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Table 1 Glossary of terms

From: Systematic identification of plausible pathways to potential harm via problem formulation for investigational releases of a population suppression gene drive to control the human malaria vector Anopheles gambiae in West Africa

Term Definition References
Analysis Plan Describes the evidence and measurement endpoints to be used in the ERA, which can be tiered to prioritize the most informative evidence for decision-making [80]
Assessment Endpoint Explicit expression of environmental or health value to be protected [37]
Direct Effect Effects on individual organisms that the transgenic itself generates, such as via predation, competition, hybridization and introduction of new parasites and diseases. [26]
Environmental Risk Assessment (ERA) Process to identify significant risks to the environment and health, estimating their magnitude and likelihood and defining any risk management required [25,26,27, 37]
Conceptual Model Environmental and health entities of value and their measurable attributes [37]
Ecosystem Services ‘Provisioning services’ such as water, ‘Regulating services’ such as pollination and ‘Supporting services’ such as nutrient recycling, delivered within an ecosystem and of benefit to humans [26, 84]
Exposure Characterisation Quantitative estimation of the likely exposure of other biota and the environment to the transgenic, conducted subsequent to the problem formulation in an ERA [26]
Exposure Route Possible route by which direct and indirect exposure to a potential harm may occur [26]
Fitness Success of an individual in surviving and reproducing, measured by the individual‘s genetic contribution to the next generation and subsequent generations [26]
Harm Adverse effect on something of value, relevant to an identified protection goal [41]
Hazard Potential adverse effects that can lead harm to the environment or health [26]
Hazard Characterisation Qualitative and/or quantitative evaluation of environmental or health adverse effects, conducted subsequent to the problem formulation in an ERA [26]
Indirect Effect Effects on individual organisms in the wider environment without immediate contact with the transgenic [26]
Limits of Concern Minimum ecological effects set for each assessment endpoint that are deemed both biologically relevant and of sufficient magnitude to cause harm. [26]
Measurement Endpoint Measurable characteristic that is related to the environmental or health value chosen as the assessment endpoint [26]
Plausible Pathway to Potential Harm Causal chain of events that would need to occur for a potential harm to a protection goal to be realised, often referred to a “pathway to harm” in the literature for brevity [41]
Potential Harm Theoretical adverse outcome relevant to a protection goal [41]
Problem Formulation First step in ERA where policy goals are identified, and pathways to harm, risk hypotheses and analysis plans are defining to guide the evaluation of data in the next steps of ERA. [26, 37]
Protection Goal Policy and legislation defining environmental or health resources to be protected, the degree of protection they deserve, or the maximum impacts that should be tolerated. [38]
Risk Combination of the magnitude of a hazard, if it occurs, and the likelihood that it occurs [27]
Risk Hypothesis Hypothesis generated in problem formulation for specific step in pathway to potential harm such that no more harm or risk will occur to a protection goal than via existing activities [41]
Valued species Species that is keystone, charismatic, threatened or endangered; identified and characterised from National Biodiversity Strategies and Actions Plans as set out by the CBD or the IUCN Red List of Threatened Species, and locally derived knowledge. [81, 82]
Vectorial capacity (V) Total number of potentially infectious bites that would eventually arise from all the mosquitoes biting a single completely infectious (i.e., all mosquito bites result in infection) host on a single day, with individual elements that contribute to this value identified below: [88,89,90]