Background 
Application A1310 seeks approval for the sale and use of food derived from soybean line MON94637 that has been genetically modified (GM) for protection against lepidopteran insect pest. 
Protection is conferred by the expression of cry1A.2 and cry1B.2 genes encoding two novel insecticidal proteins: Cry1A.2 and Cry1B.2, respectively. The Cry1A.2 and Cry1B.2 are chimeric proteins comprised of multiple domains from different Cry proteins from the soil bacterium Bacillus thuringiensis. This is the first time Food Standards Australia New Zealand (FSANZ) has assessed the Cry1A.2 and Cry1B.2 proteins. 
This safety assessment addresses food safety and nutritional issues associated with GM food. It therefore does not address: 
 • risks related to the environmental release of GM plants used in food production 
• risks to animals that may consume feed derived from GM plants 
• the safety of food derived from the non-GM (conventional) plant. 

History of use 
Soybean has a long history of safe use in the food supply. Soybean oil is widely used in cooking and as an ingredient in a wide range of manufactured products. Soybean grains are also used to make soy milk, soy sauce, soy lecithin and meat substitutes such as tofu and tempeh. 

Molecular characterisation 
The genes encoding Cry1A.2 (cry1A.2) and Cry1B.2 (cry1B.2) were introduced into soybean line MON94637 via Agrobacterium-mediated transformation. Detailed molecular analyses indicate a single copy of each of the two gene cassettes is present at a single insertion site in the MON94637 genome. There are no extraneous plasmid sequences or antibiotic resistance genes present in this line.
The introduced genetic elements were shown by molecular techniques and phenotypic analyses to be present within a single locus and stably inherited across multiple generations. 

Characterisation and safety assessment of new substances 
Both Cry1A.2 and Cry1B.2 proteins are expressed throughout the plant (except Cry1B.2 which was not detected in root tissue). Expression levels are low in grain. 
A range of characterisation studies confirmed the identity of the plant-expressed Cry1A.2 and Cry1B.2 proteins and their equivalence with the corresponding proteins produced in a bacterial expression system. The plant-derived and bacterially-derived proteins had the expected molecular weight, amino acid sequence, immunoreactivity, lack of glycosylation and enzyme activity. 
Both Cry1A.2 and Cry1B.2 proteins are rapidly degraded and heat inactivated, based on studies submitted with this application. Bioinformatics studies on the two proteins confirmed the lack of any significant amino acid sequence similarity to known protein toxins or allergens. Taken together, the evidence supports the conclusion that Cry1A.2 and Cry1B.2 are not toxic or allergenic to humans. 

Compositional analyses 
Detailed compositional analyses were performed on MON94637. Statistically significant differences in mean values were found between grain from MON94637 and the control for 3 of the 47 analytes evaluated, however these differences were within the range established for existing commercial non-GM soybean varieties. Overall, the compositional data support the conclusion that there are no biologically significant differences in the levels of key constituents in grain from MON94637 compared to non-GM soybean varieties available on the market. 

Conclusion 
No potential public health and safety concerns have been identified in the assessment of insect-protected soybean line MON94637. On the basis of the data provided in the present application and other available information, food derived from MON94637 is considered to be as safe for human consumption as food derived from non-GM soybean varieties.