × MON 89788. The EFSA GMO Panel could not complete a full assessment on the possible impact of MON 87769 × MON 89788 soybean oil on health and nutrition, because of the lack of data on dietary exposure to refined bleached deodorised (RBD) oil from MON 87769 × MON 89788 soybean. There are no concerns regarding the use of feeding stuffs derived from defatted toasted MON 87769 × MON 89788 soybean meal.
No safety concerns for the environment from the import and processing of soybean MON 87769 × MON 89788 were identified. There are no indications of an increased likelihood of establishment and spread of feral soybean MON 87769 × MON 89788 plants in the case of accidental release into the environment of viable GM soybean seeds. The unlikely, but theoretically possible, transfer of the recombinant genes from soybean MON 87769 × MON 89788 to bacteria does not give rise to a safety concern for these bacteria owing to the lack of a selective advantage. Potential interactions of soybean MON 87769 × MON 89788 with the biotic and abiotic environment were not considered relevant by the EFSA GMO Panel. The PMEM plan provided by the applicant and the reporting intervals are in line with the scope of application EFSA-GMO-NL-2010-85.
In conclusion, the EFSA GMO Panel could not complete the food and feed safety assessment of soybean MON 87769 × MON 89788 because of the lack of an appropriate nutritional assessment. The EFSA GMO Panel concludes that soybean MON 87769 × MON 89788 is unlikely to have any adverse effects on the environment, considering the scope of application EFSA-GMO-NL-2010-85.
As a full assessment on the possible health and nutritional impact of MON 87769 × MON 89788 soybean oil was not made, the EFSA GMO Panel is not in the position to comment on the post-market monitoring plan and labelling provided by the applicant, in accordance with Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003.