Background 
Application A1262 seeks approval for the sale and use of food derived from genetically modified (GM) corn line MON95275 that is protected against coleopteran insect pests, primarily western corn rootworm (WCR). Protection against coleopteran insect pests is conferred by the expression in the plant of three novel substances: the Mpp75Aa1.1 protein (encoded by the mpp75Aa1.1 gene) from Brevibacillus laterosporus, the Vpb4Da2 protein (encoded by the vpb4Da2 gene) from Bacillus thuringiensis and DvSnf7, and a double stranded RNA (dsRNA) that specifically silences the WCR DvSnf7 gene via RNA interference (RNAi). These novel substances cause midgut damage specifically in corn rootworm larvae. While FSANZ has assessed and approved numerous insecticidal proteins with a similar mechanism of action in a variety of plant species, the mpp75Aa1.1 and vpb4Da2 genes have not previously been assessed by FSANZ. DvSnf7 dsRNA has been previously assessed by FSANZ (Application A1097). 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 Mpp75Aa1.1 (mpp75Aa1.1) and Vpb4Da2 (vpbDda2), along with the DNA sequences encoding DvSnf7 dsRNA (DvSnf7.1) were introduced into corn line MON95275 via Agrobacterium-mediated transformation. This transformation also introduced a selectable marker cassette that was subsequently removed using the Cre/lox recombination system. 2 Detailed molecular analyses of corn line MON95275 indicate that a single copy of each of the linked mpp75Aa1.1, vpb4Da2, and DvSnf7.1 cassettes is present at a single insertion site in the genome. There are no extraneous plasmid sequences, selectable marker cassettes, Cre recombinase, nor 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 
Mpp75Aa1.1 and Vpb4Da2 are newly expressed proteins present in MON95275. They are expressed at a low level in grain, 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 Mpp75Aa1.1 and Vpb4Da2 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 Mpp75Aa1.1 and Vpb4Da2 are not toxic or allergenic in humans. 

DvSnf7 dsRNA 
The 240 bp DvSnf7 dsRNA expressed in MON95275 triggers RNAi specifically in corn rootworms from the genus Diabrotica. The safety of the DvSnf7 dsDNA has been previously assessed by FSANZ (Application A1097). The available data do not indicate the dsRNA expressed in this line possess different characteristics, or is likely to pose a greater risk, than other RNAi mediators naturally present in corn. 

Compositional analyses 
Detailed compositional analyses were performed on MON95275. Statistically significant differences were found between grain from MON95275 and the control for 7 of the 68 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 MON95275 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 MON95275. On the basis of the data provided in the present application and other available information, food derived from MON95275 is considered to be as safe for human consumption as food derived from non-GM corn cultivars.