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Scientific Opinion on application (EFSA-GMO-UK-2006-34) for the placing on the market of genetically modified maize 3272 with a thermotolerant alpha-amylase, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Crop Protection AG

EFSA Journal 2013;11(6):3252 [27 pp.]. doi:10.2903/j.efsa.2013.3252
  EFSA Panel on Genetically Modified Organisms (GMO) Panel Members Salvatore Arpaia, Andrew Nicholas Edmund Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, Jozsef Kiss, Gijs Kleter, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesna, Joe Perry, Nils Rostoks, Christoph Tebbe. Acknowledgment The Panel wishes to thank the members of the Standing Working Groups on Molecular Characterisation, Food and Feed Safety Assessment and Environmental Risk Assessment on GMO applications, the external expert Howard Davies for the preparatory work on this scientific opinion, and the EFSA staff members, Anna Christodoulidou, Christina Ehlert, Ana Gomes and Sylvie Mestdagh for the support provided to this scientific opinion. Contact gmo@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: On request from the Competent Authority of the United Kingdom for application (EFSA-GMO-UK-2006-34) submitted by Syngenta Crop Protection AG Question number: EFSA-Q-2006-026 Adopted: 30 May 2013 Published: 20 June 2013 Last updated: 21 August 2013. This version replaces the previous one/s. Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

Maize 3272 contains a single insert consisting of the amy797E and the pmi cassettes, expressing a thermotolerant alpha-amylase (AMY797E) and a phosphamannose isomerase (PMI). Bioinformatic analyses and genetic stability studies did not raise safety issues. The levels of the AMY797E and PMI proteins in maize 3272 have been sufficiently analysed. In the absence of an appropriately performed comparative assessment, the EFSA Panel on Genetically Modified Organisms (GMO) was not in the position to conclude either on the compositional, agronomic and phenotypic characteristics of maize 3272 or on its nutritional assessment, on the basis of the data provided. The safety assessment could therefore not be completed, and has focused mainly on the newly expressed proteins. No indications of safety concern over the toxicity of the AMY797E and PMI proteins and over the allergenicity of the PMI protein were identified. The Panel could not conclude on the potential for de novo allergic sensitisation of the AMY797E protein. The Panel has identified a gap in the data on the agronomic and phenotypic characterisation of GM maize 3272 and considers that uncertainty over these characteristics remains. However, considering the scope of this application, a weight of evidence approach from different sources of available data and the poor ability of maize to survive outside cultivated land, the Panel concluded that there is very little likelihood of any adverse environmental impacts due to the accidental release into the environment of viable grains from maize 3272. Considering its intended uses as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with a theoretically possible horizontal gene transfer from maize 3272 to prokaryotes have been analysed and did not raise safety concerns. The monitoring plan and reporting intervals were in line with the intended uses of maize 3272.

© European Food Safety Authority, 2013

Summary

Following the submission of an application (Reference EFSA-GMO-UK-2006-34) under Regulation (EC) No 1829/2003 from Syngenta Crop Protection AG, 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) maize 3272 (Unique Identifier SYN-E3272-5) for import and processing and for food and feed uses. Maize 3272 was developed to express a chimeric thermotolerant alpha-amylase (AMY797E) and a phosphomannose isomerase (PMI), as a selectable marker.

In delivering its scientific opinion, the EFSA GMO Panel considered the application EFSA-GMO-UK-2006-34, additional information provided by the applicant (Syngenta Crop Protection AG) and the scientific comments submitted by the Member States. The scope of application EFSA-GMO-UK-2006-34 is for food and feed uses and import and processing of maize 3272 and all derived products, but excludes cultivation in the European Union (EU).

The EFSA GMO Panel evaluated maize 3272 with reference to the intended uses and appropriate principles described in the EFSA GMO Panel guidance documents for the risk assessment of GM plants and derived food and feed. The scientific risk assessment evaluation 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 proteins, as individual proteins and in combination, the changed levels of natural constituents and the whole food/feed were evaluated with respect to potential toxicity, allergenicity and nutritional quality. An evaluation of environmental impacts and the post-market environmental monitoring plan were undertaken.

Maize 3272 has been genetically modified to express the AMY797E and PMI proteins. The AMY797E protein is a chimeric thermotolerant alpha-amylase encoded by gene segments derived from three parental alpha-amylase genes originating from strains of the archeal order Thermococcales. The PMI protein is a phosphomannose isomerase encoded by the pmi gene (also known as manA) derived from Escherichia coli.Expression of PMI enables transformed maize cells to utilise mannose and therefore to survive on media in which mannose is the sole source of carbon.

The molecular characterisation data established that the GM maize 3272 contains a single insert consisting of the amy797E and the pmi cassettes. Bioinformatic analyses and genetic stability studies did not raise safety issues. The levels of the AMY797E and PMI protein in maize 3272 have been sufficiently analysed.

The EFSA GMO Panel could not conclude on the comparative assessment of the compositional, agronomic and phenotypic characteristics of maize 3272, on the basis of the data provided.In the absence of an appropriately performed comparative assessment, the safety assessment could not be completed and has focused mainly on the newly expressed proteins AMY797E and PMI.

The AMY797E and PMI proteins did not show significant similarity to known toxins in bioinformatic analyses. The EFSA GMO Panel concluded that administration of the AMY797E protein to rats for 28 days did not induce adverse effects up to the highest dose tested. Based on all the available information, the EFSA GMO Panel considers that there are no indications that the newly expressed PMI protein in maize 3272 may be allergenic. In relation to the AMY797E protein, the EFSA GMO Panel could not conclude on the de novo sensitisation potential of the protein.

The EFSA GMO Panel considers that both the repeated-dose 90-day oral toxicity study and the feeding study in broiler chickens, in which material derived from a negative segregant is administered as the control material, are not adequate for the safety assessment of food/feed from GM plants. Therefore, the Panel did not consider these studies in its evaluation of maize 3272.

The application EFSA-GMO-UK-2006-34 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 maize 3272. The EFSA GMO Panel has identified a gap in the data on the agronomic and phenotypic characterisation of GM maize 3272 and considers that uncertainty over these characteristics remains. However, considering the scope of this application, a weight of evidence approach from different sources of available data and the poor ability of maize to survive outside cultivated land, the EFSA GMO Panel concluded that there is very little likelihood of any adverse environmental impacts as a result of the accidental release into the environment of viable grains from maize 3272. In the case of accidental release into the environment of viable grains of maize 3272, there are no indications of an increased likelihood of spread and establishment of feral maize 3272 plants. Considering its intended uses as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with a theoretically possible horizontal gene transfer from maize 3272 to prokaryotes (i.e. bacteria, Archaea) have been analysed and did not raise safety concerns. The post-market environmental monitoring plan and reporting intervals were in line with the intended uses of maize 3272.

In the absence of an appropriately performed comparative assessment by the applicant, the EFSA GMO Panel was not in the position to complete its risk assessment on maize 3272 and therefore does not conclude on the safety of maize 3272 compared with its conventional counterpart with respect to potential effects on human and animal health. However, the EFSA GMO Panel concluded that maize event 3272 is unlikely to have any adverse effect on the environment in the context of its intended uses.

Keywords

GMO, 3272 maize, food and feed safety, environment, import and processing, Regulation (EC) No 1829/2003, thermotolerant alpha-amylase