110. Risk assessment is the overall process of identifying the sources of potential harm (hazards) and determining both the seriousness and the likelihood of any adverse outcome that may arise. The risk assessment (summarised in Figure 4) considers risks from the proposed dealings with the GMOs that could result in harm to the health and safety of people or the environment posed by, or as a result of, gene technology. It takes into account information in the application, relevant previous approvals and current scientific knowledge.


Figure 4. The risk assessment process.

111. Once the risk assessment context has been established (see Chapter 1) the next step is hazard identification to examine what harm could arise and how it could happen during a release of these GMOs into the environment.

112. It is important to note that the word 'hazard' is used in a technical rather than a colloquial sense in this document. The hazard is a source of potential harm. There is no implication that the hazard will necessarily lead to harm. A hazard can be an event, a substance or an organism (OGTR 2007a).

113. Hazard identification involves consideration of events (including causal pathways) that may lead to harm. These events are particular sets of circumstances that might occur through interactions between the GMOs and the receiving environment as a result of the proposed dealings. They include the circumstances by which people or the environment may be exposed to the GMOs, GM plant materials, GM plant by-products, the introduced genes, or products of the introduced genes.

114. A number of hazard identification techniques are used by the Regulator and staff of the OGTR, including the use of checklists, brainstorming, commonsense, reported international experience and consultation (OGTR 2007a). In conjunction with these techniques, hazards identified from previous RARMPs prepared for licence applications of the same and similar GMOs are also considered.

115. The hazard identification process results in the compilation of a list of events. Some of these events lead to more than one adverse outcome and each adverse outcome can result from more than one event.