Background 
Application A1303 seeks approval for the sale and use of food derived from sugar beet line KWS20-1 that has been genetically modified (GM) for tolerance to the herbicides dicamba, glufosinate and glyphosate. 
Tolerance to these herbicides in KWS20-1 is conferred thorough expression of the: 
 • dmo gene from Stenotrophomonas maltophilia, which encodes a dicamba monooxygenase (DMO) protein and provides tolerance to dicamba; 
• pat gene from Streptomyces viridochromogenes, which encodes a phosphinothricin-Nacetyltransferase (PAT) protein and provides tolerance to glufosinate; 
• cp4 epsps gene from Agrobacterium sp. strain CP4, which encodes a 5- enolpyruvylshikimate-3-phosphate synthase protein (CP4 EPSPS) and provides tolerance to glyphosate. 
Food Standards Australia New Zealand (FSANZ) has previously assessed the DMO, PAT and CP4 EPSPS proteins. 
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 
Sugar beet has a long history of safe use in the food supply. The major food product derived from sugar beet is refined sugar (sucrose), which is consumed in large quantities worldwide. The byproducts of sugar beet processing – molasses and pulp – are primarily used as animal feed. 

Molecular characterisation 
The genes encoding DMO (dmo), PAT (pat) and CP4 EPSPS (cp4 epsps) were introduced into sugar beet line KWS20-1 via Agrobacterium-mediated transformation. Detailed molecular analyses indicate a single copy of each of the three gene cassettes is present at a single insertion site in the KWS20-1 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 
All three novel proteins (DMO, PAT and CP4 EPSPS) are expressed throughout KWS20-1 (except PAT which was not detected in harvestable root tissue). Expression levels for DMO and CP4 EPSPS were also lowest in harvestable root. 
Characterisation studies confirmed that the PAT and CP4 EPSPS proteins are identical to proteins previously assessed by FSANZ, while the DMO protein expressed in KWS20-1 is highly similar to DMO proteins previously assessed by FSANZ. All proteins are rapidly degraded and heat inactivated, based on studies submitted with this application and/or conclusions from previous assessments. Updated bioinformatics studies for all three 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 DMO, PAT and CP4 EPSPS are not toxic or allergenic to humans. 

Compositional analyses 
Detailed compositional analyses were performed on KWS20-1. Statistically significant differences were found between KWS20-1 and the non-GM control for 8 of the 28 analytes evaluated in root, however these differences were all within the range established for existing commercial non-GM sugar beet varieties. Overall, the compositional data support the conclusion that there are no biologically significant differences in the levels of key constituents in root from KWS20-1 compared to non-GM sugar beet varieties available on the market. 

Conclusion 
No potential public health and safety concerns have been identified in the assessment of herbicide-tolerant sugar beet line KWS20-1. On the basis of the data provided in the present application and other available information, food derived from KWS20-1 is considered to be as safe for human consumption as food derived from conventional non-GM sugar beet varieties.