Australia
October 15, 2010

DIR 105 - Invitation to comment on a consultation Risk Assessment and Risk Management Plan (RARMP) for the limited and controlled release of canola modified for herbicide tolerance - Comments close on 26 November 2010

INVITATION TO COMMENT

Consultation RARMP for Licence Application DIR 105 from Monsanto
Limited and Controlled 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 managing those risks.

The Gene Technology Regulator is currently assessing Licence Application DIR 105 from Monsanto Australia Ltd (Monsanto) for a limited and controlled release of a canola line genetically modified for herbicide tolerance.

The purpose of the trial is to conduct experiments to evaluate agronomic performance of the GM canola line, including performance of the herbicide tolerance trait, under field conditions. The trial is proposed to take place over four years, from March 2011 to December 2014, with up to 2 sites in the first year, 8 sites in the second and third years, and 20 sites in the fourth year. Sites would be a maximum of 4 ha in the first year and 10 ha in subsequent years, and would be located in 46 possible local government areas (LGAs) in New South Wales, 28 possible areas in Victoria and 53 possible LGAs in Western Australia. The GM canola would not be used for human food or animal feed.

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. A range of licence conditions are proposed, including measures to restrict the release to the size, locations and duration requested by Monsanto.

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 105 in any correspondence.

Submissions should be received by close of business on 26 November 2010.

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 105 - Questions & Answers (PDF 87 KB)

DIR 105 - Consultation Risk Assessment and Risk Management Plan (RARMP) Executive Summary (PDF 214 KB)

DIR 105 - Consultation Risk Assessment and Risk Management Plan (RARMP) Technical Summary (PDF 208 KB)

DIR 105 - Full consultation Risk Assessment and Risk Management Plan (RARMP) for the limited and controlled release of canola modified for herbicide tolerance (PDF 682 KB)

DIR 105 - Licence Application Summary (PDF 66 KB)

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: October 18, 2010