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Case Studies
The following posts are in no particular order. They are purposely randomized.
Applying New Assessment Methods (NAMs) for Assessing Semi-Volatile Organic Compounds (SVOCs) in Indoor Residential Environments
Health Canada sought expert support in advancing its efforts to develop screening values for semi-volatile organic compounds (SVOCs) commonly found in residential indoor environments. Previous work on indoor air contaminants had focused on volatile organic compounds (VOCs), where screening values were developed based on existing inhalation quantitative hazard assessments (QHAs). However, many SVOCs were identified as having insufficient data to establish such values, leaving critical gaps in risk evaluation.
Read More Development of a National Food Safety Information System and Risk Assessment Capacity in Vietnam
Authorities in Vietnam sought targeted expertise to strengthen the country’s ability to detect, assess, and respond to food safety threats. This initiative had two linked objectives: building a comprehensive, transparent, and reliable national food safety information system, and enhancing risk assessment (RA) capacity at national and sub-national levels. For the information system component, the work…
Read More Validation and Optimization of the Computational Tool for the Microbial Risk Assessment Framework (MRAF)
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.
Read More 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 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.
Read More Finalization of Risk Assessment on Secure Opioid Dispensing Devices
To support decision-making around modifications to opioid agonist treatment delivery, a detailed risk assessment was requested to evaluate the integration of secure dispensing devices for direct patient access to hydromorphone. Building on a previously conducted preliminary assessment, the work required a structured framework that would articulate hazards, assess likelihoods and risks, and identify mitigation strategies associated with introducing these devices into service delivery models.
Read More 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 the oral contraceptive Alysena, issued due to packaging issues that altered the intended dosing sequence and raised questions about potential unintended health risks.
Read More Canadian Recipient Hemovigilance System Renewal Consensus Conference
Following the planned closure of the Blood Safety Contribution Program (BSCP), support was needed to help define the structure, elements, and functions of a renewed national recipient hemovigilance system for Canada. The work centred on preparing the transfusion medicine community, federal and provincial/territorial partners, blood operators, and patient representatives to develop recommendations for a future system that could maintain national coordination, support blood and patient safety, and preserve trust in Canada’s blood system.
Read More Food Inspection Scientific Analysis & Risk Modelling
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.
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