The Office of the Gene Technology Regulator (OGTR) has initiated a technical review of the Gene Technology Regulations 2001 (the Regulations) “to provide clarity about whether organisms developed using a range of new technologies are subject to regulation as genetically modified organisms (GMOs) and ensure that new technologies are regulated in a manner commensurate with the risks they pose.”
The OGTR has prepared a Discussion Paper – titled Options for Regulating New Technologies - which canvasses four options for how new technologies could be regulated. The paper includes eight consultation questions and seeks submissions in response to the specific questions. Stakeholders are also invited to propose amendments to other technical or scientific aspects of the Regulations.
The Review of the Regulations relates to technologies in the areas of animal health, research in animal models, agricultural biotechnology and vaccines. It should be noted that the regulation of the application of new technologies to humans is outside the scope of this review.
The technical review’s guidance notes that it must maintain the current policy settings of the gene technology regulatory scheme, and therefore cannot alter the definition of ‘GMO’ in the Gene Technology Act 2000.
However, it also notes that “it is within the scope of the technical review to exclude specific techniques or organisms from regulation, via listing in the Regulations, if they were not given a clear treatment at the inception of the scheme. It is also within scope to alter exclusions if scientific understanding of the risks particular techniques or organisms pose has since changed.”
The options posed are:
- Option 1: no amendment to the GT Regulations;
- Option 2: regulate certain new technologies;
- Option 3: regulate some new technologies based on the process used; or
- Option 4: exclude certain new technologies from regulation on the basis of the outcomes they produce.
The discussion paper can be found online. Submissions can be made direct to the OGTR by 2 December 2016 via the above link or AusBiotech members can contact National Programs Manager, Helen Arthur (harthur@ausbiotech.org / 0419 914 191).