Australia
April 26, 2013

The Office of the Gene Technology Regulator (OGTR) has developed a new application form specifically for limited and controlled release (field trial) of GM plants: Application for a licence for dealings involving intentional release (DIR) of GM plants into the environment under limited and controlled conditions.

Currently only one application form exists for all types of DIRs, whether for plants, animals or other organisms, or for commercial or experimental purposes. Most of the DIR licence applications to date have been for GM plants and experience with both commercial and limited and controlled release applications indicates that the information required for their evaluation is usually quite different.

It is therefore proposed to have separate forms for commercial release applications and for limited and controlled release applications for GM plants. This will allow the science-related questions to be tailored to the specific information required for risk analysis of each application type.

At this stage, only the form for limited and controlled release of GM plants is ready for comment. The OGTR is developing a form for commercial release of GM plants and may also develop specific forms for non-plant applications. Until then, the current application form will remain in use for all other DIR licence applications.

The draft application form contains guidance designed to assist with completing the form. The example answers are intended to illustrate the kind of information I would expect to receive for conducting risk analysis. A draft without example answers can be made available upon request.

If you have any specific queries please contact the OGTR on free call 1800 181 030 or by email.

Please submit your written comments by 7 June 2013.

RTF version of Application for a licence for dealings involving intentional release (DIR) of genetically modified (GM) plants into the environment under limited and controlled conditions (RTF 1830 KB)
PDF version of Application for a licence for dealings involving intentional release (DIR) of genetically modified (GM) plants into the environment under limited and controlled conditions (PDF 1227 KB)

Website: http://www.ogtr.gov.au

Published: April 30, 2013