Australia
March 31, 2009

DIR 093 - Limited and controlled release of wheat and barley genetically modified for altered grain starch composition
DIR 093 - Invitation to comment on a consultation Risk Assessment and Risk Management Plan (RARMP) for limited and controlled release of wheat and barley genetically modified for altered grain starch composition - Comments close on 12 May 2009 - posted 30 March 2009 (PDF 52 KB)

INVITATION TO COMMENT

CONSULTATION RARMP FOR LICENCE APPLICATION DIR 093 FROM CSIRO
Limited and Controlled Release of Genetically Modified (GM) Wheat and Barley

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 093 from CSIRO for a limited and controlled release to undertake research with three wheat lines and one barley line genetically modified for altered grain starch composition.

The purpose of the trial is to evaluate grain properties of the GM wheat and barley lines grown under field conditions. This would involve generating sufficient grain to make flour for laboratory evaluation of how the flour performs in foods, and to feed selected animals to determine whether altered grain properties change the nutritional value of the GM wheat and barley. Products containing GM wheat from this trial may also be consumed by a small group of volunteers as part of a carefully controlled nutritional study. Except for the nutritional studies, plant materials from the GM lines will not enter the commercial animal feed or human food supply chain. The trial is proposed to take place, under limited and controlled conditions, at one site in the ACT, on a maximum of one hectare from 2009-2012.

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 CSIRO.

The Regulator welcomes written submissions in order to finalise the RARMP, which will then form the basis of a 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 093 in any correspondence.

Submissions should be received by close of business on 12 May 2009.

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 093 - Questions and Answers (PDF 19 KB)

DIR 093 - Consultation Risk Assessment and Risk Management Plan (RARMP) Executive Summary (PDF 70 KB)

DIR 093 - Consultation Risk Assessment and Risk Management Plan (RARMP) Technical Summary (PDF 104 KB)

DIR 093 - Full consultation Risk Assessment and Risk Management Plan (RARMP) (PDF 841 KB)

DIR 093 - Licence application summary (PDF 75 KB)

Reference material

Risk Analysis Framework for Licence Applications to the Office of the Gene Technology Regulator 2007

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