Australia
March 17, 2011

DIR 108 - Notification of Licence Application - Commercial release of canola genetically modified for herbicide tolerance and a hybrid breeding sytem (GM InVigor® x Roundup Ready® canola

NOTIFICATION OF APPLICATION

Receipt of licence application from Bayer for dealings involving intentional release of genetically modified canola (DIR 108)

Application

The Office of the Gene Technology Regulator (OGTR) has received a licence application from Bayer CropScience Pty Ltd (Bayer) for the commercial release of genetically modified (GM) canola into the environment (DIR 108). The GM canola proposed for release is known as GM InVigor® x Roundup Ready® canola and contains genes conferring tolerance to two different herbicides (glyphosate and glufosinate-ammonium), a hybrid breeding system and/or an antibiotic resistance gene.

GM InVigor® x Roundup Ready® canola was produced by conventional breeding between GM InVigor® canola and GM Roundup Ready® canola, which were individually approved by the Regulator in 2003 for commercial release under licences DIR 021/2002 and DIR 020/2002, respectively.

Bayer is seeking approval to release the GM canola in all commercial canola growing areas of Australia. GM canola and GM canola-derived products from GM InVigor® x Roundup Ready® canola would enter general commerce, including use in human food and animal feed. Food Standards Australia New Zealand (FSANZ) has approved the use of food derived from GM InVigor® canola and GM Roundup Ready® canola for human consumption. These approvals also cover GM InVigor® x Roundup Ready® canola.
Note that cultivation of GM canola may also be subject to restrictions in some Australian States and Territories for marketing reasons.

Purpose of this notification

At this stage, comment is not sought from members of the public. Later, the public will be asked to comment on a comprehensive Risk Assessment and Risk Management Plan (RARMP) for the application. The RARMP will be prepared taking into account advice received from prescribed experts, agencies and authorities, and relevant local councils, as specified in section 50 of the Gene Technology Act 2000. I expect this to be released for public comment and further advice from experts, agencies and authorities in August 2011.

In the interim, you can obtain a copy of the application by contacting my Office (see contact details below, please quote the reference number DIR 108). As the application is quite lengthy, you may prefer to view a summary of the application, which is posted on our website along with this document (under ‘What’s New’).

If you have any questions or would like to receive a hard copy of the application summary, please contact the OGTR using the details below.DIR 108 - Questions and Answers (PDF 108 KB)

DIR 108 - Licence Application Summary (PDF 193 KB)

The Office of the Gene Technology Regulator, MDP 54, GPO Box 9848, Canberra, ACT, 2601
Telephone: 1800 181 030 Facsimile: 02 6271 4202 E-mail: ogtr@health.gov.au
Website http://www.ogtr.gov.au


 

Reference Material

Risk Analysis Framework for Licence Applications to the Office of the Gene Technology Regulator (3rd Edition) 2009

The Biology of Brassica napus L. (canola)

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

Published: March 17, 2011