Following the submission of an application (EFSA-GMO-NL-2008-52) under Regulation (EC) No 1829/2003 from Bayer CropScience, 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 herbicide tolerant genetically modified (GM) soybean A5547-127 (Unique Identifier ACS-GM∅∅6-4) for food and feed uses, import and processing.
In delivering its scientific opinion, the EFSA GMO Panel considered the application EFSA-GMO-NL-2008-52, additional information supplied by the applicant, scientific comments submitted by the Member States, and relevant scientific publications. The scope of application EFSA-GMO-NL-2008-52 is for food and feed uses, import and processing of soybean A5547-127 within the European Union as any non-GM soybean but excludes cultivation in the EU. The EFSA GMO Panel evaluated soybean A5547-127 with reference to the intended uses and appropriate principles described in its Guidance Document of the Scientific Panel on Genetically Modified Organisms for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed (EFSA, 2006a). The scientific evaluation of the risk assessment included molecular characterisation of the inserted DNA and expression of the corresponding proteins. An evaluation of the comparative analysis of composition, phenotypic and agronomic characteristics was undertaken, and the safety of the new proteins and the whole food/feed was evaluated with respect to potential toxicity, allergenicity and nutritional wholesomeness. An evaluation of the environmental impacts and the post-market environmental monitoring plan were undertaken.
Soybean A5547-127 was transformed using particle bombardment. Soybean A5547-127 expresses the pat gene leading to the production of the enzyme phosphinothricin acetyl-transferase (PAT) that acetylates L-glufosinate. The PAT enzyme confers tolerance to glufosinate-ammonium containing herbicides.
The molecular characterisation data establish that the genetically modified soybean A5547-127 contains one copy of an intact pat expression cassette in a single insertion locus. Other parts of the plasmid used for transformation and present in soybean A5547-127, include two truncated, non-functional parts of the beta-lactamase (bla) gene on each side of the pat expression cassette. Bioinformatic analysis of the open reading frames spanning the junctions created as results of the transformation did not raise safety concerns. The stability of the inserted DNA was confirmed over several generations. Analysis of the levels of the PAT protein in seed from a field trial performed in the USA did not raise safety concerns.
Based on the results of a comparative analysis of data, the EFSA GMO Panel concludes that from the compositional point of view, the differences observed between the soybean A5547-127 and the conventional counterpart were not consistent across sites and years and fell within the range of natural variation of soybean. From the phenotypic and agronomic points of view, the EFSA GMO Panel concludes that soybean A5547-127 is phenotypically and agronomically not different from its conventional counterpart A5547, with the exception of the newly introduced trait.The PAT protein is quickly degraded in simulated gastric and intestinal fluids without leaving stable peptide fragments. Bioinformatics-supported studies demonstrated that the PAT protein shows no homology to known toxic and allergenic proteins. It also induced no toxicity when administered orally to mice in a repeated dose toxicity study. Testing the reaction of sera from soybean-allergic patients to extracts from soybeans A5547-127 and A5547 and commercial soybean varieties demonstrated that the overall allergenicity of soybean A5547-127 is not different from that of the conventional counterpart and commercial soybean varieties. A feeding study on broiler chickens confirmed that soybean A5547-127 is as nutritional as soybean A5547. The EFSA GMO Panel is of the opinion that soybean A5547-127 is as safe as its conventional counterpart and commercial varieties based on data from literature.
The application EFSA-GMO-NL-2008-52 is for food and feed uses, import and processing. Therefore, there is no requirement for scientific information of possible environmental effects associated with the cultivation of soybean A5547-127. There are no indications of an increased likelihood of establishment and spread of feral soybean plants in case of accidental release into the environment of viable seeds of soybean A5547-127 (e.g.; during transportation and processing), except in the presence of glufosinate-ammonium containing herbicides. Taking into account the scope of the application, the rare occurrence of feral soybean plants and the low levels of exposure through other routes, the risk to non-target organisms is extremely low. 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 EFSA GMO Panel agrees with the reporting intervals proposed by the applicant in the general surveillance plan. The EFSA GMO Panel recommends that appropriate management systems should be in place to restrict seeds of soybean A5547-127 entering cultivation as the latter requires specific approval under Directive 2001/18/EC or Regulation (EC) No 1829/2003.
In conclusion, 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.