Scientific Opinion on application (EFSA-GMO-UK-2007-43) for the placing on the market of herbicide tolerant genetically modified soybean 356043 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Pioneer

This scientific opinion is an evaluation of a risk assessment for the genetically modified herbicide tolerant soybean 356043 for food and feed uses, import and processing. Soybean 356043 contains a single copy of intact gat4601 and Glycine max-hra cassettes at a single insertion locus. The results of the bioinformatic analyses of the insert and the flanking regions, and the levels of newly expressed proteins did not raise a safety concern. The comparative analysis of phenotypic and agronomic characteristics indicated that soybean 356043 is not different from its conventional counterpart. In the composition, differences were identified between 356043 soybean and its conventional counterpart in the newly expressed proteins Glycine max-HRA and GAT4601, and the levels of the fatty acids heptadecanoic, heptadecenoic and heptadecadienoic acid and the acetylated amino acids N-acetylaspartate (NAA) and N-acetylglutamate (NAG). The safety assessment of the newly expressed proteins Glycine max-HRA and GAT4601 identified no concerns regarding potential toxicity and allergenicity. Heptadecanoic, heptadecenoic and heptadecadienoic acid are present in the diet and the intake of small amounts of these fatty acids via food or feed is not expected to produce adverse effects. NAA and NAG are normal constituents in the mammalian metabolism and the estimated increases in their intake are considered low when related to the normal intake of L-aspartic acid and L-glutamic acid. Further toxicological, allergenicity and nutritional analysis provided no indications of adverse effects. There are no indications of an increased likelihood of establishment and spread of feral soybean plants, except in the presence of the glyphosate and ALS-inhibiting herbicides neither a risk caused by a possible transfer of the recombinant gene from soybean 356043 to environmental micro-organisms. The EFSA GMO Panel considers that the information available for soybean 356043 addresses the scientific comments raised by the Member States and states that the soybean 356043, 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.

© European Food Safety Authority, 2011

Following the submission of an application (EFSA-GMO-UK-2007-43) under Regulation (EC) No 1829/2003 from Pioneer, the EFSA Panel on Genetically Modified Organisms was asked to deliver a scientific opinion on the herbicide tolerant genetically modified (GM) soybean 356043 (Unique identifier DP-356Ø43-5) for food and feed uses, import and processing.

In delivering its scientific opinion, the EFSA GMO Panel considered the application EFSA-GMO-UK-2007-43, additional information supplied by the applicant and scientific comments submitted by Member States. The scope of application EFSA-GMO-UK-2007-43 is for food and feed uses, import and processing of soybean 356043 and all derived products, but excludes cultivation in the EU. The EFSA GMO Panel assessed soybean 356043 with reference to the intended uses and 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 (EFSA, 2006a). The scientific assessment included molecular characterisation of the inserted DNA and expression of target proteins. A comparative analysis of agronomic traits and composition was undertaken, and the safety of the new protein and the whole food/feed were evaluated with respect to potential toxicity, allergenicity and nutritional quality. An assessment of environmental impacts and the post-market environmental monitoring plan were undertaken.

The molecular characterisation data establish that the genetically modified soybean 356043 contains one copy of an intact gat4601 expression cassette and a Glycine max-hra (gm-hra) cassette in a single locus. No other parts of the plasmid used for transformation are present in the transformed plant. Bioinformatic analysis of the open reading frames spanning the junctions between the inserted DNA and soybean genomic DNA did not raise safety concerns. The stability of the inserted DNA and the herbicide tolerance trait were confirmed over several generations. Analyses of the levels of newly expressed proteins in various plant tissues collected from field trials performed in South- and North America did not raise safety concerns.

The EFSA GMO Panel concludes that no differences were identified between 356043 soybean and its conventional counterpart, except for the newly expressed proteins, for higher levels of the acetylated amino acids N-acetylaspartate (NAA) and N-acetylglutamate (NAG), and the odd-chain fatty acids heptadecanoic, heptadecenoic and heptadecadienoic acid in seed from 356043 soybean. The levels of these acetylated amino acids and odd chain fatty acids fall outside the natural ranges observed for other commercial non-GM soybean varieties. The overall level of NAA and NAG (taken together) in soybean 356043 was found to be less than 0.15 % of the total amino acids. The total level of odd chain fatty acids amounts to less than 1% of total fatty acids. No statistically significant differences in total amino acid contents in seed were observed between the 356043 soybean and its conventional counterpart. Levels of major fatty acids in 356043 soybean seed were found to be comparable to those observed in the conventional counterpart.

No toxicity of the GAT4601 and the Glycine max-HRA proteins was observed in acute oral toxicity studies and repeated-dose (28 days) feeding studies using mice. The studies on in vitro digestibility of the proteins showed that most of the proteins were degraded. In bioinformatics studies the proteins showed no homology to known toxic proteins and allergens.

The odd-chain fatty acids heptadecanoic, heptadecenoic and heptadecadienoic acid are normal constituents of plants and animals and have also been identified in human tissues. There is no information indicating that the intake of small amounts of these fatty acids via food or feed causes adverse effects. The EFSA GMO Panel is of the opinion that the estimated increases in intake levels of heptadecanoic, heptadecenoic and heptadecadienoic resulting from replacement of conventional soybean oil with oil from soybean 356043 do not raise safety concerns.

NAA and NAG are normal constituents in the mammalian metabolism. They are also present in conventional foodstuffs and thus consumed as part of a normal diet. The available scientific information indicates that under normal conditions NAA and NAG, like other N-acetylated amino acids, are deacetylated in the intestine to form the corresponding L-amino acids, which are further metabolised in the body. The oral toxicity of NAA and NAG has been tested in acute and subacute (28 days) studies using rats. In addition, NAA was tested in a subchronic (90 days) feeding study and in a study on reproductive and developmental toxicity (two generation study) using rats. Considering the outcome of a conservative intake assessment, the estimated increase in intake of NAA is more than 100 fold lower than the NOEL observed in the 90-day rat feeding study with NAA. Furthermore, in relation to the normal intake of L-aspartic acid and L-glutamic acid resulting from consumption of food protein, the estimated increases in the intake of NAA and NAG are considered low. Considering all the available information, the EFSA GMO Panel is of the opinion that the estimated increases in intake levels of NAA and NAG resulting from replacement of food products derived from conventional soybeans by the respective products derived from soybean 356043 do not raise safety concerns. The same conclusion applies to the use of feed materials derived from this genetically modified soybean.

Furthermore, a subchronic 92-day feeding study in rats using diets including meal and hulls derived from soybean 356043 provided no indications of adverse effects. Testing of extracts from soybeans 356043 with sera from patients allergic to soybean showed that the overall allergenicity of the whole plant had not been changed. A 42-day feeding study using broiler chickens demonstrated that soybean 356043 is nutritionally equivalent to its conventional counterpart and commercial non-GM soybean varieties included in this study. Therefore, the EFSA GMO Panel is of the opinion that soybean 356043 is as safe as its conventional counterpart with respect to potential effects on human and animal health in the context of its intended uses.

The application EFSA-GMO-UK-2007-43 is for food and feed uses, import and processing. Therefore, there is no requirement for scientific information on possible environmental effects associated with the cultivation of soybean 356043. 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 356043 (e.g. during transportation and processing), except in the presence of glyphosate and ALS-inhibiting 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. In the context of its intended uses, the theoretically possible transfer of the recombinant genes from soybean 356043 to gut or other environmental bacteria has not been identified to be a risk due to the lack of any selective advantage. 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 356043 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 356043 addresses the scientific comments raised by the Member States and that the soybean 356043, 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.

GMO, soybean, 356043, risk assessment, food and feed safety, environment, import and processing, Regulation (EC) No 1829/2003, GAT, Glycine max-HRA, NAA, NAG