A Risk Sciences International Case Study

External Peer Consultation of the Inorganic – Late Biomonitoring Approach Draft Screening Assessment Report

Inorganic substances

Client: 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:

External Peer Consultation of the Inorganic - Late Biomonitoring Approach Draft Screening Assessment Report

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.

The work involved managing a structured external peer review process. This included identifying and screening potential reviewers for expertise and conflicts of interest, selecting suitable experts, and coordinating the delivery of charge questions and relevant materials. The consultation focused on critical scientific elements such as the appropriateness of biomarkers (e.g., whole blood concentrations), the use and description of biomonitoring equivalents (BEs), and the robustness of the weight-of-evidence approach used in the DSAR.

A primary deliverable consisted of a comprehensive report integrating detailed technical commentary and overarching observations from reviewers, systematically addressing charge questions pertaining to toxicological data, exposure estimations, and consistency with international assessment approaches. All comments and recommendations were submitted within the defined 15-business-day timeframe following receipt of the background materials, supporting the client’s objective of ensuring scientific rigour and transparency prior to publication.

Start: 2019

End: 2019

Experts related to this case study

Franco Momoli

Vice-President Chemical and Product Safety

Dr. Franco Momoli joined Risk Sciences International (RSI) in 2019 and currently serves as Vice-President, Chemical and Product Safety. In this role, he leads a multidisciplinary team of epidemiologists, risk assessors, toxicologists, and biostatisticians in conducting human health risk assessments...
Read More about Franco Momoli

Michael G. Tyshenko

Senior Health Risk Analyst

Dr. Michael G. Tyshenko is a Senior Health Risk Analyst at Risk Sciences International (RSI), where he has contributed since 2018 to some of the organization’s most complex and cross-cutting public health risk projects. As RSI’s lead on chemical peer...
Read More about Michael G. Tyshenko

More RSI Case Studies

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

Building an international alliance and campaign

UN-Habitat sought to establish a new global platform to bring coherence to international dialogue on sustainable urbanization. At the outset, this initiative had no name, no identity, and no governing structure, only the recognition that cities faced pressing challenges requiring...
Read More about Building an international alliance and campaign

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

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

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...
Read More about Technical Support for Risk-Based Decision Making (RBDM)

Update of WHO Guidance on Food Defense

To support international efforts in mitigating deliberate threats to the food system, the World Health Organization commissioned an update to its earlier guidance titled Terrorist Threats to Food. The revision aimed to broaden the original scope by addressing not only...
Read More about Update of WHO Guidance on Food Defense

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

Evaluation of Health Product Risk Communication Tools

To enhance the effectiveness of health product risk communications, a systematic evaluation was requested to assess the performance of key instruments used to disseminate safety and efficacy information. The aim was to support efforts under the Evaluating the Effectiveness of...
Read More about Evaluation of Health Product Risk Communication Tools

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

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

Pickering Nuclear Facility Re‑licensing

The client sought support to finalize a Commission Member Document (CMD) for the re‑licensing of a nuclear facility. Recognizing the complexity and sensitivity of reactor re‑licensing, they requested assistance in crafting communication materials that were both technically comprehensive and accessible...
Read More about Pickering Nuclear Facility Re‑licensing

Developing a Risk-Based Compliance Framework for Digital Service Delivery

The Financial Consumer Agency of Canada (FCAC) engaged Risk Sciences International to provide strategic advisory services aimed at enhancing its regulatory compliance model through risk-based methodologies. FCAC’s objective was to explore new approaches that would integrate digital tools and data-driven...
Read More about Developing a Risk-Based Compliance Framework for Digital Service Delivery

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

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

Analysis in Support of Risk-Based Decision-Making for the Alberta Safety Codes Council

An independent regulatory organization responsible for oversight of Alberta’s safety codes system sought to strengthen its capacity for risk-based decision-making. The organization aimed to ensure that regulatory actions—particularly in the area of petroleum storage tanks—were guided by clear, evidence-based prioritization...
Read More about Analysis in Support of Risk-Based Decision-Making for the Alberta Safety Codes Council

Expansion of the Stochastic Health Canada Quantitative Microbial Risk Assessment Tool

Health Canada sought to enhance its Quantitative Microbial Risk Assessment (QMRA) tool, originally developed over 15 years ago for stakeholders responsible for drinking water systems. With advancements in probabilistic modeling and microbial risk assessment, the client required updates to reflect...
Read More about Expansion of the Stochastic Health Canada Quantitative Microbial Risk Assessment Tool

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

Food safety risk analysis tools

The World Health Organization and the Food and Agriculture Organization of the United Nations asked RSI to develop a suite of online tools to support food regulators and the food industry in applying risk-based approaches to food safety. These organizations...
Read More about Food safety risk analysis tools

Risk-based decision making framework

The Alliance of Blood Operators (ABO) sought to move its members toward a consistent, transparent approach to risk-based decision-making. Having worked through the development of a framework, the organization now wanted formal adoption, external validation, and practical application to real-world...
Read More about Risk-based decision making framework