Australasian Biotechnology (backfiles) AusBiotech ISSN: 1036-7128 Vol. 8, Num. 1, 1998

SPECIAL FEATURE

Australian Developments in Biotechnology Regulation

Sue Meek

Code Number:AU98003
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Foreword

There is an increasing requirement to move Genetically Modified Organisms (GMOs) out of the laboratory to evaluate their safety and efficacy in the field and to obtain approvals for general (unrestricted) release and sale. This trend is generating both environmental and commercial imperatives for an efficient and effective regulatory system for biotechnology in Australia.

In addition, the implementation process for the Convention on Biodiversity, which Australia became a signatory to in 1991, has prioritised the negotiation of a Protocol on Biosafety to "regulate the safe transboundary movement of Living Modified Organisms (LMOs)". This will create a legally-binding agreement with the potential to impact significantly upon movement and trade in GMOs and may in turn require countries to changes their regulatory systems to comply with these international obligations.

The development and implementation of a nationally consistent system of regulation for GMOs in Australia requires agreement and cooperation between Commonwealth, State and Territory Governments and meaningful consultation with a wide range of interest groups. Whilst negotiations on this issue began at the end of the last decade, it is fair to say that some momentum was lost in recent years. However, the pressures outlined above have stimulated a number of separate but complementary initiatives, led to great effect by a number of Commonwealth Agencies, which demonstrate that Australia's excellent reputation internationally as an innovative leader in the development of appropriate processes for biotechnology regulation continues to be richly deserved. This feature provides an overview of these activities.

Of course, the Genetic Manipulation Advisory Committee (GMAC) continues to play a prominent role in the current mechanisms for oversight of the development and use of GMOs, despite the fact that it is a non-statutory body. GMAC's overview paper analyses the history of field testing of GMOs since the first release in 1988 from the perspectives of numbers of releases, type of organism, transformation systems, introduced traits and commercial applications.

This analysis clearly demonstrates the dominance of genetically modified plants in GMAC's workload. Hence it is perhaps not surprising that the Standing Committee on Agriculture and Resource Management (SCARM), which comprises all Australian Agriculture or Primary Industries Ministers, has taken a special interest in biotechnology regulation. SCARM has established two working groups which are reported on here. One is charged with developing Good Agricultural Practices for Genetically Modified Crops and Pastures, with the aim of developing coordinating mechanisms which will maximise the benefits from introducing new traits across the agricultural sector as a whole. The Working Group on the Regulation of Gene Technology Regulation conducted a review of existing biotechnology regulatory mechanisms, primarily from an agricultural perspective.

The latter group then identified a number of recommendations for change to existing systems which forms part of the broader, whole-of-Commonwealth Government consultative exercise being led by the Department of Industry, Science and Tourism (DIST). The Commonwealth has developed a preferred position for legislative changes which, although relatively limited in scope, it believes will deliver a nationally consistent, legally enforcable system of regulation for GMOs. This position is outlined, along with an overview of the existing, Commonwealth-level regulatory mechanisms, in DIST's paper. Negotiations commenced with the State and Territory Governments at the end of 1997. Early 1998 will see the continuation of these negotiations, as well as consultation, via calls for submissions and meetings, with broader interest groups in the community, including industry.

It seems that nothing brings the issue of biotechnology regulation into relief more starkly than the prospect of actually consuming GMOs - especially live ones! Governments around the world have adopted widely divergent positions on this issue, particularly in regard to labelling. The Australia New Zealand Food Authority (ANZFA) has been involved in determining what our approach to approving foods containing GMOs for human consumption will be. ANFA's current progress is reported here.

Back in the international arena, the final paper is from the Department of Foreign Affairs and Trade. This summarises the process by which Australia's position in the negotiations regarding the Protocol on Biosafety is developed and the inputs which we have made to date. Australia's position recognises the need to balance the protection of commercial interests with the maintenance of the environment and expresses a preference for non-safety issues, such as socio- economic consequences of trade in GMOs/LMOs, to remain outside the scope of the Protocol. Currently, the aim is to finalise the Protocol this year and further consultation will occur with industry, various levels of Government and non-government organisations as negotiations proceed.

As I hope it is apparent by now, consultation is a recurrent theme in the process of formulating these complex policy positions. Individual ABA members as well as the Association itself have significant roles and responsibilities in ensuring that appropriate input is provided on an ongoing basis which contributes to the best possible outcomes for the future of biotechnology both nationally and internationally.

Sue Meek

Special Feature Editor

Dr Sue Meek is Director of the West Australian Department of Commerce and Trade's Science and Technology Coordination Unit. She has been actively involved in national and international developments in the regulation of biotechnology for over ten years and has been the Regulatory Issues Editor of Australasian Biotechnology since 1991.

Copyright 1998 Australian Biotechnology Association Ltd.