Scientific Opinion on application (EFSA-GMO-NL-2007-39) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MON89034 x MON88017 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

This opinion reports on an evaluation of a risk assessment for placing on the market the genetically modified herbicide tolerant and insect resistant maize MON89034 x MON88017 for food and feed uses, import and processing. Conventional breeding methods were used in the production of maize MON89034 x MON88017 from inbred lines of the respective parental events. The structural integrity of the inserts in the single events as well as the phenotypes were retained in the hybrid. The expression levels of the Cry1A.105, Cry2Ab2, Cry3Bb1 and CP4 EPSPS proteins in maize MON89034 x MON88017 were demonstrated to be comparable with those of the single events. The comparative analysis of compositional, phenotypic and agronomic characteristics of this GM maize indicated equivalence with its conventional counterpart and commercial non-GM maize varieties except for the expression of the target proteins, providing resistance to certain lepidopteran and coleopteran pests and tolerance to glyphosate herbicide. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize MON89034 x MON88017. A feeding study on broiler chickens confirmed the nutritional equivalence of this GM maize to its conventional counterpart and commercial non-GM maize varieties. Considering the intended uses of maize MON89034 x MON88017, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of maize MON89034 x MON88017 was required. In case of accidental release of viable maize grain of MON89034 x MON88017 into the environment during transportation and processing, there are no indications of increased likelihood of establishment or survival of feral maize plants except in the presence of the glyphosate herbicides. In conclusion, the EFSA GMO Panel considers that the information available for maize MON89034 x MON88017 addresses the scientific comments raised by the Member States and that the maize MON89034 x MON88017 as described in this application is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. The EFSA GMO Panel concludes that maize event MON89034 x MON88017 is unlikely to have any adverse effect on human and animal health and the environment, in the context of its intended uses.

© European Food Safety Authority, 2010

This opinion, published on 27th May 2010, replaces the earlier version published on 30st March 2010.

Following the submission of an application (EFSA-GMO-NL-2007-39) under Regulation (EC) No 1829/2003 from Monsanto, the Panel on Genetically Modified Organisms was asked to deliver a scientific opinion on herbicide tolerant and insect resistant genetically modified (GM) maize MON89034 x MON88017 (Unique identifier MON-89Ø34-3 × MON-88Ø17-3) for food and feed uses, import and processing.

In delivering its scientific opinion, the EFSA GMO Panel considered the application EFSA-GMO-NL-2007-39, additional information supplied by the applicant and scientific comments submitted by Member States. Further information from applications for placing the single events MON89034 and MON88017 on the market under EU regulatory procedures was taken into account where appropriate. The scope of application EFSA-GMO-NL-2007-39 is for food and feed uses, import and processing of maize MON89034 x MON88017 and all derived products, but excludes cultivation in the EU. The EFSA GMO Panel assessed maize MON89034 x MON88017 with reference to the intended uses and appropriate principles described in the Guidance Documents of the Scientific Panel on Genetically Modified Organisms for the risk assessment of genetically modified plants and derived food and feed and for the risk assessment of genetically modified plants containing stacked transformation events. The scientific assessment included molecular characterisation of the inserted DNA and expression of target proteins. A comparative analysis of agronomic traits and composition was undertaken, and the safety of the new protein and the whole food/feed were evaluated with respect to potential toxicity, allergenicity and nutritional quality. An assessment of environmental impacts and the post-market environmental monitoring plan were undertaken.

Maize MON89034 and MON88017 have been developed for protection respectively against specific lepidopteran (Ostrinia nubilalis, Spodoptera spp., Agrotis ipsilon) and coleopteran (Diabrotica spp.) pests and for tolerance to glyphosate herbicides. Lepidopteran resistance is achieved by expression of the Cry1A.105 and Cry2Ab2 proteins derived from B. thuringiensis subsp. kurstaki in maize MON89034 and coleopteran resistance by expression of Cry3Bb1 protein from B. thuringiensis subsp. kumamotoensis) in maize MON88017, while tolerance to glyphosate is conferred by expression of CP4 EPSPS protein from a transgene derived from Agrobacterium tumefaciens (renamed Rhizobium radiobacter) strain CP4 in maize MON88017.

Molecular analysis of the DNA present in maize MON89034 x MON88017 confirmed that maize MON89034 and MON88017 inserts are present and that their structures are retained. With regard to the expression of Cry1A.105, Cry2Ab2, Cry3Bb1, and CP4 EPSPS proteins, the overall protein levels were comparable between maize MON89034 x MON88017 and the respective single events.

Based on results of the comparative analysis the EFSA GMO Panel concludes that maize MON89034 x MON88017  is compositionally, phenotypically and agronomically equivalent to its conventional counterpart and commercial non-GM maize varieties, except for the presence of Cry1A.105, Cry2Ab2, Cry3Bb1 and CP4 EPSPS proteins in maize MON89034 x MON88017. Based on the assessment of data available, including the additional information provided by the applicant in response to the EFSA GMO Panel’s requests for maize MON89034 x MON88017, for the single events and for its conventional counterpart and commercial non-GM maize varieties, the EFSA GMO Panel has found no indication that crossing of MON89034 with MON88017 maize results in an interaction between the single events which causes compositional, phenotypic or agronomic changes. The Cry1A.105 and Cry2Ab2 expressed in the parental maize line MON89034 and the Cry3Bb1 and CP4 EPSPS proteins expressed in the parental maize line MON88017 have been assessed previously and no safety concerns were identified. Given all of the information provided, the EFSA GMO Panel concludes that there is no evidence for interactions between the single events that might impact on food and feed safety. The nutritional value of maize MON89034 x MON88017 has been investigated in a feeding study with broilers which confirmed that the nutritional properties of maize MON89034 x MON88017 would be no different from those of its conventional counterpart and commercial non-GM maize varieties.

The application EFSA-GMO-NL-2007-39 concerns food and feed uses, import and processing, but excludes cultivation in the EU. Therefore, there is no requirement for scientific assessment of possible environmental effects associated with the cultivation of maize MON89034 x MON88017. There are no indications of an increased likelihood of establishment and spread of feral maize plants in case of accidental release into the environment of viable maize MON89034 x MON88017 grains during transportation and processing for food and feed uses, except in the presence of glyphosate. Taking into account the scope of the application, both the rare occurrence of feral maize plants and the low levels of exposure through other routes indicate that the risk to target and non-target organisms is extremely low. The scope of the post-market environmental monitoring plan provided by the applicant is in line with the intended uses of maize MON89034 x MON88017. 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 MON89034 x MON88017 addresses the scientific comments raised by the Member States and that the maize MON89034 x MON88017 as described in this application is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. The EFSA GMO Panel concludes that maize event MON89034 x MON88017 is unlikely to have any adverse effect on human and animal health and the environment, in the context of its intended uses.

GMO, maize (Zea mays), maize MON89034 x MON88017, insect resistant, herbicide tolerant, risk assessment, food and feed safety, environment, import and processing, Regulation (EC) No 1829/2003.