Relevance and feasibility of principles for health and environmental risk decision-making

Figures & data

Table 1. Crosswalk between ten risk decision principles and decision-making steps.

Principles (Krewski and colleagues)	Description (Krewski and colleagues)	Health Canada decision-making framework: Principle (P) or Step (S)
P1: Risk-based decision making	Risk management resources should be allocated in proportion to the magnitude of established risks that are amenable to mitigation.	-
P2: Precautionary principle	Where the potential consequences are great, uncertainty should not prevent risk	P7 (use a “precautionary” approach)
P3: Balancing risks and benefits	Where appropriate, risks may be taken in light of offsetting benefits	S2 (assess risks and benefits)
P4: Cost-effectiveness	Risk reduction actions should be taken in a cost-effective manner, in order to achieve the maximum return on investment of risk management resources.	-
P5: Risk tolerance	Efforts should be made to reduce risks to the point where they are considered tolerable	-
P6: Zero risk	In most cases, the ultimate goal of zero risk will not be attainable.	-
P7: Risk equity	Unavoidable risks should be shared in an equitable manner, and not disproportionately borne by specific groups or individuals.	-
P8: Stakeholder engagement	All stakeholders should be afforded an opportunity to participate in the process of risk management decision-making.	P2 (involve interested and affected parties)
P9: Openness and transparency	Risk management decisions should be taken in an open and transparent manner, with the basis for the decision clearly and explicitly stated	P10 (strive to make the process transparent)
P10: Flexibility	Risk management decisions should be flexible, and subject to review as new information becomes available.	P8 (tailor the process to the issue and its context)

The principles and description, as determined by Krewski and colleagues copyright © 2022, for Table 1 and the information in Tables S4 and S5 of the supplementary material, are presented and reprinted by permission of Informa UK Limited, trading as Taylor & Francis Group https://www.tandfonline.com.

Table 2. Consolidated listing of risk decision-making principles.

Krewski and colleagues:*	Health Canada’s Decision-Making Framework:
P1. Risk-based decision making	P11: Maintaining and improving health is the primary objective
P2. Precautionary principle	P12: Communicate in an effective way
P3: Balancing risks and benefits	P13: Use a broad perspective
P4: Cost-effectiveness	P14: Use a collaborative and integrated approach
P5: Risk tolerance	P15: Make effective use of sound science advice
P6: Zero risk	P16: Clearly define roles, responsibilities, & accountabilities
P7: Risk equity
P8: Stakeholder engagement	Personal Communication with Health Canada staff:
P9: Openness and transparency	P17: Weave Indigenous Knowledge and Science
P10: Flexibility	P18: Respect Ethics and Values** (includes AI)
	P19: Apply FAIR Data Principles***
	P20: Reduce, Replace, and Refine Animal Studies (3Rs)

*These experts provide an additional eighteen (18) principles in a supplementary document, but note how the ten principles provided in the main paper “ … are the most important overarching guiding principles to support modern decision-making” (Krewski, Saunders-Hastings, Larkin, et al. 2022b). **Values are within the context of organizational behavior and culture and the corresponding role for judgment in risk management, decision-making. ***FAIR: stands for Findable, Accessible, Interoperable, and Reusable.

Figure 1. Relevance of risk decision-making principles across diverse risk contexts.

The relevance of Principles P1 to P10 (Krewski and colleagues), P11 to P16 (Health Canada’s decision-making framework), and P17 to P20 (input from Health Canada staff) is provided as a percentage and reveals potential groups of principles which warrant further analysis.

Table 3. Relevance of principles P1 through P10 in ten risk decision contexts* (relevant principles**).

1. Ambient air pollution (P1, P3–5, P7–10)	6. Natural disasters (P2, P4, P7–10)
2. Artificial sweeteners (P6, P10)	7. Prion diseases (P1–5, P7–10)
3. Climate change (P1–2, P4, P7–9)	8. Hydraulic fracturing (P1–5, P7–10)
4. Nanotechnology (P1–5, P7–10)	9. Pandemic outbreak (P1–5, P7–10)
5. Chemotherapeutic agents (P1, P3–5, P9)	10. Genetically modified foods (P1–5, P8–10)
*A detailed description of the 10 risk contexts and principles is provided in Krewski et al. (2022b). *Based on the “highly” and “somewhat relevant” categories for principles identified in Figure 1 of Krewski and colleagues (2022b).

Figure 2. Association between feasibility and importance of risk decision-making.

Panel A shows that the 20 decision-making principles fall into one of five clusters. Cluster 1 includes universal decision-making principles which are mostly risk context-independent and apply to several health and environmental risk decision-making contexts. Clusters 2 and 3 are key for health and environmental risk decision-making, but their application is risk context-specific. Cluster 4 includes principles reflecting contemporary public administrative values, are context-specific, and can help guide the risk decision-making process. Cluster 5 includes principles outside the Go-zone and consequently are not considered as decision-making principles. Panel B shows the linear relationship between the two factors, feasibility and importance, for each of the twenty principles. In all cases, importance is ranked higher than feasibility for the same principle.

Figure 3. Schematic representation of different types of risk decision-making principles within the regulatory context.

The risk decision context and principles are described using the constructs of The Systems Iceberg model (events, patterns, systemic structures, and mental models) proposed by Sheffield and colleagues (Sheffield, Sankaran, and Haslett 2012). The risk decision context and universal principles are shown to be well above the wave (visible spectrum) while the fundamental, guiding, and foundational principles are shown to be below the wave (invisible spectrum). The regulatory context encapsulates everything thereby demonstrating the importance of considering, for example, legislative requirements when relying on the adaptation of this model for risk decision-making.

Krewski, D, P. Saunders-Hastings, P. Larkin, M. Westphal, G. Tyshenko, M. Leiss, W. Dusseault, M. Jerrett, and M. D. Coyle. 2022b. “Principles of Risk Decision-Making.” Journal of Toxicology and Environmental Health - Part B 25 (5): 250–278. https://doi.org/10.1080/10937404.2022.2107591

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Sheffield, J, S. Sankaran, and T. Haslett. 2012. “Systems Thinking: Taming Complexity in Project Management.” On the Horizon 20 (2): 126–136. https://doi.org/10.1108/10748121211235787

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