60. The risk assessment identifies and characterises 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 (Figure 3). Risks are identified within the context established for the risk assessment (see Chapter 1), taking into account current scientific and technical knowledge. A consideration of uncertainty, in particular knowledge gaps, occurs throughout the risk assessment process.

This figure outlines the process of risk identification followed by risk characterisation. The process is discussed in detail in paragraphs 60 to 63.

Figure 3. The risk assessment process

61. Initially, risk identification considers a wide range of circumstances whereby the GMO, or the introduced genetic material, could come into contact with people or the environment. Consideration of these circumstances leads to postulating plausible causal or exposure pathways that may give rise to harm for people or the environment from dealings with a GMO (risk scenarios).

62. Each risk scenario is evaluated to identify those risks that warrant detailed characterisation. A risk is only identified for further assessment when a risk scenario is considered to have some reasonable chance of causing harm. Pathways that do not lead to harm, or could not plausibly occur, do not advance in the risk assessment process.

63. A number of risk identification techniques are used by the Regulator and staff of the OGTR, including checklists, brainstorming, common sense, reported international experience and consultation (OGTR 2009). In conjunction with these techniques, risk scenarios postulated in previous RARMPs prepared for licence applications of the same and similar GMOs are also considered.

64. Identified risks (i.e. those identified for further assessment) are characterised in terms of the potential seriousness of harm (Consequence assessment) and the likelihood of harm (Likelihood assessment). The level of risk is then estimated from a combination of the Consequence and Likelihood assessments.