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Australasian Biotechnology (backfiles)
AusBiotech
ISSN: 1036-7128
Vol. 8, Num. 1, 1998
Australasian Biotechnology,
Volume 8 Number 1, January/February 1998, pp. 30-32

Proposals for Regulation of Gene Technology

Donn Corcoran, Manager, Gene Technology Section, and Kirsty Galloway McLean, GMAC Secretariat, Department of Industry, Science and Tourism, Canberra

Code Number:AU98007
Sizes of Files:
      Text: 12K
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Introduction

Gene Technology

Gene technology offers a number of potential benefits for human health, agriculture and the environment. Its application has already resulted in the development of new and improved pharmaceuticals, treatment of some forms of disease, and improvements in agricultural production. However, it is also possible to create organisms hazardous to human health or the environment using this technology and accordingly Australia has had a regulatory system in place for many years. This system has been designed to ensure that gene technology research and the release of genetically modified organisms into the environment do not cause problems for human health, agriculture and the environment. It has operated largely on a voluntary basis, managed by the Genetic Manipulation Advisory Committee (GMAC), although some GMO releases are already subject to statutory processes.

Overview of Australia's Current Regulatory Arrangements with Regard to GMOs

Contained Experiments and Field Trials Involving GMOs

Genetic Manipulation Advisory Committee

GMAC is a non-statutory body established to oversee the development and use of novel genetic manipulation techniques in Australia. It assesses whether such work poses potential hazards and recommends appropriate safety measures for researchers and organisations working with GMOs.

Genetic manipulation work falls into two main categories: contained work and deliberate releases. Contained work is conducted in facilities which are designed to prevent escape of the GMO. Deliberate release of a GMO into the environment includes experimental field trials and general (unrestricted, including commercial) releases.

GMAC seeks comment on proposals for the deliberate (planned) release of GMOs into the environment from members of the public and from relevant Government agencies. GMAC then provides advice to relevant Commonwealth regulatory bodies (such as the Australia New Zealand Food Authority for a food product, or the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) for an agricultural or veterinary chemical), State agriculture and environment departments, and local councils for the area of the release.

GMAC's guidelines and advice have no legislative force but sanctions could be implemented if a researcher refused to abide by GMAC's advice. In practice there has been a high degree of compliance with GMAC's requirements.

Every institution undertaking genetic manipulation must set up an Institutional Biosafety Committee (IBC). IBCs certify containment facilities, carry out the initial assessments of proposals for genetic manipulation work and are authorised to allow work of low risk to proceed.

Importation of GMOs

Australian Quarantine and Inspection Service

The Australian Quarantine and Inspection Service (AQIS) is responsible for ensuring under the Quarantine Act 1908 that products imported into Australia do not lead to the introduction, establishment and spread of pests and diseases which may endanger our plant, animal and human health environment. Import application forms require notification to AQIS if material has been genetically manipulated. In such cases, AQIS refers the importer to GMAC. Once released from quarantine, imported GMOs are subject to the same regulatory requirements as GMOs produced in Australia.

Commercial Release of GMOs and their Products

End-product regulatory requirements

In addition to assessment by GMAC, products derived using genetic engineering techniques are subject to the same end-product regulatory requirements as conventionally derived products. If the marketing or end-use of an equivalent conventional product is not regulated, GMAC's advice to proceed to commercial release is currently sufficient.

Australia New Zealand Food Authority

The Australia New Zealand Food Authority (ANZFA) develops uniform food standards, in a cooperative arrangement between all Australian States and Territories, and New Zealand, supported by the Australia New Zealand Food Authority Act 1991.

ANZFA does not currently have formal procedures in place to assess the safety of foods derived from gene technology but has prepared a draft standard for this purpose (see ANZFA's article).

National Registration Authority for Agricultural and Veterinary Chemicals

Chemical manufacturers and/or distributors are required to register with the NRA all agricultural and veterinary chemicals as defined under the Agricultural and Veterinary Chemicals Code Act 1994. Some GMOs are or have the characteristics of ag/vet chemicals and their release is regulated by the NRA.

Therapeutic Goods Administration

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration, provides the basis for a national regulatory system for therapeutic goods, including genetically manipulated pharmaceuticals.

Gene Therapy Committee

Somatic cell gene therapy involves correcting the genes in particular body cells without the alteration being inherited by subsequent generations (the deliberate insertion of DNA into human germline cells is banned in most countries including Australia). Proposals for clinical trials in human patients are submitted to the National Health and Medical Research Council's Gene Therapy Committee.

International Obligations

Under the Convention on Biological Diversity, an international Protocol on Biosafety is being negotiated to govern the transboundary movements of living modified organisms which may have an adverse effect on the conservation and sustainable use of biodiversity (see paper by Tomkinson). As an interim measure the GMAC guidelines require that exporters of GMOs provide certain information to authorities in the recipient country.

Proposals for Statutory Regulation

Commercial applications of gene technology are rapidly increasing and are expected to have a significant impact on a number of industries, including pharmaceuticals, agriculture and food production. The Commonwealth considers that there is now a need for comprehensive statutory regulation of gene technology. Agreement in principle on the need for regulation was reached in Commonwealth-State discussions in 1994 but proposed legislation did not proceed because of disagreement on technical issues. Following a review of the issue and of the role of existing legislation, the Commonwealth developed a preferred position on regulatory arrangements and in December 1997 commenced discussions with State and Territory Governments on this matter.

The Commonwealth envisages that a package of measures designed to provide uniform and comprehensive regulation of gene technology will be introduced. A national regulation system will be designed to ensure legislative backing for the comprehensive scientific analysis and risk assessment to be undertaken before GMOs are released.

The proposed measures include:

  • amendment of current legislation where appropriate to provide for assessment of and authorisation for the planned release of GMOs and relevant products;
  • introduction of new legislation to cover the release of GMOs and products not covered by existing bodies and to regulate gene technology contained research;
  • establishment of a Gene Technology Office to coordinate the release of GMOs by existing bodies and to make decisions on release of GMOs and gene technology contained research under the new legislation;
  • retention of the Genetic Manipulation Advisory Committee as an expert advisory body; and
  • as an interim measure, establishment of a Gene Technology Liaison Committee to provide advice on urgent issues which are not able to be addressed under current regulatory systems.

Although some amendment of existing legislation is envisaged, this does not imply substantial changes to existing regulatory arrangements. For example, there will be little or no change to regulatory arrangements for therapeutic goods.

Some changes to regulatory arrangements are being discussed in separate Commonwealth-State fora. Proposals for the regulation of foods and food ingredients derived from GMOs prepared by ANZFA were released for public comment in February 1997. The draft standard is expected to be considered by the Australia New Zealand Food Standards Council in early 1998.

Principles for regulation

The Commonwealth has developed the following principles for consideration as the basis of a national regulatory arrangement for gene technology:

  1. the regulatory processes should be open, transparent, clear, nationally uniform, consistently applied, and enforceable;
  2. risk assessment should be objective, science-based, and independent with respect to environmental and human safety, and should be conducted prior to release, use, and marketing of GMOs within Australia;
  3. decision-making should be the result of professional, science-based risk assessments, and take into account the wide range of benefits and costs involved;
  4. the regulatory processes should be sufficiently flexible to adjust the degree of regulation according to the inherent risks of individual GMOs or products as experience and knowledge are gained;
  5. the responsibility for making approval decisions should be clearly assigned;
  6. commercial risks should not be borne by government;
  7. the regulatory processes should be designed to minimise the costs of administration to government and of compliance by individuals, businesses and organisations;
  8. the costs of regulation should be borne as far as is practical by those wishing to release GMOs or to market products made from them;
  9. Australia's regulatory system should be harmonised with those of our major trading partners;
  10. Australia's international competitiveness should be enhanced; and
  11. consistency with Australia's international rights and obligations should be ensured.

Consultation

In the course of discussions between Commonwealth, State and Territory Governments on the development of regulatory arrangements there will be direct consultation with industry, consumer and environmental organisations to ensure that the regulatory arrangements meet agreed principles, provide continued assurance of the protection of human health, agriculture and the natural environment, and facilitate the efficient development and use of gene technology.

Copyright 1998 Australian Biotechnology Association Ltd.

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