Opinion of the Scientific Panel on Genetically Modified Organisms on an application (Reference EFSA-GMO-NL-2005-18) for the placing on the market of the glufosinate tolerant soybean A2704-12, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience

This document provides an opinion of the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) on genetically modified soybean A2704-12 (Unique Identifier ACS-GMOO5-3) developed to provide tolerance to glufosinate herbicides. In delivering its opinion the GMO Panel considered the application EFSA-GMO-NL-2005-18, additional information provided by the applicant (Bayer CropScience) and the scientific comments submitted by the Member States. The scope of application EFSA-GMO-NL-2005-18 is for food and feed uses, import and processing of soybean A2704-12 and its derived products for the same uses as any non-GM soybean (food, feed including meal, cake and oil), excluding cultivation. The GMO Panel assessed soybean A2704-12 with reference to its intended uses. The assessment followed the appropriate principles described in the Guidance Document of the Scientific Panel on Genetically Modified Organisms for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed. The scientific assessment included molecular characterization of the inserted DNA and expression of the PAT protein. A comparative analysis of agronomic traits and composition was undertaken. The potential toxicity and allergenicity of the new protein was evaluated together with the potential allergenicity of extracts of whole food/feed. Environmental assessment was undertaken, including a monitoring plan. Soybean A2704-12 is derived from the soybean variety A2704 which was transformed using particle bombardment. Soybean A2704-12 expresses the pat gene leading to the production of the enzyme phosphinothricin acetyl-transferase (PAT) that acetylates L-glufosinate-ammonium. The PAT enzyme confers tolerance to glufosinate herbicides. The molecular characterisation data established that soybean A2704-12 contains a single insert. The insert contains all of the sequences of plasmid vector pB2/35SAcK, including the vector backbone consisting of pUC19 sequences. The insert also contains two separate (3' and 5') fragments of the bla gene. These fragments do not constitute a functional gene in soybean A2704-12 and the bla gene was not expressed. Bioinformatics analysis was carried out on open reading frames (ORFs) spanning the insert, the insert/genomic junctions and the 5' chloroplastic/genomic junction regions. This analysis showed that it is unlikely that the eight putative ORFs are expressed in soybean A2704-12. Even in the unlikely event that expression did occur, any resulting polypeptides would show no significant sequence homology with known toxins or allergens. The GMO Panel is of the opinion that the molecular characterisation of the DNA insert and flanking regions of soybean A2704-12 does not raise safety concerns, and sufficient evidence for the stability of the insert structure and of the newly introduced trait was provided. The GMO Panel assessed the results of the compositional analysis of A2704-12 soybean and its comparator in the light of the field trial design, measured biological variation and the level of the studied compounds in conventional soybean varieties, and concludes that A2704-12 soybean is compositionally equivalent to the non-GM counterpart except for the introduced trait. No toxicity of the PAT protein was observed in a single dose acute toxicity study in mice using intravenous injection. Furthermore, the PAT protein is rapidly degraded under simulated gastric and intestinal conditions. The PAT protein shows no homology with known toxic proteins and/or allergens. The PAT protein has been extensively assessed in previous opinions of the EFSA GMO Panel and no concerns were raised concerning the safety of the PAT protein. Furthermore in vitro allergenicity testing of extracts of A2704 12 soybeans showed no changes in allergenicity. The application EFSA-GMO-NL-2005-18 is for food and feed uses, import and processing. There is therefore no requirement for scientific information on possible environmental effects associated with the cultivation of soybean A2704-12. Considering the scope of the application, the GMO Panel is of the opinion that the likelihood of the spread and establishment of soybean A2704-12 is very low and that unintended environmental effects due to this soybean will be no different from that of conventional soybean varieties. The scope of the monitoring plan provided by the applicant and the reporting intervals are in line with the intended uses of soybean A2704-12 since cultivation is excluded. In conclusion, taking into account all of the data assessed, the GMO Panel considers that the information available for soybean A2704-12 addresses the scientific comments raised by the Member States and that the soybean A2704-12 is as safe as its non genetically modified counterpart with respect to potential effects on human and animal health or the environment. Therefore the GMO Panel concludes that soybean A2704-12 is unlikely to have any adverse effect on human and animal health or on the environment in the context of its intended uses.