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Address: MDP 54 GPO Box 9848 Canberra ACT 2601 Website: www.ogtr.gov.au

Telephone: 1800 181 030 Facsimile: 02 6271 4202

Assessing risks from genetically modified organisms

A structured approach that supports evidence-based decisions

What is a genetically modified organism?

Genes are sets of instructions in the cells of all living creatures—animals, plants and microorganisms—that act as the blueprint for how that organism develops and functions.

Gene technology can be used on organisms to change their genes. A genetically modified organism (GMO) is one that has been modified or given a new trait through the use of gene technology.

GMOs are used in many ways in Australia. They may be used in agriculture, as a source of food, as vaccines, to produce industrial chemicals and for research.

Using risk analysis to regulate GMOs

People use risk analysis in daily life when considering activities that could involve harm—such as crossing the road, climbing a ladder or using boiling water. Risk analysis can also be applied to GMOs.

In Australia, a set of laws* control what people can do with GMOs, such as doing experiments with, developing, breeding, growing, importing or transporting GMOs. The laws are designed to protect people and the environment by identifying and managing risks posed by GMOs.

An independent person, the Gene Technology Regulator (the Regulator*) is responsible for the risk analysis of GMOs and is supported by staff in the Office of the Gene Technology Regulator. Risk analysis is a reasoned, repeatable and transparent approach to identifying and managing risks. It is based on a well-established international approach that is also used in other sectors such as finance, business, engineering and manufacturing. It provides a rigorous, evidence-based framework for decisions made by the Regulator.

All activities with a GMO in Australia need authorisation. If a GMO is grown in a field it will require a licence. Some GMOs used in a laboratory may also require a licence. The Regulator uses risk analysis to decide whether or not to issue a licence and monitors compliance with these licences.

The risk-analysis process

Before a licence is granted for a person or company to work with a GMO, the Regulator prepares a risk assessment and risk management plan. This is done on a case-by-case basis, taking into account the specific circumstances or context for each individual application.

For example: Some GM cotton has been genetically modified to resist damage by producing compounds that are toxic to certain major insect pests that feed on cotton.

Address: MDP 54 GPO Box 9848 Canberra ACT 2601 Website: www.ogtr.gov.au

Telephone: 1800 181 030 Facsimile: 02 6271 4202

To make decisions about issuing GMO licences, the Regulator:

assesses the risks

develops a management plan to control or minimise the risks

communicates and consults about the risks.

RISK ANALYSIS

Assessing the risks

The Regulator identifies possible risks by considering how a new property of a GMO may cause harm to people or the environment.

Because any organism can potentially cause harm, the Regulator compares the risk of a GMO against the risk of harm from the ‘parent’ organism.

The Regulator uses scientific and technical information from many sources to assess potential risks from a GMO, guided by a few key questions.

How serious is it?

(Assess the consequences)

What could go wrong?

(Identify risk)

How likely is it?

(Assess the likelihood)

Does it need to be managed?

(Evaluate the level of risk)

Assess the risks

Scope

Manage the risks

Communicate

and consult

Monitor and

review along

the way

For example: A risk assessment will test if risk from GM cotton is greater than risk from non-GM (parent) cotton. Risks are affected by the ability of GM cotton to become invasive and possible adverse impacts caused by the plant or its products such as cotton fibres or cottonseed oil.

Example of a possible risk: GM cotton is toxic to insect pests. Could the toxins harm birds that eat the pests? No, the toxins only bind to the gut of specific insects and are unlikely to affect birds.

Address: MDP 54 GPO Box 9848 Canberra ACT 2601 Website: www.ogtr.gov.au

Telephone: 1800 181 030 Facsimile: 02 6271 4202

Managing the risks

Risk management protects people and the environment by taking actions to reduce, mitigate and avoid risks. The Regulator develops a risk management plan for every licence application.

Asking for your input along the way

An important part of the Regulator’s approach to risk analysis is to exchange information, ideas and views between the Australian people, governments and interested groups about regulating GMOs.

Before issuing licences, the Regulator asks for detailed advice, feedback and comment from a diverse group of people on each risk assessment and risk management plan.

Risk management plan and licence

Does anything need to be done about it?

What should be done?

What can be done?

An identified risk

What protective actions are most effective, feasible and practical?

Will those protective actions create any problems of their own?

How can the protective actions be monitored?

Members of the public

Gene Technology

Regulator

Expert committees

Researchers Health workers

Government (local, state,

Commonwealth)

Farmers

Industry Other regulators

For example: A management measure for GM seeds that might become weeds could include: secure transport using double-layered containers, and cleanup actions if seed is spilled.

Address: MDP 54 GPO Box 9848 Canberra ACT 2601 Website: www.ogtr.gov.au

Telephone: 1800 181 030 Facsimile: 02 6271 4202

Communication by the Regulator includes:

giving information and advice about how GMOs are regulated

consulting experts and the public about risk and risk management plans

asking for data, advice or expert submissions

explaining licence decisions and conditions

discussing how to assess, manage and communicate risk

seeking advice about ethical issues and issues of concern to the public

talking about policy with governments (Commonwealth and state).

Want to know more?

Full details of the Regulator’s approach to risk analysis can be found in the Risk Analysis Framework* at www.ogtr.gov.au.

You can ask us about how the Regulator works, be included on a register to receive regular updates on our work, give us feedback about our website or publications, and more.

Contact the Office of the Gene Technology Regulator by:

email: ogtr@health.gov.au

online: www.ogtr.gov.au

free call: 1800 181 030

fax: 02 6271 4202

mail: MDP54, GPO Box 9848, Canberra ACT 2601.

We welcome and value your comments and questions.

* ‘The Act’ is the Gene Technology Act 2000. ‘The Regulations’ are the Gene Technology Regulations 2001.