October 14, 2008
DIR 089 - Limited and controlled release of white clover genetically modified to resist infection by Alfalfa mosaic virus
INVITATION TO COMMENT
CONSULTATION RARMP FOR LICENCE APPLICATION DIR 089 FROM DPI VICTORIA
Limited and Controlled Release of Genetically Modified (GM) White Clover
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 Acting Gene Technology Regulator is currently assessing Licence Application DIR 089 from DPI Victoria for a limited and controlled release to undertake research with one white clover line genetically modified for resistance to Alfalfa mosaic virus.
The purpose of the trial is to conduct experiments to evaluate the agronomic performance, including seed yield, of the GM white clover line under field conditions. Some seed would be collected and retained for analysis and possible future trials, subject to further approval(s). The trial is proposed to take place, under limited and controlled conditions, at one site in NSW, on a maximum of 633 m2 from 2009-2011. None of the GM plant materials from the trial would be used in 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, location and duration requested by DPI Victoria.
The Acting Regulator welcomes written submissions in order to finalise the RARMP, which will then form the basis of her decision on whether 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 089 in any correspondence.
Submissions should be received by close of business on 25 November 2008.
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 089 - Questions and Answers (PDF 17 KB)
DIR 089 - Consultation Risk Assessment and Risk Management Plan (RARMP) Executive Summary (PDF 71 KB)
DIR 089 - Consultation Risk Assessment and Risk Management Plan (RARMP) Technical Summary (PDF 77 KB)
DIR 089 - Full consultation Risk Assessment and Risk Management Plan (RARMP) for limited and controlled release of white clover genetically modified to resist infection by Alfalfa mosaic virus (PDF 648 KB)
DIR 089 - Licence Application Summary (PDF 75 KB)
Reference material
Risk Analysis Framework for Licence Applications to the Office of the Gene Technology Regulator 2007
Related documents - The Biology of Trifolium repens L. (White Clover) 2008 (PDF 648 KB)