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Gene Technology Technical Advisory Committee Meeting 11th & 12th May 2011 Canberra Communique No. 29

This is the 29th communiqué of the Gene Technology Technical Advisory Committee (GTTAC). It covers matters considered at the 39th meeting of GTTAC, held on 11 & 12 May 2011.

GTTAC is a statutory advisory committee established under the Gene Technology Act 2000 (the Act) to provide scientific and technical advice to the Gene Technology Regulator (the Regulator) and the Gene Technology Ministerial Council. All Committee members and expert advisers hold office on a part-time basis.
The Regulator receives advice from GTTAC on Risk Assessment and Risk Management Plans (RARMPs) prepared in respect of applications for licences to conduct dealings with genetically modified organisms (GMOs).
GTTAC members were appointed by the Hon Catherine King, Parliamentary Secretary for Health and Ageing on 3 February 2011 for a three year term, following consultation with the Regulator, State/Territory Ministers and relevant scientific, consumer, health, environmental and industry organisations. The term for the previous committee expired on 31 January 2011.
The purpose of this Communiqué is to provide a brief overview of the applications and RARMPs considered by GTTAC and, in accordance with Regulation 29 of the Gene Technology Regulations 2001, any resolutions the Committee has provided to the Regulator with regard to those applications and RARMPs.
The Communiqué also provides an overview of any other major issues discussed by GTTAC.

Dealings Involving the Intentional Release of Genetically Modified Organisms

Dealings Involving the Intentional Release of GMOs (DIRs) involve the limited and controlled release (field trial) of a GMO or a commercial (general) release of a GMO.
The RARMP for every DIR licence application is released for public comment as part of the consultation process. Information on how to obtain copies of applications and RARMPs for DIRs is provided at the end of this document.

GTTAC Advice

The Regulator must seek GTTAC advice on RARMPs prepared in respect of all DIR applications.
The Regulator must also seek GTTAC advice during the preparation of the RARMP for all DIR applications which are not assessed as ‘limited and controlled’ under Section 50A of the Act.

1. Advice on Consultation RARMPs – Limited and Controlled Release

GTTAC considered the Consultation RARMPs prepared in response to the following applications for limited and controlled releases:

1.1 DIR 108 – Commercial release of canola genetically modified for herbicide tolerance and a hybrid breeding system (InVigor® x Roundup Ready® canola).

GTTAC noted that application from Bayer Crop Science Pty Ltd was for the commercial release of GM canola, produced by crossing currently approved GM lines; InVigor®canola and Roundup Ready® canola. InVigor® x Roundup Ready® canola was produced by conventional breeding between InVigor® canola and Roundup Ready® canola, which were individually approved by the Regulator in 2003 for commercial release under licences DIR 021/2002 and DIR 020/2002, respectively.
The InVigor® x Roundup Ready® canola proposed for commercial release will contain genes conferring tolerance to the herbicides glufosinate-ammonium and glyphosate, and genes conferring a hybrid breeding system. Bayer is also seeking approval from the Regulator to release GM canola derived from conventional breeding between GM Roundup Ready® elite line GT73 and all GM canola lines authorised for release under licence DIR 021/2002.
The applicant proposes the release to occur in all commercial canola growing areas of Australia. GM canola and GM canola-derived products from GM InVigor® x Roundup Ready® canola would enter general commerce, including use in human food and animal feed. Food Standards Australia New Zealand (FSANZ) has approved the use of food derived from GM InVigor® canola and GM Roundup Ready® canola for human consumption. These approvals also cover GM InVigor® x Roundup Ready® canola.

RESOLUTION:
GTTAC advised the Regulator that in preparing the RARMP the Regulator should consider:
        • the potential for commercial scale growing of the GM canola to affect weediness
        • the potential for the GM canola to cross with existing non-GM herbicide tolerant canola and any possible associated risk to the environment
        • the potential for gene flow to related species and possible risk of weediness.

1.2 DIR 109 – Limited and controlled release of banana genetically modified for enhanced nutrition.

GTTAC noted that the application from the Queensland University of Technology involved the intentional release of up to 1241 lines of GM bananas on a limited scale and under controlled conditions. The modified traits are for enhanced pro-vitamin A and/or iron levels.
The trial is proposed to take place at one site in the Shire of Johnstone, Queensland on a maximum area of 2.0 ha between August 2011 and August 2013. The proposed trial is to assess various promoter-gene combinations that would enhance pro-vitamin A and/or iron levels without the associated negative effects on GM plant growth and development. The GM bananas will not be permitted to enter the commercial human or animal food supply chain.

RESOLUTION:GTTAC advised the Regulator that:
        • the Regulator should consider alternative containment measures for transport by courier.

Dealings Not Involving Intentional Release

Dealings not involving the intentional release of GMOs (DNIRs) are dealings that are usually undertaken within a facility where the organism is physically contained.

2. Advice on Consultation RARMPs – Dealings Not Involving Intentional Release

GTTAC did not consider any Consultation RARMPs prepared for dealings not involving intentional release at the meeting.

Enquiries and Risk Assessment and Risk Management Plans

For all enquiries and to obtain copies of applications or RARMPs for dealings involving
the intentional release of GMOs into the environment, please phone the OGTR on
1800 181 030. The RARMPs are also available electronically from the OGTR website.