Background 
Application A1287 seeks approval for the sale and use of food derived from corn line MON94804 that has been genetically modified (GM) to have reduced overall plant height. The short stature of MON94804 is due to the presence of one novel substance: the GA20ox_SUP microRNA (miRNA). This miRNA suppresses two genes involved in the synthesis of gibberellin (GA), a plant hormone involved in plant growth and development. The resulting decrease in GA levels in the stalk leads to an overall reduction in plant height. The GA20ox_SUP miRNA has not been previously 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 DNA sequence encoding the GA20ox_SUP miRNA (GA20ox_SUP) was introduced into corn line MON94804 via Agrobacterium-mediated transformation. This transformation also introduced a selectable marker cassette that was subsequently removed using the Cre/lox recombination system. Molecular analyses indicate that a single copy of the GA20ox_SUP cassette is present at a single insertion site in the MON94804 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 
Corn line MON94804 expresses an inverted repeat RNA sequence from the GA20ox_SUP cassette which is processed into a mature 21 nucleotide GA20ox_SUP miRNA. The mature miRNA is detectable in a variety of tissues from MON94804, as is the larger unprocessed primary miRNA transcript. The GA20ox_SUP miRNA exerts its function by suppressing the corn ZmGA20ox3 and ZmGA20ox5 genes, which are involved in GA biosynthesis, via RNA interference (RNAi). Statistically significant reductions in mRNA levels from both genes were observed in a number of MON94804 tissues. The suppression of ZmGA20ox3 and ZmGA20ox5 by GA20ox_SUP miRNA was also shown to be specific to these target genes. There are no concerns regarding the safety of the GA20ox_SUP miRNA in MON94804. The data provided do not indicate the miRNA possesses 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 MON94804. Statistically significant differences were found between grain from MON94804 and the non-GM control for 4 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 MON94804 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 short-stature corn line MON94804. On the basis of the data provided in the present application and other available information, food derived from MON94804 is considered to be as safe for human consumption as food derived from conventional non-GM corn cultivars