The Gene Technology Act 2000 (the Act) and the Gene Technology Regulations 2001 (the Regulations) provide the basis for using risk analysis to regulate activities with genetically modified organisms (GMO) in Australia. In particular, the Act mandates preparation of a risk assessment and risk management plan before issuing a licence.

Licences are required for release of a GMO into the environment or for specified GMOs in containment facilities. The decision on whether to issue a licence is made by the Gene Technology Regulator (the Regulator), an independent statutory office holder established by the Act.

The Risk Analysis Framework provides guidance on how the Regulator, together with staff under the Regulator’s direction in the Office of the Gene Technology Regulator (OGTR), implements risk analysis of GMOs in accordance with the Act and the Regulations.

The purpose of this Risk Analysis Framework is to:

  • provide a guide to the current rationale and approach to risk analysis
  • enable a consistent and rigorous risk analysis approach to evaluating licence applications
  • provide transparency on the use of risk analysis for decision making.
This version of the Risk Analysis Framework incorporates recent advances in risk analysis, increased scientific knowledge, and regulatory experience gained with GMOs both here and overseas.

The Risk Analysis Framework describes the principles of risk analysis used by the Regulator to protect human health and safety, and the environment, in accordance with the Act.

Risk analysis includes risk assessment, risk management and risk communication. Risk assessment identifies risks from plausible sets of circumstances that may result in harm to people or to the environment from gene technology, characterises the risks on the basis of seriousness and chance of harm, and evaluates the need for controls. Risk management selects and implements plans or actions to ensure that risks are appropriately managed. Risk communication is the exchange of information, ideas and views between the Regulator and stakeholders. Risk communication also conveys the rationale for decisions made by the Regulator.

The method used for risk analysis is based on the Australian Standard/New Zealand Standard ISO 31000:2009, Risk Management—Principles and guidelines.

Risk analysis integrates the assessment, management and communication of risks posed by, or as a result of, gene technology.

Establishing the risk context is the preparatory step that defines the scope and boundaries, sets the criteria against which risk will be evaluated, and describes the structures and processes for the analysis. This includes setting criteria for what is considered as harm to people or the environment. The risk context is established within the framework of the legislative requirements of the Act and Regulations.

Decisions on licence applications require case-by-case assessment, including preparation of a risk assessment and risk management plan. Details of the GMO and the proposed activities, including any proposed controls, limits or containment measures, form the specific context for the risk assessment and risk management plan. Details of the parent organism and the environment where activities with the GMO will occur form the comparative baselines.

The risk context defines the parameters within which risk is assessed, managed and communicated.

Risk assessment is a structured, reasoned approach for considering the chance of harm from certain activities with a GMO, based on scientific/technical evidence. The aim is to identify, characterise and evaluate risks to the health and safety of people or to the environment from dealings with GMOs, posed by or as the result of gene technology. The risk assessment identifies risk by considering what could go wrong and how harm might occur. Risks are then characterised by considering how serious the harm could be (consequences) and how likely it is that harm could occur within the context specified in the application. The level of risk is then evaluated by integrating consequences and likelihood, and the need for measures to reduce risk is considered where pertinent.

There is a focus on scientific/technical evidence in the risk assessment, taking into account any information received from consultation with experts and other stakeholders. This includes scientific/technical advice from the Gene Technology Technical Advisory Committee. In addition, there is consideration of knowledge gaps and other forms of uncertainty.

The risk assessment initially considers a wide range of potential pathways whereby harm might occur. Those pathways that describe substantive risks are considered in more detail and the level of risk evaluated.

Risk assessment identifies substantive risks and evaluates the level of risk based on a combination of the likelihood and consequences of potential harm.

Risk management protects the health and safety of people and the environment by controlling or mitigating risk. Risk management may be described as answering the following questions: Does anything need to be done about the risk? What can be done about it? What should be done about it? Risk management involves judgments about the choice and application of treatment measures to support decisions about whether certain activities with GMOs should be permitted.

Risk management includes preparation of a risk management plan as well as monitoring and reviewing to provide feedback on all steps in the risk analysis. The risk management plan includes licence conditions that stipulate measures to control or reduce risk. Monitoring and reviewing ensure that decisions remain valid and can be adjusted in response to changes in circumstances or new information.

The risk assessment and risk management plan forms the basis upon which the Regulator decides whether to issue or refuse a licence, and what conditions to impose if a licence is issued. To issue a licence the Regulator must be satisfied that risks can be managed to protect human health and safety and the environment. If the Regulator considers that risks posed by proposed dealings with a GMO cannot be managed, a licence would be refused.

Risk management determines appropriate control measures to manage risk and applies these through proposed licence conditions.

Risk communication is integral to the processes of risk analysis and involves an interactive dialogue between the Regulator and stakeholders to build trust in the regulatory system by discussing issues and addressing concerns relating to protecting the health and safety of people and the environment.

The Regulator undertakes extensive consultation with a diverse range of expert groups and authorities and key stakeholders, including the public, before deciding whether to issue a licence for the release of a GMO into the environment. Differing perceptions of risk can influence the approach of stakeholders to particular issues, and in such instances the Regulator can seek advice on ethical and social issues raised by gene technology from the Gene Technology Ethics and Community Consultative Committee.

The Regulator provides accessible information to interested parties on applications, risk assessment and risk management plans, dealings with GMOs, trial sites and the processes of risk assessment, risk management, and monitoring and compliance activities. The Risk Analysis Framework is part of the Regulator’s commitment to clarity, transparency and accountability of decision-making processes.

Risk communication establishes an interactive dialogue between the Regulator and stakeholders to provide open, transparent and consultative risk-based regulation of GMOs.
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