Executive summary 
Application A1280 seeks approval for the sale and use of food derived from corn line DAS1131 that has been genetically modified (GM) for tolerance to the herbicide glyphosate and protection from lepidopteran insect pests. Protection against lepidopteran insect pests is conferred by the expression of the insecticidal cry1Da2 gene encoding the Cry1Da2 protein. The cry1Da2 gene is composed of two sequences from Bacillus thuringiensis: (1) the insecticidal core toxin sequence of the cry1Da2 gene; and (2) a segment of the cry1Ab gene. Tolerance to the herbicide glyphosate is achieved by the expression of the dgt-28 epsps gene encoding the enzyme 5- enolpyruvylshikimate-3-phosphate synthase (DGT-28 EPSPS) from Streptomyces sviceus. The Cry1Da2 and DGT-28 EPSPS proteins have not previously been assessed by FSANZ. This safety assessment addresses food safety and nutritional issues associated with the 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 
Corn has a long history of safe use in the food supply. Corn-derived products are routinely used in a large number and diverse range of foods e.g. cornflour, starch products, breakfast cereals and high fructose corn syrup. 

Molecular characterisation 
The genes encoding Cry1Da2 (cry1Da2) and DGT-28 EPSPS (dgt-28 epsps) were introduced into corn line DAS1131 via Agrobacterium-mediated transformation. Detailed molecular analyses of corn line DAS1131 indicate that a single copy of each of the linked cry1Da2 and dgt-28 epsps cassettes is present at a single insertion site in the genome. There are no extraneous plasmid sequences, selectable marker cassettes or antibiotic resistance marker 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 
Newly expressed proteins 
Cry1Da2 and DGT-28 EPSPS are newly expressed proteins present in DAS1131. Cry1aD2 is expressed at a low level in grain and at a high level in pollen, while DGT-28 EPSPS is expressed at a low level in roots and at a high level in leaf tissue. Bioinformatic studies confirmed a lack of any significant amino acid sequence similarity to known protein toxins or allergens. Laboratory studies demonstrated the Cry1Da2 and DGT-28 EPSPS proteins are susceptible to the action of digestive enzymes and would be thoroughly degraded before being absorbed during passage through the gastrointestinal tract. The proteins are also susceptible to heat denaturation and degradation at the high temperatures typically used in food processing. Taken together, the evidence supports the conclusion that Cry1Da2 and DGT-28 EPSPS are not toxic or allergenic to humans. 

Herbicide metabolites 
For glyphosate, the metabolic profiles resulting from the protein/herbicide interactions have been established through a significant history of use. There are no concerns that the spraying of corn line DAS1131 with glyphosate would result in the production of metabolites that are not also produced in the non-GM crops sprayed with the same herbicide and already used in the food supply. 

Compositional analyses 
Detailed compositional analyses were performed on DAS1131. Statistically significant differences were found between grain from DAS1131 and the control for 7 of the 70 analytes evaluated, however these differences were small and all within the range established for existing commercial non-GM corn cultivars. Overall, the compositional data support the conclusion that there are no biologically significant differences in the levels of key constituents in grain from DAS1131 compared to non-GM corn cultivars available on the market. 

Conclusion 
No potential public health and safety concerns have been identified in the assessment of herbicide-tolerant and insect-protected corn line DAS1131. On the basis of the data provided in the present application and other available information, food derived from DAS1131 is considered to be as safe for human consumption as food derived from conventional non-GM corn cultivars.