126. 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 (consequence and likelihood) are always uncertain to some degree.

127. Uncertainty in risk assessments can arise from incomplete knowledge or inherent biological variability3. 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.

128. For DIR 121, uncertainty is noted particularly in relation to:

  • Risk Scenario 1, regarding unintended effects potentially leading to increases in toxicity or allergenicity
  • Risk Scenario 2, regarding unintended phenotypic changes with the potential for increasing weediness of the GMOs
  • Risk Scenario 3, regarding the potential for gene flow via pollen over long distance.
129. Additional data, including information to address these uncertainties, may be required to assess possible future applications for a larger scale trial, reduced containment conditions, or the commercial release of these GM safflower lines if they are selected for further development.

130. Chapter 3, Section 4 discusses information that may be required for future release.


3A more detailed discussion is contained in the Regulator’s Risk Analysis Framework available from the OGTR website or via Free call 1800 181 030.