Skip to content
Victorian Government Website (Victoria, the Place to Be)
State Government of Victoria, Australia, Department of Health
Victorian Government Health Information
Health Home
Main A to Z index | Site Map | About Health
Biotechnology

National framework

Page content: Background | The Gene Technology Regulatory Framework | Principles | Process | Inter-Governmental agreement

Background

Gene technology regulation in Australia is currently overseen by a number of different regulatory bodies, depending on the intended use of the relevant Genetically Modified Organism (GMO) or Genetically Modified (GM) product.

Regulators include:

  • Food Standards Australia New Zealand (FSANZ) - regulating food standards and labelling;
  • Therapeutic Goods Administration (TGA) - regulating therapeutic goods and human gene therapy;
  • Australian Pesticides and Veterinary Medicines Authority (APVMA) - regulating agricultural and veterinary chemicals;
  • National Industrial Chemicals Notification and Assessment Scheme (NICNAS) - regulating industrial chemicals;
  • Australian Quarantine and Inspection Service (AQIS) - regulating import and export of GM products or GMOs; and
  • National Health and Medical Research Council (NHMRC) - overseeing research involving human gene therapy.

The Genetic Manipulation Advisory Committee (GMAC) was established in 1987 to provide advice to these agencies on the environmental and safety implications of GMOs. However, as a non-statutory body with no direct legal power to enforce its decisions and rapid advancements in biotechnology leading to the creation of GMOs that did not fall within the mandate of existing regulators, it became necessary to provide additional safeguards to protect the Australian public.

The Gene Technology Regulatory Framework

Following negotiations between Commonwealth, State and Territory Governments, the Commonwealth Gene Technology Act 2000 was enacted in December 2000.

The Commonwealth Gene Technology Act establishes a national scheme to regulate gene technology and provides a framework to achieve coordination across all levels of Government. The national scheme is administered through the Office of the Gene Technology Regulator (OGTR) established through the Gene Technology Act 2000, and has operated since June 2001.

The object of the Act is to:

"Protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs"

The National Framework regulates gene technology through:

  • A risk assessment process where possible hazards are identified and the likelihood of their occurrence is assessed;
  • A licensing scheme for industry and institutions using biotechnology to develop products or in their research;
  • The establishment of a Canberra-based Office of the Gene Technology Regulator (GTR) to carry out those functions;
  • The creation of a Ministerial Council for Gene Technology to develop policy principles to guide the decisions of the GTR; and
  • The establishment of three independent national advisory committees with expertise in the science of gene technology , ethical matters and community concerns related to the use of gene technology.

Principles

The two key principles underpinning the scheme are:

  • Transparency in the regulatory process; and
  • Community involvement in policy development.

Process

All industry and institutions will need to apply to the GTR for a license to deal with a GMO unless:

  • The dealing falls within the exempt category within the legislation;
  • the dealing falls within a category in the legislation that is considered very low risk; or
  • the dealing has been licensed for a certain period of time and the GTR is satisfied the dealings with the GMO are sufficiently safe.

Inter-Governmental agreement

The Victorian Government is a signatory to an Inter-Governmental Agreement on the regulation of gene technology in Australia. This Agreement includes provision for the enactment of complementary State legislation to ensure the Commonwealth's coverage over gene technology is comprehensive. Complementary legislation was enacted with the Victorian Gene Technology Act 2001.