Option B: Risk-tiering model – dealings with GMOs would be classified into three authorisation pathways according to their indicative risk
Would Option B address the identified policy problems?
Would Option B address the identified policy problems?
Yes as long as the workflow for approvals is simple and clear.
Please outline any additional impacts of Option B that have not been identified in the current impact analysis.
Please outline any additional impacts of Option B that have not been identified in the current impact analysis.
Difficult to provide. Intuitively once a more streamlined approval process is in place, administrative and governance costs would be lower, but we can’t know until we see the new workflow.
How might Option B promote science innovation?
How might Option B promote science innovation?
More efficient approval processes will allow researchers to spend more time doing research. More money will be spent on the value-adding part of research as regulatory costs/time to meet compliance obligations should be reduced.
Key consultation questions
In your opinion, what Option offers the greatest net benefit? Please provide reasons supporting your choice.
In your opinion, what Option offers the greatest net benefit? Please provide reasons
Option B seems to provide the greatest net benefit. There is less categorisation of dealings, which are easier to understand. As long as there is sufficient supplementary information to provide clear examples of the types of dealings, authorisation should be simpler and more efficient. The administrative burden would seem to be the lowest of the three options. Option C, although it may clarify some of the grey areas of approval, in particular clinical trials and medical applications, seems to be the most complex of the options, based upon the authorisation pathways (attachment A). Furthermore, option C does not address all the issues of categorisation, as outlined in attachment B. Regulatory agencies working together to streamline approval process and reduce duplication should also help. The improved throughput of approvals from option B should make it easier to perform GMO research in Australia. A simplified process with greater consistency of application should also improve the safety of GMO research to humans and the environment.
Proposed new definition of 'gene technology'
Does the proposed definition of gene technology address the issues identified?
Does the proposed definition of gene technology address the issues identified?
Adding creation (of genes or other genetic material) covers chemically synthesised organisms.
Maintaining plasticity in the regulations as to what is and is not gene technology may help with reacting quickly to new technologies and concepts.
Maintaining plasticity in the regulations as to what is and is not gene technology may help with reacting quickly to new technologies and concepts.
Would interpretative guidance on the definition of gene technology issued by the Regulator be adequate, or should the Regulator have the capacity to make binding determinations that something is or is not a technique for the modification of genes or genetic material?
Would interpretative guidance on the definition of gene technology issued by the Regulator be adequate, or should the Regulator have the capacity to make binding determinations that something is or is not a technique for the modification of genes or genetic material?
Binding determinations from the regulator would be less prone to inconsistencies in interpretation between organisations. On the other hand, interpretive guidance may offer greater flexibility in different institutions to meet requirements in a safe and compliant manner.
Proposed new definition of 'genetically modified organism'
Does the proposed definition of GMO address the issues identified?
Does the proposed definition of GMO address the issues identified?
Yes
Proposed new definition of 'deal with"
Does consolidating the definition of deal with into the concepts of make, supply and use address the issues identified?
Does consolidating the definition of deal with into the concepts of make, supply and use address the issues identified?
For lay people or people having not dealt with the GT scheme before, the consolidated definitions may be conceptually easier to understand. For people that are used to the current definitions, there may not be much difference. Adding to the definition “store the GMO” and “release to the GMO into the environment” is useful.
Is it preferable to consider the role of other regulators through the consideration of risk in the new pathways described in Chapter 4, or should the intersection be addressed through a revised definition of deal with?
Is it preferable to consider the role of other regulators through the consideration of risk in the new pathways described in Chapter 4, or should the intersection be addressed through a revised definition of deal with?
Consider the role of other regulators to streamline approvals for dealings that cover multiple regulatory bodies. Duplication of review and approval across regulatory agencies is a drag on productivity. Regulators should work together to ensure the most efficient approval pathways.
Proposed authorisation pathway for non-notifiable dealings
What types of dealings would be appropriate to include in the non-notifiable pathway for Option B?
What types of dealings would be appropriate to include in the non-notifiable pathway for Option B?
The current list of exempt dealings. Knock-out and knock-in PC1 mouse models could be considered as exempt.
What are the relevant risk indicators (to be established in the GT Act) that could guide the Regulator’s determination of what is a very low risk dealing?
What are the relevant risk indicators (to be established in the GT Act) that could guide the Regulator’s determination of what is a very low risk dealing?
Low chance of unintentional exposure to non-target organisms, low risk of genomic integration from exposure, little to no environmental or human health impact if integration or release does occur.
Under Option C, what are the advantages and disadvantages of first categorising the dealing in the context of the non-notifiable dealing authorisation pathway?
Under Option C, what are the advantages and disadvantages of first categorising the dealing in the context of the non-notifiable dealing authorisation pathway?
This should reduce the burden of approval for non-notifiable dealings, particularly in the clinical trials and medical applications category, which are all currently licenced.
Proposed authorisation pathway for notifiable dealings
What types of dealings would be appropriate to include in the notifiable pathway for Option B?
What types of dealings would be appropriate to include in the notifiable pathway for Option B?
Current NLRD dealings. Potentially some currently low risk licenced dealings that are clinical trials based (eg GMO vaccines) may be able to be added to notifiable if the consensus is they are low risk.
What are the relevant risk indicators (principles) that could be considered in determining what a low risk dealing is for the purposes of categorisation as a notifiable dealing?
What are the relevant risk indicators (principles) that could be considered in determining what a low risk dealing is for the purposes of categorisation as a notifiable dealing?
Low chance of un-intentional exposure to non-target organisms, low to medium risk of genomic integration from exposure, low to moderate risk of environmental or human health impact if integration or release occurs
Essential Enablers
What current processes (that are unnecessarily burdensome) could be resolved by an improved IT system?
What current processes (that are unnecessarily burdensome) could be resolved by an improved IT system?
Improving the DNIR approval flow could be helpful. Real time indicators of application progress, and faster assessment would be better.