236. Uncertainty is an intrinsic property of risk and is present in all aspects of risk analysis, including risk assessment, risk management and risk communication. Both dimensions of risk (i.e. consequence and likelihood) are always uncertain to some degree.

237. Uncertainty in risk assessments can arise from incomplete knowledge or inherent biological variability12. For field trials, because they involve the conduct of research, some knowledge gaps are inevitable. This is one reason they are required to be conducted under specific limits and controls to restrict the spread and persistence of the GMOs and their genetic material in the environment, rather than necessarily to treat an identified risk.

238. For DIR 095 which involves early stage research, uncertainty exists in relation to the characterisation of:

  • Event 1, regarding potential increases in toxicity or allergenicity as a result of the introduced genes or RNAi constructs
  • Event 2, associated with the potential for increased survival of the GMOs
  • Event 3, associated with the potential for altered dispersal of the GMOs
  • Event 4, associated with the potential for the expression of the introduced genes or RNAi constructs to alter the potential for sugarcane
  • Event 5, associated with the potential for expression of the introduced genes or RNAi constructs to alter reproduction in the GM sugarcane
  • Event 7, associated with the potential for any unintended effects as a result of changes in biochemistry, physiology or ecology of the GM sugarcane plants
239. Uncertainty associated with many of the events stems from potential changes in the risk context for the trial over the 15 year duration proposed by the applicant. This is further discussed in Chapter 3, Section 4.1.1.

240. Additional data, including information to address these uncertainties, would be required to assess possible future applications for a larger scale trial, reduced containment conditions, or the commercial release of these GM sugarcane plants if they are selected for further development.

241. Chapter 3, Section 5 discusses information that may be required for future releases.

12A more detailed discussion is contained in the Regulator’s Risk Analysis Framework (OGTR 2007) or via Free call 1800 181 030.