risk analysis- a tool for decision making

At a very broad level people use risk analysis for activities in their daily lives whether it be taking a swim, riding a bike or walking to the store. A formal risk analysis process can be applied to decision making relating to activities with GMOs. Risk analysis is a well-established approach that is used to assist with risk management and decision making for all activities with GMOs in South Africa. This includes contained activities such as research in a laboratory or research facility; field trials at confined locations and commercial cultivation and consumption. This process allows for a rigorous science-based assessment, however the process itself is driven by society as decision making incorporates societal values (see figure below).

Input from society is a critical component of this process and ensures that social values are incorporated into and are the basis for decision making. This includes during the ‘Setting the context and scope’ step where protection goals and assessment endpoints are determined. These protection goals are things of value that society deems necessary for protection. Assessment endpoints are an unambiguous expression of the endpoint/ thing of value. A harm would be detected if there is an adverse change to an assessment endpoint. In South Africa our regulatory system also considers benefits so this is also where development goals can also be defined and included in the decision making process.

The science based risk assessment can assess safety based on the likelihood and consequences that activities with a GMO may cause a harm. Alternatively, when assessing benefits this step can determine whether the proposed benefits will be delivered. There are various tools and approaches that can be used to assist in the risk assessment process in order to ensure a scientifically rigorous process but also to identify data necessary to do the assessment.

During the ‘Risk decision making’ step the stage of development/ type of activity being applied for is an important consideration. Often uncertainty is highest during early stage development and risks are not fully characterised. This is managed by employing containment or confinement strategies and operational procedures that reduce the likelihood of any harms occurring while simultaneously allowing for the generation of biosafety data to characterise risks. This can result in changes in licence conditions and feed into evaluations for that particular GMO but may also assist with the characterisation of risks of similar GMOs. For environmental releases, such as field trials or full commercial cultivation, risk management plans including a monitoring strategy are carefully considered to ensure that any identified risks are managed to an acceptable level before a licence is issued. Risk communication is an important component of the risk analysis process and establishes a dialogue between regulators and the various stakeholders for input into the stages of the process. Access to information on the reasoning for decision making as well as any imposed risk management conditions are also given.

This risk analysis process is highly iterative both in terms of decision making for a particular application, e.g. for contained use activities in a greenhouse for a particular GM crop, but also between applications, such as when a field trial application with this same GM crop is made, as information generated in the earlier application will feed into the following application. Such information includes the establishment of protection goals and harms, biosafety data generated in the greenhouse application and identification and characterisation of risks.

The use of risk analysis in South Africa

In South Africa if a person, research institution or company wishes to conduct any activity with a GMO a permit is needed for that activity. The applicant must submit an application for a particular activity describing the activities to be conducted including the organism/s; trait/s and where these activities will be carried out. Within the context of the South African regulatory environment plausible harms must be identified and any risk characterised. Risk management measures must be proposed to address uncertainties in the characterisation of risk or to manage risks to acceptable levels. This application is assessed by regulators on a case by case basis. Regulators may require additional information from the applicant or additional risk management before a permit is approved or denied.