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

Abstract

Pre-market/prospective environmental risk assessments (ERAs) contribute to risk analyses performed to facilitate decisions about the market introduction of regulated stressors. Robust ERAs begin with an explicit problem formulation, which involves among other steps: (1) formally devising plausible pathways to harm that describe how the deployment of a regulated stressor could be harmful; (2) formulating risk hypotheses about the likelihood and severity of such events; (3) identifying the information that will be useful to test the risk hypotheses; and (4) developing a plan to acquire new data for hypothesis testing should tests with existing information be insufficient for decision-making. Here, we apply problem formulation to the assessment of possible adverse effects of RNA interference-based insecticidal genetically modified (GM) plants, GM growth hormone coho salmon, gene drive-modified mosquitoes and classical biological weed control agents on non-target organisms in a prospective manner, and of neonicotinoid insecticides on bees in a retrospective manner. In addition, specific considerations for the problem formulation for the ERA of nanomaterials and for landscape-scale population-level ERAs are given. We argue that applying problem formulation to ERA maximises the usefulness of ERA studies for decision-making, through an iterative process, because: (1) harm is defined explicitly from the start; (2) the construction of risk hypotheses is guided by policy rather than an exhaustive attempt to address any possible differences; (3) existing information is used effectively; (4) new data are collected with a clear purpose; (5) risk is characterised against well-defined criteria of hypothesis corroboration or falsification; and (6) risk assessment conclusions can be communicated clearly. However, problem formulation is still often hindered by the absence of clear policy goals and decision-making criteria (e.g. definition of protection goals and what constitutes harm) that are needed to guide the interpretation of scientific information. We therefore advocate further dialogue between risk assessors and risk managers to clarify how ERAs can address policy goals and decision-making criteria. Ideally, this dialogue should take place for all classes of regulated stressors, as this can promote alignment and consistency on the desired level of protection and maximum tolerable impacts across regulated stressors.

Conducting fit‐for‐purpose food safety risk assessments

“…In the case of regulated stressors connected to food and feed production, risk assessors use scientific information to test risk hypotheses about the likelihood and seriousness of harmful effects that may occur following a proposed activity (Devos et al., ). Hypotheses take the form that the proposed activity will pose no greater harm or risk, usually when compared with the existing activity (Raybould, , , ).…”

“…It has been asserted that problem formulation is key to identifying relevant information for the risk assessment of regulated stressors (Devos et al., ). Robust risk assessments begin with an explicit problem formulation (EFSA, ), which involves among other steps: (1) formally devising plausible pathways to harm that describe how a proposed activity could be harmful; (2) formulating risk hypotheses about the likelihood and severity of such events; (3) identifying the information that will be useful to test the risk hypotheses; and (4) developing a plan to acquire new data for hypothesis testing should tests with the available information be insufficient for decision‐making (Raybould, , , ).…”

Managing evidence in food safety and nutrition

“…Having identified and accessed relevant new data sources, the next challenge will be to ensure that the data quality (fitness‐for‐purpose) is appropriate to meet EFSA's standards of scientific rigour (Devos et al., ,b). Building on the conclusions of the EFSA Prometheus report (EFSA, ), quantitative methods for data appraisal and validation will need to continue to develop in parallel with changing approaches to data identification and retrieval to ensure its appropriate transformation into sound scientific evidence.…”

“…Problem formulation has a human and societal dimension, and is important to determine the acceptable residual level of uncertainty (e.g. Devos et al., ,b).…”

Editorial: Special Issue on EFSA's third Scientific Conference ‘Science, Food, Society’

“…Equally, informative problem formulation is key to frame premarket (prospective) environmental risk assessments of regulated stressors, though this effort is often hindered by the absence of clear policy goals and decision‐making criteria. Greater discussion and interaction between risk assessors and regulators is essential to clarify such policy goals and decision‐making criteria (Devos et al., ). Using an ecosystem services framework can strongly enhance the ecological and societal relevance of environmental risk assessment and facilitate more holistic assessments that integrate assessments across multiple stressors, geographical/temporal scales and policies/legal frames (Devos et al., ).…”