Scientific Opinion on application (EFSA-GMO-UK-2008-53) for the placing on the market of herbicide tolerant genetically modified maize 98140 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Pioneer Overseas Corporation

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Article
Panel on Genetically Modified Organisms
Acknowledgements

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 experts Boet Glandorf, Annette Pöting, Hildegard Przyrembel and Jeremy Sweet for the preparatory work on this scientific opinion, and the EFSA staff members, Jaime Aguilera, Anna Christodoulidou, Christina Ehlert, Sylvie Mestdagh, Ellen van Haver and Davide Arcella for the support provided to this scientific opinion.

EFSA Journal
EFSA Journal 2013;11(4):3139 [33 pp.].
doi
10.2903/j.efsa.2013.3139
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, Jozsef Kiss, Gijs Kleter, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesna, Joe Perry, Nils Rostoks, Christoph Tebbe.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of the United Kingdom for application (EFSA-GMO-UK-2008-53) submitted by Pioneer Overseas Corporation
Question Number
EFSA-Q-2008-301
Adopted
7 March 2013
Published
16 April 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Maize 98140 contains a single insert consisting of the gat4621 and the Zm-hra expression cassettes, providing herbicide tolerance. Bioinformatic analyses and genetic stability studies did not raise safety issues. The levels of the GAT and Zm-HRA protein in maize 98140 have been sufficiently analysed. The minimum standards for the design of field trials, set out in the EFSA GMO Panel guidance document, were not met. Therefore the EFSA GMO Panel was not in a position to conclude on the comparative assessment of the compositional, agronomic and phenotypic characteristics, on the basis of the data provided. In the absence of conclusions on the comparative assessment of composition, the risk assessment was restricted to the newly expressed proteins and to specific metabolites resulting from the acetylase activity of the GAT4621 protein. The EFSA GMO Panel has identified a gap in the data on the agronomic and phenotypic characterisation of GM maize 98140 and considers that uncertainty over these characteristics remains. However, considering the scope of this application, the available data and the poor survival capacity of maize outside cultivated land, the EFSA GMO Panel concluded that there is very little likelihood of environmental effects due to the accidental release into the environment of viable grains from maize 98140. Considering its intended use as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from maize 98140 to bacteria have not been identified. The monitoring plan and reporting intervals were in line with the intended uses of maize 98140.

Keywords
GMO, 98140 maize, food and feed safety, environment, import and processing, Regulation (EC) No 1829/2003, GAT, Zm-HRA, N-acetylated amino acids, NAA, NAG
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Number of Pages
33