Scientific Opinion on application (EFSA-GMO-NL-2008-52) for the placing on the market of herbicide tolerant genetically modified soybean A5547-127 for food and feed uses, import and processing under Regulation (EC) No 1829-2003 from Bayer CropScience

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Article
Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2011;9(5):2147 [27 pp.].
doi
10.2903/j.efsa.2011.2147
Panel members at the time of adoption
Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel Wal
Acknowledgements

The Panel wishes to thank the members of the Working Groups on Molecular Characterisation, Food and Feed and Environment for the preparatory work on this scientific opinion: EFSA’s staff members Zoltan Divéki (MC), Karine Lheureux (ENV) and Claudia Paoletti (FF) for the support provided to this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
the Competent Authority of the Netherlands for an application (EFSA-GMO-NL-2008-52) submitted by Bayer CropScience
Question Number
EFSA-Q-2008-290
Adopted
13. April 2011
Published in the EFSA Journal
10. Mai 2011
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

This scientific opinion is an evaluation of a risk assessment for the genetically modified herbicide tolerant soybean A5547-127 for food and feed uses, import and processing. Soybean A5547-127 was developed through particle bombardment. It contains a single insertion site consisting of a copy of the intact pat expression cassette, encoding the PAT protein that confers tolerance to glufosinate-ammonium containing herbicides. Other inserted sequences include two truncated parts of the beta-lactamase (bla) gene from the transformation vector on each side of the pat expression cassette. The stability of the inserted DNA was confirmed over multiple generations. The results of the bioinformatic analyses of the insert and the flanking regions, and the levels of newly expressed protein did not raise a safety concern. The comparative analysis of compositional, phenotypic and agronomic characteristics indicated that soybean A5547-127 is not different from its conventional counterpart (A5547), except for the newly expressed protein (PAT). The safety assessment of the PAT protein and the soybean A5547-127 identified no concerns regarding potential toxicity and allergenicity. A feeding study on broiler chickens confirmed that seeds of soybean A5547-127 are as nutritional as seeds of the conventional counterpart. There are no indications of an increased likelihood of establishment and spread of feral soybean plants, except in the presence of the glufosinate-ammonium containing herbicides. The risk caused by a possible transfer of the recombinant gene from soybean A5547-127 to environmental micro-organisms is regarded to be negligible due to the lack of any advantage that would be conferred in the context of its intended uses. The potential interactions of the GM plant with target organisms, non-target organisms and the abiotic environment and biogeochemical cycles were not considered an issue by the EFSA GMO Panel. The monitoring plan and reporting intervals are in line with the intended uses of soybean A5547-127. The EFSA GMO Panel considers that the information available for soybean A5547-127 addresses the scientific comments raised by the Member States and that the soybean A5547-127, 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.

Keywords
GMO, soybean (Glycine max), A5547-127, herbicide tolerance, glufosinate-ammonium containing herbicides, pat gene, PAT protein, human and animal health, import and processing, Regulation (EC) No 1829/2003
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Number of Pages
27