In support of ongoing efforts to modernize Canada's food inspection system, a request was issued for scientific and analytical expertise to enhance two critical risk-based decision tools: the Establishment-based Risk Assessment (ERA) and Importer Risk Assessment (IRA) models. These models are used to allocate inspection resources across food establishments, importers, hatcheries, feed mills, and renderers in a structured and scientifically defensible manner.

The project centered on supporting the development of a methodology that could eventually be implemented as an Artificial Intelligence (AI) or Machine Learning (ML) process. The objective was to help formalize and potentially automate how professional judgment is applied when determining the risk significance of non-compliant findings within the Canadian nuclear regulatory framework. Specifically, the…

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 structured, reproducible approach for translating mandates into scientifically answerable questions. This included creating a framework…

To support the Chemicals Management Plan under the Canadian Environmental Protection Act (CEPA), Health Canada sought expert peer consultation for a draft screening assessment report (DSAR) evaluating 47 inorganic substances identified as priorities. The client required independent scientific and technical expertise to assess whether the report’s conclusions—particularly regarding health effects, exposure pathways, and risk characterizations—were sound, complete, and defensible.

To support more effective health policy and pandemic preparedness, this project examined how environmental health factors intersect with chronic disease and influence pandemic resilience. The client sought evidence to clarify how exposures to contaminants in air, water, and soil contribute to the environmental burden of disease in Canada and exacerbate vulnerability to infectious disease outcomes, including COVID-19.

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 response to the emergence of commercial plasma operations that export plasma to international markets.

To support more consistent and quantitative assessments of new micro-organisms under the Canadian Environmental Protection Act, Health Canada's New Substances Program (NSP) sought to refine the tools and processes within its Microbial Risk Assessment Framework (MRAF). The NSP had previously collaborated with RSI to review and modernize the MRAF and develop a supporting computational tool. However, further work was required to validate the tool and ensure it aligned with current program needs and regulatory expectations.

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 advanced for registration based on its claimed selective action on β3-adrenergic receptors and a lack of mutagenic, carcinogenic, or teratogenic effects. Given its potential entry into the human food supply via meat residues, an independent expert analysis of the submission was deemed necessary to determine its safety.

Under the supervision of Director Purcell and his cabinet, the six-month project began with an internal review of attitudes, projects, responsibilities and management reporting lines. The work uncovered multiple inconsistencies and inefficiencies. What's more, there were very real risk consequences at the operational level.

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 the oral contraceptive Alysena, issued due to packaging issues that altered the intended dosing sequence and raised questions about potential unintended health risks.