Australia
May 3, 2010

INVITATION TO COMMENT

CONSULTATION RARMP FOR LICENCE APPLICATION DIR 101 FROM MONSANTO
Limited and Controlled Release of Genetically Modified (GM) Cotton

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 101 from Monsanto Australia Limited (Monsanto) for a limited and controlled release two GM cottons genetically modified for insect resistance either alone or in combination with herbicide tolerance.

The purpose of the trial is to generate data for future submissions to regulatory agencies, to breed and develop varieties using elite germplasm suitable for use under Australian conditions, and for seed increase. The trial is proposed to take place in up to 34 local government areas in NSW, Qld and WA, on a maximum total area of 1,150 ha over four years from 2010 to 2014. The GM cottons would not be used for human food or animal feed as part of the release.

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 101 in any correspondence.

Submissions should be received by close of business on 15 June 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 101 - Questions and Answeres (PDF 15 KB)

DIR 101 - Consultation Risk Assessment and Risk Management Plan (RARMP) Executive Summary (PDF 80 KB)

DIR 101 - Consultation Risk Assessment and Risk Management Plan (RARMP) Technical Summary (PDF 135 KB)

DIR 101 - Full Consultation Risk Assessment and Risk Management Plan (RARMP) for the limited and controlled release of cotton genetically modified for insect resistance and herbicide tolerance (PDF 517 KB)

DIR 101 - Licence Application Summary (PDF 69 KB)

Reference material

Risk Analysis Framework for Licence Applications to the Office of the Gene Technology Regulator (3rd Edition) 2009

The Biology of Gossypium hirsutum L. and Gossypium barbadese L. (cotton) in Australia

Map of Local Government Areas where cotton is grown

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

Published: May 3, 2010