A Risk Sciences International Case Study

Technical Support for Risk-Based Decision Making (RBDM)

Cannabis production

Client: Cannabis Directorate, Health Canada

Listing of the client in no way affirms the client's support, sponsorship, or validation in any form of Risk Sciences International or the RSI staff member(s) who conducted this project during their stay with RSI or prior to joining the company. This case study is displayed for informative purposes only to demonstrate the capacity of RSI staff members. This case study reveals no proprietary information or information deemed sensitive.

Project description:

Technical Support for Risk-Based Decision Making (RBDM)

To enhance the oversight of cannabis production under its regulatory mandate, the Cannabis Directorate sought expert support in developing a risk-based decision-making framework tailored to its compliance and enforcement responsibilities. The directorate aimed to better assess and respond to non-conformance with Good Production Practices (GPP) as defined in the Cannabis Act and Regulations, using a data-driven approach.

To meet this objective, RSI was engaged to deliver a suite of tools and guidance documents supporting the design and application of risk-based methodologies. This included the creation of public risk lexicons and taxonomies for hazards, harms, and risk controls specific to cannabis production. A common measurement methodology was developed to assess diverse risks across the Directorate’s mandate, supplemented by preliminary risk estimates based on selected use cases. These estimates served both analytical and training functions.

RSI further supported the development of practical guidelines for risk assessment and led efforts to establish a data acquisition strategy that addressed gaps in existing program data. Foundational work also included designing a structured data model to integrate risk, control, and cost dimensions in a way that supported evidence-based decision-making.

Start: 2021

End: 2022

Experts related to this case study

Greg Paoli

CEO, Principal Risk Scientist

Greg Paoli is the CEO and Principal Risk Scientist at Risk Sciences International (RSI), a firm he co-founded in 2006 following the integration of his earlier consultancy, Decisionalysis Risk Consultants, with the consulting activities of the McLaughlin Centre for Population...
Read More about Greg Paoli

Anne Wiles

Senior Analyst

Dr. Anne Wiles joined Risk Sciences International (RSI) in 2008, where she currently serves as a Senior Analyst specializing in risk communication, perception, and governance. With a distinctive blend of expertise in language, regulation, and the use of science in...
Read More about Anne Wiles

More RSI Case Studies

RSI presents a very small selection of case studies to highlight some of its key work.

Evaluation of Drug Recall Communication and Risk Determination Processes

In response to public and ministerial concerns about the timeliness and adequacy of information shared during a major prescription drug recall, Health Canada commissioned an independent review to assess its response to the event. The situation involved a recall of...
Read More about Evaluation of Drug Recall Communication and Risk Determination Processes

Drinking Water Guidelines for Manganese

Establishing science-based drinking water guidelines for manganese requires integrating diverse regulatory approaches, emerging modeling tools, and evolving toxicological evidence. The client commissioned this project to systematically assess existing manganese drinking water guidelines and the scientific foundations upon which they are...
Read More about Drinking Water Guidelines for Manganese

Systematic Review of Artificial Sweeteners and Health Risks

A comprehensive systematic review was undertaken to assess experimental evidence regarding the potential health risks associated with artificial sweeteners, specifically focusing on cancer and pre-term delivery. The client sought a rigorous analysis of both in vivo and in vitro experimental...
Read More about Systematic Review of Artificial Sweeteners and Health Risks

External Peer Review of the Draft Screening Assessment Report on Selected C3-C5 Alcohols

To support the quality and defensibility of regulatory decision-making under the Canadian Environmental Protection Act, 1999 (CEPA), Health Canada engaged Risk Sciences International to coordinate an independent external peer review of the Draft Screening Assessment Report (DSAR) for Selected C3-C5...
Read More about External Peer Review of the Draft Screening Assessment Report on Selected C3-C5 Alcohols

Contraceptive recall review

Health Canada requested an external review following significant public criticism of its handling of a pharmaceutical recall. The case involved a contraceptive drug that was withdrawn due to packaging errors, and the department faced questions about whether it had acted...
Read More about Contraceptive recall review

Communication material on lithium in drinking water and health risks

To support public communication around emerging drinking water concerns, RSI was engaged to develop accessible, scientifically grounded materials on lithium exposure and its potential health effects. The work focused on equipping stakeholders with clear, credible information that could inform both...
Read More about Communication material on lithium in drinking water and health risks

EFSA Framework for Problem Formulation

To enhance the methodological rigour of its scientific assessments, EFSA sought to develop a standardised framework for problem formulation (PF) within its non-application scientific assessment protocols. The goal was to support the planning phase of these assessments by establishing a...
Read More about EFSA Framework for Problem Formulation

Risk Assessment of the Impact of Lethality Standards on Salmonellosis from Ready-to-Eat (RTE) Meat and Poultry Products

To support regulatory decision-making, a comprehensive risk assessment was conducted to evaluate how varying lethality performance standards would impact the public health burden of salmonellosis associated with Ready-to-Eat (RTE) meat and poultry products. The primary objective was to quantify the...
Read More about Risk Assessment of the Impact of Lethality Standards on Salmonellosis from Ready-to-Eat (RTE) Meat and Poultry Products

Wildfire and residential smoke risk communication

Government authorities faced recurring challenges in communicating health risks from smoke caused by both wildfires and residential burning. While these events were becoming more frequent and more severe, the public health messages often failed to resonate with affected communities or...
Read More about Wildfire and residential smoke risk communication

Measuring impact of zoonotic animal diseases in Canada

The Canadian Food Inspection Agency sought RSI’s support in exploring how human health impacts from zoonotic diseases could be compared consistently with other public health risks. Traditionally, animal disease control decisions relied on veterinary and economic measures, but there was...
Read More about Measuring impact of zoonotic animal diseases in Canada

Age-Related Cognitive Decline: Systematic Review and Meta-Analysis

The College of Physicians & Surgeons of Alberta (CPSA) commissioned a systematic review and meta-analysis to support evidence-informed decision-making around age-related cognitive decline among practicing physicians. The initiative was led by CPSA’s Physician Health Monitoring Program (PHMP), which sought to...
Read More about Age-Related Cognitive Decline: Systematic Review and Meta-Analysis

Evaluation of Toxicological Data on Experior

To support the evaluation of a new veterinary pharmaceutical product intended for use in bovines, a scientific review was requested of submitted toxicological data related to the active compound LY488756. This compound, proposed under the product name Experior, had been...
Read More about Evaluation of Toxicological Data on Experior

Risk-Based Decision-Making (RBDM) Support for Plasma Supply / Sufficiency

Facing renewed challenges in securing a reliable domestic plasma supply, Canadian Blood Services sought support to apply a Risk-Based Decision-Making (RBDM) framework. The objective was to assess the value and implications of expanding domestic plasma collection and processing capacity in...
Read More about Risk-Based Decision-Making (RBDM) Support for Plasma Supply / Sufficiency

Characterizing uncertainty in MAF values estimated using the KEMI MAF

The client sought to improve understanding of uncertainties surrounding the application of mixture assessment factors (MAFs) for aquatic receptors, specifically those estimated using the KEMI methodology. While the KEMI MAF approach is considered technically robust, its assumptions—particularly about chemical-specific controls,...
Read More about Characterizing uncertainty in MAF values estimated using the KEMI MAF

Environmental Public Health Approach (EPHA) to Chemicals Expert Workshop

To advance the Government of Canada’s Chemicals Management Plan (CMP), a virtual expert workshop was planned and hosted to refine and evaluate a Canadian framework for the Environmental Public Health Approach (EPHA) to chemicals. The initiative focused on developing case...
Read More about Environmental Public Health Approach (EPHA) to Chemicals Expert Workshop

Assessing the Impact of Interstudy Variation in LOAELs on Findings of Low-Dose Additivity in In Vivo Studies of Mixtures

Demonstrating the safe use of chemical mixtures remains a critical challenge in toxicological science. In recent years, studies have suggested that chemicals can exhibit dose additivity—causing a combined effect—even when each chemical individually is below its effect threshold. This project...
Read More about Assessing the Impact of Interstudy Variation in LOAELs on Findings of Low-Dose Additivity in In Vivo Studies of Mixtures

Risk-Based Decision Making (RBDM) Compliance and Enforcement

Innovation, Science and Economic Development Canada (ISED), through its Spectrum Management Innovation Directorate, sought support in applying risk-based decision making (RBDM) across its compliance and enforcement responsibilities. The department was looking for a structured and data-driven approach to prioritize regulatory...
Read More about Risk-Based Decision Making (RBDM) Compliance and Enforcement

Institutional & communications assessment

In the mid-1990s the International Organization for Migration (IOM) faced one of the most pivotal moments in its history. Though it counted 76 member states, it remained outside the United Nations system, and its work was increasingly perceived to overlap...
Read More about Institutional & communications assessment