187. 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.

188. Uncertainty in risk assessments can arise from incomplete knowledge or inherent biological variability1 . For field trials, because they are often at an early, proof-of-concept stage and involve further experimentation, 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.

189. For DIR 092 which involves early stage research, uncertainty exists in relation to the characterisation of:

  • Event 1, regarding potential increases in allergenicity or intolerance of ingested or inhaled wheat flour as a result of the introduced RNAi constructs, particularly those targeting gliadins
  • Event 2, associated with a potential for increased weediness of the GMOs
  • Event 7, due to incomplete molecular characterisation of the GMOs.
190. 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 wheat lines if they are selected for further development.

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

1A more detailed discussion is contained in the Regulator’s Risk Analysis Framework (OGTR 2007) available at Documents relating to the Risk Assessment process or via Free call 1800 181 030.