121. The risk assessment begins with postulation of potential pathways that might lead to harm to the health and safety of people or the environment during the proposed release of GMOs due to gene technology, and how it could happen, in comparison to the parent organism and within the context of the receiving environment.

122. Three risk scenarios were postulated whereby the proposed dealings might give rise to harm to people or the environment. This included consideration of whether expression of the introduced genetic elements 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 it occurred were also assessed.

123. A risk is only identified when a risk scenario is considered to have some chance of causing harm. Risk scenarios that do not lead to harm, or could not reasonably occur, do not represent an identified risk and do not advance any further in the risk assessment process.

124. The characterisation of the three risk scenarios in relation to both the seriousness and likelihood of harm, in the context of the control measures proposed by the applicant and considering both the short and long term, did not give rise to any identified risks that could be greater than negligible and required further assessment. The principal reasons for this include:

  • limits on the size, locations and duration of the release proposed by CSIRO
  • controls proposed by CSIRO to restrict the spread and persistence of the GM safflower plants and their genetic material
  • the genetic modifications are unlikely to give rise to adverse effects on human health and safety or the environment
  • widespread presence of the same and similar genes in the environment and lack of evidence of harm from them
  • limited ability and opportunity for the GM safflower plants to transfer the introduced genetic material to commercial safflower crops or wild safflower populations
  • none of the GM plant material or products will enter human food or animal feed supply chains.
125. Therefore, any risks to the health and safety of people, or the environment, from the proposed release of the GM safflower plants into the environment is 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.