Scientific Opinion on application EFSA-GMO-NL-2011-93 for the placing on the market of the herbicide-tolerant genetically modified soybean MON 87708 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

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Article
Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2013;11(10):3355 [30 pp.].
doi
10.2903/j.efsa.2013.3355
Panel members at the time of adoption
Salvatore Arpaia, Andrew Nicholas Edmund Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, József Kiss, Gijs Kleter, Martinus Løvik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesná, Joe Perry, Nils Rostoks and Christoph Tebbe
Acknowledgements

The Panel wishes to thank the members of the Working Group on Molecular Characterisation, Food and Feed Safety Assessment and Environmental Risk Assessment on GMO applications, including Christer Andersson, Annette Poëting, Sirpa Kärenlampi and Fabien Nogué for the preparatory work on this scientific opinion, and EFSA staff: Zoltán Divéki, Christina Ehlert, Antonio Fernández Dumont and Sylvie Mestdagh for the support provided to this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of the Netherlands for an application (EFSA-GMO-NL-2011-93) submitted by Monsanto
Question Number
EFSA-Q-2011-00122
Adopted
12. September 2013
Published
3. Oktober 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Soybean MON 87708 contains a single insert consisting of the dmo expression cassette. The DMO (dicamba mono-oxygenase) proteins confer tolerance to dicamba-based herbicides. Bioinformatic analyses of the inserted DNA and flanking regions do not raise safety issues. The levels of DMO proteins in soybean MON 87708 have been sufficiently analysed. The stability of the genetic modification has been demonstrated. No differences were identified in the compositional data of forage and seeds obtained from soybean MON 87708 or in its agronomic and phenotypic characteristics that would require further assessment with regard to safety by the GMO Panel. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the DMO proteins, or of soybean MON 87708. The compositional data indicating that soybean MON 87708 is as nutritious as non-GM soybean varieties were supported by the outcome of a chicken study. There are no indications of an increased likelihood of establishment and spread of feral GM soybean plants. Considering the scope of this application, potential interactions of soybean MON 87708 with the biotic and abiotic environment were not considered to be an issue. Environmental risks associated with an unlikely but theoretically possible horizontal gene transfer from soybean MON 87708 to bacteria have not been identified. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87708. In conclusion, the GMO Panel considers that the information available for soybean MON 87708 addresses the scientific comments raised by the Member States, and that the soybean MON 87708, as described in this application, is as safe as its conventional counterpart and non-GM soybean reference varieties with respect to potential effects on human and animal health or the environment, in the context of its intended uses.

Summary

Following the submission of an application (EFSA-GMO-NL-2011-93) 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 genetically modified (GM) herbicide-tolerant soybean MON 87708 (Unique Identifier MON-877Ø8-9) for food and feed uses, import and processing.

In delivering its Scientific Opinion the EFSA GMO Panel considered the application EFSA-GMO-NL-2011-93, additional information provided by the applicant, scientific comments submitted by the Member States and relevant scientific publications. The scope of application EFSA-GMO-NL-2011-93 is for food and feed uses, import and processing of soybean MON 87708 within the European Union (EU), as for any other non-GM soybean, but excludes cultivation in the EU. The EFSA GMO Panel evaluated soybean MON 87708 with respect to the scope and the appropriate principles described in its Guidance Documents for the risk assessment of GM plants and derived food and feed, and on the post-market environmental monitoring of GM plants. The scientific evaluation included the molecular characterisation of the inserted DNA and the analysis of the expression of the corresponding proteins. An evaluation of the comparative analysis of compositional, phenotypic and agronomic 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. Evaluation of the environmental impacts and of the post-market environmental monitoring plan was undertaken.

The molecular characterisation data establish that the genetically modified soybean MON 87708 contains one copy of an intact dmo expression cassette in a single locus. No other parts of the plasmid used for transformation are present in soybean MON 87708. The results of the bioinformatic analyses of the inserted DNA and the flanking regions do not raise safety issues. The levels of DMO proteins in soybean MON 87708 have been sufficiently analysed and the stability of the genetic modification has been demonstrated.

The EFSA GMO Panel compared the compositional, phenotypic and agronomic characteristics of soybean MON 87708, the conventional counterpart (A3525) and other non-GM soybean reference varieties, and assessed all statistically significant differences between soybean MON 87708 and A3525 for which equivalence with the non-GM reference varieties could not be established. It is concluded that no differences were identified in the compositional data of forage and seeds obtained from soybean MON 87708 or in its agronomic and phenotypic characteristics that would require further assessment with regard to safety by the EFSA GMO Panel.

The DMO proteins are degraded by proteolytic enzymes, and bioinformatics-supported studies demonstrated that these proteins show no similarity to known toxic and allergenic proteins. No toxicity of the DMO proteins was observed in 28-day and acute toxicity studies in mice. The result of a 90-day feeding study in rats with diets containing toasted defatted soybean meal from soybean MON 87708, its conventional counterpart or any of two non-GM soybean varieties did not raise safety concerns. There are no indications that the genetic modification might significantly change the overall allergenicity of soybean MON 87708 when compared with that of its conventional counterpart. The compositional data indicating that soybean MON 87708 is as nutritious as non-GM soybean varieties were supported by the outcome of a chicken study. In conclusion, the EFSA GMO Panel is of the opinion that soybean MON 87708 is as safe and as nutritious as its conventional counterpart and non-GM reference varieties, in the context of its intended uses.

The scope of application EFSA-GMO-NL-2011-93 is for food and feed uses, import and processing and does not include cultivation. Therefore, there is no requirement for scientific information on possible environmental effects associated with the cultivation of soybean MON 87708 in the EU. There are no indications of an increased likelihood of establishment and spread of feral GM soybean plants in event of accidental release into the environment of viable soybean MON 87708 grains during transport and processing for food and feed uses. Considering its intended uses as food and feed, potential interactions of soybean MON 87708 with the biotic and abiotic environment were not considered to be an issue by the EFSA GMO Panel. The unlikely, but theoretically possible, transfer of the recombinant gene from soybean MON 87708 to environmental bacteria does not raise any safety concern because no selective advantage will be conferred on the recipients. The scope of the post-market environmental monitoring plan provided by the applicant is in line with the intended uses of soybean MON 87708. Furthermore, the EFSA GMO Panel agrees with the reporting intervals proposed by the applicant in the post-market environmental monitoring plan.

In conclusion, the EFSA GMO Panel considers that the information available for soybean MON 87708 addresses the scientific issues indicated in the relevant Guidance Documents of the EFSA GMO Panel and the scientific comments raised by the Member States, and that soybean MON 87708, as described in this application, is as safe as its conventional counterpart and non-GM soybean reference varieties with respect to potential effects on human and animal health or the environment, in the context of its intended uses.

It should be noted that the assessment of potential consumer health risks resulting from dicamba residues and its metabolites in soybean MON 87708 is under the remit of the EFSA Pesticides Unit.

Keywords
GMO, soybean MON 87708, Regulation (EC) No 1829/2003, DMO protein, food and feed safety, environment, import and processing
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Number of Pages
30