183. The risk assessment begins with a hazard identification process to consider what harm to the health and safety of people or the environment could arise during this release of GMOs due to gene technology, and how it could happen, in comparison to the non-GM parent organism and in the context of the proposed receiving environment.

184. Eight events were identified whereby the proposed dealings might give rise to harm to people or the environment. This included consideration of whether, or not, expression of the introduced gene could result in products that are toxic or allergenic to people or other organisms; alter characteristics that may impact on the spread and persistence of the GM plants; or produce unintended changes in their biochemistry or physiology. The opportunity for gene flow to other organisms and its effects if this occurred was also assessed.

185. A risk is only identified when a hazard is considered to have some chance of causing harm. Events that do not lead to an adverse outcome, or could not reasonably occur, do not represent an identified risk and do not advance any further in the risk assessment process.

186. The characterisation of the eight events in relation to both the magnitude and probability of harm, in the context of the control measures proposed by the applicant, did not give rise to any identified risks that required further assessment. The principal reasons for this include:

  • limits on the size, location and duration of the release proposed by CSIRO
  • suitability of controls proposed by CSIRO to restrict the dissemination and persistence of the GM wheat plants and their genetic material
  • limited ability and opportunity for the GM wheat lines to transfer the introduced RNAi constructs to commercial wheat crops or other sexually related species
  • none of the GM plant materials or products will be used in human food or animal feed, with the exception of rat and pig nutritional studies, from which no material will enter the human food or animal feed supply chain
  • widespread presence of the same sequences from which the introduced RNAi constructs are composed in the environment and lack of known toxicity or evidence of harm from them.
Therefore, any risks of harm to the health and safety of people, or the environment, from the proposed release of the GM wheat lines into the environment are considered to be negligible. Hence, the Regulator considers that the dealings involved in this proposed release do not pose a significant risk to either people or the environment.