This brochure is designed to introduce Victorian safeguards for controlling gene technology through regulation.

A single national regulatory scheme

All activities involving gene technology in Australia fall under a national regulatory scheme, which is agreed to by state and federal governments. The schemes aim is to protect environment and the publics health and safety, by identifying potential harm posed by, or as a result from, gene technology. The national Office of the Gene Technology Regulator (OGTR), in Canberra, is responsible for regulating all genetically modified organisms (GMOs). The Gene Technology Regulator (GTR) administers laws about gene technology. The GTR decides whether to allow, restrict or prohibit proposed gene technology activities through a licensing system. All Australian Governments have agreed the GTR is the only authority that can make decisions on licence applications for gene technology activities. Other national regulators control the sale and safety of commercial GMO or GM products, in the same way they would handle similar items produced in traditional ways. For instance, the Therapeutic Goods Administration would regulate a GM medicine while a GM food would be regulated by the Food Standards Authority Australia New Zealand. All approved activities using gene technology are subject to periodic, and sometimes unannounced, visits by the regulators. Similarly, the buildings and facilities where activities take place, and the people carrying out such activities, are also checked. There are high penalties if licence conditions are not adhered to.

Figure 1 This information also informs the risk assessments used by GM product regulators. Framework for risk assessment followed by the GTR
Identification of hazards (what causes harm?) Risk assessment (how likely is it to occur?) Risk management (how can it be stopped or controlled?)

Biotechnology
Biotechnology is a broad term that describes the use of biological systems in living organisms to create new products or alter existing products. The word has been used for more than a century to describe techniques used in enzyme production, alcoholic fermentation and the cross breeding of plants. Processes of biotechnology are also used in waste reduction, food and medicine production, and in creating renewable energy resources.

Public consultation
When a proposed activity involving gene technology will take place in the open, there is an extensive public consultation before a licence is given. The OGTR has a public database of all GMOs and GM products approved in Australia.

Communication and consultation with applicants, stakeholders and communities

Victorian Governments role Managing safety through managing risk

Some GM activities have long been recognised as involving small or negligible risk and do not need to be licensed. These take place in a secure building, and never in the open environment. For all other licence applications, the GTR decides whether there is any unmanageable risk either to the environment or public health and safety. If there is a significant risk that cannot be managed, the licence will not be granted. Where risk is manageable, a licence may be granted subject to conditions. Legislation governs the amount and the details of information that the licence applicant provides. This includes information about the potential for the GMO to: be harmful to other organisms hurt the ecosystem transfer genetic material to other organisms spread throughout the environment be able to survive better than other organisms in the environment be toxic, allergenic or able to cause disease in other organisms. The responsible use of biotechnology offers Australia many opportunities to greatly increase its international competitiveness and the standard of living for all Australians. The Victorian State Government develops its biotechnology policies according to five broad principles: to optimise the economic, environmental and societal benefits available through biotechnology to protect and promote the health of the Victorian community to assure environmental safety and sustainability to require all actions are undertaken within an ethical framework to ensure there is full consultation, communication, transparency, monitoring and accountability. The Victorian Governments input participation in national biotechnology policy is coordinated across several State Government Departments. State Government scientists and technical experts review proposed activities, and advise on what impact they could have in Victoria. The Minister for Health is the lead minister for biotechnology safety and ethics and represents Victoria on the national Gene Technology Ministerial

Gene technology
Gene technology is a special application of biotechnology, where scientists insert genetic information into the cells of plants, animals and micro-organisms. The genes carrying the information might come from a similar or different species of organism than the receiving cell. This process gives the altered organism a new function or ability that would not be possible using other methods. The term genetically modified (GM) describes the altered organisms and products derived from them. Examples where gene technology has been used include producing insulin used by diabetics, creating plants that are resistant to disease or pests and developing foods that have a greater nutritional value.

Council. This council is responsible for oversighting the work of the Gene Technology Regulator. The Victorian Biotechnology Ethics Advisory Committee is an independent group that advises the Minister for Health on ethical matters relating to the use of gene technology and non-traditional biotechnologies in Victoria.

Gene technology in health

Gene technology is used to develop new sources of therapeutic products and medicines. For example, genetically modified bacteria have replaced pigs as the main a source of insulin for Australian diabetics. All genetically modified therapeutic products and medicines must undergo rigorous testing before they are available for general use. Related biotechnologies are developing new therapies and cures for diseases that are now untreatable. However, some research processes, such as those using stem cells from human embryos, have additional legislative controls reflecting community concern.

Only six of the these 13 plants have GM varieties that are currently approved for use in food for human consumption in Australia. The approved GM foods include: corn potatoes oil and linters from cotton canola and oil from canola.

Further information
Biotechnology in health Department of Human Services 9637 4998 www.dhs.vic.gov.au Biotechnology in agriculture Department of Primary Industries 136 186 www.dpi.vic.gov.au Approvals for GM foods and labelling requirements www.foodstandards.gov.au Australian regulation of gene technology www.ogtr.gov.au Australian regulation of human stem cells www.nhmrc.gov.au Approvals for GM therapeutics www.tga.gov.au General inquiries on biotechnology and gene technology Gene Technology Information Service 1800 631 276 www.biotechnology.gov.au Commonwealth Scientific and Industrial Research Organisation (CSIRO) 1300 363 400 www.csiro.gov.au Victorian Biotechnology Ethics Advisory Committee www.health.vic.gov.au/biotechnology Victorian Biotechnology Strategic Development Plan for Victoria www.biotechnology.vic.gov.au

Gene technology in Victoria

Laws and regulations

Most of these GM foods are grown overseas and imported. GM foods must be labelled under Australian food law.

Growing GM crops commercially

The GTR has no power to assess or manage trade or agricultural risks posed by GM crops. In 2003, the GTR approved the commercial growing of two varieties of GM canola in Australia. There are also several other licences allowing the commercial growing of GM cotton and GM carnations in suitable areas of Australia. Due to concerns about the potential impact of the commercial production of GM canola on Victorian markets and trade, the Victorian Government adopted a moratorium (until 2008) on the commercial release of GM canola in the State.

Gene technology in agriculture

The use of gene technology to produce new varieties of agricultural crops has been adopted widely throughout the world. There are currently 13 different varieties of GM plants available worldwide, which are commercially grown and used in the production of food and animal feeds: canola chicory corn cotton melon (cantaloupe) papaya potato rice soy squash sugar beet tomato flax/linseed.

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