Following the submission of an application (EFSA-GMO-NL-2009-70) 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 the genetically modified (GM) drought tolerant maize MON 87460 for food and feed uses, import and processing of maize MON 87460 and all derived products but excluding cultivation in the European Union (EU).
In delivering its Scientific Opinion, the EFSA GMO Panel considered: the application EFSA-GMO-NL-2009-70; additional information supplied by the applicant; scientific comments submitted by the Member States; and relevant scientific publications.
The EFSA GMO Panel evaluated maize MON 87460 with reference to the intended uses and principles described in its risk assessment and monitoring guidelines. The scientific evaluation of the risk assessment included molecular characterisation of the inserted DNA and expression of the target proteins. An evaluation of the comparative analysis of composition and agronomic and phenotypic traits was undertaken, and the safety of the newly expressed proteins and the whole food/feed were evaluated with respect to potential toxicity, allergenicity and nutritional quality. An evaluation of environmental impacts and of the post-market environmental monitoring plan was undertaken.
Maize MON 87460 was developed through Agrobacterium-mediated transformation and expresses the cold shock protein B (CspB) from Bacillus subtilis and neomycin phosphotransferase II (NPTII) from Tn5 of Escherichia coli. Maize MON 87460 was developed to provide reduced yield loss under conditions in which water is limited compared with conventional maize. The CspB protein is an RNA chaperone associated with enhanced abiotic stress tolerance in bacteria and plants, through its interaction with RNA secondary structures, limiting their misfolding and allowing cells to maintain cellular functions under various stress conditions. In maize MON 87460, this genetic modification aims to reduce yield loss caused by drought stress.
The molecular characterisation data establish that maize MON 87460 contains a single copy of the cspB and nptII expression cassettes, and lacks other sequences from the transformation vector. Bioinformatic analysis of the flanking sequences and the open reading frames spanning the junctions created by the transformation did not raise safety issues. The stability of the inserted DNA was confirmed over multiple generations. The levels of the CspB and NPTII protein from maize MON 87460 grown in field studies performed under different environmental conditions, including water-limited conditions, were assessed.
The EFSA GMO Panel compared the composition and phenotypic and agronomic characteristics of maize MON 87460 with those of its conventional counterpart and assessed all statistically significant differences identified. The EFSA GMO Panel concludes that, besides the expression of the CspB and NPTII proteins, some differences were observed in the composition of forage and grain produced from maize MON 87460, compared with its conventional counterpart, when grown under well-watered conditions. Given the magnitude of these changes and the characteristics of these endpoints, the EFSA GMO Panel concludes that the observed differences do not raise safety concerns for humans and animals. The EFSA GMO Panel notes that under water-limited and other stressful conditions, maize MON 87460 can show enhanced agronomic performance characteristics (e.g. yield) and some differences in chemical composition in comparison with its conventional counterpart. Given the intended trait, the observed differences were not unexpected, and did indicate no safety concerns.
The safety assessment of the newly expressed protein and the whole crop included an analysis of data from analytical and bioinformatics studies, as well as in vitro pepsin and pancreatin resistance tests with the CspB protein and a subchronic 90-day rat feeding study. The NPTII protein has been evaluated previously and did not raise safety concerns. The EFSA GMO Panel concludes that maize MON 87460 is as safe as its conventional counterpart; there is no evidence that the genetic modification might significantly change the overall allergenicity of maize MON 87460. The results of the study on chickens for fattening concerning zootechnical performance support the conclusion that maize MON 87460 can be used as other maize sources as a feedingstuff in animal nutrition. The EFSA GMO Panel considers that maize MON 87460 is as safe and as nutritious as its conventional counterpart and commercial varieties, and concluded that this maize and derived products are unlikely to have adverse effects on human and animal health, in the context of their intended uses.
The application EFSA-GMO-NL-2009-70 covers the import and processing of maize MON 87460 for food and feed uses but excludes its cultivation in the EU. Therefore, there is no requirement for scientific information on the possible environmental effects associated with the cultivation of maize MON 87460. There are no indications of an increased likelihood of the establishment and spread of feral maize plants in cases of accidental release into the environment of viable grains from maize MON 87460 during transport and processing. Considering the intended uses of maize MON 87460 as food and feed, interactions with the biotic and abiotic environment are not considered to be an issue owing to the low levels of exposure. Risks associated with a theoretically possible horizontal transfer from maize MON 87460 nptII and cspB genes to bacteria have been analysed in detail, including different scenarios of integration, and did not raise safety concerns for the intended uses of maize MON 87460. The scope of the post-market environmental monitoring plan provided by the applicant is in line with the intended uses of maize MON 87460. Furthermore, the EFSA GMO Panel agrees with the reporting intervals proposed by the applicant in the general surveillance plan.
In conclusion, the EFSA GMO Panel considers that the information available for maize MON 87460 addresses scientific issues indicated by its risk assessment and monitoring guidelines and the scientific comments raised by the Member States, and that maize MON 87460, as described in this application, is as safe as its conventional counterpart and non-GM reference varieties with respect to potential effects on human and animal health and the environment, in the context of its intended uses.