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
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.