Application A1302 seeks approval for the sale and use of food derived from corn line MZIR260 that has been genetically modified (GM) for protection against lepidopteran insect pest. 
Protection against lepidopteran insect pests is conferred by the expression of the eCry1Gb.1Ig-03 gene encoding the insecticidal eCry1Gb.1Ig protein. The eCry1Gb.1Ig-03 gene is composed of two sequences from Bacillus thuringiensis: (1) the cry1Gb gene; and (2) the cry1Ig gene. MZIR260 also expresses the phosphomannose isomerase (PMI) protein from Escherichia coli strain K-12 as a selectable marker. The PMI protein has been assessed previously by Food Standards Australia New Zealand (FSANZ). This is the first time FSANZ has assessed the eCry1Gb.1Ig protein. 
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 eCry1Gb.1Ig (eCry1Gb.1Ig-03) and PMI (pmi-15) were introduced into corn line MZIR260 via Agrobacterium-mediated transformation. Molecular analyses indicate that a single copy of each of the linked eCry1Gb.1Ig-03 and pmi-15 expression cassettes is present at a single insertion site in the MZIR260 genome. There are no extraneous plasmid sequences 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 
Both eCry1Gb.1Ig and PMI are expressed throughout MZIR260. Expression levels are low in grain. Bioinformatic studies confirmed the lack of any significant amino acid sequence similarity between eCry1Gb.1Ig and known protein toxins or allergens. Laboratory studies demonstrated that the eCry1Gb.1Ig protein is susceptible to the action of digestive enzymes and would be thoroughly degraded before being absorbed during passage through the gastrointestinal tract. eCry1Gb.1Ig is also susceptible to heat inactivation at temperatures typically used in food processing. 
Characterisation studies confirmed that the PMI protein is identical to proteins previously assessed by FSANZ. Updated bioinformatic analyses for the PMI protein are consistent with previous analyses showing that this protein has no significant homology with any known allergens or toxins. 
 Taken together, the evidence supports the conclusion that eCry1Gb.1Ig and PMI are not toxic or allergenic to humans. 

Compositional analyses  
Detailed compositional analyses were performed on MZIR260. Statistically significant differences were found between grain from MZIR260 and the control for 11 of the 58 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 MZIR260 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 insect-protected corn line MZIR260. On the basis of the data provided in the present application and other available information, food derived from MZIR260 is considered to be as safe for human consumption as food derived from conventional non-GM corn cultivars.