AusBiotech has made a submission to the Department of Health in response to the Third Review of the National Gene Technology Scheme. The submission supports the overarching findings that the Gene Technology Act (2000), remains appropriate and the Gene Technology Agreement (2001) should be maintained. AusBiotech made several key recommendations:
- That renewed definitions within the act be consistent, accurate and adequately reflect both regulator and trade implications;
- Reiterated its previously presented position that certain synthetic biology technologies be excluded from the act based on what it produces;
- Rejects that a further review is necessary to determine the approach for the regulation of broader environmental releases of genetically modified organisms.
The submission from AusBiotech follows an extensive consultation process (July 2018 – May 2018) involving formal submissions and engagement with AusBiotech members and the AusAg and Foodtech committee members from the public and private sectors.
The submission raises the issue of inconsistency between state, territory and federal governments and the Gene Technology Act. Ensuring these are updated accurately, but also consistent across the country should be a priority for governments. Whilst there remains inconsistency and lack of continuity, the community will continue to lack confidence in the Scheme and its administration, if this is not addressed adequately.
The review found that synthetic biology is currently within the scope of the Scheme that the Act incorporate Option 4 which was to exclude organisms modified by SDN-1, SDN-2 and ODM from regulation, on the basis that the genetic changes they carry are similar to or indistinguishable from the products of conventional breeding.
AusBiotech recommends that the review of regulations excludes certain types of new technologies based on the product or outcome produced by it and this would support innovation and uptake of new technologies.
A further review determining the approach to regulating the release of genetically modified organisms, is unnecessary and will likely result in additional, and scientifically unjustified, regulatory burden. The current Scheme already addresses over-regulation with specific risk assessment requirements for the organisms used in biological control, and are examined on a case by case basis depending on both the GMO and its intended use.
AusBiotech has a strong position to foster a growing, strong and profitable biotechnology and life science industry in Australia through representation, advocacy and the provision of services and benefits to its members to help the industry realise its nationally important economic potential.”