<p style="text-align: justify;">Soybean (<i>Glycine max</i>) was grown as a commercial crop in 84 countries in 2006 with a combined harvest of 220 million metric tonnes. The major producers of soybeans were the United States, Brazil, Argentina, China, India, Paraguay and Canada. Soybean is grown primarily for its seed which has many uses in the food and industrial sectors, and represents one of the major sources of edible vegetable oil and of proteins for livestock feed use.</p>

<p style="text-align: justify;">A major food use of soybean in North America and Europe is as purified oil, used in margarines, shortenings, and cooking and salad oils. It is also a major ingredient in food products such as tofu, tempeh, soya sauce, simulated milk and meat products, and is a minor ingredient in many processed foods. Soybean meal is used as a supplement in feed rations for livestock.</p>

<p style="text-align: justify;">Weeds are a major production problem in soybean cultivation. Typically, weeds are managed using a combination of cultural (<i>e.g.</i> seed bed preparation, using clean seed, variety selection, and planting date) and chemical controls. Depending on the production area and the prevalent weed species, herbicides may be applied before planting (<i>e.g.</i> pendimethalin, trifluralin, metribuzin), after planting but before emergence (<i>e.g.</i> pendimethalin, linuron, imazethapyr), and/or after emergence (<i>e.g.</i> bentazon, acifluorfen, fomesafen). Commonly, several different herbicides are required to adequately control weeds in soybean fields.</p>

<p style="text-align: justify;">The soybean line MON89788 was developed to allow for the use of glyphosate, the active ingredient in the herbicide Roundup&reg;, as a weed control option. This genetically engineered soybean line contains a form of the plant enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) that allows MON89788 to survive the otherwise lethal application of glyphosate. The EPSPS gene put into MON89788 was isolated from a strain of the common soil bacterium <i>Agrobacterium tumefaciens</i> called CP4 and the form of EPSPS enzyme produced by this gene is tolerant to glyphosate. This gene is the same as that used in the first glyphosate-tolerant soybean line GTS-40-3-2, however a different promoter has been used in MON88788 &ndash; a chimeric promoter containing the Figwort Mosaic Virus 35S enhancer and the promoter from the <i>Arabidopsis thaliana tsf1</i> elongation factor EF-1 alpha.</p>

<p style="text-align: justify;">The EPSPS enzyme is part of an important biochemical pathway in plants called the shikimate pathway, that is involved in the production of aromatic amino acids and other aromatic compounds. When conventional plants are treated with glyphosate, the plants cannot produce the aromatic amino acids needed to grow and survive. EPSPS is present in all plants, bacteria, and fungi. It is not present in animals, which do not synthesize their own aromatic amino acids. Because the aromatic amino acid biosynthetic pathway is not present in mammals, birds or aquatic life forms, glyphosate has little if any toxicity for these organisms. The EPSPS enzyme is naturally present in foods derived from plant and microbial sources.</p>

<p style="text-align: justify;">MON89788 was developed by introducing the CP4 EPSPS gene into a commercial soybean variety using <i>Agrobacterium tumefaciens</i>-mediated transformation of meristem-derived material from soybean variety A3244. A3244 is an elite maturity group III soybean variety which was developed and selected for transformation based on its superior agronomic performance over other soybean lines.</p>

<p style="text-align: justify;">MON89788 has been tested in field trials in the United States, starting in 2001. MON89788 soybean plants have been evaluated extensively to confirm that they exhibit the desired agronomic characteristics, that tolerance to glyphosate is stable under field conditions, and that they do not present a plant pest risk. The field tests weree conducted in agricultural settings under physical and reproductive confinement conditions.</p>

<p style="text-align: justify;">Soybean does not have any weedy relatives with which it can crossbreed in the continental United States and Canada. Cultivated soybean can naturally cross with the wild annual species <i>G. soja</i>, however <i>G. soja</i>, which occurs naturally in China, Korea, Japan, Taiwan and the former USSR, is not naturalized in North America. Additionally, soybean plants are almost completely self-pollinated and reproductive characteristics such as pollen production and viability were unchanged by the genetic modification resulting in MON89788. It was therefore concluded that the potential for transfer of the glyphosate tolerance trait from the transgenic line to soybean relatives through gene flow (outcrossing) was negligible in managed ecosystems, and that there was no potential for transfer to wild species in Canada and the continental United States.</p>

<p style="text-align: justify;">The food and livestock feed safety of MON89788 soybean was established based on; the lack of any sequence homology between the CP4 EPSPS protein and known toxin sequences: the fact that CP4 EPSPS protein constitutes a small amount of the protein in MON89788 soybeans so there is little dietary exposure; the lack of toxicity or allergenicity of EPSPS proteins from plants, bacteria and fungi; and by direct laboratory studies of the CP4 EPSPS protein. The nutritional equivalence and wholesomeness of MON89788 soybeans compared to conventional (non-GM) soybeans was demonstrated by the analysis of key nutrients, including proximates (<i>e.g.</i> protein, fat, fibre, ash, and carbohydrates), amino acid and fatty acid composition, as well as anti-nutrients.</p>
