Modern biotechnology has extended humans' manipulation and modification of biological resources for a range of purposes. New techniques (many of a molecular nature) have enabled the development and commercialisation of novel products. For example, the generation of plants with desirable traits (increased grain yield or resistance to disease), the use of bacteria for the production of proteins that are important to human health, and the deployment of biological control agents (specific bacterial or fungal strains) to control the spread of pests, such as weeds, insects or plant diseases.
Gene technology uses molecular techniques to directly study and manipulate genes. Amongst these techniques, 'genetic engineering' or 'genetic modification', enable the genetic material of a living organism to be deliberately altered to introduce a new trait, or enhance or remove an existing trait. Genetically modified organisms (GMOs) are generated by modifying genes within a species, or by moving genes from one species to another. Gene technology is different from the conventional breeding of organisms, as it enables the transfer of genetic material between organisms that are not sexually compatible, and to introduce a trait into an organism that would not otherwise occur in that organism.
In Australia, GMOs such as herbicide tolerant and insect resistant cotton and canola are grown commercially. The introduction of these traits to those crops has increased our ability to control weeds and pests that reduce crop yield. GM crops released in other countries include not only cotton and canola, but also maize, plum, potato, soybean and tomato.
Role of the Department
The Department plays a role in the sound management of the risks posed by the release of the products of biotechnology into the Australian environment.
The Department has two main responsibilities:
1. Provision of advice to the Gene Technology Regulator
The cornerstone of the regulation of the release into the Australian environment of GMOs is the Gene Technology Act 2000. The object of this Act is to protect the health and safety of people and the environment by identifying and managing the risks posed by GMOs. Under the Act, the Gene Technology Regulator, supported by the Office of the Gene Technology Regulator, must seek advice from the Minister for the Environment when preparing a risk assessment and risk management plan (RARMP) for the release of a GMO into the Australian environment. The RARMP forms the basis of the Regulator’s decision whether to grant a licence to release any GMO.
The Department reviews consultation RARMPs, and prepares advice from the Minister to the Regulator that considers the risks posed to the environment by the proposed release.
Environmental Risks posed by GMOs
The genetic modification of an organism could introduce traits that could enable it to cause harms to our environment. Australia has a unique environment, and the impacts of any GMO will not necessarily be the same here as in other countries.
The risks of GMOs include:
- production of a compound by the organism that is toxic or allergenic, potentially causing harm to animals (including humans) that use this organism as a food source
- increasing the ability of the organism to establish and spread in the environment, potentially competing with native species and reducing native biodiversity
- transfer of the introduced genetic material to another organism, which then causes environmental harms
2. Assessment of the environmental safety of biological products regulated as agricultural chemicals and veterinary medicines by the Australian Pesticides and Veterinary Medicines Authority (APVMA)
The APVMA regulates to the point of sale viable micro-organisms (such as bacteria, fungi, viruses, protozoa, and nematodes) that are used as agricultural pesticides or as veterinary vaccines and medicines. The Department assesses the risks posed to the environment by the proposed use of these products. These assessments are used by the APVMA in deciding whether to grant a permit or registration for a product.
Environmental Risks posed by Micro-organisms
The assessment of the risks posed to the environment by micro-organisms is similar to that for GMOs. The Department considers the characteristics of the organism, in particular its ability to establish and spread in the environment, and cause harm to other (non-target) organisms. Such harms include being toxic to other organisms, and/or infecting these organisms and causing disease (pathogenicity). Micro-organisms have a relatively high propensity to transfer genetic material by non-sexual means (horizontal gene transfer) and genetic recombination. The transfer of genes could generate an organism with a competitive advantage over native species that could harm the environment.
Environment Protection and Biodiversity Conservation Act 1999
The Department administers the Environment Protection and Biodiversity Conservation Act 1999 (EPBC Act). This Act regulates actions that are likely to have a significant impact on matters of national environmental significance, and also actions on Australian Government land or actions by the Australian Government that are likely to have a significant impact on the environment. These provisions may be relevant to the release of a GMO or micro-organism, if it is determined that this action may have a significant impact on matters protected under the EPBC Act. In these circumstances the Minister may have the power to not approve an action.