Frequently asked questions

Biotechnology Australia ceased operations on 30 June 2008. The information on this website has been archived and will no longer be updated.

This page aims to provide answers to some of the more common questions asked by members of the community about biotechnology and gene technology. More detailed information on these topics may be obtained from pages that concentrate on specific issues.

Issues covered by this fact sheet are:

1. Are genetically modified (GM) foods safe?

2. Can genetically modified foods cause allergies in some people?

3. Can genetically modified organisms escape into the environment?

4. Who is responsible for regulating GMOs in Australia?

5. What is the approval process that food companies or agribusiness firms must follow to get GM food products onto the market?

6. Are companies subject to any penalties if they break rules governing GMOs?

7. Doesn’t the fact that genetically modified crops are owned by multinationals mean that international agribusiness companies will control Australian farmers?

8. Are the characteristics placed in a GM plant, e.g. soy beans, passed onto the next generation of soy bean plants? Put another way, do GM plants pass on that trait in reproduction?

9. Is it possible to place animal genes in plants and vice versa?

10. Is this occurring?

1. Are genetically modified foods safe?

Genetically modified (GM) foods have ingredients in them that have been modified by a technique called gene technology. This technology allows food producers to alter certain characteristics of a food crop by introducing genetic material and/or proteins from another source. An example of this is a corn plant with a gene that makes it resistant to insect attack.

Australia has one of the safest food supplies in the world. Food Standards Australia New Zealand (FSANZ) is an independent bi-national organisation, and is a partnership between the Australian Government, State and Territory governments and the New Zealand Government. FSANZ’s role is to protect the health and safety of the people of Australia and New Zealand by maintaining a safe food supply.

All GM foods must be assessed by FSANZ, be determined to be safe, and approved by the Australia New Zealand Food Standards Council - made up of the Australian Government, State and Territory Health Ministers of Australia, and the New Zealand Health Minister, before they are allowed to be sold for human consumption.
GM foods generally contain new genetic material (DNA) and proteins. They are new in the sense that they may not have previously existed in the food. In making an assessment, FSANZ examines the safety of these new components separately and fully. In addition, other characteristics of the food such as the levels of nutrients and naturally occurring allergens, toxins and anti-nutrients are also considered in detail, as these may be affected by the genetic modification. Any significant differences in these properties between the GM food and its conventionally produced equivalent are assessed for potential health effects.

When FSANZ makes a recommendation on the safety of a GM food, it goes through a process of public consultation and the safety assessment report is available on the FSANZ website.

So far, FSANZ has approved a number of GM ingredients for use in food in Australia and New Zealand. These include soy beans, corn, potato, canola and cotton (cotton oil is used in some foods). No genetically modified fresh fruit, vegetables, meat or fish have yet been approved for sale in Australia.

For more information on GM food safety visit www.foodstandards.gov.au or contact FSANZ on (02) 6271 2241.

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2. Can genetically modified (GM) foods cause allergies in some people?

People with food allergies have an unusual immune reaction when they are exposed to specific proteins, called allergens, in food. About 2% of people across all ages have a food allergy of some sort. These people usually only react to one or a few allergens in one or two specific foods. The majority of foods do not cause any allergy in the majority of people.

Such allergens may also be present in conventional foods that are subsequently genetically modified. For example, soy naturally contains proteins that cause allergic reactions in some people. Unless the proteins are specifically removed, they will remain in GM soy varieties.

FSANZ checks to ensure that the levels of naturally occurring allergens in GM foods have not significantly increased above the natural range found in the conventional food.

FSANZ also checks to ensure that the new proteins in GM foods are not likely to be allergenic - by, for example, investigating whether the protein has come from a food which is known to contain allergens, if they are similar to known allergens, or if they have any physical characteristics that are similar to known allergens.

If FSANZ had scientific evidence that a new protein in a GM food was allergenic, it is unlikely that the food containing that protein would be permitted to be sold in Australia and New Zealand, even with appropriate labelling. This is because it is considered inappropriate to increase the level of exposure of the community to allergens in the food supply.

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3. Can genetically modified organisms escape into the environment?

One concern held by the community is that genetically modified organisms (GMOs) may unintentionally ‘escape’ into the environment. The Gene Technology Regulator takes steps to minimise such a risk.

In respect of laboratory-based research, there are strict requirements which set out the various levels of physical containment (PC) required in a laboratory for conducting GMO research so as to prevent GMOs from entering the environment. The laboratories are classified as PC 2, PC 3 and PC 4, the details about which can be obtained from the OGTR web site www.ogtr.gov.au.

The requirements include the use of safety cabinets, specific work practices, sterilisation of equipment, airtight doors and windows, and the use of reduced air pressure in work areas. The laboratory precautions required to undertake GMO research are determined by the Gene Technology Regulator in accordance with the Gene Technology Act 2000 (the Act), Gene Technology Regulations 2001, and the Guidelines for Certification of Facilities/Physical Containment Requirements.

Concerning GMO field trials, the Gene Technology Regulator (Regulator), in accordance with the Act, requires a person who wishes to conduct a field trial of a GMO crop, to make and application for a licence to undertake the trial.

When assessing such an application, the Regulator must consider whether the proposed trial poses a significant risk to the health and safety of people or to the environment. This includes whether the applicant has made provision to limit the spread of genetic material beyond the trial site, and also to limit the persistence of the genetic material at the trial site.

The Regulator must develop a risk assessment and risk management plan in relation to the proposed dealing with a GMO and provide an opportunity for public comment on the plan. In addition, the Regulator can set conditions on the GMO trial licence which are enforceable under the Act. Staff from the Regulator’s Office monitor compliance against the licence conditions.

Research into the likelihood of gene from GMOs transferring into the environment is also underway in Australia. Preliminary results from the Waite Institute, a campus of Adelaide University, suggests that outcrossing from domesticated crops to weedy and indigenous wild relatives such as transfer from canola to surrounding weed species is possible, but the frequency of such events is extremely low. In an experiment carried out by researchers at the Institute, where herbicide-tolerant canola plants were grown closely alongside wild radish, only two out of 75 million plants cross-pollinated.

The CSIRO, together with Environment Australia, is also currently undertaking research to discover what ecological effects might result from GMOs being released into the environment. For more information on this study, please see Fact sheet 11 – CSIRO Environmental Implications of Genetically Modified Organisms.

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4. Who is responsible for regulating GMOs and GM products in Australia?

Several government agencies are responsible for ensuring that all genetically modified organisms and products are assessed for public and environmental safety.

The main regulators are:
The Office of the Gene Technology Regulator (OGTR) is responsible for administering organisms and the Gene Technology Act 2000, which has as its object, to protect the health and safety of people, and to protect the environment, by identifying risks posed by gene technology, and by managing those risks through regulating certain dealings with GMOs. (www.ogtr.gov.au)

Food Standards Australia New Zealand (FSANZ), supported by the Australia New Zealand Food Authority Act (1991), works with the Australia New Zealand Food Standards Council (ANZFSC), to develop and maintain laws and systems which ensure the safety, and regulate the labelling, of food, in Australia and New Zealand. (www.foodstandards.gov.au)

Australian Competition and Consumer Commission (ACCC) administers the Trade Practices Act (1974) and the Prices Surveillance Act (1983), to protect consumers from unfair trading, and false, misleading, and deceptive conduct. (www.accc.gov.au)

Australian Quarantine and Inspection Service (AQIS) develops policies and procedures relating to incoming passengers, mail, animals and plants, that have quarantine significance. This includes genetically manipulated products imported into Australia that may pose a pest and disease risk. (www.aqis.gov.au)

National Occupational Health and Safety Commission (NOHSC) is responsible for encouraging community awareness, and developing policies and strategies for occupational health and safety. Specifically the NOHSC is responsible for assessment of industrial chemicals. (www.nohsc.gov.au)

The Australian Pesticides and Veterinary Medicines Authority is responsible for the system which evaluates, registers and regulates agricultural and veterinary chemicals. (www.apvma.gov.au)

Therapeutic Goods Administration (TGA) is responsible for administrating the provisions of the Therapeutic Goods Act (1989), which provides a national framework for the regulation of therapeutic goods in Australia to ensure their quality, safety and efficacy. GM pharmaceuticals are addressed under this system. (www.tga.gov.au)

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5. What is the approval process that food companies or agribusiness firms must follow to get GM food products onto the market?

All GM foods in Australia and New Zealand must be assessed by FSANZ, determined to be safe, and approved by the Australia New Zealand Food Standards Council (ANZFSC) - made up of Australian Government, State and Territory Health Ministers, and the New Zealand Health Minister, before they can be legally sold.

Producers of GM foods must apply to FSANZ to seek approval for the food to enter the food supply in Australia (and New Zealand). This application is made at the commodity level - that is as a new primary product (eg: Bt corn). Until that commodity is approved, foods containing it, or ingredients derived from it, cannot be lawfully sold.

The producer of the food must provide a large amount of scientific information so that FSANZ can complete a full safety assessment. FSANZ supplements this data with information derived from a number of other sources, such as peer-reviewed scientific literature, general technical information, independent scientists, other regulatory agencies, international bodies and the wider community.

The FSANZ safety assessment process involves working in detail through a number of safety issues. In general, a GM food is recommended as safe for human consumption if FSANZ is satisfied that:

All new genetic information has been examined in detail;

• The new genetic material stays the same and is passed on in a predictable way from generation to generation;
• The new proteins have been examined in detail;
• The new proteins are unlikely to be toxic or allergenic;
• The new proteins do not cause any detectable toxicity in animal studies;
• The potential transfer of new genetic material to cells in the human digestive tract will not have a significant impact on human health;
• The levels of naturally occurring toxins, allergens and anti-nutrients in the GM food are not significantly increased compared to the non-GM food; and
• The composition of the food is not significantly altered compared with the non-GM food.

FSANZ then prepares a detailed safety report on the food, which is reviewed by an independent panel of experts before they are provided to the community through consultations that are part of the approvals process. Through these consultations the views of the community are sought and legitimate issues must be addressed before a final decision is made by the ANZFSC on the approval of the GM food.

In addition, all GM foods sold in Australia and New Zealand must be correctly labelled, in accordance with Standard 1.5.2 of the Food Standards Code. This Standard prescribes that all genetically modified foods containing new DNA and/or proteins, or altered characteristics, must be labelled.
For more information about GM food safety assessment or GM food labelling, visit the FSANZ website - www.foodstandards.gov.au

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6. Are companies subject to any penalties if they break rules governing GMOs?

The Gene Technology Act 2000 establishes offences for unauthorised dealings with genetically modified organisms. If such dealings occur, offenders are subject to penalties of up $1.1 million, or 5 years’ imprisonment. These penalties are described in more detail in Part 4, Division 2 of the Gene Technology Act.
With respect to food products, the new joint Australia New Zealand Food Standards Code, gazetted on 20 December 2000, provides a common set of food regulations in Australia and New Zealand, including standards for GM foods.

Food standards have the force of law. It is a criminal offence in Australia to supply food that does not comply with relevant food standards. Notwithstanding food standards, it is also an offence to sell food which is damaged, deteriorated or perished, which is adulterated, or which is unfit for human consumption.

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7. Doesn't the fact that genetically modified crops are owned by multinationals mean that international agribusiness companies will control Australian farmers?

Large companies own much of the intellectual property, or knowledge, associated with new applications of gene technology and this concerns many people. 

However, not all biotechnology-related research relies on large corporations. There are government-funded organisations, such as universities and the CSIRO, both in Australia and internationally, that also conduct research in this area. For instance, the strains of GM cotton in use here were developed in Australia in conjunction with the CSIRO.

Modern biotechnology is highly specialised and therefore needs skilled people with expensive laboratories and sophisticated equipment. A large company often has the money to spend on this, and usually has existing facilities and experience. The fact that the companies make profits allows them to invest in new technologies.

This is why it is mainly big companies that have the money and skill to develop powerful new medicines, for example. Many other procedures in modern agriculture - such as the creation of pest-killing chemical sprays or the manufacture of fertilisers - also rely on large companies.

Governments carefully regulate businesses in areas that affect human health and the environment. Biotechnology is no exception. Corporations are unlikely to invest millions on products that are unwanted by consumers and will not sell. In this way, the community can influence the course of scientific research. Companies would not bother with products that consumers do not feel they benefit from, as such products would not sell.

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8. Are the characteristics placed in a GM plant, e.g. soy beans, passed onto the next generation of soy bean plants?  Put another way, do GM plants pass on that trait in reproduction?

Yes. Usually the new characteristics are a permanent feature of the modified plant in the same way as changes selected for by conventional breeding programs.

Most crop plants are modified by inserting genes into the nucleus, and so the genes for the introduced trait are passed on to the offspring during reproduction.

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9. Is it possible to place animal genes in plants and vice versa?

Yes. The genetic material, DNA, of all living things is essentially the same. Genes usually differ only slightly between species, compared to within species.

Because DNA is so similar between species, transfer of genes between species occurs in some situations in nature. In many plants and some animals, gene migration can occur not only between subpopulations of the same species but also between different (but still related) species. This is called hybridisation.

Gene transfer can also sometimes occur in nature between unrelated species. For example, some species of soil bacteria in the family Agrobacterium can transfer genes into plant roots. Also, some species of bacteria can transfer small segments of DNA called plasmids between species, and take up naked DNA from within the environment through their cell wall.

Genetic engineering technology makes it possible to transfer genes between a wider range of species that can occur in nature. This means that gene technology allows breeders to select from a greater number of traits than is possible to select from using traditional breeding methods.

Once the required gene is selected, its DNA is ‘cut’ out from the surrounding DNA. There are a number of techniques that can be used to transfer the gene into a new cell. These include:

• coating tiny silver bullets with the gene, then ‘firing’ the DNA into cells;
• placing the gene into the DNA of a specially created disabled virus which then infects the new cells: and
• treating the new cell so that its surrounding membrane and/or wall are weakened, allowing the new DNA into the cell.

Organisms containing gene(s) originally from other species are called transgenic.

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10. Is this occurring?

Yes, this is occurring. For example, the majority of insulin currently used by diabetics in Australia is produced by bacteria engineered to contain a copy of the human insulin gene.

Bt cotton, which makes up about 30% of Australia’s cotton crop, relies on a gene from the bacterial species Bacillus thuringiensis to make it pest resistant.

There is also the possibility of new applications of this technology becoming available in the future.
CSIRO scientists recently developed Australia’s first genetically modified grapevine. The team is aiming to create grapevines with enhanced flavour, improved colour development and increased disease resistance. The opportunity to introduce disease resistance and other valuable characteristics into grapevines without changing the essential quality of varieties offers Australia large potential gains in the winery and vineyard as well as to consumers and the environment. This grape vine is not currently under commercial production.

The Pest Animal Control Cooperative Research Centre is developing vaccines to control pest animals by limiting their reproduction. Delivery of the vaccines is likely to be through baits, or by using a virus which spreads naturally through the target pest population. The vaccines are created by genetically modifying a carrier virus to include DNA for sperm, egg or other key reproductive proteins. The product is a modified virus, which during infection of the pest causes an immune response which attacks the animal's own sperm or eggs and prevents reproduction. The use of fertility control vaccines promises to be more cost-effective, more humane and more environmentally friendly than current methods of control.

All research and releases using transgenic organisms must comply with legislation to protect human health and safety and the environment administered by the Office of the Gene Technology Regulator (OGTR).

More information on current developments in gene technology in Australia is available from the CSIRO Gene Technology website - http://genetech.csiro.au

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