Australia
April 1, 2010

INVITATION TO COMMENT

CONSULTATION RARMP FOR LICENCE APPLICATION DIR 099 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 099 from the Commonwealth Scientific and Industrial Research Organisation (CSIRO) for a limited and controlled release to undertake research with 11 lines of wheat and 3 lines of barley that have been genetically modified for altered grain composition or enhanced nutrient utilisation efficiency.

The purpose of the trial is to characterise growth and yield characteristics of the GM plants when grown under field conditions. In addition, CSIRO aims to generate sufficient grain to assess changes in grain composition and how this may affect dough characteristics and end-product quality. The trial is proposed to take place in the local government areas of Narrabri (New South Wales) and Corrigin (Western Australia), on a maximum area of 2 ha per season, between May 2010 and June 2013. The GM wheat and barley 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 CSIRO.
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 099 in any correspondence.

Submissions should be received by close of business on 13 May 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 099 - Questions & Answers (PDF 14 KB)

DIR 099 - Consultation Risk Assessment and Risk Management Plan (RARMP) Executive Summary (PDF 63 KB)

DIR 099 - Consultation Risk Assessment and Risk Management Plan (RARMP) Technical Summary (PDF 70 KB)

DIR 099 - Full Consultation Risk Assessment and Risk Management Plan (RARMP) for limited and controlled release of wheat and barley genetically modified for altered grain composition or nutrient utilisation efficiency (PDF 516 KB)

DIR 099 - Licence Application Summary (PDF 66 KB)


Reference material

Risk Analysis Framework for Licence Applications to the Office of the Gene Technology Regulator 2009

The Biology of Triticum aestivum L. em Thell (Wheat) (2008 version)

The Biology of Hordeum vulgare L. (Barley) (2008 version)

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

Published: April 1, 2010