138. 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.

139. Uncertainty in risk assessments can arise from incomplete knowledge or inherent biological variability. For field trials, because they involve the conduct of research, some knowledge gaps are inevitable5. 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.

140. For DIR 113, the primary purpose of which is to undertake research, uncertainty is noted particularly in relation to the characterisation of:

    • Risk scenario 2, regarding potential increases in toxicity to non-target invertebrates as a result of the combination of the introduced insect resistance genes
    • Risk scenario 4, regarding potential increases in toxicity to non-target invertebrates and/or weediness as a result of gene transfer to commercially approved GM cotton varieties leading to expression of new combinations of stacked insect resistance genes.
    • Risk scenario 5, associated with the potential for any unintended effects as a result of changes to biochemistry, physiology or ecology of the GM cotton plants, particularly levels of toxins and nutrients.
141. 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 cotton varieties if they are selected for further development.

142. Chapter 3, Section 4 discusses information that may be required for future releases.


5A more detailed discussion is contained in the Regulator’s Risk Analysis Framework available via Free call 1800 181 030.