research article on health and wellness in canada

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• Published: 11 August 2020

Indigenous perspectives on wellness and health in Canada: study protocol for a scoping review

• K. Thiessen   ORCID: orcid.org/0000-0001-5500-2220 1 ,
• M. Haworth-Brockman 2 ,
• R. Stout 3 ,
• P. Moffitt 4 ,
• J. Gelowitz 5 ,
• J. Schneider 1 &
• L. Demczuk 6  

Systematic Reviews volume  9 , Article number:  177 ( 2020 ) Cite this article

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Indigenous communities are often portrayed from a deficit-based lens; however, Indigenous communities have self-determined perspectives of health and well-being that are strength based. The objective of this study will be to systematically map the literature on perspectives, concepts, and constructs of wellness and well-being in Indigenous communities in Canada.

A scoping review protocol was designed following the Arksey and O’Malley framework. We will search the following electronic databases (from inception onwards): MEDLINE, EMBASE, Web of Science, CINAHL, Academic Search Complete, Anthropology Plus, Bibliography of Native North Americans, Canadian Business and Current Affairs, and Circumpolar Health Bibliographic Database. Grey literature will be identified through searching dissertation databases, Google Scholar, and conference abstracts. We will include all types of literature in English, published and unpublished, including any study design, reviews and meta-analyses, dissertations, reports, and books. The literature considered should describe or reflect Indigenous perspectives that identify concepts or constructs related to well-being or wellness; literature can be from any setting in Canada. Two reviewers will independently screen all citations, full-text reports, and abstract data. Data analysis will involve quantitative descriptions (e.g. frequencies) and qualitative content analysis methods.

This review will provide a synthesis of the literature on Indigenous perspectives, concepts, and constructs of wellness and well-being in Canada. We anticipate the study will contribute to improve our understanding of how Indigenous communities conceptualize and embody wellness. Our findings will provide a basis for engaging Indigenous stakeholders in future health research and informing future interpretations of how wellness is conceptualized, whether written or unwritten.

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Western conceptualizations of health reflecting colonialist regimes portray Indigenous communities from a deficit-based lens while ignoring communities’ strengths and self-determined perspectives of health and well-being [ 1 , 2 , 3 ]. It is known that the biomedical model focuses on secondary prevention, which is the prevention of disease [ 4 ], thus disease focused. Furthermore, ongoing and historical colonization of Indigenous persons results in destructive mechanisms with significant detrimental consequences for the health and well-being of Indigenous communities [ 5 , 6 ].

In the last decade, articles and reports in the literature have demonstrated that numerous studies have sought nation-specific Indigenous perspectives and constructs of wellness and well-being. For example, some articles identified constructs such as connection to culture (i.e. engaging in Indigenous philosophies, beliefs, practices, and values), community, and family and traditional activities as restorative to well-being [ 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ]. Connection to land, nutrition, food, and financial security was also viewed as important to the wellness of a community [ 18 , 19 , 20 ], and specific articles discussed mental wellness from Indigenous youths’ perspectives [ 10 , 21 ]. Indigenous indicators of wellness must be culturally sensitive, reflecting a positive view of self, in a person’s self-defined state of well-being [ 1 ]. This is much more complex than some biomedical approaches whereby the provider aims to ‘change’ behaviour [ 4 ]. Methods for this preliminary scanning have not yet been reported; to the best of our knowledge, no scoping review exists on this topic. The objective of this study will be to systematically map the literature on perspectives, concepts, and constructs of wellness and well-being in Indigenous communities in Canada.

In this paper, we describe a protocol for a scoping review on Indigenous perspectives of wellness and well-being in Canada.

This protocol will guide our scoping review which will inform the results from a larger funded study, a multi-site collaborative investigation of existing maternity service delivery models, and their impact on supporting persons to maintain health and wellness in the context of their own community [ 22 ]. Because our larger study is only focused on Northern Canadian communities, we have limited the parameters of this protocol to Indigenous people of Canada

While there is an array of review methodologies to use, we chose a scoping review for two distinct reasons. First, we are specifically interested in exploring conceptual boundaries related to Indigenous wellness to inform our current primary research study [ 1 , 2 ]. Second, scoping reviews have matured as a methodologically rigorous approach [ 3 , 4 , 5 , 6 ] to ensure transparency and rigour in rapidly mapping a broad landscape of study designs and grey literature [ 1 ].

Study design

The review protocol has been registered within the Open Science Framework database (osf.io/3c5d4) and is being reported in accordance with the guidance provided in the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) extension for Scoping Reviews (PRISMA-ScR) [ 23 ] and the PRISMA extension for protocols (PRISMA-P) [ 24 ] (see PRISMA-P checklist in Additional file 1 ).

The Arksey and O’Malley 5-stage framework for conducting scoping reviews [ 25 ] will guide the methodology. Additionally, we will include a sixth step based on Levac et al.’s [ 26 ] recommendations as we did in an earlier scoping review [ 27 ].

The six steps will be as follows:

Develop a research question. In our study, our research questions of interest, in relation to Indigenous peoples in Canada are as follows:

How are well-being and wellness described in the literature, and what are the associated constructs?

What additional concepts are associated with well-being and/or wellness?

Are there indicators of well-being and/or wellness defined by Indigenous communities?

Search for relevant material.

Define study selection.

Chart the data.

Collate, summarize, and report results. Results will be organized in tables according to the research questions.

Consult with stakeholders. Results will be verbally shared for discussion with Indigenous elders via sharing circles.

We adopted Levac et al.’s stage 6 [ 26 ] to enhance the review through consultations with Indigenous stakeholders to share our results, and to compare and contrast with non-written concepts of wellness existing amongst communities.

Eligibility criteria

The Population-Concept-Context (PCC) framework will be used to align the study selection with the research question [ 28 ]. While sources will not be limited by a specific time for review, they must include a focus on Indigenous peoples in Canada and measure or focus on specific concepts, perspectives, or constructs of well-being or wellness. Indigenous people in Canada include Inuit, Métis, and First Nations [ 29 ]. We acknowledge that some Indigenous peoples of Canada do not identify with these specific terms [ 23 ], but the terms are frequently used in Canadian documents.

Sources screened will include documents published in English, published and unpublished, including research of any study design, reviews and meta-analyses, dissertations, reports, books, and book chapters. Articles referencing Indigenous persons or communities residing on or off reserve as well as those living in urban settings will be included.

The literature included for review must describe or reflect Indigenous perspectives that identify concepts or constructs related to well-being or wellness; literature can be from any setting in Canada. Inclusion criteria in order of priority will be as follows:

Indigenous authored or co-authored. This will be determined as best as possible based on examples found in other published reviews [ 24 , 30 , 31 ] where Indigenous authorship is identified, our own knowledge of the scholars/writers, the writers’ own self-declarations, and any further inquiry we need to do.

Other authors, where the documents meet the other criteria listed here.

About Indigenous peoples (First Nations, Métis, Inuit) (e.g. amongst the interrelated peoples and cultures of Canada).

Take a strength-based approach; that is, assume that the perspectives described are affirming.

The literature must describe or reflect Indigenous perspectives regarding concepts or constructs of well-being or wellness. For example, the First Nations Mental Wellness Continuum Framework from Thunderbird Partnership Foundation [ 32 ] draws on established teachings. As the introduction describes, ‘It aims to support all individuals across the lifespan, including those with multiple and complex needs. The centre of the model refers to the interconnection between mental, physical, spiritual, and emotional behaviour—purpose, hope, meaning, and belonging. A balance between all of these elements leads to optimal mental wellness’ [ 32 ]. The framework and related documents apply to our scoping review because they were developed by community experts and knowledge keepers.

Sources of evidence: search process

The literature will be retrieved through a structured search of electronic databases (from inception onwards): MEDLINE, EMBASE, Web of Science, CINAHL, Academic Search Complete, Anthropology Plus, Bibliography of Native North Americans, Canadian Business and Current Affairs, and Circumpolar Health Bibliographic Database.

The second source of relevant material will be retrieved through a search for grey literature (that is, not from peer-review journals) from websites (Additional file 2 ) and by using Google Scholar, Dissertations & Theses, iPortal Indigenous studies portal research tool, and Sociological Abstracts. The references of included documents will be followed up to identify any additional evidence sources, and a selected list of journals will be hand-searched. Scopus and Google Scholar will be used to identify citing literature.

The search strategy will be designed by one professional librarian (LD) and peer reviewed by an Indigenous health librarian (JL), using the Peer Review of Electronic Search Strategies (PRESS) checklist [ 33 ]. The input from the Indigenous scholar on our team (RS) will be integral for this step. The searches will be executed, and citations managed in a reference management system by the first librarian.

A preliminary scoping search of two databases, EMBASE for health literature and Canadian Business and Current Affairs for Canadian periodicals including relevant Indigenous and native study titles, will be conducted to identify all relevant keywords and subject headings. Following the initial search, the search strategies will be finalized and run in all identified resources. The initial search will be based on keywords describing Indigenous peoples in Canada and keywords describing the concepts of well-being and wellness. Database techniques including truncation, adjacency, and Boolean operators will be used as appropriate. A draft search strategy for EMBASE (Ovid) is provided in Additional file 3 .

Study selection

Based on the pre-defined inclusion criteria above, screening criteria will be established and piloted on a random 10% sample of abstracts and modified as necessary. Two researchers (KT and MHB) will screen the study title, authors, abstract, and descriptors for possible inclusion and full-text review. The same two investigators will independently review the full texts of potentially eligible studies for inclusion and resolve disagreements through discussion with additional reviewers (RS and PM) if necessary. The PRISMA flow diagram will be used to report all stages of the flow of the study selection [ 34 ].

Data extraction

Data will be independently extracted by two investigators (KT and MHB) using a custom form that will be pilot tested. There will be two stages of data extraction, title and abstract review, and full article review. Disagreement will be resolved through discussion and additional reviewers (RS and PM) if necessary. Inter-rater agreement will be calculated with Cohen’s K statistic. Authors of the individual studies will be contacted for additional information if necessary.

Descriptive variables

The following descriptive variables will be extracted for each included study, but additional categories may be identified iteratively as the literature is reviewed.

Authors (Indigenous/non-Indigenous)

Year of publication

Jurisdictions or geographic location

Type of literature

Concept(s) identified

Construct(s) identified

Articles acknowledged/considered the OCAP principles: ownership, control, access, and possession [ 35 ]

Key findings on perspectives of well-being

Key terminology used

Source of perspectives (i.e. male, female, two-spirited, personal, community, reserve, rural, urban setting)

Data management

Data will be managed with a shared spreadsheet file. The file will contain all the stages (title/abstract/full article review) of the review for both peer-reviewed literature and grey literature sources. All references will be organized in a shared folder amongst the team on Mendeley©. This ensures we account for duplicates and have accurate counts of each stage.

Participants and public involvement

Our scoping review team has expertise in health and well-being, Indigenous scholarship and ways of knowing, and conducting scoping and systematic reviews. One of our team members is an Indigenous scholar who will provide insight and feedback throughout the project. Consultations with knowledge keepers and Indigenous stakeholders will be done in stage 6 of the scoping review to ensure no salient documents are missed.

Data synthesis

The results of the review will be summarized with descriptive analysis (quantitative) and synthesis of the relevant information (context, concepts, constructs). We hope to create a meaningful diagram or table of wellness definitions and details around our findings. We will also engage Indigenous stakeholders to confirm and enhance the meaning of results from the review.

We will take our preliminary results to the larger community of elders and researchers who make up our grant team on the larger project. Their insights on the documents we retrieve and the knowledge they include will strengthen our interpretation and analysis. This step will be essential to ensuring we continue to honour the knowledge sharing that is the foundation of our work.

The scoping review in this protocol will identify, collect, and synthetize available literature on Indigenous perspectives, concepts, and constructs of wellness and well-being in Canada. We are not aware of another scoping review addressing this specific topic.

As we initiate a project on appropriate policy and systems approaches for maternal and child health and wellness in Indigenous communities, this scoping review will inform the language and paradigms to be considered and shared in the various sites and communities of our national project. In our opinion, this review will help to discuss relevant Indigenous constructs and concepts of wellness when we engage with Indigenous scholars, students, and the Northern Indigenous Advisory groups in the larger study to ensure the results are contextualized. Through the relationships we have cultivated in northern Indigenous communities, we have an opportunity to deepen our understanding of how Indigenous communities define wellness and well-being and engender discussions of how the review findings compare with unwritten knowledge of wellness and well-being.

The results of this review will also inform further stages of our grant, including the nature of questions asked for qualitative data collection, and can be used to inform new scholarship by other researchers in Canada. As a research team, we will determine an appropriate journal for publication

The potential limitations we anticipate based on the project thus far are that we may miss older documents and knowledge that are not available via library and online search strategies. The scoping review methodology will allow us to modify (and document any changes) the search protocols as needed. We do not anticipate any operational issues, as this research teams has worked well together in the past.

Availability of data and materials

All data available from public sites and databases via the university.

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Acknowledgements

The authors would like to acknowledge Janice Linton’s* valuable contributions to this review.

*Indigenous Health Librarian & Liaison Librarian for Community Health Sciences, Neil John Maclean Health Sciences Library, University of Manitoba, Bannatyne Campus

Dr. Kellie Thiessen holds a Career Development Award from the Canadian Child Health Clinician Scientist Program (CCHCSP) which supports her research programme. Additionally, Dr. Thiessen is supported by a CIHR Project Grant.

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K. Thiessen & J. Schneider

Community Health Sciences, Rady Faculty of Health Sciences, University of Manitoba, 750 Bannatyne Avenue, Winnipeg, Manitoba, R3E 0W3, Canada

M. Haworth-Brockman

National Collaborating Centre for Indigenous Health, 3333 University Way, Prince George, British Columbia, V2N 4Z9, Canada

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Max Rady Faculty of Medicine, Rady Faculty of Health Sciences, University of Manitoba, 583 Elgin Avenue, Winnipeg, Manitoba, R3A 0L2, Canada

J. Gelowitz

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K. Thiessen is the first author and one of two reviewers for the proposed scoping review. She has had extensive involvement in the development of the methodology for this scoping review and has worked closely with the librarians to ensure a rigorous search strategy is executed. M. Haworth-Brockman is the second reviewer for this proposed scoping review. She has also had extensive involvement in the development of the methodology for this scoping review and has worked closely with our librarian team on the search strategy process. R. Stout is an Indigenous scholar who has given insight and guidance regarding research with Indigenous persons. She supports the project so the content remains authentic and reflects an Indigenous lens in a comprehensive manner. R. Stout is a 3rd reviewer for the scoping review. P. Moffit is an academic who has extensive involvement with research in Northern communities over the last 40 years. She has given guidance and feedback on the protocol and continues to work with us to ensure our search strategy is comprehensive. She will provide critical feedback to every stage of our review. J. Gelowitz is an Indigenous medical student on our team. He is working with J. Schneider on identifying the grey literature sources. He also offers critical insight regarding Indigenous issues and provides another Indigenous lens from a medical perspective. J. Schneider is our research coordinator. She has worked extensively on identifying the grey literature sources and works closely with our librarian team to ensure rigour and organization of sources as they pertain to our protocol. L. Demczuk is our primary librarian who has spent extensive time in creating and running the search strategy for the scoping review based on this protocol. L. Demczuk works closely with another librarian to support this project and to ensure the validity of the search strategy. She has given feedback throughout the protocol. All authors gave feedback on this protocol.

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Correspondence to K. Thiessen .

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Supplementary information

Additional file 1..

PRISMA-P checklist.

Additional file 2.

Identified websites relevant to Indigenous health and research in Canada.

Additional file 3.

Proposed sample search strategy for EMBASE (Ovid).

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Thiessen, K., Haworth-Brockman, M., Stout, R. et al. Indigenous perspectives on wellness and health in Canada: study protocol for a scoping review. Syst Rev 9 , 177 (2020). https://doi.org/10.1186/s13643-020-01428-0

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Analytical Studies Branch Research Paper Series Moving Forward on Well-being (Quality of Life) Measures in Canada

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• Note to Readers

Executive summary

• 1 Introduction

2.1 Selected well-being indicator frameworks

2.2 well-being indicator frameworks and the policy process—international experiences, 2.3 well-being indicator frameworks and the policy process—canadian experiences, 3.1 world happiness reports, 3.2 integrating subjective well-being into policy, 3.3 implications for data collection and measurement, 4.1 updating the system of national accounts, 5.1 digitalization, 5.2 job quality in a changing new world of work, 5.3 affordability and economic uncertainty, 5.4 populism and social cohesion, 5.5 neighbourhoods, communities and the built environment, 5.6 environment and climate change, 6 moving forward with well-being measurement, appendix a: summary of well-being indicators, appendix b: selected government of canada well-being frameworks, appendix c: other selected well-being frameworks, appendix d: criteria for quality indicators, appendix e: data collection options at statistics canada.

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There is continued and growing awareness of the need to integrate information on economic, social and environmental conditions to better measure the well-being or quality of life and progress of nations, a need to move ‘Beyond GDP .’ Many countries are moving beyond just the measurement and monitoring of indicators to a more fulsome integration of quality of life into the policy process. The Government of Canada is moving in a similar direction. This provides Statistics Canada with an opportunity to take stock and review the status of well-being measurement in Canada. The overall objective of this paper is to provide an overview of selected approaches to measuring and reporting well-being in Canada and internationally, and to identify opportunities to move forward with new and enhanced measures to address current social, economic and environmental issues facing Canada that may impact the well-being of its population. This report highlights six trends and proposes a range of data development and measurement activities to advance well-being measurement in the following key areas: digitization, affordability and economic uncertainty, the quality of jobs, social cohesion, neighbourhoods and the built environment and climate change.

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Note to Readers:

This report was prepared prior to the onset of the COVID-19 pandemic, which has had and continues to have unprecedented health, social, and economic impacts on the quality of the lives of Canadians. This has only served to further amplify the importance of moving forward with the further development of a comprehensive quality of life framework that integrates social, economic and environmental measures to guide and monitor progress related to the pandemic recovery.  The deliberations and recommendations in this report remain, if not are more, relevant given the new context and reality Canadians are facing.

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There is continued and growing awareness of the need to integrate information on economic, social and environmental conditions to better measure the well-being and progress of nations, a need to move ‘Beyond GDP ’ to account for social and environmental outcomes in addition to standard economic measures. The proliferation of well-being measures have moved leaders in some countries to go beyond just the measurement and monitoring of these indicators to a more fulsome integration of well-being into the policy process. The Government of Canada is moving in a similar direction. This provides Statistics Canada with an opportunity to take stock and review the status of well-being measurement in Canada. As the country’s national statistical organization responsible for many of the indicators used in current well-being frameworks, Statistics Canada is well positioned to conduct such a stock-take and identify opportunities to strengthen the statistical system with respect to quality of life measurement to support the federal government plans moving forward. The overall objective of this paper is to provide an overview of selected approaches to measuring and reporting well-being in Canada and internationally, and to identify opportunities to move forward with new and enhanced measures to address current social, economic and environmental issues facing Canada that may impact the well-being of its population.

The review of well-being frameworks focusses on three well-being multi-dimensional frameworks national in scope and to which Statistics Canada is a major contributor of data for the indicators—the Canadian Index of Well-being (University of Waterloo), the Better Life Initiative (Organisation for Economic Co-operation and Development), and Sustainable Development Goals (United Nations). While each framework has been developed independently to meet different needs and goals, there is a clear convergence of domains into four key areas: society, economy, environment and institutions. Common domains include health, living standards, jobs and employment, education, time use, and community vitality. Other approaches to well-being measurement include the subjective approach which advocates an umbrella measure of quality of life ( e.g. , life satisfaction) and efforts to integrate well-being measures in the System of National Accounts.

Internationally, countries are moving beyond the simple reporting of well-being measures toward the integration of this concept in the policy process. Those countries who moved forward with this approach have developed largely multi-dimensional indicator based well-being frameworks that have been led by key government departments ( e.g. , Finance or Treasury), created through consultations, and leveraged measurement expertise from their respective national statistical organizations. In many cases, governments have used a range of legislative and policy mechanisms to support the use of well-being frameworks in the policy process, including mandatory reporting of well-being indicators.

In 2019, the Minister of Innovation, Science and Industry, as the Minister responsible for Statistics Canada, was tasked with supporting the Minister of Middle Class Prosperity and Associate Minister of Finance to better incorporating quality of life measurements into decision-making and budgeting. This represents a unique opportunity to take a critical look at the current state of well-being measurement in Canada. The results of this paper point to opportunities to advance a new government-led framework that both builds on existing well-being measures and advances new measures to address gaps related to the current social, economic and environmental trends impacting the lives of Canadians. This report highlights six trends and proposes a range of data development and measurement activities to advance well-being measurement in the following key areas: digitization, affordability and economic uncertainty, the quality of jobs, social cohesion, neighbourhoods and the built environment, and climate change.

1 Introduction

There is continued and growing awareness of the need to integrate information on economic, social and environmental conditions to better measure the well-being and progress of nations. High-profile reports since the last recession have coalesced around the notion that the measurements of economies have not sufficiently reflected the experiences of citizens nor captured the true costs of production (Stiglitz, Sen and Fitoussi 2009). They argue that the focus on aggregate economic outcomes is misplaced when growth is not inclusive or when environmental degradation and negative social outcomes are not fully accounted for. In this context, there is increased focus among governments at all levels to look at the economy, civil society and environment in an integrated manner that goes ‘Beyond GDP .’

At the United Nations (UN), this effort is reflected in the 2030 Agenda of leaving no one behind and the development of Sustainable Development Goals (SDGs). Note  At the Organisation for Economic Co-operation and Development (OECD) and in several member countries, new models that make better use of well-being indicators are being used to measure, track and analyze well-being and sustainability. Canada, too, is moving in this direction. Canada’s statistical infrastructure continues to evolve in response to the many changes in its economy, society and environment, and federal departments are implementing new indicator frameworks to guide, monitor and evaluate policies and programs.  Work is also on-going at the provincial and municipal levels and within academia and non-governmental organizations.

In late 2019, the new Minister of Middle Class Prosperity was tasked:

…to better incorporate quality of life measurements into government decision-making and budgeting, drawing on lessons from other jurisdictions such as New Zealand and Scotland. (Justin Trudeau, Prime Minister of Canada 2019)

This increases both the importance of, and demands upon, statistical measures of quality of life, alternatively titled well-being, as the government seeks to embed this concept more deeply in the policy process.

The understanding and definition of well-being is thus central within this context. Various approaches to well-being are evident in the research literature and international policy community. The overall objective of this paper is to provide an overview of selected approaches to measuring and reporting on well-being and identify opportunities to move forward with new and enhanced measures to address current social, economic and environmental issues facing Canada that may impact the well-being of its population.

The paper is divided into six sections. Sections 2 to 4 provide an overview of three approaches to measuring well-being, including well-being indicator frameworks, the subjective well-being approach, and briefly, the System of National Accounts (SNA). Emphasis is on the first two approaches as they are most germane to the mandated task above. Section 2 focuses more specifically on three well-being indicator frameworks which are multi-dimensional and national in scope and to which Statistics Canada is a major contributor of indicators—the Canadian Index of Well-being (University of Waterloo), the Better Life Initiative ( OECD ), and Sustainable Development Goals ( UN ). This section also includes insights regarding how the concept of well-being and related indicators are being more closely integrated in the policy process.

Section 5 draws attention to economic, social and environmental issues that have potential impacts for the well-being of citizens including digitization, job quality, affordability and economic uncertainty, the role of neighbourhoods and built environment and climate change. These issues are raised and discussed in the context of implications for well-being being measurement, highlighting the work Statistics Canada is doing to advance well-being measures as well as identify remaining gaps. While there are a broad range of indicators currently used to monitor and track the well-being of Canadians, there are opportunities to further develop new and timely measures to address these key issues which are also the focus of policy makers.

Finally, Section 6 draws the main elements of Statistics Canada’s strategy for engaging in, and supporting the Government of Canada’s objective of incorporating well-being within the policy process and advancing measurement in key areas.

2 Well-being indicator frameworks

Well-being indicator frameworks are being developed and used for policy purposes in a growing number of countries. Such frameworks typically comprised various aspects, or domains, identified as important contributors to, or elements of, well-being. Multi-dimensional frameworks typically include domains such as health, education, work, material conditions, social ties, and environment, with a set of indicators presented within each. Differences in indicator scores can be tracked over time or compared between groups to gauge improvements or deteriorations in conditions. Indicators are sometimes combined into an aggregated well-being index or set of well-being indices. The well-being indicator field itself has a fifty-year history, as discussed in a recent edition of Social Indicators Research (volume no.  135) (Land and Michalos 2018).

Over the last decade or so, the application of well-being indicator frameworks have become more prominent in public policy discussions. The United Kingdom (U.K.) was one of the first countries to measure well-being with the implementation of their Measuring Well-being Program in 2010 (Everett 2015), with a Measures of National Well-being Dashboard (United Kingdom. Office of National Statistics 2019) published by the Office of National Statistics. France and Wales introduced statutory requirements to report to Parliament regularly on the state of national well-being to inform policy development. In New Zealand, the Living Standards Framework (LSF) was developed by the New Zealand Treasury (Smith 2018). The LSF Dashboard, first released in 2018, informs the New Zealand Treasury’s advice to Ministers on priorities for improving wellbeing (Government of New Zealand. The Tresury n.d. ). This initiative led to the first well-being budget, which prioritizes a range of initiatives in the areas of mental health, vulnerable populations, and an environmentally sustainable economy. The outcomes of their budget will be measured using their Treasury’s LFS (Government of New Zealand 2019).

Initiatives in other countries are profiled in Exton and Shinwell (2018). Further information regarding international frameworks is available upon request.

In recent years, as the recognition of the importance of well-being has been emphasized throughout the world, a multitude of well-being frameworks have been developed both in Canada and beyond (appendices A, B and C provide an overview of some of these). Many of these frameworks focus on individual-level well-being, while others focus on families, children and youth, or communities. A comprehensive review of these frameworks is useful, if not essential, in understanding well-being from various perspectives and within different societal contexts.

For the purposes of this paper, three specific well-being indicator frameworks, to which Statistics Canada is a primary contributor of data and/or indicators, are considered in detail.

2.1.1 Canadian Index of Well-being

The Canadian Index of Well-being (CIW) began in the early 2000s under the auspices of the Atkinson Charitable Foundation and is designed to measure the economic, health, social and environmental well-being of Canadians. The initiative commenced with three rounds of public consultations and with input from researchers, indicator users, and various agencies and organizations. This culminated in the identification of a set of core values underpinning well-being ( i.e. , fairness, diversity, equity, inclusion, health, safety, economic security, democracy and sustainability) and a set of 8 domains of life that contribute to, and affect, the well-being of Canadians ( CIW 2019; Smale 2019; Michalos et al. 2011). These domains include community vitality, democratic engagement, education, environment, healthy populations, leisure and culture, living standards, and time use (see Figure 1). Each domain is populated with 8 indicators. The overall CIW framework thus includes 64 indicators, 8 sub-indices and the aggregate CIW itself. Each of the 8 indicators in each domain is assigned equal weight in the construction of the domain index, and each of the 8 domain sub-indices are assigned equal weight in the construction of the CIW overall.

The title of Figure 1 is “Community index of well-being framework.”

The figure consist of a large oval surrounded by medium-sized ovals. The medium-sized ovals have the same size. Each medium-sized oval is connected to the large one with a straight line. Around each medium-sized oval are eight small ovals. The small ovals are of the same size. They are connected to the medium-sized ovals with a straight line. The background colour of the large and small ovals as well as the frame around the medium-sized ovals is the same colour (blue). The medium-sized ovals have a white background.

The text in the large oval is “Canadian Index of Wellbeing.” It is white. The tip of a grey arrow is touching the large oval. The text at the beginning of the grey arrow, which is situated outside the diagram, in the lower-right area of the image, is “ CIW Composite Index, 64 indicators consolidated into a single CIW average.” (CIW is the abbreviation for “Canadian Index of Wellbeing.”)

The text in each one of the medium-sized ovals is different. It is as follows, starting from the upper-portion of the diagram: “Healthy Population,” “Democratic Engagement,” “Community Vitality,” “Environment,” “Leisure and Culture,” “Time Use,” “Education,” and “Living Standards.” The small ovals around each medium-sized oval are numbered from 1 to 8. The numbers are white in colour.

The tip of one grey arrow touches the medium-sized oval “Healthy Population” and the tip of another touches the medium-sized oval “Demographic Engagement.” The beginning of each of these two grey arrows converges to the text “8 Domains” written in black. This text is located outside the diagram in the top right area of the image.

The tip of one grey arrow touches the small oval “1” attached to the “Community Vitality” medium-sized oval, the tip of another grey arrow touches the small oval “2,” and the tip of another grey arrow touches the small oval “3” attached to the same medium-sized oval. The beginning of each of these three arrows converge to the text “8 Indicators in each domain” written in black. This text is located outside the diagram in the upper right portion of the image.

This diagram conveys the following message: The medium-sized ovals with their respective labels (Healthy Population, Democratic Engagement, Community Vitality, Environment, Leisure and Culture, Time Use, Education, Living Standards) represent the eight domains of life that contribute to, and affect, the well-being of Canadians. Each domain has an index and is populated with eight indicators represented by the eight small ovals numbered 1 to 8. Each of the eight indicators in each domain is assigned equal weight in the construction of the domain index, and each of the domain sub-indices are assigned equal weight in the construction of the Canadian Index of Wellbeing. The overall Canadian Index of Wellbeing includes 64 indicators.

The note and source of Figure 1 read as follows:

Note: CIW: Canadian Index of Wellbeing.

Source: University of Waterloo, n.d., “Framework,” Canadian Index of Wellbeing.

The CIW draws on a wide range of data sources, although information from Statistics Canada is used most extensively ( e.g. , General Social Survey [GSS], Canadian Community Health Survey, Labour Force Survey, Census of Population). Indicators are available at different frequencies, from annually to every five years.

The most recent annual report of the CIW was published in 2016, providing results up to 2014. In addition to national-level results for Canada, the CIW provides provincial-level information for Ontario, Nova Scotia, and Saskatchewan. The CIW experience in local communities across Canada is noteworthy. The CIW developed its Community Well-being Survey, with the questionnaire designed to collect information in each of the eight domains applying many of the questions available on Statistics Canada surveys such as the GSS . Between 2012 and 2020, the survey was fielded in 11 locations across Canada, as the CIW responded to local needs and worked in close collaboration with local stakeholders. Note  A collaborative initiative involving the CIW and Engage Nova Scotia, a non-profit organization, is currently underway. Survey responses have been collected from almost 13,000 individuals residing in 10 regions of the province using a non-probabilistic sampling technique.

In 2010, the CIW was moved from the Atkinson Foundation to the University of Waterloo, Faculty of Applied Health Science, where it has been headquartered since. Discussions are currently underway to move the initiative to a new institution.

2.1.2 Organisation for Economic Co-operation and Development—Better Life Initiative (How’s Life?)

The OECD ’s Better Life Initiative to measure well-being and progress ( OECD n.d. ) was launched in May 2011 in response to the recommendations in the 2009 report of the Commission on the Measurement of Economic Performance and Social Progress (Stiglitz, Sen and Fitoussi 2009). The Better Life initiative is composed of three components—building the evidence base ( i.e. , Framework, How’s Life?), building better measures and stimulating debate—and is designed to support the OECD ’s mandate of “better policies for better lives.” The OECD Well-being framework builds on national and international initiatives, the academic literature, the recommendations of Stiglitz, Sen and Fitoussi (2009), and input from National Statistical Offices (NSOs) represented on the OECD Committee on Statistics and Statistical Policy.

The How’s Life? framework identifies three pillars for understanding and measuring well-being—quality of life, material conditions and sustainability. These pillars are supported by 11 dimensions of current well-being and 4 sources of capital supporting future well-being. The 11 dimensions of current well-being include 8 reflecting quality of life (health status, work-life balance, knowledge and skills, social connections, civic engagement and governance, environmental quality, personal security, and subjective well-being) and three reflecting material conditions (income and wealth, jobs and earning, and housing). In addition to tracking progress over time, the Better life data are used to measure and monitor inequalities across a range of dimensions, such as education, age, income, gender, and migrant status ( OECD 2017).

The How’s Life? report is published every two years and provides information on well-being across approximately 40 countries. The results are targeted to a broad audience using a range of dissemination products, such as regional and country-specific reports, downloadable data, and an online platform ( OECD Better Life Index n.d. ) that enables individuals to construct a customized well-being index using the values (or weights) that they themselves attach to each of the 11 well-being dimensions.

How’s Life? is supported by data from national statistical organizations, the United Nations, the OECD itself, and the Gallup World Poll. Statistics Canada is a major contributor of data for Canada. The OECD plans to expand the How’s Life? initiative to more countries, improve well-being indicators in domains in which measurement is currently weak, and adapting existing indicators to changing circumstances.

In the most recent edition, How’s Life? 2020 , the OECD Statistics and Data Directorate charts whether life is getting better for people in 37 OECD countries and 4 partner countries ( OECD iLibrary 2020). This fifth edition presents the latest evidence from an updated set of over 80 indicators, covering current well-being outcomes, inequalities, and resources for future well-being. Since 2010, people’s well-being has improved in many respects, but progress has been slow or deteriorated in others, including how people connect with each other and their government. Large gaps by gender, age and education persist across most well-being outcomes. Generally, OECD countries that do better on average also feature greater equality between population groups and fewer people living in deprivation. Many OECD countries with poorer well-being in 2010 have since experienced the greatest gains. However, advances in current well-being have not always been matched by improvements in the resources that sustain well-being over time, with warning signs emerging across natural, human, economic and social capital. Beyond an overall analysis of well-being trends since 2010, this report explores in detail the 15 dimensions of the OECD Better Life Initiative, including health, subjective well-being, social connections, natural capital, and more, and looks at each country’s performance in dedicated country profiles.

The title of Figure 2 is “The Well-being Framework of the Organisation for Economic Co-operation and Development”

The figure consists of a square divided in two parts horizontally. The title of each part is written in white on a grey background. The title of the upper part is “Current Well-being.” The title of the lower part is “Resources for Future Well-being.”

In the “Current Well-being” part, there are two sections. The section at the left has the following title: “Key dimensions.” The title is written in grey on a white background. It is surrounded by a square grey frame. Under this title, 11 dimensions are listed in two columns (six dimensions in the left column and five in the right column. The dimensions appear together with their respective icons. The icons are circles of different colours that appear at the left of the dimensions. Each of the circles contains an image. The dimensions and their respective images are as follows: “Income and Wealth” (stack of dollars); “Work and Job Quality” (briefcase; “Housing” (house); “Health” (cross); “Knowledge and Skills” (book); “Environment Quality” (fir tree); “Subjective Well-being (heart)”; “Safety” (person running); “Work-life Balance” (scale); “Social Connections” (three persons); and “Civil Engagement” (crossed-out square).

At the right side of the list of dimensions and their respective icons is a grey vertical line bent with a point at the center in the direction of the section at the right.

The section at the right has the following title: “How we measure them.” The title is written in grey on a white background. It is surrounded by a square grey frame. In this section there are four rectangles of the same size. The rectangles are grey. Each rectangle contains an image and has a title under it. The images are white. The titles are black.

The upper-left image is bull’s eye with an arrow pointing to its centre. Its title is “Averages.”

The upper-right image contains three symbols. The symbols for a man and a woman that are superposed and contain the “equal” symbol in their centre. This symbol is located at the upper-left corner. The symbol for a diploma. This symbol is located at the upper-right corner. Three persons of decreasing size: the one at the left is large, the one in the center is medium-sized and the one at the right is small. This symbol is located at the bottom and center of the image. The title of the upper-right image is “Inequalities between groups.”

The lower-left image contains a staircase with one person standing on the bottom stair and another person standing on the top stair. Its title is “Inequalities between top and bottom performers.”

The lower-right image contains a person that is sitting, head hanging down and arms resting on thighs. Its title is “Deprivations.”

In the “Resources for Future Well-being part of the image, there are also two sections. The section at the left is named “Key dimensions.” The title is written in grey on a white background. It is surrounded by a square grey frame. Under this title, four dimensions are listed in two columns (two dimensions in the left column and two in the right column. The dimensions appear together with their respective icons. The icons are black circles. They appear at the left of the dimensions. Each of the circles contains a white image. The dimensions and their respective images are as follows: “Natural Capital” (tree, bird and land); “Economic Capital” (bridge); Human Capital (silhouette of a human head seen sideways with three lights in the brain area); “Social Capital” (handshake).

The section at the right has the following title: “How we measure them.” The title is written in grey on a white background. It is surrounded by a square grey frame. In this section there are four rectangles of the same size. The rectangles are grey. Each rectangle contains an image and has a title beside it. The images are white. The titles of the images are black.

In the upper-left image there are two piles of coins. The image title is “Stocks.” In the upper right image are six arrows, the three top ones point to the right and the three bottom ones point to the left. The image title is “Flows.”

In the lower-left image is a triangle with a grey-coloured exclamation mark in its centre. The title of the image is “Risk factors.”

In the lower-right image is the representation, of a muscled human arm with elbow bent. The title of the image is “Resilience.”

The source of the image is as follows:

Source: OECD i Library, 2020, How’s Life? 2020: Measuring Well-being.

2.1.3 Sustainable Development Goals

The 2030 Agenda for Sustainable Development ( UNDESA . Sustainable Development n.d. ) represents a shared vision for partnership, peace and prosperity and a commitment to leave no one behind. The Agenda is supported by 17 Social Development Goals (SDGs) (United Nations. Sustainable Development Goals n.d.a), 169 targets (The Global Goals for Sustainable Development 2018) and more than 232 indicators (United Nations. Sustainable Development Goals. n.d.b) (Figure 3). These address the three equally important pillars of sustainable development—the economy, the society and the environment. The SDGs also cover five key elements, also known as the 5 Ps: people, prosperity, planet, peace, and partnership.

The initiative draws on the success of the Millennium Development Goals (MDGs) (World Health Organization 2018), a series of 8 goals that UN Member States had agreed to try to achieve between the year 2000 and 2015. The MDG targets included halving extreme poverty rates, halting the spread of HIV/AIDS and providing universal primary education (United Nations 2015). In contrast to the SDGs , which target all countries, the MDGs were mainly aimed at developing countries, with the support of developed countries and international organisations.

The SDGs also adopted three important principles:

• Interlinkages: Goals and indicators are interlinked and can have impacts, positive or negative, on each other.
• Leave no one behind: The idea that nobody should be left behind, and that a country will be as successful as the least successful of its people. This element points to the importance of data disaggregation, to ensure the whole spectrum of different realities is represented.
• Reporting: Reporting is central to the achievement of the SDGs . Results and progress should be tracked as often as possible and reported in a neutral and impartial way.

The title of Figure 3 is “Sustainable Development Goals.”

The figure consists of 18 squares of equal size and dimensions. They are arranged in three rows of six squares each. The bottom right square is not numbered. The other squares are numbered from 1 to 17. They are have a different background colour. In each square, except the unnumbered bottom right one, the goal numbers appear at the top left corner, with a goal name to the right of them. Below the goal number and name is the symbol for the goal. The number, goal name and symbol are mostly white.

Centered above the 18 squares is written the title “Sustainable Development Goals” in large print on a white background. The colour of “Sustainable Development” is in a lighter shade of blue than the colour of “Goals,” except for the letter “o” in “Goals”: it is composed of 17 sections of different colours. These colours are the same as the background colours of the squares representing the goals. The word “Goals” is in larger print than the words “Sustainable Development.”

In the unnumbered bottom-right square “Sustainable Development Goals” also appears in the same 17 colours as those of the text centered above the 18 squares, but in a smaller font. It appears in a square of the same dimensions as the 17 other squares. Its background is light grey.

The number, goal name and symbol for each of the 17 goals are as follows, from left to right and top to bottom: 1, No Poverty (6 persons of different gender and ages, the three at the left holding hands); 2, Zero Hunger (bowl of hot food); 3, Good Healh and Well Being (graphical representation of a heart beat with a heart shape at the right end of it); Quality Education (copybook and pencil); 5, Gender Equality (superposed symbols for men and women with an equal symbol in the middle); 6, Clean Water and Sanitation (glass delineated in black, full of water in white colour with a blue water drop in the middle; the bottom of the glass takes the shape of the tip of an arrow); 7, Affordable and Clean Energy (white symbol of a sun with rays, in its centre is the power symbol found on the button of some technological devices; the power symbol is the same colour as the background); 8, Decent Work and Economic Growth (three bars of a bar chart with an arrow going in an upwards direction placed on top of them); 9, Industry Innovation and Infrastructure (four blocks stacked to form a corner; three blocks have one white face, the other faces delineated in white look transparent); 10, Reduced Inequalities (equal sign surrounded with four arrow heads [one on top, one at the bottom, one at the right, and one at the left]; the arrow heads point to the opposite side of the symbol and form the four corners of a square); 11 Sustainable Cities and Communities (faces of four buildings of equal width but of various heights and shapes); 12, Responsible Consumption and Production (curved line in the shape of the number 8 in a horizontal position, one of the ends of the line is in the shape of an arrow head); 13, Climate Action (white oval shape with the representation of the earth in the centre; the continents are green and the water is white; the overall shape resembles an open eye); 14, Life Below Water (two horizontal curved lines representing water and a white fish seen sideways under the curved lines); 15, Life on Land (a tree on the left, three birds in flight on the right, and two straight horizontal lines below them representing the surface of the land); 16, Peace, Justice and Strong Institutions (a white bird seen from the side and carrying a small tree branch with leaves in its beak; the bird is standing on a judge’s hammer); 17, Partnerships for the Goals (five circles delineated in white, partially overlapping on each side; the overlapped portions form the shape of a flower with five petals).

The source for Figure 3 is as follows:

Source:  Government of Canada, 2018, The 2030 Agenda for Sustainable Development.

While there are similarities between the UN SDGs and the OECD ’s How’s Life? ( e.g. , multi-dimensionality, similar domains), it has been noted that “the OECD well-being framework is an analytic and diagnostic tool to assess the conditions of a community, whereas the 2030 Agenda is a list of policy commitments agreed by world leaders.” ( OECD 2019, p.  4).

In 2015, Canada pledged commitment to the SDGs and work began on the development of a national strategy led by the Department of Employment and Social Development Canada (ESDC), supported by Statistics Canada, on behalf of the Government of Canada. The approach is one of developing a whole-of-Canada national strategy for the 2030 Agenda built on numerous engagements with a range of stakeholders including federal, provincial and municipal governments, Indigenous peoples, the private sector, civil society and Canadians at large. The development of the strategy was informed by a national consultation conducted between March 15, 2019, and May 15, 2019, with a range of stakeholders using multiple platforms and approaches. The results formed the basis of recommendations for Canada’s 2030 Agenda and proposed actions in the areas of leadership, governance and policy coherence; awareness, engagement and partnerships; accountability, transparency and reporting; Reconciliation and the 2030 Agenda and investing in SDGs (Government of Canada 2019a).

In an effort to advance the strategy, recommendations were made to further embed the SDGs in the federal government policy process as part of 30 Actions to 2030 (Government of Canada 2019a, Annex I – 30 actions to 2030). This includes recommendations pertaining to leadership, links to policy, and a new Canadian Indicator Framework.

2.1.4 Mapping well-being frameworks

In order to evaluate the relative relevance of different well-being frameworks to the current Canadian experience, and to ensure that no domains of importance are overlooked when developing a new framework for Canada, it us useful to undertake a comparative mapping of existing frameworks.

While each of the three frameworks considered in this paper has been developed independently to meet different needs and goals, a comparative review of the specific domains and indicators identifies numerous areas of convergence (Table 1). Overall, the three frameworks can be summarized as identifying domains of well-being in four key areas: society, economy, environment and institutions. Within each domain, the frameworks share similar areas of focus such as health, basic living standards, education and community as well as similar indicators (see Appendix A for a more detailed summary). This demonstrates the solid base which can be leveraged to move forward with a quality of life framework in Canada as well as identify potential gaps to meet emerging social, economic and environmental concerns moving forward.

Well-being frameworks are beneficial for use in a public policy setting because they can provide the “potential for prevention rather than crisis-driven policy.” (Wollny, Apps and Henricson 2020). The degree to which well-being indicator frameworks are currently integrated within the policy process, however, can be viewed along a continuum.

At one end are indicator frameworks that have no formal connection with policy processes, but are offered instead as public information. Barrington-Leigh and Escande (2018) note the challenges of visibility and longevity that such initiatives have faced. And while the OECD notes that indicator initiatives provided for public information may shift opinion and inform public and policy debate, it goes on to note that “it is necessary to go beyond simply making indicators available to wide audiences” and look further to their role in policy (Exton and Shinwell 2018, p. 19). Whitby et al. (2014) distinguish between parallel and integrated approaches to policy in the context of ‘Beyond GDP ’, arguing that “…it is important to emphasise that ‘balanced’ [policy making] does not just mean the adoption of social and environmental goals in parallel with economic goals (experience tells us that economic objectives tend to trump other ones) but rather a more integrated approach to economic and other policy making” ( p.  12).

In 2018, the OECD released a study highlighting the progress made by several countries towards the development and regular reporting of well-being indicators, and identifying the mechanisms used to entrench them in the policy process. The study was based on a review of 15 countries and detailed case studies on their use in policy making in seven. These included Ecuador, France, Italy, New Zealand, Scotland, Sweden, and the United Kingdom (Exton and Shinwell 2018). Among those countries engaged in the development of well-being frameworks and indicators, the following observations were noted:

• Most frameworks were developed in the last decade, with the exception of some countries including the Netherlands whose Life Situation Index which dates back to 1974;
• All the frameworks have adopted a multi-dimensional approach with indicators reflecting a range of economic and material well-being and overall quality of life supported by both objective and subjective measures including measures of subjective well-being ( i.e. , satisfaction with life);
• Consultation with a broad range of stakeholders were held with varying levels of intensity to inform the development of the measurement framework;
• Government leadership at the national level was key in all cases but varied with some using Centre of Government offices ( i.e. , Prime Minister’s office Israel, Sweden and Finland; Federal Chancellery in Germany) or ministries responsible for finance and or planning ( e.g. , Italy, France, Ecuador, New Zealand) with a clear intent of integrating the frameworks in the policy process;
• In the majority of cases, the National Statistical Office (NSO) played a key role as either the lead or co-lead agency for the development of the well-being measurement framework.

The study, now two years old in a rapidly changing world, found that countries varied in the extent to which well-being metrics are incorporated in the policy process. Among countries engaged in well-being indicator measurement, some used well-being metrics in a single stage of the policy process, such as priority/agenda setting (the Netherlands) or policy formulation (New Zealand), while others include well-being metrics in multiple stages of the process (Ecuador, France, Italy, Scotland, Sweden, United Kingdom, and United Arab Emirates).

Exton and Shinwell (2018) also report that governments have used a range of legislative and policy mechanisms to support the use of well-being frameworks. Mandatory reporting of well-being indicators at the outset of budgeting or policy processes is one example (the Netherlands), while legislative requirements for the monitoring and reporting of selected indicators is another (France, Italy, and Ecuador). Lastly, the OECD also notes that government leadership at the national level, with a clear intent of integrating well-being frameworks in the policy process, was a key element in well-being framework initiatives implemented over the past decade.

In an earlier review based on case studies in seven countries, Whitby et al. (2014) highlight a range of challenges facing the integration of well-being frameworks within the policy process, grouping these into three categories:

• Political barriers: The effectiveness of alternative well-being frameworks in the policy process may be limited if well-being indicators are not publicly accepted or endorsed as desired outcomes, resulting in a lack of democratic legitimacy. Exton and Shinwell (2018) note that countries implementing well-being frameworks over the past decade engaged in public consultation “…with varying levels of intensity, scale and goals.” (p. 9). Public consultation was also a critical element in the development of the CIW . Whitby et al. (2018) also identify “lack of [a] strong narrative that engages the public” and “lack of a clear political imperative” as two other potential political barriers to the use of alternative well-being frameworks in the policy process.
• Indicator barriers: Conceptual and methodological challenges regarding the measurement of well-being may pose a challenge to well-being frameworks. The frequency of data collection and timeliness of indicators are two challenges. Data collected on a five-year cycle or indicators that are two or three years out of data are likely to be inadequate for policy decision-making. The construction of composite indices, and the weights that are applied to each of the constituent elements, is another persistent challenge.
• Process and structural barriers: Integrating alternative well-being frameworks into the policy process may pose, what Whitby et al. call ‘process’ challenges. Alternative well-being frameworks are, by design, multi-dimensional and their use in policy processes requires an approach that cuts across government departments, policy areas, and disciplinary boundaries. The multi-dimensionality of alternative well-being frameworks also necessitates the use of a range of methodological approaches and analytical techniques. Whitby et al. (2014) report:

We found persistent perceptions among mainstream policy actors that if alternative indicators are to succeed their methodologies must be consistent with the current economic model and be directly linkable to existing economic instruments and tools ( e.g. , cost-benefit analysis, resource efficiency)” ( p.  15)

In an effort to promote the sharing of experiences and expertise among officials working to embed wellbeing outcomes in economic policy, the governments of Scotland, Iceland and New Zealand formally launched the Wellbeing Economy Governments (WEG) initiative in 2018. WEG Members attended the October 2019 OECD Workshop, Putting Well-being Metrics into Policy Action ( OECD 2019), aimed at exploring the policy uptake of well-being, inclusiveness and sustainability indicators, focussing on the types of evidence and analysis that policy makers need, and how practical policy mechanisms could be adapted to apply this evidence on a more systematic basis.

While Canada currently does not have a well-being framework integrated in the policy process at the federal level, it is important to draw attention to the range of existing initiatives to integrate aspects of well-being in selected policy areas. There are several national level frameworks developed to support federal policies related to the well-being of specific populations (see appendices B and C). A few of these include the Community Well-being Index for Indigenous peoples (Crown-Indigenous Relations and Northern Affairs Canada and Indigenous Services Canada and other Agencies), the Canadian Index for Measuring Integration (2020) which examines four dimensions of immigrant integration to assess the gaps between immigrants and the Canadian-born population (The Canadian Institute for Identities and Migration, the Association of Canadian Studies and Immigration, Refugees and Citizenship Canada), the Gender Results Framework (Women and Gender Equality), and the Veterans’ Well-being Act (Veterans Affairs Canada and Department of National Defence and Canadian Forces). With the support of Employment and Social Development Canada and Social Development Partnerships funding, the Vanier Institute of the Family has been developing a Family Well-being Index and associated indicators in consultation with project advisors (Vanier Institute of the Family 2020a). These frameworks vary in their dimensions and indicators as they are designed to highlight issues and metrics of particular relevance to specific populations.

There are also numerous federal policies that touch on specific dimensions of well-being. For example, the Public Health Agency of Canada, in collaboration with national and provincial organizations including Statistics Canada, released indicators on health inequalities across socio-economic groups as part of the Health Inequalities Reporting Initiative. The intersectionality of well-being in the domains across health, income and employment is highlighted. Similarly, Canadian Heritage is leading Canada’s anti-racism strategy—Building a Foundation for Change: Canada’s Anti-Racism Strategy 2019–2022. The objective is to find ways to counter racism in its various forms, with a strong focus on community-based projects. The strategy is guided by a vision of Canada where all Canadians benefit from equitable access to and participation in the economic, cultural, social and political spheres. Brief summaries of selected well-being frameworks and polices in Canada are provided in Appendix B.

Nonetheless, the large number of indicator initiatives fielded by federal, provincial and regional governments, non-governmental organizations, academics, and private sector institutions testifies to the ‘sea of indicators’ characterizing the current environment. This diversity and ‘over-abundance’ of indicators may itself pose challenges, such as competition between the producers of indicator frameworks and confusion among potential users (Whitby et al. 2014).

The incorporation of well-being measurement into the policy process has implications for Canada’s statistical system. Statistics Canada data are used extensively in indicator initiatives, both nationally and internationally. It is important for the agency to continue to be responsive to the evolving needs of indicator users. Note 

3 The subjective well-being approach

While most well-being frameworks include subjective measures, the subjective well-being approach advocates for use of quality of life as the primary measure of well-being. In a recent report, Helliwell (2018) argues for the use of a subjective measure such as life satisfaction as they provide an “umbrella measure” of quality of life.

In the subjective well-being (SWB) approach, “fundamental importance is attached to the evaluations that people make of their own lives.” Proponents of the approach view “…the appeal and usefulness of subjective measures of well-being data, and especially life evaluations, as being due to their primary nature—as unvarnished measures of what people actually think about the quality of their lives” (Helliwell 2018, p.  966).

In its 2013 OECD Guidelines on Measuring Subjective Well-being ( OECD 2013),  the OECD defines SWB as:

Good mental states, including all of the various evaluations, positive and negative, that people make of their lives and the affective reactions of people to their experiences (p. 10).

This definition covers different aspects of well-being, which the OECD further delineates into three elements:

• Life evaluations— the reflective assessments that people make of their life, or some aspect of it
• Affect— a person’s feelings or emotional state, usually at a particular time ( e.g. , sadness, worry or happiness yesterday)
• Eudaimonia— an individual’s sense of purpose or meaning in life, and psychological functioning.

The OECD recommends that a question pertaining to life satisfaction serve as the primary measure of SWB , when a single measure is required . This question asks:

The following question asks how satisfied you feel, on a scale from 0 to 10. Zero means you feel “not at all satisfied” and 10 means to feel “completely satisfied”. Overall, how satisfied are you with life as a whole these days?”

Life satisfaction provides an ‘umbrella measure’ that allows the factors contributing to, or detracting from, well-being to be identified. These measures can thus be used to compare well-being across communities and populations (including measuring inequalities, support research to better understand what drives quality of life), and to inform policy priority setting and decision-making. This approach avoids several challenges facing well-being indicator frameworks including the inherent difficulty of creating a single index from multiple indicators and the choices that must be made regarding which indicators to include, and how to weight reflect their relative importance. If a single composite measure is not created, how to comprehensively understand well-being across multiple indicators and domains is a challenge. Instead, indicators should be used to better understand what drives differences and changes over time in an overall umbrella measure of well-being such as life satisfaction.

In 2011, the United Nations General Assembly adopted a resolution calling on member states “to undertake steps that give more importance to happiness and well-being in determining how to achieve and measure social and economic development.” (cited in Helliwell 2019a). The following year, the first edition of the World Happiness Report was released (Global Council for Happiness and Wellbeing 2019). Based on a review of international data and evidence related to the science of happiness, the report demonstrated that the quality of people’s lives can be coherently, reliably and validly assessed by a collection of subjective measures of well-being collectively referred to as “happiness.”

Subsequent annual World Happiness Reports present new evidence on the factors that support well-being, in-depth country assessments, and happiness scores across countries, drawing primarily on data provided by the Gallup World Poll. For example, the 2017 World Happiness Report showed that three-quarters of the variation in average life evaluations observed across more than 150 countries are explained by six variables: gross domestic product (GDP) per capita, healthy life expectancy, having someone to count on in times of trouble, sense of freedom to make key life decisions, trust, and generosity (Helliwell, Huang and Wang 2017). The 2019 World Happiness Report compared average life evaluations in 132 countries over the period from 2005–2008 to 2016–2018 concluding that the greatest losses in life evaluation occurred in Venezuela and Syria (Global Council for Happiness and Wellbeing 2019).

As with well-being indicator frameworks, the integration of Subjective Well-Being (SWB) measures within policy processes is still in its early days. Nonetheless, many applications of SWB tools and metrics can be found in different policy areas. The Global Happiness and Well-being Policy Report 2019 , published by the Global Council for Happiness and Wellbeing (2019), highlights innovative practices, evidence and policy recommendations to promote happiness and well-being in six areas: education, workplace, personal happiness, public health, city design, and metrics.

New projects to incorporate happiness in the policy processes are underway in Canada. Statistics Canada has been asked by Canadian Heritage (PCH) and the Canada Council for the Arts to develop an app to address a critical data gap in SWB measures. For these partners, there is a need to empirically demonstrate outcomes related to investments in arts, culture and heritage activities. In response, Statistics Canada is piloting a first use of an app for smartphones that will test the Experience Sampling Method (ESM), which will collect data on SWB measured in the moment against the activity of the respondent at the moment—a method endorsed by the OECD as the most appropriate method for collecting in the moment subjective measures of well-being ( OECD 2013). The ESM app will enable reporting of cause-and-effect results at the outcomes level on program and policy areas (Fujiwara and MacKerron 2015).

Another application in the policy domain is life satisfaction analysis designed to convert the difference in life satisfaction associated with an observed characteristic—say, percentage of green space in a neighbourhood—into the estimated change in income that would be required to yield the same increase in well-being (Ambrey and Fleming 2014). This approach was used by PCH to estimate the value of the wellbeing impacts of arts, culture and sports participation in Canada (Lemyre, Mader, and Ambard 2018). This approach is also currently being assessed by federal researchers with the Privy Council Office and Public Health Agency of Canada in a study titled A life satisfaction approach to valuing the impacts of healthy behaviours on subjective-well-being (Joyce 2019). They report that physical activity and smoke-free living are associated with increases in life satisfaction that are equivalent to increases in weekly household income of $631 and $563 respectively. The research community is also engaged in the development of SWB -based tools, including the monetization of life satisfaction for inclusion in the policy process. For example, a special session on Government Budgeting for Happiness is scheduled for the 2020 annual conference of the Society for Quality-of-Life Studies.

Subjective measures of well-being have been the subject of much methodological assessment. The validity of SWB measures has been confirmed in various studies using alternative approaches and lines of evidence (see reviews in Frijters et al. [2019] and Helliwell and Wang [2012]). Likewise, the relationships between the different elements of SWB —life evaluations, positive and negative affect, and eudaimonia—have been scrutinized, as have various survey design and measurement issues. This is evident in the 265 pages of the OECD ’s Guidelines on Measuring Subjective Well-being ( OECD 2013), and in a large research literature. Statistics Canada too has assessed life satisfaction responses, analysing issues such as item non-response, survey day and survey month effects, survey framing effects, and survey mode effects (Bonikowska et al. 2014; Arim and Schellenberg 2019).

Statistics Canada has collected a large volume of information using the life satisfaction question. The question is easy to administer, taking less than 20 seconds to answer, and yields a low rate of item non-response (again, supporting the view that the respondents understand and are able to answer the question). The life satisfaction question has been included on the General Social Survey (GSS) in most years since 2003, on the Canadian Community Health Survey (CCHS) since 2009, on the Longitudinal and International Survey of Adults (LISA) since 2014, and on the Canadian Housing Survey (CHS) since 2018. Altogether, between 2009 and 2018 Statistics Canada collected information on the life satisfaction of approximately 800,000 survey respondents. Large samples across household surveys create opportunity for ‘pooling’ data across sources and survey years, thereby increasing the scope for research on specific populations or detailed geographies. Linkages between these large pooled samples and administrative data sources create further opportunity for research. This large repository of life satisfaction data is situated within a broad and rich set of both individual- and neighbourhood-level covariates, providing scope to further expand the evidence related to SWB .  The ability to combine and interpret life satisfaction data from a range of surveys is dependent in part on comparability and understanding the impacts of questions asked in the context of different surveys.

4 Economic frameworks—the System of National Accounts

In addition to the well-being indicator framework and SWB approaches discussed above, adaptations and innovations in other measurement systems are underway. The objective of this section is to highlight work on the System of National Accounts (SNA). It is widely recognized that gross domestic product (GDP) is a measure of economic activity, not a metric of economic well-being or sustainability. Yet many believe there should be a much closer relationship between macroeconomic accounting frameworks, governed by the international SNA , and well-being and sustainability.

An update to the SNA 2008, the current standard for national accounting, is underway, and the need to incorporate well-being and sustainability measures is one of three key streams on the research agenda. With a leadership role for this research stream, Statistics Canada is well positioned to influence the effort, which involves input from a wide variety of international experts in a range of research spheres.

A long-term vision for expanding the traditional SNA framework to encompass elements of well-being and sustainability might involve a fully elaborated, integrated information system that drills down to micro data sets, and integrates information from a broad range of multidisciplinary spheres. Recognizing that this vision is not practically viable as a generalized international standard in the short term, a more pragmatic approach is being taken for the next update, drawing on key areas where significant measurement frameworks have been developed in the form of specialized “satellite accounts,” closely connected with the dimensions of well-being and sustainability.

Five areas are currently in scope for elaboration, each drawing on a team of designated experts for its development. In general, these are areas where well-established information frameworks and international guidance already exist. They are briefly described below:

• Unpaid household work: Recognizing non-market activities undertaken in the home (often by women) and trade-offs with work in the labour market, caregiving and volunteering. Relationships with time use and developments in the digital economy.
• Environmental–economic accounting: Building in dimensions of the System of Integrated Environmental and Economic Accounts (SEEA) for a more fully elaborated SNA framework explicitly accounting for natural resources, ecosystem services and other environmental impacts.
• Distributions for the household sector: Regularly reporting on distributions of national accounts household income consumption, saving and wealth by quantile or socio-demographic characteristics.
• Education and human capital: Recognizing education and human capital as an investment that creates and ongoing return. More explicitly accounting for labour characteristics in macroeconomic outputs and productivity measures.
• Health and social conditions: Appropriate measurement of non-market outputs in the health care sector and capacity to link outputs to health outcomes.

While the challenges are considerable and will differ by domain, the intent is to build elaborations or extensions to the SNA rather than radically redefine existing macro measures, such as the GDP , which adequately serve their intended purpose. Neither is the intent to replace the GDP with another single headline indicator. The new, broader, information framework would not be restricted to monetary measures and would aim to enable analysis of interactions of these new dimensions with traditional monetary indicators, as well as linkages among the added dimensions. The expanded system would also relate, at a broad level, to established well-being frameworks, such as the OECD Better Life Index or the Sustainable Development Goals (SDGs).

The development of new international standards to better integrate established measures of economic growth ( i.e. , GDP ) with measures of well-being and environmental sustainability will involve an elaborate range of stakeholders and take considerable time to establish and implement. There may, however, be a number of short-term opportunities to take further steps in this direction, to better showcase work that has already been done, and to build awareness opportunities for collaborative work. Some specific ideas, outlined below, could be a starting point for further development:

• Establish a regular quarterly release for the household sector drawing on information already produced, including context from the Distributions of Household Economic Accounts program.
• Update estimates of households’ unpaid work with recent time use information, with a focus on developments in the digital economy ( e.g. , offering services on line, participation in platform/“gig” economy).
• Further develop and implement output-based measures for dimensions of the health care sector.
• Build socio-economic characteristics of employment and hours worked into the labour productivity database, facilitating analysis aligned with national accounts indicators and the bridging of social and economic measures in labour accounts.
• Highlighting work on economic–environmental linkages.

5 Current social, economic and environmental trends—implications for well-being measurement

Regardless of how it is measured, the well-being of Canadians continues to be impacted by a broad range of economic, social and environmental developments. Proponents of both the well-being indicator framework approach and the SWB approach have both drawn attention to common themes and issues which represent potential gaps in current measurement frameworks. Six of these are highlighted and described below including implications for the measurement of new and/or timely measures of well-being. In all cases, the following proposals to advance the measurements of well-being will be conducted in accordance with best practices for the development of indicators and would leverage the range of data collection options available at Statistics Canada. More information regarding criteria for quality indicators and data collection options are available in appendices D and E respectively.

It is now widely recognized that the digital transformation—the social and economic changes associated with Information and Communication Technologies (ICT), automation, artificial intelligence, and other digital technologies—continues to reshape the lives of individuals, communities, and societies. The breadth of the digital transformation is immense, affecting virtually all aspects of peoples’ lives. The impacts of the digital transformation are also varied, ranging from minor adaptations in daily life to potentially transformative changes in fundamental values and processes. And individuals, while often leading ‘tech-saturated’ lives already, continue to face rapid and ongoing technological change.

There are divergent views regarding the opportunities and risks that the digital transformation poses to well-being. For example, a 2018 Pew Research Center study involving over 1,100 technology experts, health specialists, and other key informants found that 47% expect well-being “...to be more helped than harmed by digital life in the next decade,” 32% expect well-being to be more harmed than helped, while the remaining 21% did not expect much change in well-being (Anderson and Rainie 2018). More broadly, questions regarding the impacts of technological change are being raised across many quarters. For example, a recent expert panel identified five aspects of well-being that appear susceptible to the impacts of technology but have received little or no attention in well-being frameworks. These include: human development (including early childhood learning), mental health across the life span, social inclusion, personal and public security, and governance (Gluckman and Allen 2018). This highlights how much is still unknown and how wide ranging the data needs are in this field.

The potential impacts of technological change on well-being have been underscored by well-being researchers. For example, Land and Michalos (2018) highlight the scope and potential impacts of automation and social media, and underscore the importance of updating well-being indicator frameworks to reflect these challenges. Similarly, the impacts of new technologies on well-being are the focus of several chapters of the 2019 World Happiness Report.

Implications for well-being measurement

To better understand the implications of digitization for the measurement of well-being, Statistics Canada is leading an in-depth review of data collect practices in the United Nations Economic Commission for Europe (UNECE) member countries for the Conference of European Statisticians (CES). The review will be published by the CES in 2020. Several of the following initiatives could subsequently be undertaken by Statistics Canada:

• Engaging with the international community: Statistics Canada is prepared to lead an international working group on ‘Measuring Well-Being in the Era of the Digital Society’ for the CES . Building on the in-depth review, the broad objective would be to further advance data collection and measurement practices in this area, with specific priorities established at the CES Plenary meetings held semi-annually.
• Using existing data to inform new well-being indicators: Information on technology use is currently available on Statistics Canada surveys, such as the 2016 GSS (Canadians at Work and Home), the 2014 and 2019 GSS (Victimization) (Statistics Canada 2019a), the 2018 Canadian Internet Use Survey (CIUS), and the LISA. A program of research that exploits this information will be undertaken on issues such as the perceived impacts of social media use; on-line victimization; digital skills; and technology use among population groups ( e.g. , seniors). This research will help inform the identification of relevant indicators moving forward, including the intensity and frequency use of digital devices and their impact on adults and children, as well as by other intersecting identities. Further work and data collection are needed to understand the link with mental health.
• Embedding well-being in existing surveys: The CIUS will be fielded in 2020 and 2022, offering opportunity to update survey content in response to emerging issues and priorities. Questions on well-being are among the refinements being made to the 2020 survey. Further refinements to the 2022 survey will be informed by consultation and analysis.
• Using a new survey approach to address gaps: In 2020, Statistics Canada started piloting its Web Panel Survey—an online data collection platform that will field approximately 10 minutes of questionnaire content to representative samples of Canadians on a monthly basis. An experimental module of questions on Canadians’ perceptions and experiences of disinformation developed for the Internet and is scheduled to be fielded in the fall of 2020. Information on other aspects of digitalization and well-being could be collected using this vehicle.
• Using new technologies to advance well-being measurement: As part of a new application that will collect real time information from Canadians using smart technologies, Statistics Canada intends to field the Well-being Check. This app will measure in-the-moment well-being indicators ( e.g. , happiness, anxiety) as well as contextual information ( e.g. , what you are doing, who you are with). This initiative, which uses Experience Sampling Method, is set to be piloted in the summer of 2020. This approach could be used to collect well-being measures moving forward.
• Measuring the impact of free services: Estimate the impact of free services such as social networks, cloud storage, point-to-point video service ( e.g. , Skype) on the well-being of users.
• Evaluate individuals’ satisfaction and happiness in light of these changes.

It is not enough to know how the “average” Canadian is doing. It is also important to identify who is being left behind, who may be more resilient and who may experience the greatest degree of opportunity flourishing, so that appropriate policy responses can be designed to support different populations in Canada. Therefore, the development of new indicators must provide an understanding of how the benefits and costs of digital transformation are being realized by different demographic groups such as women, youth, persons with a disability, persons at risk of poverty, Indigenous Peoples, recent immigrants, minority groups and seniors.

Changes in Canadian workplaces are relevant to the discussion of well-being. Indeed, given the fact that most working-age individuals spend a significant fraction of their lives working creates a strong link between quality of life and job satisfaction. Today’s jobs differ drastically from those in the past. The remarkable changes in industrial structure, along with technological advancements, changes in the intensity of firm competition and international trade over the past four decades have resulted in changes in several job characteristics. Overall today’s jobs are less likely to be full-time, permanent, unionized or covered by a registered pension plan than they were in the early 1980s.

Job characteristics have changed in different ways for different groups of workers. For example, wages in full-time jobs have grown faster for older workers than for younger ones. Jobs in education, health care and social assistance have become relatively more important for women but not for men. The manufacturing decline observed since the early 2000s reduced wages and full-year, full-time employment rates of men, especially less-educated men living in the affected areas, but had little impact on women (Morissette 2018).

Not all workers are equally represented in high-quality jobs. An assessment of job quality in Canada (Chen and Mehdi 2018) finds diverse patterns of job quality across sectors and socio-demographics groups. In particular, workers with a high school diploma or less education are more likely than other workers to be in jobs involving less flexible work schedules, low autonomy, lack of training opportunities and employment benefits. While young workers are more likely than older workers to hold jobs with involuntary and irregular work schedules, they do relatively well in terms of manageable workload and access to informal training.

As a result of automation driven by the introduction of computer-based technologies, some occupations saw their share of total employment drop significantly (Frenette and Frank 2020). For example, only 7% of women aged 17 to 64 were employed in office support occupations in 2019, down from 13% in 1989. Several groups of workers are more likely to face a high risk, including older workers (55 or above), workers with no postsecondary credentials or with postsecondary credentials in certain fields, individuals with low literacy or numeracy proficiency, low earners, part-time workers, employees in small firms, and manufacturing workers.

Along with the changes documented above, gig employment is another changing dimension of work. Contrary to employees, gig workers are usually not in an employer–employee relationship. This includes highly skilled freelancers as well as on-demand workers hired for jobs through the growing number of online platforms. Statistics Canada has pioneered a clearly defined methodological framework for identifying gig workers in Canada based on various Canadian administrative sources (Jeon, Liu and Ostrovsky 2019). The study shows that the percentage of workers involved in gig work increased from 5.5% in 2005 to 8.2% in 2016. More than half of gig workers combine gig work with wages and salaries from another job, and the annual income of a typical gig worker was usually low. Gig work was more prevalent among workers in occupations in arts, entertainment and recreation, and among immigrants.

The changing nature of work and impact on well-being are also influenced by the decisions of firms. These include decisions that directly impact workers, such as levels of remuneration, the nature of the employment contract, the availability of pensions and health plans, work-life balance initiatives, and employee and family support programs. The impacts of automation and technologies in the workplace on task content, skill requirements and job security are also centre stage in research and public discussion. Business decisions also affect consumers and the public at large, such as charitable and philanthropic initiatives, the creation of safe and healthy products, and the fostering of a secure and healthy environment both in the workplace and in the community at large.

Based on their meta-analysis of 339 studies undertaken by Gallup, Krekel, Ward and de Neuve (2019) report a positive correlation between employee well-being and several firm-level measures of performance, including productivity, customer satisfaction, staff turnover, and stock price. They go on to highlight workplace interventions pertaining to social relationships ( e.g. , employee supervision), task content and work-life balance.

These new forms of employment interrelate with multiple facets of economic well-being of Canadians, such as work conditions and benefits, access to employment insurance, family-work balance and older workers’ transition to retirement and retirement income. To continue to build the data and evidence base to understand the changing nature of work and impact on well-being, the following activities could be undertaken to advance well-being measurement in this area:

• Measuring the gig-economy: While some research already confirms that workers in non-standard employment arrangements cumulate many disadvantages in the workplace other than being low-paid, it remains unclear how gig employment exactly intersects with precarity and overall socio-economic well-being. Statistics Canada is looking at potential survey–administrative integrated data sources that could shed light on multidimensional quality indicators of non-standard employment.
• Understanding quality of work by sector: Impacts of all these changes diverge at the regional and sectoral levels. Certain sectors and regions are facing significant labour and skill shortages while some others have much higher unemployment rates. This labour market imbalance was voiced by many industrial stakeholders and urges more nuanced analysis. Moreover, with some resource-based industries transitioning to a low-carbon economy, the way in which workers transition at local labour markets and across industries, as well as needs for necessary reskilling and upskilling are emerging questions that require further integrated data and analytical evidence linking the labour demand and supply information at a more granular level. Statistics Canada has started to consider the possibilities of linking demand data such as Job Vacancy and Wage Survey of employers with supply data such as Labour Force Survey to gauge the unmet needs and address this information gap.
• Well-being benefits of new job opportunities: While so far much of the focus has been on the risks and challenges posed by the new world of work, in recent years we also see increasing needs for data and analysis on new opportunities ( e.g. , new jobs and skills) to help harness a complete understanding of the prospects of future jobs.
• Measuring the impact of firms on employee well-being: The development of firm-level, individual-level, and employer–employee matched data files at Statistics Canada provides a foundation upon which further data collection and analysis relevant to the workplace and well-being can be built.
• Job quality: Re-administer job quality and other related questions asked in the 2016 GSS on Canadians at Work and Home, the last cycle of the GSS to have asked a comprehensive set of questions measuring quality of life of Canadians and their views about work, and work–life balance (Statistics Canada 2019a).

In the Canadian context, there are three distinct lines of analysis that focus on trends in affordability and economic uncertainty and their implications for the economic well-being of families. The first line of analysis centres on the escalation of housing prices in major urban centres, most notably in Vancouver and Toronto, and on the concomitant effects that rising home prices have inter alia on families looking to purchase homes, or on existing homeowners who, after taking on high levels of mortgage debt, may be less able to absorb financial stresses associated with income shocks or rising debt-serving costs. Household debt-to-income levels had risen markedly in many Canadian cities, and concerns over escalating home prices have precipitated a range of policy responses from federal and provincial governments designed to curb the influence of foreign and/or speculative investors as potential sources of home price inflation.

Homeownership matters to economic well-being because it is the central vehicle through which many families, particularly those with mid-range incomes, build and accumulate wealth over the course of their economic life, especially in an era of declining pension coverage. Families that invest in homeownership have markedly higher net financial worth than those that remain in the rental market. These distinctions are readily apparent among younger families. For instance, millennials between the ages of 30 and 34 who own their homes have a median net worth of about $300,000, compared to about $20,000 among those who do not own their principal residence. Market conditions that make transitions to homeownership increasingly difficult for mid-range earners can be expected to have a material impact on the extent to which many families are able to build wealth over time.

The second line of analysis that examines how pressures related to affordability are affecting economic well-being focuses on the extent to which rising living costs are placing increasing stress on family pocketbooks. While nominal earnings growth for mid-earning families have generally kept pace with consumer inflation, increases in the costs of living—which relate more narrowly to prices increases for food, transportation and shelter, or for (largely) non-discretionary services related to health, education, and childcare—have outpaced nominal earnings growth in recent years and now account for a larger share of overall household spending. While the pace at which the prices for these goods and services have risen relative to household earnings varies considerably across the country, the general increase in these living costs is likely to underlie much of the sentiment data that identifies pocketbook issues as the major stressor facing many Canadian families.

The third line of analysis focuses on subjective measures of individuals’ assessment of their economic well-being. Such measures better capture angst and feelings of uncertainty related to economic situation, feelings which in turn impact overall well-being. Economic well-being has been linked to a significant part of the variation in overall life satisfaction of Eastern Europeans (key driver for overall life satisfaction) (Hayo and Seifert 2003). In Canada, results from the 2016 General Social Survey (GSS), too, highlight a link between subjective economic well-being and overall life satisfaction. Moreover, GSS results also show that there is a different relationship between objective economic measures and subjective economic measures when it comes to being satisfied with one’s life. Among seniors, for example, there is no significant association between family income and life satisfaction but economic well-being is associated with life satisfaction. For instance, those who reported that their retirement income was insufficient and those who stated that financial concerns represented their main source of stress had lower life satisfaction scores (Statistics Canada 2018).

Subjective measures capturing the stresses, worries and aspirations of people in Canada are fielded less often and in far less comprehensive a manner. The relative lack of subjective information is a data gap, especially when economic indicators and polling results tell seemingly different stories about the financial security of Canadians. This gap is exacerbated when traditional economic indicators are released monthly or quarterly but Canadians’ outlooks as measured on household surveys are released sporadically and are a year or more out-of-date.

While most well-being frameworks include measures of economic well-being such as income and living standards, more is needed to understand the diversity of experiences and potential inequality as well as subjective measures to better understand how individuals feel about their economic situation—these concepts are currently not measured in more traditional economic indicators. The following activities could be undertaken to address these gaps:

• Measuring the pressure of housing on economic and overall well-being: New data from the Canadian Housing Statistics Program and the CHS can be used to support more detailed assessments of pressures related to housing affordability, particularly as these relate to differences in family income and other socio-demographic factors. The challenge will be to identify a small set of variables (at a sufficient level of geographic granularity) that can be used to track meaningful differences in housing market activity and outcomes for specific groups over time.
• Measuring differences in cost of living: Data on rising living costs present more of a challenge from a measurement perspective. Progress here may depend on the development of specialized price indexes that more fully capture movements in cost-of-living expenditures for specific groups of households relative to incomes. This would support a more rigorous analysis of the evolution of these costs pressures for specific types of families.
• Understanding subjective measures of economic well-being: Subjective measures of economic well-being have been captured in selected Statistics Canada surveys including the 2016 GSS (Statistics Canada 2019a). For example, questions available in the 2016 GSS include those related to future economic and financial situation ( i.e. , will it be better, the same or worse). These data can be used to study the feasibility of using such indicators as subjective measures of economic well-being moving forward.
• New data collection of subjective measures of well-being: Additional data collection will be required to collect subjective measures of well-being on a routine basis. At this time, while the Agency does collect some information, it is currently on an ad hoc basis. Regular data collection on key subjective measures is required to support timely and meaningful reporting.
• Using external data sources: Statistics Canada could seek partnerships with external data providers such as polling firms that also conduct survey among Canadians to assess and track subjective measures of economic well-being. For example, Bloomberg Nanos Canadian Confidence Index (BNCCI) is a weekly measurement of the economic mood of Canadians.

Subjective measures of attitudes and outlooks extend beyond financial and economic issues. The past decade has seen the emergence of populist political movements in several countries. Note  Various explanations for this have been offered. One view is that populism is a response among some segments of national populations to a ‘runaway world’ of change that “…is emerging in ‘an anarchic, haphazard, fashion….fraught with anxieties, as well as scarred by deep divisions and a feeling that we are all ‘in the grip of forces over which we have no control’” (Cox 2017, p.  9). The result, it is argued, is a loss of self-identity and sense of one’s place in the world and receptivity to populist movements that promise a return to “more stable, more settled times” (p. 9).

The notion of populism and societal fragmentation can be linked to underlying economic and social conditions that lead individuals to feel marginalized and “left behind.” Changing economic conditions related to globalization and technological change, it is argued, have benefitted some segments of the population but left others behind. In the face of stagnating wages, job insecurity, and financial precariousness, segments of the population may see populist movements as a way to return to more prosperous times. Underlying both accounts is a sense of individual powerlessness and a loss of faith in traditional political leaders to make decisions on behalf of ‘the people’ (Cox 2017).

Underlying social factors associated with populism could be understood through a framework of social cohesion and trust in public institutions. A fractured, divided society where values are not shared, or where groups of people are economically or socially isolated, will lead a lashing out through votes, towards a politician who claims to represent them and who will agree to take-down the elite who have left them in the fractured state. Social cohesion is a closely related concept to understand the root causes of today’s populism (Bowlby 2019). The OECD (2011) defines social cohesion as “a cohesive society that works towards the well-being of all its members, fights exclusion and marginalization, creates a sense of belonging, promotes trust, and offers its members the opportunity of upward social mobility.” Social cohesion, according to the OECD , comprises of social inclusion, social mobility and social capital.

In Canada, the definition of social cohesion used by the Department of Canadian Heritage (PCH) emphasizes “…the willingness of individuals to cooperate and work together at all levels of society to achieve collective goals” (Jeannotte 2003). PCH is leading Government-wide work on social cohesion, having been tasked with exploring and assessing indicators that could serve as a proxy for social cohesion or social fracturing in Canada, such as inequality and support for diversity. Policy efforts to address social cohesion include a focus on the Digital Citizen to build resilience against online disinformation and Multicultural Programs to support initiatives aimed at addressing racism and discrimination. Statistics Canada has supported PCH in an initial review of social cohesion indicators and more intensive collaboration is expected to take place in 2020-2021.

What are the implications of populism for the measurement of well-being? To address this question, the focus must be placed less on measuring and monitoring populism and the political interests of individuals per se, but rather focus on the underlying economic and social conditions. While there are a range of economic ( e.g. , income, employment) and social cohesion ( e.g. , community vitality) indicators currently included in exiting well-being framework, the following advances could be made to further refine measures to address these issues:

• Measures to identify who is at risk: The fractious nature of populism further emphasizes the need to disaggregate measures and indicators of economic well-being ( e.g. , income, employment) to better identify population groups who may be “at-risk” of being left behind; these many be defined geographically, by industry or by individual characteristics ( e.g. , age, sex, ethnicity, immigration status).
• Measuring inequality: There is a need to emphasize measures of economic inequality ( e.g. , Gini coefficient) to better monitor disparities in addition to more traditional measures of economic well-being based on averages ( e.g. , average income).
• Measuring subjective economic well-being: The feeling of uncertainty and concerns about being left behind economically associated with populism provides further evidence of the need for subjective measures of economic well-being in addition to objective measures ( e.g. , unemployment rates, poverty rates).

On the social side, the following efforts could be undertaken to enhance existing measures of social cohesion:

• More frequently collected measures of social cohesion: Address data gaps and/or enhance current measures by developing modules of content that can be included in new web panel or planned omnibus collection platforms. These proposals are currently being developed as part of the work to modernize the GSS and would identify new combinations of questions that could be fielded as modules in a more timely way to address indicator needs as required.
• Ensuring adequate sample sizes: Increase sample sizes for surveys that focus on diversity topics so that characteristics and activities of ‘non-majority’ groups can be better analysed and so that data outputs can be disaggregated at a more detailed level than in the past. For example, PCH has purchased an oversample for the 2020 Social Identity Cycle of the GSS for this specific reason, and Indigenous Services Canada funded an additional sample on the 2019 Victimization Survey.
• Undertake in-depth analysis of social cohesion indicators currently available in Statistics Canada surveys , including the GSS and the Canadian Housing Survey (CHS) to inform the development of new measures moving forward.

The geographic scale at which well-being is measured, analyzed and applied in the policy process is another salient theme. As noted previously, local communities and regional governments continue to express interest in well-being indicator frameworks, as evidenced by recent projects undertaken in partnership with the Canadian Index of Well-being (CIW). Likewise, Whitby et al. (2014) underscore the receptivity of local communities to such initiatives, reporting that

The most prolific successes that we encountered were achieved by local level indicators, perhaps because the distance between producer and user of the indicators is much smaller…making it easier to achieve a better ‘fit’ while also achieving legitimacy and relevance. ( p.  16).

Similarly, community- and neighbourhood-level perspectives on well-being is evident in the SWB approach. Some recent Canadian publications along this line include Lu, Schellenberg and Hou (2015) and Helliwell, Shiplett and Barrington-Leigh (2018). Many of the factors that play an important role in subjective well-being, such as social supports, welcoming communities, trust, generosity and a healthy environment (Helliwell 2019b) play out at the local level, with important implications for data collection and measurement. The relationships between neighbourhood characteristics and the well-being of residents is also highly relevant to many areas of public policy, such as population health, housing, and urban planning.

Recent evidence from Statistics Canada, for example, reveal a strong connection between living in a walkable neighbourhood and physical activity among adults (Colley et al. 2019). Neighbourhood characteristics can also have a negative impact on well-being. Data from the General Social Survey (GSS) on Victimization show that Canadians who perceive one or more indicators of neighbourhood disorder are more likely to report being afraid when walking alone after dark, using or taking public transportation, or when home alone in the evenings and that Canadians who perceive disorder in their neighbourhoods also report lower average life satisfaction overall than those who do not (Cotter 2016).

The importance of the concept of community is further emphasized by national organizations such as the Canada Mortgage and Housing Corporation (2018) who have emphasized the importance that neighbourhoods play in addition to housing in Canada’s National Housing Strategy.

The demand for neighbourhood level information has implications for various activities at Statistics Canada, including data development, measurement development and validation, research, and access/dissemination:

• Using existing surveys to gather needed data by revising and adding questions, by fielding survey modules more quickly and frequently and by increasing sample sizes: for example, Statistics Canada is working on revisions to the 2020 CHS , including the addition of questions on trust, community belonging, and subjective definitions of ‘neighbourhoods.’ As well, the GSS is being modernized and, for existing survey cycles, GSS partners have provided funding to supplement sample sizes in order to obtain a more granular level of data: the 2020 GSS on Social Identity and the 2019 GSS on Victimization both include important questions on well-being and inclusion (some of which can be used to provide community indicators at the national and provincial level), and sample supplements recently funded by PCH and Indigenous Services Canada will improve the possibilities for analysis at the metropolitan area level.
• Understanding social ties at the local level: The Community Well-Being Survey was fielded by the CIW in Nova Scotia in 2019, yielding a sample of almost 13,000 Nova Scotians and a large set of ‘field-tested’ questions. A factor analysis identifying core elements of the social fabric at the local level would help guide measurement moving forward. Similar analysis could potentially be undertaken with data provided by the 2013 and 2020 GSS cycles on Social Identity.
• Understanding the relationships between neighbourhood characteristics and well-being: Statistics Canada is using pooled CCHS files data and a suite of neighbourhood-level variables from different sources to document the correlation between neighbourhood characteristics at the dissemination area (DA) level ( e.g. , proximity to transit and amenities, crime, household income, population density) and life satisfaction, net of individual characteristics. The sample includes 45,000 respondents, in 7,000 DA s, across 31 census metropolitan areas. This work will inform the identification of critical neighbourhood indicators that could be considered as part of a well-being framework.
• Using administrative data to create new measures at the neighbourhood level: Administrative data provide tremendous opportunity for creating new measures at the neighbourhood level. In general, these data offer national coverage and are available on a routine basis ( i.e. , monthly, annually). For example, existing administrative and census data were used to create measures of walkability (Colley et al. 2019). Tax and residential data are currently being used to create measures of income mixing.
• Measuring social ties at the local level: There is a need to strengthen Statistics Canada’s concepts and measures of social ties, supports and belonging at the local level. The questions currently used yield different results among some populations and are fielded inconsistently across surveys. An assessment of the strengths and weaknesses of survey questions would help guide measurement strategies moving forward building on work previously conducted by the Agency.

The United Nations ( n.d. ) refers to climate change as the “defining issue of our time and that we are at a defining moment”; and “the impacts of climate change are global in scope and unprecedented in scale.” Canadians from coast to coast to coast are increasingly concerned about the significant risks posed by climate change and have asked the government to respond accordingly. The climate crisis is having a direct impact on the economic, social and well-being of people in this country and on the integrity of our natural systems.

Substantial research activity has been devoted to understand, for example, how health outcomes are negatively influenced by environmental hazards such as air pollution (Burnett et al. 2018), forest fires (Henderson et al. 2011), and water pollution (Medeiros et al. 2017), as well as shaped by environmental benefits such as green space (Crouse et al. 2017) and proximity to water (Crouse et al. 2018). However, the environment is constantly in flux—global climate change and more localized human activities such as changes to land use and urban planning also influence health. For example, the unusual 2018 forest fires in British Columbia had detrimental effects on both the Canadian economy and the well-being of those who were directly affected by these events (Wang and Strong 2019). The 2019 Canada’s Changing Climate Report led by Environment and Climate Change Canada summarized these changes in the Canadian context, including changes to temperature patterns, rainfall, snow cover, climate extremes, freshwater availability, and sea level (Bush and Lemmen 2019).

Although there is a growing understanding on how the environment and our own well-being are interconnected, the full extent of this relationship merits further exploration. Exposures to environmental factors is not equal amongst all people in Canada—for example, air pollution is higher for immigrant and visible minority populations in urban areas (Pinault, van Donkelaar and Martin 2017). In addition to differences in exposures, susceptibility to environmental factors may also be unequal. For example, air pollution can have a greater health impact on diabetics (Pinault et al. 2018) or those experiencing stress (Thomson 2019). Access to services such as health care and social infrastructure are also unequally distributed within Canada (Shah, Bell and Wilson 2016). It is therefore of utmost importance to understand how these distinct elements translate to differences in health outcomes and indicators of well-being among Canadians, in the context of a changing environmental landscape.

A key initiative to help assess these impacts and measure progress has been the integration of multiple data sources from various partners. Over the past several years, Statistics Canada has been a leader in developing integrated datasets ( e.g. , Tjepkema et al. 2019). For example, these data have been used to examine the effects of exposure to long-term ambient air pollution and mortality (Christidis et al. 2019; Pappin et al. 2019). In the future, new environmental data can be integrated with Statistics Canada’s data holdings, including powerful analytical health cohorts that can be leveraged towards disentangling these differences in exposure, susceptibility, and health outcomes among environmental hazards or benefits, considered alone or in combination.

Canada has limited, fragmented and incomplete information on this complex issue to make informed evidence-based investments and policy decisions to protect Canadians and Canada’s natural resources assets. To advance well-being measurement on the environment and climate change, the following activities are recommended:

• Register of Ecosystem Assets that would establish and monitor the extent and condition of Canada’s ecosystems—such as wetlands, forests and flood plains—along with the services they provide—air filtration, water purification, flood protection, habitat conservation and carbon sequestration; and
• A complete suite of environmental accounts that link environmental information to the vast array of socio-economic data available in the System of National Accounts and elsewhere in the Canadian national statistical system.
• Environment and well-being: As is currently done for cultural and sports activities, the ESM app could be used to gather data on effects of nature and environment on people’s well-being. This has been a major use of the data from the Mappiness app in the U.K. (Williams 2017). New questions on the environment and well-being could be added to other data collection vehicles as well.
• Measures of environmental justice: Knowing that exposures to environmental factors are not equally distributed across all Canadians, new indicators of environmental justice are needed. The Census and health surveys can be attached to environmental exposures of air pollution, forest fire / smoke proximity, lack of greenness, and other measures to create descriptive statistics of differences in exposures among different population groups in Canada. Additionally, back-cast environmental data can be used to describe how exposures to hazards have changed over time. For example, these initiatives could determine if long-term reductions in traffic-related air pollution have affected all population groups equally. Continuing with existing research, longitudinal cohorts created through data integration such as the CanCHEC and the CCHS linked to Vital Statistics data (i.e, mortality) can be used to assess differences in susceptibility to these exposures among populations defined by chronic disease conditions and social parameters.

More and more, countries around the world are moving beyond simply measuring and monitoring towards integrating well-being measurement in the policy process, aligning government priorities and funding decisions to advance the well-being of their citizenry. As suggested in the ministerial mandate letters, the Government of Canada is invested in moving in this direction. Several key lessons from international experiences suggest the need for strong leadership within government to advance the well-being agenda; the use of a range of legislative and policy mechanisms such as mandatory reporting to support the integration of well-being frameworks in the policy process; and the need for governments to work hand-in-hand with national statistical organizations to advance well-being measurement.

In Canada, there have been significant gains made in the measurement of well-being with the development of several national and international multi-dimensional frameworks populated with a range of objective and subjective indicators. Advances in the study of subjective measures of well-being such a quality of life continue to deepen our understanding of what drives quality of life among people in this country.

Nevertheless, despite the advances that have been made to date, several gaps in well-being measurement have been identified given the current economic, social and environmental trends impacting the well-being of people in Canada. Several options are presented in this report to advance well-being measurement in areas such as the impacts of digitization, affordability and economic uncertainty, quality of work, social cohesion, neighbourhoods and climate change. A measured approach should be adopted, beginning with the use of existing data to conduct the necessary research and analysis to develop new measures informed by expert opinion and international experiences, and guided by quality standards. Administrative data and new data collection approaches should be leveraged to deliver indicators that are timely and sustainable, and enable the appropriate levels of disaggregation to highlight the diversity of experiences and realities among Canadians.

To support the use of well-being measures to advance an integrated policy approach that considers the social, environmental and economic goals and related interdependencies, the well-being measures themselves should be integrated. This can be achieved at various levels. As has been done with frameworks internationally, well-being indicators should be presented in an integrated and interactive tool that allows users to better understand the relationships within and across domains. Further integration can be achieved at the microdata level by advancing initiatives such as the expansion of the System of National Accounts framework to encompass elements of well-being and sustainability starting with the development of specialized ‘satellite accounts.’ A similar approach has been advocated for social statistics through the development of a social accounting framework (Hicks 2011). Data on a range of well-being domains can also be integrated at the individual level to better understand the relationships between various aspects of well-being; this approach is best suited to further advance studies of ‘umbrella measures’ of well-being such as quality of life to better understand what domains are most significant.

Moving forward, Statistics Canada stands prepared to collaborate with federal and other partners to develop a framework and new well-being indicators that reflects core Canadian values, addresses the diversity of experiences and regional realities, and supports government decision-making.

Gender Results Framework (Government of Canada)

Introduced in Budget 2018, the Gender Results Framework (GRF) (Status of Women Canada 2020) represents the Government of Canada’s vision for gender equality, highlighting the key issues that matter most. It is a whole-of government tool designed to track how Canada is currently performing; define what is needed to achieve greater equality and determine how progress will be measured going forward.

Under this framework, the federal government has identified six key areas where change is required to advance gender equality:

• Education and skills development
• Economic participation and prosperity
• Leadership and democratic participation
• Gender-based violence and access to justice
• Poverty reduction, health and well-being
• Gender equality around the world

Youth Policy (Government of Canada)

Canada’s first-ever youth policy (Government of Canada 2020) reflects the values and priorities of young Canadians, gives young people a voice in matters important to them, and creates more opportunities for young people to build a stronger and more inclusive Canada. Canada’s youth policy represents a whole-of-government approach aimed at improving youth outcomes and involving young people in federal decision-making.

The title of Figure B.1 is “Canada’s Youth Policy, youth identified priorities.”

Figure B.1 presents the six following priorities: “Leadership & Impact,” “Health & Wellness,” “Innovation, Skills & Learning,” “Employment,” “Truth & Reconciliation,” and “Environment & Climate Action.”

Each one of the priorities listed is shown a different colour. The background of the figure is white. The three first priorities listed appear on the top row and the three last, on the bottom row. The top and bottom rows are separated by a horizontal dotted grey line, and each priority is separated from the other ones by a vertical dotted grey line.

The source for Figure B.1 is as follows:

Source: Government of Canada, n.d. , Canada’s Youth Policy. Infographic.

Community Well-being Index—Indigenous Services Canada

Indigenous Services Canada is home to the Community Well-being (CWB) Index (Government of Canada 2019b), which was developed to help measure the quality of life of First Nations and Inuit communities in Canada relative to other communities and over time. This tool uses Statistics Canada's Census of Population data to produce 'well-being' scores for individual communities based on four indicators:

• Education (High School Plus; University);
• Labour Force (Participation, Employment);
• Income (Total per Capita); and,
• Housing (Quantity: defined on the basis of overcrowding; Quality: defined based on the need for major repairs).

Results are available in the publication Aboriginal Demographics and Well-Being (Aboriginal Affairs and Northern Development Canada 2013).

Veterans Well-being Act

Canada’s Veterans Well-being Act (2005) recognizes and fulfils the obligation of the people and Government of Canada to show just and due appreciation to members and veterans for their service to Canada. This obligation includes providing services, assistance and compensation to members and veterans who have been injured or have died as a result of military service and extends to their spouses or common-law partners or survivors and orphans. Topics covered by the Act include the following:

• Career Transition Services;
• Education and Training Benefits;
• Rehabilitation Services, Vocational Assistance and Financial Benefits;
• Critical Injury, Pain and Suffering, Death and Detention;
• Caregiver Recognition Benefits;
• Health and Retirement Benefits;
• Transition to Civilian Life.

Canadian Forces Well-being Framework (National Defence and Canadian Armed Forces, Veterans Affairs Canada)

The Department of National Defence and Canadian Forces has also developed a Well-being Framework (Government of Canada 2019c) which comprises a list of ‘Dos’ (as opposed to ‘Do Nots’) for transitioning from military to civilian life. The model of well-being adopted by the Canadian Armed Forces and Veterans Affairs Canada considers how a person is doing in seven domains:

• Employment or other main activity;
• Life skills and preparedness;
• Social integration;
• Housing/physical environment; and
• Cultural and social environment.

Canadian Index for Measuring Integration

The data-driven Canadian Index for Measuring Integration (CIMI) (2020) is used to inform policy, service and program delivery as it relates to immigrant integration in Canada. The CIMI assesses gaps in well-being between immigrants and the Canadian-born population by examining four dimensions of immigrant integration: (1) economic; (2) social; (3) civic and democratic participation; (4) health.

The key objective of the CIMI is to provide a credible framework for ongoing assessment of the state of immigrant integration in Canada. The CIMI as a measurement tool fills an existing knowledge gap by evaluating the performance of immigrants compared to the Canadian-born population. Changes and trends overtime—as of 1991—are assessed for all 10 provinces and 35 cities (census metropolitan areas) across the country.

The selection of indicators included in the CIMI is guided by both conceptual and methodological considerations based on a literature review and recommendations by an Expert Advisory Committee.  The CIMI is powered by the Association for Canadian Studies, the Canadian Institute for Identities and Migration and Immigration, Refugees and Citizenship Canada.

Canadian Index of Child and Youth Well-being

UNICEF’s Canadian Index of Child and Youth Well-being (UNICEF Canada 2019) was developed in 2013/2014 and is based on the organizations’ social accountability efforts, developed in collaboration with the Canadian Index of Wellbeing, a pan-Canadian Advisory Reference Group and children and youth themselves. The Index explicitly recognizes the following: children and youth have distinct needs from adults including education; deprivations in childhood such as food insecurity can have more severe and lasting impacts on children than on adults; and children experience life in Canada differently, even though they have the same human rights as adults—for instance, children report significantly lower life satisfaction than adults.

The Canadian Index of Child and Youth Well-being is organized around a vision of a Canada where:

• Every child has adequate food, water and shelter and opportunity. 
• Every child is—and feels—safe and secure.
• Every child is physically, mentally and spiritually healthy.
• Every child enjoys equitable opportunities.
• Every child feels happy and inspired.
• Every child has access to education that supports their full potential.
• Every child is free to play, laugh and wonder. 
• Every child is—and feels—free to dream. 
• Every child has a strong sense of who they are, where they come from and who they want to be.
• Every child feels heard and empowered.

The title of Figure C.1 is “Canadian Index of Child and Youth Well-being, UNICEF Canada and ONE youth.”

The background of Figure C.1 is white. On it there is a drawing representing the silhouette of a tree in light grey colour. There are eight indices on the end of the tree branches, and one index on the tree trunk, right before the branches fan out. Each of the nine indices is in a rectangle of a different colour. The names of the indices are shown in white.

Above each index is an icon representing it. The icons are outlined in the same colour as the background colour of the index they represent and the background of the icons is white. The icons are circular and delineated with a pale grey line.

The indices and their respective icons are as follows, starting with the index on the tree trunk and going to the left: “We are happy and respected” (front view of the upper-body of a child with raised arms; the only facial feature shown is its smiling mouth); “We are connected to our environment” (side view of a child sitting, with its right arm raised, flexed and resting on its knee; its right hand is holding a flower); “We are secure” (front view of the upper body of a child with its arms flexed over its chest, its hands closed with both thumbs up; the only facial feature shown is its smiling mouth); “We belong” (front view of the upper body of an adult and of a child, the adult is holding the child, the only facial feature of both the child and adult is their smiling mouth); “We are learning” (front view of upper body of a child above a horizontal line, representing the surface of a desk; the child has its left arm raised; the only shown facial feature of the child is its smiling face); “We are healthy” (side view of the upper body of a child in a running position, the only facial feature shown is its smiling mouth); “We are free to play” (side view of a child sitting on a swing and swinging; the only facial feature shown is its smiling mouth); “We are participating” (front view of upper bodies of three children of different ages, arms over each other’s shoulders; the child at the left has its right arm free raised, and the child at the right has its arm free and away from its body; the only facial feature shown is their smiling mouths); “We are protected” (side view of a child under a blanket, its head, left arm and shoulder showing; it is resting on its right forearm and the only facial feature shown is its smiling mouth).

The source for Figure C.1 is as follows:

Source: UNICEF Canada and ONE Youth, n.d. , Where Does Canada Stand? The Canadian Index of Child and Youth Well-being: 2019 Baseline Report.

Canadian Family Well-Being Index

The Vanier Institute of the Family (2020b) is working with researchers from diverse disciplines and backgrounds to develop the Canadian Family Well-Being Index, a multi-faceted measure of well-being that will provide unique insight into the many components of well-being through a family lens.

The Index builds upon established Canadian indices that measure various aspects of communities, including the experiences of Indigenous peoples, refugees, and children and youth in Canada. 

The development of the Index started in September 2019 and is continuing in 2020.

To ensure the overall quality of indicators, Guèvremont, Findlay and Cohen (2019) applied the Statistics Canada quality framework to guide the selection of early childhood criteria. Building on this work, the following criteria are based on the Statistics Canada Quality Assurance Framework—Statistical Outputs to guide the selection of well-being indicators (Statistics Canada 2017a):

• Relevance: Relevance is defined as the degree to which statistical information meets the real needs of users, including information on subjects that are important to them, and in a format and within a time frame that meets their needs. For example, if well-being measures are to be used as monitor and evaluate policies, they must sensitive to policy changes.
• Accuracy and reliability: Accuracy is defined as the degree to which the information correctly describes the phenomena it was designed to measure. A valid indicator is free from bias or systematic error. Reliability refers to the degree to which the statistical information is consistent over time in terms of both multiple measurements of the same phenomenon and a series of measurements over time. These are critical criteria, for example, in cases where well-being indicators will be tracked over time to measure change and progress.
• Timeliness: Timeliness is defined as the delay between the reference point (or the end of the reference period) to which the indicator pertains and the date on which the information becomes available. Timeliness is less of a concern for well-being indicators that change slowly overtime ( e.g. , life expectancy) but important for those measures that maybe more sensitive to changing events ( e.g. , employment rate).
• Accessibility and clarity: Accessibility is defined as the ease with which the indicator can be identified, obtained and used. This criteria also relates to the cost of obtaining or creating the indicator. Indicators derived from existing administrative data are less costly than indicators from survey data that require data collection. Clarity refers to the degree to which metadata and other information are provided so that users are able to locate and select products or services that correspond to their needs. These elements are critical in guiding the creation and dissemination of well-being measures.
• Coherence and comparability: Coherence is defined as the degree to which the indicator can be successfully brought together with other statistical information within a broad analytic framework over time. This dimension refers to the use of standard concepts, classifications, and target populations, which promote coherence. Comparability refers the extent to which differences over time or among sources can be attributed to changes in the true values of the statistics, and not to changes in definition or measurement. The use of standards to guide the disaggregation of well-being indicators will be critical to ensure the overall coherence and comparability of measures for example.

Statistics Canada has a long tradition of conducting surveys to collect the data needed to fulfill the Agency’s mandate to report on the country’s social, economic and environmental conditions. While surveys remain an important tool to collect the data we need, the Agency uses a range of approaches to collect and gather data to support the statistical programs. Many of the following methods may be relevant for the collection and creation of new well-being measures.

• Advances in survey-based data collection: Surveys are and will continue to be an important mode of data collection, particularly for subjective measures. Statistics Canada continues to advance the methodology and processes used for direct collection introducing different collection modes ( i.e. , online) and sampling approaches to improve timeliness and address issues related to respondent burden and lowering responses rates. Building on successes such as the Rapid Statistics program, the Agency is investigating and experimenting with new modes collection including the establishment of a new integrated data platform which will seek to unify data collection of similar content and/or target populations and support a range of collection options ( i.e. , probabilistic household panels, omnibus surveys). For example, probabilistic panels will be used recruit individuals willing to complete short surveys by electronic questionnaire and who could be contacted directly and cost-effectively by email or other leading-edge methods such as SMS or apps. These new advances will be critical in supporting the collection of subjective measures of well-being.
• Administrative data: Administrative data are information collected by government or private sector organizations as part of their ongoing operations ( e.g. , records of births and deaths, taxation records, immigration records). There are several advantages to using administrative data, including reduced respondent burden, timeliness, cost effective and coverage. To ensure that the data are fit for use, administrative data products are assessed against established quality criteria. Statistics Canada has a long history of repurposing data collected by other organizations and their use is guided by Statistics Canadas Policy on the Use of Administrative Data Obtained under the Statistics Act (Statistics Canada 2019b, 2016). Administrative data provide a cost-effective approach to generate new objective measures of well-being and given that they often represent a ‘census’ of events, can support the creation of disaggregated measures by either geography or population group.
• Data integration: Microdata linkage is an internationally recognized statistical method to integrate data by bringing together information about an entity from two or more sources to form a combined microdata file about that same entity ( i.e. , people, businesses). Statistics Canada routinely conducts microdata linkage to address data gaps, reduce respondent burden and create new data sources for indicator development and research. To support these activities, the Agency established the Social Data Linkage Environment (SDLE) to ensure that microdata linkages related to individuals are conducted using advanced statistical methods and in accordance with the Directive on Microdata Linkage to respect privacy and ensure confidentiality (Statistics Canada 2017b, c, d).
• Statistical modelling: Small area estimation is one example of the use of statistical modelling to address data gaps particularly to produce estimates for specified sub-populations or small areas when data do exist at that level or the sample size is so small that direct estimates are not reliable enough to be published. Examples of small areas include a geographical region ( e.g. , county, municipality, neighbourhood) or a small population group ( e.g. , ethnicity) or a population group within a geographic region (Hidiroglou, Beaumont and Yung 2019). These approaches could be considered to produce disaggregated estimates of well-being particularly where indicators are needed at lower levels of geography.
• Big data: Big data are defined as largely unstructured voluminous data generated as a result of regular monitoring or transactions. Statistics Canada has been using big data sources, including satellite images and scanner data, to estimate agriculture and economic measures currently estimated using direct collection methods ( e.g. , surveys). Big data sources, including those from social media, may be considered as potential sources to generate new experimental measures of well-being.

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Relationships to land as a determinant of wellness for Indigenous women, two-spirit, trans, and gender diverse people of reproductive age in Toronto, Canada

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• Danette Jubinville   ORCID: orcid.org/0000-0003-1861-4708 1 , 2 ,
• Janet Smylie 3 , 4 ,
• Sara Wolfe 5 ,
• Cheryllee Bourgeois 5 ,
• Nicole S. Berry 1 ,
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Disparities in Indigenous reproductive health reflect Canada’s historic and ongoing colonial relationship with Indigenous peoples, which includes persistent inequities in health and social services. Reproductive justice scholars and activists advocate for intersectional approaches to enhancing Indigenous health equity that recognize land as a central determinant of wellness. The purpose of this study is to examine the association between relationships to land and wellness in a study of urban Indigenous women, two-spirit, trans, and gender diverse people of reproductive age in Canada’s largest city, Toronto.

Data were obtained from the cross-sectional Our Health Counts (OHC) Toronto study, which employed respondent-driven sampling methods ( n = 323) and a community-directed comprehensive health assessment survey. In an exploratory analysis, we took an Indigenous reproductive justice theoretical approach to multivariable logistic regression.

After adjusting for covariates, there was a statistically significant positive association between relationships to the land and wellness that was estimated with good precision (OR 3.7, 95% CI 2.5–5.3).

Our findings indicate that among urban Indigenous women, two-spirit, trans, and gender diverse people of reproductive age there is a positive association between feeling strong in their relationships to land and feeling balanced in the four domains of health (physical, spiritual, mental, and emotional). The community-based, community-directed design of OHC Toronto was congruent with a reproductive justice approach to research. Reproductive justice theories are adaptable to quantitative research on Indigenous reproductive health and can yield novel insights for supporting Indigenous wellness.

Les disparités que connaissent les peuples autochtones sur le plan de la santé reproductive sont le reflet des relations coloniales historiques et continues du Canada avec ces peuples, encore entachées d’iniquités dans les domaines de la santé et des services sociaux. Théoricien·nes et militant·es de la justice reproductive préconisent des approches intersectionnelles pour améliorer l’équité en santé chez les peuples autochtones, approches qui reconnaissent le territoire comme un déterminant central du bien-être. Nous avons voulu examiner l’association entre les relations avec le territoire et le bien-être dans une étude menée auprès de femmes et de personnes autochtones bispirituelles, trans et de diverses identités de genre en âge de procréer vivant à Toronto, la plus grande ville du Canada.

Nos données proviennent de l’étude transversale Our Health Counts (OHC) Toronto, qui a employé des méthodes d’échantillonnage en fonction des répondant·es ( n = 323) et une enquête d’évaluation globale de la santé dirigée par la communauté. Dans une analyse exploratoire, nous avons employé la régression logistique multivariée selon une approche théorique de justice reproductive autochtone.

Après l’apport d’ajustements pour tenir compte des covariables, nous avons observé une association positive significative entre les relations avec le territoire et le bien-être, que nous avons estimée avec une bonne précision (RC 3,7, IC de 95 % 2,5–5,3).

D’après nos constatations, il y a chez les femmes et les personnes autochtones bispirituelles, trans et de diverses identités de genre en âge de procréer vivant en milieu urbain une association positive entre un fort sentiment d’appartenance au territoire et un sentiment d’équilibre entre les quatre domaines de la santé (physique, spirituel, mental et émotionnel). L’étude OHC Toronto ayant été conçue par et pour la communauté, elle est conforme à une approche de recherche axée sur la justice reproductive. Les théories de la justice reproductive peuvent être adaptées à la recherche quantitative sur la santé reproductive autochtone, et elles peuvent jeter un nouvel éclairage sur les moyens d’appuyer le bien-être des personnes autochtones.

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Introduction

Reproductive well-being—which the World Health Organization (World Health Organization, 2019 ) defines as “a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity, in all matters relating to the reproductive system and to its functions and processes”—is essential to overall health in any society. In Canada, Indigenous (First Nations, Inuit, and Métis) people face intersecting inequities across determinants of health commonly associated with reproductive health, such as gendered violence and access to reproductive, sexual, and maternal healthcare (Nelson, 2017 ; Yee et al., 2011 ). Indigenous reproductive health inequities stem from colonial policies and processes designed to eliminate Indigenous people and gain access to Indigenous lands and resources (Gurr, 2015 ; Smith, 2005 ; Wolfe, 2006 ). Childbearing Indigenous people have endured state processes that specifically endangered Indigenous reproduction, such as the outlawing of Indigenous midwifery, child apprehension, routine evacuation for childbirth, coercive sterilization, and abusive abortions (Stote, 2015 ). Indigenous feminist scholars contend that colonial systems have targeted women and childbearing people because they hold representational significance as the ones who birth and raise Indigenous nations (Anderson, 2004 ; Million, 2013 ; Stote, 2015 ).

To address systemic inequities that impact Indigenous reproductive well-being, scholars and activists have been engaging the theoretical lens of reproductive justice since it was first introduced by Black feminists in 1994 (Ross and Solinger, 2017 ). Reproductive justice theorists take an intersectional, social justice–oriented approach to reproductive health equity, affirming the right of childbearing people to have (or not have) children, to maintain bodily autonomy, to gender and sexual freedom, and to parent children in safe and sustainable communities (Ross and Solinger, 2017 ). While not all Indigenous women, two-spirit, trans, and gender diverse people can, will, or want to have children, these groups have unique and specific reproductive health needs, and are disproportionately negatively impacted when these needs go unmet. By centring the knowledge and experiences of Indigenous childbearing people, Indigenous reproductive justice theories reveal the gendered, racialized, and sexualized nature of colonialism, and underscore the importance of Indigenous self-determination, land, and culture to reproductive well-being (Gurr, 2015 ).

Reproductive justice research has shown how Indigenous peoples’ relationships to land have resulted in disproportionate risks of reproductive harm, in particular through exploring the impacts of resource extraction and other pollution-producing projects on fetal development, breast/chestfeeding, birth rates, and gender-based violence in Indigenous communities (Hoover et al., 2012 ; Smith, 2005 ; Wiebe, 2016 ). Gendered colonial policies such as the Indian Act, residential schools, and child welfare systems deliberately undermined the relationships of Indigenous women, two-spirit, gender diverse, and LGBTQQI people to land (Million, 2013 ). Threats to the land uniquely impact childbearing people: degradation of ecosystems poses heightened health risks for childbearing people and infants, and development and resource extraction projects create known risks of gendered violence for Indigenous communities (Smith, 2005 ).

Land is particularly important to Indigenous reproductive justice because land is a foundational determinant of Indigenous health. Richmond ( 2015 , p. 58) writes: “The relationship between First Nations peoples and the land is a multifaceted one, and formative for countless social determinants of health, including social relationships, spirituality, and access to foods and medicines.” Relationships with land enhance Indigenous wellness through facilitating cultural connection, positive identity formation, and health-promoting land-based lifeways, such as traditional food and medicine gathering (Parlee et al., 2005 ). Given the many barriers Indigenous childbearing people face to achieving well-being in a colonial context, scholars and activists theorize relationships to land as crucial to reproductive justice (Danforth, 2010 ; Wiebe, 2016 ).

Despite what is known about the significance of land to Indigenous health, very little quantitative research explores the connection between relationships to land and wellness among the childbearing population. This is particularly true for urban centres. The majority of Indigenous people in Canada live in cities (Statistics Canada, 2017 ), which are located on Indigenous lands. Without quantitative data to influence health policy and practice by demonstrating the significance of land to the wellness of Indigenous childbearing people, research gaps in this area create potential barriers to Indigenous reproductive justice.

The purpose of this paper is to examine whether relationships to land are associated with wellness in a sample of urban Indigenous women, two-spirit, trans, and gender diverse people of reproductive age (aged 15–44) living in Toronto, Ontario. This research question was determined through a community-based research partnership with two Indigenous-led organizations, the Seventh Generation Midwives Toronto (SGMT) and the Well Living House Action Research Centre for Indigenous Infant, Child and Family Health and Well-Being (WLH), which is based at St. Michael’s Hospital (SMH), Unity Health Toronto. Data came from Our Health Counts (OHC) Toronto, an urban Indigenous population health study led by SGMT and WLH. In an exploratory effort, this secondary analysis took an Indigenous reproductive justice theoretical approach to multivariable regression. Regression modelling was chosen for its compatibility with the OHC Toronto data collection method, respondent-driven sampling (RDS).

Our Health Counts Toronto

Located in the traditional territories of the Mississaugas of the Credit, the Anishnabeg, the Chippewa, the Haudenosaunee, and the Wendat peoples, Toronto is Canada’s largest metropolis. Approximately 55,000 First Nations, Inuit, and Métis people from diverse nations live in the census metropolitan area (Rotondi et al., 2017 ). As in other Canadian cities, limitations with national statistics have resulted in significant data gaps concerning the health of urban Indigenous people in Toronto (Rotondi et al., 2017 ). These data gaps have impacted the quality and availability of services that promote reproductive well-being for urban Indigenous peoples.

To develop a comprehensive health database by and for Indigenous peoples living in the City of Toronto, the OHC Toronto study was conducted by WLH and SGMT between 2014 and 2018. Indigenous values, data sovereignty principles of Ownership, Control, Access, and Possession (OCAP©), and SGMT ownership and control of data holdings are embedded in a research, publication, and data-sharing agreement between SGMT and the WLH. The community-partnered, community-directed governance structure of OHC Toronto includes an Advisory Council of Indigenous Grandparents as well as collaborative involvement of over 20 Indigenous and allied service providers who co-developed the survey. SGMT acts as the data custodian, responsible for ownership and control of data holdings.

OHC Toronto was given ethics approval by the SMH Research Ethics Board (REB# 14-083c). As a secondary analysis, this offshoot study was conducted through a community-based research partnership governed by the OHC Toronto Data Use Protocol Agreement. This study was also given ethical approval by the Office of Research Ethics at Simon Fraser University (REB# 2018s0180).

Reproductive justice approach

OHC Toronto partners and collaborators identified reproductive health as a research priority, given the importance of reproductive health measures to overall population health (Wolfe et al., 2018 ). Survey data showed that the fertility rate for Indigenous people of reproductive age is 2.12 children, compared to 1.51 per woman living in Ontario (Wolfe et al., 2018 ). Based on OHC Toronto’s population size estimate, approximately 1036–1408 children are expected to be born to Indigenous women, two-spirit, trans, and gender diverse people per year in the City of Toronto (Wolfe et al., 2018 ). While there is demonstrated need for reproductive health services, 27% of Indigenous adults in Toronto believe reproductive health services are inadequate (Wolfe et al., 2018 ).

This study arises from a community-based research partnership between WLH, SGMT, and co-author Jubinville, a Cree/Saulteaux/Jewish/European woman who is a Vancouver-based graduate student, mother, and doula. These partners share a vision for enhancing equity in reproductive health services for Indigenous peoples, and this vision was brought forward into our study approach. Given the lack of studies that apply an Indigenous reproductive justice theoretical lens to statistical analyses, our efforts to do so are exploratory and rely on several methodological choices modelled after common practices in the existing literature (see Hoover et al., 2012 ; Gurr, 2015 ; Wiebe, 2016 ).

The methodological choices that form the basis of our reproductive justice approach include the following: (1) research is conducted through a community-led research partnership; (2) research is contextualized and analyzed drawing on Indigenous and intersectional feminist perspectives on reproductive justice; (3) researchers offer a positionality statement; (4) research draws on Indigenous knowledge for understanding reproductive health; (5) research methods seek to be inclusive and gender-affirming; (6) strengths-based, community-led solutions are highlighted where possible; and (7) the purpose of the research is to advance Indigenous peoples’ goals for reproductive justice. We expand below on how these choices informed our statistical model.

OHC sampling strategy

Indigenous community surveyors who received specialized training in cultural safety and sensitivity collected OHC Toronto’s baseline health data between April 13, 2015 and March 31, 2016, using respondent-driven sampling. RDS aims to capture hard-to-reach populations by tapping into social networks, similar to chain referral sampling (Heckathorn, 1997 ). The initial sample included 916 adults aged 15+ who self-identified as Indigenous (First Nations, Inuit, and/or Métis) and lived or accessed health and/or social services in the City of Toronto. This included the exception of one non-Indigenous respondent who had Indigenous children. Sampling for OHC Toronto was reported previously (Rotondi et al., 2017 ).

Indigenous reproductive health sample

Following other OHC Toronto reproductive health analyses (Wolfe et al., 2018 ), the selection criteria for our sample included those who: (1) participated in the OHC Toronto Adult Survey; (2) identified as a woman, trans, or gender diverse person (this included people who further identified as two-spirit, which was asked as a separate question); and (3) were aged between 15 and 44 inclusive at the time of the survey ( n = 323). All OHC Toronto Adult Survey participants who identified as men or were over the age of 45 were excluded.

Directed acyclic graph

Directed acyclic graphs (DAGs) are commonly used in health research when estimating causal effects (Tennant et al., 2021 ). DAGs help researchers to identify which variables require conditioning for control of confounding, while also providing “a simple and transparent way for observational data scientists to identify and demonstrate their knowledge, theories and assumptions about the causal relationships between variables” (Tennant et al., 2021 , p. 622). Our DAG (Figure 1 ) was designed by Jubinville and reflects two main sources of subject matter knowledge: first, the knowledge, theories, and assumptions gleaned from the reproductive justice and Indigenous feminist literature; second, Jubinville’s background causal knowledge stemming from her own experiences as an urban Indigenous woman and birthworker as well as conversations with the OHC Toronto community partners and collaborators.

Directed acyclic graph (DAG) of effect of relationship to land on wellness

By following the graphical rules for completing a DAG (Greenland and Robins, 1999 ), we identified 19 covariates that required conditioning for control of confounding in the association between our exposure variable “relationship to land” and the outcome “wellness.” Fifteen covariates were measured using data from the OHC Toronto survey and two were unmeasured: “environmental contamination” and “Indigenous governance.” Two covariates (“colonialism” and “capitalism”) were not included in the model but were considered controlled for as everyone in the target population was assumed to have the same value for these macro variables.

For analysis purposes, the outcome variable “wellness” was recoded as a binary variable, with one category representing those who reported feeling balanced in their physical, emotional, mental, and spiritual health all or most of the time. This construct of wellness was determined through OHC Toronto’s community-partnered survey development and reflects the holistic concept of balance between the four domains of health, often expressed in Indigenous health spaces through referencing the Medicine Wheel (Quinless, 2022 ).

The exposure variable, “relationship to land,” was also recoded into a dichotomous variable, with one category representing those who reported feeling strong in their relationship to the land all or most of the time. To enhance power and precision in the model, data for measuring covariates were collapsed into dichotomous categories, with the exception of the continuous variable, age. (For variable definitions, see Tables 1 - 2 in Supplementary Material .)

Statistical analysis

Logistic regression modelling within the potential outcomes framework of causal modeling was used to estimate the total causal effect of relationships to land on wellness. The GLIMMIX procedure in SAS® V.9.4 was used to estimate weighted and adjusted associations between measurements, following conclusions of previous OHC studies that tested various modelling approaches (Beckett et al., 2018 ; Kitching et al., 2019 ). Models were weighted to account for unequal probability of sampling due to variability in individual network size, as reported previously (Beckett et al., 2018 ).

Odds ratios (ORs) and 95% confidence intervals (CIs) were generated for the total effect of relationship to land on wellness. Statistical significance was judged at alpha=0.05 (two-sided). Data were missing from 8 variables; these 15 missing cases were handled by case deletion ( n = 308).

Table 1 shows the distribution of variables by wellness. Table 2 shows that after adjusting for all 15 measured covariates there was a statistically significant positive association between wellness and relationship to land that was estimated with good precision (OR 3.7, 95% CI 2.5–5.3).

This study hypothesized that relationships to land would have a positive association with wellness. After adjusting for covariates, we found a statistically significant and meaningful effect (3.7, 95% CI 2.5–5.3). Our findings indicate that among urban Indigenous women, two-spirit, trans, and gender diverse people of reproductive age there is a positive association between feeling strong in their relationships to land and feeling balanced in their physical, spiritual, mental, and emotional health. Reproductive justice theorists argue relationships to land are foundational to the wellness of childbearing Indigenous people; these findings add quantitative evidence to support this argument.

Advancing reproductive justice for Indigenous peoples requires mobilization around relational, land-based concepts of wellness and care in reproductive health services. Indigenous models of reproductive care, such as Indigenous midwifery, affirm the importance of land to the wellness of childbearing people through honouring language, traditional medicines, oral traditions, ceremonies, kinship, and Indigenous values in service delivery (National Aboriginal Council of Midwives, 2016 ). The findings of OHC Toronto confirm the success of midwifery services for the urban Indigenous population of Toronto; 32% of Indigenous people used a midwife as their prenatal care provider, compared to 8% of women in the Toronto Central Local Health Integration Network (Wolfe et al., 2018 ).

Reproductive events such as birth, menarche, pregnancy, postpartum, menopause, and death are significant opportunities for engaging cultural practices that strengthen relationships to land. Historically, Indigenous birthworkers tended to these transitions as rites of passage through providing land-based medical and spiritual care, but today are constrained by jurisdictional issues, health policies, educational barriers, and funding challenges (National Aboriginal Council of Midwives, 2016 ). The Indigenous-led movement for “Birth on Country” in urban and rural areas of Australia highlights the need for increased access to Indigenous birthworkers, alongside other strategies that strengthen birthers’ and infants’ relationships to land, such as birthing close to home, extended family support, and placenta ceremonies (Marriott et al., 2019 ).

This study fits within a growing body of literature related to Indigenous reproductive justice. Indigenous reproductive justice research calls for transformation to health policies and services to reflect Indigenous intersectional, decolonial, and socioecological philosophies on health and wellness. In addition to culturally relevant and culturally safe reproductive health services, this transformation may include broader implementation of the United Nations Declaration on the Rights of Indigenous Peoples and the calls to action from the National Inquiry into Missing and Murdered Indigenous Women and Girls. Enacting the principles of reproductive justice may also include reform to policies and practices that are known to cause harm to Indigenous people and disrupt Indigenous relationships to land, such as the routine evacuation of pregnant Indigenous women from rural and remote communities, child apprehensions, resource extraction, and other development projects that put the environment at risk.

Strengths and limitations

A strength of this study was the community-based partnership with OHC Toronto, which gathered comprehensive population-level demographic, health status, and health service use information for Indigenous peoples in Toronto through exercising principles of OCAP®. Particular strengths of OHC Toronto were the community-partnered survey design and sampling strategy, which engaged Indigenous subpopulations that have historically been marginalized in national statistics, such as two-spirit, trans, and gender diverse Indigenous people. The community-directed, Indigenous-led nature of OHC Toronto resulted in an ideal dataset for exploring the possibility of approaching logistic regression through the lens of reproductive justice.

The inclusive survey design of OHC Toronto offered participants multiple categories for self-identification of Indigenous heritage, gender, and sexuality. While this was a strength of the study, low sample sizes of trans and gender diverse participants precluded the possibility of disaggregating data without compromising participant safety and confidentiality. Kitching et al. ( 2019 ) note that the RDS design of OHC Toronto may have also undersampled Métis and Inuit subpopulations. Because the experiences and perspectives of historically marginalized community members are critical to Indigenous reproductive justice, future studies could consider oversampling these populations or using mixed methods to enrich the data.

The exposure and outcome variables in this study (relationship to land and wellness) relied on self-reports. While self-reported measures respect the autonomy of individuals in determining their own health status, the data may be subject to recall error. Attempts to reduce recall error were made through community-based survey development and the appointment of Indigenous community surveyors with cultural safety and sensitivity training. This study was also limited by the cross-sectional nature of the data because we could not discount that part of the association we observed was due to the reverse effect of wellness on relationship to land. Future studies could better observe dynamic concepts such as wellness and relationship to land through a longitudinal design.

In this study, the outcome variable “wellness” was constructed based on a holistic concept of health and determined through OHC Toronto’s community-partnered survey development. Whether or not this construct of wellness resonates for all OHC Toronto participants is beyond the scope of this paper. As Indigenous health research trends towards locally grounded, Nation-specific knowledge and concepts, researchers must collaborate with communities to determine which constructs of wellness are valid within their own knowledge systems and how best to measure them.

Reliance on secondary data created inherent limitations with missing or imperfectly constructed data for concepts in our DAG. Considering that this study was designed after OHC data collection was complete, it is a testament to the success of the community survey design that data were available to measure most variables prescribed by our DAG. Of 19 covariates required to control for confounding, only two could not be included in our model: “environmental contamination” and “Indigenous governance.” Confounding was partially addressed by controlling for mediators between missing covariates and “relationship to land” and “wellness.” Nonetheless, missing data and potential construct invalidity may have led to some residual confounding in the model. This potential confounding, if present, would most likely lead to a bias away from the null.

We used a DAG to illustrate our way of thinking about the causal relationships that confound the association between relationships to land and wellness. Too often, assumptions made by quantitative researchers lack transparency and/or reflect colonial worldviews (Walter and Andersen, 2013 ). We aimed to avoid these pitfalls by making our concept of reality explicit through the use of a DAG. It is possible that other researchers might generate a different DAG for the effect of relationship to land on wellness based on their own subject matter knowledge (Hernán et al., 2002 ).

By using a DAG, we were able to extend our Indigenous reproductive justice theoretical approach into our statistical model. Graphical rules about how to complete the DAG resulted in a complex map of covariates that confound the causal connection between relationships to land and wellness. Data collected using RDS methods require large sample size due to large design effects, and the high number of covariates exacerbated existing challenges with power and precision in our model. Researchers interested in engaging these methods should note the requirement for large sample sizes. We also note that RDS methodological development is ongoing. While we used weighted models for this study, emerging evidence suggests that unweighted models may be appropriate for RDS regression analyses (Avery et al., 2019 ).

The community-partnered, community-directed methodology of OHC Toronto facilitated a strengths-based exploration of the association between relationships to land and wellness among urban Indigenous childbearing people and was congruent with a reproductive justice approach. Reproductive justice research emphasizes the ways in which Indigenous people and lands are intimately connected, and how policies and practices that disregard Indigenous peoples’ knowledge and agency over their own bodies and their own lands create reproductive harms that span generations. The findings of this study reflect community and research understandings that relationships to land are not only a risk factor for illness, they are also important to wellness.

This study adds quantitative evidence to the growing field of Indigenous reproductive justice research, which calls for investments into reproductive health services that strengthen Indigenous relationships to land, such as Indigenous midwifery care, and which troubles policies and practices that diminish Indigenous relationships to land, such as resource extraction, for being harmful to reproductive well-being. The exploratory design of this study found that reproductive justice theories were adaptable to quantitative research focused on Indigenous reproductive health equity.

Contributions to knowledge

What does this study add to existing knowledge?

Our exploratory study took an Indigenous reproductive justice theoretical approach to secondary statistical analysis.

Our reproductive justice approach relied on several methodological choices aimed at centring Indigenous knowledge and community perspectives. This approach is extended to our statistical model, as illustrated by a directed acyclic graph (DAG).

We found a statistically significant and positive association between relationships to land and self-reported wellness among urban Indigenous women, two-spirit, trans, and gender diverse people of reproductive age (15-44).

Our findings add to academic and community understandings of land as a foundational determinant of Indigenous reproductive well-being.

What are the key implications for public health interventions, practice or policy?

Our findings suggest that policies, practices, and interventions aimed at strengthening Indigenous relationships to land could have a positive impact on the health and well-being for urban Indigenous women, two-spirit, trans, and gender diverse people of childbearing age.

In light of our findings, relational, land-based models of health and care can be seen as a best practice for enhancing Indigenous reproductive health services. Indigenous birthworkers, such as midwives and doulas, advance Indigenous reproductive justice and wellness by promoting connections to land through incorporating language, traditional foods and medicines, ceremonies, and Indigenous values into their services for childbearing people.

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Availability of data and material

Data were accessed with the permission of the Seventh Generation Midwives Toronto and the Well Living House through an OHC Toronto Data Use Protocol Agreement, in alignment with the principles of OCAP®.

Code availability

The GLIMMIX procedure in SAS® V.9.4 was used to estimate associations between measurements. Participants were weighted using the RDS-II estimator.

The Our Health Counts Toronto project was funded by a Canadian Institutes of Health Research (CIHR) Operating Grant. This offshoot study was supported by a Canadian Institutes of Health Research (CIHR) Graduate Scholarship (CGS-M), Simon Fraser University, the Irving K. Barber Scholarship Society and the Indigenous Mentorship Network of the Pacific Northwest.

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Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada

Danette Jubinville, Nicole S. Berry & Scott Venners

Ekw’í7tl Indigenous Doula Collective, Vancouver, British Columbia, Canada

Danette Jubinville

Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Toronto, Ontario, Canada

Janet Smylie & Kristen O’Brien

Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada

Janet Smylie

Seventh Generation Midwives Toronto, Toronto, Ontario, Canada

Sara Wolfe & Cheryllee Bourgeois

School of Kinesiology and Health Science, York University, Toronto, Ontario, Canada

Michael Rotondi

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Contributions

All authors contributed to the study conception and design. Data collection was performed by the Our Health Counts Toronto study. Material preparation and analysis were performed by Danette Jubinville and Scott Venners. The first draft of the manuscript was written by Danette Jubinville and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Correspondence to Danette Jubinville .

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The authors declare no competing interests.

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The Our Health Counts Toronto study received ethical approval from the St. Michael’s Hospital Research Ethics Board (REB# 14-083c) as well as the Well Living House Counsel of Grandparents and community partner Seven Generations Midwives Toronto. As a secondary analysis, this offshoot study adheres to the OHC Toronto Data Use Protocol Agreement. These Our Health Counts Toronto data governance processes are aligned with the research principles of Ownership, Control, Access, and Possession (OCAP®) for Indigenous data sovereignty (OCAP® is a registered trademark of the First Nations Information Governance Centre). This study was also given ethical approval by the Office of Research Ethics at Simon Fraser University (REB# 2018s0180).

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This study uses secondary data collected for the Our Health Counts Toronto project, which obtained informed consent from all individual participants included in the study.

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Jubinville, D., Smylie, J., Wolfe, S. et al. Relationships to land as a determinant of wellness for Indigenous women, two-spirit, trans, and gender diverse people of reproductive age in Toronto, Canada. Can J Public Health (2022). https://doi.org/10.17269/s41997-022-00678-w

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Health Canada: Compilation of research abstracts 2020-2021

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Organization: Health Canada

Published: 2022-05-16

Introduction

This document encompasses in-house research including contracted social, physical and natural science activities toward generation of new knowledge conducted within Health Canada in 2020-2021. In this context, research is defined as:

" the systematic investigative process of inquiry, including development, testing and analysis, carried out in pursuance of the departmental mandate, in order to discover, interpret or analyse facts, events or behaviours, to develop and revise theories, or to make practical applications with the help of such facts, laws or theories designed to develop or contribute to knowledge. " Footnote  1

Such research includes:

• methods development,
• adaptation of methods should they be publishable and thereby making a contribution to scientific knowledge,
• monitoring, surveillance and testing to inform risk assessments and risk management options, or to characterise a situation and establish trends,
• clinical research,
• epidemiological studies, and
• new methods for data analysis, including non-laboratory based methods such as algorithms and data mining.

The importance of research within Health Canada cannot be overstated: the various projects, collaborations, and expertise pursued by the Department demonstrate its commitment to protecting the health and safety of Canadians.

This document should be viewed as a reference tool, a summary of many of the research projects being undertaken in the Department. Developed to support Branch and Departmental programs and in particular research, risk assessment, management and policy communities, it has the potential to support broader collaboration and partnerships in addition to supporting the exchange and/or uptake of information to assist evidence-based decision making and policy objectives.

Attempts have been made to provide each project summary in non-technical language, and to include a short description of how the research relates to Health Canada's mandate. For ease of reference, the work has been grouped by theme.

A test system for the exposure of lung cells to microplastics under conditions that model real-life human exposures

Acute and chronic health effects of ambient pm2.5 oxidative potential, adverse birth outcomes and childhood diseases of ambient pm2.5 oxidative potential and pm2.5 components, aerosol sars-cov-2 in hospitals and long-term care homes during the covid-19 pandemic, air health trend indicator (ahti): development and updates, an online survey on kitchen ventilation in canadian homes, analyses of non-linear concentration-response functions for short term exposure to air, aqhi updates by expanding temporal and spatial coverages, association between air pollution and covid-19 dynamics in canada, associations between blood volatile organic compounds, and changes in hematologic and biochemical profiles, in a population-based study, calgary spatial and temporal exposure modelling (cstem) study, canadian atlantic marine air pollution study (camaps), canepic study - canadian environment, pregnancy, infant and child study, chronic disease and air pollution: disease trajectory and intervention (route) study, commuter air pollution intervention study, effect modifiers of the associations between traffic exposure and cardiovascular, respiratory and neurological disease-related mortality in a long-term canadian cohort (aaphi), hybrid exposure models to predict spatially and temporally resolved air pollution concentrations at local and national scales, ice arena air quality project, impact of temporal variation of industrial emissions of air pollutants on asthma incidence in children of quebec - an approach to accountability study, indoor air quality and the effects on children's respiratory health in first nations reserves in the sioux lookout zone, integrated urban models (ium) project, interaction between gene variants and air pollution in aqhi panel studies participants, joint effects of exposure to aeroallergens and outdoor air pollution in the urban environment, longitudinal effects of air pollution, aeroallergens and urban environment features in the toronto child health evaluation questionnaire (tcheq) cohort, long-term exposure to ambient air pollution and effects on cardiovascular, respiratory and neurological health in an older population: the canadian longitudinal study on aging, maple: the microplastics air pollution laboratory and exposure project: developing methods to detect, quantify, and characterize airborne microplastics, mobilizing changes in air quality during the covid-19 shutdown as a guide for future sustainable development, new homes air quality study, quebec air pollution exposure and epidemiology study (qapee), short and intermediate-term exposures to ambient air pollution from biomass burning and changes in retinal microvascular responses in children, spatial modelling to support health studies, subway air quality investigation (saqi), the air quality benefits assessment tool (aqbat) - update, the association between air pollution and covid-19 related mortality in santiago, chile: a daily time series analysis, the association between air pollution and hospitalization for patients with systemic lupus erythematosus in chile: a daily time series analysis, the association between air pollution and the degree of difficulty controlling sleep disordered breathing by positive airway pressure therapy (ottawa hospital research institute), the association between pregnancy exposure to air pollution and autism in children, the covid-19 pandemic and air pollution effect (covid-air) study, the role of stress and stress reactivity in mediating impacts of air pollutants on the brain and lungs, time-dependent vulnerability to air pollution in a pregnancy cohort (mirec), trainyard neighbourhood air quality study (tynaq), international interlaboratory study on cannabis oil, rapid identification of visible foreign matter by ftir spectroscopy, validation of a rapid method for the enumeration of microorganisms in dried cannabis, a qualitative and quantitative evaluation report on the alberta real time surveillance system network (artssn), building sustainable health systems: focus on climate resilience (1), building sustainable health systems: focus on climate resilience (2), cantemp: national temperature-related excess mortality and morbidity estimates, climate change and heat vulnerabilities of canadian workers: focus on central and western provinces of canada, economic analysis of climate change impacts on health and on the health system: an overview.

• Establishing evidence-based indoor temperature thresholds to protect health.

Extreme weather and climate change: population health and health system

Greening for growth: an economic estimate of the health benefits of exposure to green spaces.

• Health of Canadians in a changing climate: Advancing our knowledge for action 2021.

HealthADAPT lessons learned research initiative

• Improving the identification of heat associated deaths in Canada: Estimating the effectiveness of medical attendance at the place of death and implications for Heat Alert and Response Systems (HARS) (Health Canada - British Columbia Centre for Disease Control MOA, 2019-21)

Investigation of the conditions for thermally comfortable playgrounds in Canada

Potential impacts of climate change on human health risk assessments of contaminated sites in canada (march 2021), urban trees and human health outcomes: a scoping review, deet usage study, dermal absorption of flame retardants in a survey of consumer products, development of a high throughput chamber test method for the determination of semi-volatile organic compounds from consumer products, development of methodology for home dust microbiome analysis towards canadian exposure assessments of biotechnology microbes, development of methods for identification and hazard assessment of biotechnology-related microorganisms: assessment of virulence of opportunistic human pathogens in microbial mixtures, development of pathogenicity test methods for assessing the hazard of microorganisms used in biotechnology, environmental concentration of veterinary and human drug substances in surface water, identification of unknown substances in e-cigarette refill fluids and vapors, in vitro toxicity screening of nanoforms of zinc oxide, increases in exposure calls related to selected cleaners and disinfectants at the onset of the covid-19 pandemic: data from canadian poison centres, portable automated biosensing of potential dual-use biological threats to critical water systems (drdc-cssp), addition of benzodiazepines to opioid identification method by ultra performance liquid chromatography coupled with quadrupole time of flight high resolution mass spectrometry (uplc-qtof hr ms e ).

• Collaborative harm reduction initiative between Health Canada and British Columbia Centre on Substance Use for accurate community based drug checking

d,l-Methamphetamine survey in looking for synthesis route specific information

Identification and quantitation of cocaine, heroin, methamphetamine, and mdma by ultra performance liquid chromatography (uplc) triple quadrupole mass spectrometry, impact of filtering pharmaceutical opiates as a replacement for street opioids during covid, metformin environmental fate and effects study.

• qNMR multicomponent identification and quantification of street drugs presented.

Method development and validation of vitamin K (K1 and K2 subtype MK4) in retail foods to support the Canadian nutrient file

An integrated testing strategy to assess somatic and germ cell mutations using the oecd's transgenic rodent test guideline tg 488 and the mutamouse model, assessment of the carcinogenic potential of cmp-chemicals through the application and investigation of the syrian hamster embryo cell transformation assay (she-cta), assessment of the performance and predictiveness of an optimized in vitro developmental neurotoxicity assay using proven developmental neurotoxicants and negative controls, associations among urinary triclosan and bisphenol a concentrations and serum sex steroid hormone measures in the canadian and u.s. populations (cmp m&s), automated workflows for chemical scoping and data mining: advance approaches to prioritization and problem formulation, characterization and toxicological testing of metal oxide nanoparticles and nanocellulose (cmp), characterization of residential exposures to cmp metals and organics, cohort profile: health effects monitoring programme in ndilǫ, dettah and yellowknife (ykhemp), creation of a master database of mercury and methylmercury levels in top country foods contributing to exposure among indigenous communities, derivation of biomonitoring equivalents for organics and inorganics for interpreting biomonitoring data to support chemical risk assessment, determination of risk assessment ufs (uncertainty factors) for estimation of exposure limits to environmental mutagens, developing in vitro screening methods for metabolic disruptors in adipocytes, development and application of fit-for-purpose, adverse outcome pathway-based testing strategies to enhance hazard and risk assessment of chemicals causing genomic damage.

• Development and application of novel next generation sequencing approaches for mutagenicity testing in the 21st century

Development and validation of rapid methods to assess endocrine toxicity

Development of a screening approach to assess endocrine disrupting activity of chemicals using (quantitative) structure activity relationship ([q]sar) approaches and in vitro high throughput data, development of an integrated analysis tool for genotoxicity assessment (iatga), development of non-targeted screening analysis approaches for identifying emerging metabolites and chemicals in human fluids as exposure biomarkers using high-resolution mass spectrometry, direct comparison of the sub-acute toxicities of bisphenol a, f and s using a standardized oecd exposure protocol, effect of country food preparation on concentrations and bioaccessibility of mercury and associated metals, endocrine disrupting chemicals: towards responsible replacements (cihr team grant mcgill university), endocrine disrupting chemicals: towards responsible replacements - determination of organophosphate esters (opes) and their metabolites in breast milk, food and water samples, estimating the number of cases of male infertility due to prenatal dioxin and furan exposures in canada, evaluation of dermal decontamination to reduce firefighters' exposures to combustion-derived pahs (polycyclic aromatic hydrocarbons) (ottawa fire services, canadian forces fire marshall, ottawa professional firefighters association, association des pompiers de montréal, international association of firefighters, and institut de protection contre les incendies du québec), evaluation of in vitro methodologies to resolve the differences in toxicity characteristics of newly synthesized nanosilica particle (sinp) variants optimally to assist read-across in risk assessment of nanoparticles, evaluation of select adme models to determine suitability and performance for existing substances and for broader implementation in chemicals risk assessment, expanding high-throughput toxicokinetics chemical space to increase its applicability to existing substances, exposure load: using biomonitoring data to quantify multi-chemical exposure burden in a population (cmp m&s).

• GeneTox21 - An integrated platform for in vitro genetic toxicity assessment and regulatory evaluation of new and existing substances

Health risk assessment of arsenic exposure among the residents in Ndilǫ, Dettah, and Yellowknife, Northwest Territories, Canada

Impacts of major projects on traditional foods and implications for food security of indigenous peoples: a current state of practice in canada, implementing in vitro bioactivity data to modernize priority setting of chemical inventories, in vitro pharmacokinetics for high throughput data interpretation (part 2), in vitro to in vivo extrapolation (ivive) toxicokinetics of cmp chemicals.

• In vitro toxicity testing of TiO2 nanoforms

In vitro toxicokinetics for data interpretation

Incorporating computational workflows for the identification of risk assessment priorities under the canadian environmental protection act, investigating the effects of dissolution rates of metal-based nanoparticles on cellular responses (cmp), machine learning models for predicting endocrine disrupting chemicals, maternal-infant research on environmental chemicals (mirec) research platform, mirec endo: pubertal timing, endocrine and metabolic function, modelling and assessment of short-duration exposures to lead in soil, multimedia exposure to replacement chemicals of emerging concern and selected cmp3 chemicals.

• National Biomonitoring Program under the Canadian Health Measures Survey (CHMS) - Cycles 5-6 (2016-2019) and cycles 7-8 (2022-2025) (CMP M&S)

Northern Contaminants Program (NCP)

Phase identification of metal oxide nanopowders purchased from on-line distributors, project apollo: assessment of game-based learning digital solutions for optimized environmental health outreach targeting youth, putting databases together: a study of association between environmental chemical exposure levels and health outcomes, quantitative read-across using cheminformatics approaches, refining and deploying a quantitative framework for the analysis and regulatory interpretation of genetic toxicity dose-response data, regional analysis of chms biomonitoring data, relative toxic potency of silica and titanium dioxide nanoparticle variants.

• Review of available human biomonitoring data to improve the understanding of firefighters’ exposures to combustion-derived toxicants of concern

Sublethal effects of selective serotonin reuptake inhibitors (SSRIs) in the freshwater snail Planorbella pilsbryi and amphipod Hyalella azteca

• Systematic characterisation and preliminary validation of genomics-guided non-animal test models ( in vitro / ex vivo ) and methods for nanomaterial safety assessment

Systematic meta-analysis and review tools (SMART) in support of science assessments

Testing the effects of selective serotonin reuptake inhibitors (ssris) on zebrafish ( brachydanio rerio ), the impact of dissolution behaviour of metal oxide nanomaterials on toxicological response, toward risk assessment modernization - a new approach methodology based integrated approach for screening potential genotoxic chemicals, uptake rates of silicone based personal sampling devices – proof of principle, use of gene expression profiles to facilitate read-across for 24 priority pfas.

• Use of new approach methodologies to facilitate potency ranking and evalute mode of action for 25 bisphenols

Validation of the zebrafish (Brachydanio rerio) model as an in vitro NAM for the assessment of chemicals for endocrine disruption and general toxicity

Estimating pesticide concentrations in cranberry flood water.

• Health Canada’s Pest Management Regulatory Agency: Results of a multi-year analysis on dermal absorption

Modelling efficiency of a vegetative filter strip at mitigating pesticides in surface runoff

Refining pesticide health risk assessments for workers in the greenhouse environment, regulatory use of exposure task force data.

• Update on the Pest Management Regulatory Agency’s approach to non-animal testing

DQSP: A program that monitors quality of pharmaceutical products on the Canadian market

Inter-laboratory study of nitroso-compound determination in angiotensin ii receptor blocker (arb) drugs, rapid confirmation of burkholderia cepacia complex by molecular method, a better understanding of radon dosimetry through indoor aerosol characterisation and computational simulation, an assessment of uncertainty using two different modelling techniques to estimate the cost effectiveness of mitigating radon in existing housing in canada, assay development for biological dosimetry.

• Assessing the impact of new strategies for communicating radon gas health risk, testing, and mitigation information to Canada’s younger age demographic

Assessment of radon mitigation strategies in the Canadian environment

Atmospheric nuclear forensics capability advancement project (anfcap), biomarkers for exposure to low doses of ionizing radiation, cost effectiveness analyses of interventions to reduce residential radon exposure in canada, development of a reference dosimeter for separating the neutron contribution from the other cosmic ray components, development of an adverse outcome pathway (aop) relevant to uranium induced kidney toxicity.

• Domestic radon exposure and childhood leukemia: a population-based study in Canada.

Emergency dosimetry

Estimating the geospatial requirements for protective actions in the vicinity of canadian nuclear generating stations, exploring the adverse outcome pathway in radiation risk assessment, exposure characterization – cone beam computed tomography x-ray, fixed point surveillance network, forensic radionuclide event analysis and reconstruction (frear), handheld laser device usage and injuries: results from the canadian community health survey (cchs).

• Health Canada’s Total Diet Study

Identification of biomarkers of radon gas exposure

Indoor tanning equipment usage and injuries: results from the canadian community health survey (cchs), justification and methodology for the characterization of baseline noise.

• Longitudinal analyses of nuclear energy workers in the National Dose Registry (CANDU Owners Group’s low dose Strategic Research and Development program)

Measuring psychosocial impacts from protective actions in nuclear emergencies

• Measuring workloadNational Biomonitoring Program with paired detectors

Medical countermeasures for lung deposition

Modelling temperature elevation in the skin from millimeter wave radiofrequency fields, monitoring of radioactivity in caribou and beluga in response to the fukushima accident (northern contaminants program), national radon program behavioural study, new methodology for the analysis of radio-strontium in milk, personal listening devices (plds) and impairment to hearing, radioactivity monitoring and assessment in the canadian arctic: participation in an international research project of the arctic monitoring and assessment programme (amap) 2023, radon research - understanding radon risk in occupational and residential settings, review of equilibrium factors for dose assessment, self-reported exposure to occupational noise and cardiovascular disease in canada: results from the canadian health measures survey, survey of cs-137 in bird species harvested across canada, systematic review on the strength of evidence for an association between noise exposure and changes in biological risk factors for stress-mediated illnesses., the canadian radiological monitoring network (crmn).

• The Comprehensive Nuclear Test-Ban Treaty radionuclide stations and radionuclide laboratory monitoring

Transcriptional benchmark dose modeling in a mouse skin model in response to UV radiation from a commercial sunbed

Validating emergency surveillance activities in a known quantity of radioactive material.

• Wind Turbine Noise and Health Study: Sleep Analysis
• Designing cost-effective drinking water surveys in the 21-st century: Optimizing target analytes, site selection, sampling and analytical methods

Transformation of microplastics by drinking water oxidants and its effects on sorption and leaching of emerging chemicals of potential health concern

Air quality.

Health Canada is responsible for assessing risks to health posed by inhaled pollutants. The environmental prevalence of microplastics has raised questions about potential toxicity. As inhalation is a potential route of exposure, tools that realistically model human inhalation exposures are needed. Traditional toxicity testing of inhaled contaminants involves exposure of animals; growing interest in moving away from animal models (due to ethical concerns, uncertain relevance to humans, high cost) has prompted development of devices that expose human cells and tissue samples to airborne test materials. Air-liquid interface (ALI) exposures mimic lung conditions: cells/tissues more closely resemble lung cells/tissues compared to conventional submerged cell cultures, and exposures occur by air. This study aims to establish an ALI exposure system that enables reproducible testing of microplastics and other airborne contaminants under conditions that model real-life human exposures. Human cells grown at the air-liquid interface are exposed to contaminants carried by a stream of air, as occurs in the lungs. Exposure conditions are optimised through real-time monitoring of temperature, humidity, and cellular deposition of airborne microplastics in the nano- and micro- size ranges. Established conditions and protocols maintain cell viability during exposure to air, thereby ensuring that toxic and inflammatory responses are specific to test agents. The system will provide an innovative approach to assess effects of inhaled contaminants (e.g. complex mixtures of gaseous and particulate air pollutants, combustion emissions, traffic-related pollutants, secondary organic aerosols, metals, nanoparticles, microplastics, vaping products, etc.) without animal exposures. Importantly, this will provide Health Canada with the capacity to assess health-relevant biological responses in human cells to the actual atmospheres to which people are exposed, rather than using extracts or simplified model materials, thereby more closely modeling human lung toxicity and improving hazard identification and mechanistic studies in support of regulatory needs. (PI: Errol Thomson)

Health Canada is responsible for assessing risks to health posed by inhaled pollutants. Airborne fine particulate matter (PM2.5) is measured as the mass of particles present in the air. This measurement is used worldwide to regulate ambient air quality and is based on years of epidemiological and toxicological evidence suggesting adverse health effects. Nevertheless, it is widely recognized that particle mass concentration is merely a surrogate measure of the true underlying cause of PM-induced health effects, often termed the "biologically effective dose". In particular, oxidative stress is known to play an important role in PM-induced health effects including both respiratory and cardiovascular outcomes. As a result, PM oxidative potential measurements have been proposed as a promising integrated measure of overall particle toxicity. This study builds on a national survey of outdoor PM2.5 oxidative potential conducted between 2016-2018 at 40 locations across Canada with laboratory analyses completed in 2020. These data will be linked to data on emergency room visits and population-based cohorts to support epidemiological analyses. Analyses of acute health outcomes is currently underway. Publication expected in 2021. (PI: Scott Weichenthal).

Health Canada is responsible for assessing risks to health posed by inhaled pollutants. Oxidative stress is known to play an important role in PM-induced health effects including both respiratory and cardiovascular outcomes. As a result, PM oxidative potential measurements have been proposed as a promising integrated measure of overall particle toxicity. In addition, composition elements of PM2.5 may have differential toxicity and consequently different health impacts. This study evaluates whether PM2.5 oxidative potential and PM2.5 composition is associated with adverse birth outcomes and childhood diseases. The study will contribute to updating risk assessment guidelines for particulate matter and other criteria pollutants (i.e., O3 and NO 2 [ozone and nitrogen dioxide]) and will contribute to the Air Quality Management System in identifying the most health effective approaches to improving air quality and local air zone management strategies. A scientific article was published in 2018 on the association of PM2.5 oxidative potential and adverse birth outcomes. Another scientific article focusing on PM2.5 components and development of childhood asthma and paediatric cancers was published in 2020. A manuscript is expected to be published on PM2.5 composition and adverse birth outcomes in 2021. (PI: Éric Lavigne).

Health Canada (HC) is responsible for assessing risks to health posed by inhaled pollutants. To support the response to the COVID-19 pandemic, HC expertise in aerosol monitoring was leveraged to help clarify transmission risks beyond close contact. Few studies have quantified aerosol concentrations of SARS-CoV-2 in hospitals and long-term care homes, and fewer still have examined samples for viability. In an effort to provide this information, this study deployed particulate air samplers in hospital ward and ICU rooms with COVID-19-positive patients, as well as in rooms in long-term care homes experiencing outbreaks. Samplers were placed between 2 and 3 meters from patients. Aerosol (small liquid particles suspended in air) samples were collected onto gelatin filters by Ultrasonic Personal Air Samplers (UPAS) fitted with size-selective nozzles, which were operated for 16 hours, after which samples were assayed for viable SARS-CoV-2 virus and for the viral genome by polymerase chain reaction (PCR). The sampling methods were validated at the National Microbiology Laboratory. In total, 138 samples were collected from 99 rooms; no viable virus was recovered, though low levels of the SARS-CoV-2 genome were detected in approximately 15% of rooms sampled. This project was conducted in collaboration with the Public Health Agency of Canada and partners from the University of Manitoba and University of Ottawa (PI: Gary Mallach). https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258151.

Health Canada is responsible for assessing adverse health risks of outdoor air pollution on Canadian health to support the "Addressing Air Pollution Horizontal Initiative". The AHTI provides information on how the health risks associated with exposure to outdoor air pollution change over time. The AHTI measures day-to-day changes in non-accidental deaths including those due to heart, circulatory and respiratory conditions a few days after exposure to two major air pollutants, ground-level ozone and fine particulate matters (PM2.5). The current AHTI is based on 22-24 major urban cities across Canada, accounting for geographical differences in air pollution concentration levels and climate for 29 years (ozone) and 12 years (PM2.5). The AHTI reports and updates are posted on Environment and Climate Change Canada's website, and accessible to all Canadians since 2011. The AHTI will be updated on a regular basis in five areas: study period, number of cities, health outcomes, vulnerable subpopulations, and perspective on short-term exposure. Recent health data for 2013-2015 and additional cities have been added to the study in order to obtain more reliable and less biased estimates of public health risks. In addition to mortality, daily hospitalizations are now being monitored, which amounts to approximately 10x the daily mortality, allowing researchers to obtain more information on specific causes of hospitalization. Subpopulation groups, such as the elderly (>65 years) will be studied by age and biological sex as these subgroups are expected to be more vulnerable to air pollution. Finally, exposure to air pollution can be short-term or long-term without consensus on the definition. As an on-going study, the project will develop new advanced statistical models to better understand deaths and hospitalizations attributable to two air pollutants concomitantly, to estimate combined health risk. The findings can be used to inform future studies on sub-populations vulnerable to outdoor air pollution. (PI: Hwashin Shin)

Health Canada's Guidance for Particulate Matter in Residential Indoor Air identified cooking as one of the major indoor sources of fine particulate matter (PM2.5), and gas stoves have the potential to be a significant source of indoor nitrogen dioxide (NO 2 ). Sufficient kitchen ventilation is important to reduce cooking exposures. Published data on residential cooking and ventilation behaviors are limited. In particular, little is known in the prevalence of kitchen ventilation and use patterns in Canadian homes. Without knowing how natural and mechanical ventilation is normally used during cooking, exposure estimates could be erroneous. To fill this gap, this research conducted a nationwide online survey to collect information on the characteristics of cooking and kitchen ventilation use in Canadian homes. Sample collection was built through a probability-based method to balance each sample group across age, gender, region, and household income for representative results. The survey was conducted from January 13 to February 24, 2020 with completed responses collected for 4500 homes across Canada. The survey responses will be used to develop a profile of characteristics and usage of kitchen ventilation systems in Canadian homes and to understand people's knowledge of cooking exposures and kitchen ventilation. The results can be used to support more accurate modeling of the impact of cooking on indoor air quality and to inform risk management strategies. A report outlining the results is expected to be published on Canada.ca in 2021. (PI: Liu Sun)

Health Canada has an interest in understanding the negative health impacts of air pollution concentration levels on human health. Traditional methods of risk assessment for outdoor air pollution have generally assumed a risk model that is a linear in shape. Many of the risk models included in the Air Quality Benefits Assessment Tool (AQBAT) make this assumption. However, new evidence is emerging that relationships between outdoor concentrations of air pollutants and health may not all be best characterized by linear risk models. In this study, new elaborated non-linear risk models have been used to assess relationships between short-term exposure and health impact. Data obtained from emergency department visits for cardiac problems and exposure to nitrogen dioxide, and respiratory diseases and ambient ozone exposure are used to develop the models. Concentration-response curves developed for a series of lagged exposures are summarized as one common parametric function. The constructed function is applied to represent risk along concentration. The study is generating knowledge on air health effects represented as concentration-response curves, and is developing a methodology to generate non-linear functions to represent the impact of air pollution on human health. (PI: Mieczysław Szyszkowicz)

Health Canada has a mandate to assess health risks of sources and components of air pollution, identifying specific vulnerable populations, and helping Canadians maintain and improve their health. The Air Quality Health Index (AQHI) is an important daily communication tool to provide guidance to the public on protecting their health from the adverse health effect of short-term exposure to outdoor air pollution. The current AQHI sums the individual risks associated with three major air pollutants, ground-level ozone, nitrogen dioxide (NO 2 ) and fine particulate matter (PM2.5). This project will improve and update the current AQHI in four areas: 1) improved modelling, 2) extension of study areas, 3) reflection of more recent study periods, and 4) additional health outcomes. First, the current AQHI is based on three single pollutant models for the three air pollutants individually, which could result in under- or over-estimates depending on their correlations. It is desirable to fully represent the effect of their combined exposures on health, accounting for the interactions among the three air pollutants. Second, while the AQHI is designed for national usage, it is based on urban areas only, due to air pollution data availability so expanding to rural areas and more urban locations is desirable. In terms of time periods, the tool is based on data for 1991-2000. Recognizing that the Canadian demographic profile, air quality profile, and medical care have changed since 2000, the exposure-health outcome relationship over time may have changed and thus expansion to recent years (2001-2015) is necessary. Finally, the AQHI considers mortality but will now be extended to hospitalization. The study findings will improve daily communications with Canadians and protect Canadians from avoidable risks by providing new information on adverse health effects related to the three major air pollutants. (PI: Hwashin Shin)

Health Canada is responsible for assessing risks to health posed by inhaled pollutants. Spread of SARS-CoV-2, like other respiratory viruses, can be due to easy aerial transmissions of respiratory droplets, exposing the virus to external environmental conditions. Short term exposure to air pollution is a risk factor for respiratory infections. In fact, there is growing evidence that small particles may enhance the transport and spread of SARS-CoV-2, a finding with profound implications. In addition, air pollution may increase levels of sensitivity to being infected by depleting immune defenses. This study aims to evaluate the short term effect of air pollution on COVID-19 confirmed cases across Canadian health regions using an epidemiological case-crossover study. Specifically, environmental data will be used for each health region across Canada and evaluate whether day-to-day changes in air pollution might affect the transmission rate of COVID-19 on a daily basis. A manuscript was submitted for publication in June 2021 and expect results to be published in 2021 (PI: Éric Lavigne).

Health Canada is responsible for the assessment and management of health risks to Canadians associated with exposure to air pollutants in the environment. In this study, Health Canada assessed the influence of volatile organic compound (VOC) exposure on hematological and serum biochemical parameters in the Canadian population. Associations between VOCs and hematogical profiles, serum tests reflecting liver and kidney function and glucose metabolism are not well known. Using generalized linear mixed models adjusting for age, sex, smoking, alcohol consumption, BMI, education and household income, the association between selected VOCs and hematogical profiles, serum tests reflecting liver and kidney function and glucose metabolism were tested in 3,950 participants of the Canadian Health Measures Survey. This study provides evidence that exposure to VOCs, at levels found in the Canadian population, may influence blood cell counts and indicators of liver and kidney function. Renal hyperfiltration is postulated to be one mechanism explaining the inverse association between serum VOC and creatinine concentrations. (PI: Sabit Cakmak)

Canadian air zones represent a complex mixture of urban and rural land-use impacted by diverse emissions sources. The critical challenge for local air quality management lies in determining which pollution sources have the greatest impact on human exposure and health. This study collected summer and winter air pollution measurements at 125 locations in Calgary and surrounding rural areas, as well as yearlong measurements in a subset of sampling locations. These measurements are being combined with land-use and emissions data to identify source contributions and map short term (daily and weekly) and long term (seasonal and annual) exposure to air pollutants (NO 2 , VOCs, PM10, PM2.5, black carbon, and metals) across these communities. Air pollution data generated by this study will be applied in existing health cohorts to examine a variety of adverse health outcomes. Results will also be used in collaboration with local and provincial air zone managers to develop and evaluate strategies for improving local air quality and reducing health risks. An initial manuscript is expected to be published in 2021. Further land use regression modelling for NO 2 will be completed by fall 2021. (PI: Markey Johnson)

Large marine vessels have historically used bunker fuel oil (BFO), which can significantly contribute to air pollution in areas near commercial ports and seaways and may even adversely influence air quality at inland locations through the movement of polluted air masses. Over the period 2012 to 2015, lower-sulphur marine fuel regulations were introduced for large ships operating in Canadian coastal waters and ports with the intention of reducing vessel emissions of SO2 and PM2.5 and thus improving ambient air quality in Canadian port cities. The Canadian Atlantic Marine Air Pollution Study (CAMAPS) investigates the impact these regulations have had on ambient exposures for Canadians living in Halifax, Nova Scotia. Ambient exposure sampling was carried out for criteria air pollutants (SO2, PM2.5, NO 2 , CO, O3) and PM2.5 elemental composition over a one-year period downwind and upwind of the Halifax harbour (by prevailing winds), at the Bedford Basin inlet, and at select community sites to support pre- and post-Regulation comparisons, intra-urban comparisons, and source apportionment models. To further assess the potential impacts of the regulations on human health, sampling included measurement of black carbon (BC). Analysis will apply toxicity-equivalent exposure estimates for PM2.5-associated PAHs. Field datasets have been produced. Findings to date indicate that the low-sulphur marine fuel regulations have substantially reduced ambient exposures to SO2 and contributed to a moderate improvement in Halifax particulate air quality. Source apportionment modeling will be applied to quantify pre- and post-regulatory marine sector emission contributions to ambient PM2.5 and PM2.5-associated air toxics (e.g., heavy metals) relative to other transport and non-transport source types. A scientific article outlining the efficacy of the lower-sulphur marine fuel regulations was published in 2021. (PI: Angelos Anastasopolos)

Exposure to ambient air pollution during pregnancy has been associated with low birth weight, preterm birth, maternal health outcomes and several childhood atopic diseases and neurodevelopmental outcomes. However, evidence of the impact of air pollution on these outcomes is still limited due to other factors that may be involved in this complex relationship that may not have been accounted for in previous studies (e.g. smoking and alcohol consumption during pregnancy, maternal body mass index, maternal weight gain during pregnancy, maternal comorbidities, etc.). Further evidence is also required regarding forest fire exposure during pregnancy and impacts of other important urban environmental factors (e.g. greenness, walkability, noise, heat, etc.) on adverse birth, maternal and childhood outcomes. This study aims to evaluate the risk of air pollution on birth outcomes, maternal pregnancy complications and childhood diseases while taking into consideration the complex exposures to other environmental factors present in urban environments. The findings of this study will be used to support Health Canada's risk assessments, regulatory decision-makings and health messaging in addressing impacts of air pollution. A scientific manuscript focusing on the interelationships between urban environmental factors and maternal outcomes will be published in 2021. Results of impacts of forest fires on adverse birth outcomes across Canada will be available for presentation in 2021 (PI: Éric Lavigne)

Over the past decade, there has been mounting evidence linking low levels of ambient air pollution to a higher risk of premature mortality around the world. However, important questions remain - the exact mechanism and pathways, whereby the accumulation of air pollution exposures elicits premature death, requires more precise elucidation. Because health is a dynamic state, encompassing successive episodes of good and poor health states, this information is crucial for supporting health guidance, as well as for estimating the burden of air pollution. Health Canada is conducting a study to investigate the important role of exposure to air pollution in affecting individuals' health trajectories, and how this unfolds along different physiological pathways. A better understanding of the ways in which air pollution shapes health trajectories will help identify key pathways of public health significance and inform public polices. The second objective of the ROUTE Study is to further evaluate the effectiveness of some widely-implemented or potential individual- and policy-level interventions in reducing air health effects. Air pollution has major public health and economic consequences, but considerable uncertainty exists concerning which actions can be taken to reduce its effects. To achieve the two objectives, the ROUTE Study will draw on Big Data sources, and use state-of-the-art causal inference methodologies. Results of this study will fill important gaps in air health research and support policy decisions and public actions on mitigating air pollution effects in Canada and elsewhere. (PI: Hong Chen)

Traffic related air pollution (TRAP) is a well-recognised contributor to smog and is linked to adverse health outcomes. Although traffic pollutants can travel long distances, exposure to the highest levels of emissions occur closest to the source; e.g. in a car in dense traffic conditions. Time spent in-vehicle may contribute up to half of commuters' daily exposure to certain air pollutants. Most new cars now have, or allow for, a cabin air filter, but it is not known how well cabin air filtration can reduce exposure to TRAP. In this intervention study, Health Canada measured commuters' exposure to air pollutants in rush hour traffic during fall, 2014. Short term cardiopulmonary health indicators such as blood pressure, heart rate variability and respiratory inflammation and measured pollutant levels inside and outside vehicles were tracked. Effects on cognition (mental processing and judgement) were also measured in this real world environment where any deficit could be important to safety. Preliminary results show that participants' heart and cognitive function were found to be impacted by in-vehicle air pollution exposures. Cabin air filtration reduced in-vehicle particulate exposures by approximately one third. In-vehicle pollutant concentrations were notably elevated in tunnels. This research will contribute to the understanding of how this environment contributes to Canadians' overall air pollution exposure and potential health impacts as well as test the effectiveness of cabin filters as a direct and economical exposure reduction intervention. A scientific publication is expected to be submitted in 2021. (PI: Gary Mallach)

National health and population-level data are considered in risk assessments carried out by Health Canada and other federal Government Departments and Agencies. The Canadian Census–Tax–Mortality Cohort comprises 3.5 million respondents, with detailed individual and household characteristics, and includes mortality information up to 2016 including respiratory diseases, cardiovascular complications, ischemic heart disease, cerebrovascular disease, neurological diseases including Alzheimer's and Parkinson's, and chronic obstructive pulmonary disease (COPD), and diseases with known associations to traffic exposures. In this study, national traffic density data will be linked to the cohort to examine the association between traffic density and mortality due to cardiovascular, respiratory, diabetes and neurological disease causes. An assessment will then be carried out as to whether certain individual or environmental factors render individuals more or less susceptible to the adverse effects of traffic density. The factors to be investigated will include socioeconomic and sociodemographic status, weather, and the amount of neighborhood green space (vegetation). The relationship between traffic exposure and health is present within the context of a changing, warming climate, where high seasonal average temperatures and urban heat islands, urban or metropolitan areas that reach significantly warmer temperatures than surrounding rural areas, may provide additional burdens on health that disproportionately affect certain socioeconomic groups. People can be additionally stressed by limited access to green space due to urban design; socioeconomic and sociodemographic characteristics, long term seasonal average temperatures, urban heat islands, and residential greenness may modify the association between traffic exposure and mortality. The results will allow for more accurate traffic-related risk estimates for socio-economic and sociodemographic sub-populations by taking into account the complex interactions between health and exposure to traffic, socioeconomic and sociodemographic factors or characteristics (age, sex, family education and income, employment status, visible minorities, immigrants), weather, microclimates, and green space. (PI: Sabit Cakmak)

Health Canada is responsible for assessing risks to health posed by inhaled pollutants. Land-use regression (LUR) models provide long term estimates of air pollution at a fine spatial scale. Chemical transport models produce temporally resolved estimates of air pollution concentrations at a coarse spatial state. This study combines LUR and chemical transport models to provide spatially and temporally refined estimates of air pollution exposure at both local and national scales. Better estimates of air pollution exposure improves our ability to assess the health risks associated with both long term and short term exposure to air pollution. The results will strengthen retrospective and prospective epidemiological studies by providing more accurate exposure estimates. Hybrid models for NO 2 and PM2.5 have been developed for a single test year. These models will be expanded to cover the period from 2000-2014, and estimate contributions of different source types (e.g., transportation, industrial, and biomass burning) to ambient NO 2 , PM2.5, and O3. The data generated by this project will be applied in existing health cohorts to estimate the impacts of short term air pollution in urban and non-urban areas across Canada and to identify sources with stronger long term health impacts. (PI: Markey Johnson)

Fossil fuel powered ice resurfacers (Zambonis®) emit several pollutants, notably nitrogen dioxide (NO 2 ) and carbon monoxide (CO). Some segments of the population that regularly use ice arenas (including children, the elderly and those with asthma and other cardiovascular and respiratory conditions) are considered susceptible to adverse health effects after exposure to these pollutants. Provincial partners requested assistance in developing improved best practices, based upon scientific evidence, to reduce the health effects from exposure to air pollution in ice arenas. Currently, there are insufficient data on the levels of combustion-related pollutants (namely NO 2 and CO) in arenas, and insufficient evidence supporting the effectiveness of currently recommended pollutant reduction strategies. The Indoor Air Contaminants Assessment Section (IACAS) of Health Canada designed a research study to investigate and address these issues. In the winter of 2017/2018, levels of air pollutants were measured continuously for seven days in four arenas in Ottawa and four arenas in Saskatchewan. These results are being used to better understand pollutant levels and temporal variation in the arenas, and to evaluate the use of portable monitoring equipment. The second phase of the study, conducted in winter of 2019-2020, assessed pollution reduction strategies in ice arenas, including the impact of different ice resurfacer fuel types and impact of changes in ventilation practices. The data are currently being used for development of implementable best practices for air quality in ice arenas, targeted for provincial/territorial and municipal partners. Publication of the research results and best practices is slated for FY 2021-2022. (PI: Aaron Wilson; Christie Cole; Corinne Stocco; Morgan MacNeill)

Industrial emissions contribute to local and regional air pollutant concentrations. In Quebec, significant reduction in industrial air pollutant emissions has been observed over the past decades, because of plant closures and government regulatory actions. Such reductions offer an opportunity to evaluate the potential emission reduction-associated health benefits. Health Canada is collaborating with the Quebec Public Health Agency (INSPQ) and the University of Toronto to conduct a study on the associations between changes over time in exposure to ambient fine particulate matter (PM2.5), nitrogen dioxide and sulphur dioxide emitted from industrial sources and childhood asthma incidence in Quebec. A birth cohort for children who resided in Quebec in 2002-2015 has been created to study asthma incidence. A chemical transport model is being used to estimate ambient air pollutant concentrations resulting from industry and transportation sectors. Yearly changes in exposure to ambient pollutants emitted from industrial sectors in each small area (census tracts in urban centres and local health service territories in rural areas) are estimated. The associations between industry emission-related concentrations of ambient pollutants and childhood asthma onset will be studied using fixed-effects regression models. Specific industrial sectors petroleum refineries, metal smelters and pulp and paper mills will be studied separately. Using the concentration-response relationship generated from this study, modelling of potential health benefits of policy scenarios may be carried out targeting emissions from various industrial sectors. This project contributes to the evidence regarding the impact of government regulatory/non-regulatory actions on industrial emissions on children's lung health. Concentration-response functions produced from this project may help estimate the costs/benefits of reducing industrial emissions, and set priorities in air quality management actions on specific industrial sectors. (PI: Ling Liu)

According to the Canadian Paediatric Society, housing directly affects the health of children and youth. First Nations and Inuit are disproportionately affected by crowded and inadequate housing, which has been associated with increased hospital admissions of children for respiratory tract illnesses. It has been shown that Aboriginal children in communities in the Sioux Lookout Zone (Sioux Lookout First Nations Health Authority; SLZ) in northern Ontario have elevated rates of asthma, bronchiolitis and pneumonia, but there is little information on their indoor environmental quality. Working with local officials, a preliminary assessment revealed houses with issues including dampness and contaminants associated with wood stoves, as well as other problems. This study aims to evaluate Indoor Environmental Quality (IEQ) in houses of 50-100 children living in four isolated communities in this area in relation to respiratory health and related utilisation of health care services. Community consultations with the relevant Nations Hamlet Councils and local medical officers of health are incorporated into the process. Consenting households receive a respiratory health questionnaire for their youngest child and a standardized housing inspection is being carried out in partnership with Band officials. Monitors record basic indoor environmental quality and the relationship between it and the child's respiratory health will be examined. Working more effectively with the communities, this research will help us to identify simple home improvements and other building interventions that could improve the respiratory health of this vulnerable population. The findings will also be used to inform future, similar studies/interventions in remote First Nations (FN) reserves across Canada. Field work was completed in the spring of 2019, and analysis of the data is underway. Participant reports for all four (4) First Nations communities have been completed and support given to housing authorities to support training of local technicians on air quality issues. One paper is anticipated for publication in 2021. (PI: Gary Mallach)

In support of the federal government's plans to take action to address air pollution in Canada, researchers from the University of Windsor, Health Canada, and Ryerson University are leading a joint effort to develop tools to support local and federal agencies in making decisions that will reduce urban air pollution and create healthier cities. Integrated Urban Models (IUM) are complex simulation platforms that act as a virtual laboratory to allow urban planners and decision makers to evaluate the impacts of development and transportation decisions and policies. This study will add air pollution exposure and health impacts, as well as other sustainability indicators to SMARTPLANS, an existing IUM. This study will provide support for evaluating alternate land use and transportation planning policies and create healthier Canadian cities. Specifically, SMARTPLANS will utilize data on local transportation, land use, economic and travel activity, as well as air pollution, health, and economic indicators, to simulate land use and transportation system infrastructure and policy changes, with the goal of assessing which decisions will maximize social and economic benefits, while minimizing negative environmental and health impacts. SMARTPLANS will help to promote healthier cities by facilitating analysis of the impacts of alternate planning and policy decisions on a variety of social, economic, environmental, and health indicators, including exposure to air pollution and health impacts of air pollution in the Canadian population. The study will culminate in the development of a user-friendly planning support tool that will be freely available to policy makers, air zone managers, researchers, public health practitioners, and other stakeholders across Canada. The SMARTPLANS platform will be developed for 5 cities across Canada: London, Halifax, Vancouver, Ottawa, and Calgary. (PI: Markey Johnson)

This research study addresses Health Canada's mandate regarding factors mediating vulnerability to adverse effects of air pollution, with implications for regulatory decision-making and health messaging. Research is needed to improve our understanding of the biological mechanisms of the health effects of air pollution, specifically for associations at low pollution concentrations observed in Canada. Research is also needed to better characterise and reduce health risks of air pollution for Canadians, especially vulnerable groups. Recent studies have suggested that common, heritable, genetic differences may influence susceptibility of individuals to health effects of air pollution. Specifically, genes involved in responses to oxidative stress have been investigated as possible factors that alter sensitivity to air pollution. From 2013 to 2015 saliva DNA samples were collected from 176 participants in the Air Quality Health Index (AQHI) Panel Studies. Study participants also provided 10 weeks of daily and weekly health data (lung and cardiovascular function tests, symptoms, activities). To this point, all samples have been analyzed and study participants have been characterized with respect to the presence of 23 gene variants, and assigned an overall gene score reflecting the combined presence of multiple variants. In the next phase, analysis of health measure data will determine whether the health effects of air pollution differ between individuals with or without these gene variants, thereby evaluating the importance of oxidative stress as a mechanism for air pollution effects; and determine whether the morbidity data support the mortality-based AQHI formula (public information tool). These findings may provide important biological information about how even very low pollution levels can affect health and suggest possible mechanistic links between air pollution and health effects. This information could be useful for future development of interventions or messaging to protect individuals who have a genetic susceptibility to the effects of air pollution mediated oxidative stress. (PI: Dave Stieb)

Short term exposure to aeroallergens has been associated with the exacerbation of asthma and allergy symptoms. The joint effects of aeroallergens and outdoor air pollution on asthma exacerbation has also been investigated, however findings have been inconclusive. As well, growing evidence is showing that exposure to outdoor air pollution during gestation and early life is associated with the development of asthma and allergic symptoms among children. Little is known regarding the joint exposures of aeroallergens and air pollution among children. A major limitation of the available epidemiologic literature is that exposure has typically been assessed on the basis of pollen data from only one or few monitoring stations per city. Thus, current data do not capture intra-urban spatial heterogeneity of pollen concentrations providing less accurate data for exposure assessment when studying potential human health effects and potential interactive effects with outdoor air pollution. In this context, a land use regression (LUR) model approach based on environmental determinants will be developed for predicting the variability of pollen concentrations at fine spatial scales in the city of Toronto. Results are expected for the fall 2019 and will be published in 2021. Using the Canadian Healthy Infant Longitudinal Development (CHILD) study, a Canadian Institute of Health Research (CIHR) and Health Canada funded birth cohort, the combined effects of exposure to outdoor air pollution and aeroallergens on asthma incidence among Canadian children will be evaluated. A scientific paper based on the characterization of aeroallergens in Canada has been published in 2018. A scientific paper based on results of joint effects of aeroallergens and air pollution on atopic disease development using the CHILD Study will be published in 2021. A scientific manuscript on the spatio-temporal variations of aeroallergens in the city of Toronto will be published in 2021 (PI: Éric Lavigne)

Health Canada has an interest in better understanding the multiple sources of exposure that characterize diverse features of urban environments. The Toronto Child Health Evaluation Questionnaire (TCHEQ) study established a cohort of 5,619 grades one and two (aged 5 to 9) Toronto school children in 2006, collecting detailed data on the child's and parents' health, sociodemographic characteristics and exposures in the home environment. There are few other Canadian cohorts of children of this size. In the original study, the prevalence of asthma was associated with nitrogen dioxide in those children with other allergic disease such as hay fever and eczema. In the previous round of CARA funding, TCHEQ participants were linked to Ontario health care utilization data housed at the Institute of Clinical Evaluative Sciences (ICES) to determine the incidence of new cases of asthma and other allergic disease 10 years after the original study, and to examine their associations with air pollution. To date, analyses have revealed that exposures to oxidant air pollutants (ozone and nitrogen dioxide), but not fine particulate matter, were associated with an increased risk of incident asthma and eczema. In this phase of the study, analyses will examine the incidence of allergic disease in association with oxidative potential and aeroallergens (pollen and spores), link the cohort to other outcomes including early childhood development, and conduct updated linkage to health care data 15 years after the original study. A better understanding of longitudinal effects of air pollution and aeroallergens and the ability to control exposure sources supports Health Canada's efforts related to regulatory decision-making and health messaging. (PI: Dave Stieb)

The Canadian Longitudinal Study on Aging (CLSA) is a population based national study which will follow the health, lifestyle, social and economic transitions, and trajectories of 50,000 Canadians, aged 45 to 85 years old, at three-year intervals for 20 years. Health Canada's goal is to collaborate with the CLSA over the many years of follow-up to study the effects of ambient air pollution on healthy aging. The current proposal is to measure change in cognitive function measures and the incidence of cardiac, pulmonary and neurologic disease during six-years of follow-up, associated with the average neighbourhood concentrations of ozone (O3), nitrogen dioxide (NO 2 ), and fine particulate matter (PM2.5), during a six year period. Exposure will be estimated by satellite monitoring, Environment and Climate Change Canada's National Air Pollution Surveillance program (NAPS) ground monitors and land-use regression techniques, where appropriate. Traffic-related air pollution will be estimated by the proximity of residence to roadways. This project has already received AAPHI funding (2016-2019) for the first three year follow-up. This project aims to update the data linkage (air pollution and climate variables to the CLSA data base) and data analysis to include another three years of follow up for a total of six years. A longitudinal study will help clarify the health effects of air quality among the elderly, and build the foundation necessary to continue this legacy study over a twenty year period. A secondary aim is to determine if susceptible subgroups exist through stratifying results by gender, education, income, rural versus urban locations and the presence (at the time of study inception) of chronic comorbid conditions including diabetes, cardiovascular disease, and chronic obstructive lung disease. This study will be unique and provide some of the most definitive information available on the relationship between air quality and cognitive function in Canada. (PI: Bob Dales)

Microplastics are small particles of plastic measuring less than five millimeters in length. With growing concern on their ecological and human health impacts, the Government of Canada is leading international efforts to protect the environment from microplastic plastic pollution. In support of Canada's Plastics Science Agenda , the government has prioritized research on: a) the detection, quantification, and characterization of plastics in the environment; and b) impacts on wildlife, human health, and the environment. Very few studies have purported to measure microplastics concentrations in air, and there is a need to develop rigorous scientific protocols to strengthen future efforts. No studies to date have investigated the impact that exposure to airborne microplastics has on human health. The purpose of this study is to develop and optimise sample collection, and subsequent microscopic and analytical methods to detect, quantify and characterise different types of microplastics in both indoor and outdoor samples. As Canadians spend approximately 90% of their time indoors, data on both indoor and outdoor microplastic exposures will be required to understand their sources, pathways, fate, and distribution; and to identify and prioritize specific microplastic categories or mixtures for future research, risk assessment/management. (PI: Sabina Halappanavar)

Air pollution is one of the top global environmental health burdens, which contributes to approximately 15,300 premature deaths in Canada, and costs approximately $120 billion per year to the Canadian economy. Addressing air pollution, especially traffic related air pollution (TRAP) in urban areas, remains a priority for Health Canada. The Regulatory Operations and Enforcement Branch, Environmental Health Program in Ontario funded a research project in collaboration with the University of Toronto's Southern Ontario Centre for Atmospheric Aerosol Research to understand how different traffic emission sources affect air quality in the Greater Toronto Area. The primary goal of this study was to compare different methods to analyze the sources and levels of TRAP in the city of Toronto and parts of highway 401 during pre- and post-COVID-19 pandemic lockdown. This research also provided an understanding of the capacity of available resources to measure changes in air quality that can guide future investment in public health and sustainability. Results indicate a significant reduction of pollutants (nitrogen oxides, ultrafine particles, black carbon, carbon monoxide and carbon dioxide) during the pandemic when compared the pollution level with pre-pandemic period from 2017-2019. This study also identified substantial reductions (40-60%) of particulate matter 2.5 (PM2.5) from cooking, and tailpipe and non-tailpipe emissions from vehicles. The reduction of PM2.5 from tailpipe emissions during the pandemic was mainly due to a reduced number of trucks in the urban environment, highlighting the importance of targeted strategies to reduce heavy emitters on roadways to mitigate the levels of TRAP more effectively. Results from this study contribute to guide future policy changes that will support improved air quality and sustainable development in the Province of Ontario and in Canada. This study benefits Health Canada by providing guidance on future policy development for improving air quality. (PI: Mainul Husain; Greg Evans, University of Toronto)

Building materials have been found to release pollutants into indoor air. Recent studies suggest that, as building envelopes become even tighter, levels of volatile organic compounds (VOCs) in newly built homes may exceed health-based exposure limits. There is also concern over the concentrations of semi-volatile organic compounds (SVOCs), including flame retardants, in this environment. However, existing studies typically involve a small number of homes, usually occur at one point in time, and are not evaluated within a Canadian context. To address these knowledge gaps, this multi-year study measures concentrations of VOCs and SVOCs immediately before occupancy, as well as at multiple time points during the first year of occupancy, in 40 newly constructed homes in Ottawa. Information about factors that affect the monitoring results, including air exchange rate, occupant behaviour and housing characteristics are also being collected. The objectives of the New Homes Air Quality Study are to measure concentrations of VOCs and SVOCs in new homes; to understand how these concentrations compare to existing health-based exposure limits and/or concentrations previously measured in Canadian homes; and to examine how these concentrations change during the first year of occupancy. The study also provides the opportunity to undertake preliminary work on microplastics, an emerging issue and a priority for the Government of Canada. Results from the study will inform risk assessment and risk mitigation activities such as providing health-based guidance to organizations and individuals relating to indoor air contaminants in new homes. They may also inform the development of product standards and modifications to the national building code. The COVID-19 pandemic has had a significant impact on the duration of field work, which was initiated in 2019 and will be extended to 2023/24. (PI: Corinne Stocco)

Urban air pollutants such as nitrogen dioxide (NO 2 ), black carbon (BC), fine particulate matter (PM2.5), and ultrafine particles (UFPs) are ubiquitous in Canadian urban environments and have been suggested as factors contributing to the risk of several cardiopulmonary diseases and cancers. Past research at Health Canada has contributed to air pollution exposure modelling for several pollutants in several Canadian cities. However, Quebec City remains a major urban center with few air pollution exposure Land Use Regression (LUR) surfaces. The creation of new LUR surfaces would be beneficial for a city rich in epidemiological data from the Quebec Integrated Chronic Disease Surveillance System. As well, there is local concern that air pollution related to the Quebec City seaport and the Jean Lesage international airport pose risks to human health. Analyses that test the association of these point sources to ambient air pollutants would be valuable to developing policy around these issues. Oxidative potential can serve as an indicator the potential biological activity of particulate matter and provide a metric independent of mass concentration. Analysis of the spatial and temporal variation of oxidative potential (OP) of PM2.5 in the city and the relationship between OP and point sources will improve understanding of PM associated health risks. The source and size characteristics of different size ranges of UFPs may have distinct health effects. This study is applying novel techniques to characterise UFPs by source and test for associations with Quebec City's sea and air ports. Similarly, relating PM2.5 OP to health effects may reveal health risks of PM2.5 independent of mass concentration. It aims to generate exposure models for several pollutants in the region that will substantially reduce exposure misclassification in the linkage of air pollution data to epidemiological cohorts in Quebec City and advance understanding of health impacts of these pollutants. Analysis is ongoing. (PI: Keith Van Ryswyk)

Health Canada is responsible for assessing risks to health posed by inhaled pollutants. Epidemiological studies of the cardiovascular health effects of fine particulate air pollution (PM2.5) primarily reflect urban areas and few studies have examined non-traffic sources of particulate air pollution. Recent studies have demonstrated that biomass burning as a source of PM2.5 may modify the acute cardiovascular health effects of this pollutant among elderly subjects; however, the components and biological mechanisms underlying this association are not entirely clear. Moreover, it is not clear how such exposures may impact cardiovascular health in children. This investigation will examine the impact of short (e.g. 24-hours) and intermediate term (e.g. 1 month) exposures to PM2.5 from biomass burning on microvascular responses in school children over the course of a heating season in Courtenay and Cumberland, British Columbia. Few studies have evaluated the cardiovascular health effects of air pollution exposures among children; however, since microvascular dysfunction is a known contributor to the development of cardiovascular disease, it is important to understand how early life exposures may impact vascular health. In particular, retinal arteriole narrowing has been identified as a predictor of hypertension in both children and adults and may serve as a marker for similar changes in the coronary microvasculature. In this study, retinal microvascular diameter will be assessed prospectively using repeated within-subject measurements collected using a non-invasive retinal imaging technique. Daily mean PM2.5 mass concentration data will be collected from fixed-site monitors and monthly mean PM2.5 oxidative potential will also be determined. Collectively, the proposed investigation will provide important information related to the impact of PM2.5 (and PM2.5 oxidative potential) on cardiovascular health and will support ongoing efforts to reduce the public health impacts of air pollution from biomass burning in Canada and abroad. Data collection was completed in May 2020. Publications are expected in 2021. (PI: Scott Weichenthal)

Several high-profile national- and local-scale air pollution health studies in Canada rely on Health Canada scientists to provide estimates of exposure to air pollution which are required to carry out epidemiologic analyses. Health Canada is working with academic partners to carry out intensive ambient air pollution monitoring, and develop land-use regression (LUR) models for Ottawa, London, Calgary, and Halifax. Such models allow for the prediction of concentrations of pollutants at a neighbourhood or household level, which reduces the error associated with obtaining data from central site monitors. LUR models are being developed by Health Canada based on data obtained to predict the concentrations of elements (such as metals) in airborne particulate matter in Calgary and Halifax. LUR models are being used to support local- and national-scale health studies investigating air pollution impacts on respiratory, cardiovascular (e.g. stroke), developmental (e.g. birth outcomes, gestational diabetes), autoimmune diseases and cancer outcomes. These LUR models support research investigating links between air pollution and a variety of adverse health outcomes including mortality, atherosclerosis, systemic autoimmune rheumatic disease, and birth outcomes. LUR models and other exposure data developed by Health Canada's Air Program are now available through several venues including The Canadian Urban Environmental Health Research Consortium (CANUE). The Halifax land use regression modelling for metals is expected to be published in 2021. (PI: Markey Johnson)

Airborne particulate matter (PM) is a global health concern, and its metallic components have been shown to have cardio pulmonary health effects. Particulate matter in subway systems has been characterized as being highly enriched in steel-based elements such as iron, chromium, manganese, zinc, and nickel as well as brake pad-related elements such as copper and tin. In Canada, the Urban Transportation Exposure Study (UTES) characterized the PM exposures in three Canadian subway systems and found that most of a typical commuter's daily exposure to particulate iron manganese and chromium would occur while in the subway and more than 20% of their daily exposure to PM2.5 mass would result from a typical 70-minute subway ride in the Toronto subway. Similar values were found for the Montreal and Vancouver subway systems. This study returned to the Toronto Subway and has evaluated two interventions, night time tunnel vacuuming and changes in subway trains, for their potential to reduce fine particulate matter (PM2.5). Further, fine particles from the subway are being compared to that of two ambient sites in Toronto. Data from this study will be valuable towards designing air quality policy in this unique environment which is visited by millions of Canadians on a daily basis. Two papers are anticipated for publication in 2021. (PI: Keith Van Ryswyk)

The Air Quality Benefits Assessment Tool (AQBAT) is a computer application developed by Health Canada which is designed to estimate the human health impacts of changes in Canada's ambient air quality. It is used to estimate the benefits (positive impacts) or damages (negative impacts) of proposed regulatory initiatives related to outdoor air quality as mandated by the Treasury Board Cabinet Directive on Regulatory Management (when developing new regulations that affect air quality, Treasury Board requires that Health Canada quantify the human health and associated economic benefits of estimated changes in air quality). AQBAT consists of a Microsoft Excel application file which enables the user to define, run, examine and save the inputs and outputs for specific scenarios combining pollutants, health endpoints, geographic areas and scenario years. It contains historical and projected population data, pollutant concentration data, annual baseline health endpoint occurrence rates, and Health Canada endorsed concentration-response functions and health endpoint valuations. It utilizes the @Risk add-in software to perform Monte Carlo simulations, which allow the user to examine the effects of uncertainties on estimated health impacts. AQBAT is a knowledge translation tool in that it applies findings from research studies of the health effects of air pollution to develop concentration-response functions and economic valuation estimates used in quantifying health impacts and their economic value. AQBAT has been applied to numerous regulatory and non-regulatory scenarios including impacts of vehicle electrification, impacts of wildfire smoke, assessment of climate change impacts, and Human Health Risk Assessments for Diesel Exhaust and Biodiesel. Ongoing updating of data, parameters and methodology is required to ensure that assessments of regulatory initiatives reflect the most current science such that they most effectively protect the health of Canadians and do not impose unwarranted costs to society. Version 3 of AQBAT was released in 2019. (PI: Dave Stieb)

Health Canada is responsible for the assessment and management of health risks to Canadians associated with exposure to air pollutants in the environment. In this study, Health Canada and collaborators in Chile assessed the risk associated with air pollutants and COVID-19 mortality. Exposure to ambient air pollution is a risk factor for morbidity and mortality from lung and heart disease. However, it is not certain if short term exposure to ambient air pollution concentration influences COVID-19 related mortality. Using ambient air pollution (ozone, nitrogen dioxide, carbon monoxide and particulate matter) and climate data from seven air monitoring stations distributed in the nine urban centres in Santiago, Chile, along with daily deaths from laboratory confirmed or suspected COVID-19 between March 16 and August 31, 2020, an association between ambient air pollution and daily COVID-19 mortality were tested. Our findings suggest that acute increases in air pollution may be one risk factor for daily COVID-19 mortality. There were no significant differences in risk of mortality by sex, but relative risk generally increased with age. This study provides evidence that daily increases in air pollution may increase the risk of dying from COVID-19, especially in the elderly. (PIs: Sabit Cakmak and Bob Dales)

Health Canada is responsible for the assessment and management of health risks to Canadians associated with exposure to air pollutants in the environment. In this study, Health Canada and collaborators in Chile assessed the risk associated with air pollutants and systemic lupus erythematosus (SLE). SLE, characterized by humoral and cellular immune system dysregulation, loss of self-tolerance and production of auto-antibodies to self-antigens with chronic inflammation and damage to multiple organs, can be debilitating and even fatal, but its association with air pollution is not well known. Using ambient air pollution (ozone, nitrogen dioxide, sulfur dioxide, carbon monoxide and particulate matter) and climate data from seven air monitoring stations distributed in the seven urban centres in Santiago, Chile, along with daily patient hospitalization data from 2001 to 2012, an association between ambient air pollution and daily hospital admissions for SLE were tested. Our findings suggest that acute increases in air pollution may be one risk factor for hospitalization of patients with a primary diagnosis of SLE. (PI: Sabit Cakmak)

Obstructive sleep apnea (OSA) has been shown to be linked to heart disease, hypertension, diabetes and depression. Sleep disordered breathing, which is characterized by abnormal or insufficient breathing in sleep causing sleep fragmentation and a reduction in blood oxygen level, has been associated with oxidative stress and inflammatory biomarkers. Positive airway pressure (PAP) treatment which helps keep the windpipe open during sleep is the treatment of choice for OSA. However, adherence with PAP treatment is low and multiple factors may affect PAP usage including environmental considerations. OSA and air pollution have been linked to increased cardiovascular diseases and mortality and may lead to symptoms of nervous system inflammation, including sensory discomfort and fatigue, the latter being a common manifestation of poor quality sleep. However, the association between pollution and OSA is still poorly understood and current evidence is very limited, though some human and animal studies have demonstrated that air pollution has an effect on OSA. Indoor air pollution, especially particulate matter which is small enough to be deposited in the upper airways of the respiratory tract, may potentially cause irritation and inflammation of the upper airways, reduce airway patency and consequently may lead to OSA development or worsening of existing OSA symptoms. This study aims to establish the concentration-response function for OSA by comparing day-to-day and night-to-night changes in air pollution with night-to-night changes in control of sleep apnea as measured by data from individuals'' CPAP machines. The results of this study will allow researchers to determine if air pollution aggravates sleep apnea and to what degree. This will help Federal evaluators determine the burden of illness/disease due to air pollution in the Canadian population, will be useful for determining the total economic impact of air pollution, and in the end, help with decisions about air quality standards. (PI: Bob Dales; Dr Tetyana Kendzerska [Ottawa Hospital Research Institute])

Health Canada is responsible for assessing public health risks of air pollution, identifying specific vulnerable populations, and reducing the negative impacts of environmental exposures on the health of Canadians. This project examines neurological effect of outdoor air pollution on children through maternal exposure during pre-pregnancy and pregnancy. The study focuses on Autism Spectrum Disorder (ASD) in young children, which is a complex developmental disorder, characterized by difficulties in social communication and interaction that can persist throughout life. In Canada, the Public Health Agency of Canada released a report of the National Autism Spectrum Disorder Surveillance System, focusing on prevalence and incidence in children (ages 5-17) from six provinces and one territory. With limited studies on the association between air pollution and childhood ASD in Canada, Health Canada is undertaking an epidemiological research study to investigate negative effects of maternal exposure to various air pollutants during pregnancy on ASD in children aged five or under; a vulnerable Canadian subpopulation in Ontario. In contrast, positive effects of neighbourhood green space and walkability are also examined. The study objective is to estimate the associations between exposure to air pollution (and/or green space and walkability) and ASD in children born between April 1, 2012 and March 31, 2020. This study examines pairs of children with ASD and their mothers based on key linkages and then estimates the association between maternal exposure to air pollution and ASD in children based on a matched case-control design with a matching ratio of 1:5. Evaluation during the perinatal period is essential since it is the period of critical brain development during which an environmental exposure can influence neurodevelopment. Study findings will help to understand potential causation or prevention of the occurrence of ASD in children and thus reduce burden of societal and family related health care and costs. (PI: Hwashin Shin)

The COVID-19 pandemic is one of the greatest health challenges in our time. Since the outbreak, it has claimed over 3.8 million lives, shut down many nations, and triggered a global socioeconomic crisis. There is unprecedented urgency to understand who are most vulnerable to COVID-19 and which factors may inflict severe illness after the infection. This information is critical for supporting population-level interventions that are essential to stem the tide of the COVID-19 crisis. Health Canada is conducting a study to investigate whether COVID-19 patients who have been exposed to poor air quality are at greater risk for hospitalization, admission to an intensive care unit, use of a ventilator, and death. There are emerging observations linking air quality to COVID-19 mortality, but more research is needed to better understand the potential role of air pollution in affecting COVID severity. The second objective of the COVID-Air project is to further investigate whether air pollution reductions due to the lockdown may yield any health benefit. The lockdown emulates an unprecedented regulatory action that resulted in drastic traffic reductions over vast regions simultaneously. Results of this study will make unique contributions to advancing our understanding about the intersection between COVID-19 and air pollution and the potential role of air pollution mitigation in curbing the COVID-19 crisis, thereby supporting the mandate of Health Canada in the eras of COVID-19 pandemic and post-COVID recovery. (PI: Hong Chen)

Health Canada is responsible for assessing the health risks associated with exposure to air pollution. Even at the relatively low average pollutant levels typically experienced in Canada, exposure to air pollution is associated with increased risk of neurological and mental health disorders (e.g. cognitive decline, dementia, depression). However, underlying mechanisms are unclear. Stress may be a central unifying mechanism. Health Canada research has shown experimentally that inhaled ambient particulate matter and ozone provoke a stress response, causing the release of stress hormones that impact biological systems throughout the body. The brain is highly sensitive to stress, and chronic stress exerts profound biochemical and structural effects on the brain that contribute to local and systemic disease processes. This study investigates the role of stress responses in mediating impacts of pollutant inhalation on the brain and lungs. In vivo and in vitro models are used to examine biological pathways that link pollutant effects in the lungs and blood to the brain, and in turn feedback to impact the lungs and other organs. In collaboration with researchers at the University of British Columbia, stress biomarkers are assessed in a human diesel exhaust chamber study to extend laboratory findings to humans. Knowledge gained is being used to explore stress hormone involvement in associations between air pollution and brain development in a birth cohort in collaboration with researchers at ISGlobal (Barcelona, Spain). By linking results from experimental models to humans, this project will support the causal basis of epidemiological associations and inform effective risk assessment and management strategies. (PI: Errol Thomson)

Identifying impacts of air pollution exposure during critical fetal developmental periods has been prioritized under Health Canada's program to address air pollution and by international air pollution regulatory programs. However, traditional approaches have had limited success in addressing this issue. This study will apply an emerging novel approach (multilevel Bayesian modeling) to identify periods of susceptibility to air pollution during fetal development in the Maternal-Infant Research on Environmental Chemicals (MIREC) cohort. Air pollution exposures will be estimated using coupled satellite remote sensing and National Air Pollution Surveillance program (NAPS) data, an approach that Health Canada researchers have previously validated in Windsor, Ontario. The study results suggest that exposure to ambient air pollution during critical periods of pregnancy may be associated with lower birth weight among term infants. A manuscript is expected for submission to a journal in 2021. (PI: Markey Johnson)

Canada has a large railway network, with nearly 50,000 km of railway and hundreds of train yards. Train yards are nodes in the railway network that intensify polluting activity, with locomotives operating 24hr/day year-round along with transport trucks and freight-handling equipment. Railway corridors and train yards frequently intersect residential areas, including large urban cities where the majority of Canadians live and work, raising health concerns about the rail sector's significant air pollution releases. Railway-generated air pollution is complex, combining fossil fuel (diesel) combustion emissions with friction/wear emissions (steel rails/wheels, brakes) and dust resuspension. These gaseous and particulate matter (PM) releases include a suite of pollutants with known acute and chronic health effects, including nitrogen dioxide (NO 2 ), sulphur dioxide (SO2), and respirable particles in multiple size fractions (UFP, PM2.5, PM2.5-10) and containing toxic elements (e.g., heavy metals, PAHs) that may contribute to oxidative stress. Residents exposed to railway air pollution may also experience related noise pollution with potentially cumulative health effects. Canadian train yards constitute an air health knowledge gap, lacking relevant emissions and exposure data to characterize impacts on urban air quality and health. To address this air health knowledge gap, the Trainyard Neighbourhood Air Quality (TyNAQ) research project will conduct near-source and community air quality sampling campaigns for multiple air pollutants and noise near a large Canadian urban train yard in Toronto, Canada. Field work is taking place 2020-2021. (PI: Angelos T. Anastasopolos)

Worldwide, governments are dealing with a wave of public interest in cannabis oil products. The legal status of these products varies significantly from country to country depending on how laws governing controlled substances and access to cannabis for different purposes are written. Canada can be regarded as an international leader in regulation of cannabis products since it is one of few jurisdictions where cannabis products can be massively produced legally, and are subject to defined quality requirements. Canada is the second country in the world and the first G20 country to have legalized cannabis for recreational purposes nationwide. Health Canada's mandate is to promote and protect the health of Canadians through leadership, partnership, innovation and action in public health. Health Canada's Health Products Laboratory Program led an international laboratory study for testing of Cannabis Oil products. The goal of this study is to conduct an inter-laboratory testing of a common set of cannabis oil products (provided by reputable legal Canadian producers) using the participants' analytical method of choice to quantify the total levels of tetrahydrocannabinol (THC) and cannabidiol (CBD) in order to verify if results are comparable and to detect trends. Ten laboratories from various countries including Canada, the USA, Singapore, Swiss, Australia and United Kingdom participated in the study. Since Canadian cannabis oil products were sent to participants, this study will also assist foreign participants to better understand the labelling requirements for these products in Canada. Participants will have the opportunity to rigorously prove their capacity and readiness in cannabis testing, e.g. for accreditation purposes. (PI : Justin Morin)

One of Health Canada's microbiology laboratory mandates is to evaluate the foreign matter found in health products and cannabis for the safety of Canadians. Currently, the identification of visible foreign matter relies on microscopic observation, where the result is often inconclusive due to limitations of visual inspection. In order to improve the efficiency and accuracy of visible foreign matter identification, a novel method was developed: rapid identification of visible foreign matter by Fourier-transform infrared (FTIR) spectroscopy. This spectroscopic method obtains the unique spectrum of a sample (foreign matter) by illuminating it with a light source (infrared). Foreign matter absorbs the specific amount of energy from the light source, which is used to vibrate its unique chemical structures. Because no two different materials have the same chemical structure, a FTIR spectrum of a foreign matter is considered its fingerprint. The identity of foreign matter is then predicted within a few minutes by comparing its unique spectrum against the reference spectral database. This work included customization of the research-grade spectra analysis software into that of a "one-click, user-friendly" approach with an aim to offer a technique that no longer requires a highly trained specialist. This method provides a consistent and accurate identification of visible foreign matter in health products and cannabis within a few days. This project is funded under the Deputy Minister's Solutions Fund in support of the pharmaceutical drugs, natural health products and cannabis departmental priorities. (PI : Hayline Kim)

One of Health Canada's mandates is to ensure that legally sold cannabis complies with cannabis regulations in terms of its microbial content. In order to be able to verify the compliance of these products, microbiological analyses are carried out. According to our service standard, results must be issued within a maximum of 21 days. The classical microbiological method used routinely in the laboratory for microbial enumeration is very time consuming and requires a lot of material. To shorten the analysis time and improve the service standard, a study was conducted to validate an automated enumeration method developed by BioMérieux for food products using a specialized device, the TEMPO. A first study was carried out on 30 dried cannabis samples to compare the results of the TEMPO with the plate enumeration method of the European Pharmacopoeia (Ph.Eur. 2.6.31) currently in use. The results demonstrated a significant difference between the two methods. It was suspected that the difference was related to the incubation time which is very different between the two methods. This led to a second study to verify this assumption. To date, a pre-study assessing the effect of incubation time on bacterial count by the automated TEMPO method has been performed. The results obtained are encouraging and a second validation study with new parameters is in preparation. The HC's Microbiology laboratory receives funds for the cannabis departmental priority. (PI : Jamile Ahmarani)

Climate Change

The Climate Change and Innovation Bureau has a long-term target of ensuring that Canadians are resilient to the health effects of climate change. The evaluation of the ARTSSN completed in October of 2020 by Alberta Health Services, was the second evaluationof existing real-time syndromic surveillance systems.The purpose was to identify the key components for an effective, comprehensive real-time surveillance system to assess the health impacts of climate change. The outputs from this research, in combination with reports from previous studies, will directly address program activities Health Canada is required to deliver on as written in the treasury board submission approved in 2016, Adapting to Climate Change Impacts. Specifically, these will inform Health Canada in the development of Pan-Canadian national monitoring and surveillance activities and provide guidance as Health Canada works with provincial and territorial partners to expand the availability of systems that collect real-time data about climate-related health issues and the public health information management systems that support them. (PI: Victor Gallant)

Climate change affects health through a range of pathways, including increasing frequency and intensity of hazardous extreme weather events, altering transmission of water-borne and vector-borne disease, and undermining the environmental and social determinants of health such as the quality and quantity of freshwater supplies, and of food. It therefore places stress on the infrastructure, management systems and capacity of health systems. Health Canada and the World Health Organization (WHO) have collaborated on climate change and health for approximately 20 years, resulting in publications, webinars and activities that continue to assist health authorities globally and across Canada in their efforts to prepare for the health impacts of climate change. This multi-year project will investigate and develop

• Tools for assessing climate change vulnerability of healthcare facilities;
• Targeted guidance for prioritization of available health adaptation options, and indicators for measuring overall health system resilience; and
• A framework for monitoring and surveillance of climate-sensitive diseases.

Results of this research and guideline development will advance efforts to promote health system resilience to climate change around the world. (PI: Rebekka Schnitter).

The connections between health, economics and climate action have been less explored in policy and practice. Limited information on climate change's economic costs and stresses to health systems challenges attempts to develop climate resiliency in the health sector and to scale-up near term and longer term adaptation investments. Through this project, the World Health Organization (WHO) seeks to collaborate with economists to guide the health sector and the climate community in better understanding the economic costs and health gains and savings relating to climate change action and/or inaction. Taking action on climate change carries significant health, social and economic implications. These include benefits from the reduced risk to human health that result from adaptation to global warming, and the large health gains that can be achieved by actions that reduce greenhouse gas emissions and improve air quality. Health gains can be assigned an economic value. The social benefits of climate change can be set against the economic costs of policy interventions. Through this project, the WHO seeks to develop a more coherent approach to health, economics and climate change and a higher priority for health in climate change mitigation and adaptation policy by providing a clear common understanding of how these considerations should be jointly assessed. This will include the development of an overall health, climate change and economic framework. The organization also aims to review existing tools for health, climate and economic assessment to assist in improving global practice in selecting health adaptation options, and in promoting actions that improve health outcomes and climate change mitigation. Finally, executing a policy simulation exercise will contribute to an improvement in the global practice of analyzing the health, economic and climate change implications. (PI: Victor Gallant).

The Climate Change and Innovation Bureau has a long-term target of ensuring that Canadians are resilient to the health effects of climate change. This includes monitoring the heat-related health impacts in Canada (per 100 000 people) every 3 years, with a baseline established by the end of fiscal year 2021-2022. This project aims to establish baseline risk estimates for climate-related illness and death in Canada by cities and health regions, and project future temperature-related mortality and morbidity risk under different climate change scenarios. Mortality data will come from the Canadian Vital Statistics-Death Database for 1986 to 2015, and the morbidity data will be available from the Discharge Abstract Database for 1994 to 2015. This research takes into account demographic changes through projections made by Statistics Canada with weather data obtained from weather stations in the different cities and health regions. Investigators will obtain modeled daily temperature series for 1990-2099 for each city and health region, from five Global Circulation Models (GCM), under each Representative Concentration Pathway (RCP) and will compute health impacts by estimating exposure-response relationships between observed daily temperature and daily mortality and morbidity counts in each city and health region. The excess mortality and morbidity (with a sub-analysis investigating cause-specific mortality and morbidity, and analyses by sex and socioeconomic factors where available) for each GCM/RCP combination will subsequently be projected. This study will offer a comprehensive characterization of climate change impacts due to changes in exposure to non-optimal outdoor temperature, across various regions in Canada, and under alternative scenarios of global warming. (PI: Chris Hebbern; Éric Lavigne)

Increases in temperature and the number of extreme heat events have been identified as key issues related to climate change for workers in Canada. Studies conducted in Quebec have highlighted that the daily compensation of workers for health problems related to excessive exposure to heat and for traumatic work-related injuries increases with outdoor temperatures in the summer. These associations have never been evaluated elsewhere in Canada and the impacts of a warming climate on these claims have not been studied in Quebec or in other Canadian provinces. This project aimed to establish associations between the summer outdoor temperatures in five provinces (Ontario, Quebec, Manitoba, Saskatchewan, and Alberta) and the compensated occupational health problems related to overexposure to heat and associated traumatic work-related injuries. In addition, it aimed to estimate the health impacts of climate warming by calculating the change in such compensation by 2050. The project, conducted by the Institut national de santé publique du Québec, was completed in November 2020. (Collaborator: Peter Berry; Monique D'Amour)

The Climate Change and Innovation Bureau has a long-term target of ensuring that Canadians are resilient to the health effects of climate change. Although climate change could affect some countries and regions more than others, all countries are expected to be affected. The objective of this project is to provide a targeted, evidence-based (where data are available) overview of the literature published between 2000 and 2019 linked to climate change and climate-related health impacts and their attributed costs in Canada and elsewhere. This project is a first step in addressing the need to better understand increased costs on the health system (the need for costing of these impacts was identified as a priority at a February 2018 Experts Meeting on Climate Change and Health Monitoring and Surveillance that was hosted by Health Canada, as well as by HealthADAPT G&C recipients in March 2019). The report will serve as an informational tool to increase the awareness of public health officials, planners, decision makers, and other stakeholders of the costs that climate change could pose to human health and the health system. The analysis, impacts, methods and data identified in this project may be used to inform the conduct of an in-house economic cost-benefit analysis in the future. (PI:Victor Gallant; Modjgan Alishahi, PhD Student)

Establishing evidence-based indoor temperature thresholds to protect health

Extreme heat is a major health risk in Canada resulting in a significant number of preventable illnesses and deaths annually, and is only expected to increase in severity, frequency and duration due to the changing climate. Most heat-related fatalities occur indoors where Canadians, especially vulnerable people like the elderly and the chronically ill, spend most of their time. The aim of this research is to establish evidence-based indoor temperature guidance in support of Health Canada's role in reducing negative health impacts of climate change. In 2018, the Climate Change and Innovation Bureau funded a review authored by Dr. Glen P. Kenny (University of Ottawa) that identified a need to improve understanding of how the human body responds to heat stress indoors, especially in at-risk populations. Physiological experiments are now underway to assess how individuals respond to a range of temperatures which will help determine indoor temperature conditions that are potentially dangerous for human health. This laboratory-based research was launched in early 2019 for older adults (65 to 80 years old), who have a reduced ability to adapt to heat and are therefore a population of concern. In 2019, preliminary field observations were completed for children and adolescents (10-14 years old), another population of concern. Data gathering and further literature reviews were completed as a means of building the evidence-base for this project, including for children and other potential vulnerable populations. These reviews have been completed and have been published in 2020. A final report is expected to be completed in the winter of 2022 and the results will be used in developing guidance needed to better protect Canadian health from heat risks indoors. (PI: Victor Gallant; Kerri Warner)

The Climate Change and Innovation Bureau has a long-term target of ensuring that Canadians are resilient to the health effects of climate change. Extreme weather and disasters are among the most severe threats of climate change facing Canadians in the future. Climate change is expected to increase the frequency and severity of a number of natural hazards including extreme heat events, floods, wildfires, droughts, ice storms, and tornadoes. To inform the development of effective adaptation measures from local to national levels in Canada, greater information on links between meteorological, hydrological and climate hazards and health, including key drivers of vulnerability are needed. This research project will provide information on the latest scientific research on extreme weather in a changing climate and implications for population health and health system implications. This study was published in 2021. (PI: Peter Berry)

The Climate Change and Innovation Bureau has a long-term target of ensuring that Canadians are resilient to the health effects of climate change. This research project led by the Institut national de santé publique du Québec, aims to quantify certain socio-economic benefits linked to the use of green spaces in urban areas, as a tool for adapting to the challenges posed by climate change. There is currently little information on this subject worldwide. The project will focus on the main urban areas of Quebec, working to develop a methodology that can be generalized to other comparable cities here and elsewhere (other provinces of Canada, USA, etc.) in the future. The main objective of the research project is to quantitatively document the impact of green spaces on human health and their potential for adaptation to climate change. To do this, the study will carry out a systematic review of the scientific literature on the subject, and a web survey on exposure to urban green spaces in Quebec and their use in several contexts. Next, the research project will quantify the economic benefits resulting from the current use and future establishment of additional green spaces in urban areas. It is hypothesized that these benefits will stem from the potential reduction in health costs and the improvement of future resilience in adaptation to climate change. Finally, the researchers plan to prepare recommendations for applying the quantification methodology across Canada and comparable territories. These recommendations will relate to the methodological framework, the available data, the harmonization of the parameters to be used, and the conditions for their use. (Collaborator: Monique D'Amour; Victor Gallant; Modjgan Alishahi).

Health of Canadians in a changing climate: Advancing our knowledge for action 3021

The Government of Canada is preparing a series of resources about how Canada's climate is changing. The Climate Change and Innovation Bureau (CCIB) at Health Canada is taking the lead along with a range of governmental and non-governmental partners. The development of the next climate change and health assessment that will be part of the Government of Canada Climate Change Impacts and Adaptation Knowledge Assessment to be released in 2021.This report will build on the two previous climate change and health assessments, delivered in 2008 and 2014 . The objective of the assessment is to present new knowledge about climate change impacts on the health of Canadians, populations of highest concern and vulnerable regions to inform effective actions by health sector decision makers to protect health. Through consultation with partners and input from individual Canadians the resulting report, Canada in a Changing Climate: Advancing our Knowledge for Action will:

• Examine climate change impacts on the health of Canadians;
• Explore climate change impacts to the health system; and,
• Investigate measures to effectively adapt to a changing climate and reduce future climate change

The final assessment is expected to be released in 2021. (PI: Peter Berry)

The HealthADAPT Program is a multi-year capacity building program introduced in 2018 to help the Canadian health sector prepare for and respond to the health impacts of climate change. The Program supports the development, testing and implementation of local and regional climate change health adaptation plans and aims to increase understanding of the impact of climate change on health systems, the health of Canadians and communities potentially at higher risk. The Program launched a call for proposals in 2018 and currently funds 10 health authorities across 5 provinces and territories until March 2022. The objective of the HealthADAPT Lessons Learned Research Initiative is to provide health authorities in Canada with practical guidance on how to address climate-driven health risks within their jurisdictions, with a specific emphasis on how to get started on a climate change and health vulnerability and adaptation (V&A) assessment. This research initiative will include: surveys with HealthADAPT funding recipients to evaluate their experiences with the program, and surveys with Canadian health authorities who have not conducted climate change and health V&As to better understand any barriers to getting started. Additionally, this research will include: key informant interviews with all HealthADAPT funding recipients to understand any challenges and opportunities they experienced getting started on their projects, and key informant interview with climate change and health experts who support health authorities with climate change and health V&As. This research will inform a guidance document that will provide an overview of lessons learned from the HealthADAPT Program. The production and distribution of this guidance document will support the HealthADAPT Program's overarching aim of building capacity among health authorities across in Canada to prepare for and respond to the impacts of climate change. (PI: Katie Hayes)

Improving the identification of heat associated deaths in Canada: Estimating the effectiveness of medical attendance at the place of death and implications for Heat Alert and Response Systems (HARS) (Health Canada – British Columbia Centre for Disease Control MOA, 3019-21)

One of the mandates of the Climate Change and Innovation Bureau, in relation to heat hazard, is to improve the estimation of the health risks of heat. In many locations, heat associated mortality is greatly under-estimated and there are wide variances in heat-associated death estimates between jurisdictions for the same heat event. It is unclear if these differences reflect true differences or different approaches to estimation. By identifying all indirect and direct heat-associated deaths and when, where and why these deaths happen, effective and appropriate risk communication approaches and risk management actions can be informed. In 2016, the British Columbia Centre for Disease Control (BC CDC) published a unique methodology (https://doi.org/10.1186/s12940-016-0195-z) for identifying deaths associated with heat that may have otherwise been missed in traditional reports of coroners and other surveillance sources. In collaboration with local and provincial health authorities, BC CDC is examining the mortality data from past heat events and control periods in Ontario and Quebec to apply this framework. This research study will compare results from current and new methodologies to assess differenecs in deaths attributed to hot weather across jurisdictions. The results will be used to inform development of a more cohesive Canadian approach. (Collaborator: Rebecca Stranberg)

The Climate Change and Innovation Bureau has a long-term target of ensuring that Canadians are resilient to the health effects of climate change. Planning and designing thermally comfortable outdoor spaces is increasingly important in the context of climate change, particularly as children are more vulnerable than adults to environmental extremes. Playground infrastructure can present some of the highest surface temperatures within an urban area and can result in unsafe heat exposure and heat-related injuries. In Canada, existing playground standards focus on equipment and surfacing to reduce trip- and fall- related injuries, but have not addressed environmental factors affecting unsafe exposure and heat stress. In partnership with the Standards Council of Canada, the goal of this project was to develop proposed guidelines for designing thermally comfortable playgrounds in Canada, for inclusion within the CAN/CSA-Z614 Children's play spaces and equipment standard. To that end, the project team conducted a detailed literature review of relevant research, standards, and design practices, conducted a needs assessment survey with a broad range of Canadian and international experts and stakeholders, and produced recommendations for an informative thermal comfort annex. This project has resulted in several important outcomes. First, the project team produced a report with design advice for improving thermal comfort at playgrounds across Canada. Second, the Canadian Standards Association has approved a six page annex with similar guidance. Third, an NGO has integrated "thermal comfort" considerations into their national school ground greening design competition. Thermally safe and comfortable play spaces will help ensure that Canada's playgrounds are designed to minimize environmental health risks for children. A summary of this work was published in the Canadian Journal of Public Health in 2021. (PI: Alexandra Rutledge; Gregory Richardson)

Health Canada has a mandate under the Federal Contaminated Sites Action Plan (FCSAP) program to provide expert scientific risk assessment/mitigation advice, technical training and other tools to assist federal custodian departments in assessing and managing human health risks for their contaminated sites. Currently, there is no guidance that specifies how Climate Change (CC) should be taken into account in the context of a Human Health Risk Assessment (HHRA). This project documented the current state of knowledge on CC considerations within the scope of an HHRA. Specific objectives included the identification of CC associated events and processes that can affect the components of HHRAs including exposure and toxicity assessments, and risk characterization of chemicals of potential concerns (COPCs). COPCs including arsenic (As), cadmium (Cd), lead (Pb), mercury (Hg), per- and polyfluoroalkyl substances (PFAS), and petroleum hydrocarbons (PHC) were used to evaluate whether the influence of CC can be incorporated into the existing HHRA framework. It is important to understand both chemical and non-chemical related human health impacts. New approaches (e.g. Adverse Outcome Pathway) that integrate the combined effects of chemical exposure and climate change are being developed for possible use in the HHRAs. The scoping review identified many data and knowledge gaps. For risk characterization, a cumulative assessment appears to appropriately address the effects of chemical and non-chemical stressors. Further evaluation of these models were recommended. The magnitude of the effect of climate change on the dose-response is not exactly known. Furthermore, a lack of methodologies were identified that can integrate the health risk associated with the direct and indirect effects of climate change. A number of follow up studies on cumulative models, receptor characterization and additional evaluation of exposure and toxicity assessments related to contaminated sites risk management were recommended. (PI: Asish Mohapatra; Dr. Laurie Chan (University of Ottawa) in association with Canada North Environmental Services Ontario)

Public perceptions of the health impacts of climate change in Canada, 2021/22

The Climate Change and Innovation Bureau has a long-term target of ensuring that Canadians are resilient to the health effects of climate change. In order to develop effective information tools that will protect the health of Canadians from the impacts of climate change, it is important to understand their current level of awareness. This includes understanding their perceptions of climate change-related health risks as well as their knowledge of the issues affecting them now and into the future. Health Canada's Climate Change Performance Information Profile requires updated public opinion research (POR) information every 5 years. The Department undertook POR in 2008 and 2017 and therefore the next update is required by the end of March 2022. Planning for this POR survey began in 2020. In consultation with internal and external stakeholders a review of the previous POR survey questionnaires was carried out to identify those questions that remain relevant and which should be kept for the upcoming POR. The updated POR survey will also include questions related to emerging issues, such as the mental health impacts of climate change. This update will determine how public awareness and understanding of climate change has changed since 2017 and may help the department create more effective public health communication campaigns surrounding its information and training programs aimed at protecting the health of Canadians from climate change related impacts. The project is linked to Health Canada's Climate Change Program, which seeks to increase the level of awareness among Canadians of extreme heat health risks and other climate change hazards. Information on climate change, health risks and health protection advice is provided to the general public. (PI: Lubna Salman)

The urban forest is a green infrastructure system that delivers multiple environmental, economic, social and health services, and functions in cities. Environmental benefits of urban trees are well understood, but no review to date has examined how urban trees affect human health. This review provides a comprehensive summary of existing literature on the health impacts of urban trees that can inform future research, policy, and nature-based public health interventions. A systematic search used keywords representing human health, environmental health, and urban forestry. Following screening and appraisal of several thousand articles, 201 studies were conceptually sorted into a three-part framework. Reducing Harm, representing 41% of studies, includes topics such as air pollution, ultraviolet radiation, heat exposure, and pollen. Restoring Capacities, at 31%, includes attention restoration, mental health, stress reduction, and clinical outcomes. Building Capacities, at 28%, includes topics such as birth outcomes, active living, and weight status. The studies that were reviewed show substantial heterogeneity in purpose and method yet indicate important health outcomes associated with people's exposure to trees. This review will help inform future research and practice, and demonstrates why urban forest planning and management should strategically promote trees as a social determinant of public health. This review was published in June 2020 and includes a list of 198 references as supplementary materials. (PI: Gregory Richardson)

Consumer Product Safety

Health Canada helps to protect the health of Canadians by assessing and managing the risks associated with exposure to environmental chemicals. DEET is the common name for N,N-Diethyl-m-toluamide, an active ingredient in personal insect repellents approved by Health Canada for use by children and adults. DEET helps protect against mosquito, blackfly and tick bites. The purpose of this study is to generate biomonitoring data from DEET used by children in a camp setting. Following parental consent, about 125 children aged 7 to 13 years participating in overnight camps and who are already planning to use DEET were recruited. Urine samples were gathered over the course of one 24-hour day in the camp setting and analysed to determine the amount of DEET and two metabolites in the body. The study, which complements other studies by Health Canada that measure chemical exposures in children from typical use, will provide a better understanding of Canadian children's exposure to DEET and inform any future recommendations. (PI: Jennifer Gibson; Kim Irwin)

The Chemicals Management Plan (CMP) is a Government of Canada initiative aimed at reducing the risks posed by chemicals to Canadians and their environment. Organic flame retardants were among the chemicals identified as priorities for action in the second and third phases of CMP. In 2019-20, in order to support risk assessment and risk management strategies for flame retardants, the Product Safety Laboratory (PSL) tested a series of polymeric foam consumer products for the total concentration of five flame retardants: tris(1-chloro-2-propyl)phosphate (TCPP), tris(1,3-dichloro-2-propyl) phosphate (TDCPP), 1,3,5-Triazine-2,4,6-triamine (melamine), triethyl phosphate (TEP), and isopropylphenyl phosphate (IPPP). The current project expands on the work from 2019-20, by examining the dermal absorption of TEP, IPPP, and melamine using a simulated sweat system. PSL developed and validated test methods for the dermal absorption of TEP, IPPP and melamine, and tested a subset of consumer products from the 2019-20 project. A total of 27 specimens were tested for the dermal absorption of melamine, and 30 specimens were tested for the dermal absorption of TEP and IPPP. In addition to dermal absorption, this project examined loss of flame retardant concentration over time in storage, by testing the identified subset of consumer products for total concentration following 20 months in storage. The dataset generated from this project will further support risk assessment and risk management strategies for TEP, IPPP and melamine. (PI: Nathalie Ritchot; Katrina Griffiths)

Health Canada is responsible for the assessment and management of health risks to Canadians associated with exposure to chemicals in the environment. Consumer products are major indoor sources of many chemicals including semi-volatile organic compounds (SVOCs) such as plasticizers and flame retardants. SVOCs in these products can enter indoor environments through evaporation if they are not chemically bound to the materials. The rate of evaporation, also called emission rate, is a critical piece of information in estimating SVOC levels indoors in order to assess human exposure to SVOCs from products. Due to relatively low vapour pressure and great tendency to be absorbed on surface materials, emission rates of SVOCs are difficult to measure using traditional environmental chamber tests. Further, when temperature increases, the emission rate also increases and desorption tendency decreases. The relationship between temperature and emission rates can be established through an empirical model. This project uses chamber tests at elevated temperatures to develop high-throughput methods to generate emission rates of selected bulk SVOCs, including plasticizers and flame retardants, and of SVOC-containing products. The emission rates are then used to predict levels of SVOCs in indoor air as a result of using SVOC-containing products indoors through available indoor air fate models. Prediction of SVOC levels in indoor air will support human exposure assessment and development of indoor air policies and guidelines. (PI: Jiping Zhu)

Health Canada assesses and manages risks of biotechnology microorganisms under CEPA (Canadian Environmental Protection Act, 1999). The scope of management includes microorganisms on the Domestic Substance List (DSL) that are contained as active ingredients in some types of microbe-based cleaning products (MBCPs). These products are used as alternatives, or additives, to chemicals-based cleaners and likely contribute to the biomass found in house dust. The exposure patterns of MBCPs in home environments are unknown and without this information, risk cannot be accurately evaluated. In recent years, initiatives have taken place to analyze Canadian house dust ((Canadian House Dust Survey and Canadian Healthy Infant Longitudinal Development (CHILD) birth cohort study)) and these initiatives have helped provide an understanding of Canadian house dust composition. This project examines metagenomic DNA extracted from dust samples from Canadian homes in order to inform the assessment of MBCPs derived from biotechnology microbes. Metagenomic DNA analysis is necessary because microbial cultivation methods can only support the growth of a fraction of microbial flora. The overall objectives are to develop methodology for estimation of DSL microbial presence in house dust and provide insight into the microbial content of homes where MBCPs are used, versus those homes where chemicals-based cleaning products are used. (PI: Phil Shwed)

Microorganisms formulated as heterogeneous mixtures (i.e., microbial mixtures, consortia) must undergo a detailed screening for human pathogenicity and environmental impact by manufacturers. Under current regulations, each microorganism within the mixture must be screened separately which can be costly and time-consuming. Towards understanding if pathogenic characteristics would be masked in mixtures of microorganisms compared to pure cultures, this project aims to compare virulence characteristics (e.g., growth temperature, antibiotic resistance, cellular toxicity) of several known pathogens in pure cultures compared to within a mixture of microorganisms used in biotechnology. The goal is to develop and adapt methods so that they can be applied to any type of heterogeneous microbial mixture being considered for commercial biotechnology applications. (PI: Azam Tayabali)

Microorganisms routinely used in biotechnology for industrial (e.g., biofuel production), consumer (e.g., cleaning products), or emerging applications (e.g., synthetic biology) can be related to those capable of causing infections, especially in people with compromised immunity. Pathogens that can infect people with compromised immune systems are known as opportunistic pathogens. These opportunistic pathogens may share traits with biotechnology-related microbes, which could be a serious problem for risk management. Therefore, it is critical that reliable pathogenicity testing protocols are established to ensure that risk assessments are carried out with the best available data. This project will develop clear, stepwise methods to test the pathogenicity of new microorganisms considered for biotechnology applications. Standardized pathogenicity laboratory methods for opportunistic pathogens do not currently exist, but are needed in order to reduce the regulatory burden associated with non-standardized industry submissions. These methods will enable regulators to guide the biotechnology industry when they notify Health Canada of new microorganisms to be imported into or manufactured in Canada. Examples of these novel methods are advanced intercellular communication toxicity assays, simultaneously screening for multiple indicators of toxicity, and methods to eventually eliminate the need for animal testing. Ultimately, microbial test methods and new laboratory models will greatly advance science-based decision-making for regulators/evaluators, ensure risk assessments take into consideration the most sensitive people in our population, and ultimately result in safer biotechnology products available to the consumer. (PI: Azam Tayabali)

The Food and Drugs Act (F&DA) Substances Assessment Division within the New Substances Assessment and Control Bureau has been established to conduct assessments of the potential environmental and health risk to the general population associated with environmental exposure to substances in F&DA products such as human drugs, biologics, veterinary drugs, cosmetics, novel foods, food additives, natural health products and medical devices. The goals of this research project were to: (a) develop and validate additional methodologies required to analyze a panel of drug substances; and (b) characterize environmental concentrations of 16 R-ICL (Revised In Commerce List) drug substances used in high volume in Canada from sites impacted by agricultural activities and waste water treatment plant (WWTP) effluents across six watersheds in Ontario/Quebec. A total of 228 water samples were analyzed by Liquid Chromatography Mass Spectroscopy (LC-MS), resulting in detections for 11 of the 16 compounds. Venlafaxine was the most detected with 158 hits, while tazobactam and fluvoxamine were only reported from 2 and 1 sites, respectively. Although only detected in 34 surface water samples, guanylurea, the breakdown product of metformin, was detected in the highest concentrations. These data will be used directly in the environmental assessments of substances listed on the Revised In Commerce List and new substances in products regulated by the F&DA notified under the New Substances Notification Regulations of the Canadian Environmental Protection Act, 1999 (CEPA). (PI: Dianne Hughes; Jean Grundy)

Electronic vaping products (EVPs), or e-cigarettes, are battery powered devices that are used to create an aerosol which is inhaled by the user. EVPs are used by hundreds of thousands of Canadians to obtain nicotine. An aerosol is created from a liquid, known as e-liquid, that is housed in a tank or cartridge and usually consists of propylene glycol, glycerol, nicotine, and various flavorings. When used, the devices vaporize the e-liquid by way of a heating element or coil, housed in an atomizer. This vapor then quickly condenses into an aerosol that is inhaled. Many of the substances found in e-liquids, as part of a review conducted by Health Canada's Tobacco Control - Office of Research and Surveillance (ORS), are well-known harmful chemicals also found in tobacco. However, very little is known on the full composition of the thousands of e-liquid formulations available on the Canadian market. The objective of this study is to build Health Canada's capacity in the analysis of complex mixtures of e-liquids. The results of the open characterization will complement the existing body of knowledge on components of e-liquids. It will also support decision making and regulatory activities in providing TORS with data on the chemical composition of electronic cigarettes refill fluids and their aerosols, from products available in the Canadian market. (PI: Cariton Kubwabo)

Health Canada is responsible for assessment and management of risks associated with engineered nanomaterials. Engineered nanomaterials (NMs) including nanoforms of zinc oxides (ZnO) are incorporated into various consumer products. Nano zinc oxide, for instance, has wide ranging applications in paints, coatings, building materials, antibacterial agents, sunscreens, moisturizers, food packaging, etc. These NMs thus can have human health implications and furthermore are problematic in terms of hazard identification and risk evaluation due to lack of reliable physico-chemical and toxicity data, creating a challenge for government agencies towards establishing effective hazard evaluation guidelines. The recent data gap analysis of nanoscale forms of substances on the Domestic Substances List (DSL) of the New Substances Assessment and Control Bureau (NSACB) of Health Canada has identified the nano ZnO (CAS RN 1314-13-2) as one of the 53 nanomaterials in commerce in Canada under the CMP that requires information to help tailor assessment and management approaches. This work is designed to conduct in vitro cytotoxicity screening of nano-zinc oxide forms in two types of lung cells to determine their relative toxicities, using various toxicity testing approaches. Oxidative stress changes and secreted proteins were measured to gain information on toxicity pathways. In addition, association between nano ZnO potencies and their physico-chemical properties is also studied. Toxicity information obtained from this work will support advance the risk assessment processes by NSACB will also support Health Canada's commitments to the Organisation for Economic Cooperation and Development (OECD)- Working Party on Manufactured Nanomaterials (WPMN). (PI: Premkumari Kumarathasan; Azam Tayabali)

The Canadian Surveillance System for Poison Information (CSSPI) led by Health Canada is a developing network of poison centres, health authorities and regulatory agencies that facilitates early detection of poisoning incidents and alerting at the national level to inform harm reduction interventions. In response to the COVID-19 pandemic, concerns were raised over the potential for misuse of cleaning products and disinfectants; the CSSPI network monitored and assessed these concerns. An overall increase in calls about select cleaning products and disinfectants occurred concurrently with the pandemic, with percentage increases for selected products as high as 400% compared to the same period in the previous year. (PI: Abdool Yasseen)

New genetic engineering and synthetic biology technologies are generating unknown threats that need to be assessed and countered. This project aims to advance a biological sensor to detect specific bacteria ( Bacillus species) commonly used in biotechnology applications, but that could be manipulated to function as agents of bioterrorism. These bacteria are termed 'dual-use' because of their capacity to be used for both beneficial and malicious activities. The proposed device is envisaged to be physically linked to water systems (e.g., potable water supplies, dams, pipelines, treatment plants, and recreational sites), and repeatedly (i.e., daily) concentrate and sample bacteria without user intervention. This project also aims to provide fundamental knowledge on the pathogenic potential of bacteria used in biotechnology applications. This will be done by developing a method to mimic an infectious mechanism shared by close relatives of the known biological threat, Bacillus anthracis , which is the etiological agent of anthrax. More specifically, Bacillus anthracis infects specific white blood cells called macrophages, so testing whether other biotechnology bacteria can infect macrophages will provide a functional method to assess pathogenicity. Furthermore, this project will investigate whether biotechnology-related Bacillus species can be detected in natural surface waters. Ultimately, the project aims to develop an innovative biological sensor for automated detection of potential dual-use Bacillus strains, and generate important information on the pathogenic potential and environmental occurrence of biotechnology-related Bacillus species that are close relatives to known human pathogens. (PI: Azam Tayabali)

Controlled Substances

The mandate of Health Canada's Drug Analysis Service (DAS) laboratory is to identify controlled substances to support public safety and law enforcement. Benzodiazepines are a class of drugs that are among the highest prescribed in the pharmaceutical market. Recent trends in seized drugs indicate the addition of new designer benzodiazepines that are often mixed with other harmful drugs, such as opioids. Since Benzodiazepines are potent abused drugs and studies have shown there are increased risks with its dependence and withdrawal, the detection of such compounds is crucial in the protection of the health of Canadians. Historically in DAS, the methods used to detect benzodiazepines required extra work with labor intensive extractions using less sensitive instrumentation. Therefore, the creation of a new analytical method to detect and certify these compounds in an accurate and efficient manner was required. This project, led by the DAS Laboratory, aims to correctly detect and identify these compounds using highly sensitive instrumentation: Time of Flight Mass Spectrometry. Through the addition of benzodiazepines to the scope of the previously validated opioid identification method by UPLC-QToF HR MS E , these analytes can be quickly and effectively reported. The overall process required to certify these compounds is now simplified and more samples can be accurately analyzed in a shorter amount of time. The DAS is funded under the Canadian Drugs and Substances Strategy (CDSS) in support of the controlled substances departmental priority. (PI : Stephanie Dubland)

Collaborative harm reduction initiative between Health Canada and British Columbia Centre on Substance Use for accurate community based drug checking

In British Columbia, where nearly 90% of opioid overdoses occur indoors, making it difficult for first responders to respond, the implementation of drug checking programs has had a positive impact. A pilot project was implemented to check the contents of street drugs in British Columbia using methods that could be used in point-of-care facilities, enabling clients to have their drugs tested in real-time and providing an opportunity for immediate feedback in the community. Health Canada's Drug Analysis Service (DAS) and British Columbia Centre on Substance Use (BCCSU) have worked together to better understand gaps in detection of the FTIR and test strip method used in the community. Where gaps are identified, other methods for detection have been explored. Current gaps in community detection include carfentanil, etizolam, synthetic cannabinoids and potent benzodiazepines. A quantitative Nuclear Magnetic Resonance method for opioids has been used to provide relative % composition of the components in street drug mixtures. In addition, other sensitive techniques including a Liquid Chromatographic Mass Spectrometry assay of the opioid(s) and potent benzodiazepine mixtures are also performed where needed for dilute mixtures. As of July 2021, 13 knowledge products have been published or accepted and 5 more manuscripts are in preparation based on data from this collaborative agreement. The DAS is funded under the Canadian Drugs and Substances Strategy (CDSS) in support of the controlled substances departmental priority. (PI : Richard Laing)

The Drug Analysis Service's (DAS) mandate is to provide quality scientific and technical services to assist with the enforcement of the Controlled Drugs and Substances Act and Regulations. For forensic intelligence purposes, analysis residues from methamphetamine samples were analyzed by the DAS to obtain further chemical profiling information. While both methamphetamine enantiomers ( d and l ) are scheduled in Canada under the Controlled Drugs and Substances Act (CDSA), the distinction between the two enantiomers has important implication for law enforcement in monitoring trends associated with methamphetamine manufacturing, specifically synthetic routes and precursors used. It is hypothesized that the ban on precursor pseudoephedrine and ephedrine by Canada, US and Mexico drove illicit producers to use phenyl-2-propanone (P2P) process in Mexico, while in Canada access to health product supplements and decongestants has permitted a steady domestic supply. Samples were quantitated using an internal standard solution containing maleic acid in deuterated water. To differentiate between the two enantiomers, NMR experiments were performed under a chiral environment by using chiral resolving reagent (R)-(+)-1,1'-bi(2-naphthol) or BINOL. All the sample residuals were found to be d -methamphetamine. These results are consistent with methamphetamine profiling reports from the U.S. Drug Enforcement Agency (DEA) special testing laboratory. Presently, DAS is unable to differentiate the source of the d -methamphetamine produced from either the ephedrine method or the enantiomeric enrichment of d -methamphetamine from the P2P method, until, if or when, more specific techniques and methods are developed in DAS to achieve this goal. The DAS is funded under the Canadian Drugs and Substances Strategy (CDSS) in support of the controlled substances departmental priority. (PI : Richard Laing)

The Drug Analysis Service's (DAS) mandate is to provide quality scientific and technical services to assist with the enforcement of the Controlled Drugs and Substances Act and Regulations. The level of purity of a drug is important for investigative and sentencing purposes. Previous methods used by DAS focused on the quantitation of one specific compound at a time. This project involves the development of a new method to measure effectively the concentration of cocaine, heroin, methamphetamine and MDMA within an exhibit. Besides simultaneous quantitation of multiple drugs of interest, the method utilizes a Triple Quadruple Mass Spectrometer, an instrument that is able to identify accurately compounds at low concentrations. Statistics of seized drug exhibits show that there is a trend towards the mixing of drugs. Unlike in research environments, where samples are relatively pure or mixed in simple matrices, seized drugs are often present in complicated mixtures. The technology used in the method is able to effectively separate the compounds of interest from complicated mixtures, and accurately identify and measure the individual purity of these compounds. Various testing in the validation phase ensured the applicability of the method to real samples. Since the implementation of the method, it has been applied to a large number of exhibits and is greatly beneficial for the efficient and accurate testing of these compounds. The DAS is funded under the Canadian Drugs and Substances Strategy (CDSS) in support of the controlled substances departmental priority. (PI : Stephanie Dubland)

In March 2020, Vancouver Coastal Health and the British Columbia Centre on Substance Use released a new risk mitigation interim clinical guidance that promotes the prescription of pharmaceutical alternatives to the toxic drug supply as a means of reducing overdose risk. It is suspected that a considerable proportion of those receiving prescribed pharmaceutical alternatives in the form of oral tablets or capsules will likely inject them. As oral formulations of tablets and capsules are intended for ingestion, they contain binders, fillers, coatings, waxes, and dyes that can cause a number of health issues if injected, but there is a lack of published studies on the efficacy of filters prior to injection. The BC Center for Disease Control has approached Health Canada's Drug Analysis Service (DAS) and a study on the effect of filters on the recovery of active ingredients, namely morphine sulfate and hydromorphone hydrochloride, using three different filters and in hot and cold water preparations was carried out. Based on DAS' results, no single approach is consistently better for each formulation. Hot preparation does not consistently produce higher recovery of active ingredient as initially expected. DAS's study is strictly focusing on the effect of filters on the recovery of active ingredients and not on the potential risks that may be associated with the route of administration. It cannot be used to develop guidance on how to reduce harm associated with dissolving and injecting oral pharmaceutical formulations. The DAS is funded under the Canadian Drugs and Substances Strategy (CDSS) in support of the controlled substances departmental priority. (PI: Richard Laing)

The Food and Drugs Act (F&DA) Substances Assessment Division within the New Substances Assessment and Control Bureau has been established to conduct assessments of the potential environmental and health risk to the general population associated with environmental exposure to substances in F&DA products such as human drugs, biologics, veterinary drugs, cosmetics, novel foods, food additives, natural health products and medical devices. Currently, one of the most prevalent contaminants is the type-2 diabetic drug, metformin, prescribed to ~120 million people globally, often detected in the ng-µg/L concentration range in surface waters and wastewater effluents. However, there is very little in the scientific literature describing metformin's fate and effects in the aquatic environment. Recent laboratory research observed significant effects on larval growth and metabolite profiling and a shift in hepatic sex steroid levels were seen in adult medaka. This raised concern regarding metformin's effects on wild fish, but also on its fate and potential effects in the aquatic ecosystem as a whole. To address these concerns, Health Canada partnered with Environment and Climate Change Canada, Aquatic Contaminants Research Division. An 8-week mesocosm study was conducted at the IISD-Experimental Lakes Area to investigate the fate of metformin in the aquatic environment and the effects of the compound on aquatic biota via a food web-analysis. As metformin was fairly stable in the mesocosms, the study was extended to follow degradation of metformin through the fall and winter of 2019 and through the following spring and summer of 2020. In addition to observing the fate of metformin through additional seasons, engineered floating wetlands were deployed in mesocosms to assess their ability to take up metformin, removing it from the aquatic system. These data will be used directly in the environmental assessments of substances listed on the Revised In Commerce List and new substances in products regulated by the F&DA notified under the New Substances Notification Regulations of the Canadian Environmental Protection Act, 1999 (CEPA). (PI: Dianne Hughes; Jean Grundy)

Method validation for the analysis of 14 drugs of concern and metabolites in wastewater

Health Canada has a mandate to reduce the harms to Canadians associated with the use of opioids and other psychoactive substances. Wastewater based epidemiology for drugs of concern and their metabolites is a developing scientific field that allows for establishing temporal and geographical trends for drug consumption. In collaboration with Statistics Canada, a method was validated to measure drugs in wastewater for the Canadian Wastewater Survey. A method of analysis involving the quantitation for the following 14 drugs of concern and metabolites was developed for wastewater analysis: amphetamine, benzoylecogonine, cocaine, codeine, fentanyl, heroin, 6-monoacetylmorphine (6-MAM), MDMA, methadone, methamphetamine, morphine, 11-Nor-9-carboxyl-D9-tetrahydrocannabinol (THC-COOH). The method has a method detection limit ranging from 0.2 ng/L to 16ng/L and a method quantitation limit ranging from 0.6 ng/L to 53.3 ng/L. Assessment of accuracy and precision demonstrated that the method has a % recovery ranging from 80% to 115% and a % relative standard of deviation (%RSD) ranging from 3% to 25% across the three spike levels. This validated method will be used to determine levels of drugs of concern from various wastewater treatment plants across five Canadian cities. HC's Food Laboratory receives funding from Statistics Canada, Centre for Population Health Data, for this project in support of the controlled substances departmental priority. (PI: Kerry Kwong)

qNMR multicomponent identification and quantification of street drugs presented

In 2018, the Drug Analysis Service (DAS) received funding under the Canadian Drugs and Substances Strategy to provide expanded analysis for project work for non-traditional clients such as provincial health authorities, regional or community based drug checking programs. Drug mixtures are often comprised of known molecules of interest – such as drug molecules and cutting agents for which high quality reference NMR spectra exist. However, when significant resonance overlap occurs, the analysis and interpretation of NMR spectra can become prohibitively time consuming or entirely infeasible. This obstacle provides a significant challenge for the implementation of NMR as a routine, high-throughput instrument in a forensic laboratory. To overcome this, DAS has developed a novel multi-component, multi-resonance algorithm to analyze complex drug mixtures using quantitative nuclear magnetic resonance (qNMR) spectroscopy, a powerful analytical technique in the identification and quantitation of components present in a sample. The 1 H NMR spectrum of the drug mixture can be reduced to a linear combination of reference spectra, and the analysis of the drug mixture becomes a signal decomposition problem to find the weights for each of the reference spectra to reconstruct the mixture spectrum. The NMRquant algorithm can identify, separate, and quantitate overlapping resonances from different components in commonly encountered drug matrices. This turnkey solution has allowed for the successful implementation of for the analysis of hard drugs and cannabis resin. Key strengths of the method include simple sample preparation, quick analysis time, high specificity, and flexible library that allows for adaptation to new compounds. The DAS is funded under the Canadian Drugs and Substances Strategy (CDSS) in support of the controlled substances departmental priority. (PI: Richard Laing)

Food & Nutrition

The Canadian Nutrient File (CNF) is a comprehensive food composition database for reporting amounts of nutrients in foods commonly consumed in Canada. There is currently very little information on the levels of vitamin K in foods from Canadian sources. The data that are available are typically limited to levels of K1, one of the two naturally occurring vitamin K subtypes. Vitamin K is a group of fat-soluble vitamins found in foods, which perform several essential functions in the human body, including production of blood-clotting proteins. Vitamin K1 occurs naturally in plants, especially dark green leafy vegetables like spinach and kale. In animals, K1 is converted to MK4 (a subtype of vitamin K2), so it is found in foods of animal origin. Determination of both K1 and MK4 in the foods we eat is therefore critical to understanding our dietary intake of vitamin K. The Food Lab has developed and validated a method to determine vitamin K in a variety of food samples collected for SNAP-CAN. This will be the first time that Canadian generated data for vitamin K1 and MK4 will be reported in the CNF. Briefly, the method uses enzyme digestion to break down proteins, followed by extraction with hexane to isolate the fat-soluble vitamins. This extract is purified and concentrated, and levels of K1 and MK4 are determined using ultra-high performance liquid chromatography and tandem mass spectrometry. Detection levels are 0.05 µg/100 g for K1, and 0.06 µg/100 g for MK4. (PI: Monica Dyck)

Health Impacts of Chemicals

Health Canada contributes to the development and standardization of internationally accepted test guidelines (TGs) for the Organisation for Economic Cooperation and Development (OECD). TGs are routinely used for assessing the safety of chemicals before they come on the market. HC has played a fundamental role in developing TG 488 (Transgenic Rodent Mutation Assay) for evaluating the induction of mutations (i.e., changes in the DNA sequence) in germ cells (sperm and eggs) or in somatic cells (all other cell types in the body). Mutations in germ cells may be transmitted to offspring resulting in heritable genetic effects that impact both the individual and population; mutations in somatic cells increase the risk that an individual will develop cancer. Despite these distinct implications, regulatory testing is done almost exclusively in somatic cells. A significant hurdle is the need for a second set of animals for germ cell testing, because of the duration of spermatogenesis, the process producing sperm. Previous work conducted under this project has generated critical data that has recently lead the OECD to update TG 488 on the recommended design for germ cell mutagenicity. This work suggested that it may be possible to select a single time-point for analyzing mutations in somatic and germ cells of the same animals with comparable sensitivity. However, more data is needed to demonstrate the impact of the germ-cell specific time point for detecting mutations in somatic tissues. In new work, data has been generated demonstrating the suitability of this single time-point for mutagenicity testing in somatic tissues. This integrated approach will significantly reduce the number of animals that are needed for testing. (PI: Francesco Marchetti)

The Organisation for Economic Co-operation and Development (OECD), in which Canada is a member country, and the European Centre for the Validation of Alternative Methods (ECVAM), are international agencies collaborating to set standards to be used by industries worldwide to identify toxic chemicals. Among evaluated cell transformation assays, the "Syrian Hamster Embryo Cell Transformation Assay" (SHE-CTA), was found to be the most accurate CTA to identify chemicals with the ability to induce cancer. In contrast to other tests, the SHE-CTA detects both the chemicals that induce cancer by damaging DNA and those that do not damage DNA (which are difficult to identify). Some OECD-member countries raised concerns that the molecular mechanisms in the SHE-CTA may not be relevant to those in humans. Nevertheless, the advantages of this test, and its consideration in proposed chemical testing strategies by the U.S. Environmental Protection Agency's (Office of Chemical Safety and Pollution Prevention), may influence companies to generate SHE-CTA data, which will also eventually be submitted for review by Health Canada. The initial research plan involved the development of the SHE-CTA in the laboratory to: (1) gain expertise in conducting this assay and test priority chemicals, (2) investigate mechanisms of cell transformation, and (3) identify endpoints that can improve this assay. The chronology of DNA changes were demonstrated starting from normal cells up to the time at which they become potential cancer cells. Based on these findings, methods to improve the assay can be suggested and tested. Collectively, these in vitro data will assist HC in the development of chemical testing strategies, in strengthening predictions of chemicals that can increase the risk of developing cancers, and in providing alternatives to reduce dependence on in vivo rodent cancer bioassays. (PI: Daniel Desaulniers)

Many in vitro assays have been proposed for Developmental Neurotoxicity Testing (DNT). However, the reliability and reproducibility of these assays will need to be properly validated before they can be used to inform chemical health risk assessments by Health Canada and other regulatory agencies. Cerebellar Granule Cells (CGCs) harvested from rat pup brains are a popular experimental in vitro model used to study neurodevelopment and neurotoxicity. CGCs are easy to grow and can recapitulate neuron differentiation and maturation processes observed in vivo . Genes associated with CGCs neuro development have been identified and used to screen chemicals for potential developmental neurotoxicity. Unfortunately, replication of these findings at Health Canada proved challenging, as gene expression measurement protocols were often poorly described, quality controls infrequently reported and CGCs themselves presented significant batch-to-batch variability. In spite of these issues, a reliable in vitro DNT protocol based on commercially-sourced CGCs and reagents was optimized and a subset of developmentally-regulated genes presenting reproducible expression patterns across different laboratories was identified. Promising preliminary results suggest that proven developmental neurotoxicants can be differentiated from non-neurotoxic controls based on the expression of this subset of key genes involved in neuron differentiation and maturation. The complete and transparent description of a reliable in vitro DNT assay using well-characterised CGCs and neurodevelopmental biomarker genes will facilitate future investigations and inter-laboratory comparisons. Further validation of this CGC-based assay may lead to its inclusion in a yet-to-be-determined battery of in vitro DNT assays that will support the screening and prioritization of potential developmental neurotoxicants. (PI: Guillaume Pelletier)

Health Canada helps to protect the health of Canadians by assessing and managing the risks associated with exposure to environmental chemicals. People are commonly exposed to triclosan, an antimicrobial agent, and bisphenol A (BPA), the basis of polycarbonate plastics. There is some evidence that these chemicals can disrupt the endocrine system, such as the levels and functions of reproductive hormones. Concentrations of triclosan and BPA were compared in urine in the Canadian and U.S. populations using nationally-representative data from the 2012–2015 Canadian Health Measures Survey (CHMS) and the 2013–2016 National Health and Nutrition Examination Survey (NHANES). The relationship between triclosan or BPA and reproductive hormones was also examined, such as estrogen and testosterone. We found that levels of triclosan were higher in some Canadians and the levels of BPA were higher in some Americans. Higher levels of triclosan or BPA found were related to changes in the levels of estrogen and testosterone, especially in children and adolescents. Additional research is necessary to confirm these findings and determine their potential public health significance. Link: https://doi.org/10.1016/j.envint.2020.106229 (PI: Annie St-Amand)

Health Canada has a mandate to assess the health risks of chemicals to which Canadians are exposed. Modernization of approaches to prioritization and assessment is fundamental to advance the manner by which complex and emerging issues of concern such as endocrine disrupting chemicals, regrettable substitution and cumulative risk are considered. Emerging existing substances are currently identified through the 2014 Approach For the Identification of Risk Assessment Priorities (IRAP) process; problem formulation (PF) provides a mechanism through which computational tools and innovative approaches can be used to define substance groupings, describe the data landscape and triage substances. PF defines the gap between a problem and a solution, and makes a plan that teases out what is needed to close the gap, which may include data collection or generation, risk assessment or monitoring, as examples. Following IRAP, further scoping is needed to identify chemicals that may also be of concern but not captured due to the paucity of data for a large number of chemicals. There is also a desire to rapidly mine data to inform PF outcomes. This project explores automated workflows to avoid resource intensive manual tasks and expedite early steps in PF. A computational algorithm was developed to scan inventories to identify chemicals with a common moiety (e.g. a phenol ring) or belonging to a class (e.g. bisphenol). Chemicals that lack defined chemical structures such as UVCB's (substances of unknown or variable composition, complex reaction products, or biological materials) are searched using key phrases, e.g. "bisphenol". Another computational program was developed, which cross-references chemical lists with online databases (e.g. PubChem, CompTox, and ChemIDplus), to gather information such as physical-chemical properties, toxicity and exposure data as available. The aim of this work is to develop and implement automated workflows to gain efficiencies and enhance the robustness of early scoping activities. This work should allow for the refinement of chemical groups based on evolving science and for information to be collected that will be useful for decision making in the context of PF and assessment. (PI: Sean Collins)

Manufactured nanomaterials (NMs) are being widely used in industrial applications as well as in consumer products, leading to concerns regarding increased exposure and associated human health risks. Health Canada (HC) is responsible for risk assessment of NMs which are regulated under the Canadian Environmental Protection Act, 1999 (CEPA). As part of Canada's Chemicals Management Plan (CMP), HC has developed strategies to address NMs that are listed on the Domestic Substances List (DSL) and has identified a number of priority NMs for which data on physico-chemical characterization and toxicity are required for regulatory human health risk assessment. To fill these data needs, HC collaborated with the National Research Council's (NRC) Nanoscale Measurement group of the Metrology Research Centre on a project to characterize the physico-chemical properties (e.g. size, shape, size distribution, surface area, surface charge, and surface chemistry) of representative nanoforms of prioritized NMs, including titanium dioxide (TiO 2 ), copper oxide (CuO), and nanocellulose. This project also investigated the potential toxicological effects of TiO 2 and CuO NMs on selected cultured cells to examine their effects on cell viability, membrane integrity, and ability to induce cellular stress. Data obtained from this project will not only inform Health Canada's regulatory decisions on the priority DSL NMs but also give better understanding of the relationships between toxicological potentials of the representative nanoforms and available physico-chemical properties to permit read-across for risk assessment of these prioritized NMs (PIs: Kathy Nguyen; Djordje Vladisavljevic)

Health Canada assesses potential exposures of the general population to chemical substances through all routes (inhalation, ingestion and contact on the skin) and all possible sources (including ambient and indoor air, food, soil, dust, and consumer products). As Canadians spend more than 90% of their time indoors, there is an increasing demand for information on indoor environmental exposures. This research examines settled house dust samples collected from 1025 homes in 13 cities under the Canadian House Dust Study (CHDS), which was designed to provide a representative national baseline. This study focuses on metals, but also considers synthetic organic compounds including bisphenol A, pesticides, flame retardants, synthetic musks, bactericides, surfactants, and plasticizers. Metals enter the home by residents tracking in outside dirt and by infiltration of airborne particles which settle on hard surfaces, carpets and in crevices. In addition, metal and synthetic organic compounds in consumer products and building materials, such as plasticizers and drying agents in surface coatings, also accumulate in indoor particles as products deteriorate with age and wear. Nationally representative levels of contaminants will be reported as both concentrations and loadings to accommodate various approaches to estimating exposures. Correlations between house characteristics (such as house age, construction materials and environmental setting) and the chemical datasets will help to identify exposure sources and trends. The study focuses primarily on childhood exposures to house dust through normal hand-to-mouth ingestion behaviour. The study also looks at potential inhalation exposures by characterizing re-suspended dust in carpeted versus non-carpeted homes. Dust particles undergo physical and chemical transformations in the indoor environment, which may increase their bioaccessibility (solubility in the lung and gastrointestinal tract), and therefore metal bioaccessibility will be measured. This research supports Health Canada's risk assessment and management activities, with particular focus on mitigation of childhood residential exposures to chemical substances. (PI: Pat Rasmussen; Suzanne Beauchemin)

The Yellowknife Health Effects Monitoring Programme (YKHEMP) was established to examine the relationship between exposure to arsenic and other chemicals of potential concern (such as antimony, cadmium, lead, manganese and vanadium) and health outcomes. A total of 2037 individuals were recruited, including children (age 3–19) and adults (age 20+) residing in Dettah, Ndilǫ, and Yellowknife, Northwest Territories, Canada, in two waves: Fall 2017; and Spring 2018. In Yellowknife, there were 891 (675 adults, 216 children) randomly selected participants with a participation rate of 64%. In addition, 875 (669 adults, 206 children) volunteer participants were recruited. A total of 225 (137 adults, 88 children) of the Yellowknife Dene First Nation (YKDFN), and 46 (33 adults, 13 children) of the North Slave Métis Alliance participated in the study. Each participant answered a lifestyle questionnaire as well as provided toenail clippings and urine for contaminant testing, and saliva samples for testing of genetic polymorphisms associated with arsenic metabolism. Participants also provided consent to have their medical records reviewed by the research team for the past 5 years to allow for the investigation between exposure and health outcomes. The adult YKHEMP participants had lower urinary total arsenic but the children had higher inorganic arsenic than the general Canadian population. There was no difference in urinary total arsenic concentrations between adults and children; however, urinary inorganic arsenic concentrations were generally higher in children than in adults in all four YKHEMP sampling groups. The adult YKDFN participants had lower urinary total arsenic and inorganic arsenic concentrations compared with the random selected and volunteer participants. YKHEMP is designed as a prospective cohort study; the children participants will be re examined in 2022 and both adult and children participants in 2027. Article published in BMJ Open in 2020. (PI: Asish Mohapatra; Dr. Laurie Chan (University of Ottawa)).

Health Canada has a mandate, in the context of major projects subject to federal impact/environmental assessments, to provide advice regarding the human health risk assessment (HHRA) of contaminants found in country/traditional foods, including mercury (Hg). Health Canada's current HHRA framework assumes that 100% of Hg in country foods is present as methylmercury (MeHg), the form that is readily absorbed. However, recent science indicates that this assumption and resulting risk assessments may be overly conservative, potentially leading to unnecessary consumption advisories and causing Indigenous communities to turn to less nutritious commercial foods. The objective of this project is to create a master database of Hg and MeHg levels in the country food items that contribute the most to Hg exposure among Indigenous communities across Canada, in order to identify potentially more realistic MeHg-to-Total Hg (THg) ratios. Eighty-five top contributing country food items were identified based on the Inuit Health Survey (2007-2008), the First Nations Food, Nutrition and Environment Study (2017-2019), and through consultations with experts in the field. A critical review of the published and grey literature was carried out to document the existing knowledge on the concentrations of Hg species reported/measured in the key country food items identified. Means and standard deviations of THg and MeHg concentrations (µg/g wet weight) and mean MeHg:THg ratios (%MeHg) (for country food items for which there is sufficient data) will be integrated into the database. This data will be used to identify food items with significantly less than 100% MeHg and to conduct more realistic HHRAs. Additional information gathered in the database (e.g., sample location, age) will be used to identify factors that may influence the %MeHg and to create a geographic information systems-based database that would allow risk assessors to find associations between pollution hotspots of Hg and levels in country foods. (PI: Laurie Chan (University of Ottawa); Alexandra Iliescu; Gregory Kaminski)

Biomonitoring can provide valuable data on the presence of trace levels of chemicals in human blood, urine or breast milk. Determining the presence of a chemical, however, is not enough to establish the potential risk to human health. A biomonitoring equivalent (BE) is the concentration of a chemical in human tissue or fluid that corresponds to an allowable exposure guidance value, such as a reference dose (RfD) or tolerable daily intake (TDI), that is considered safe. BEs are an integral part of the hazard and risk characterization and resulting data are used to inform the health risk assessment for many chemicals. As a part of the third phase of the CMP, risk assessments of inorganic chemical groups are being conducted. The overall research objective is to derive biomonitoring equivalents (BE) for metals to interpret biomonitoring data in support of the chemical risk assessments. BEs for additional chemicals were also generated for corresponding biomonitoring data as a part of a CHMS Biobank project. Risk assessments for the latest metals began in FY 2018/2019. Over a dozen open access scientific publications, two science approach documents and a final screening assessment report have been released since then. The list of published works on inorganic metals includes molybdenum, silver, titanium, lithium, aluminium, bismuth, cyanide, zinc, beryllium, barium, tin, antimony, iodine, neodymium, yttrium, cerium, praseodymium, and thallium. A database was produced to help analyze different biomonitoring values from various health agencies. (PI: Andy Nong)

Genetic damage is associated with numerous human diseases, and chemical screening programs routinely assess genetic toxicity. The results of genetic toxicity tests have traditionally been evaluated using qualitative binning (i.e., yes or no) that merely identifies agents that can damage genetic material (i.e., DNA). However, there is increasing interest in quantitative analyses of genetic toxicity test results, and estimation of human exposure limits that effectively minimise the likelihood of adverse health effects associated with genetic damage (e.g., cancer and human genetic diseases). Estimation of exposure limits requires use of uncertainty factors (UF) that account for differences between humans and experimental animals, for inter-individual differences in human sensitivity, for the short treatments of experimental animals, and for the severity of genetic damage. This work is employing analysis of published data to evaluate the UFs for inter-individual human variability and treatment duration that are currently being used to calculate exposure limits to genotoxic substances. To critically evaluate the currently-used inter-individual sensitivity UF of 10, analyses of over 800 datasets extracted from the scientific literature is assessing the effect of eliminating a cultured cell's ability to repair damaged DNA. Analyses of published human epidemiological data are assessing variability in humans' ability to repair damaged DNA, i.e., human DNA repair capacity. Additional analysis of epidemiological data is evaluating the effect of genetic differences in the ability to repair DNA on the risk of developing cancer. Finally, analysis of published animal experiment results is evaluating the effect of treatment duration on the level of adverse genetic effects caused by long-term chemical exposures. The results obtained to date indicate that the default UFs of 10 might be appropriate for calculation of exposure limits that can effectively minimise the risk of the adverse health effects associated with genetic damage. (PI: Paul White)

Evidence from animal and human studies suggests that exposure to commercial chemicals is associated with adverse health outcomes including diabetes, cardiovascular disease, endocrine cancers and obesity which are afflicting the human population in the developed world. The fat tissue and the fat cells are not only responsible for storage of excess caloric consumption but also potently influence the metabolism of the entire organism via the secretion into the blood stream of hormones and other factors that affect the function of other organs. It is hypothesised that one of the ways by which the fat tissue affects cardiovascular disease, high blood pressure and diabetes is through an imbalance in the factors secreted by this tissue. This makes the fat tissue a likely target for chemical effects. A hormone known to contribute to cardiovascular and metabolic disease, including diabetes, is the stress hormone cortisol. Increased cortisol level is associated with increased mid body fat accumulation and an increase in cardiovascular disease and type 2 diabetes. It has been postulated that chronic exposure to cortisol leads to a change in the metabolic function of the fat cells. As previously shown in cell models, chemicals such as bisphenols and flame retardants can act through the same pathway as the stress hormone in fat cell formation. However, it is unclear whether the resulting fat cell is healthy or contributes to disease through imbalanced secretion of soluble factors. To date, there is limited information and no high content or validated screening method for the functionality of the fat cells exposed to chemicals. This project is working to develop a screening method which can both identify substances that drive fat cell formation and determine if they contribute to metabolic disease. (PI: Ella Atlas)

The Canadian Environmental Protection Act, 1999, requires the evaluation of the health effects of chemicals that are in the Canadian marketplace. However, conventional toxicology tests are time consuming, expensive, and require large numbers of animals. Health Canada (HC) regulators are in urgent need of new tests to meet legislated mandates. New methods proposed to identify toxicological hazards are based on measuring a chemical's ability to disrupt critical biological processes. Genomics is a powerful tool to identify biological changes because it surveys effects across all of the genes in tissues/cells following a challenge. The use human cells in culture offers considerable advantages including increased throughput, reduced animal use, and cost savings. The need to modernize regulatory toxicology tests by making greater use of human cells in culture (instead of animals) and genomic methodologies has been emphasized internationally, but practical examples of use in human health risk assessment are required. This project works toward the unifying purpose of providing genomic solutions to support Canadian regulatory sciences and the challenges/needs noted above. The overarching objective of the project is to develop and implement practical genomic methods in human cells in culture for hazard identification and risk assessment of environmental chemicals in the area of genetic toxicology (damage to DNA). This project harnesses the adverse outcome pathways (AOP) knowledge base towards its objectives; AOPs catalogue cellular perturbations that are associated with detrimental health outcomes following chemical exposures. The project is building expert-informed AOPs to develop testing strategies implementing state-of-the-science genomic methods to predict genetic diseases like cancer. The methods, data, and analytical tools will be made publicly available to enable widespread use of the technologies/approaches. Case studies applying the modern test strategies are being applied to evaluate the effectiveness of the proposed approaches, assess feasibility to regulatory adoption, and provide data for human health risk assessment. (PI: Carole Yauk (University of Ottawa); Francesco Marchetti)

Development and application of novel next generation sequencing approaches for mutagenicity testing in the 21 st century

The Canadian Environmental Protection Act, 1999, mandates that chemicals coming into commerce must be tested for the ability to induce mutations (changes in DNA sequence). Mutations occur at each cell division either because of random errors or because of exposure to a toxic agent. When mutations happen in tissues, they may generate cancer. When mutations happen in sperm or eggs, they can be transmitted to the offspring and result in a variety of genetic diseases. Existing mutagenicity tests have limitations. Specifically, they measure mutations in a single gene (the human genome has ~20,000 genes) or use genetically modified laboratory rodents where mutations are measured in a bacterial gene. Also, these methods are not suited for studying transmitted mutations in the offspring because they would require large numbers of animals. Recently, significant improvements in DNA sequencing technologies enabled the identification of mutations over the entire genome. These methodologies were used to analyze the genomes from human families to identify environmental exposures that increase the number of transmitted mutations to future generations. In addition, a new sequencing approach as a replacement of existing methods for mutation testing is being evaluated. This new method allows the analysis of mutations in many genes in parallel without the need for genetically modified rodents, and, it provides information on the mechanism of mutation induction. Lastly, computational approaches are being used to analyze mutations induced by chemicals and have shown that each chemical produces specific patterns, some of which are observed in cancers with known environmental causes (e.g., lung cancer and tobacco smoking). This approach provides a venue to identify novel environmental causes of cancer. Overall, this project will generate foundational data to modernize and improve regulatory testing for mutagenicity. This project is linked to Health Canada's priority of effectively and efficiently assessing the potential adverse health effects of chemicals and is expected to provide regulatory knowledge to help prevent cancer and other genetic diseases. (PI: Francesco Marchetti).

There are growing concerns that exposures to commercial chemicals cause harm by interfering with the hormonal control of growth and development of the brain, reproductive tract and lead to metabolic and stress-related problems. Developing rapid methods to identify chemicals posing these hazards is a critical need for safety assessment. Building on experience gained in previous studies, the current project seeks to 1) develop rapid methods to detect chemical toxicity to thyroid hormone signalling (very important to early brain development) and 2) identify, characterize and develop assays for the enzymes that are inhibited by some organophosphate flame retardants (OPFR) leading to toxicity to the ovary and adrenal gland. Separate assays based on molecular targets of thyroid hormone disruptors will be refined and further validated using a robust list of substances known or suspected of interfering with TH signalling. High-throughput assays based on these molecules will be developed into protocols fit for toxicity test guideline development through the Organization of Economic Cooperation and Development (OECD). Health Canada is collaborating with the US EPA to further develop and validate a high throughput assay of to screen chemicals for thyroid peroxidase inhibition. Secondly, innovative methods will be employed to identify proteins that react with the flame retardant molecules. Early results show that these are enzymes involved in cholesterol metabolism. Assays for these enzymes are currently being developed and these will be used to compare the potency across all phosphate flame retardants that are used in Canada. These studies will help inform risk assessment activities and support assessment and minimization of the risks of chemical use. (PI: Mike Wade)

In the follow up report to the review of the Canadian Environmental Protection Act, 1999 (CEPA), the Government of Canada is committed to continuously improving its ability to address endocrine disrupting substances and to keep pace with scientific developments including new approach methodologies (NAM). In line with this commitment, the current study begins to advance the development of a tiered strategy that proposes to incorporate predictive models and a sequential testing strategy involving the consideration of NAMs. In this pilot analysis a group of bisphenols and related substances are being evaluated to determine the relevance and reliability of a suite of models to predict the endocrine disrupting potential of these select chemicals. It is well known that endocrine disrupting chemicals act through interaction with receptors to interfere with hormonal signalling leading to health effects. Accordingly, this study aims to assess a chemical's binding potential to a series of receptors using both in silico models and high throughput in vitro data generated by the US Environmental Protection Agency ToxCast TM Program in order to determine endocrine activity for our set of chemicals. Models under evaluation include Oasis TIMES, VEGA, CASE Ultratox, USEPA rtER Expert System, P&G's DART scheme, ChemProp models as well as Endocrine Disruptome. To begin to incorporate the next tier of information, data available from various endocrine related assays from the ToxCast TM and Tox21 TM programs will be integrated. The information acquired from the analysis and integration of the in silico and in vitro data sources will support the early development of a proposed tiered approach to screen chemicals for potential endocrine disrupting activity. (PI: Sunil Kulkarni)

Genetic damage is associated with a variety of human diseases; routine toxicological screening of chemicals in commerce requires identification of substances that can damage genetic material (i.e., genetic toxicity assessment). A related CMP-funded project is developing an efficient, effective, high(er) throughput genetic toxicity assessment platform based on analysis of cultured cells; the platform is known as GeneTox21. Compound screening using the GeneTox21 platform generates large amounts of complex data; the regulatory utility of the data depends on the user's (e.g., clients and stakeholders) ability to organize, browse, analyse, display and interpret the information in an intuitive and user-friendly fashion. A recent research endeavour established an innovative, user-friendly bioinformatic tool known as DREAM-TK; the tool allows users to browse, analyse and interpret complex toxicological test results. DREAM-TK constitutes a foundation for the development of a related tool for efficient interpretation of test results generated using the GeneTox21 platform; a tool to facilitate essential interpretation of genetic toxicity screening data in a regulatory context. This work is building on the DREAM-TK paradigm, and developing a bioinformatic platform to browse, visualise, analyze, and interpret GeneTox21 results; the tool being delevlooped is called the Integrated Analysis Tool for Genotoxicity Assessment or IATGA. Work conducted to date has built a beta test version of IATGA; interactions with regulatory group have highlighted avenues for improving functionality. Bioinformtic tools such as IATGA are essential for effective and efficient chemical safety assessments based on simultaneous interpretation of results generated using several (geno)toxicity assessment tools. (PI: Paul White)

Health Canada is responsible for the assessment and management of health risks to Canadians associated with exposure to chemicals in the environment. Over the past decade, the sensitivity of biomonitoring approaches have considerably improved as it relates to human exposure assessment of some targeted chemicals. However, there is still a gap between pre-selected targets and our capability of qualitatively and quantitatively determining unknown and new substances of emerging concern (also known as emerging substances) in human biofluids (e.g. urine, follicular fluids and blood). As a result, non-targeted approaches have gained much attention in risk assessment of human exposure to unknown and emerging chemical contaminants. The proposed four-year project plan, as a proof of concept study, is using high-resolution mass spectrometry to develop new non-targeted analytical methods, which aims to rapidly screen and identify new metabolites of these chemicals and some parent compounds in human biofluids as potential biomarkers for assessment of human exposure to substances, including CMP priority chemicals and other emerging chemicals. Suspected, unknown, and emerging contaminants will be screened and identified based on accurate mass measurements with high-resolution mass spectrometry, fragmentation patterns, retention time with prediction models, and the structural similarity of known chemical groups. These newly developed analytical methods will provide valuable screening information for metabolites and parent compounds as to the identification of potential emerging contaminants for future assessments under CMP; models will be developed to provide semi-quantitative information of identified unknown chemicals without using standards; they will also generate meaningful knowledge regarding metabolites derived from emerging chemicals in human biofluids. The developed methods may be applied to analysis of samples collected in the Canadian Health Measures Study and Ontario Health Study and will also be beneficial to broader scientific communities. Method development and validation will include metabolites of selected CMP priority chemicals, but not necessarily limited to flame-retardants, BPA analogues, plasticizers, UV filters and stabilizers, their alternative or replacement chemicals, and mercapturic acids in various environmental samples and human biofluids such as urine, serum, plasma, and follicular fluids. (PI: Yong-Lai Feng)

Bisphenols are chemicals produced in large quantities for use primarily in the production of polycarbonate plastics and epoxy resins. Bisphenol F (BPF) and bisphenol S (BPS) are bisphenol A (BPA) substitutes prioritized for measurement in the cycles 7 and 8 of the Canadian Health Measures Survey (CHMS). BPF and BPS both present structural similarities to BPA and their levels in environmental and human samples are increasing. Information on BPF and BPS toxicities is much more limited than for BPA, making it difficult to properly evaluate the potential health consequences of BPA substitution by BPF and BPS. In this study, the toxicities of BPA, BPF and BPS were directly compared when administered to rats over a wide dose range according to a regulatory toxicology protocol based on OECD 407 Guidelines (Repeated Dose 28-Day Oral Toxicity Study in Rodents). Given the relatively limited effects of BPA on the parameters prescribed by the OECD 407 Guidelines, perturbations of endocrine functions were further investigated. Based on published information on the in vivo and in vitro toxicities of BPA, BPF and BPS, additional serum hormone levels were measured, while the expression of specific genes involved in their biosynthesis and degradation will be assessed in the liver. By directly comparing the in vivo toxicities of BPA, BPF and BPS, this project will allow a better assessment of the potential human health risks associated with the substitution of BPA by BPF and BPS. It will also contribute to a better interpretation of CHMS biomonitoring data. (PI: Guillaume Pelletier)

Country/traditional foods are defined as foods sourced outside of commercial food systems. These include food that is trapped, fished, hunted, harvested or grown for subsistence or medicinal purposes. Mercury (Hg) found in country foods, which are consumed more frequently by Indigenous communities, can pose health risks to Canadians in communities that rely on fishing and hunting to complete their diet. Health Canada's approach to estimating human exposure to Hg from country foods consumption assumes that: (1) all Hg is present as methylmercury (MeHg), the neurotoxic form; (2) Hg levels remain constant during food preparation; (3) all MeHg in country food is absorbed by humans; and, (4) Hg interactions with selenium (Se) and arsenic (As) do not alter human exposure. However, these assumptions and resulting human health risk assessments may be overly conservative, potentially leading to unnecessary consumption advisories and causing Indigenous communities to turn to less nutritious commercial foods. To test these assumptions, concentrations of Hg, MeHg, As and Se will be measured in fresh, frozen and cooked samples of grey seal liver, muscle and kidney, and of whitefish muscle. Country food samples will be prepared according to traditional methods, and methods with contrasting cooking temperatures. The resulting changes in metal speciation, including changes in %MeHg (i.e., percent of total Hg present as MeHg), will be documented. To evaluate whether all Hg in country foods consumed is absorbed by humans, simulated human digestion experiments will be conducted on 'prepared' versus 'unprepared' country food items. This will be done using a modified in vitro physiologically-based extraction test to estimate how the bioaccessibility of Hg, MeHg, As and Se is altered following both the gastric and gastro-intestinal phases of digestion. The study results could contribute to the refinement of Health Canada advice regarding human health risk assessments of Hg exposure from country food consumption, and to better inform potential risk management measures. (PI: Marc Amyot (University of Montreal); Alexandra Iliescu; Gregory Kaminski)

Scientific and public concern mount about the potential health impacts due to widespread use of chemicals suspected of causing endocrine disruption and Health Canada has a mandate to regulate chemicals to which Canadians are exposed. Regulatory action and/or consumer pressure have caused a reduction in the use of a number of suspected endocrine disruptors including pentabromodiphenyl ethers (PBDE; flame retardants), bisphenol A (BPA) and diethylhexyl phthalate (DEHP). In response, a large number of chemicals have been introduced into the marketplace as substitutes; some of which may pose similar risks due to structural or functional similarities. In this study, chemicals used as replacements for PBDE, BPA and DEHP are screened with in vitro assays to determine effects on thyroid hormone or steroid hormone production. In particular, large number of structurally similar compounds that are potential replacements for bisphenol have been screened for effects on steroidogenesis (20) and thyroid peroxidase inhibition (38). Results will inform the potential hazards of use of these replacements and help identify less toxic alternatives. (PIs: Dr Barbara Hales [McGill University]; Tara Barton McLaren. Collaborators: Mike Wade; Ella Atlas; Cariton Kubwabo)

Health Canada has a mandate to regulate chemicals to which Canadians are exposed. Several chemicals that have been banned from the Canadian marketplace due to their toxicity, have been replaced by alternate chemicals for which there is limited knowledge. Health Canada is collaborating on a CIHR (Canadian Institutes of Health Research) Team Grant project to investigate the exposure and hazards of substances used as replacements for polybrominated diphenyl ethers (PBDEs) flame retardants. PBDEs, initially used in home furnishings, were removed from commerce in 2008 in Canada due to their persistence in the environment and their tendency to accumulate in human and animal tissues. Manufacturers are increasingly using organophosphate esters (OPEs) as a replacement to PBDEs to ensure that their products continue to meet the flammability standards in a variety of home furnishings, fabrics, clothing, electronics, and motor vehicles. Health Canada's Biomonitoring Laboratory has developed and validated analytical methods for OPEs and their metabolites in food, water and breast milk.This study examined dietary exposures to OPE flame retardants and plasticizers as well as other chemicals in 3 locations: 1) Montreal, Canada (urban developed world), 2) Pretoria, South Africa (urban less developed), and 3) the Vhembe region of Limpopo province of South Africa (rural, poorly developed). The data will support epidemiological analysis and contribute to the dietary assessment of exposure to these chemicals. This dataset is the first assessment of breast milk that allows comparison between the levels of these substances in Canada and in less developed countries, using identical sample collection and analytical methods. (PI: Cariton Kubwabo; in collaboration with McGill University)

The Performance Measurement Division of the Risk Management Bureau conducts performance measurement evaluations on the risk management of toxic substances to determine whether actions taken to help protect Canadians and their environment are meaningful and effective. This study is in support of the performance measurement and evaluation of dioxins and furans. Dioxins and furans are two groups of persistent organic pollutants that were declared toxic to human health in 1990 under the Canadian Environmental Protection Act , 1988. The Government of Canada has implemented several risk management actions since the early 1990s to reduce exposures to these chemicals. One of the more sensitive health endpoints is reduced fertility in males born to mothers exposed to high levels of dioxins and furans. The objectives of this study are to help assess the performance of risk management actions by estimating the number of cases of male infertility in Canada that may have occurred due to dioxin and furan exposures over time. Estimates of dioxin and furan concentrations will be obtained using several Canadian human milk surveys conducted over the years. The number of cases of male infertility attributed to dioxin and furan exposures will be estimated, then compared to estimates in a scenario where exposures to these chemicals did not decrease over time. This will then provide an idea of the number of cases of male infertility that may have been prevented by risk management actions. (PI: Michael Elten)

Health Canada is responsible for the assessment and management of health risks to Canadians associated with exposure to chemicals in the environment. Firefighters face serious risks on the job, including heat, physical and mental stress, as well as exposure to a toxic environment both in and around fires. In recent years, statistics have shown that these exposures have taken their toll on firefighters. For example, it has been shown that firefighters have an increased cancer risk compared to the general population. Previous studies have shown skin to be a major route of exposure. Skin cleaning wipes are the most practical and suggested method for dermal decontamination for firefighters yet little research has been done to assess if this is effective, and whether or not different types of wipes or other skin cleaning methods (e.g., soap and water) are better at removing dermally-deposited contaminants. This project is specifically designed to collect the necessary information to make sound, evidence-based decisions on how to optimally protect firefighters from dermal exposure to combustion emissions. An intervention study at training fire events in Ottawa has been designed to assess the effectiveness of the use of skin cleaning protocols. Exposures to PAHs are measured and compared between participants following current decontamination protocols (i.e., the control group), and those who add an additional dermal decontamination step using skin cleaning wipes or a wash cloth with soap and water (i.e., the intervention groups). These research activities are conducted at training fires, where exposures are relatively uniform across the participants. Ultimately, the research will contribute to a greater understanding of the effectiveness of skin cleaning procedures and furthermore, whether different protocols are superior to others in removing hazardous contaminants deposited on the skin. The results will be used to develop new protocols, or modify existing practices, to minimize dermal absorption of contaminants among firefighters. (PI: Jules Blais [University of Ottawa], and Collaborator: Paul White)

Health Canada is responsible for assessment and management of risks associated with engineered nanomaterials. Cellular respiration is a critical aspect of cell health and thus functioning of mitochondria, the power-house of the cell, can be of importance in terms of toxicity testing of nanosilica particles (SiNPs). Typically, in vitro cell viability assays incorporate assessment of mitochondrial performance. Previous observations indicated subcellular localization of SiNPs in the mitochondria by transmission electron microscopy (TEM) analyses and others have reported mitochondrial oxidative stress in response to nanoparticle exposure. Mitochondrial protein changes were measured after exposure to nonporous SiNPs following mass spectrometry analysis. Association between physicochemical properties of the SiNPs and mitochondrial protein changes were tested. Suitability of this methodology for screening nanoparticles for mitochondrial toxicity is tested in this work. These findings can support OECD test guideline development, provide a mechanistic basis to rank and prioritize SiNPs that are on the Domestic Substances List (DSL) for further toxicological testing as well as support the activities on risk assessment of these materials by the New Substances Assessment and Control Bureau. (PI: Premkumari Kumarathasan)

Absorption, Distribution, Metabolism, and Excretion (ADME) characteristics of a chemical are important for understanding (toxico) kinetics and the mode of action for predicting toxicity. These parameters provide important insight into how a chemical behaves inside the body following exposure. In vitro and/or in vivo toxicokinetic data are often not available for the large number of chemicals that require assessment. Since prediction and simulation of various ADME properties is considerably more resource efficient than generating in vitro or in vivo data there is an emphasis on the development of methods such as those based upon quantitative structure–activity relationship (QSAR) and molecular modeling to complement or replace the need for empirical data when sufficient confidence can be demonstrated. To ensure applicability of the ADME predictive tools to environmental chemicals in Canada, there is the need to carry out internal validation of these in silico models in a focused manner to support priority setting and assessment of chemicals of greatest interest for human health risk assessment under the ongoing and future Chemicals Management Program. In this project, available published experimental ADME data on chemicals is being collected. Through statistical analysis on the predictions obtained for known chemicals the performance of select in silico ADME prediction models will be evaluated. Further, using chemical similarity analysis (clustering analysis) it will be determined how many of these chemicals (with ADME data) are structurally similar (or identical) to chemicals on the Canadian Domestic Substances List (DSL). This exercise will provide an approach to assess confidence in the ADME predictions both from the perspective of model reliability as well as model suitability for the DSL chemical space. (PI: Sunil Kulkarni)

There is increased interest in the use of new approach methodologies (NAMs) in risk assessment, including bioactive concentrations (µM) measured in in vitro toxicology assays. In order to translate bioactivity concentrations to human relevant doses (mg/kg/bw) for hazard assessment, in vitro to in vivo extrapolation (IVIVE) methods are required. The US Environmental Protection Agency developed a high-throughput toxicokinetics (HTTK) model for IVIVE that is being explored at Health Canada. The model has been paired with ToxCast™ data to enhance chemical screening through determination of Bioactivity Exposure Ratios. However, the HTTK chemical space is primarily comprised of pesticides and pharmaceuticals, with limited data for industrial or environmental compounds. Furthermore, there are few comparisons between in vitro predictions with the model and in vivo toxicokinetics analyses. This study aims to identify and compile available toxicokinetics data to understand the chemical space covered by HTTK models and how this compares to the chemical space of interest (i.e., Canada's Domestic Substance List). This will allow for the establishment of the applicability domain for current HTTK models and the identification of environmental compounds to which the models can be appropriately applied. Also, this project seeks to establish and provide recommendations for addressing the uncertainty when applying HTTK methods to chemicals outside this defined applicability domain. The findings will guide future research into expanding on the coverage of HTTK chemical space through the targeting of chemical features or properties, currently inadequately covered by HTTK models, for future toxicokinetics analyses. (PI: Marc Beal; Sunil Kulkarni)

Assessing the impacts of multiple chemical exposures from different sources has long been a challenge for scientists and regulators. The Exposure Load method has been developed to quantify multi-chemical exposures and understand how chemical burdens vary within a population by taking advantage of human biomonitoring data. Biomonitoring is the measurement of chemicals in urine, blood or other tissues, reflecting real-world exposures from all sources and routes. For this analysis data was used from the Canadian Health Measures Survey (CHMS), a national survey led by Statistics Canada in partnership with Health Canada and the Public Health Agency of Canada. Exposure Load counts the number of chemicals measured in the blood or urine of individuals above a defined concentration threshold (which indicates exposure), and then sums the counts for multiple chemicals of interest and expresses the result for a population. 44 blood and urine biomarkers were used representing 26 chemical groups for 1,858 participants aged 12 to 79 years from cycles 3 and 4 of the CHMS. Initial findings support that Canadians are concurrently exposed to many chemicals at lower concentrations, and to fewer chemicals at high concentrations. It was also found that the youngest age group (12–19 year olds) had a significantly lower Exposure Load than older individuals, smokers incurred a much higher Exposure Load than nonsmokers, but males and females did not substantially differ. Health Canada protects the health of Canadians by assessing and managing the risks associated with exposure to environmental chemicals, and Exposure Load analysis supports and informs this mandate by providing valuable nationally-representative information about multi-chemical exposure burdens in the Canadian population. Additional Exposure Load analysis is planned. Link: https://doi.org/10.1016/j.ijheh.2021.113704 (PI: Jeff Willey)

GeneTox21 – An integrated platform for in vitro genetic toxicity assessment and regulatory evaluation of new and existing substances

Genetic damage is associated with numerous human diseases, and chemical screening programs routinely assess a chemical's ability to damage DNA (i.e., genetic toxicity). Traditional assessment tools (i.e., bioassays) are laborious and not conducive to high-throughput (HT), high-content chemical screening using tools that employ cultured cells (i.e., in vitro bioassays). Physical manifestation of genetic damage (e.g., mutations and chromosome damage) requires cellular replication; thus, no in vitro genetic toxicity assay can truly be considered HT. Even the most rapid assays require 24+ hours from cell exposure to data acquisition; consequently, no in vitro , HT, multi-endpoint system for genetic toxicity screening has been established. However, HT scoring technologies (e.g., flow cytometry) can be employed to increase the throughput and precision of some traditional in vitro genetic toxicity assays. Assays using such newer scoring technologies can be considered higher throughput in comparison with the traditional approach (e.g., manual microscopy). This project aims to establish an integrated, multi-assay, higher throughput platform for the assessment of chemically-induced genetic toxicity. The system includes multi-measurement, per-cell assays for an array of effects (i.e., MicroFlow® and MultiFlow™ tools), the high-throughput CometChip® assay for DNA breaks, a miniaturized version of the Salmonella fluctuation test (i.e., Ames II), a gene expression profiling assay for cellular responses to DNA damage, and high-throughput microscopy for per-cell in situ imaging. The performance of the higher throughput system is being evaluated by analysis of 35 reference compounds and 20 data-poor compounds prioritized for regulatory screening. The overall performance of the assay is being evaluated; it will subsequently be deployed for routine generation of genetic toxicity profiles for prioritized substances. The platform, termed GeneTox21, will be internationally promoted to encourage its adoption for routine genetic toxicity assessment of new and existing substances. (PI: Paul White)

There are concerns in Yellowknife, Northwest Territories, Canada, about arsenic (As) exposure due to past mining operations, particularly the former Giant Mine. The objective of this study was to characterize the risk of arsenic exposure, and associated risk factors among the local residents. Arsenic and its species were quantified in urine (n = 1966) using inductively coupled mass spectrometry. Children in the study were found to have significantly higher (p < 0.05) urinary inorganic-related As (uiAs) concentrations than children in the general Canadian population, as well as higher levels than adults in the study. Additionally, uiAs concentrations in children, particularly those above the 95th percentile, are above the Biomonitoring Equivalents (BE) levels that are associated with dermal effects, vascular problems and cancer risks. Multiple linear regression results showed that market seafood (fish and shellfish), and rice consumption frequency were significantly positively associated with uiAs. Specific to children, drinking lake water was positively associated with uiAs. Specific to adults, consumption of local mushrooms and berries was significantly positively associated with uiAs while there was a significant negative association with age, smoking and recreational water activities. The risk factors identified in this research can be used for public health education to lower arsenic intake. Overall, these results support the need for an ongoing monitoring program. Article published in International Journal of Hygiene and Environmental Health in 2020. (PI: Asish Mohapatra; Dr. Laurie Chan (University of Ottawa))

Traditional food is a nutritionally high-quality food resource that helps combat food insecurity, influences (directly or indirectly) all dimensions of the holistic definition of health, and is closely tied to the culture and identity of Indigenous peoples. This work will summarize the principles, current practices and methodologies, and basic information that Health Canada will seek during its review of traditional food and food security assessments, submitted by proponents of major projects under the Impact Assessment Act . Relevant and targeted methods gathered from the literature can be adapted to enhance current practices for evaluating traditional food security for Indigenous peoples. The work builds on a previous product titled "Methods for Determining Impacts on Traditional Food Security in Indigenous Communities", which were specifically developed by three First Nations in the Athabasca oil sands region of Alberta. This document will be appended to the final published product. (PI: Aurelia Thevenot) Dataset not expected.

Internationally, there are thousands of existing and newly introduced chemicals in commerce, highlighting the ongoing importance of innovative approaches to identify emerging chemicals of concern. For many chemicals, there is a paucity of hazard and exposure data. Thus, there is a crucial need for efficient and robust approaches to address data gaps and support risk-based prioritization. Several studies have demonstrated the utility of in in vitro bioactivity data from the ToxCast program in deriving points of departure (PODs). ToxCast contains data for nearly 1,400 endpoints per chemical, and the bioactivity concentrations, indicative of potential adverse outcomes, can be converted to human-equivalent PODs using high-throughput toxicokinetics (HTTK) modeling. However, data gaps need to be addressed for broader application: the limited chemical space of HTTK and quantitative high-throughput screening data. Here the applicability of in silico models to address these data needs was explored. Specifically, ADMET predictor for HTTK predictions and a generalized read-across approach to predict ToxCast bioactivity potency was used. These models were applied to profile 5,801 chemicals on Canada's Domestic Substance List (DSL). To evaluate the approach's performance, bioactivity PODs were compared with in vivo results from the EPA Toxicity Values database for 1,042 DSL chemicals. Comparisons demonstrated that the bioactivity PODs, based on ToxCast data or read-across, were conservative for 95% of the chemicals. Comparing bioactivity PODs to human exposure estimates supports the identification of chemicals of potential interest for further work. The bioactivity workflow shows promise as a powerful screening tool to support effective triaging of chemical inventories. (PI: Marc Beal; Tara Barton-Maclaren)

Health Canada is responsible for assessing the risk to human health of thousands of substances present in the environment. The assessment of individual substances is tedious and unrealistic for a holistic risk assessment therefore, the use of high throughput screening (HTS), a combination of multiple signals from various sources and substances is increasing. Under a research project funded through the CMP, Health Canada researchers and regulatory scientists are collaboratively investigating the utility of integrating in vitro toxicity tools for human health risk assessment. The generation of pharmacokinetic parameters is crucial to the interpretation of the HTS data and the estimation of levels of human exposure that will provide a better basis for informed decision on a chemical's potential for toxicity. The aim of this project is to conduct in vitro experiments in order to generate required pharmacokinetic parameters for a series of chemical classes such as complex phenols, glycols, plasticizers, perfluorinated compounds and flame retardants identified by risk assessors. More than 200 chemicals were analyzed by an external company and results will be used by Health Canada scientists to develop a science approach document on the application of in vitro HTS data for regulatory purposes. (PI: Andy Nong)

Advances in toxicity testing have led to a rise in in vitro and high-throughput approaches to predict potential biological effects following chemical exposures. Health Canada is responsible for assessing the risk to human health of thousands of substances present in the environment. The challenge remains to relate these screening results with exposure guidance values based on actual animal or human effects. To address this challenge, new exposure and in-silico methods were developed to help interpret and extrapolate the in vitro measures. The latest development in translating the in vitro measures has been the use of drug metabolism pharmacokinetic tests, also known as in vitro toxicokinetics (TK), to generate critical data for computer models to incorporate when predicting the fate of a chemical in vivo based on in vitro toxicity assays concentrations ( in vitro to in vivo extrapolation – IVIVE). However, current in vitro TK studies and models used to extrapolate the concentrations observed from in vitro toxicity tests are made on basic assumptions that are not necessarily true in vivo for all environmental chemicals. Other biological processes such as gut absorption and metabolic activation have yet to be accounted for in past modeling efforts. The resulting omission may result in misinterpreting human dose exposures based on in vitro measures. The goal of this research is to develop better in vitro toxicokinetic data and consistent biological extrapolation models to predict realistic doses in vivo where potential toxicological effects would be anticipated based on measures from high throughput in vitro assay toxicity database. These tests and models will explore the largest family of substances recently used as replacements to plasticizers, flame retardants and perfluorinated chemicals that are identified on the Health Canada CMP priority list and found in the US Environmental Protection Agency ToxCast™ program. This effort will help Health Canada develop tools, including a database, and supporting data to predict toxicity of chemicals for high throughput risk assessments with IVIVE and help identify chemicals to be considered safe or alternatively trigger additional testing for the health of Canadians. (PI: Andy Nong)

In vitro toxicity testing of TiO 2 nanoforms

Health Canada is responsible for assessment and management of risks associated with engineered nanomaterials. Nano-sized titanium dioxide (TiO 2 ) is valued for its high tensile strength, electronic, optical and catalytic properties, with annual production exceeding four million tons per year. Due to this prevalence, these nanomaterials are on a priority list developed by New Substances Assessment and Control Bureau (NSACB) that need to be thoroughly assessed for health and environmental hazard. Health Canada is responsible for assessment and management of risks associated with engineered nanomaterials. TiO 2 can be manufactured with various chemical modifications, which are known as nanoforms. Since there is no information available on the comparative toxicity of these nanoforms, the current project aims to screen 11 nanoforms of TiO 2 using cultured lung cells (i.e., epithelial cells) and immune cells (i.e., macrophage) to determine their relative toxicities. Cellular toxicity was measured by assessing cell viability, cellular metabolic activity, and membrane integrity. Also, certain cellular stress pathways were measured following exposure to these nanoparticles. The association between these toxicity indicators and their physical (e.g., size, shape) and chemical (e.g., surface charge, reactivity) properties will reveal the most important nanoform characteristics contributing to toxicity. This data will be provided to our regulatory colleagues to support risk assessment of TiO 2 and support HC's commitment to the Organisation for Economic Cooperation and Development (OECD) - Working Party on Manufactured Nanomaterials (WPMN). (PI: Premkumari Kumarathasan; Azam Tayabali)

Health Canada has been exploring the use of new approach methodologies to evaluate health risks from chemicals. This study develops computer models and applications to help interpret and relate new testing data and approaches into population daily exposure levels for regulatory purposes. An abundance of toxicity data known as high throughput screening is now available thanks to large international testing initiatives. These tests screen thousands of chemicals over various biological responses measured in cells, tissues or even small organisms. As a joint effort between Health Canada and the US Environmental Protection Agency, additional experimental chemical kinetic information, also known as in vitro toxicokinetics, are generated to aid with the computer models to predict exposure levels. Web applications that combine all this knowledge and help predict the potential harm from chemicals are also being designed for regulatory end users. By investigating different categories of environmental chemicals, case studies are being prepared to address key elements and considerations in the use of computer application with high throughput screening data to predict and evaluate health concerns. Eventually, the computing research will provide a better basis for informed decision making to prioritize and evaluate chemicals from potential health risks in the next cycle of Health Canada Chemicals Management Plan. (PI: Andy Nong)

Since 2006, priorities for risk assessment of chemicals and other substances under the Canadian Environmental Protection Act, 1999 (CEPA) have largely been based on the results of categorization of the Domestic Substances List (DSL). The categorization process was a multi-year initiative that relied upon the manual curation of chemical hazard and exposure information in order to make prioritization decisions. Moreover, the process mainly relied on toxicity testing results available at the time to prioritize chemicals. Data poor chemicals, while potentially hazardous, were generally not prioritized for assessment due to lack of data. In the 15 years since categorization, there has been a tremendous increase in both the availability of public toxicity datasets as well as the development of in silico and in vitro screening technologies for hazard assessment. Furthermore, proposed amendments to CEPA include the establishment of a new plan to identify chemicals management priorities that reflect the evolving science in the field. As a result, the Existing Substances Risk Assessment Bureau has been developing computational workflows that automate the collection and weighing of evidence related to in vivo , in vitro and in silico outcomes across the 28,000 chemicals on the DSL. For in vivo and in vitro data collection, the workflow makes use of scripts for web-scraping and other methods (e.g. API calls) to rapidly query electronic sources of information. Moreover, for data poor chemicals, several in silico models have been developed that make use of machine learning technologies to predict toxicity. The workflow applies rule-based algorithms to weigh the collected data/information across multiple regulatory endpoints in order to prioritize chemicals for further assessment or information gathering activities. The computational workflow is being developed using open source software (KNIME, R, Python) to increase methodology sharing opportunities. (PI: Matthew Gagné)

Metal-base nanomaterials (NMs) are extensively incorporated in consumer products, including cosmetics, sunscreens, textiles, personal care products, therapeutic products, and paints. As a result, likelihood of human exposure to these materials has also increased. Health Canada (HC) is responsible for conducting human health risk assessments of manufactured NMs whose Chemical Abstracts Service Registry Numbers (CASRNs) appear on the Domestic Substances List (DSL). The variety of NM forms which may be manufactured with the same CASRN is very broad, and there is uncertainty whether all such forms pose similar hazards to human health and whether NM physico-chemical properties, including dissolution, have effects on their toxicity. To fill existing data gaps for nanoforms, HC collaborated with the Health and Environments Research Centre (HERC) Laboratory at Dalhousie University on a project to study the solubility and to determine the toxicological profiling of seven nanoforms of zinc oxide (ZnO) NM to establish the relationship between dissolution rates of these nanoforms and their cellular responses. The dissolution rates of the representative nanoforms were measured in different biological solutions and matrices and the cultured lung cells were exposed to the test nanoforms through an air-liquid interface system, an exposure system that mimics realistic exposure conditions to NMs through inhalation. The toxicological profiles of ZnO nanoforms were compared based on their effects on cell viability and membrane integrity, as well as the ability to induce cellular stress and inflammatory responses. The data obtained from this project will be used directly in nanomaterial risk assessments and will also allow evaluators at HC to determine how this particular property of nanomaterials affects the cellular responses from NM exposure and will allow for refinement of tools and approaches that HC evaluators are able to use for assessment of risk of nanomaterials on the DSL (PI: Kathy Nguyen; Djordje Vladisavljevic)

There are ongoing efforts in the regulatory community to identify and assess chemicals with the potential for endocrine disrupting activity. Endocrine disrupting chemicals (EDCs) have been linked to effects on reproduction and development, learning disabilities, cognitive and brain development, thyroid effects as well as cancer. A majority of commercial chemicals have very limited data and conventional toxicity testing methods are time consuming and require significant resources, both in cost and animals. These methodologies are less feasible given the rapidly changing chemical landscape including a continual stream of new and complex chemistries. Further, the resource intensive approach may not always be needed when screening for a particular mode of action such as endocrine disruption when in fact a large number of chemicals on the market are not EDCs. To gain efficiencies in screening and identifying chemicals of greater potential concern, new approach methodologies are being developed and employed which can perform rapid screening to focus priority setting and assessment activities. Current methodologies for this field were found to only cover a limited number of substances. In this project, multiple machine learning models were developed which predict endocrine disruption activity of a chemical. This is accomplished by using simple structural information and training the model to predict the activity in a process known as (quantitative or qualitative) structural-activity relationship ([Q]SAR). The aim of this work is to develop and implement the machine learning models to screen the Domestic Substances List for substances of potential concern as a result of endocrine activity to allow for more focused prioritization and evaluation of potentially harmful chemicals. A manuscript highlighting the methodology and models developed for this work is currently in preparation. (PI: Sean Collins)

The Maternal-Infant Research on Environmental Chemicals (MIREC) Research Platform encompasses the original MIREC Study of Canadian pregnant women and the follow-up studies of some of their infants (MIREC-Infant Development: MIREC-ID) and young children (MIREC-Child Development at age 3: MIREC-CD3 and MIREC- Early Childhood Biomonitoring and Neurodevelopment: MIREC-CD Plus) and is designed to obtain pan-Canadian data on maternal and fetal/early life exposure to priority environmental chemicals and potential adverse health effects on the pregnancy, and newborn and infant/childhood growth and development. For the original MIREC Study, co-led by Health Canada researchers, approximately 2,000 women were recruited in the 1 st trimester of pregnancy from 10 cities across Canada and followed through to delivery. Questionnaires administered during pregnancy and post-delivery collected information on occupation, lifestyle, medical history, environmental exposures and diet. Information on the pregnancy and the infant were collected from medical charts. Maternal blood, urine, hair and milk as well as cord blood and infant meconium were collected and analyzed for numerous environmental chemicals and nutrients. Subsequent follow-up studies of the infants and young children were designed to examine the potential association between prenatal exposure to various chemicals and the risk of adverse effects on infant growth, and potential markers of reproductive toxicity (MIREC-ID), child behaviour (MIREC-CD3) and neurodevelopment (MIREC-CD Plus). Child blood and urine samples were analyzed to address gaps in data for young children on several metals/elements and non-persistent chemicals (phthalates, phenols, pyrethroids) (MIREC-CD Plus). The Platform also includes the MIREC Biobank of biospecimens collected for future research on the health of mothers and their children. The project continues to generate new knowledge on early life cumulative exposure to endocrine disrupting chemicals and potential health risks in vulnerable populations of pregnant women, fetuses, infants, and young children that contributes to risk assessment and management of chemicals. (PI: Jillian Ashley-Martin)

MIREC ENDO is a new longitudinal component of the Maternal-Infant Research on Environmental Chemicals (MIREC) Research Platform studying the metabolic health of MIREC mothers over time and the pubertal growth and development and metabolic health of the MIREC children. The results of this study will address critical information gaps for Health Canada on the potential role of early life and childhood exposures to endocrine disrupting chemicals on children's metabolic function, growth (e.g., obesity) and the onset and progression of puberty, as well as whether maternal health status and chemical exposures during pregnancy have any long-term health impacts on the women. To do this, researchers are collecting and analyzing biospecimens for hormones and chemicals, conducting clinical health assessments of mothers and children and collecting questionnaire-based data from the cohort at key ages relevant to pubertal onset, namely 7-9 years of age, 10-12 years of age, 13-15 years of age and from the MIREC mothers. The first phase of the study recruited over 500 mothers and children and successfully responded to the challenges of the COVID-19 by adopting at-home based data collection tools. In addition, 1 st trimester maternal urine samples from the MIREC Biobank have been analysed for a number of emerging chemicals including organophosphate flame retardants, glyphosate, and bisphenol analogues. Planning for the second phase of the study – recruitment of 10-12 year old children – is underway. This study incorporates sex- and gender-based analysis. The project has resulted in new analytical methods for emerging chemicals and will generate new knowledge on cumulative exposure to chemical mixtures and potential health effects in vulnerable populations through various critical life stages that will support risk assessment and risk management policies. (PI: Jillian Ashley-Martin)

Lead is a naturally occurring substance found at contaminated sites, and scientific research on human health effects from lead is continuously evolving. Young children are sensitive to harmful effects of lead on their developing neurological systems with effects from childhood exposures lasting a lifetime. To support management of lead at these sites, Health Canada (HC) is investigating methods to assess health risks from lead exposure. As a Federal Contaminated Sites Action Plan (FCSAP) expert support department, HC provides guidance to federal departments on potential risks to human health. Using FCSAP funding, one ongoing effort has been the development of scientific guidance to assess non-cancer effects from short-duration (less-than-chronic) exposures to chemicals. Lead, given its prevalence and the technical challenges with assessing associated risks, proves an interesting candidate for investigation from a short-duration assessment perspective. Preliminary investigation into the applicability of mathematical models to determine blood lead level (BLL) changes was undertaken. This exercise was based on a comparison of varying levels of lead in soil, and subsequent health effects on various age groups. Two pharmacokinetic models from the US EPA (Integrated Exposure Uptake Biokinetic and All-Ages Lead Model) were used to simulate BLLs. The starting lead soil concentration of 140 mg/kg (a withdrawn Soil Quality Guideline), a concentration similar to background soil concentrations in Ontario, was assumed. Keeping total exposure constant (1 or 2 weeks), soil concentrations were increased in increments proportional to the reduction in frequency, with daily exposure assumed as baseline. Modelled changes in BLLs were compared to reference values from European Food Safety Authority (2010), which are based on 1 IQ decrement in children. Preliminary results indicate some dose averaging over a week may be acceptable within certain soil concentration ranges however, further peer review is planned to refine the findings of this study. (PI: Sue-Jin An; Nicole Somers (Inrinsik Corp.))

Health Canada is responsible for the assessment and management of health risks to Canadians associated with exposure to chemicals in the environment. Several jurisdictions around the world have begun regulating the production, use and importation of various specific chemical compounds [e.g. bisphenol A (BPA), polybrominated diphenyl ether (PBDE) flame retardants, phthalates, parabens and triclosan] that have been shown to exhibit a range of health effects including endocrine disrupting properties. Consequently, many alternative chemicals have been introduced into the market as replacement chemicals; however, their exposure and potential health risks have not yet been assessed in Canada. The goal of this 4-year project is to generate Canadian exposure data for compounds including selected flame retardants, quaternary ammonium compounds, BPA analogues, alternative plasticizers, and alternatives to parabens and triclosan, in environmental and biological matrices, as well as children's products (baby bottles). Where unavailable, new analytical methods will be developed for quantitative analysis. This will be achieved by using archived specimens or new samples of dust, water, urine, serum, follicular amniotic fluid, and placental tissues collected from a variety of populations and residential homes across Canada. Furthermore, biological modeling of some of these chemicals will provide an insight into the relationship between the measured levels in different matrices and estimated daily exposure. The data generated will inform the risk assessment and/or risk management of those chemicals, and may be used to assess potential health outcomes. It can also be used to support the planning of future biomonitoring initiatives including the CHMS. (PI: Cariton Kubwabo)

National Biomonitoring Program under the Canadian Health Measures Survey (CHMS) – Cycles 5-6 (2016-2019) and cycles 7-8 (2022-2025) (CMP M&S)

The National Biomonitoring Program is conducted as a component of the Canadian Health Measures Survey (CHMS), which is a national survey led by Statistics Canada, in partnership with Health Canada and the Public Health Agency of Canada. Through personal interviews and the collection of physical measurements, this ongoing survey provides nationally-representative data on indicators of environmental exposures, chronic and infectious diseases, fitness, and nutritional status. The physical measurements include biomonitoring, the measurement of environmental chemicals or their metabolites in blood, urine and/or hair samples. Health Canada's Population Studies Division is responsible for the National Biomonitoring Program that encompasses planning, collection, quality control, reporting and dissemination, as well as analysis and interpretation of national biomonitoring data. The program establishes baseline concentrations and trends for environmental chemicals of concern in Canadians and help meet the regulatory and public health data needs. Key milestones for the national biomonitoring program during FY 2020-2021 included: 1) publication of the first Report on Human Biomonitoring of Environmental Chemicals in Pooled Samples that included data for persistent environmental chemicals such as dioxins and furans measured in cycles 1, 3, 4 and 5 of the CHMS; 2) drafting of the Sixth Report of Human Biomonitoring of Environmental Chemicals in Canada that includes data for 79 environmental chemicals (e.g. alternate plasticizers and pesticides) collected from CHMS cycle 6 (2018-2019); 3) publication of a key paper introducing exposure load as an approach to quantifying multi-chemical exposure burden at the population level, and another describing associations between exposure to triclosan or bisphenol A and serum sex steroid hormones in Canadians; 4); publication of an online biomonitoring guidance value database and comparison tool (https://biomonitoring.shinyapps.io/guidance/); 5) Refinement of analytical methods for certain chemicals prioritized for biomonitoring in CHMS cycle 7, including a novel method that captures 28 chlorinated paraffin congeners; and 6) Initiation of analysis of the CHMS biobank samples during the CHMS gap year (Jan - Dec 2020) to meet near-term data needs of stakeholders.

The Northern Contaminants Program (NCP) was established in response to concerns about human exposure to elevated levels of contaminants in wildlife species that are important to the traditional diets of northern indigenous people. The program's main objective is to work towards reducing and, where possible, eliminating contaminants in traditional/country foods, while providing information that assists individuals and communities in making informed decisions about their food use. Biomonitoring and health outcome studies continue to be undertaken to characterize human exposures to, and the health impacts of, environmental chemicals in the northern population. In 2020-2021, five human health project proposals were funded to address exposure to contaminants and links to country foods and nutritional status and the development and evaluation of health communication tools. Along with colleagues in the Health Products and Food Branch (HPFB), staff from the Population Studies Division is leading the human health component of the NCP. The NCP currently provides Canada's main contribution to the contaminants component of the Arctic Monitoring Assessment Programme (AMAP) under the Arctic Council. A Human Health Assessment Group (HHAG) was established under AMAP, through which trend monitoring and assessment of implications and impacts of pollutants on the health of Arctic residents is undertaken. (PI: Cheryl Khoury)

Health Canada is responsible for assessing and managing risks associated with engineered nanomaterials (materials in a size range of 1-100 nanometers). As part of their risk assessment activities, New Substances Assessment and Control Bureau (NSACB) purchased commercially available metal oxide nanopowders to characterize their physical-chemical and toxicological properties. For metal oxide nanomaterials, identifying the mineral phase and crystallinity is critical for their risk assessment because distinct phases exhibit different solubility and toxicity. Mineral phase identification is usually achieved using powder X-ray diffraction (XRD). This research assists NSACB in their physical-chemical characterization of eight groups of metal oxides (Cu, Ni, Ce, Al, Fe, Mn, Ti and Zn) to complement on-going toxicological studies on the same nanomaterials. The goal is to use powder X-Ray diffraction to identify the mineral phases (crystalline and amorphous) of several nanoforms of each of the priority metal oxides, and estimate crystallite size based on XRD spectral features. By confirming mineral phases, purity and particle size of these nanomaterials, the results of the proposed research will bring to completion the full physical-chemical characterization of the initial 54 nanopowders listed for investigation by NSACB and add value to the toxicological investigations conducted on these nanomaterials. (PI: Suzanne Beauchemin; Pat Rasmussen)

The COVID-19 pandemic has posed challenges for traditional methods of outreach that serve to help people maintain and improve their health. "Building Back Better" is a priority across the federal Government, and expanding digital capacity through use of modern technologies is one of the ways that outreach delivery is being adapted. In particular, game-based learning on digital platforms has been shown to increase user engagement and comprehension. This may offer an effective method for the outreach to youth, which the Government has identified as a priority group. The Regulatory Operations and Enforcement Branch, Environmental Health Program in Ontario, the Transformation Office, and the Canada School of Public Service are collaborating on a project under the Solutions Fund Initiative that will explore the effectiveness and feasibility of game-based learning digital solutions as a tool to increase awareness and motivate behaviour change about environmental health hazards among youth. Digital solution technologies under examination include web-based applications, 360 o 3D video production, augmented reality, virtual reality, and mixed-reality. The effectiveness of a solution considers user engagement, and behaviour change; feasibility is evaluated based on financial costs, accessibility, and learning resource supports. The project adopts a human-centred design approach which optimizes system development by focusing on user needs. Methods involve a review of literature and identification of market trends on game-based learning, consultation with behavioural specialists regarding behaviour change measurement, and facilitated group discussions with stakeholders on digital solutions. The assessment will provide suggestions on game-based learning designs and platforms for new and improved outreach to youth. Potential next steps will be to develop digital solution prototype(s) informed by the results of this study. (PI: Joel Kaushansky; Phoebe Tung)

Health Canada is responsible for the assessment and management of health risks to Canadians associated with exposure to chemicals in the environment. Chemicals management around the globe has mainly focused on individual or groups of chemicals based on the hazards associated with their chemical properties, and the degree to which individuals or the environment are exposed to those chemicals. Information that has so far been available does not provide sufficient understanding of the impact of exposure to certain chemicals (or groups of chemicals) and the link with specific human disease outcomes. Consideration of an approach beyond looking at chemical exposures but rather looking to links between exposures (single chemical and in combination) and diseases within a framework that also considers other health factors is therefore warranted. In this study two databases will be linked together by Statistics Canada for the first time: the Canadian Health Measures Survey biomonitoring data for all 5 cycles from 2007-2017 and the Canadian Cancer Registry. Results will be analyzed and recommendations for further study will be made. (PI: Mary Lysyk)

Health Canada is responsible for the assessment and management of health risks to Canadians associated with exposure to chemicals in the environment. Read-across is a common data-gap filling method used in risk assessment of substances that lack data regarding toxicological properties. Generally, it is easier to carry out qualitative read-across for well-defined toxicity endpoints such as mutagenicity and skin sensitization. The challenge begins when one needs to read-across endpoints such as repeat dose toxicity (RDT) or developmental and reproductive toxicity due to the complexity of the mechanism of actions leading to a diversity of adverse outcomes. In a recent collaborative effort, a cheminformatics-based approach was developed through the incorporation of toxicity endpoint-specific information to estimate confidence bounds for the NOAEL (no observed adverse effect level) of a target substance to support read across for RDT in the absence of empirical test data (Yang et al. 2020). This method incorporates not only structural similarity but also biological similarity as well as endpoint specific information. Examples presented in this initial investigation using a database enriched with antimicrobials illustrated reliability of the approach for this chemical space however further work is needed to refine NOEL (no observed effect level) bound estimates and improve the broader applicability. The main objective of this study is to determine how this method performs when applied to a larger set of compounds that are dissimilar to the previous chemical space; bisphenols will be explored as an initial chemical subset. Demonstrating accuracy and characterizing uncertainties of this methodology when applied to diverse groups of chemicals is a critical step toward gaining confidence for further use to support quantitative reading across to complex toxicity endpoints. (PI: Sunil Kulkarni; Chihae Yang)

Genetic damage is associated with numerous human diseases, and chemical screening programs routinely assess genetic toxicity. The results of genetic toxicity tests have traditionally been evaluated using qualitative binning (i.e., yes or no) that merely identifies DNA-damaging agents. However, there is increasing interest in quantitative analyses of genetic toxicity test results, and the use of chemical-specific potency values (i.e., Point-of-Departure or PoD metrics) to determine human exposure limits and assess the likelihood of adverse health effects. Earlier work determined the most suitable PoD metric for routine analyses of genetic toxicity test data and developed a preliminary approach to determine human exposure limits that correspond with negligible likelihood of adverse effect. This research study addresses issues that hinder routine use of PoD metrics, such as the Benchmark Dose (BMD), to assess the likelihood of chemically-induced genetic effects. More specifically, the project uses dose-response data collected from the scientific literature to determine test-specific Critical Effect Size (CES) values. These values, which are also known as Benchmark Response (BMR) values, are required to determine the dose associated with a toxicologically meaningful response; and moreover, to determine the exposure limit associated with minimal risk of adverse human health effects. Analyses of published data is also being used to empirically-determine values for the uncertainty factors used to interpret experimental toxicity assessment data for human health risk assessment. Related analyses of published test data are being used to compare regulatory assessments based on genetic toxicity data with those based on carcinogenicity data (i.e., case studies). The results obtained will be used to develop a framework for routine quantitative use of genetic toxicity data for regulatory evaluations of new and existing chemicals. Interactions with stakeholders will permit an evaluation of the proposed framework, and international promotion of quantitative methods for regulatory evaluations of genotoxic chemicals. (PI: Paul White)

The Canadian Health Measures Survey (CHMS), an ongoing national health survey conducted in two-year cycles, collects extensive data on blood and urinary concentration of environmental chemicals that are used to assess chemical exposures in Canadians. Although the data collected is only nationally representative within each cycle of CHMS, combining data from multiple cycles of the CHMS allows calculation of chemical concentrations that are representative at the regional level for the 5 different CHMS regions: Atlantic, Quebec, Ontario, Prairies, and British Columbia. The aim of this ongoing project is to develop statistically robust estimates of concentrations of chemicals at the regional level and secondarily, to explore opportunities for calculation of valid estimates at smaller geographical scales. In the first-ever regional analysis of CHMS data published in FY 2019-2020, blood and/or urinary concentrations of several environmental chemicals for the provinces of Quebec and Ontario, as well as the entire CHMS (representing Canada) minus Quebec, and the entire CHMS minus Ontario were compared. The analysis showed several regional differences in exposures to chemicals and helped assessment of contributing factors. Continued regional-scale assessments under this project will involve additional CHMS regions (e.g. British Columbia), and help relating exposures to regional or point sources of pollutants and/or sociodemographic or lifestyle factors unique to a region. Ultimately, these data may contribute to a regional-scale prioritization of control measures to reduce chemical exposures in Canadians. (PI: Annie St-Amand)

Health Canada is responsible for assessment and management of risks associated with engineered nanomaterials. Manufactured nanomaterials (NMs) provide challenges in hazard identification and risk evaluation due to lack of reliable physico-chemical and toxicity data, creating a difficulty for government agencies to establish effective safety evaluation guidelines. Furthermore, engineered NMs are reaching the market through consumer products and applications such as paints, sealants and cosmetics, there are also new reports suggesting that these NMs are found in ambient atmospheres and consequently can have public health implications. The project is designed to address the needs of the risk assessment process for NMs, specifically nanosilica and nanotitanium dioxide, which exhibit the potential to reach the atmosphere and may potentially be harmful to human health and environment. Understanding the toxicity of NMs can also help understand the health outcomes due to components of air pollutants that are in nano size range. In this work, Health Canada investigators, in collaboration with academic and Environment and Climate Change Canada partners, are probing toxicity characteristics of these NMs with varying physical and chemical properties. Influence of composition, size and surface coating characteristics of these NMs on their toxicity in lung epithelial cells and macrophages, and in cells from biopsy samples from healthy and pulmonary diseases (e.g. cystic fibrosis) are being assessed. Oxidizing ability of these particles were determined. Also, uptake of amorphous silica nanoparticles into the macrophage cells were examined. The information obtained from this work will advance our understanding on the health consequences of exposure to NMs, in providing toxicity information to contribute to the risk assessment of these materials (e.g. NSACB), and also can assist in the design of less toxic NMs. (PI: Premkumari Kumarathasan)

Review of available human biomonitoring data to improve the understanding of firefighters' exposures to combustion-derived toxicants of concern

Health Canada is responsible for the assessment and management of health risks to Canadians associated with exposure to chemicals in the environment. Firefighters experience elevated risks of cancer and other serious illnesses. Their exposures to chemicals in combustion emissions, including polycyclic aromatic hydrocarbons (PAHs), flame retardants, and PFAS (per- and polyfluoroalkyl substances) are of concern. Some of these substances are known to be able to cause adverse health effects in exposed cells and experimental animals, i.e., they are toxic. To date, the precise levels and routes of firefighters' exposures to these substances is not well understood. This work is collecting and analysing firefighter exposure data from the scientific literature; more specifically, biomonitoring data on the levels of the aforementioned substances in firefighter blood, and/or the levels of substance metabolites in firefighter urine. The work is also collecting and analysing published data on the levels of the aforementioned substances in the firefighters' occupational environment, more specifically, the levels of substances in fire hall dust, in air collected at the fire suppression scene, and on the surfaces of firefighter PPE (Personal Protective Equipment). The data collected to date confirmed that firefighter blood and urine contain the prioritised toxicants and toxicant metabolites, respectively; moreover, that the prioritised substances are present in the firefighting occupational environment. The biomonitoring data are being compared to national biomonitoring surveys in Canada (Canadian Health Measures Survey) and the United States (National Health and Nutrition Examination Survey). Most of the data reflecting the levels of the prioritized substances in the firefighting occupational environment comprise fire hall dust contamination data; these data are being compared with worldwide house dust contamination data. Levels of toxicants in air collected at the fire suppression scene are being compared with urban air contamination values. Analyses of all collected data are currently underway; the results will form the basis for design of a follow-up biomonitoring study of Canadian firefighters. (PIs: Paul White; Rocio Aranda-Rodriguez; Leona MacKinnon; Elyse Bernard; Peter Mochungong; Virginie Bergeron; Catherine Campbell)

The Food and Drugs Act (F&DA) Substances Assessment Division within the New Substances Assessment and Control Bureau has been established to conduct assessments of the potential environmental and health risk to the general population associated with environmental exposure to substances in F&DA products such as human drugs, biologics, veterinary drugs, cosmetics, novel foods, food additives, natural health products and medical devices. The goals of this research project were: (1) to develop methods for the extraction and analysis of SSRIs citalopram, paroxetine, fluoxetine, and sertraline; (2) to complete a fate study to determine the stability of the compounds in 6 L aquaria; and (3) to complete short-term studies to determine the toxicity of citalopram, paroxetine, fluoxetine, and sertraline in two native freshwater invertebrates, the File Ramshorn snail Planorbella pilsbryi and the amphipod Hyalella azteca . To achieve these goals, analytical methods were developed for the analysis of SSRIs in aqueous samples, a 2-week fate study with a mixture of SSRIs of interest was completed, and short-term testing with individual chemicals on snail embryos and juvenile amphipods was completed. These data will be used directly in the environmental assessments of substances listed on the Revised In Commerce List and new substances in products regulated by the F&DA notified under the New Substances Notification Regulations of the Canadian Environmental Protection Act, 1999 (CEPA). (PI: Jane Pappas; Dianne Hughes; Jean Grundy)

Systematic characterisation and preliminary validation of genomics-guided non-animal test models (in vitro/ex vivo) and methods for nanomaterial safety assessment

Broadly defined, nanomaterials (NMs) are a novel class of man-made substances that exhibit a size range of 1-100 nanometers (one nanometer is one billionth of a meter). While their nano size-associated physical and chemical properties make them attractive for various industrial and consumer product applications, the same properties can complicate their safety assessments. Health Canada (HC) is responsible for regulating products containing NMs in Canada however, an effective risk assessment strategy and appropriate tools for evaluating NM-induced toxicity are not available. While the 'gold standard' for evaluating toxicity of substances involves testing in animals, owing to their time and resource intensiveness, animal-reliant methods are not optimal for NM testing. Thus, the overarching objective of the proposal is to identify and optimise animal alternatives (involving cells derived from animal or human tissues) that are already in development at HC and in other organisations internationally, and demonstrate their relevance and sensitivity to assess NM-induced responses in animal tissues. The optimised tools will be used to generate toxicological data for the effective risk assessment of NMs at HC. The study is conducted in collaboration with New Substances Assessment and Control Bureau of HC, and the results will enhance HC's ability to assess and manage the risks of adverse effects from exposure to NMs in products and the environment. (PI: Sabina Halappanavar)

Science assessments involve the review of large amounts of research data with a view to evaluate the existence of a causal relationship between the exposure and response in question. Like the assessment process, systematic reviews formalize the review process by identifying, determining the relevance of, critically appraising, and extracting data from relevant literature according to a standard protocol. In a meta-analysis, results from individual studies are quantitatively pooled to provide an overall quantitative estimate of the magnitude of association between an exposure and response. Systematic reviews and meta-analyses provide a powerful summary of the weight of evidence which may be particularly informative in assessing the existence of a causal association. In this study, a standard protocol, data management and analysis tools were developed, and as a test case, these tools were applied to evidence from 86 studies linking short-term nitrogen dioxide (NO 2 ) exposure to ischemic heart disease (IHD) morbidity, and 76 studies of long-term exposure and mortality. Pooling results across these studies showed that short term NO 2 exposure was significantly associated with IHD morbidity, while long term exposure was significantly associated with mortality from all causes as well as specific causes including cardiovascular disease, respiratory disease and lung cancer. The evidence was considered sufficient to infer a likely causal relationship between short term NO 2 exposure and IHD morbidity, while the evidence was considered suggestive of, but not sufficient to infer, a causal relationship between long term NO 2 exposure and mortality. The results highlight the need for additional research to understand physiological mechanisms through which NO 2 contributes to both morbidity and mortality, and to evaluate the role of confounding factors such as other air pollutants, noise and stress. The synthesis tools should prove valuable in future risk assessments. (PI: Dave Stieb)

The Food and Drugs Act (F&DA) Substances Assessment Division within the New Substances Assessment and Control Bureau has been established to conduct assessments of the potential environmental and health risk to the general population associated with environmental exposure to substances in F&DA products, and to integrate innovative science into the risk assessment and risk management of new substances. There are eleven Selective Serotonin Reuptake Inhibitors (SSRIs) on the Revised In Commerce List (R-ICL) which have been identified as priorities for risk assessment and grouped together as they are known to have the same mode of action. The goals of this research study are to evaluate zebrafish models that, when combined, could provide information on the potential consequences of long-term exposure to environmentally-relevant levels of five different SSRIs from a higher (systems) perspective. A robust model that tests multiple physiological parameters has been developed, including growth, behaviour, fecundity, bioaccumulation and changes in gene expression that can be used to assess the fitness of juvenile and adult fish following chemical substance exposure. These data will be used directly in the environmental assessments of substances listed on the R-ICL and will be used to scope the feasibility of a cumulative risk assessment process for substances notified under the New Substances Notification Regulations of the Canadian Environmental Protection Act, 1999 (CEPA), in support of a Chemicals Management Plan Post-2020 initiative. (PI: Dianne Hughes; Jane Pappas; Jean Grundy)

Health Canada is responsible for assessment and management of risks associated with engineered nanomaterials (materials in a size range of 1-100 nanometers). The New Substances Assessment and Control Bureau (NSACB) has identified metal oxide nanomaterials as high priority for assessment under the CMP. The toxicological behavior of nanomaterials (NMs) is closely associated with their distinct physical-chemical properties. This research is investigating the influence of dissolution behaviour of NMs on their toxic potential. The term "dissolution behaviour" includes solubility as well as changes in suspension stability (e.g. size, agglomeration/aggregation, surface area, and surface charge) of NMs dispersed in different aqueous media. Although NM solubility has been recognized as one of the key properties that must be determined for accurate categorization of toxicological potential, standardized solubility test methods for nanomaterials are lacking. This study focuses on eight groups of metal oxides determined by NSACB to be in commerce in Canada (copper, nickel, zinc, titanium, iron, manganese, cerium and aluminum), many of which are used in consumer products to which Canadians are regularly exposed. The study investigates solubility of eight individual metal oxide NMs and determine the impact of solubility on their toxicity using toxicogenomics tools (to investigate the changes in the expression of all genes simultaneously). In addition, environmental releases of metal oxide and metallic NMs used in the automobile industry (e.g. iron oxides and platinum) will be investigated using road dust samples collected from the expressway network in the City of Toronto, providing a realistic exposure scenario. The results of the proposed research will inform HC risk assessments and will help HC meet its commitments associated with the Organisation for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN). (PI: Pat Rasmussen; Sabina Halappanavar; Suzanne Beauchemin)

New Approach Methodologies (NAMs) are emerging approaches or tests, considered to be synonymous with alternative test strategies, that can inform chemical risk assessments in the absence of traditional toxicity data. Currently, there are substantial international efforts to develop NAM-based approaches that provide information related to regulatory endpoints. The aims of this project are to provide support for applying in vitro genetic toxicity data, with a novel data analysis and interpretation framework, in future priority setting initiatives and quantitative risk assessments of organic chemicals. In this study, assessment will be based on the results of a high throughput in vitro test battery currently being developed by collaborators within Environmental Health Science and Research Bureau. The test battery consists of higher throughput versions of well-established genetic toxicity assays, some of which are functionally related to established OECD test guidelines. The development of this NAM-based approach will begin with the assessment of over 30 data-rich reference compounds with in vitro genetic toxicology data made available by international collaborators. An in-depth case-study is being conducted to scrutinize the utility of the NAM-based approach for risk assessment and regulatory decision-making. Specifically, in vitro to in vivo extrapolation will be coupled with assay results to establish administered dose equivalents, which will be compared to human exposure estimates and points of departure from traditional animal studies. Once established, this integrated approach could be used for routine chemical screening and future risk assessments. (PI: Marc Beal; Paul White)

The Chemicals Management Plan (CMP) aims to assess the risks to human health posed by thousands of chemicals but only a fraction of these chemicals have known human exposure data. It has been evident from previous assessment cycles that changes to priority setting paradigm must be made in order to assess chemicals more effectively and to identify potential triggers for future assessments. There has been extensive work in the environmental analysis and biomonitoring front, but personal exposure has been overlooked. Unlike biomonitoring, personal exposure can provide dosimetry data. The use of personal passive sampling devices (PSDs) are limited to those compounds that can be measured at environmental concentrations but often require longer sampling periods, thus limiting the practical wear time or number of subjects that can be monitored. In recent years, there has been a growing interest in using silicone PSDs for monitoring indoor air and water. In a study carried out at Oregon State University, a wide range of chemicals absorbed on silicone wristbands (SWs) worn by 22 participants were identified. However, the main limitation in the published work was the lack of uptake rate values, the constant contact between SW and skin, surfaces and clothing. Without the uptake rate, the concentration found in the SW cannot be translated to the environmental concentration or exposure estimation, which restricts the use of these data for risk assessment. Our project aims to fill current data gaps in the determination of uptake rates in different sorbent materials: silicone (use as wristbands, SW); and new material developed at North Caroline State University (CIPS). In addition, silicone wristbands will be deployed during firefighters training exercises in order to assess their exposure to polycyclic aromatic hydrocarbons (PAHs). (PI: Rocio Aranda-Rodriguez)

Per- and poly-fluoroalkylated substances (PFAS) are a large class of man-made chemicals that are ubiquitously found in the environment due to their wide variety of industrial and commercial uses, their persistence and their high mobility. There are concerns for PFAS exposure through environmental media (e.g., water, soil, foods) to cause potential adverse health effects including liver and kidney toxicity, increased cholesterol levels and delays in mammary gland development. Although there is a growing body of knowledge on PFOS (perfluorooctanesulfonic acid) and PFOA (perfluorooctanoic acid) toxicity, there is little known about the many other PFAS. Health Canada has identified toxicity testing for PFAS as a research priority. To date, >3,000 PFAS have been identified; it is recognized that not all PFAS can be tested to develop health-based values. Therefore, Health Canada compiled a list of 24 PFAS that best represent variability in chemical composition across PFAS and importantly, have been found in Canadian drinking water or have analytical methods for detection in drinking water. Acquiring information on data poor substances for risk assessment has been challenging for regulatory agencies worldwide, including Health Canada, due to the cost and length of traditional toxicological research. In an effort to accelerate the pace of risk assessments, the international toxicology and risk assessment communities are investing in case studies to demonstrate the utility of new approach methodologies (NAMs) that are cost/time effective in chemical evaluations. This research employs gene expression profiling in human liver cells in culture to facilitate assessment of various PFAS. Objectives include: 1) applying gene expression data to acquire mode of action and potency information on poorly studied PFAS ; 2) to explore how PFAS behave in mixtures; 3) to use the data as a case-study for the use of NAMs in risk assessment. (PI: Carole Yauk (University of Ottawa); Ella Atlas)

Use of new approach methodologies to facilitate potency ranking and evaluate mode of action for 25 bisphenols

BPA is an endocrine disrupting chemical (EDC) that is the topic of both regulatory and public concern. Its use has been banned from products available to consumers, including baby bottles (Canada) and thermal paper (European Union). These bans have led to increased use of BPA alternatives as replacements, many of which are chemically similar. BPA and alternatives were examined using New Approach Methodologies (NAMs) that integrate in silico and in vitro methods. BPA's cellular effects occur primarily through its interaction with the estrogen receptor (ER). When active, the ER interacts with the DNA to modify gene expression. Therefore, changes in gene expression represent BPA's earliest toxicological effect on the cell that can be reliably measured. Here, 25 BPA alternatives, were assessed for: i) general systemic toxicity (hazard-independent) that does not predict the potential of specific adverse effects; and ii) estrogen receptor (ER) pathway-specific expression of genes related to the ER pathway. The objectives are: (1) to expose human mammary epithelial cells (MCF7 cells) to an extended dose range of known BPA alternatives; (2) to measure changes in gene expression; (3) to perform dose response modeling and potency ranking of these substances relative to BPA and estradiol; and (4) compare these outcomes to current estimates from in vivo (i.e., animal) studies. In doing so, a weight of evidence approach combining both in silico predictions and in vitro data will be used to characterize the potential hazards and compare relative potencies within this group of 25 substances. These data have contributed to the development of an Integrated Approach to Testing and Assessment under the OECD Working Party for Hazard Assessment (WPHA), which has the overarching goal to advance the application of New Approach Methods (NAMs) in prioritization and risk assessment. (PI: Tara Barton-Maclaren; Ella Atlas).

The Food and Drugs Act (F&DA) Substances Assessment Division within the New Substances Assessment and Control Bureau has been established to conduct assessments of the potential environmental and health risk to the general population associated with environmental exposure to substances in F&DA products, and to integrate innovative science into the risk assessment and risk management of new substances. In 2018, given the momentum of the international regulatory community to eliminate animal testing in chemical risk assessment, Health Canada, in partnership with National Research Council (NRC) Canada, initiated research to develop the zebrafish model as a potential alternative to the rodent model for generating data for chemical risk assessments. Using 20 test compounds, the goal of this research project is to: develop a model to evaluate general toxicity using traditional biomarkers (e.g., morphological, tissue and behavioral changes) as well as novel markers such as changes in gene expression (transcriptomics). Additionally, methods to assess the kinetics of absorption, distribution, metabolism and excretion (ADME) have been developed and 10/20 test compounds have been evaluated. In order to further develop the model to evaluate chemicals for endocrine disruption, a platform was developed using traditional tissue markers (melatonin, cortisol, norepinephrine) and an evaluation of gene expression changes using transcriptomic testing. Integral to this work is collaboration with the international zebrafish research and regulatory community. These data will be used to validate the zebrafish New Approach Methods (NAMs) as predictive tools in assessing the toxicity of substances notified under the New Substances Notification Regulations of the Canadian Environmental Protection Act, 1999 (CEPA). It will also be used to facilitate the 3Rs (reduction, refinement, and/or replacement of animals in toxicity testing) in chemical risk assessment. (PI: Cindy Woodland; Jean Grundy)

Health Canada's Pest Management Regulatory Agency (PMRA) is responsible for pesticide regulation in Canada under authority of the Pest Control Products Act (PCPA). Cranberry production in Canada has been increasing, and, with it, requests for registering pesticides for use on cranberries. Cranberry production is a unique combination of relatively wet and dry processes. Cranberry bogs must be well-drained, but also occasionally flooded, as most are harvested by flooding. Thus, cranberry bogs are usually constructed in layered structure - peat over sand with drainage tiles on the bottom. Cranberries also require highly acidic soil (pH 4-5). With high organic carbon contents, desorption, particularly after aging, becomes an important factor to consider. Common methods used for estimating environmental concentrations (EECs) of pesticides in surface waters from runoff from agricultural lands are not suitable for estimating concentrations in cranberry floodwater. The PMRA developed a simple model to estimate pesticide concentrations in cranberry floodwater and post-flood drainage. The model uses the calculations found in the US EPA's Variable Volume Water Model (VVWM) and Pesticides in Flooded Agriculture (PFAM) models. It considers degradation in soil and floodwater, transfer of pesticide from soil to floodwater and pesticide in post-flood drainage, and allows routing the floodwater through several cranberry bogs. Furthermore, using azoxystrobin and chlorantraniliprole as representative pesticides and in collaboration with a cranberry farm, the PMRA conducted aged sorption/desorption laboratory studies and analyzed soil and water samples throughout the 2019 growing season. Water samples were collected daily during flooding and from drainage pipes during growth and after flooding. The model was tested using the measured desorption parameters and soil pesticide concentrations prior to flooding. Other model parameters were set to default values, which are the same as those used in VVWM and PFAM for surface water estimations. The model predicts a transfer of pesticide from field to floodwater comparable to that measured in the field. (PI: I. Kennedy; L. Gui; C. Hart)

Health Canada's Pest Management Regulatory Agency: Results of a multi-year analysis on dermal absorption

Health Canada's Pest Management Regulatory Agency (PMRA) is responsible for pesticide regulation under authority of the Pest Control Products Act (PCPA). Using a multi-stakeholder and collaborative approach, the PMRA has been involved in a multi-year analysis related to dermal absorption. The onset of this initiative led to the development of a position paper on the use of in vitro dermal absorption data for health risk assessments. This paper also outlined the Triple Pack approach of combining data from in vivo rat, in vitro rat, and in vitro human data and using this to estimate a human dermal absorption factor for health risk assessments. Subsequent work resulted in a streamlined in vivo dermal absorption test guideline that detailed how to reduce animal use and cost, while maintaining scientific integrity and utility for risk assessment purposes. Standardization of the data requirements resulted in the submission of studies that were of better quality, thereby allowing the PMRA and other experts to undertake a retrospective analysis. The outcome of this analysis was published in the Journal ALTEX: Alternatives to Animal Experimentation, and has now demonstrated that the routine requirement of an in vivo study to characterize dermal absorption may be replaced by in vitro data. (PI: K. Irwin; S. Ramji)

Health Canada's Pest Management Regulatory Agency (PMRA) is responsible for pesticide regulation in Canada under authority of the Pest Control Products Act (PCPA). General guidance to mitigate pesticide runoff from treated areas into aquatic habitats appears on all product labels with outdoor uses, with the exception of registered uses where exposure from runoff is not expected (for example, insect baits and greenhouses). The PMRA recognizes the potential for a Vegetative Filter Strip (VFS) to help protect aquatic organisms in waterbodies from exposure to certain pesticides through runoff. Vegetative filter strips are bands of non-cropped grassy land (that may also include shrubs, trees, or other vegetation) between treated fields and water bodies. A computer model for simulating a VFS was integrated into current models used to estimate pesticide exposures through runoff. The ability to model the effectiveness of a VFS allows rapid initial assessments without the burden of expensive and time consuming field experiments. Computer simulations, which estimate the effectiveness of a VFS to reduce pesticides in runoff for a range of agricultural regions in Canada, have demonstrated the importance of strip width and soil properties. Most commercial and domestic class pesticide labels for products used outdoors recommend including a VFS between the treated area and the edge of a water body to reduce contamination through runoff. For certain pesticides, commercial class product labels include the requirement for a mandatory VFS of at least 10 metres wide that must be constructed between the field edge and adjacent, downhill aquatic habitats to protect aquatic organisms from pesticide runoff. The decision to make the VFS mandatory on certain products includes consideration of the physicochemical properties of the pesticide. Currently, the presence of a VFS is not considered during evaluation of the amount of a pesticide that may enter drinking water sources. (PI: J.N. Westgate; M. Whiteside)

Health Canada's Pest Management Regulatory Agency (PMRA) is responsible for the federal regulation of pesticides in Canada. The Pest Control Products Act provides the legislative framework and corresponding policies, and guidance documents provide additional details on the data requirements for determining the safety of these products to both human health and the environment, and also that these products have value when used according to label directions. Only pest control products that have acceptable risk are registered for use in Canada, which includes products that will be used in a greenhouse. In a greenhouse environment and after a pesticide is applied to a crop, greenhouse workers can be exposed to the pesticide residue that remains, due to crop contact from post-application hand labour activities such as pruning, thinning, or harvesting. In turn, PMRA collaborated with the Agriculture and Agrifood Canada's Pest Management Centre and industry to determine if a standardized daily rate of residue decline could be established for greenhouse crops. This rate of decline value could then be used in pesticide risk assessments for greenhouse workers, to more accurately assess their exposure to a pesticide following application to either ornamental and vegetable crops. Having this value is an important aspect in determining the length of time that must elapse before a worker can safely conduct the necessary hand labour tasks on treated crops. (PI: K. Parsons; J. Selwyn; C. Moase)

Health Canada's Pest Management Regulatory Agency (PMRA) is responsible for the federal regulation of pesticides in Canada. The Pest Control Products Act provides the legislative framework, and corresponding policies and guidance documents provide additional details on the data requirements for determining the safety of these products to both human health and the environment, and also that these products have value when used according to label directions. Only pest control products that have acceptable risk are registered for use in Canada. The PMRA data requirements for human health risk assessments includes studies to assess the degree and nature of exposure to specific human populations, such as workers and children. These data requirements can be addressed using chemical-specific exposure studies. On the other hand, scientific methodology that allows exposure studies conducted with one pesticide to be used for the assessment of many pesticide active ingredients in a generic manner, such as handler exposure studies, is another option. Much of the generic exposure data has been developed by experts who have formed exposure task forces. The regulatory input on the various protocols is incorporated throughout the process in a collaborative and scientific manner. Overall, this has resulted in a large, comprehensive, and modern collection of data, and has been an efficient mechanism for developing data required for pesticide submissions. It has also allowed pesticide regulatory authorities, such as the PMRA, to use these studies, when applicable, in lieu of chemical-specific data. (PI: C. Vizena; T. Satchwill; S. Ramji; I. Pilote)

Update on the Pest Management Regulatory Agency's approach to non-animal testing

Health Canada's Pest Management Regulatory Agency (PMRA) is responsible for the federal regulation of pesticides in Canada. The regulatory review of pesticides, in Canada and internationally, currently relies primarily upon animal studies. Over the years and as a means to reduce, refine and/or replace existing animal studies, non-animal based alternative approaches have and continue to be developed. The Canadian regulatory framework for pest control products has sufficient flexibility to allow for incorporation of validated alternative approaches such as: in silico methods ([quantitative] structure activity relationship ([Q]SAR) models), integrated approaches to testing and assessment (IATA), adverse outcome pathways (AOPs), and Tox21 and RISK21 approaches. More recently, consideration of new approach methodologies (NAMs) has also come to the forefront and this has reignited discussions on the current pace of incorporation of alternative methods in existing regulatory approaches for chemicals, which includes pesticides. As global acceptance of such approaches highlights the importance of having internationally recognized technical guidelines, such as those developed by the Organisation for Economic Co-operation and Development (OECD), the PMRA continues to be actively involved in several, ongoing multi-stakeholder initiatives. Given the importance of human safety and protection, when considering alternative approaches, robust scientific scrutiny of these methods is necessary so to help facilitate their adoption for regulatory purposes. (PI: Y. Bhuller; D. Ramsingh)

Pharmaceutical Drugs

As part of Health Canada's mandate to ensure the health and safety of Canadians, every year the Health Products (HP) Laboratory Program collects and tests pharmaceutical products that have a Drug Identification Number (DIN) under the Drug Quality Surveillance Program (DQSP). The purpose of the DQSP is to ensure the quality of pharmaceutical products on the Canadian market through testing the quality of the products, and by verifying the methods used by the company to control product quality. Besides ensuring the health and safety of Canadians, the DQSP is required to fulfill Health Canada's obligations to conduct drug quality surveillance under our Mutual Recognition Agreements with other countries. The program has operated for decades, with the selection strategy for products to be tested more recently transitioning to a risk-based approach. The new risk-based selection criteria consider newly marketed products (75%), risk intelligence from partners (15%), and random selection (10%) to ensure that any marketed DIN product could potentially be sampled and tested. It covers risk factors that are hidden or not otherwise explicitly included in the other models. This new model is similar to the US FDA's DQST Drug Quality Sampling and Testing Program and includes practices from the European Medicine Evaluation Agency (EMEA). Over the last seven years, the HP laboratories have tested more than 580 finished products and active pharmaceutical ingredients. When a product is found to have deficiency (5% of them), work is done in close collaboration with ROEB inspectors to implement compliance and enforcement activities. HC's Health Products Laboratories receive funds through cost recovery fees (DELS) in support of the pharmaceutical drugs departmental priority. (PI: Josée Trudel)

Health Canada has a mandate to ensure the health and safety of Canadians and provide regulatory oversight of the Canadian pharmaceutical drug supply. In fulfilling this role, the Department and its international regulatory partners became aware of high levels of nitrosamine impurities in Angiotensin II Receptor Blockers (ARB) products (which relax veins and arteries to lower blood pressure) in the global supply chain. Since then, nitrosamine impurities have been found in several other drugs on the Canadian market including ranitidine, metformin, varenicline, amitriptyline, etc.. As nitrosamines are generally considered quite toxic, their presence in human pharmaceutical products are a major concern for international regulators. For example, the nitrosamine impurity N-nitrosodimethylamine (NDMA) which was detected above acceptable limits in multiple products on the Canadian market is classified as "probably carcinogenic to humans". This study was proposed by the US FDA and was presented to the Nitrosamine International Strategic Group. Six laboratories from various countries (Australia, Switzerland, Ireland, France, Germany, US, and Canada) agreed to participate in the study; the goal of which is for each participating laboratory to test an identical set of samples using their own analytical methods in order to: i) assess the observed variation in results generated by their different analytical methods; ii) identify the factors that contribute to these variations, and; establish performance criteria for measuring nitrosamines in ARB Drugs. The results of this study should prove useful to manufacturers of pharmaceutical products and the regulatory community by helping them development sensitive, accurate and robust methods (or improve current methods) for testing of toxic nitrosamine impurities in potentially any human pharmaceutical. Hence, this project is directly related to Health Canada's mandate and aims to prevent and reduce risk to individual health by helping to ensure that the method of analysis for nitrosamines are suitable for their intended use. HC's Health Products Laboratories receive funds through cost recovery fees (DELS) in support of the pharmaceutical drugs departmental priority. (PI: Y. Su)

One of the mandates of Health Canada is to be a leader in compliance and law enforcement by protecting and informing Canadians against associated health risks with products, substances and the environment. One of which is post-marketing surveillance that is carried out in chemistry and microbiology laboratories. In recent years, health products have been recalled in Canada and the United States following microbial contamination by a group of bacteria called Burkholderia cepacia complex (Bcc). Bcc is a group of bacteria that are commonly found in the environment (soil, water, plants). Member strains of this complex can be opportunistic pathogens primarily affecting immunosuppressed individuals, especially people with cystic fibrosis. The Bcc complex so far includes 23 genetically closely related species. Members of the Bcc group are capable of forming biofilms, are resistant to disinfectants and are frequent contaminants of water systems. They are therefore problematic for liquid pharmaceutical products. No rapid method has yet been developed to detect these microorganisms in health products. The microbiology laboratory project consisted of validating a proposed rapid confirmation protocol by molecular method (PCR) of member isolates of Burkholderia cepacia complex. The method has been tested and validated on 59 isolates from various clinical and environmental sources. The developed method will be submitted for scientific publication. The HC's Microbiology Laboratory receive funds through cost recovery fees (DELS) and A-Base in support of the pharmaceutical drugs, natural health products and cannabis priorities. (PI: Karine Lebel)

Radiation Protection

Health Canada is committed to informing Canadians about the health risk of radon as part of the mandate to ensure the health and safety of Canadians. Radon is the second leading cause of lung cancer, after smoking. Although the guideline for radon exposure in homes is expressed as the concentration of radon gas, it is actually the short-lived radon progenies that deposit most of the energy that contributes to the radiation dose. The majority of the radon progenies attach to particulate matter; deposition in the lung, therefore, is dependent upon particle concentration and relative size distribution. In this study, measurements of indoor aerosol characteristics relevant to radon dosimetry, such as radon progeny concentration, equilibrium factor, unattached fraction, and radon progeny particle size distribution will be carried out. These characteristic parameters will be used in conjunction with a radon dosimetry computational simulation tool to calculate radiation dose to lung. The knowledge generated from this project will improve our ability to assess residential radon dose and associated risk. (PI: Baki Sadi)

Health Canada is committed to informing Canadians about the health risk of radon as part of the mandate to ensure the health and safety of Canadians. Long-term exposure to radon gas is the second leading cause of lung cancer, after smoking. In Canada, it was estimated for 2016 that 34% of lung cancer deaths attributed to radon in women and 27% in men. A previous analysis demonstrated that mitigation of high radon levels in existing housing in addition to reducing radon ingress in new housing is only cost effective where regional radon levels are high; therefore, it was important to assess the sensitivity of the cost effectiveness estimate to parameter uncertainty. The cost-utility analysis is a secondary analysis that incorporates many different published datasets to model the costs and the benefits of a health intervention. This analysis was focussed on evaluating the uncertainty associated with the estimates of cost effectiveness of interventions to reduce residential radon in existing housing only, according to the choice of model used, the rate of radon testing and mitigation in existing housing, the renewal rate of the housing stock, and the distribution of the number of residents per dwelling. The results showed that the cost effectiveness would improve at increased rates of testing and mitigation of existing housing. The estimates were not sensitive to the choice of model used, nor to the housing renewal rate, nor to the increase in one person households and decrease in two-person households reported recently for Canada. Based on the study findings, recommendations to home owners to test and mitigate high radon concentrations in existing housing are strengthened. Policy options and communication of these results to the public will be explored to encourage homeowners and thereby increase the rates of radon testing and mitigation. (PI: Janet Gaskin, NRC; Jeff Whyte, University of Ottawa; Doug Coyle)

Health Canada has a mandate to support emergency response and the National Biological Dosimetry Response Plan, linked to the Federal Nuclear Emergency Plan. In the case of a nuclear/radiological event it is imperative to quickly identify exposed individuals for the purpose of medical intervention, and to identify first responders who must be restricted from further exposure. Even for a lesser-scale event, many concerned members of the public will seek an assessment of their radiation exposure. The assessment of radiation dose is called dosimetry and when biological material is used for this dose assessment, it is termed biological dosimetry. This research involves the development of imaging flow cytometry methods for high throughput biological dosimetry. In addition, genomic, proteomic and metabolomic endpoints are being examined as new biomarkers for radiation damage to estimate the dose of ionizing radiation absorbed by an individual. (PI: Lindsay Beaton)

Assessing the impact of new strategies for communicating radon gas health risk, testing, and mitigation information to Canada's younger age demographic

Health Canada is committed to informing Canadians about the health risk of radon as part of the mandate to ensure the health and safety of Canadians. This study, conducted by Evict Radon, involves the development, execution, and evaluation of multiple new communication strategies designed to increase radon awareness, promote radon testing, and encourage mitigation of radon risk for Canadians between the ages of 25-38. Evidence suggests that current radon awareness strategies are not effectively reaching younger Canadians. Data collected in previous studies indicate that communication tactics such as print media, and/or media cycle approaches work well with older age groups, but not well with younger populations (ages 25-38). There is a need to find the best communication strategy for these demographics that can help Health Canada to enhance the effectiveness of radon education and awareness. Younger Canadians are more likely to respond to advice obtained via peer-to-peer recommendations, delivered through transitory stories, and posts on social media platforms. A minimum of three different communication strategies will be piloted during the fall of 2020 and 2021. For each communication strategy, awareness uptake, psychosocial, and behavioural data will be complied, and a detailed demographic survey of participants will be completed. This study will contribute the on-going task of informing Canadians about the health risk of radon gas. It will also contribute to developing awareness campaigns in the future. (PI: Madison Pecoskie (Evict Radon); Dr. Goodarzi (University of Calgary))

Health Canada is committed to informing Canadians about the health risk of radon as part of the mandate to ensure the health and safety of Canadians. Exposure to indoor radon is the leading cause of lung cancer among non-smokers, and the second-leading cause among smokers. Radon enters a home as radon gas and quickly decays through a series of short-lived radioisotopes. Health Canada and the National Research Council's (NRC) Ventilation and Indoor Air Quality Group of the Construction Portfolio collaborate closely on radon mitigation studies. Ongoing work focuses on evaluating the performance of full vertical passive stack mitigation systems in specialized testing facilities and in homes ("field studies"). Preliminary results, including field studies conducted in the National Capital Region, indicate that these are effective radon reduction solutions under test conditions. In this study, field studies will be conducted in different regions in Canada to investigate the impacts of different climatic factors (e.g., indoor and outdoor temperature, relative humidity, air pressure), geographic conditions and construction patterns on the performance of the systems. Testing will be conducted in both the summer and winter seasons. This research supports national radon mitigation guidance and standards and will inform future revisions to the National Building Code. (PI: Zhou Liang Grace [National Research Council] Michel Gauthier; Adelene Gaw)

As the lead department of the Federal Nuclear Emergency Plan, Health Canada has the mandate for coordinating the preparedness and response activities of a nuclear emergency. In a collaborative effort to improve Canada's ability to deduce the origin and nature of global nuclear activities, eight partner institutions have launched a multi-faceted project to address any gaps in Canada's nuclear forensic capabilities. Under the ANFCAP project, Health Canada (HC) leads the measurement and instrumentation stream that will commission state-of-the-art radiation detection systems in three different laboratories, each specializing in the measurement of specific types of radioactivity. These include: (1) a multi-detector system at Health Canada specializing in the measurement of radioactive noble gases, (2) a dual-detector system at the Canadian Nuclear Safety Commission (CNSC) Laboratory aiming to unscramble the complex signals from special nuclear materials, and (3) a dual-detector system at the Sudbury Neutrino Observatory Laboratory (SNOLAB), where the deep underground location enables the detection of the smallest traces of radioactivity. These systems aim to push the limits of detection of rare radioisotopes indicative of nuclear events and provide crucial information on the licit or illicit nature of the underlying activities. These advancements will dramatically enhance Canada's capability to monitor for any indications of nuclear activity, fulfilling Health Canada's mandate to protect Canadians from the radiation exposure risks posed by global nuclear threats, and further support Health Canada's obligations under the Comprehensive Nuclear-Test-Ban Treaty) (PI: Pawel Mekarski; Nadereh St-Amant [CNSC]; Jeter Hall [SNOLAB])

Health Canada acts, on request, as the principal health advisor to other federal departments and agencies on occupational and public health matters related to radiation safety as part of Health Canada's mandate to protect the health and safety of Canadians. CCRPB (Consumer and Clinical Radiation Protection Bureau) conducts research to support Health Canada's advice on radiation health impacts based on state-of-the-art science. Currently, it is assumed that the health risks resulting from radiation exposure are linearly proportional to dose without a threshold. However, the scientific knowledge emerging over the last decades clearly indicates that biological effects and the underpinning risk for human adverse health outcomes at doses below 50-100 mGy is uncertain. This includes radiation effects related to chronic and acute exposures, low and high doses and varied dose rates. There is also lack of clarity on the effects from different radiation qualities and how they impact different organs, tissues and induce cellular damage eventually leading to cancer and other adverse outcomes. It is widely recognised that more mechanistic research is needed to help address and reduce uncertainties at low doses. This study is investigating the biological effects of low-dose radiation; it exploits "omics" (e.g. proteomics, genomics) technology, a validated tool in biological research to generate new knowledge regarding the shape of the dose-response relationship; identifying key mechanistic pathways and threshold doses at which these pathways are activated and how they differ with radiation qualities and biological tissues. The results will feed into the related activities of developing of Adverse Outcome Pathway for ionizing radiation. A better understanding will provide a more biologically meaningful basis for reliable health risk estimation essential for a robust system of radiation protection. (PI: Vinita Chauhan)

Health Canada is committed to informing Canadians about the health risk of radon as part of the mandate to ensure the health and safety of Canadians. The inhalation of radon poses a risk to human health and long-term exposure to radon is the second leading cause of lung cancer, after smoking. This work estimates the incremental cost effectiveness ratios for the 2012 populations in Canada, each province/territory, and 17 census metropolitan areas, for practical radon mitigation scenarios to reduce residential radon exposures. Sixteen intervention scenarios compare radon mitigation implemented at differing rates in new and existing housing relative to preventive measures installed at construction, using three different radon mitigation thresholds. A period life-table analysis, a secondary data analysis, was conducted using data derived from two recent Canadian radon surveys, along with Canadian mortality and quality of life data. Analyses adopted a lifetime horizon and a discount rate of 1.5%. Results of the work to date indicate that reducing radon ingress in new construction is cost effective across Canada, and expanding the intervention to also include the mitigating of high radon levels in existing housing is cost effective where regional radon levels are high. This information on the cost per unit health benefit estimated to result from an intervention will be used to prioritize strategies for reducing the burden of radon-induced lung cancer in Canada. (PI: Janet Gaskin; Jeff Whyte (NRC); Doug Coyle, Nicholas Birkett, Daniel Krewksi (University of Ottawa))

The Radiation Protection Bureau (RPB) has a long-standing commitment to protect and promote the health of Canadians from ionizing radiation exposure in daily living and working environments. For almost two decades, RPB has been operating a Fixed Point Surveillance (FPS) network for monitoring radiation exposure and the associated health risks arising from man-made sources and naturally occurring radiation materials. The network is comprised of more than seventy 3"x3" sodium iodide (NaI) gamma spectroscopic dosimeters distributed across Canada and the recorded energy spectrum below 3MeV has been used for radiation identification and dose estimations. The FPS network's potential as a cosmic dose monitoring system has recently been explored by using the recorded count rate above 3MeV. The observed counts at various FPS locations were found to correlate well with the theoretical cosmic doses in which the geographical and solar cycle effects were included. The result suggested that the FPS network can be used to monitor not only terrestrial radiation but also cosmic radiation if well calibrated. To become a cosmic ray dose monitoring system, the FPS network has to be experimentally calibrated by a reference dosimeter. For this purpose, Tissue Equivalent Proportional Counter (TEPC) is proposed as a reference dosimeter to calibrate the recorded FPS cosmic ray count rate to H*(10) dose rate. TEPC has been widely used for cosmic ray dose estimation at high altitude (e.g at commercial aviation level or international space station) and is capable of separating the neutron contribution from the other cosmic ray components. As a reference dosimeter, the TEPC instrument itself has to be calibrated; conducted in various exposure scenarios (gamma, neutron, mixed field, high energy neutron field). The calibrated TEPC instrument will then be used to perform side-by-side measurement with our FPS detectors to calibrate the count rates. It has participated in a boat survey, comparing/calibrating multiple types of detectors. (PI: Weihua Zhang)

Uranium is a naturally occurring radioactive element as well as a heavy metal. Biological and health effects of uranium have been attributed to both its radiological and chemical toxicity. While the majority of the published studies indicate uranium toxicity is primarily due to chemical damage to the kidney, other in vitro and in vivo experiments show genotoxic effects that could be attributed to both chemical and radiological toxicity. Due to potential occupational exposure in the uranium-based nuclear fuel cycle, environmental exposure from mining and other industrial activities and chronic exposure through drinking water, especially in communities served by underground well water, adverse health effects of uranium is a concern to risk assessors and regulators in both radiological and chemical communities. The objective of this project is to define an adverse outcome pathway (AOP) relevant to uranium-induced kidney toxicity for submission to the Organization for Economic Co-operation and Development (OECD) Extended Advisory Group on Molecular Screening and Toxicogenomics (EAGMST). (PI: Baki Sadi)

Domestic radon exposure and childhood leukemia: a population-based study in Canada

Health Canada is committed to informing Canadians about the health risk of radon as part of the mandate to ensure the health and safety of Canadians. Long-term exposure to radon gas is recognized as an important cause of lung cancer. This study examines the possibility, first raised using a data set collected in the 1970s, or a possible link between average radon concentrations in the home and the incidence of childhood leukemia and lymphoma in Canada. Following the launch of the National Radon Program in 2007, Health Canada completed a long-term radon survey in 33 census metropolitan areas (CMAs), which covers about 70% of the Canadian population. Data obtained was examined alongside leukemia and lymphoma incidence rates among children (0 - 14 years of age) in the past decade (2006-2015), exploring linkages between city-level average radon concentrations and leukemia and lymphoma incidence rates in 33 major Canadian cities. Analyses were conducted for 6 subtypes of leukemia and lymphoma. Estimated exposures of red bone marrow to domestic radon were low and no associations were found between radon exposure at home and an increased risk for developing leukemia among children under 15 years of age living in the CMAs. These result add to the body of evidence indicating no significant correlation between radon exposure and leukemia. Article published in Radiation Environment and Medicine (March 2021) (PI: Jing Chen; Lin Xie)

As the lead department of the Federal Nuclear Emergency Plan, Health Canada has the mandate for coordinating the preparedness and response activities of a nuclear emergency. Nuclear and radiological emergencies are relatively rare but, when they occur, emergency workers, first responders and the general public may receive significant external and internal exposures from a range of radionuclides. Radiological assessment and protective actions need to be implemented promptly to mitigate the impact on human health. A methodology for the quantitative description of exposures is among the essential elements of emergency management systems. The current dosimetry system recommended by the International Commission on Radiological Protection (ICRP) focuses on situations where doses and associated radiological risks are low and the primary objectives are to optimize protection against stochastic health effects and to demonstrate compliance with regulatory requirements; such system needs to be expanded to address the requirements for emergency situations. The goal of this research study is to develop reference methodologies and datasets that would expand the current ICRP dosimetry system for performing radiological assessments in emergency exposure situations. An expanded dosimetry system will consider both stochastic effects and harmful tissue reactions, situation-specific conditions, such as contamination of wounds, thyroid blocking, decorporation treatment, individual- or group-specific characteristics (e.g. iodine-deficient diet in the affected region). Standard estimates of effective dose will be complemented by more detailed individualised assessments of absorbed doses/absorbed dose rates in organ and tissues of individuals of various ages. (PI: Chunsheng Li; ICRP Task Group 112).

Health Canada is the lead department responsible for administration of the Federal Nuclear Emergency Plan (FNEP). Under the FNEP, Health Canada has specific responsibilities related to assessing the radiological impacts of a nuclear emergency in Canada or abroad and recommending the use of protective actions to reduce radiation exposures. Current international guidance related to preparedness planning for protective actions is based on an understanding of the impact of nuclear emergencies at Light Water Reactor (LWR) technology nuclear generating stations rather than the CANada Deuterium Uranium (CANDU) technology used at nuclear generating stations in Canada. This research will examine the potential environmental contamination and radiation doses resulting from a hypothetical severe CANDU reactor accident and will take into consideration the unique meteorological conditions encountered at each of the four nuclear generating station locations in Canada. The study will analyse daily atmospheric dispersion modeling runs completed using the Accident Reporting and Guidance Operations System (ARGOS) in combination with Environment and Climate Change Canada's long-range atmospheric dispersion model, Modèle Lagrangien de Dispersion de Particules (MLDP). MLDP is the only atmospheric dispersion model available in Canada that utilises a full 3-D representation of the atmosphere based on the Global or Regional Deterministic Prediction System and is operationally used for modeling the transport, dispersion and deposition of various types of pollutants (e.g. radioactive materials, volcanic ash, chemicals, etc.). To date, two years of modelling runs have been completed. The results will be analysed in the framework of the dosimetric guidance values recommended in Health Canada's 2018 publication 'Generic Criteria and Operational Intervention Levels for Nuclear Emergency Preparedness and Response' and will provide insight on the geospatial extent of the need for protective actions to reduce radiation exposures due to a nuclear emergency in Canada. Analysis of the first year model results is currently underway. (PI: Lauren Bergman)

Toxicological assessments carried out by Health Canada support the Department's mandate for ensuring health and safety of Canadians in that they contribute to the overall characterization of risk of a substance. The Organisation for Economic Co-operation and Development (OECD), operating under the Extended Advisory Group for Molecular Screening and Toxicogenomics (EAGMST), has been developing the Adverse Outcome Pathway (AOP) approach to consolidate evidence for chemical toxicity spanning multiple levels of biological organization. The knowledge transcribed in AOPs, provides a structured framework to transparently organize data, examine the weight of evidence and identify causal relationships between stressors and adverse effects of regulatory relevance. The AOP framework has undergone substantial maturation in the field of hazard characterization of chemicals over the last decade, and most recently gained attention from the radiation research community as a means to advance the mechanistic understanding of human and ecological health effects from exposure to ionizing radiation at low dose and low dose-rates. To fully exploit the value of such approaches for facilitating risk assessment and radiation protection, solicitation of experiences and active cooperation between research communities is needed. As a result, the Radiation and Chemical joint AOP topical group was formed in December 2020 on initiative from the OECD Nuclear Energy Agency Committee on Radiation Protection and Public Health High Level Group on Low Dose Research. The purpose of the joint AOP topical group, chaired by Health Canada, is to advance the use of AOPs in radiation research and foster broader implementation of AOPs into hazard and risk assessment. With global representation, it serves as a forum to discuss, identify and collaboratively develop joint initiatives that support research and possibly regulatory sciences. The topical group will specifically engage, promote, implement and assess the feasibility of using the AOP framework to a) organize and evaluate mechanistic knowledge relevant to protection of human and environmental health, b) identify data gaps and research needs pertinent to expanding the knowledge domain for low dose/dose rate radiation effects, and (c) demonstrate utility to support risk assessment by developing radiation-relevant case studies (PI: Vinita Chauhan).

Health Canada has a mandate to assess and manage health risks from devices that emit radiation. Cone beam computed tomography (CBCT) is a diagnostic X-ray imaging modality, used in dental and medical radiography, that produces 3-dimensional (3D) images of the volume of interest, which is similar to conventional computed tomography (CT). However, CBCT devices acquire X-ray images with a single, sometimes partial, rotation of a wide X-ray beam around the patient, as opposed to conventional CT devices which typically use numerous axial or helical rotations of a narrow X-ray fan-beam around the patient. In order to measure the radiation output of conventional CT devices, there are a number of different metrics that can be used. But the different methods used to generate/produce an image by CBCT devices can significantly impact the applicability and accuracy of the various metrics used to assess radiation output. This research study will investigate various CT radiation output metrics as applied to CBCT devices, including metrics proposed by industry/radiation protection organisations specifically for CBCT, to determine their ability/capacity to accurately measure the radiation output of the devices. Furthermore, the level of scattered radiation received by a patient with and without a lead apron will also be evaluated. As exposures to X-rays carries a risk of biological damage, which decreases as the level of exposure is reduced, this research will allow for more effective evaluation of the risks to patients from CBCT devices, including in comparison to other modalities of medical X-ray imaging. The results will also help to better inform regulatory and guidance initiatives for the devices. (PI: Sarah Cuddy-Walsh)

As the lead department of the Federal Nuclear Emergency Plan, Health Canada has the mandate for coordinating the preparedness and response activities in the event of a nuclear emergency. The Radiation Surveillance Division (RSD) operates a network of 80 Fixed Point Surveillance (FPS) spectroscopic Sodium Iodide (NaI) detectors measuring, in real-time, airborne radiation. The detectors are distributed across the country to provide population representative radiation risk assessments with enhanced monitoring around Canadian nuclear power plants in support of emergency management and response. Data collected by the FPS network is used to assess radiation dose levels, which are subsequently made available to Canadians through the Government of Canada public website. The networks can also be used to assist decision-making during a nuclear emergency to ensure the health and safety of Canadians. Real-time FPS monitoring data is automatically transmitted to the International Atomic Energy Agency's (IAEA) International Radiation Monitoring Information System (IRMIS) to help fulfil Canada's obligations under the Convention on Early Notification of a Nuclear Accident. The data is also posted automatically on the European Radiation Data Exchange Platform (EURDEP) for public consumption alongside data from over 5500 monitoring stations in 39 countries. The amount of data automatically transferred to these systems on an annual basis represents approximately 2.5 million data points. (PI: Kurt Ungar)

As the lead department of the Federal Nuclear Emergency Plan, Health Canada has the mandate for coordinating the preparedness and response activities in the event of a nuclear emergency. The Radiation Protection Bureau (RPB) receives and analyzes data from hundreds of radiation sensors within Canada and around the world. When unattributed releases of radioactive material are detected, for example Ru-106 nuclear tests and nuclear accidents (Fukushima), decision-makers require a forensic capability to characterize, locate and assess the nature of radionuclides for an effective incident response. The FREAR project is unique in that it makes use of monitoring sites that detect and do not detect the release to characterize the source to inform response actions and better protect the public. The FREAR project seeks to use all available information to create a Bayesian (statistical) characterization of the source. The output of the FREAR algorithm provides decision makers with the best assessment to better protect the health of Canadians. (PI: Ian Hoffman)

Health Canada has a mandate that includes assessing and managing risks from radiation emitting devices. In 2014, Health Canada used the Canadian Community Health Survey (CCHS) to collect prevalence estimates of laser device usage and injuries in Canada. The survey found that 1.1% of Canadians reported an injury from a laser device. The majority of injuries were to the eye, with injuries also occurring in the skin, and often were the result of laser exposure from someone else's use of the device. Cosmetic treatments employing lasers were the most common cause of injuries. In 2019, Health Canada conducted a 5-year follow-up study using the CCHS, focusing on the prevalence of injuries from handheld laser devices in the previous 12 months, excluding cosmetic laser exposure. Factors such as the frequency and type of injury sustained, as well as whether the injury was the result of personal use or someone else's use was collected and analysed. The 2019 survey found that 12.4% Canadians reported using or being exposed to a handheld laser in the previous year. Laser pointers represented the majority of handheld lasers used in Canada. Youth between the ages of 12 to 17 made up almost a quarter of all users of these devices. Higher handheld laser device usage was found among those with university education and those within the higher income categories. Overall, very few Canadians reported discomfort or injury involving a handheld laser device in the past 12 months. A quarter of users indicated that they had intentionally directed the laser beam at their eyes or skin or those of someone else. Most respondents obtained their handheld lasers by some undisclosed means or purchased it from a retail store or online. Handheld lasers pose a potential hazard to the public, particularly to children, who are unaware of the risks. This information was gathered to support efforts to monitor and address an emerging health concern regarding handheld laser devices. (PI: Sami Qutob)

Health Canada's Total Diet Study

Ingestion of excessive amounts of contaminants, including radioactive elements, through the food supply can be detrimental for the health of Canadians. Every year, the Radiation Surveillance Division (RSD) participates in Health Canada's Total Diet Study program. The program analyzes a wide range of food products present in a typical Canadian diet, to estimate levels of exposure that Canadians accumulate through the food supply. The RSD is responsible for analyzing the samples for radioactive elements and ensuring that the levels found in foods remain safely within acceptable national and international guidelines. The results of Health Canada's Total Diet Study help ensure food available to Canadians remains safely within acceptable national and international guidelines. (PI: JF Mercier; Robert Dabeka)

Health Canada is committed to informing Canadians about the health risk of radon as part of the mandate to ensure the health and safety of Canadians. Radon gas is a well-characterized human carcinogen. Studies have provided evidence of an association between residential radon and lung cancer risk, however, an understanding of the mechanistic basis of this relationship remains limited. Radon gas enters homes from different sources including: surrounding soil and rocks, and water supplies, where it can diffuse and accumulate to levels where it can pose a health risk. This study will examine how radon gas can affect blood and whether indicators of exposure, known as biomarkers, can be identified. The work will be conducted in partnership with members of the Canadian Partnership for Tomorrow Project (CPTP), a program that contains a repository of bio-banked biological samples. Geographic mapping will be leveraged to help identify participants living in high and low radon risk zones. Blood samples will be taken from participants and then analyzed to identify associations between radon gas exposure and the presence of specific biomarkers. The outcomes of this work will provide an understanding of the types of bio-molecules that are released into the blood when individuals are living in high radon areas and the types of technologies that are sensitive to the detection of chronic-level exposures. New knowledge in this area will help direct future research at Health Canada and will inform current national/international standards. (PI: Vinita Chauhan; Michel Gauthier)

Health Canada has a mandate that includes assessing and managing risks from radiation emitting devices. The early onset of skin cancer has been associated with tanning equipment use, where increased use is correlated with increased risk. In 2014, Health Canada used the Canadian Community Health Survey (CCHS) to collect prevalence estimates of indoor tanning and associated injuries (to the eyes and skin). The survey found that 4.5% of Canadians used indoor UV tanning equipment in the past 12 months and usage was more prevalent among young females (aged 18-34). The majority of users indicated they used tanning equipment to develop a base tan. The current results from the 2019 CCHS represent a 5-year follow-up from the 2014 survey. As before, the rapid response component of the 2019 CCHS collected data on the use of tanning equipment in the previous 12 months, including reasons for use, frequency/duration of use, precautions taken, and adverse reactions or injuries providing a more robust estimate of the extent tanning equipment usage and injuries. The 2019 survey found that 3.0% of Canadians reported that they had used indoor tanning equipment in the past year, representing a 33% significant decline from usage prevalence in 2014. The majority of users were female and females aged 18-34 were significantly more prevalent users compared to females aged 45 or older. The prevalence of indoor tanning was higher among people without a university degree, however there were no differences in prevalence by household income or region. Most users indicated they used indoor tanning equipment within a tanning salon and the most common reason for usage continued to be for the development of a base tan. Over one third of all users reported undergoing more than 10 sessions in the past year. The information generated by this research will strengthen our knowledge base on trends in usage and user behaviour which is valuable for targeting communications to the public and developing evidence-based risk management decisions. (PI: Sami Qutob)

Health Canada's mandate includes the assessment and management of health risks from sound emitting devices, as well as a legal obligation to provide advice on environmental noise under the Impact Assessment Act. Outdoors, background noise sources can interfere with or prevent valid measurements. Measurement methods are needed to quantify the noise from these sources. When acoustical measurements are conducted outdoors, dominant intruding background noise sources include: low to mid frequency environmental noise from distant anthropomorphic sources; high frequency noise from nearby insects and birds; and low frequency noise from wind acting directly on the microphone. The purpose of this project is to quantify these sources. Measurements are made throughout the year in local suburban and rural outdoor environments, as well as at a residential location near the ocean. Local high frequency noise from birds and insects is filtered out of the measurement following an American National Standards Institute (ANSI) standard for environmental noise measurement. This standard is used because the air absorbs most of the high frequency noise after it travels a few hundred meters. Its use allows the anthropomorphic, and the insect or bird noise to be separated. All measurements use an oversized 0.75 m diameter spherical microphone windscreen to obtain measurements uncontaminated by wind noise. Comparison with simultaneous measurements using commonly used windscreens allows quantification of the wind noise levels in typical measurements. This research approach is novel because measurements are being made in realistic environments as opposed to a wind tunnel. (PI: Stephen Keith)

Longitudinal analyses of nuclear energy workers in the National Dose Registry (CANDU Owners Group's low dose Strategic Research and Development program)

Health Canada has a mandate to protect the population from risks due to radiation. Radiation is a recognized carcinogen; however, there are many uncertainties about the nature of the dose-response relationship at lower levels. Radiation can also influence the risk of other adverse health outcomes. This study will make use of the updated record linkage of workers in the Canadian National Dose Registry to national mortality and cancer incidence data in order to characterize associations between low levels of radiation exposure and different causes of death, and low levels of exposure and different types of cancer incidence. Modelling efforts will evaluate the impact of exposure latencies and differential exposure-response relationships by age and sex, and life table methods will be used to estimate the impacts of ionizing radiation on life expectancy. Results will add to the body of evidence that underpins national and international recommendations for radation risk assessment and risk management. (PI: Paul Villeneuve (Carleton University); Lydia Zablotska (University of California, San Francisco); Rachel Lane (Canadian Nuclear Safety Commission); Minh Do (Carleton University and the Ontario Occupational Cancer Research Center); Susana Abraham Cottagirl (Carleton University); Tim Prendergast (HC)).

As the lead department of the Federal Nuclear Emergency Plan, Health Canada has the mandate for coordinating the preparedness and response activities of a nuclear emergency. Lessons from past nuclear emergencies indicate that psychosocial impacts like Post Traumatic Stress Disorder, depression, suicide rates and anxiety in impacted populations may outweigh radiological health impacts; and should be considered when developing emergency response plans. Internationally, there are no tools to compare psychosocial and mental health impacts to radiological impacts. Nuclear emergency response plans and protective actions are based on radiation detriment (measured in Sieverts). A corresponding unit of psychosocial detriment is required to consider psychosocial impacts in emergency response plans. The first phase of the study will develop the psychosocial unit of detriment for nuclear emergency planning and response. Statistical analysis of mental health survey data on Canadian population to measure the psychosocial impact of protective actions in emergencies will also be conducted. Key factors for psychosocial effects include evacuations, extended displacements, risk perception and socioeconomic changes. By applying a weighting factor to psychosocial impact from other emergencies, a unit of detriment that can be compared to the Sievert is proposed. A Difference-in-Difference (DiD) statistical model is applied to quantify psychosocial impacts between the disaster impacted and control populations. Repeating DiD analysis on data from other countries, will help validate quantification of psychosocial impacts measured in Canada with other countries. Finally, a decision-making tool will be developed to incorporate radiological and non-radiological psychosocial health consequences when implementing protective actions following a nuclear emergency. This tool is applicable in all phases of nuclear emergency preparedness and response. In mitigation, the tool will communicate importance of psychosocial impacts in emergencies to educate planners, responders and public on risks associated with impacts. In preparedness, it will help develop protection strategies so that plans consider the psychosocial impacts and mechanisms to balance these against radiological impacts. During response, decision makers will be able to consider psychosocial impacts of implementing protective actions for radiation exposures. In recovery, it will account for resources needed to address and mitigate psychosocial impacts following the emergency. (PI: Tristan Barr)

Measuring workload with paired detectors

Health Canada has a mandate to protect the population from risks due to radiation. Linear accelerators (LINACs) are commonly used to treat patients with cancer by targeting tumours with beams of high-energy radiation. For the health and safety of workers it is important to measure the LINAC's annual workload for each available photon energy, which determines the radiation dose outside the bunker. As Canada's leading dosimetry provider, NDSD has partnered with radiotherapy experts to explore a technique to measure the workload using paired detectors. The signals from the two detectors can give sufficient information to separate the signal contributions from 6 and 18 MV photon fields and combined with a calibration factor to yield the number of monitor units (a measure of accelerator output) delivered for each energy. Initial experiments used a pairing of a CR-39 NTD neutron dosimeter, capable of discriminating between the two fields, with a TLD-100 thermoluminescent dosimeter responsive to both fields. While the CR-39 NTD signals were too saturated to be of use under this experiment's exposure conditions, the TLD-100 proved to be excellent for determining workloads when it was exposed to a single energy,suggesting that the TLD-100 could be an excellent detector choice if paired with a suitable second detector. Experiments currently underway are investigating the pairing of the TLD-100 with an optically-stimulated luminescence (OSL) dosimeter, which does not saturate at high doses. If successful, this research could lead to a much more efficient way for LINAC operators to calculate workload, thereby making it easier to manage their radiation safety programs. (PI: Robert Corns (Eastern Carolina University, USA); Charles Schroeder (CancerCare Manitoba); Gurpreet Sandhu (BC Cancer); Keith Henderson; Elizabeth Inrig; Ian McKay)

Health Canada has a mandate to protect the population from risks due to radiation. During a radiological or nuclear emergency, first responders and the public may be internally contaminated by radionuclides via inhalation. This study aims to evaluate the effectiveness and/or applicability of specific measures to counter a large deposition of these contaminants. There are two types of contaminants being studied in this research project: (1) Inhaled insoluble radioactive materials that remain in the lungs for a prolonged time period and are not removed easily. This component investigates the application of approved drugs or their combination for effective removal of inhaled insoluble materials from the lungs, using an animal model; and (2) Inhaled soluble radioactive materials that are currently treated using decorporation agents, such as DTPA-Zn. For these, the treatment efficacy is compromised due to the rapid clearance of the drug from the body. This component investigates the application of nanoparticles to slow down the clearance of the drug so to improve the removal efficacy, using an animal model. Results of this project will support the preparedness and response to radiological and nuclear emergencies, in both guideline development and medical countermeasures preparedness. (PI: Chunsheng Li; Canadian Nuclear Laboratories)

The growth of devices emitting radiofrequencies (RF) and emerging wireless broadband technology in the millimeter wave spectrum over the last few years has raised public concerns about possible associations between RF energy and adverse health outcomes. The Department's mandate regarding human exposure to RF electromagnetic energy from wireless devices includes carrying out research into possible health effects, monitoring the scientific literature related to such effects on an ongoing basis, and developing RF exposure guidelines, commonly referred to as Safety Code 6. Safety Code 6 sets recommended limits for safe human exposure to electromagnetic fields (EMF). The objective of this study is to model the potential increase in temperature in human skin from exposure to millimetre wave radiofrequency (RF) fields. Since millimeter wave RF fields are absorbed almost entirely within the uppermost layers of the skin and subcutaneous fat, numerical models are being developed to predict the rate of and/or steady-state increase in skin surface temperature taking into account both intensity and beam-diameter. The analytical model developed in this study can be used to assess frequency-dependent power density thresholds that would result in a defined tissue temperature increase. Alternatively this model can be used to estimate a maximum tissue temperature resulting from RF emitting devices based upon the radiation characteristics of the device. The results of this research are intended to provide Health Canada, other levels of government and the broader scientific community with models that can be used to analyse thermal health effect limits for human exposure to millimeter wave. (PI: Greg Gajda; Mykola Zhuk)

Health Canada has a mandate to protect the population from risks due to radiation. Following the 2011 accident at the Fukushima Daiichi nuclear power station in Japan, concerns in northern communities were expressed regarding the safety of caribou and beluga whales as food sources. Historically, studies following the Chernobyl accident in 1986 had shown that radioactivity in some northern Canadian caribou increased, although the animals were still considered safe to eat. Using samples provided through the Northern Contaminants Program, radionuclides are being measured in samples of caribou, beluga, and beluga prey species collected before the Fukushima accident, shortly afterwards, and several years later, after the radioactive contamination had crossed the Pacific Ocean. The results of the comparison of some of the samples before the accident and shortly afterwards have been published. To date, no increase has been observed in any of the species and levels are expected to remain well below established guidelines for radioactivity in food. (PI: Trevor Stocki)

Health Canada is committed to informing Canadians about the health risk of radon as part of the mandate to ensure the health and safety of Canadians. The National Radon Program (NRP) has an extensive outreach program to motivate Canadians to take action to protect themselves from radon-induced lung cancer. In January 2020, the NRP initiated a behaviour intervention trial to assess the whether a behaviourally-informed intervention – specifically, a postcard with straightforward messaging – led to a significant incremental increase in awareness and in test kit purchases. Separate treatment and control groups were drawn from areas where there was little grassroots radon activity, which was assumed to correspond to limited radon awareness in the community, and where there was a high level of activity, corresponding to higher pre-existing radon awareness levels. All communities in the trial had previously been identified as having an elevated risk of high residential radon levels (based on the Cross Canada Radon Survey and other data). Influence was assessed by comparing website traffic and test kit purchases between groups who received the postcard and those who did not. Anecdotal evidence was also collected. Findings indicate that the behaviourally informed postcard increased awareness of radon and, further, increased awareness more within high grassroots communities compared to low grassroots communities. The study also found that receiving the postcard increased the likelihood that people would purchase a radon test kit, and that this increase was higher in communities with more pre-existing grassroots activity compared to those with less. While the study showed an increase in test kit purchases among those who received the postcard, absolute numbers were still quite small, indicating that behaviourally-informed postcards on their own are not an effective solution to the challenge of increasing Canadian radon testing and mitigation rates. This early study shows promise for using behavioural science to assess and improve the effectiveness of radon action campaigns. Results are available at https://takeactiononradon.ca/wp-content/uploads/NRP-Behavioural-Study-Final-Report-ENG-2020.pdf (PI: Jane Howe (Deloitte Canada); Kelley Bush, Katelyn Penstone)

Safeguarding the well-being of Canadians with respect to environmental radioactivity is underpinned by the nation-wide monitoring and measurement activities of the Radiation Surveillance Division (RSD). Of the sample types used to assess direct radiological impact to Canadians, commercial milk products are important considering that: 1) many radionuclides of concern are efficiently incorporated into milk from the surrounding environment 2) they are pooled-samples that represent large geographical areas, and 3) the consumption of milk is very common. For these reasons, the radio-analysis of milk is an important component of comprehensive environmental surveillance programs around the world. From a health-impact perspective, the most relevant radionuclide associated with milk is strontium-90 in consideration of its abundance, nature of decay, and long radiological and biological persistence (i.e. half-life). Unfortunately, owing mostly to the complex nature of milk, it is also one of the most demanding radionuclides to measure precisely and unequivocally in a reasonable timeframe. For this reason, current methodology employed in the RSD is reserved for ad hoc capacity and, even then, has proven to fall well-short of sample throughput demands encountered in an emergency context. To address this gap, new methodology has been developed to dramatically reduce sample analysis time, effort, and complexity with a concomitant bolstering of data integrity and confidence. This achievement has been rooted in several innovations that are being stitched together to form a rigorously characterized and demonstrably robust analysis methodology. (PI: Dr. Michael Cooke)

Health Canada conducts research to assess the potential health risks from noise as part of its mandate to protect the health and safety of Canadians. This includes noise risks from PLDs. It is well known that prolonged exposure to loud noise can cause noise induced hearing loss. Previously, Health Canada has assessed the typical volume setting on PLDs (e.g. MP3 players) used by students and correlated these findings to their self-reported and measured hearing status. These pilot studies have served as the rationale to conduct larger investigations. For the first time, national data was collected on hearing health among Canadians aged 3-79 as part of the Canadian Health Measures Survey (CHMS) (Cycles 3 and 4). This data included objectively measured hearing acuity in addition to self-reported exposures to loud workplace and leisure noise, and has led to publications on the prevalence of occupation-related hearing loss among Canadians. In 2019, Health Canada published a report on the prevalence of loud leisure noise exposure among Canadians, aged 6 to 79. Noise exposure from cumulative and specific sources of loud leisure noise activities, including PLDs, were estimated based on a common occupational limit (i.e. equivalent to or greater than 85 dBA (A-weighted decibels) for 40 hours or more per week). Health Canada will be undertaking a subsequent analysis to evaluate the impact of loud PLD usage and other loud leisure noise exposures on the hearing health of Canadians, aged 6 to 29. Collectively, these study findings will be used by Health Canada to estimate (characterize) the prevalence of noise-induced hearing loss among Canadians, including children/adolescents and young adults, from prolonged exposure to noisy devices (e.g. PLDs) capable of hazardously high volume levels. It will also help to inform policy makers, educators and health care professionals. (PI: Katya Feder)

Access to reliable and up-to-date information is essential for the development of science-based decision-making regarding ongoing changes in the Arctic and their global implications. Related AMAP summary reports have therefore been developed specifically for policy-makers, summarizing the main findings of the assessment. Since 2019, an international team of experts (including Health Canada) has been conducting an assessment of Arctic radioactivity issues. The information contained in this study will be fully referenced, and is based on peer-reviewed and published research and monitoring results since 2014. The updated radioactivity assessment will include new radioactivity data, effects of radon on human health, and data on radionuclides dumped or transferred into the Arctic. It will also introduce Health Canada research on the impact of climate change on the transportation of natural radionuclides in the Arctic. These studies will improve Health Canada's ability to estimate the increased Pb-210 and Po-210 activity level in the Arctic region due to northern contaminants, and to model atmospheric radionuclide transportation that is crucial to assess radiation dose to humans. (PI: Weihua Zhang).

Health Canada is committed to informing Canadians about the health risk of radon as part of the mandate to ensure the health and safety of Canadians. Long-term exposure to radon gas is recognized as an important cause of lung cancer. Radon is a naturally occurring radioactive gas and can accumulate in enclosed spaces that have contact with the ground, including mines, caves, other workplaces, and homes. It is important to consider exposure from all sources in order to properly assess risk and to prioritize areas where intervention will be most effective. Recent work in this area has explored whether excluding lifetime residential exposure from epidemiological studies of radon risk based on miners (i.e., including only occupational exposure) could impact the quality of the exposure characterization and, therefore, the resulting exposure risk-relationship (published in Radiation Environmental Biophysics, October 2020). In a second study, Canadian labour statistics, time statistics and more than 7600 long-term radon measurements from workplaces were used to calculate hypothetical radon exposures for 20 job categories (based on North American Industry Classification System). Results were compared with residential radon exposure based on more than 22 000 long-term radon tests conducted in Canadian homes. Due to the relatively high radon concentration in homes compared to many workplaces as well as the fact that Canadians spend more time indoors at home than they do at work, it was calculated that exposure at home contributes to 90% of workers' total radon exposure, on average (Journal of Radiological Protection, March 2021). Health Canada's National Radon Program and partners use this work to strengthen guidance, regulation, and policy and reduce the burden of radon-induced disease on Canadians. (PI: Jing Chen)

Health Canada is committed to informing Canadians about the health risk of radon as part of the mandate to ensure the health and safety of Canadians. Exposure to indoor radon is the leading cause of lung cancer among non-smokers, and the second-leading cause among smokers. Radon enters a home as radon gas and quickly decays through a series of short-lived radioisotopes. Breathing in the radon gas actually contributes relatively little to the radiation dose to the lung. It is the inhalation of the short-lived radon decay products that delivers most of the dose that, ultimately, can lead to lung cancer. The same radon gas concentrations can have different decay product concentrations under different environmental conditions, which are accounted for in dose assessment using an equilibrium factor. Equilibrium factors are often estimated; however, in this study, published measurements from more than 20 countries are reviewed, encompassing indoor and outdoor residential, public, and occupational environments. In the indoor residential environment, equilibrium factor values are shown to be significantly higher in poorly ventilated houses and in homes with smokers. In some occupational environments (mines, caves, and thermal spas), there was a range of equilibrium factors, suggesting that location, environment, and operation-specific values are more appropriate than an average for assessing exposure for these workers. This information is valuable for identifying populations at higher risk from radon exposure and for targeting radon reduction programs, including the National Radon Program. Article published in Health Physics, September 2020. (PI: Jing Chen; Naomi Harley)

Health Canada has a mandate that includes the assessment of radiation health hazards and the provision of radiation safety advice to other federal programs and departments. Self-reported occupational noise exposure has been associated with impaired hearing, but its relationship with extra-auditory affects remains uncertain. This research assessed the association between self-reported occupational noise exposure and cardiovascular outcomes. Participants (n=6318, ~50% male) from the Canadian Health Measures Survey (2012-2015) aged 20-79 years were randomly recruited across Canada. An in-person household interview included basic demographics, perceived stress, diagnosed health conditions and self-reported exposure to a noisy work environment. Direct physiological assessment in a mobile examination centre permitted the determination of biomarkers/risk factors related to cardiovascular function. Logistic or linear regression models explored the association between self-reported occupational noise exposure and several cardiovascular endpoints after adjusting for confounding variables. After adjustments, there was no evidence for an association between occupational noise and any of the evaluated endpoints, which included but were not limited to blood pressure, heart rate, blood glucose, insulin, lipids, diagnosed hypertension, medication for hypertension, myocardial infarction, stroke, or heart disease. There was no evidence that self-reported occupational noise exposure was associated with evaluated cardiovascular-related biomarkers, or cardiovascular diseases among Canadians aged 20-79 years. This study, and others like it, provides an important contribution to an evidence base that could inform policy related to occupational noise exposure. (PI: David Michaud)

Health Canada has a mandate to protect the population from risks due to radiation. A historic data set containing unpublished measurements of Cs-137 radioactivity in 238 pooled samples of pectoral muscle from 1892 birds representing 37 species, was analyzed in order to determine if birds were contaminated due to global weapons fallout and/or the Chernobyl accident; to understand baseline cesium levels in birds across the country; and, to ensure the birds were safe to eat. Current work is leveraging this data set to improve capabilities to assess the impacts of release of radionuclides on country food chains. Samples were obtained from 173 locations across Canada (including locations in the Arctic); mostly in the fall hunting seasons between 1989 and 1995. Each of these composite samples was then measured by gamma spectrometry. Various methods of correlating measurements with environmental Cs-137 levels and species' habits were explored in order to determine environmental radiological transfer factors for six different foraging groups. All of the Cs-137 measurements in the samples were very low; therefore, there was no evidence of a human health risk. This work was published in the Journal of Environmental Radioactivity (December 2020). Work will continue using data from samples that were obtained within the boundary for the Arctic Monitoring and Assessment Programme (AMAP) and results will be submitted as part of the 2023 AMAP report (see "Radioactivity monitoring and assessment in the Canadian Arctic" later in this report). (PI: Trevor Stocki; Birgit Braune [ECCC])

Health Canada conducts research to assess the potential health risks from noise as part of its mandate to protect the health and safety of Canadians. Noise can lead to adverse health effects through an increase in stress reactions that may increase the risk of developing stress-mediated health effects, such as cardiovascular disease (when sustained at high levels of noise). Exposure to loud noise can cause an increase in stress reactions that can include (but are not limited to) changes in cortisol, adrenaline, epinephrine, heart rate, and blood pressure. These changes may occur independently of, or be (statistically) associated with, annoyance. The purpose of the systematic review (funded by the Safe Environment Directorate's Impact Assessment Fund (IAF)) was to evaluate the strength of evidence between noise exposure and changes in the biological parameters known to contribute to the development of stress-mediated adverse health effects in humans. That noise is capable of acting as a stressor is insufficient, by itself, to fully inform the Department's advice on noise because advice cannot aim to eliminate noise-induced stress/annoyance reactions altogether. Dose-response analyses examined the effect of a 10 dB increase in noise exposure. Risk of bias (RoB) of individual studies was assessed using the Risk of Bias of Nonrandomized Studies - of Exposures. The certainty of the body of evidence for each outcome was based on a GRADE approach. A total of 151 primary studies reporting on blood pressure, heart rate, vascular resistance, cardiac output, waist circumference, cortisol, adrenaline, noradrenaline, glucose, cholesterol, hypertension, pre-eclampsia, gestational diabetes and gestational hypertension in humans were identified. Evidence of increased noise exposure on short- and long-term biomarkers of stress was very low. Based on the systematic review, there is very low certainty evidence to support statements linking noise exposure to stress-mediated illnesses at the population level. (PI: David Michaud)

The Canadian Radiological Monitoring Network (CRMN) comprises 26 sampling stations distributed across Canada that routinely send environmental samples to the Radiation Surveillance Division (RSD). These samples are analyzed for radionuclides that may adversely impact the health and well-being of Canadians as part of the mandate to ensure the health and safety of Canadians. Sample matrices include airborne particulates collected by filters, precipitation (rain or snow), drinking water, and milk. The detection techniques employed to identify and quantify radionuclides of interest are gamma spectrometry, alpha spectrometry, gas proportional counting, liquid scintillation counting, and inductively-coupled mass spectrometry. The CRMN additionally operates 12 sampling stations, predominantly concentrated about the Gentilly and Pt. Lepreau nuclear power generating stations, to collect water-vapour samples for assessment of tritium content, which is used as a metric to assess reactor leakage. Continuous and comprehensive monitoring provides a current and accurate determination of background radioactivity in Canada, and enables early detection and rapid response in the event of a national or international incident with radiological consequence. (PI: JF Mercier)

As the lead department of the Federal Nuclear Emergency Plan, Health Canada has the mandate for coordinating the preparedness and response activities of a nuclear emergency. The Comprehensive Nuclear Test-Ban Treaty (CTBT) was adopted by the United Nations General Assembly in 1996 and serves as an effective nuclear non-proliferation and disarmament measure. The treaty has a comprehensive verification regime to ensure that no nuclear explosion goes undetected. The verification regime consists of the International Monitoring System (IMS) and International Data Centre (IDC), a consultation and clarification process, on-site inspections and confidence building measures and a Canadian National Data Centre (NDC) managed by Natural Resources Canada (NRCan). The IMS consists of stations and laboratories located throughout the world which use one of four technologies to collect data: 1) Seismic monitoring, 2) Infrasound monitoring, 3) Hydroacoustic monitoring, and 4) Radionuclide monitoring. As part of the IMS, the Radiation Surveillance Division (RSD) manages four radionuclide stations and one radionuclide laboratory. The RSD also maintains a platform for the automated and interactive analysis of airborne radionuclide measurements on behalf of the Canadian NDC including all such data from the IMS and from the Canadian Radioligical Monitoring Network (CRMN). Along with partners at Environment and Climate Change Canada, the Radiation Surveillance Division further supports the NDC in assessment of treaty relevant events events as well as other significant atmospheric releases of radionuclides. The activity results in a dataset from the analysis of over 30,000 samples a year. This year was highlighted by the submission CTBT radioisotope laboratory documentation as a major milestone in the addition of Noble Gas analysis to its capabilities certified by the CTBTO. Certification is to be completed in early 2022 pending a site visit by CTBTO authorities. (PI: Kurt Ungar)

Health Canada has a mandate that includes assessing and managing risks from radiation emitting devices. In 2016, the European Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) concluded that there is strong evidence that ultraviolet radiation (UVR) from tanning equipment usage is carcinogenic and the risk of developing cancer increases with both frequency and the age of the user. SCHEER also concluded that there is no safe limit for exposure to UVR from tanning equipment as there is no defined threshold for the development of adverse long-term health associated with exposure. This is due to the stochastic nature of cancer induction and the dose levels required for the production of a tan. There is also no established threshold level of UVR-irradiance or UVR-dose for long-term stochastic effects, such as cancer, from currently available data. More sensitive mechanistic studies and advanced analysis tools may provide more insight into the estimations of UVR exposure thresholds and possible adverse outcomes through transOMIC pathway analysis. A recent review of the scientific literature suggests that the application of Bench Mark Dose (BMD) modelling of transcriptional data offers significant advantages over traditional genomic bioinformatics approaches. In 2019, Health Canada conducted a study to use BMD modelling of transcriptomic responses in mouse skin using a broad-range of UVR doses emitted from a UV cosmetic tanning lamp. This work is the first of its kind to employ BMD modelling of transcriptomic response data in a live mouse model exposed to a biologically-relevant dose range of UVR emissions approximating a spectra of a typical UVR cosmetic tanning bed. This data will provide a point-of-departure assessment of molecular responses to UVR exposure to determine biologically-relevant thresholds of UVR responses that may preclude the occurrence of longer term pathophysiological consequences. (PI: Sami Qutob)

As the lead department of the Federal Nuclear Emergency Plan, Health Canada has the mandate for coordinating the preparedness and response activities of a nuclear emergency. Health Canada's Radiation Protection Bureau maintains a field team for assurance-monitoring activities in the event of a nuclear emergency. The field team is prepared to conduct dose rate surveys, soil sampling, in-situ gamma spectrometry in the field, and to implement contamination control procedures following radiological dispersion events. These capacities were tested when the field team deployed and monitored in a field with a known amount of evenly distributed radioactive material (La-140). Two types of dose rate surveys were conducted, one using the average of a 30 second measurement at several location and the second using a backpack system to take point measurements while walking through the grid. Radiation dose rates measured by the instruments were 30% lower than expected implying the need for a correction factor which should include the shielding effect by the operator. The soil sampling procedure proved to be effective for collecting samples quickly however should be improved to ensure a consistency of collected volumes. An accurate estimate of the distributed activity was found using in situ gamma spectroscopy measurements and applying a Monte-Carlo simulated correction factor. The measurement analysis of samples with the mobile nuclear laboratory was quick with results from 10 samples produced within 4 hours of collection. Finally, the contamination control procedures proved to be effective for both personnel and for samples, resulting in no undesirable (>2 times background) contamination outside of the controlled access zone. By testing procedures in an evenly dispersed known quantity of radioactive material, several methods were improved thereby ensuring the preparedness of the Radiation Protection Bureau's Field Response Team. (PI: Rory McCutcheon-Wickham)

Wind Turbine Noise and Health Study: Sleep analysis

The Wind Turbine Noise and Health Study (WTNHS) (2012-2014) was conducted by Health Canada, in collaboration with Statistics Canada and other external experts, in order to better understand the effects of wind turbine noise (WTN) on human health and well-being. Measured endpoints included an automated blood pressure/heart rate assessment, hair cortisol concentrations and sleep actigraphy. In addition, self-reported data were collected during a face-to-face computer-assisted interview at participants' homes. While this study was completed and the preliminary results were announced in the fall of 2014, due to the volume of data collected, the publication of detailed results in peer reviewed scientific journals occurred throughout 2015-2019. A total of 14 journal articles have been published to date and additional analyses are ongoing. The current work from the WTNHS relates to a more detailed analysis of sleep actigraphy where, in the first analysis, sleep will be evaluated in 10-min time intervals that are time-synchronized to wind turbine operations; and, the second analysis will focus on determining the WTN sound pressure level that is associated with a 3% prevalence of self-reported high sleep disturbance, which is the sleep disturbance level on which the WHO currently bases its noise guidance. The results of this analysis will provide the most comprehensive assessment of self-reported sleep disturbance to date, and contribute to a global evidence base on which future decisions by Health Canada, other levels of government, and the broader scientific community, may be informed. The scientific results from these studies on WTN continue to inform legal proceedings related to wind turbine installations in Canada and around the world. (PI: David Michaud)

Water Quality

Designing cost-effective drinking water surveys in the 31-st century: optimizing target analytes, site selection, sampling and analytical methods.

Sampling, shipping and analysis are the most common causes of high cost for drinking water surveys. Drinking water is an active medium; therefore, specific sampling protocols are essential for some water contaminants and require well-trained personnel to obtain consistent results. Shipping is usually costly as significant volumes may be required to analyse trace levels of contaminants and different analytical methods are applied to determine various types of water contaminants, resulting in a variety of sample collection and processing requirements and sometimes various analytical laboratories. Over the years, Health Canada has conducted multiple targeted surveys and two national surveys on drinking water to generate data used for the development of Guidelines for Canadian Drinking Water Quality. The results have also been used to conduct human health risk assessments. The main objective of this project is to determine cost effective ways to design and perform future drinking water surveys. Specific areas for optimization include the selection of the sampling sites, classes of contaminants, sample volume, on-site sample concentration techniques, as well as analytical methods. The in-house expertise developed at Health Canada will be used to aggregate the knowledge generated over the years in drinking water sampling and analysis, and new emerging analytical tools explored to reduce the analytical methods-to-contaminants ratio. The ultimate goal is to reduce the cost of future surveys while improving data quantity/quality as required to fulfil Health Canada's mandate to protect and improve the health of Canadians. (PI: Anca-Maria Tugulea)

Microplastics have been found to sorb (adsorb or absorb) organic pollutants and metals, some of which may be of concern to human health. Under certain environmental conditions and during drinking water treatment, microplastics may also undergo changes in their physical characteristics and chemical composition that may affect their sorption and leaching behaviour to these chemicals. It is unclear whether exposure to chemicals from microplastics represent a significant source of exposure compared to total exposure from other sources and more research is needed before a human health risk assessment on microplastics is possible. The aim of this research is to develop protocols for assessing how microplastics are transformed when subjected to oxidation and weathering conditions representative of oxidant and UV exposures in drinking water treatment plants, and how their capacity for sorption/leaching of selected target hydrophobic organic chemicals and a metal ion are influenced.

This study enhances our understanding of the effect of weathering of microplastics from a UV-ozone advanced oxidation process on their sorption and desorption behavior. The data will have the potential to feed into longer-term studies of hydrophobic organic chemical interactions, with a wider variety of weathered plastics (fibers, fragments, pigmented particles) from other possible sources of human exposure. (PI: Subhasis Ghoshal [McGill University]; contact: Tamara Desroches (HC))

Definition developed by HECSB Research Governance Committee and approved by HECS Executive Committee, June 2013

Return to footnote 1 referrer

Page details

Enhancing health and wellness by, for and with Indigenous youth in Canada: a scoping review

Affiliations.

• 1 Health Sciences Program, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, S7N 5E5, Canada. [email protected].
• 2 Sturgeon Lake Youth Center, Sturgeon Lake First Nation, Sturgeon Lake, Saskatchewan, S0J 2E1, Canada.
• 3 University of Saskatchewan, Saskatoon, Saskatchewan, S7N 0X1, Canada.
• 4 Research Division, Department of Academic Family Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, S7M 3Y5, Canada. [email protected].
• PMID: 36038858
• PMCID: PMC9422134
• DOI: 10.1186/s12889-022-14047-2

Background: Indigenous youth in Canada face profound health inequities which are shaped by the rippling effects of intergenerational trauma, caused by the historical and contemporary colonial policies that reinforce negative stereotypes regarding them. Moreover, wellness promotion strategies for these youth are replete with individualistic Western concepts that excludes avenues for them to access holistic practices grounded in their culture. Our scoping review explored strategies, approaches, and ways health and wellness can be enhanced by, for, and with Indigenous youth in Canada by identifying barriers/roadblocks and facilitators/strengths to enhancing wellness among Indigenous youth in Canada.

Methods: We applied a systematic approach to searching and critically reviewing peer-reviewed literature using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews [PRISMA-ScR] as a reporting guideline. Our search strategy focused on specific keywords and MeSH terms for three major areas: Indigenous youth, health, and Canada. We used these keywords, to systematically search the following electronic databases published in English between January 01, 2017, to May 22, 2021: Medline [Ovid], PubMed, ERIC, Web of Science, Scopus, and iportal. We also used hand-searching and snowballing methods to identify relevant articles. Data collected were analysed for contents and themes.

Results: From an initial 1695 articles collated, 20 articles met inclusion criteria for this review. Key facilitators/strengths to enhancing health and wellness by, for, and with Indigenous youth that emerged from our review included: promoting culturally appropriate interventions to engage Indigenous youth; using strength-based approaches; reliance on the wisdom of community Elders; taking responsibility; and providing access to wellness supports. Key barriers/roadblocks included: lack of community support for wellness promotion activities among Indigenous youth; structural/organizational issues within Indigenous communities; discrimination and social exclusion; cultural illiteracy among youth; cultural discordance with mainstream health systems and services; and addictions and risky behaviours.

Conclusion: This scoping review extracted 20 relevant articles about ways to engage Indigenous youth in health and wellness enhancement. Our findings demonstrate the importance of promoting health by, and with Indigenous youth, by engaging them in activities reflexive of their cultural norms, rather than imposing control measures that are incompatible with their value systems.

Keywords: Authentic engagement; Culture as treatment; Health; Indigenous youth; Wellness; Wellness promotion.

© 2022. The Author(s).

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• Systematic Review
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The state of workplace health and wellness in Canada | 2024

Dialogue’s 2024 research is now available. This year, we're diving deep into new topics that truly matter to you.

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The 2024 state of workplace health and wellness in Canada

Sign up for our latest research series focusing on the perspectives of working Canadians when it comes to their health and well-being. Plus, HR leaders weigh in on their top workplace challenges, and how they're navigating the benefits landscape.

In our 2024 research series, get access to 4 exclusive reports

From exploring benefits trends and engagement, to digging into sleep and financial well-being, this year’s research series will reveal how Canadians really feel — and how HR leaders are stepping up.

Spoiler: There's still a critical gap between what employees expect, and the support organizations are providing.

Sign up for the newest report in this exclusive series, and be the first to receive the subsequent reports as soon as they’re published!

The state of workplace health and wellness in Canada

While HR leaders strive to meet the needs of their workforce, employees report that available support and services fall short. Nearly all working Canadians express a desire to enhance their personal well-being and believe employers can play a role in supporting them.

With learnings like this, you will be equipped to drive change in your organization.

The 2024 report dives into data to understand a variety of issues: 

More than 50% of employees have never accessed their EAP.

89% of employees believe their employers should provide well-being support, yet more than half say their employer hasn’t acted on it.

Over 70% of HR leaders say that talent attraction and retention are a challenge.

Get access to the full report for essential insights and practical tips you can implement today.

The declining mental health of working Canadians

Various lifestyle factors impact Canadians’ mental well-being, including inadequate sleep, lack of physical activity, and feelings of loneliness.  With 1 in 3 noting a decline in their mental health in the past year, employers must take notice. There are clear opportunities to enhance employees' mental well-being, but it's essential to adopt a holistic and tailored approach.  Our latest report in the 2024 research series delves into fresh insights:

42% of employees rate their mental health as fair or poor.

32% attribute work-related stress to poor sleep.

Only 1 in 4 feel very comfortable seeking professional mental healthcare. 

 Explore the factors influencing mental health, understand employee needs, and adapt your well-being strategy to safeguard your workforce.

The growing focus on financial well-being

A whopping 96% of working Canadians believe that finances are a major contributor to overall well-being. And the vast majority of employers agree.

But only 62% of organizations offer financial counselling and support. 

Discover how employees' financial well-being can impact organizational health and success.

Bridging the health gap in diverse workplaces

Workplaces are getting more diverse, with people of all ages, backgrounds, genders, and experiences teaming up for common goals.  

Diversity sparks innovation and growth, but it can also pose challenges when dealing with the varying well-being needs of employees. 

Understand how your diverse team views their benefits to build a supportive system that includes everyone. 

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Fostering wellness and growth to create the Best Workplaces

The right culture provides opportunity for growth. RSM Canada created five attributes it wanted its employees to exemplify – being caring, curious, collaborative, courageous and critical thinkers – helping the company earn a spot on this year’s Great Place To Work® list of Best Workplaces™ and positioning it for a four-fold growth in revenue since its inception. supplied

Continuing the trend of the past several years, health and wellness is on the minds of working Canadians and the companies that employ them. Great Place To Work® research proves time and time again that, when employees feel healthy and well, they and their business are more likely to excel.

“As a global organization, we are seeing that individual wellness and mental health is an escalating problem in our society,” says Alison Grenier, head of culture and research, Great Place To Work®. “The good news is that there has been a positive shift where more people feel safe sharing that they are struggling, and more companies are making substantial investments in programs and supports for their employees.”

AbbVie, a leading research-driven pharmaceutical company in Canada and around the globe, is one of those companies, earning it a spot on the list of Best Workplaces™ published by Great Place To Work®.

“It’s a wonderful recognition and reflective of every one of our employees and how they show up. Being on the list helps us to attract, retain and engage the best people,” says Almir Lourens, head of human resources, Canada.

Since AbbVie was created in 2013, it has launched 44 new medications or indications and grown its operations in Canada to more than 1,100 employees across the country. With such rapid growth, AbbVie has been intentional about making sure employees feel valued and have a sense of purpose.

“The patient is at the centre of everything we do. It’s incredible to see the value we’re adding to the health care system and for our patients. Our employees anchor themselves in that purpose,” Lourens says.

Year-round programs and initiatives are centred on four pillars – inspired futures, balanced lives, healthy minds and active bodies – to give employees the energy and resilience to be their best selves. AbbVie supports workplace flexibility when it makes sense for roles, employees and locations. The company offers healthy choices in its cafeterias with menus available online that describe nutritional details and choices. National and global wellness events and challenges aim to help employees be healthy and active.

During the AbbVie in Motion campaign in the summer, employees from teams across the company kept track of their activity minutes. Last year, they exercised almost 15 million minutes collectively during the AbbVie (WOW) or Week of Well Being, with fun and engaging programs and activities to help employees to relax and refocus.

The company is intentional about reducing the number of meetings and emails, so employees have more time to be creative and feel inspired. Lunch hours are blocked in everyone’s calendars, there are no Friday afternoon meetings and emails are only sent between 8:30 a.m. and 5 p.m. The company also transformed its annual directors’ awards to become culture awards three years ago, a step toward reinforcing the behaviours it wants to see in the organization.

Jose Tolovi Neto, managing partner, Great Place To Work® Canada, says things have changed since Great Place To Work® began surveying employees 30 years ago.

“Today, businesses are looking more closely at those things that matter and are relevant to people. What is important for every generation and especially our youth today is that connection to purpose. People want to feel inspired.”

The story of RSM Canada continues to inspire, earning it a place on the Best Workplaces™ for three of its six years in business in Canada. The firm was co-founded by Harry Blum, national managing partner, and Rhonda Kloser, national chief operating offer.

Blum says being on the list validates everything the firm has done to create a best-in-class culture that rivals any in the industry.

“After three years of refining our focus and getting traction in the marketplace, it became important to us that what we were saying about our experience was real,” Blum says. That is when they decided to approach Great Place To Work®. “We wanted third-party validation, and we love that Great Place To Work® asked our employees and didn’t just take our word for it,” he says.

Transforming the business into a value-added advisory to include consulting, tax and audit services, Blum and Kloser set out to create a culture that could be its currency. They created five attributes they wanted their employees to exemplify: caring, curious, collaborative, courageous and critical thinkers. “Where we are different is that these attributes became our defining DNA. The challenge continues to be instilling these attributes in our people and living up to this commitment ourselves,” Blum says.

At RSM Canada, culture also means opportunity for growth. While employees begin as generalists, it is not long before they are encouraged and supported to specialize as an industry expert in an area they are passionate about. “People said it wouldn’t work,” Blum says. “Today, we’ve grown to more than 1,000 employees and quadrupled our revenue. As the original founders, it’s inspirational to see that we are still here, and we’ve got more to go. Our growth is contagious, and people want to be part of that.”

In the wake of the pandemic, Blum witnessed firsthand its impact on the health of its employees. Still young, the firm quickly mobilized a homegrown solution to create and share mental health resources and expertise, including simple tips in the form of Mental Health Minutes for dealing with the realities and stressors of work at that time. They shared the information on the social media platform LinkedIn and in their communities. They brought in guest speakers to talk about addressing burnout and feelings of isolation. Since then, RSM has introduced a third-party application. Employees can sign up for lessons and reminders about their mental health and they can access psychologists and social workers on call.

When looking ahead to the future, Blum says: “We will be different, we will challenge status quo, and always through the lens of how we create best-in-class experiences for our people, our clients and the community.”

Canada’s Best Workplaces™ are raising the bar when it comes to innovative, employee-driven strategies that help recruit, retain and reward their employees. Being acknowledged on the list of Best Workplaces™ is something that companies like Achievers – an award-winning employee recognition software company – never takes for granted.

“Being recognized on the list of Best Workplaces isn’t just an accolade but a testament to putting people at the heart of our organization,” says Achievers’ chief executive officer Jeff Cates. “For us, it’s not about the title but it’s the profound impact on creating an environment where employees can do the best work of their lives.”

Building a healthy company for customers starts with building a healthy company from within. Great Place To Work® offers a wealth of knowledge and resources to help companies strike the right balance. To learn more about how to become certified as a Great Place To Work®, visit greatplacetowork.ca .

Read more about the 2024 Best Workplaces™ in Canada here

Advertising feature produced by Globe Content Studio with Great Place to Work. The Globe’s editorial department was not involved.

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A Peek Inside the Brains of ‘Super-Agers’

New research explores why some octogenarians have exceptional memories.

By Dana G. Smith

When it comes to aging, we tend to assume that cognition gets worse as we get older. Our thoughts may slow down or become confused, or we may start to forget things, like the name of our high school English teacher or what we meant to buy at the grocery store.

But that’s not the case for everyone.

For a little over a decade, scientists have been studying a subset of people they call “super-agers.” These individuals are age 80 and up, but they have the memory ability of a person 20 to 30 years younger.

Most research on aging and memory focuses on the other side of the equation — people who develop dementia in their later years. But, “if we’re constantly talking about what’s going wrong in aging, it’s not capturing the full spectrum of what’s happening in the older adult population,” said Emily Rogalski, a professor of neurology at the University of Chicago, who published one of the first studies on super-agers in 2012.

A paper published Monday in the Journal of Neuroscience helps shed light on what’s so special about the brains of super-agers. The biggest takeaway, in combination with a companion study that came out last year on the same group of individuals, is that their brains have less atrophy than their peers’ do.

The research was conducted on 119 octogenarians from Spain: 64 super-agers and 55 older adults with normal memory abilities for their age. The participants completed multiple tests assessing their memory, motor and verbal skills; underwent brain scans and blood draws; and answered questions about their lifestyle and behaviors.

The scientists found that the super-agers had more volume in areas of the brain important for memory, most notably the hippocampus and entorhinal cortex. They also had better preserved connectivity between regions in the front of the brain that are involved in cognition. Both the super-agers and the control group showed minimal signs of Alzheimer’s disease in their brains.

“By having two groups that have low levels of Alzheimer’s markers, but striking cognitive differences and striking differences in their brain, then we’re really speaking to a resistance to age-related decline,” said Dr. Bryan Strange, a professor of clinical neuroscience at the Polytechnic University of Madrid, who led the studies.

These findings are backed up by Dr. Rogalski’s research , initially conducted when she was at Northwestern University, which showed that super-agers’ brains looked more like 50- or 60-year-olds’ brains than their 80-year-old peers. When followed over several years, the super-agers’ brains atrophied at a slower rate than average.

No precise numbers exist on how many super-agers there are among us, but Dr. Rogalski said they’re “relatively rare,” noting that “far less than 10 percent” of the people she sees end up meeting the criteria.

But when you meet a super-ager, you know it, Dr. Strange said. “They are really quite energetic people, you can see. Motivated, on the ball, elderly individuals.”

Experts don’t know how someone becomes a super-ager, though there were a few differences in health and lifestyle behaviors between the two groups in the Spanish study. Most notably, the super-agers had slightly better physical health, both in terms of blood pressure and glucose metabolism, and they performed better on a test of mobility . The super-agers didn’t report doing more exercise at their current age than the typical older adults, but they were more active in middle age. They also reported better mental health .

But overall, Dr. Strange said, there were a lot of similarities between the super-agers and the regular agers. “There are a lot of things that are not particularly striking about them,” he said. And, he added, “we see some surprising omissions, things that you would expect to be associated with super-agers that weren’t really there.” For example, there were no differences between the groups in terms of their diets, the amount of sleep they got, their professional backgrounds or their alcohol and tobacco use.

The behaviors of some of the Chicago super-agers were similarly a surprise. Some exercised regularly, but some never had; some stuck to a Mediterranean diet, others subsisted off TV dinners; and a few of them still smoked cigarettes. However, one consistency among the group was that they tended to have strong social relationships , Dr. Rogalski said.

“In an ideal world, you’d find out that, like, all the super-agers, you know, ate six tomatoes every day and that was the key,” said Tessa Harrison, an assistant project scientist at the University of California, Berkeley, who collaborated with Dr. Rogalski on the first Chicago super-ager study.

Instead, Dr. Harrison continued, super-agers probably have “some sort of lucky predisposition or some resistance mechanism in the brain that’s on the molecular level that we don’t understand yet,” possibly related to their genes.

While there isn’t a recipe for becoming a super-ager, scientists do know that, in general , eating healthily, staying physically active, getting enough sleep and maintaining social connections are important for healthy brain aging.

Dana G. Smith is a Times reporter covering personal health, particularly aging and brain health. More about Dana G. Smith

A Guide to Aging Well

Looking to grow old gracefully we can help..

The “car key conversation,” when it’s time for an aging driver to hit the brakes, can be painful for families to navigate . Experts say there are ways to have it with empathy and care.

Calorie restriction and intermittent fasting both increase longevity in animals, aging experts say. Here’s what that means for you .

Researchers are investigating how our biology changes as we grow older — and whether there are ways to stop it .

You need more than strength to age well — you also need power. Here’s how to measure how much power you have  and here’s how to increase yours .

Ignore the hyperbaric chambers and infrared light: These are the evidence-backed secrets to aging well .

Your body’s need for fuel shifts as you get older. Your eating habits should shift , too.

People who think positively about getting older often live longer, healthier lives. These tips can help you reconsider your perspective .

Here’s how you know

• U.S. Department of Health and Human Services
• National Institutes of Health

Music and Health: What You Need To Know

.header_greentext{color:green!important;font-size:24px!important;font-weight:500!important;}.header_bluetext{color:blue!important;font-size:18px!important;font-weight:500!important;}.header_redtext{color:red!important;font-size:28px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;font-size:28px!important;font-weight:500!important;}.header_purpletext{color:purple!important;font-size:31px!important;font-weight:500!important;}.header_yellowtext{color:yellow!important;font-size:20px!important;font-weight:500!important;}.header_blacktext{color:black!important;font-size:22px!important;font-weight:500!important;}.header_whitetext{color:white!important;font-size:22px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;}.Green_Header{color:green!important;font-size:24px!important;font-weight:500!important;}.Blue_Header{color:blue!important;font-size:18px!important;font-weight:500!important;}.Red_Header{color:red!important;font-size:28px!important;font-weight:500!important;}.Purple_Header{color:purple!important;font-size:31px!important;font-weight:500!important;}.Yellow_Header{color:yellow!important;font-size:20px!important;font-weight:500!important;}.Black_Header{color:black!important;font-size:22px!important;font-weight:500!important;}.White_Header{color:white!important;font-size:22px!important;font-weight:500!important;} Can music be good for you?

Yes, according to a growing body of research. Listening to or making music affects the brain in ways that may help promote health and manage disease symptoms.

Performing or listening to music activates a variety of structures in the brain that are involved in thinking, sensation, movement, and emotion. These brain effects may have physical and psychological benefits. For example, music causes the release of brain chemicals (neurotransmitters and hormones) that can evoke emotional reactions, memories, and feelings and promote social bonds. Music can even affect the structure of the brain. Certain structures in the brain have been found to be larger in musicians than nonmusicians, with particularly noticeable changes in people who started their musical training at an early age.

Increasing evidence suggests that music-based interventions may be helpful for health conditions that occur during childhood, adulthood, or aging. However, because much of the research on music-based interventions is preliminary, few definite conclusions about their effects have been reached. Many reports on the potential benefits of music-based interventions come from observations of individuals or small groups of people. Evidence of this type is valuable for suggesting new ideas, but carefully designed, scientifically rigorous studies of larger numbers of people are needed to provide stronger evidence on whether music-based interventions are effective for specific purposes.

.header_greentext{color:green!important;font-size:24px!important;font-weight:500!important;}.header_bluetext{color:blue!important;font-size:18px!important;font-weight:500!important;}.header_redtext{color:red!important;font-size:28px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;font-size:28px!important;font-weight:500!important;}.header_purpletext{color:purple!important;font-size:31px!important;font-weight:500!important;}.header_yellowtext{color:yellow!important;font-size:20px!important;font-weight:500!important;}.header_blacktext{color:black!important;font-size:22px!important;font-weight:500!important;}.header_whitetext{color:white!important;font-size:22px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;}.Green_Header{color:green!important;font-size:24px!important;font-weight:500!important;}.Blue_Header{color:blue!important;font-size:18px!important;font-weight:500!important;}.Red_Header{color:red!important;font-size:28px!important;font-weight:500!important;}.Purple_Header{color:purple!important;font-size:31px!important;font-weight:500!important;}.Yellow_Header{color:yellow!important;font-size:20px!important;font-weight:500!important;}.Black_Header{color:black!important;font-size:22px!important;font-weight:500!important;}.White_Header{color:white!important;font-size:22px!important;font-weight:500!important;} What is music therapy?

Music therapy is a health profession in which music is used within a therapeutic relationship to address physical, emotional, cognitive, and social needs. The term “music therapy” is not a description of a specific type of intervention. Instead, it indicates the education, training, and credentials of the therapist who is delivering the intervention.

Music therapy may involve a variety of different activities, including music improvisation, music listening, song writing, music performance, and learning through music. Music therapists may work in many different settings, such as hospitals, outpatient clinics, nursing homes, senior centers, rehabilitation facilities, or schools.

Some of the music-based interventions described in this fact sheet fit the definition of music therapy, but others do not. For example, music-based interventions that involve listening to recorded music are often delivered by health professionals other than music therapists (such as nurses), and therefore do not fit the definition of music therapy.

You can learn more about music therapy on the website of the American Music Therapy Association .

.header_greentext{color:green!important;font-size:24px!important;font-weight:500!important;}.header_bluetext{color:blue!important;font-size:18px!important;font-weight:500!important;}.header_redtext{color:red!important;font-size:28px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;font-size:28px!important;font-weight:500!important;}.header_purpletext{color:purple!important;font-size:31px!important;font-weight:500!important;}.header_yellowtext{color:yellow!important;font-size:20px!important;font-weight:500!important;}.header_blacktext{color:black!important;font-size:22px!important;font-weight:500!important;}.header_whitetext{color:white!important;font-size:22px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;}.Green_Header{color:green!important;font-size:24px!important;font-weight:500!important;}.Blue_Header{color:blue!important;font-size:18px!important;font-weight:500!important;}.Red_Header{color:red!important;font-size:28px!important;font-weight:500!important;}.Purple_Header{color:purple!important;font-size:31px!important;font-weight:500!important;}.Yellow_Header{color:yellow!important;font-size:20px!important;font-weight:500!important;}.Black_Header{color:black!important;font-size:22px!important;font-weight:500!important;}.White_Header{color:white!important;font-size:22px!important;font-weight:500!important;} Can music be harmful?

In general, research studies of music-based interventions do not show any negative effects. However, listening to music at too high a volume can contribute to noise-induced hearing loss. You can find out about this type of hearing loss on the National Institute on Deafness and Other Communication Disorders website .

In addition, because music can be associated with strong memories or emotional reactions, some people may be distressed by exposure to specific pieces or types of music. Extensive playing of musical instruments can lead to pain and injury. Music-based interventions that involve exercise or other types of movement could also lead to injury if appropriate safety precautions are not taken.

.header_greentext{color:green!important;font-size:24px!important;font-weight:500!important;}.header_bluetext{color:blue!important;font-size:18px!important;font-weight:500!important;}.header_redtext{color:red!important;font-size:28px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;font-size:28px!important;font-weight:500!important;}.header_purpletext{color:purple!important;font-size:31px!important;font-weight:500!important;}.header_yellowtext{color:yellow!important;font-size:20px!important;font-weight:500!important;}.header_blacktext{color:black!important;font-size:22px!important;font-weight:500!important;}.header_whitetext{color:white!important;font-size:22px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;}.Green_Header{color:green!important;font-size:24px!important;font-weight:500!important;}.Blue_Header{color:blue!important;font-size:18px!important;font-weight:500!important;}.Red_Header{color:red!important;font-size:28px!important;font-weight:500!important;}.Purple_Header{color:purple!important;font-size:31px!important;font-weight:500!important;}.Yellow_Header{color:yellow!important;font-size:20px!important;font-weight:500!important;}.Black_Header{color:black!important;font-size:22px!important;font-weight:500!important;}.White_Header{color:white!important;font-size:22px!important;font-weight:500!important;} What does research show about music-based interventions for people with health conditions?

The preliminary research that has been done so far suggests that music-based interventions may be helpful for anxiety, depressive symptoms, and pain associated with a variety of health conditions, as well as for some other symptoms associated with dementia, multiple sclerosis, Parkinson’s disease, and other conditions. 

.header_greentext{color:green!important;font-size:24px!important;font-weight:500!important;}.header_bluetext{color:blue!important;font-size:18px!important;font-weight:500!important;}.header_redtext{color:red!important;font-size:28px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;font-size:28px!important;font-weight:500!important;}.header_purpletext{color:purple!important;font-size:31px!important;font-weight:500!important;}.header_yellowtext{color:yellow!important;font-size:20px!important;font-weight:500!important;}.header_blacktext{color:black!important;font-size:22px!important;font-weight:500!important;}.header_whitetext{color:white!important;font-size:22px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;}.Green_Header{color:green!important;font-size:24px!important;font-weight:500!important;}.Blue_Header{color:blue!important;font-size:18px!important;font-weight:500!important;}.Red_Header{color:red!important;font-size:28px!important;font-weight:500!important;}.Purple_Header{color:purple!important;font-size:31px!important;font-weight:500!important;}.Yellow_Header{color:yellow!important;font-size:20px!important;font-weight:500!important;}.Black_Header{color:black!important;font-size:22px!important;font-weight:500!important;}.White_Header{color:white!important;font-size:22px!important;font-weight:500!important;} Pain

As mentioned in other sections of this fact sheet, there’s evidence that music-based interventions may help to relieve pain associated with specific health conditions. The two review articles listed below describe evidence indicating that music may be helpful for pain more generally. Newer research continues to find evidence that music may be helpful for pain from a variety of causes, but not every study has shown a beneficial effect. 

• A 2016 review looked at 97 studies (9,184 participants) of music-based interventions for acute or chronic pain associated with a variety of health problems and medical procedures. The overall evidence suggested that music-based interventions may have beneficial effects on both pain intensity and emotional distress from pain and may lead to decreased use of pain-relieving medicines.
• A 2017 review of 14 randomized trials (1,178 participants) of music-based interventions for various types of chronic pain found that the interventions reduced self-reported chronic pain and associated depressive symptoms, with a greater effect when the music was chosen by the participant rather than the researcher. The study participants had a variety of conditions that can cause chronic pain, including cancer, fibromyalgia, multiple sclerosis, or osteoarthritis, and most of the interventions involved listening to recorded music.
• Many but not all newer studies of music-based interventions for pain have had promising results. For example, in recent studies, music-based interventions were helpful for pain associated with childbirth, cancer chemotherapy, a procedure in which shock waves are used to break up kidney stones, retrieval of eggs for in vitro fertilization, treatment of nose fractures, and sickle cell disease. However, music didn’t seem to be helpful for reducing moderate pain further after use of a lidocaine spray for loop electrosurgical excision (a gynecological procedure), and the results of studies on pain during cystoscopy (a procedure in which a tube is inserted into the bladder) and pain during colonoscopy were inconsistent.

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Music-based interventions have been evaluated for their effects on anxiety in a variety of disease conditions and health care settings. Some examples are given in this section, and others are discussed in the sections on specific health conditions. Most studies have had promising results, except for studies on anxiety associated with dental care.

• A 2013 review of 26 studies (2,051 participants) showed that listening to recorded music significantly reduced anxiety in people who were waiting to have surgery. However, there was potential for bias in most of the studies because the investigators who performed the studies knew which participants had listened to music.
• A 2016 review of 17 studies (1,381 participants) that evaluated the effect of music-based interventions on anxiety in adults with cancer suggested that the interventions may have a large anxiety-reducing effect. However, there was a high risk of bias in the studies. 
• A 2015 review of 5 studies (290 participants) in people who were having dialysis treatments suggested that listening to music reduced anxiety. However, these studies have limitations because of their small size and high risk of bias.
• A 2018 review concluded that it’s unclear whether listening to music is helpful for dental anxiety. Some studies have suggested that listening to music as a distraction may not be adequate to reduce anxiety in children or highly anxious adults who are having dental care. More active types of music-based interventions (for example, a music-assisted relaxation technique that’s taught to the patient in advance) might be helpful in dental settings but have not been evaluated in formal studies.  

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It’s uncertain whether music-based interventions are helpful for people with ASD.

• A 2021 review of 22 studies (850 participants) on music therapy for children with ASD was unable to reach any definite conclusions on whether adding music therapy to their care is beneficial, although some studies had promising results. For example, some studies of educational music therapy (involving techniques such as musical games) showed possible benefits on the children’s speech, and some studies of improvisational music therapy (in which children produce music) showed possible benefits on social functioning.
• One particularly notable study of music therapy for children with ASD (which was included in the review described above) was a multinational trial involving 364 children from 9 countries. It is the largest study completed so far, and its design was especially rigorous. In this study, the severity of symptoms related to difficulties in social communication did not differ between children who received music therapy along with standard care and those who received standard care alone.

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Preliminary evidence suggests that music-based interventions may be helpful for several types of distress in people with cancer.

• A 2021 review of randomized controlled trials (studies in which participants were randomly assigned to a music-based intervention group or a control group), which included 81 trials and 5,576 participants, concluded that in adults with cancer, music interventions may have a large anxiety-reducing effect, a moderately strong beneficial effect on depression, a moderate pain-reducing effect, and a large effect on the quality of life. Most of the trials had a high risk of bias, so their results need to be interpreted with caution. Only seven of the studies included in this review involved children. Two of these studies suggested a beneficial effect on anxiety; no other conclusions could be reached from the small amount of evidence available.
• A 2021 review of 11 studies (491 participants) on music interventions for children and adolescents with cancer, which included some studies that were less rigorous than a randomized controlled trial, found evidence suggesting that music-based interventions may decrease anxiety, perceived pain, and depression symptoms and improve state of mind, self-esteem, and quality of life.

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A 2021 systematic review of 12 studies (812 participants) showed that music-based interventions were helpful for shortness of breath, anxiety, and sleep quality in adults with COPD but were not helpful for depression. Because the studies were brief (several days to 12 months) and because researchers measured effects in different ways in different studies, there is some uncertainty about the conclusions.

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Much research is being done on the potential benefits of music-based interventions for people with cognitive impairment or various types of dementia, such as Alzheimer’s disease. Limited evidence suggests that music-based interventions may improve emotional well-being, behavioral challenges, and quality of life in people with these conditions. Whether the interventions have benefits for cognitive functioning is unclear; effects might depend on the population studied or the type of intervention used.

• A 2018 review evaluated 22 studies (1,097 participants) of music-based interventions for people with dementia who were living in institutions. Some of the interventions were receptive (listening to music), some were active (singing, playing instruments, moving to music, etc.), and some were a combination of the two. The evidence from these studies indicated that music-based interventions probably reduce depressive symptoms and improve overall behavioral challenges. They may also improve emotional well-being and quality of life and reduce anxiety. However, the interventions may have little or no effect on agitation, aggression, or cognitive function.
• A 2021 review looked at 21 studies (1,472 participants) of people with either mild cognitive impairment or mild or moderate dementia; some of the people studied were living in institutions, but others were living in the community. All the music interventions were active; studies that only involved listening to music were not included. Nine of the studies (495 participants) were included in a quantitative analysis of effects on cognitive functioning; this analysis indicated that the music-based interventions had a small beneficial effect. There was also some evidence for beneficial effects on mood and quality of life.

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A 2017 review looked at 9 studies (421 participants) of music-based interventions in adults or adolescents with depression. There was moderate-quality evidence that adding music-based interventions to usual treatment improved depression symptoms when compared with usual treatment alone. Music-based interventions also helped decrease anxiety levels and improve functioning of people with depression (for example, their ability to maintain involvement in work, activities, and relationships).

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A 2020 systematic review of 7 studies (334 participants) found evidence that music-based interventions were beneficial for pain, depression, and quality of life in people with fibromyalgia. However, the amount of research was limited, and the quality of the research was low.

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A 2021 review of music-based interventions for people with multiple sclerosis (10 trials, 429 participants) found consistent evidence that the interventions were beneficial for coordination, balance, some aspects of gait and walking, emotional status, and pain, but no effect was observed for mental fatigability or memory.

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Researchers are evaluating the potential benefits of several types of music-based interventions for Parkinson’s disease symptoms. 

• Rhythmic auditory stimulation.  Rhythmic auditory stimulation uses pulsed sounds (such as those produced by a metronome) to help people synchronize their movements to the rhythm of the sounds. This technique is used to help people with Parkinson’s disease improve their ability to walk. A 2021 analysis of 5 studies (209 total participants) showed significant improvements in gait speed and stride length in people with Parkinson’s disease who participated in rhythmic auditory stimulation. However, the quality of evidence was low, and the number of studies and participants was small.
• Music-based movement therapy.  Music-based movement therapy combines physical activities such as dance or rhythmic exercises with music. Therapies that involve physical activity have been shown to be helpful for a variety of Parkinson’s disease symptoms. Adding music to the therapy might have additional benefits by providing auditory cues for movement and making the activities more enjoyable. A 2021 analysis of 17 studies (598 participants) of music-based movement therapy showed evidence of improvements in motor function, balance, freezing of gait, walking speed, and mental health but not gait cadence, stride length, or quality of life.
• Singing. The potential benefits of singing for people with Parkinson’s disease have been studied primarily in terms of effects on speech. In a 2016 review of 7 studies (102 participants), 5 studies found some evidence of a beneficial effect on speech.

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Music-based interventions are widely used in neonatal intensive care units. However, evidence for physiological benefits for newborn infants is limited. 

• In a 2020 review of 16 studies (826 infants), 12 of the studies found some evidence of benefits on physiological outcomes (such as heart rate or oxygen saturation), but several of the studies included only small numbers of infants, and the intervention methods used varied from one study to another. The reviewers concluded that the current data are insufficient to confirm physiological benefits. No harmful effects of music-based interventions were seen in the studies included in this review.

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Music-based interventions have been evaluated as adjunct treatments (additions to usual treatment) for people with schizophrenia. A 2020 review of 18 studies (1,212 participants) indicated that adjunct music-based interventions may improve a group of schizophrenia symptoms known as “negative symptoms,” such as reduced emotion and self-neglect, as well as depression symptoms and quality of life. However, music-based interventions did not reduce “positive symptoms,” such as hallucinations and delusions. The quality of the evidence was low.

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Listening to music may improve sleep quality in people with insomnia.

• A 2022 review looked at 13 studies (1,007 participants) that examined the effect of listening to recorded music in people with insomnia. The studies suggested music had no effect on insomnia severity compared to no treatment or treatment as usual. Moderate-certainty evidence did suggest, however, that listening to music has a beneficial effect on subjective sleep quality. The studies also provided low-certainty evidence that listening to music might help improve the speed of falling asleep, the length of time spent sleeping, and the amount of time a person is asleep compared to the total time spent in bed.
• It’s common for older people to have trouble sleeping. A 2021 review looked at 16 studies of music-based interventions for sleep in older adults (812 participants); 11 studies evaluated music listening, and the other 5 evaluated more complex interventions. The results were mixed, with some studies suggesting that the music interventions were helpful, while others did not.

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Music-based interventions, particularly music therapy, may be helpful for improving physical and psychological markers associated with stress, according to two related reviews.

• In a 2020 review with 104 studies (9,617 participants), investigators looked at the effects of a variety of music-based interventions on measures associated with stress, including both physical measures (heart rate, blood pressure, and levels of stress-related hormones) and psychological measures (anxiety, nervousness, restlessness, and feelings of worry). The music-based interventions had a small-to-medium sized beneficial effect on the physical measures and a medium-to-large beneficial effect on the psychological measures. 
• A second review looked at 47 studies (2,747 participants) of music therapy (excluding other music-based interventions) and found an overall medium-to-large beneficial effect on stress-related outcomes. The effects were greater than those seen in the larger review. The investigators who performed the review suggested that the opportunity for music therapists to tailor interventions to the needs of individual patients might account for the difference.

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Music-based interventions may be helpful in the rehabilitation of people who have had a stroke. A 2019 review of 27 studies (730 participants) found positive effects on physical status (upper-limb activity, various aspects of walking, balance), cognition (paying attention, communication), and mood. In particular, rhythmic auditory stimulation (which involves the use of a metronome combined with physical activities) had beneficial effects on gait and balance, and receptive music therapy (which involves listening to music while performing another task) was helpful for mood and some aspects of cognitive function.

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Tinnitus is the symptom that people often describe as “ringing in the ears,” although it can also sound like roaring, clicking, hissing, or buzzing. It can be caused by noise-induced hearing loss, blockage of the ear canal by earwax, ear or sinus infections, or other health conditions, or by starting or stopping various medications. Sometimes, tinnitus has no obvious cause.

• Sound therapies. Various types of sounds, including music, have been used to try to mask tinnitus. However, according to a 2019 review of studies conducted up to that time, the effects of these sound therapies are modest; few people achieve complete remission of tinnitus from sound therapies.
• Notched music therapy. A specific type of music therapy called “notched” music therapy has been suggested as a possible way to reduce the severity of tinnitus. Notched music therapy involves listening to music that has been modified to remove sounds close in frequency to the frequency of the tinnitus sound perceived by the patient. Two recent studies that compared notched music with conventional music did not find notched music to be more helpful in reducing the symptoms or impact of tinnitus. However, some earlier studies suggested that the loudness of tinnitus sounds could be reduced with notched music therapy.

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NIH and the John F. Kennedy Center for the Performing Arts, in association with the National Endowment for the Arts, are sponsoring an initiative called Sound Health to increase understanding of music’s effect on the brain and the potential clinical applications. The first Sound Health research projects began in 2019. Some projects are investigating music’s mechanism of action in the brain and how music may be applied to treat symptoms of disorders such as Parkinson’s disease, stroke, and chronic pain. Others are looking at the effects of music on children’s developing brains.

Topics of NCCIH-supported studies within the Sound Health initiative include:

• The effects of music-based interventions on neurodevelopment and pain response in preterm infants
• Using self-generated rhythmic cues to enhance gait in people with Parkinson’s disease
• The impact of singing interventions on markers of cardiovascular health in older people with cardiovascular disease

In collaboration with the Foundation for the NIH and the Renée Fleming Foundation, NIH has developed a toolkit for rigorous, reproducible, well-powered music-based interventions for brain disorders of aging, such as Alzheimer’s disease, Parkinson’s disease, and stroke. Three workshops were held in 2021 to gather input from experts in a variety of relevant fields, and a request for information was issued to get stakeholder feedback. The toolkit , which was released in 2023, will be pilot tested in demonstration projects. NCCIH is playing a lead role in this effort.

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Nccih clearinghouse.

The NCCIH Clearinghouse provides information on NCCIH and complementary and integrative health approaches, including publications and searches of Federal databases of scientific and medical literature. The Clearinghouse does not provide medical advice, treatment recommendations, or referrals to practitioners.

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Know the Science

NCCIH and the National Institutes of Health (NIH) provide tools to help you understand the basics and terminology of scientific research so you can make well-informed decisions about your health. Know the Science features a variety of materials, including interactive modules, quizzes, and videos, as well as links to informative content from Federal resources designed to help consumers make sense of health information.

Explaining How Research Works (NIH)

Know the Science: How To Make Sense of a Scientific Journal Article

Understanding Clinical Studies (NIH)

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• Aalbers   S, Fusar-Poli L, Freeman RE, et al.  Music therapy for depression . Cochrane Database of Systematic Reviews. 2017;(11):CD004517. Accessed at cochranelibrary.com on October 29, 2021.
• Bieleninik Ł, Geretsegger M, Mössler K, et al.  Effects of improvisational music therapy vs enhanced standard care on symptom severity among children with autism spectrum disorder. The TIME—a randomized clinical trial . JAMA. 2017;318(6):525-535.
• Bradt J, Dileo C, Magill L, et al. Music interventions for improving psychological and physical outcomes in cancer patients . Cochrane Database of Systematic Reviews. 2016;(8):CD006911. Accessed at cochranelibrary.com on October 29, 2021.
• Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety . Cochrane Database of Systematic Reviews. 2013;(6):CD006908. Accessed at cochranelibrary.com  on October 29, 2021.
• Burrai F, Apuzzo L, Zanotti R. Effectiveness of rhythmic auditory stimulation on gait in Parkinson disease: a systematic review and meta-analysis . Holistic Nursing Practice. June 11, 2021. [Epub ahead of print].
• Cheever T, Taylor A, Finkelstein R, et al. NIH/Kennedy Center workshop on music and the brain: finding harmony . Neuron. 2018;97(6):1214-1218.
• Collins FS, Fleming R. Sound health: an NIH-Kennedy Center initiative to explore music and the mind . JAMA. 2017;317(24):2470-2471.
• de Witte   M, da Silva Pinho A, Stams G-J, et al. Music therapy for stress reduction: a systematic review and meta-analysis . Health Psychology Review. 2022;16(1):134-159.
• de Witte   M, Spruit A, van Hooren S, et al. Effects of music interventions on stress-related outcomes: a systematic review and two meta-analyses . Health Psychology Review. 2020;14(2):294-324.
• Dorris   JL, Neely S, Terhorst L, et al. Effects of music participation for mild cognitive impairment and dementia: a systematic review and meta-analysis . Journal of the American Geriatrics Society.  2021;69(9):2659-2667.
• Foroushani SM, Herman CA, Wiseman CA, et al. Evaluating physiologic outcomes of music interventions in the neonatal intensive care unit: a systematic review . Journal of Perinatology. 2020;40(12):1770-1779.
• Garza-Villareal   EA, Pando V, Vuust P, et al. Music-induced analgesia in chronic pain conditions: a systematic review and meta-analysis . Pain Physician. 2017;20(7):597-610.
• Jespersen KV, Pando-Naude V, Koenig J, et al. Listening to music for insomnia in adults . Cochrane Database of Systematic Reviews. 2022;(8):CD010459. Accessed at cochranelibrary.com on September 8, 2022.
• Lee   JH. The effects of music on pain: a meta-analysis . Journal of Music Therapy. 2016;53(4):430-477.
• van der Steen   JT, Smaling HJ, van der Wouden JC, et al. Music-based therapeutic interventions for people with dementia . Cochrane Database of Systematic Reviews. 2018;(7):CD003447. Accessed at cochranelibrary.com on October 29, 2021.

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• Atipas   S, Therdphaothai J, Suvansit K, et al. A randomized, controlled trial of notched music therapy for tinnitus patients. Journal of International Advanced Otology. 2021;17(3):221-227.
• Barnish J, Atkinson RA, Barran SM, et al. Potential benefit of singing for people with Parkinson’s disease: a systematic review. Journal of Parkinson’s Disease. 2016;6(3):473-484.
• Bird HA. Overuse syndrome in musicians. Clinical Rheumatology. 2013;32(4):475-479.
• Bradt J, Teague A. Music interventions for dental anxiety. Oral Diseases. 2018;24(3):300-306.
• Brancatisano O, Baird A, Thompson WF. Why is music therapeutic for neurological disorders? The therapeutic music capacities model. Neuroscience and Biobehavioral Reviews. 2020;112:600-615.
• Buglione A, Saccone G, Mas M, et al. Effect of music on labor and delivery in nulliparous singleton pregnancies: a randomized clinical trial. Archives of Gynecology and Obstetrics.  2020;310(3):693-698.
• Burrai F, Magavern EF, Micheluzzi V, et al. Effectiveness of music to improve anxiety in hemodialysis patients. A systematic review and meta-analysis. Holistic Nursing Practice. 2020;34(6):324-333.
• Cakmak O, Cimen S, Tarhan H, et al. Listening to music during shock wave lithotripsy decreases anxiety, pain, and dissatisfaction. A randomized controlled study. Wiener Klinische Wochenscrift.  2017;129(19-20):687-691.
• Ç elebi D, Y ı lmaz E, Ş ahin ST, et al. The effect of music therapy during colonoscopy on pain, anxiety and patient comfort: a randomized controlled trial. Complementary Therapies in Clinical Practice. 2020;38:101084.
• Chantawong N, Charoenkwan K. Effects of music listening during loop electrosurgical excision procedure on pain and anxiety: a randomized trial. Journal of Lower Genital Tract Disease. 2017;21(4):307-310.
• Cheung CWC, Yee AWW, Chan PS, et al. The impact of music therapy on pain and stress reduction during oocyte retrieval—a randomized controlled trial. Reproductive Biomedicine Online. 2018;37(2):145-152.
• Çift   A, Benlioğlu C. Effect of different musical types on patient’s relaxation, anxiety and pain perception during shock wave lithotripsy: a randomized controlled study. Urology Journal. 2020;17(1):19-23.
• Gonz á lez-Mart í n-Moreno   M, Garrido-Ardila EM, Jim é nez-Palomares M, et al. Music-based interventions in paediatric and adolescents oncology patients: a systematic review. Children. 2021;8(2):73.
• Huang J, Yuan X, Zhang N, et al. Music therapy in adults with COPD. Respiratory Care. 2021;66(3):501-509.
• Jia   R, Liang D, Yu J, et al. The effectiveness of adjunct music therapy for patients with schizophrenia: a meta-analysis. Psychiatry Research. 2020;293:113464.
• Ko SY, Leung DYP, Wong EML. Effects of easy listening music intervention on satisfaction, anxiety, and pain in patients undergoing colonoscopy: a pilot randomized controlled trial. Clinical Interventions in Aging. 2019;14:977-986.
• Koelsch S. A neuroscientific perspective on music therapy. Annals of the New York Academy of Sciences. 2009;1169:374-384.
• Le Perf   G, Donguy A-L, Thebault G. Nuanced effects of music interventions on rehabilitation outcomes after stroke: a systematic review. Topics in Stroke Rehabilitation.  2019;26(6):473-484.
• Lopes   J, Keppers II. Music-based therapy in rehabilitation of people with multiple sclerosis: a systematic review of clinical trials. Arquivos de Neuro-psiquiatria.  2021;79(6):527-535.
• Mayer-Benarous   H, Benarous X, Vonthron F, et al. Music therapy for children with autistic spectrum disorder and/or other neurodevelopmental disorders: a systematic review. Frontiers in Psychiatry. 2021;12:643234.
• McClintock G, Wong E, Mancuso P, et al. Music during flexible cystoscopy for pain and anxiety – a patient-blinded randomized control trial. BJU International. 2021;128 Suppl 1:27-32. 
• Mumm J-N, Eismann L, Rodler S, et al. Listening to music during outpatient cystoscopy reduces pain and anxiety and increases satisfaction: results from a prospective randomized study. Urologia Internationalis . 2021;105(9-10):792-798. 
• Ortega   A, Gauna F, Munoz D, et al. Music therapy for pain and anxiety management in nasal bone fracture reduction: randomized controlled clinical trial. Otolaryngology—Head and Neck Surgery. 2019;161(4):613-619.
• Perković R, Dević K, Hrkać A, et al. Relationship between education of pregnant women and listening to classical music with the experience of pain in childbirth and the occurrence of psychological symptoms in puerperium. Psychiatria Danubina. 2021;33(Suppl 13):260-270.
• Petrovsky DV, Ramesh P, McPhillips MV, et al. Effects of music interventions on sleep in older adults: a systematic review. Geriatric Nursing.  2021;42(4):869-879.
• Pienkowski M. Rationale and efficacy of sound therapies for tinnitus and hyperacusis. Neuroscience. 2019;407:120-134.
• Piromchai   P, Chompunut S, Kasemsiri P, et al. A three-arm, single-blind, randomized controlled trial examining the effects of notched music therapy, conventional music therapy, and counseling on tinnitus. Otology & Neurotology. 2021;42(2):335-340.
• Robb SL, Hanson-Abromeit D, May L, et al. Reporting quality of music intervention research in healthcare: a systematic review. Complementary Therapies in Medicine. 2018;38:24-41.
• Rodgers-Melnick SN, Matthie N, Jenerette C, et al. The effects of a single electronic music improvisation session on the pain of adults with sickle cell disease: a mixed methods pilot study. Journal of Music Therapy.  2018;55(2):156-185.
• Silverman MJ, Gooding LF, Yinger O. It’s…complicated: a theoretical model of music-induced harm. Journal of Music Therapy. 2020;57(3):251-281.
• Speranza L, Pulcrano S, Perrone-Capano C, et al. Music affects functional brain connectivity and is effective in the treatment of neurological disorders. Reviews in the Neurosciences. March 24, 2022. [Epub ahead of print].
• Tang   H, Chen L, Wang Y, et al. The efficacy of music therapy to relieve pain, anxiety, and promote sleep quality, in patients with small cell lung cancer receiving platinum-based chemotherapy. Supportive Care in Cancer. 2021;29(12):7299-7306.
• Wang M, Yi G, Gao H, et al. Music-based interventions to improve fibromyalgia syndrome: a meta-analysis. Explore. 2020;16(6):357-362.
• Wolff AL, Ling DI, Casey EK, et al. Feasibility and impact of a musculoskeletal health for musicians (MHM) program for musician students: a randomized controlled pilot study. Journal of Hand Therapy. 2021:34(2):159-165.
• Zhou   Z, Zhou R, Wei W, et al. Effects of music-based movement therapy on motor function, balance, gait, mental health, and quality of life for patients with Parkinson’s disease: a systematic review and meta-analysis. Clinical Rehabilitation. 2021;35(7):937-951.

Acknowledgments

NCCIH thanks Wen Chen, Ph.D., Emmeline Edwards, Ph.D., and David Shurtleff, Ph.D., NCCIH, for their review of this fact sheet. 

This publication is not copyrighted and is in the public domain. Duplication is encouraged.

NCCIH has provided this material for your information. It is not intended to substitute for the medical expertise and advice of your health care provider(s). We encourage you to discuss any decisions about treatment or care with your health care provider. The mention of any product, service, or therapy is not an endorsement by NCCIH.

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Canada was first to receive a new drug application for just 33 of the 337 drugs that received approval from at least two of the regulatory agencies in the United States, Europe, and Canada during the time period evaluated by CHPI.

And of the 92 drugs that sought approval in all three regulatory regimes between 2018 and 2022, just one launched in Canada first. American patients had first dibs on 85 of those drugs.

A February 2024 RAND Corporation study found that "most new drugs are sold first in the United States" and that "the United States has access to the largest share of new drugs overall," precisely because the "latitude to set prices" encourages companies to introduce drugs here "before launching in countries that use external reference pricing" or other forms of price controls.

That may not be the case for long. Medicare is in the process of setting price caps on 10 popular drugs in Part D, as authorized under the 2022 Inflation Reduction Act. Those caps will take effect in January 2026. The following year, 15 drugs under Part D will be ensnared by these price controls. In 2028, 15 from Medicare Parts B and D will be subject to price controls. And in 2029 and thereafter, it's 20 drugs from Parts B and D. The Democrats have already proposed to increase those numbers .

One study estimates that the IRA's price controls will reduce pharmaceutical companies' revenue — and thus the amount of money available for research and development — to such an extent that they'll develop 139 fewer drugs by 2035 .

States are working to implement price controls of their own, too. Colorado announced in March that the state's Prescription Drug Affordability Review Board would begin setting "upper payment limit[s]" on drugs it thinks are too expensive. The board claims that over 600 drugs currently meet that threshold.

Colorado is hardly an outlier. At least eight other states have created similar bodies. Thus far, only Colorado, Washington, Minnesota, and Maryland have the authority to set price caps.

The fact that states are embracing this type of strategy is bad news, regardless of how many boards have power at the moment. They all function like Canada's Patented Medicine Prices Review Board , the agency responsible for my home country's lag in drug approvals and access.

It would be folly to think the United States could implement Canadian-style price controls and not suffer Canadian-style results. If the Biden administration and state governments continue to push for price caps, review boards, and "negotiations" with drug makers, they will inevitably restrict patients' ability to access new medicines.

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Children and adults are gobbling supplements. Do you know the risks?

Among some population groups, it’s not unusual to down four or more vitamins or supplements every day, new research shows

Americans spend billions of dollars every year on dietary supplements that claim to promote almost every aspect of our health. But how much do you know about the supplements you’re taking?

A recent government study found that nearly 60 percent of adults take vitamins, minerals, fish oil, herbal capsules, melatonin, probiotics and other types of dietary supplements. While most people used just one or two supplements — multivitamins and vitamin D were the two most popular products — it was not uncommon for people to report using three, four or more supplements at a time.

Among some parts of the population, it’s not unusual to down a handful of vitamins or supplements every day. About 15 percent of adults said they used four or more dietary supplements. Among older adults, the number reporting multi-supplement use is even higher — about 25 percent of adults 60 or older use four or more. About 35 percent of children and adolescents used dietary supplements, and nearly 10 percent of children between 2 and 5 years old were given two or more dietary supplements.

Experts say that vitamin and mineral supplements are generally safe when taken in small to moderate doses, like the amounts found in a basic multivitamin. Dietary supplements can be beneficial for pregnant women and for people with nutrient deficiencies and other health conditions. A clinical trial earlier this year found that for people who are 60 and older, taking a daily multivitamin helped to slow memory loss. Other studies have found that probiotic supplements can help with gastrointestinal disorders such as irritable bowel syndrome.

But taking supplements comes with risks, and for many healthy adults, it’s not always clear from research that the benefits outweigh the risks.

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In fact, some randomized trials have found that assigning people to take supplements with large doses of beta-carotene, selenium, and vitamins A, C, and E actually increased mortality rates. Rigorous clinical trials have also failed to support the hype around vitamin D, finding that people who were assigned to take the popular supplement did not develop lower rates of cardiovascular disease, cancer or bone fractures despite widespread marketing claims to the contrary.

Supplements don’t follow the same rules as drugs

Many people assume that the Food and Drug Administration tests supplements for safety. But that’s not how it works .

“Dietary supplements enter the market before there’s any real review of them by the FDA,” said Amy B. Cadwallader, the director of regulatory and public policy development at the United States Pharmacopeia, a nonprofit organization that examines the quality of drugs, food and dietary supplements.

Under federal law, companies are allowed to operate on the honor system. The FDA’s role in regulating supplements mostly involves trying to make sure products are safe and accurately labeled after they have already entered the marketplace.

Are you getting what you paid for?

In the United States, companies sell an estimated 90,000 dietary supplements, representing a roughly $50 billion industry . As a result, some experts say, consumers who buy supplements can’t always be sure that they are getting what they paid for. Studies of melatonin , fish oil , probiotics , ginkgo biloba , and other supplements have found that the doses and compounds listed on their labels are often not what are found in their bottles.

• In one study in the journal Pediatric Research , researchers tested 16 probiotic supplements and found that only one of them contained the specific bacterial strains listed on its label.
• In another study , researchers tested 30 dietary supplements that claimed to strengthen immune health and found that 17 of the products were “misbranded.” These supplements either lacked key ingredients listed on their labels — such as vitamin B12, garlic extract, ginger root and folate — or they contained a variety of unlisted ingredients.
• One study by the FDA estimated that the agency is notified of less than 1 percent of all adverse events linked to supplement use. Another study by the federal government estimated that injuries caused by supplements are responsible for about 23,000 emergency room visits each year.

Howard Luks, an orthopedic surgeon and sports medicine specialist in New York, said he routinely encounters patients who worry about potential side effects from medications but have no problem taking 10 or 20 supplements that they heard about from health influencers on social media. He said that many people who lost trust in public health authorities during the pandemic have turned to social media influencers for health advice.

“They view supplements as being holistic, natural, and therefore not potentially harmful for them,” he said.

In one case study published in March, doctors in New Jersey described a 76-year-old woman who went to an emergency room after experiencing heart palpitations, dizziness and fainting episodes. It turned out she had been taking black cohosh, an herbal supplement often used to treat hot flashes. A few days after stopping the supplement, her heartbeat returned to normal, and her other symptoms disappeared.

In another recent case , a 47-year-old woman in Houston suffered jaundice and liver damage after taking a supplement containing a blend of probiotics and herbal extracts. The case report noted that dietary supplements account for about 20 percent of drug-induced liver injuries nationwide.

How to shop smarter for supplements

Here are some tips when buying supplements.

Look for third-party certifications: The United States Pharmacopeia, or USP, vets dietary supplements to ensure they are meeting high standards for factors such as purity and potency. USP has a voluntary program through which companies can have their supplements and facilities routinely tested and examined. Companies that meet the organizations high standards are allowed to use a black and yellow “USP Verified” logo on their products. You can find them using the product-finder search tool on USP’s website. NSF is another independent group that tests and reviews dietary supplements. You can look for the blue and white “NSF” logo on your supplements or go to the group’s website to look up products.

Do your homework. Consumerlab.com is an independent laboratory that tests dietary supplements to see if they contain the ingredients and doses listed on their labels. The company publishes reports with their findings on a wide variety of supplements, which you can access on their website for a fee.

Talk to your doctor or pharmacist . Many people don’t realize that a lot of supplements and medications use the same metabolic pathways and that they can cause dangerous side effects when you combine them, said Michael Schuh, an assistant professor of pharmacy, family medicine and palliative medicine at the Mayo Clinic in Florida.

Vitamins E and K, ginseng, ginkgo biloba, resveratrol, turmeric and CoQ10 for example can interact with blood thinning medications. Vitamin C can interact with statins, niacin, estrogen, warfarin and chemotherapy drugs. St. John’s wort can make antidepressants and birth control pills less effective.

“We see it with a lot of supplements,” Schuh said. “Even something like resveratrol from grape skins: When you take it in concentrated form, it can interact with a lot of medications.”

Do you have a question about healthy eating? Email [email protected] and we may answer your question in a future column.

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Hormones for menopause are safe, study finds. here's what changed.

Allison Aubrey

Low-dose estrogen can be taken orally, but it's also now available in patches, gels and creams. svetikd/Getty Images hide caption

Low-dose estrogen can be taken orally, but it's also now available in patches, gels and creams.

The benefits of hormone therapy for the treatment of menopause symptoms outweigh the risks. That's the conclusion of a new study published in the medical journal JAMA.

"Among women below the age of 60, we found hormone therapy has low risk of adverse events and [is] safe for treating bothersome hot flashes, night sweats and other menopausal symptoms, " says study author Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women's Hospital. This is a departure from the advice many women have been given in the past.

The new analysis is based on two decades of follow-up data from the Women's Health Initiative study, which followed thousands of women taking hormone replacement therapy. The study was halted after it was found that women taking Prempro, which is a combination of estrogen and progestin, had higher risks of breast cancer and stroke.

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"The findings were surprising," Manson says, pointing out that the reason the randomized trial was conducted was because scientists were trying to determine if hormone therapy decreased the risk of heart disease and other conditions.

After the initial findings came out, many women abruptly stopped the therapy. Prescriptions plummeted, and many healthcare providers still hesitate to recommend hormone therapy. But menopause experts say it's time to reconsider hormone therapy, because there's a lot known now that wasn't known two decades ago.

Most significantly, there are now different types of hormones — delivered at lower doses — that are shown to be safer.

"Women should know that hormone therapy is safe and beneficial," says Dr. Lauren Streicher , a clinical professor of obstetrics and gynecology at Northwestern University Feinberg School of Medicine.

Looking back, Dr. Streicher says, it's clear the Women's Health Initiative study was flawed and that some of the risks that were identified were linked to the type of hormones that women were given.

"We learned what not to do," Streicher says. The type of progestin used, known as medroxyprogesterone acetate , was "highly problematic," she says. This may have been linked to the increase in breast cancer seen among women in the earlier study. "So we don't prescribe that anymore," Streicher says.

Increasingly, other types of hormones are used, such as micronized progesterone which does not increase the risk of breast cancer, Streicher says. Micronized progesterone is a bioidentical hormone that has a molecular structure identical to the progesterone produced by women's ovaries, and tends to have fewer side effects.

Another problem with the study was the age of the women enrolled. Most of the women were over the age of 60, Streicher says. "And we know that there is a window of opportunity when it is the safest to start hormone therapy and that you get the most benefit." That window is typically between ages 50 and 60, she says.

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Another risk identified in the Women's Health Initiative study, was an increased incidence of pulmonary embolism among women taking hormones. A pulmonary embolism is a blood clot that blocks blood flow to the lungs.

Since women in the study were taking estrogen orally, by pill, this may have increased their risk, Streicher says. A better option for people at risk of clots is to take estrogen through the skin, via a patch, a cream or gel.

"The advantage of a transdermal estrogen is that it is not metabolized by the liver," Streicher says. "And because it's not metabolized by the liver, we don't see that increase in blood clots."

With a range of hormone therapies available now, Dr Streicher says there's not a one-size fits all approach. "Hormone therapy is beneficial way beyond the benefits to just helping with hot flashes," she says. Ongoing research points to protection against bone loss and heart disease , too.

Streicher says women should talk to their healthcare providers about what options may best suit their needs.

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This story was edited by Jane Greenhalgh

• hot flashes
• hormone therapy
• hormone replacement therapy