Uncertainty can also arise from a lack of experience with the GMO itself. In regards to MON 88302 canola, the level of uncertainty is considered to be low given that this GMO has been approved for commercial production in the United States and Canada. In addition, the Roundup Ready® canola, which contains the same gene, has been commercially cp4 epsps grown in Australia and overseas (eg Canada and the USA) for many years without adverse effects for human health and safety or the environment. The uncertainty has been taken into account in assessment of risk scenarios, and is not sufficient to affect the conclusions on the overall level of risk. Risk evaluation Risk is evaluated against the objective of protecting the health and safety of people and the environment to determine the of concern and, subsequently, the need for controls to mitigate or reduce risk. Risk evaluation may also aid consideration of whether the proposed dealings should be authorised, need further assessment, or require collection of additional information. Factors used to determine risks need treatment may include: risk criteria level of risk uncertainty associated with risk characterisation interactions between substantive risks. Five risk scenarios were postulated whereby the proposed dealings might give rise to harm to people or the environment. The level of risk for each scenario was considered negligible in relation to both the seriousness and likelihood of harm, and by considering both the short and long term. The principal reasons for these conclusions are summarised in Table 3. The (OGTR 2013a), which guides the risk assessment and risk Risk Analysis Framework management process, defines negligible risks as insubstantial with no present need to invoke actions for their mitigation. Therefore, no controls are required to treat these negligible risks. Therefore, the Regulator considers that the dealings involved in this proposed release do not pose a significant risk to either people or the environment.
Uncertainty can also arise from a lack of experience with the GMO itself. In regards to MON 88302 canola, the level of uncertainty is considered to be low given that this GMO has been approved for commercial production in the United States and Canada. In addition, the Roundup Ready® canola, which contains the same cp4 epsps gene, has been commercially grown in Australia and overseas (eg Canada and the USA) for many years without adverse effects for human health and safety or the environment. The uncertainty has been taken into account in assessment of risk scenarios, and is not sufficient to affect the conclusions on the overall level of risk. Risk evaluation Risk is evaluated against the objective of protecting the health and safety of people and the environment to determine the of concern and, subsequently, the need for controls to mitigate or reduce risk. Risk evaluation may also aid consideration of whether the proposed dealings should be authorised, need further assessment, or require collection of additional information. Factors used to determine risks need treatment may include: risk criteria level of risk uncertainty associated with risk characterisation interactions between substantive risks. Five risk scenarios were postulated whereby the proposed dealings might give rise to harm to people or the environment. The level of risk for each scenario was considered negligible in relation to both the seriousness and likelihood of harm, and by considering both the short and long term. The principal reasons for these conclusions are summarised in Table 3. The Risk Analysis Framework (OGTR 2013a), which guides the risk assessment and risk management process, defines negligible risks as insubstantial with no present need to invoke actions for their mitigation. Therefore, no controls are required to treat these negligible risks. Therefore, the Regulator considers that the dealings involved in this proposed release do not pose a significant risk to either people or the environment.
dir127rarmp.docx