Appendix 2 National regulatory arrangements
The Gene Technology Regulator (GTR) and her office, the Office of the Gene Technology Regulator (OGTR) decide whether there is any risk to human health or the environment. In this process, they must consult with and take into account the views of a number of other agencies including Food Standards Australia New Zealand (FSANZ), the Agricultural Pesticides and Veterinary Medicines Authority (APVMA), the Therapeutic Goods Administration (TGA) and the Australian Quarantine and Inspection Service (AQIS).
Food Standards Australia New Zealand
FSANZ is responsible for food safety and all GM foods or ingredients to be sold in Australia must undergo a mandatory pre-market safety assessment to ensure that it is safe for human consumption. FSANZ also regulates the labelling of GM foods and since December 2001 has required that all GM food sold in Australia be labelled if novel DNA or protein is present in the final product. Through the Victorian Food Act 1984, the Victorian Government confers the responsibility for assessing food safety risks to FSANZ.
Agricultural Pesticides and Veterinary Medicines Authority
The APVMA is responsible for the regulation of pesticides and veterinary medicines up to and including the point of retail sale and administers the National Registration Scheme for Agricultural and Veterinary Chemicals in partnership with the States and Territories. The APVMA's responsibility for regulation of pesticides includes a responsibility for herbicides (weedicides) such as those approved for use over Roundup Ready® GM canola and Liberty® GM canola crops.
Therapeutic Goods Administration
The TGA is responsible for the regulation of therapeutic goods in Australia. The Therapeutic Goods Act 1989 confers responsibility to the TGA to ensure the quality, safety and efficacy of medicines, including those that are GM or derived from a GM process. The regulatory framework is based on a risk management approach designed to ensure public health and safety. Under the Act, the TGA is responsible for product labelling and appearance and other provisions. Some provisions, such as the scheduling of substances and the safe storage of therapeutic goods, are covered by relevant State or Territory legislation.
Australian Quarantine and Inspection Service (AQIS)
AQIS is responsible for ensuring that products imported into Australia do not lead to the introduction, establishment and spread of pests and diseases that may endanger plants, animals and human life or health. GM products imported into Australia that could potentially pose a pest and disease risk fall under the Quarantine Act 1908 administered by AQIS. In the first instance, an import application form must be completed for proposed importation of GM material. AQIS assesses import proposals using an Import Risk Analysis process. AQIS also advises importers to contact the OGTR, as the importer must also comply with OGTR requirements.
AQIS also certifies the export of agri-food products and commodities from Australia in accordance with the requirements of the Export Control Act 1982. AQIS identifies and inspects products and commodities, then certifies that they meet the requirements of the importing country governments.
In providing this certification, AQIS relies upon advice from a number of sources, mostly third-party State or Commonwealth Government agencies, to provide verification data to support certification. When an importing country has a requirement as to the GM status of a product or commodity as part of certification, AQIS will attach to its export certification a statement from the OGTR as to the commercial status of the product or commodity in Australia.