Government Oversight and Regulation

Australia’s regulatory framework for enabling technologies is made up of federal and state regulatory agencies. Coordination of the Australian Government regulators and related policy, research and funding agencies is carried out through the HSE Working Group. The regulatory roles fall to the differing agencies depending on the end-use of the enabling technology. Some technologies require approval from more than one agency. An overview of the regulatory framework is below:

  • Border Protection: Border protection is carried out by Australian Customs Service (Customs).
  • Consumer Products: As a consumer product regulator, the Australian Competition and Consumer Commission (ACCC), in consultation with other risk regulators, determines the health risks of consumer products containing nano-scale materials by investigating the possible hazards in the composite materials in products and the potential exposure to these nanomaterials when using the product. Further nanotechnology in consumer products information can be accessed via the Product Safety Australia website.
  • Food: Food Standards Australia New Zealand (FSANZ) is a bi-national Government agency whose responsibility is to develop and administer the Australia New Zealand Food Standards Code, which lists requirements for foods such as nanomaterial additives, food safety, labelling and GM foods.
  • Environment: The Australian Government Department of the Environment undertakes activities (particularly consultancies) to assess the impact of nanotechnologies, including nanomaterials and biotechnologies, on the environment. The Department of the Environment assists the Minister for the Environment in providing advice to the Gene Technology Regulator on genetically modified organisms. It provides advice to the APVMA on biopesticides and advice to other areas of the Department on the environmental safety of biological products and other biotechnology issues.
  • Industrial Chemicals: Industrial chemicals are regulated through the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). Nanomaterials introduced for industrial uses (including cosmetics) fall within the remit of NICNAS. NICNAS regulates industrial chemicals that are, or contain, genetically modified products.
  • Gene Technology: Genetically modified organisms (GMOs), are regulated by the Gene Technology Regulator under a nationally consistent scheme made up of the Commonwealth Gene Technology Act 2000 and corresponding state and territory legislation. The object of the Gene Technology Act 2000 is to protect the health and safety of people, and 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. Dealings with GMOs are prohibited unless authorised by the Gene Technology Regulator. The Gene Technology Regulator receives advice from the Environment Minister and other regulatory agencies.
  • Medicines: Medicines, medical devices and diagnostics are regulated by the Therapeutic Goods Administration (TGA). The TGA has stringent procedures and guidelines in place for the regulation of medicinal therapeutics derived from biotechnologies. These guidelines include information on active and medicinal products, vaccines and blood/plasma. The TGA is conducting a comprehensive review of current regulatory arrangements to ensure that those arrangements remain adequate to assess and manage the risks that may be associated with products manufactured using increasingly sophisticated nanotechnologies. The TGA is also continuing to closely monitor developments around nanotechnology internationally to ensure a rapid response to any new issues identified.
  • Pesticides and Veterinary Medicines: The Australian Pesticides and Veterinary Medicines Authority (APVMA) assesses and regulates agvet products up to the point of retail sale, of pesticides and veterinary medicines. Veterinary medicinal products, including both chemical and biological products are a regulated by the APVMA in Australia. The APVMA specifically assesses and regulate biotechnology research, production and sale of pesticides and veterinary medicines. The APVMA regulates any agvet product up to the point of retail sale that either contains a Genetically Modified Organism (GMO) or one that is to be used in a Genetically Modified (GM) crop. APVMA permits cover the use of chemicals in GM crop trials, yet do not regulate the actual GM crops themselves. The APVMA liaises closely with the Office of the Gene Technology regulator (OGTR) in the assessment of GMO products. The APVMA also regulates agvet products which contain nanomaterials.
  • Workplace Safety: Regulation around workplace health and safety is carried out at state level but coordinated through Safe Work Australia. Safe Work Australia aims to reduce the risk posed by the development and use of these nanomaterials not only in the workplace but also in the general community.
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