Regulatory Framework in Australia
Office of the Gene Technology Regulator (OGTR)
Food Standards Australia New Zealand (FSANZ)
Australian Government Department of Agriculture, Fisheries and Forestry (DAFF)
Australian Pesticides and Veterinary Medicines Authority (APVMA)
Therapeutic Goods Administration
The Commonwealth Gene Technology Act 2000 (the Act) came into force on 21 June 2001 and is a key component of the national regulatory framework for genetically modified organisms (GMOs). This legislation was developed in consultation with all States and Territories over a number of years and provides a cooperative national approach. The Act established the position of the Gene Technology Regulator (the Regulator) to administer the legislation. The Regulator is supported by the Office of the Gene Technology Regulator (OGTR).
The Act regulates all dealings with live and viable GMOs in Australia, including research, manufacture, import, production, propagation, transport and disposal of GMOs.
A statutory review of the Act by an independent panel was completed in 2006. The review found that the Act and the national regulatory scheme were working well and no major changes were required, and recommended a number of minor changes to improve the operation of the Act at the margin. The Gene Technology Ministerial Council, which oversees the cooperative national legislative scheme, appointed the panel. The states, territories and the Australian Government responded to the recommendations. The statutory review recommended that the Act be reviewed in five years to ensure that it continues to accommodate emerging trends. A new review has commenced in 2011. More information on this process can be found on the Department of Health and Aging website.
Dealings involving the intentional release of a GMO into the environment are illegal in Australia unless conducted pursuant to a licence from the Regulator. This applies to both limited and controlled releases (eg field trials) and commercial scale releases. Before issuing such a licence, the Gene Technology Regulator must prepare a risk assessment and risk management plan (RARMP) that identifies any potential risks to the health and safety of people and the environment posed by gene technology, and the means of managing those risks.
For licence applications for environmental release of GMOs the Regulator must consult on the RARMP with States and Territories, other Australian Government agencies, relevant local councils and the public. The Regulator consults with DAFF through the Australian Quarantine and Inspection Service (AQIS) and Biosecurity Australia.
The Act makes a distinction between GMOs (live and viable) and genetically modified (GM) products. The OGTR does not directly regulate the use of GM products. However, the use of GM products is regulated by other regulatory agencies in a number of situations. For example the use of GM products in food for human consumption is regulated by Food Standards Australia New Zealand (FSANZ), the use of GM products as human therapeutics is regulated by the Therapeutic Goods Administration (TGA) and the use of GM products as veterinary therapeutics is regulated by the Australian Pesticides and Veterinary Medicines Authority (APVMA).
The OGTR maintains a Record of GMO and GM Product Dealings (GMO Record) on its website. The GMO Record is a complete list of all GMO dealings approved by the Regulator and of all GM product approvals notified to the Regulator by other product regulators. The purpose of the GMO Record is to provide the Australian public with ready access to information about GMOs and GM products being used in Australia. Australia is, we understand, the first country in the world to make such a comprehensive record available to the general community. The GMO Record is a substantive demonstration of the openness and transparency which underpins the regulatory system for GMOs operating in Australia.
Food Standards Australia New Zealand (FSANZ)
GM food safety is the responsibility of FSANZ. Standard 1.5.2 of the Australia New Zealand Food Standards Code requires that all GM foods or ingredients to be sold in Australia undergo a mandatory pre-market safety assessment to ensure they are safe for human consumption. In addition, since December 2001, Australia has had in place a mandatory labelling regime that requires all GM food sold in Australia to be labelled as such if novel DNA or protein is present in the final product.
FSANZ carries out safety assessments on a case-by-case basis, which means each new genetic modification is assessed individually for its potential impact on the safety of the food. FSANZ compares the GM food with a similar, commonly eaten non-GM food from a molecular, toxicological, nutritional and compositional point of view. If the genetic modification causes an adverse effect in the food, such as increasing its allergenicity or toxicity, it will not be approved. The safety assessment protocol used by FSANZ for GM foods is based on internationally recognised principles for assessing the safety of whole foods.
The Code also requires that food (including ingredients, food additives and processing aids) derived from GM crops be labelled as GM if any genetic material and/or protein other than that normally present in the food is contained in the final product. Highly refined foods such as oils and sugars, that do not normally contain any genetic material or protein, may require labelling if they possess characteristics that are significantly altered from the non-GM counterpart. This labelling requirement ensures consumers are advised where there is GM content and can make informed choices.
For more information about GM food labelling requirements see FSANZ’s User Guide - Labelling Genetically Modified Food.
DAFF also participates in domestic food regulatory policy and comments on the assessment and approval of GM foods by FSANZ and related labelling issues. In relation to the Imported Food Inspection Scheme, AQIS has operational responsibility for inspection and sampling required in accordance with the Imported Food Control Act 1992, and FSANZ advises on food risk assessment policy for the scheme.
The Australian Quarantine and Inspection Service (AQIS) , which forms part of DAFF, has three functions: regulation of imports for quarantine purposes, inspection and certification of exported primary products consistent with the importing country’s quarantine requirements and Australian export legislation and imported food inspection to meet Australian food standards.
AQIS inspects imported plants, parts of plants, plant products, animals and microbial-derived products, for quarantine risk. Under the Quarantine Act 1908, AQIS requires importers of a range of goods of quarantine concern to give notice of a proposed importation. In order to assist in the regulation of imports of GM goods, this requirement has been extended to GM seeds. If an importer seeks to import a GM seed, AQIS advises Biosecurity Australia, also part of DAFF, which considers the pest and disease ramifications compared to its conventional counterparts. Prospective importers of other goods of quarantine concern, are also asked to specify if the goods have been genetically modified. Information on what other types of GM goods are being imported is regularly provided to the OGTR. The OGTR's monitoring of this and other information will determine if other classes of goods of quarantine concern, that require prior assessment for genetic modifications, begin to be imported. In this case, AQIS will respond to any request for assistance by ensuring that arrangements are implemented to refer import applications to the appropriate authority for assessment.
AQIS also certifies exports of agri-food products and commodities from Australia in accordance with the requirements of the Export Control Act 1982. Based on identification and inspection of products and commodities, AQIS certifies that products and commodities for export from Australia meet the quarantine requirements of importing country governments. When an importing country has a government requirement for certification as to the GM status of a product or commodity AQIS attaches to its export certification a statement from the OGTR that there has been no commercial release of that commodity in Australia when appropriate.
Under the Imported Food Control Act 1992, AQIS administers the imported food inspection scheme and has responsibility for inspection and sampling of imported food to check for safety and compliance with the food standards detailed in the Australia New Zealand Food Standards Code. This inspection scheme is risk based and priority is given to those foods that FSANZ considers to pose a medium to high risk to public health. Imported GM food is monitored for compliance with Australian standards.
The Agricultural and Veterinary Chemicals Administration Act 1992, contains a section (section 8A) which requires the APVMA to consult the Gene Technology Regulator for making certain decisions. The relevant decisions are when the APVMA decides to grant an application, make a variation or reconsider any of the following:
a) approval of an active constituent that is, or contains, a GM product
b) registration or listed registration of a chemical product that is, or contains, a GM product
c) approval of a label for containers for a chemical product that is, or contains, a GM product
d) permit approvals for a product that is, or contains, a GM product
The use of GM products as human therapeutics is regulated by the Therapeutic Goods Administration.
04 Jul 2011