2. Simplifying Approval Processes for Laboratory Research
2.1 Summary
This section addresses two proposals recommended by the Royal Commission on Genetic Modification aimed at simplifying the approval processes for low-risk genetic modification that occurs in contained laboratories:
- group (project-based) approvals for the development of low-risk GMOs
- delegation of approval of importation of low-risk GMOs to Institutional Biological Safety Committees (IBSCs).
These proposals also aim to better align the procedures with the way scientific research actually takes place. Overall they would reduce unnecessary compliance costs without changing the scope of what would be permitted as low-risk work, or altering the level of permissible risk. Some related work suggested by the Royal Commission is already under way or has been completed (for example, new organism application forms and the standard covering safety practices in laboratories). Also, the HSNO (Low-Risk Genetic Modification) Regulations are being amended.
While the changes to the regulations go some way towards streamlining the approval process, the system may be further improved by changes to the HSNO Act itself. The following two sections address:
- how group approvals could be provided for instead of the current case-by-case approval of individual organisms
- how flexibility to use a range of low-risk procedures under one approval could be provided
- how the identification requirements for low-risk GMOs produced during the project could be simplified
- how approval of the importation of low-risk GMOs might be delegated to IBSCs.
It is proposed that, instead of focusing on the particular organisms being genetically modified, the HSNO approval process for low-risk experiments should focus on the broader circumstances or low-risk nature of the genetic modifications proposed in a research project. It is also proposed that a means be provided to vary the approval, where those circumstances change during the course of the research. The requirement to identify the organism resulting from the approved low-risk experiments would be removed or simplified.
The HSNO Act does not distinguish between low- and higher-risk genetically modified organisms (GMOs) in the same way it does for processes used in low- and higher-risk genetic modifications. In order to enable the delegation to IBSCs of approvals for the importation of low-risk GMOs, it is proposed that criteria be developed for defining a low-risk GMO in a manner similar to that for a low-risk genetic modification, and then allow both low-risk developments and low-risk GMO importations to be rapidly assessed by IBSCs.
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