Hypothesis-Led Ecological Risk Assessment of GM Crops to Support Decision-Making About Product Use

Sustainable use of CRISPR/Cas in fish aquaculture: the biosafety perspective

“…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 events occurrence (Raybould 2020). Risk has also been defined as hazard multiplied by exposure' (Dorne and Fink-Gremmels 2013).…”

“…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:…”

Potential use of gene drive modified insects against disease vectors, agricultural pests and invasive species poses new challenges for risk assessment

“…an adverse effect on something of value defined by relevant protection goals) will occur and the severity of harm if it occurs based on reasonable scenarios outlining causal events. This process is framed by a problem formulation approach that articulates protection goals and decision-making criteria for assessing risks and devising tests of hypotheses that meet those criteria [81][82][83][84]. Decisions to approve a permit for release, given potential risk management, is are taken by risk managers [9].…”

“…Precedents suggest that the problem formulation approach provides a compelling framework to organize existing knowledge and identify relevant new knowledge and uncertainties on engineered GDs to support case-specific risk assessments and decisionmaking [3,71,77,98]. The approach involves (Figure 1), (1) identifying protection goals and making them operational in risk assessment, (2) devising plausible pathways to harm that describe how a release could be harmful, (3) formulating risk hypotheses about the likelihood and severity of such events, (4) identifying the information needed to test risk hypotheses, and (5) developing plans to acquire new data for hypothesis testing if tests with existing information are insufficient for decision-making [15,[81][82][83][84]. Enabling the testing of risk hypotheses makes the prospective pathway to harm approach very powerful for risk assessment because harm is defined explicitly, existing information is used effectively, new data are collected with a clear purpose, and risk is characterized against well-defined criteria of hypothesis corroboration or falsification.…”