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Health Canada has notified Aventis CropScience Canada, that it has no objection to the food use of soybean lines A2704-12 and A5547-127, which have been developed to be tolerant to the broad spectrum herbicide glufosinate ammonium. The Department conducted a comprehensive assessment of these soybean lines according to the Guidelines for the Safety Assessment of Novel Foods. These Guidelines are based upon internationally accepted principles for establishing the safety of foods with novel traits.
The following provides a summary regarding the Aventis CropScience Canada notification to Health Canada and contains no confidential business information.
The soybean lines A2704-12 and A5547-127 were developed through a specific genetic modification to be tolerant to glufosinate ammonium. The soybean plants have been transformed with a bacterial gene, phosphinothricin -N-acetyltransferase (PAT), that confers resistance to the glufosinate ammonium herbicides. The soybeans will be used in the same food applications as conventional soybeans.
Transformation events A2704-12 and A5547-127 were created using particle mediated transformation to introduce plasmid DNA into soybean cells. The inserted DNA sequence consists of the pat gene, a partial copy of the bla (b-lactamase) marker gene, and a bacterial origin of replication for cloning purposes in Escherichia coli. The pat gene is derived from Streptomyces viridochromogenes strain TŘ 494 and codes for the PAT enzyme which detoxifies L-phosphonitricin, the active ingredient in the herbicide glufosinate ammonium. This gene has been altered with plant codons for increased expression without altering the amino acid profile of the protein. The bla marker gene was originally isolated from pBR322 a plasmid of Escherichia coli. This gene confers resistance against b-lactam antibiotics (penicillin, ampicillin, etc.) and is commonly used as a selectable marker. As expected, the transformed plant events do not express the b-lactamase protein as an entire bla sequence has not been inserted into the plant genome. In addition, the bla gene in under the control of a bacterial promoter and would not be expressed in eukaryotic cells.
Two copies of the pat gene were detected in the genome of soybean event A2704-12. Event A5547-127 was found to have one copy of the pat gene.
Compositional analyses demonstrated that the levels of significant constituents (macro and micro nutrients, endogenous toxicants and anti-nutrients) for the modified soybean lines falls within the anticipated range for unmodified soybean varieties. The novel protein PAT is present at very low levels (0.003% of the crude protein) in soybean seed. Processed soybean fractions contained 2 to 3 orders of magnitude less PAT protein than the unprocessed seed.
Glufosinate ammonium tolerant soybean lines are expected to be used in similar applications as traditional soybean varieties by the food industry and will not result in a change in consumption patterns or dietary exposure.
Compositional analysis included the following data; calcium, phosphorous, potassium, amino acid profile, proximate analysis, fatty acid profile, stacchyose, raffinose, phytic acid, trypsin inhibitor, isoflavones and lectin. Based on the submitted data, there is no scientific evidence to suggest that the composition of the modified soybean lines is different from that of unmodified soybean lines. Soybean lines A2704-12 and A5547-127 should have no significant impact on the nutritional qaulity of the Canadian food supply.
The petitioner has provided data to indicate that there are no allergy or toxicity concerns with soybean lines A2704-12 and A5547-127. The allergenicity, digestive fate and acute toxicity of the PAT protein expressed in the modified lines has been addressed. The pat gene has been previously approved by Health Canada for use in genetically modified corn and canola lines. Based on the extremely low level of exposure to the PAT protein from the soybean lines, its lack of toxicity and unlikelihood of allergenicity, there is no toxicological concern with respect to human consumption.
Health Canada's review of the information presented in support of the food use of glufosinate tolerant soybean lines A2704-12 and A5547-127, concluded that this line does not present human food safety concerns. Health Canada is of the opinion that products from these soybean lines are as safe and nutritious as those made from currently available commercial soybean varieties. Health Canada=s opinion pertains only to the food use of glufosinate ammonium tolerant soybean lines A20704-12 and A5547-127. Issues relating to growing these soybean lines in Canada and their use as animal feed are addressed separately through existing regulatory processes in the Canadian Food Inspection Agency.