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July 2013

Twelve years after Australia’s gene technology regulatory scheme commenced, a milestone was reached on 12 July 2013 with the issuing of the 100th licence for dealings involving intentional release (DIR) of a genetically modified organism (GMO). The Gene Technology Regulator approved DIR 120, an application for a field trial of a new type of cotton that has been genetically modified for insect resistance and herbicide tolerance.

As with all licence applications, the approval for DIR 120 was given only after the Regulator was satisfied that any potential risks had been identified and assessed and could be managed to protect people and the environment. The decision was made after completion of a comprehensive Risk Assessment and Risk Management Plan by the OGTR and extensive, public consultation according to the provisions of the Gene Technology Act 2000 (the Act). The Act and the Gene Technology Regulations commenced in 2001 and, together with corresponding State and Territory legislation, they underpin the national regulatory scheme for GMOs. It has been subject to two independent reviews, both of which concluded that the scheme is operating efficiently and effectively.

Since 2001, over 20 000 applications and notifications have been processed by the OGTR, including over 500 licences for dealings not involving intentional release (eg for human and veterinary medical research conducted in laboratories) and, now, 100 DIR licences. These approvals have all been based on robust and extensive independent scientific assessment and risk analysis. They reflect the effectiveness and maturity of the regulatory scheme, something that is further highlighted by the high levels of compliance of the regulated community and the absence of any credible evidence of harmful effects of GMOs on health or the environment.

Most DIR licences that have been issued are for limited and controlled field trials of new genetically modified crops. They have included trials with crops as diverse as cotton, canola, wheat, barley, pineapple, sugarcane and bananas. There have also been DIR licences for commercially growing crops such as cotton and canola. Other DIR licences have been granted for veterinary and medical applications, including clinical trials for a vaccine against prostate cancer and commercial release of a vaccine to protect against Japanese encephalitis.

Detailed information on DIR 120 and all DIR licences can be found on the OGTR website.