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Communiqué




This communiqué covers matters considered at the 41st meeting of the Gene Technology Technical Advisory Committee (GTTAC) (6 March 2012)



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 Legislative and Governance Forum on Gene Technology (formerly the Gene Technology Ministerial Council). All Committee members and expert advisers hold office on a part-time basis1.

The Regulator seeks 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). The purpose of this Communiqué is to provide a brief overview of GTTAC’s consideration of applications and RARMPs and, in accordance with Regulation 29 of the Gene Technology Regulations 2001, any Committee resolutions provided to the Regulator regarding those applications and RARMPs.

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. The Regulator may seek GTTAC advice on RARMPs prepared in respect of all DIR applications.

1. Advice on Consultation RARMPS – Limited and Controlled Release

GTTAC considered the Consultation RARMP prepared in response to the following application for limited controlled releases:

1.1 DIR 112 - Limited and controlled release of wheat and barley genetically modified for altered grain composition and nutrient utilisation efficiency.

GTTAC noted that the application from the Commonwealth Scientific and Industrial Research Organisation (CSIRO) was for a limited and controlled release of genetically modified (GM) wheat and barley lines, modified for altered grain composition and nutrient utilisation efficiency. The trial is proposed to take place at one site in Western Australia.

The primary purpose of the trial is to assess whether the respective genetic modifications result in increased biomass and yield of the GM plants compared to the unmodified plants. The GM wheat and barley would not be permitted to enter the commercial human food or animal feed supply chains. GTTAC noted the key points in the consultation RARMP including that:
  • the risk assessment concludes that this release poses negligible risks to the health and safety of people and to the environment; and
  • these negligible risks do not require specific risk treatment measures.
GTTAC also noted the draft licence conditions, which are similar to those used for other recent wheat and barley licences.

RESOLUTION:

GTTAC advised the Regulator that:
  1. The Committee agrees with the overall conclusions of the RARMP;
  2. the Regulator should consider clarifying arrangements for buffer zones between the trials at the location; and
  3. the Regulator should consider clarifying the wording in the RARMP relating to handling of GM and non-GM material grown at the location.

1.2 DIR 113 - Limited and controlled release of cotton genetically modified for insect resistance and herbicide tolerance.

GTTAC noted that the application from Bayer CropScience Pty Ltd for a limited and controlled release of GM cotton varieties, modified for insect resistance and herbicide tolerance. The field trial is proposed to take place at up to six sites per year in a number of local government areas (LGAs) in New South Wales (NSW), Western Australia (WA), and Queensland (QLD).

The purpose of the proposed trial is to assess the agronomic performance of the GM cotton varieties, and to produce seed for use in further studies or releases (subject to additional approvals). The GM cotton varieties would not be permitted to enter the commercial human or animal food supply chains. GTTAC noted the key points in the consultation RARMP including that:
  • the risk assessment concludes that this release poses negligible risks to the health and safety of people and to the environment; and
  • these negligible risks do not require specific risk treatment measures.
GTTAC also noted that a number of the individual GM lines involved in this application have been approved for commercial release overseas and that all of the individual GM events have been approved for food use in Australia by Food Standards Australia New Zealand (FSANZ).

RESOLUTION:

GTTAC advised the Regulator that:
  • The Committee agrees with the overall conclusions of the RARMP.

1.3 DIR 114 - Limited and controlled release of canola genetically modified for herbicide tolerance.

Pioneer Hi-Bred Australia Pty Ltd has applied for a licence for dealings involving the intentional release of one line of GM canola on a limited scale and under controlled conditions. The GM canola line has been genetically modified for herbicide tolerance. The trial is proposed to take place over four years with up to 8 sites planted in the first year and 20 sites in subsequent years.

GTTAC noted the conclusions of the RARMP including that:
  • the risk assessment concludes that this release poses negligible risks to the health and safety of people and to the environment.
  • these negligible risks do not require specific risk treatment measures.
RESOLUTION:

GTTAC advised the Regulator that:
  • The Committee agrees with the overall conclusions of the RARMP.

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 Office of the Gene Technology Regulator (OGTR) on 1800 181 030. RARMPs are also available electronically from our website.


1On 3 February 2011, GTTAC members were appointed for a three year term by the Hon Catherine King MP, Parliamentary Secretary for Health and Ageing.