133. 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.

134. Six risk scenarios were identified whereby the proposed dealings might give rise to harm to people or the environment. This included consideration of whether expression of the introduced genes 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.

135. 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.

136. The characterisation of the six risk scenarios in relation to both the seriousness and likelihood of harm, in the context of the limits and controls proposed by the applicant and considering both the short and the long term, did not give rise to any identified risks that warranted further assessment. The principal reasons for this include:

    • widespread presence of the same or homologous genes and proteins in the environment
    • toxicity of the proteins encoded by the introduced insect resistance genes is expected to be restricted to target insects and a limited range of related non-target insects
    • plant characteristics and abiotic factors limiting the ability of GM or non-GM cotton plants to establish and persist in non-cultivated environments
    • limited ability and opportunity for the GM cotton plants to transfer the introduced genes to commercial cotton crops or other cotton plants
    • limits on the size, locations and duration of the release proposed by Bayer
    • suitability of controls proposed by Bayer to restrict the spread and persistence of the GM cotton plants and their genetic material
    • none of the GM plant materials or products will enter commercial human or animal food supply chains.
137. Therefore, any risks to the health and safety of people, or the environment, from the proposed release of the GM cotton 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.