Regulators of Genetically Modified (GM) Products

Definition: A genetically modified product (GM product) means a thing (other than a GMO) derived or produced from a GMO (section 10 of the Act).

In Australia, GM products are regulated by a range of agencies with the appropriate expertise to assess any risks that may be associated with the GM product. In this way, duplication of regulatory oversight is, where at all possible, avoided.

For example: a recombinant protein such as insulin, that is used to treat diabetic patients to control blood sugar levels, is produced by GM bacteria and subsequently purified for clinical use. Production of the GM bacteria requires authorisation under the Gene Technology Act 2000. In addition:

  • When manufactured for administration in humans (i.e. as a human therapeutic) it is also regulated by the Therapeutic Goods Administration.
  • When manufactured for use in animals (i.e. as a veterinary medicine) it is also regulated by the Australian Pesticides and Veterinary Medicines Authority.
    The following table details the regulatory agencies with responsibilities for the regulation of GM products in Australia. Should you require additional information regarding GM products, this should be sought directly from the applicable agency’s website.

    Please note, that as of 10 March 2016, the Gene Technology Regulator is no longer required under legislation to maintain a record of GM products authorised by other regulatory agencies.

    Regulatory agencyGM products regulatedWebsite
    Food Standards Australia New Zealandhuman
    Therapeutic Goods Administrationhuman
    Australian Industrial Chemicals Introduction Schemeindustrial
    Australian Pesticides and Veterinary Medicines Authorityagricultural chemicals and veterinary
    Department of Agriculture and Water Resourcesimport and export

    Other relevant Australian websites

    Commonwealth Science and Industrial Research Organisation (CSIRO)
    Department of Defence – Defence Export Controls
    Department of the Environment and Energy
    Legislative and Governance Forum on Gene Technology
    IP Australia

    Relevant overseas websites

    U.S. Department of Agriculture
    Animal and Plant Health Inspection Service, United States Department of Agriculture (USDA)
    U.S. Food and Drug Administration
    National Centre for Biotechnology - US Government
    University Wisconsin-Madison Biotechnology Centre
    Biotech and Biological Sciences Research Council, UK
    National Centre for Biotechnology Education, Reading University, UK
    New Zealand
    New Zealand Biotechnology Association
    Canadian Food Inspection Agency
    Food and Agriculture Organisation of the United Nations (FAO)
    Convention on Biological Diversity (CBD)
    Organisation for Economic Cooperation and Development (OECD)
    OECD Biosafety - Biotrack

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