Box 2.

Risk Assessment: definitions of terms & concepts

Risk: the likelihood of an adverse event happening, and the seriousness of the harm represented by the event´s occurrence (Raybould 2020). Risk has also been defined as ´hazard multiplied by exposure` (Dorne and Fink-Gremmels 2013). The decision maker, i.e., the regulatory authority of a country decides the level of risk allowable for a given GMO event
Risk assessment: the process of determining the occurrence, frequency and consequences of harmful events
Hazard: is an event or substance that can have harmful effect
Harm: an event or substance that can have adverse effect on the goals that the regulatory authority wishes to protect, such as wild species, biodiversity, human and animal health, etc. For an illustration of pathway to harm, see (Raybould 2020)
Aims of risk assessments: (i) Environmental risk assessment (ERA): aims to identify potential impacts on the valued components (protection goals) of the environment, and to estimate the probability and magnitude of these impacts if a GMO is accidentally or intentionally introduced into the environment
(ii) Food safety risk assessment: aims to identify substances in the GMO that may be hazardous (such as toxicity or allergenicity) to human or animal health
Risk assessment methodologies:
(a) Based on statistical nature of output:
(i) Qualitative: produces nominal (e.g. list of endangered species) or ordinal (e.g. low, medium, high) outputs;
(ii) Semi-quantitative: produces interval variables (e.g. 1–5, 5–50, > 50) as outputs;
(iii) Quantitative: produces continuous risk estimates, which may or may not be grouped into categories
(b) Based on period of occurrence of event:
(i) Retrospective: attempts to identify the causes and characteristics of harmful events that have already occurred;
(ii) Predictive: seeks to predict the likelihood and consequence of a harmful effect that has not yet occurred. See (Kapuscinski 2007) for a comprehensive discussion on types of risk assessment