Putting problem formulation at the forefront of GMO risk analysis

Abstract

When applying risk assessment and the broader process of risk analysis to decisions regarding the dissemination of genetically modified organisms (GMOs), the process has a tendency to become remarkably complex. Further, as greater numbers of countries consider authorising the large-scale dissemination of GMOs, and as GMOs with more complex traits reach late stages of development, there has been increasing concern about the burden posed by the complexity of risk analysis. We present here an improved approach for GMO risk analysis that gives a central role to problem formulation. Further, the risk analysis strategy has been clarified and simplified in order to make rigorously scientific risk assessment and risk analysis more broadly accessible to diverse stakeholder groups.

Using problem formulation for fit‐for‐purpose pre‐market environmental risk assessments of regulated stressors

“…To further frame ERA, plausible pathways (also called conceptual models) are constructed to describe how the proposed activity could lead to possible harm to operational protection goals (Raybould, , , ; Johnson et al., ; Nickson, ; Wolt et al., ; Gray, ; Tepfer et al., ; Layton et al., ; Sauve‐Ciencewicki et al., ). As with adverse outcome pathways (Lanzoni et al., ), a pathway to harm is a causal chain of events that need to occur for a harm to be realised (Tepfer et al., ; Craig et al., ).…”

“…It is a method that enables identifying potential harms derived from the deployment of a regulated stressor and potential pathway(s) to such harm, and defining the actual information genuinely needed to assess the likelihood of the harm to occur and its seriousness. This helps to focus the risk assessment on those phenomena that are important for decision-makers and steer it from those that are less important or irrelevant (Raybould, 2006(Raybould, , 2007(Raybould, , 2010Tepfer et al, 2013;Garcia-Alonso and Raybould, 2014;Gray, 2014;Devos et al, 2016a). In essence, problem formulation is concerned with maximising the practical utility of ERA in decision-making (Raybould and Macdonald, 2018).…”

How to include socio-economic considerations in decision-making on agricultural biotechnology? Two models from Kenya and South Africa

“…Various scholars and organizations have for example discussed the benefits and drawbacks for ex ante or ex post assessments (Falck-Zepeda 2009) and the importance of carefully manage the expectations arising from regulatory frameworks (COGEM 2014). Also different methodologies have been proposed for performing these assessments, ranging from economics-oriented methods like cost-benefit analysis (Hall and Moran 2003), social-economic impact analysis (Stabinsky 2000), and effectiveness tests (Chaturvedi et al 2012), to broader frameworks that include different types of public participation (Fransen et al 2005), scenario planning methodologies (AHTEG-SEC 2014), and problem formulation tools (Tepfer et al 2013).…”

Advancing environmental risk assessment of regulated products under EFSA's remit

“…However, not all information on the ecology of regulated products available in the scientific literature is equally relevant to ERA. It would explain how the deployment of the regulated product could lead to adverse effects on something of value through a chain of events taking account of both hazard and exposure (Tepfer et al, 2013). It is therefore important to demarcate ERA studies from ecological research, and to explain how an ecological study has relevance to the ERA of a regulated product (Raybould, 2006(Raybould, , 2007(Raybould, , 2010Johnson et al, 2007).…”

“…The provision of a conceptual model will underpin the usefulness of scientific information to ERA. It would explain how the deployment of the regulated product could lead to adverse effects on something of value through a chain of events taking account of both hazard and exposure (Tepfer et al, 2013).…”