Introduction
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Contaminants and Risk Team, NSW Office of Environment and Heritage
Findings - Theme 1 - Technical Issues
Findings 3 to 7:
Response
Finding 6: Intentional release - post release monitoring.
We appreciate that post release monitoring is recognised as an issue for consideration. However, there needs to be explicit inclusion and discussion on the use of field trials to collect data that address issues raised in the RARMP. For example considering GM cotton plants, the specificity of the particular gene product as expressed in the plant (eg Bt toxins) needs to be assessed against target and non-target species in the field situation. There is a risk of unintended impacts/ effects on non-target species. This is best assessed using field trials to gather data. The field trials would give data spatially across a State in any one growing season, combined with temporal data considering trials that go for more than one year (trials are typically 2-3 years). To achieve this, relevant monitoring conditions need to be routinely included in the DIR licenses.
We appreciate that post release monitoring is recognised as an issue for consideration. However, there needs to be explicit inclusion and discussion on the use of field trials to collect data that address issues raised in the RARMP. For example considering GM cotton plants, the specificity of the particular gene product as expressed in the plant (eg Bt toxins) needs to be assessed against target and non-target species in the field situation. There is a risk of unintended impacts/ effects on non-target species. This is best assessed using field trials to gather data. The field trials would give data spatially across a State in any one growing season, combined with temporal data considering trials that go for more than one year (trials are typically 2-3 years). To achieve this, relevant monitoring conditions need to be routinely included in the DIR licenses.
Findings - Theme 2 - Regulatory Issues
Findings 8 - 15:
Response
Finding 8-Regulatory triggers
We note that discussion on product vs process triggers has been included. However, we do not support the conclusion that process triggers are maintained. For intentional environmental release of a GMO targeting invasive biota (e.g. in aquatic environments), the end-product rather than the process will become increasingly important. This is because advances in technologies are rapid, and often several technologies and processes are combined to achieve the end-product. Whilst the information on the processes is critical in informing risk, it is the end-product that needs to be assessed. As discussed in Finding 7, long term field trials over multiple generations is critical, but also needs to consider trials which include multiple species and species interactions. This is because behavioural responses and consequences can significantly influence intended outcomes. Also, risk of intentional release of GMO not only needs to be assessed under the assumption that the GMO function will work as intended, but also assess the risk if it does not work as effectively as intended (e.g. would release of a GMO that is an invasive species potentially result in propagation of that species in the environment if the GMO end-product does not function as effectively as intended). This is important in anticipation of the application techniques such as gene drives. Such relative risks need to be considered
We note that discussion on product vs process triggers has been included. However, we do not support the conclusion that process triggers are maintained. For intentional environmental release of a GMO targeting invasive biota (e.g. in aquatic environments), the end-product rather than the process will become increasingly important. This is because advances in technologies are rapid, and often several technologies and processes are combined to achieve the end-product. Whilst the information on the processes is critical in informing risk, it is the end-product that needs to be assessed. As discussed in Finding 7, long term field trials over multiple generations is critical, but also needs to consider trials which include multiple species and species interactions. This is because behavioural responses and consequences can significantly influence intended outcomes. Also, risk of intentional release of GMO not only needs to be assessed under the assumption that the GMO function will work as intended, but also assess the risk if it does not work as effectively as intended (e.g. would release of a GMO that is an invasive species potentially result in propagation of that species in the environment if the GMO end-product does not function as effectively as intended). This is important in anticipation of the application techniques such as gene drives. Such relative risks need to be considered
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
Findings 24-26: Coordination with other regulators
Consideration is given to how the OGTR intearacts with other Commonwealth agencies and jurisdictions. However, there needs to be greater discussion about how OGTR engages with State agencies. Currently each State has a nominated agency, that the OGTR deals with directly. Within any one State, the nominated agency collates comments from all other invited agencies. This causes unnecessary conflict between State agencies, as differing opinions on hazards identified and risk assessment is often seen as counter-productive.
Related to this is ‘Commercial in confidence’. The current restriction is far too narrow, only allowing the nominated State agency access to such information. Consequently, insufficient information is released to allow all agencies to inform the risk assessment.
Both issues can be rectified, by the OGTR dealing directly with all stakeholder agencies in any one State. This would result in each agency being able to give direct feedback to the OGTR. This would allow a more comprehensive identification of potential hazards for consideration in the RARMP, improving the risk assessment process. In addition, each agency would have access to ‘Commercial in Confidence’ information to better inform the risk assessment process.
Consideration is given to how the OGTR intearacts with other Commonwealth agencies and jurisdictions. However, there needs to be greater discussion about how OGTR engages with State agencies. Currently each State has a nominated agency, that the OGTR deals with directly. Within any one State, the nominated agency collates comments from all other invited agencies. This causes unnecessary conflict between State agencies, as differing opinions on hazards identified and risk assessment is often seen as counter-productive.
Related to this is ‘Commercial in confidence’. The current restriction is far too narrow, only allowing the nominated State agency access to such information. Consequently, insufficient information is released to allow all agencies to inform the risk assessment.
Both issues can be rectified, by the OGTR dealing directly with all stakeholder agencies in any one State. This would result in each agency being able to give direct feedback to the OGTR. This would allow a more comprehensive identification of potential hazards for consideration in the RARMP, improving the risk assessment process. In addition, each agency would have access to ‘Commercial in Confidence’ information to better inform the risk assessment process.