Parrma, Idaho
February 21, 2012
EFSA Journal 2012;10(2):2560 [34 pp.]. doi:10.2903/j.efsa.2012.2560
Type: Opinion of the Scientific Committee/Scientific Panel
On request from: Competent Authority of the Netherlands for an application (EFSA-GMO-BE-2010-73) submitted by Monsanto
Question number: EFSA-Q-2009-00761
Adopted: 26 January 2012
Published: 15 February 2012
Affiliation: European Food Safety Authority (EFSA), Parma, Italy
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Abstract
This scientific opinion is an evaluation of a risk assessment for placing on the market the genetically modified (GM) insect-resistant and herbicide-tolerant soybean MON 87701 × MON 89788 for food and feed uses, import and processing. Soybean MON 87701 × MON 89788 was produced by conventional crossing methods, and the F1 plant is hemizygous for all newly introduced traits. The soybean contains the Cry1Ac and CP4 epsps genes conferring resistance against certain lepidopteran target pests and tolerance to glyphosate-based herbicides. No biologically relevant differences were identified in the composition or agronomic and phenotypic characteristics of soybean MON 87701 × MON 89788, as compared with its comparator, except that it expresses the Cry1Ac and CP4 EPSPS proteins. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of soybean MON 87701 × MON 89788. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering its intended use as food and feed, environmental risks associated with an unlikely but theoretically possible horizontal gene transfer from soybean MON 87701 × MON 89788 to bacteria have not been identified. Potential interactions of soybean MON 87701 × MON 89788 with the biotic and abiotic environment were not considered to be an issue owing to the low level of exposure. The monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87701 × MON 89788. In conclusion, the EFSA GMO Panel considers that the information available for soybean MON 87701 × MON 89788 addresses the scientific comments raised by Member States and that the soybean MON 87701 × MON 89788, as described in this application, is as safe as its comparator with respect to potential effects on human and animal health and the environment, in the context of its intended uses.
© European Food Safety Authority, 2012
Summary
Following the submission of an application (EFSA-GMO-NL-2009-73) 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 insect-resistant genetically modified (GM) soybean MON 87701 × MON 89788 (Unique Identifier MON-877Ø1-2 × MON-89788-1) for food and feed uses, import and processing.
In delivering its scientific opinion, the EFSA GMO Panel considered the application EFSA-GMO-NL-2009-73, additional information supplied by the applicant, scientific comments submitted by the Member States and relevant scientific publications. Further information from applications for placing on the market under European Union regulatory procedures the single soybean events MON 87701 and MON 89788 was taken into account. The scope of application EFSA-GMO-NL-2009-73 is for food and feed uses, import and processing of soybean MON 87701 × MON 89788 within the EU in the same way as any non-GM soybean but excludes cultivation in the EU. The EFSA GMO Panel evaluated soybean MON 87701 × MON 89788 with reference to the intended uses and appropriate principles described in its guidance documents of the Scientific Panel on Genetically Modified Organismsfor the risk assessment of genetically modified plants and derived food and feed (EFSA 2006) and for the risk assessment of GM plants containing stacked transformation events (EFSA 2007). The scientific evaluation of the risk assessment included molecular characterisation of the inserted DNA and expression of the corresponding proteins. An evaluation of the comparative analysis of the composition and phenotypic and agronomic characteristics was undertaken, and the safety of the new proteins and the whole food/feed was evaluated with respect to potential toxicity, allergenicity and nutritional wholesomeness. An evaluation of the environmental impacts and the post-market environmental monitoring plan was also undertaken.
The single soybean events MON 87701 and MON 89788 were the subject of separate earlier risk assessment evaluations by the EFSA GMO Panel. The EFSA GMO Panel concluded that they are unlikely to have any adverse effect on human and animal health and the environment, in the context of their intended uses (EFSA 2008, 2011a). The placing on the market of products containing, consisting of or produced from genetically modified soybean MON 89788 was authorised pursuant to Regulation (EC) No 1829/2003. No new genes, in addition to those occurring in soybean MON 87701 and MON 89788, have been introduced in soybean MON 87701 × MON 89788. Soybean MON 87701 × MON 89788 was produced by conventional crossing of the single soybean events to combine in the same stack resistance against certain lepidopteran target pests and tolerance to glyphosate-based herbicides.
Molecular analysis has confirmed that soybean MON 87701 and MON 89788 inserts are present and that their structures are retained in soybean MON 87701 × MON 89788. The result of the updated bioinformatic analyses of the flanking sequences and the open reading frames spanning the insert–plant DNA junctions did not reveal a safety concern. The overall levels of the Cry1Ac and CP4 EPSPS proteins were comparable to those of the corresponding single soybean events MON 87701 and MON 89788.
The EFSA GMO Panel compared the composition and phenotypic and agronomic characteristics of soybean MON 87701 × MON 89788 with its comparator (A5547), assessed all statistically significant differences identified, and came to the conclusion that no biologically relevant differences were identified in the composition or phenotypic and agronomic characteristics of soybean MON 87701 × MON 89788 as compared with its comparator (A5547) and that the composition fell within the range of non-GM soybean varieties, except that soybean MON 87701 × MON 89788 expressed the CP4 EPSPS and Cry1Ac proteins. A small increase in final stand count in soybean MON 87701 × MON 89788 was observed, but no safety issues were identified linked to this increase. The risk assessment included an analysis of data from analytical and bioinformatics studies, as well as in vitro and in vivo studies. The EFSA GMO Panel concluded that soybean MON 87701 × MON 89788 is as safe as its comparator and that the overall allergenicity of the whole plant has not changed.
Potential interaction between the soybean events with respect to an effect on human and animal health were the focus of the assessment on food/feed issues. On the basis of the known functional characteristics and modes of action of the newly expressed proteins (Cry1Ac and CP4 EPSPS), the EFSA GMO Panel considers it unlikely that interactions between these proteins would occur that would raise any safety concerns. Thus, the Panel is of the opinion that soybean MON 87701 × MON 89788 is as safe and as nutritious as its comparator and commercial soybean varieties, in the context of its intended uses.
The application EFSA-GMO-NL-2009-73 concerns food and feed uses, import and processing. Therefore, there is no requirement for scientific information on possible environmental effects associated with the cultivation of soybean MON 87701 × MON 89788. There are no indications of an increased likelihood of the establishment and spread of feral soybean plants in the event of the accidental release into the environment of viable soybean MON 87701 × MON 89788 grains during transport and processing for food and feed uses, except under conditions of infestation by the specific lepidopteran pests or the application of glyphosate-based herbicides. Taking into account the scope of the application, both the rare occurrence of feral soybean plants and the low levels of exposure to the environment indicate that the risk to target and non-target organisms is extremely low. The unlikely but theoretically possible transfer of the recombinant gene from soybean MON 87701 × MON 89788 to environmental bacteria does not raise concern owing to the lack of a selective advantage in the context of its intended uses. The scope of the post-market environmental monitoring plan provided by the applicant is in line with the intended uses of soybean MON 87701 × MON 89788. Furthermore, the EFSA GMO Panel agrees with the reporting intervals proposed by the applicant in its general surveillance plan.
In conclusion, the EFSA GMO Panel considers that the information available for soybean MON 87701 × MON 89788 addresses the scientific issues indicated by the guidance document of the EFSA GMO Panel and the scientific comments raised by the Member States, and that soybean MON 87701 × MON 89788 is as safe as its comparator with respect to potential effects on human and animal health or the environment in the context of its intended uses. In addition, the EFSA GMO Panel is of the opinion that crossing of single soybean events MON 87701 and MON 89788 to produce soybean MON 87701 × MON 89788 does not result in interactions between the events that would affect the safety of soybean MON 87701 × MON 89788 with respect to potential effects on human and animal health and on the environment, in the context of its intended uses.
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