Australia
August 23, 2011
INVITATION TO COMMENT
Consultation RARMP for licence application DIR 108 from Bayer CropScience Pty Ltd
Commercial Release of Genetically Modified (GM) Canola
Australia’s gene technology regulatory system is designed to protect the health and safety of people and the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks.
The Gene Technology Regulator is currently assessing Licence Application DIR 108 from Bayer CropScience Pty Ltd for a commercial release of GM canola, known as InVigor® x Roundup Ready® canola, genetically modified for tolerance to two different herbicides (glyphosate and glufosinate ammonium) and a hybrid breeding system.
Subject to any State government requirements imposed for marketing reasons, the proposed commercial release of GM canola plants would take place in all canola growing regions in Australia. Products from the GM canola plants are proposed to be used in the same way as those from non-GM and other commercially approved GM canola.
A consultation Risk Assessment and Risk Management Plan (RARMP) has been prepared, which concludes that the proposed release would pose negligible risk to human health and safety or to the environment. If a licence were to be issued, general conditions are proposed to ensure there is ongoing oversight of the release.
The Regulator welcomes written submissions in order to finalise the RARMP, which will then form the basis of a decision on whether or not to issue the licence. The consultation RARMP and related documents can be obtained from the website <http://www.ogtr.gov.au> under ‘What’s New’ or by contacting the Office. Please quote application DIR 108 in any correspondence.
Submissions should be received by close of business on 18 October 2011.
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
DIR 108 - Questions and Answers
DIR 108 - Consultation Risk Assessment and Risk Management Plan (RARMP) Executive Summary
DIR 108 - Consultation Risk assessment and Risk Management Plan (RARMP) Technical Summary
DIR 108 - Full Consultation Risk Assessment and Risk Management Plan (RARMP) Executive Summary for commercial release of canola gemetically modified for herbicide tolerance and a hybrid breeding sytem (GM InVigor® x Roundup Ready® canola
DIR 108 - Licence Application Summary
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)