While the Review of the National Gene Technology Scheme is underway in stages, industry has welcomed the interim outcome of the 2016 Technical Review of the Gene Technology Regulations, which provides guidance for the future regulation of new breeding technologies and “organisms containing engineered gene drives” - and signals commencement of phase two of the 2017 consultation.
AusBiotech made submissions to the 2016 Technical Review of the Gene Technology Regulations and the 2017 Review of the National Gene Technology Regulatory Scheme, with the support of the AusAg & Foodtech Committee members from the public and private sectors, on behalf of members.
AusBiotech has advocated, like many in industry, for the adoption of Option 4, which excludes certain new breeding technologies from regulation on the basis of the product and/or outcomes they produce are no different to that what occurs in traditional breeding, except that they are more accurate in delivering outcomes. While Option 3, to regulate some new technologies based upon the process used, has been selected, this is accepted as an interim measure and welcomed on that basis. Under Option 3, organisms modified using site-directed nucleases without templates to guide genome repair (i.e. SDN-1) would not be regulated as genetically modified organisms (GMOs).
Mr Glenn Cross, CEO of AusBiotech, said “It is critical to the future introduction of biotechnology into Australia that the related regulation remains science‐based, rigorous and transparent.”
“AusBiotech cannot emphasise strongly enough the imperative that legislation and regulation pertaining to gene technology must keep pace with innovation, to enable the economic, efficiency and environmental benefits from new technologies to be realised.”
The review of Gene Technology Regulations aimed to reflect current technology and scientific knowledge and provide clarity about whether organisms developed using a range of new technologies are subject to regulation as GMOs and ensure that those new technologies requiring regulation is undertaken in a manner commensurate with the risks they pose.
During the discussion paper consultation, the OGTR said that it learnt “some stakeholders are not aware that organisms genetically modified utilising gene drives in their development are GMOs.” The Regulator has recently issued guidance for Institutional Biosafety Committees and researchers on the regulatory requirements for organisms containing engineered gene drives.
Phase Two of the consultation, led by the Department of Health and using the feedback received from Phase One consultation, commenced today and will conclude on the 15 December 2017, and the draft legislation is anticipated to be available from the OGTR this week for consultation until late January 2018.
There are numerous ways to participate in Phase two of the consultation process including a series of workshops and webinars that will be held in November and December 2017 across most states and territories, to explore the issues identified in Phase One consultation.
A third phase of consultation is planned to test proposed outcomes with stakeholders, is expected to open in early 2018.