First 'go to grow' given by Gene Technology Regulator
In brief: Senior Associate Lorien Beazley outlines the decision-making process and details relating to the first licence for the release of GMOs granted by The Office of the Gene Technology Regulator.
On 19 January this year, the Gene Technology Regulator, Dr Sue Meek, announced she had approved the application, and had issued the first licence under the Gene Technology Act (GTA), to trial certain GM cotton.
In our 18 December 2001 edition of Biotech News, we reported that The Office of the Gene Technology Regulator (OGTR) had asked for public comment on the application of Cotton Seed Distributors Pty Ltd (CSD) to release genetically modified strains of cotton into the environment for research and development purposes (for our earlier article, click here). CSD's application for the release of genetically modified organisms (GMO) was the first accepted by the OGTR.
What did the OGTR consider?
In addition to the public, OGTR consulted the Local, State and Commonwealth Governments. The Gene Technology Technical Advisory Committee (a statutory body under the GTA) also played a consultative role. The hazards identified as being possibly associated with the release of the GM cotton included:
- the possibility of the GM cotton being toxic or allergenic and the effect it would have on humans or other organisms;
- the effect inherent 'weediness' could have on the environment (that is, the likelihood of the GM cotton becoming a weed);
- the possibility of the 'cross breeding' of GM cotton characteristics to other organisms;
- the possibility of target insects developing resistance to GM cotton proteins and the effect this would have long term.
Licence conditions were put in place to deal with hazards 2 and 3 above (see more details below). The likelihood of adverse impacts on humans or other species (other than the target insects) associated with hazards 1 and 4 above was considered to be very low, and no conditions were implemented to manage those risks.
What kind of licence was granted?
CSD has a licence to carry out a limited release of 2 types of insect and pesticide resistant strains of GM cotton into the environment to evaluate the agronomic performance of the strains, and to produce commercial quantities of seed for further evaluation. It is intended that this will lead to a commercial release of the product in 2003. Under the licence, CSD may:
- conduct experiments on the GM cotton;
- make, develop, produce or manufacture the GM cotton;
- propagate the GM cotton;
- grow, raise or culture the GM cotton; and
- possess, supply, use, transport or dispose of the GM cotton during the course of the above activities.
The original application was for release in six sites over a total of 480 hectares. The licence has been limited to release in a 122 hectare area adjacent to Adams Street, Comet in the shire of Emerald, Queensland.
Under the licence, there are obligations to:
- comply with the GTA;
- release the GM cotton late in the cotton planting season (but not later than 28 February 2002);
- restrict the use of the GM cotton from the trial, including ensuring none of the cotton plants produced in the trial (or their by-products) will be used for human or animal feed;
- manage the risks associated with the risk of 'weediness';
- manage the risk associated with the likelihood of gene transfer into other plants from the GM cotton (including risks associated with all gene sequences such as insect resistance genes, antibiotic resistant genes, GUS marker genes, herbicide tolerant genes, and viral regulatory sequences);
- isolate the GM cotton crop from other cotton by at least 50 metres and monitor the adequacy of the 50 metre exclusion zone;
- destroy all non-essential product post harvest;
- monitor (and remove all cotton plants from) the site for 12 months post harvest.
CSD must comply with the licence conditions, and must act on any further direction of GTR that the GTR deems necessary to protect the health and safety of people, organisms or the environment. The OGTR will monitor the site for compliance during the term of the licence, which continues until it is either cancelled or surrendered..
Has anyone else applied?
Applications currently before the OGTR include applications from:
- CSIRO for a project for agronomic assessment and seed increase in the Northern Territory;
- Agriculture WA under projects for:
- improved alkaloid production in poppy oilseed;
- integrated pest management systems for INGARD cotton in WA; and
- preliminary field evaluation of Bollgard II cotton in the Kimberley region of WA; and
- Aventis CropScience under a project regarding the development of the InVigor Canola for the Australian Cropping System.