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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


Arpaia, Salvatore; Birch, Andrew N E; Chesson, Andrew; du Jardin, Patrick; Gathmann, Achim; Gropp, Jürgen; Herman, Lieve; Hoen-Sorteberg, Hilde-Gunn; Jones, Huw; Kiss, Jozsef; Kleter, Gijs; Lovik, Martinus; Messéan, Antoine; Naegeli, H; Nielsen, Kaare Magne; Ovesna, Jaroslava; Perry, Joe; Rostoks, Nils; Tebbe, Christoph (2013). 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. EFSA Journal, 11(4):3139.

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.

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.

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Additional indexing

Item Type:Journal Article, not refereed, further contribution
Communities & Collections:05 Vetsuisse Faculty > Institute of Veterinary Pharmacology and Toxicology
Dewey Decimal Classification:570 Life sciences; biology
Language:English
Date:2013
Deposited On:28 Jan 2014 12:12
Last Modified:05 Apr 2016 17:33
Publisher:European Food Safety Authority (EFSA), Parma
ISSN:1831-4732
Publisher DOI:https://doi.org/10.2903/j.efsa.2013.3139
Official URL:http://www.efsa.europa.eu/en/efsajournal/pub/3139.htm
Permanent URL: https://doi.org/10.5167/uzh-91104

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