Page 4: Health Canada – 2014–2015 – Supplementary Information Tables – Departmental Performance Report - Horizontal Initiatives

Horizontal Initiatives

Chemicals Management Plan

General Information

Name of lead department(s)

Health Canada/Environment Canada

Federal partner organization(s)

Public Health Agency of Canada

Non-federal and non-governmental partner(s)

N/A

Start date of the horizontal initiative

2011-12 (second phase)

End date of the Horizontal Initiative

2015-16 (second phase)

Total federal funding allocated (start to end date) (dollars)

$515,692,950

Funding contributed by non-federal and non-governmental partners (dollars)

N/A

Description of the horizontal initiative

Originally launched in 2006, the Chemicals Management Plan (CMP) enables the Government of Canada to protect human health and the environment by addressing substances of concern in Canada. It is a science-based approach that includes:

  • Setting priorities and government-imposed timelines for risk assessment and risk management (RM) of chemicals of concern.
  • Enhancing research, monitoring and surveillance.
  • Increasing industry stewardship and responsibilities for substances.
  • Collaborating internationally on chemicals assessment and management.
  • Communicating to Canadians the potential risks of chemical substances.
  • Engaging industry to inform risk assessment and RM action while also enhancing trust in the program.

Jointly managed by Health Canada and Environment Canada, the CMP brings all existing federal chemical programs together under a single strategy. This integrated approach allows the Government of Canada to address various routes of exposure to chronic and acute hazardous substances. It also enables the use of the most appropriate management tools among a full suite of federal laws, which include the Canadian Environmental Protection Act (CEPA) 1999, the Canada Consumer Product Safety Act (CCPSA) (which replaced the Hazardous Products Act (HPA) in June 2011), the Food and Drugs Act (F&DA), and the Pest Control Products Act (PCPA).

Building on lessons learned in the first four years of the program, the CMP priority setting was refined and, under the second phase of the CMP, the remaining substances were grouped to facilitate more efficient assessments, industry participation and Risk Management (RM). Integration across government programs remains critical since many remaining substances are found in consumer, health, drug and other products.

The same core functions continue in phase two of the CMP: risk assessment; RM; compliance promotion and enforcement; research; monitoring and surveillance; stakeholder engagement and risk communications; and, policy and program management.

The following program areas are involved in CMP activities:

In Health Canada:

  • Health Products and Food Branch:
    • Biologics and Genetic Therapies Directorate.
    • Food Directorate.
    • Natural and Non-prescription Health Products Directorate.
    • Policy, Planning and International Affairs Directorate.
    • Therapeutics Products Directorate.
    • Veterinary Drugs Directorate.
  • Healthy Environments and Consumer Safety Branch:
    • Consumer Product Safety Directorate.
    • Safe Environments Directorate.
    • Environmental and Radiation Health Sciences Directorate.
  • Regions and Programs Bureau:
    • Product Safety Program.
    • Environmental Health Program.
  • Pest Management Regulatory Agency.

In the Public Health Agency of Canada:

  • Office of Border Health Services:
    • Travelling Public Program.

In Environment Canada:

  • Environmental Stewardship Branch:
    • Industrial Sectors, Chemicals and Waste Directorate.
    • Legislative and Regulatory Affairs Directorate.
    • Energy and Transportation Directorate.
    • Environmental Protection Operations Directorate.
  • Science and Technology Branch:
    • Science and Risk Assessment Directorate.
    • Wildlife and Landscape Sciences Directorate.
    • Atmospheric Science and Technology Directorate.
    • Water Science and Technology Directorate.
  • Enforcement Branch
  • Strategic Policy Branch:
    • Economic Analysis Directorate.

For more information, see the Government of Canada Chemical Substances Portal.

Shared outcome(s)

Immediate Outcomes:

  • Knowledge, information and data on substances of concern is used by Health Canada and Environment Canada to inform RM, risk communication and stakeholder engagement, research, risk assessment, and monitoring and surveillance activities.
  • Canadians and stakeholder groups understand information on the risks and safe use of substances of concern.
  • Targeted industry conforms or complies with requirements of RM measures.
  • Targeted industry takes voluntary action to protect Canadians and the environment.
  • Targeted industry understands its obligations to take action to protect Canadians and the Environment.

Intermediate Outcomes

  • Canadians use information on the risks and safe use of substances of concern to avoid or minimize risks posed by these substances.
  • Risks associated with harmful substances in humans, the environment, food and consumer products are prevented, minimized or eliminated.

Final Outcome:

  • Reduced threats to health and the environment from harmful substances.
Governance structure(s)

In meeting their obligations pursuant to the CMP, Environment Canada and Health Canada deliver their responsibilities through established internal departmental governance structures. CMP governance is assured through a joint Assistant Deputy Ministers Committee (CMP ADM Committee). The CMP ADM Committee is supported by the CEPA DGs committee, which is comprised of representatives of the core program areas. This is supplemented by the Chemicals Management Executive Committee (CMEC) which is the extended group of Directors General required for implementation of the CMP.

Performance highlights

In 2014-15, Health Canada and Environment Canada continued to assess and manage the potential health and ecological risks from remaining priority existing substances. Screening Assessment Reports and Risk Management Strategies for most priorities were completed, and risk management measures for substances considered harmful to human health and the environment continued to be developed, implemented, tracked and monitored. As well, all new substance notifications received in 2014-15 were assessed, and risk management instruments developed, within mandated timeframes, as required.

Health Canada continued to conduct risk assessments and develop and implement risk management measures to address risks posed by harmful chemicals in foods and food packaging materials, consumer products, cosmetics and drinking water while work continued on the re-evaluation of previously approved pesticides according to legislated timelines and requirements under the Pest Control Products Act.

The program continued to conduct research and monitoring programs to address existing and emerging chemicals of concern, and to inform risk assessment needs and risk management activities.

Compliance strategies and enforcement plans were also developed and delivered for CMP substances. The focus in 2014-15 was on delivering compliance promotion activities for the highest priority instruments as determined by the compliance priority setting process. Regions conducted activities to support compliance promotion for stakeholders regarding their legal obligations related to CMP (e.g., stakeholder database updates, Section 71 data review and follow-up).

Stakeholder engagement activities continued in 2014-15. A pan-regional public outreach strategy was developed and implemented to increase public awareness of CMP achievements. This included the targeted delivery, by regional staff, of chemical awareness sessions for frontline service providers - including First Nations and early childhood educators. These sessions informed opinion leaders and key stakeholders on ways to mitigate chemical-related health risks.

Results achieved by non-federal and non-governmental partners

N/A

Contact information:
  • Suzanne Leppinen
    Director, Chemicals Policy Bureau
    Safe Environments Directorate
    Healthy Environments and Consumer Safety Branch
    Health Canada
    Tunney's Pasture
    Ottawa, Ontario
    K1A 0K9
    Postal Locator: 4905B
    Telephone: 613-941-8071
    E-mail: suzanne.leppinen@hc-sc.gc.ca
  • Greg Carreau
    Executive Director, Program Development and Engagement
    Program Development and Engagement
    Science and Risk Assessment Directorate
    Environment Canada
    200, boul. Sacré-Coeur
    Gatineau, QC, K1A 0H3
    Office 8-873
    Telephone: 819-953-6072
    E-mail: greg.carreau@ec.gc.ca

Performance information

Federal Organizations Link to department's Program Alignment Architecture Contributing programs and activities Total allocation (from start date to end date) 2014-15
Planned spending Actual spending Expected Results Actual results

Health Canada

Health Products

Risk Management, Compliance Promotion and Enforcement

10,388,591 2,077,718 1,808,662 ER 1.1
See Note 17.1
AR 1.1
See note 18.1

Food Safety and Nutrition

Risk Assessment

5,847,961 1,169,591 1,286,527

Risk Management, Compliance Promotion and Enforcement

5,261,930 1,052,386 1,109,467

Research

3,617,680 723,536 750,938

Monitoring and Surveillance

5,418,614 1,083,724 1,146,611

Stakeholder Engagement and Risk Communications

1,024,405 204,881 224,529

Environmental Risks to Health

Risk Assessment

57,469,134 11,493,827 9,952,763

Risk Management, Compliance Promotion and Enforcement

63,158,441 11,358,548 10,280,505

ResearchTable 1 - Footnote 1

51,248,090 13,349,618 19,781,047

Monitoring and Surveillance

43,316,924 8,663,385 8,196,773

Stakeholder Engagement and Risk Communications

10,137,982 2,027,596 1,122,823

Policy and Program Management

12,118,469 2,324,072 2,035,443

Consumer Product and Workplace Safety

Risk Assessment

12,780,412 2,556,082 2,565,349

Risk Management, Compliance Promotion and Enforcement

12,928,576 2,585,715 2,596,917

Pesticides

Risk Assessment

20,903,463 4,180,693 4,180,693

Risk Management, Compliance Promotion and Enforcement

4,411,229 882,246 882,246

Research

1,734,562 346,912 346,912

Internal Services

36,877,934 7,334,268 7,334,268

Public Health Agency of Canada

Health Security

Risk Management, Compliance Promotion and Enforcement

9,548,553 3,182,851 3,182,279

ER 2.1

AR 2.1

Environment Canada

Substances and Waste Management

Risk Assessment

17,419,056 3,483,811 4,031,726

ER 3.1

AR 3.1

Risk Management

68,446,359 13,689,272 12,525,915

Research

9,652,435 1,930,487Table 1 - Footnote 2 2,652,660

Monitoring and Surveillance

24,584,760 4,916,952 3,641,865

Compliance Promotion and Enforcement - Pollution

Compliance Promotion

4,337,745 867,549 841,367

Enforcement

11,282,295 2,249,448 1,952,238

Internal Services

11,777,350 2,362,481Table 1 - Footnote 2 2,362,481

Total

515,692,950 106,097,649 106,793,004

Note:
13% PWGSC accommodations funding is included in the Performance Information table. Health Canada's planned spending differs from previously reported in the RPP 2014-15 due to rounding.

Footnote 1

The amounts include funding for the Banting Lab Retrofit Project (laboratory renewal).

Return to footnote 1 referrer

Footnote 2

$113K planned spending redistributed from Internal Services to Research to support research facilities.

Return to footnote 2 referrer

ER 1.1 - Expected Results: Health Canada
  • Information on risks of substances to inform risk management, monitoring and surveillance and research activities (Risk Assessment).
  • Risk management measures under CEPA, PCPA, HPA/CCPSA and F&DA (Risk Management, Compliance Promotion and Enforcement).
  • Drinking water quality guideline technical documents/guidance documents (Risk Management, Compliance Promotion and Enforcement).
  • Science-based information on the risks posed by substances, in accordance with annual research plans (Research).
  • Data generated on the use, release, exposure and presence of substances of concern in humans, the environment, food and consumer products (Monitoring and Surveillance).
  • Engagement, consultation and communication products to inform the public and stakeholders (Stakeholder Engagement and Risk Communications).
ER 2.1 - Expected Results: Public Health Agency of Canada
  • Risk management measures under PCPA, HPA/CCPSA and F&DA (Risk Management, Compliance Promotion and Enforcement).
ER 3.1 - Expected Results: Environment Canada
  • Information on risks of substances to inform risk management, monitoring and surveillance and research activities (Risk Assessment).
  • Risk management measures under CEPA and the Fisheries Act (Risk Management).
  • Science-based information on the risks posed by substances, in accordance with annual research plans (Research).
  • Data generated on the use, release, exposure and presence of substances of concern in humans, the environment, food and consumer products (Monitoring and Surveillance).
  • Information on obligations to conform or comply with risk management control measures (Compliance Promotion).
  • Inspections, investigations and enforcement actions (Enforcement).
AR 1.1/ AR 3.1 - Actual Results: Health Canada/Environment Canada
Risk Assessment/Risk Management

A key component of the CMP has been to assess, and manage as appropriate, the potential risks of approximately 4,300 priority existing substances by 2020. Some 1,100 chemicals were addressed in the first phase of the CMP, including the assessment of 200 of the highest priority substances in Challenge to industry and, as required, risk management actions were initiated. The second phase of the CMP involves the continued assessment and management of the potential health and ecological risks associated with approximately 1,500 substances by 2016 through the substance groupings initiative, rapid screening, and other approaches. As of March 31, 2015, draft decisions have been published for approximately 2,700 of those 4,300 substances.

In 2014-15, Health Canada and Environment Canada continued to assess and manage the potential health and ecological risks from the remaining high priorities, which includes substances from Challenge to industry, the Petroleum Sector Stream Approach and the Substance Groupings Initiative, as well as the assessment of other substances deemed to be a priority. Screening Assessment Reports (SARs) for 71% of CMP II priorities (1,500 substances) were completed in 2014-15, and risk management measures continued to be developed, implemented, tracked and monitored. Work with other jurisdictions bilaterally and in multinational fora to undertake regional and multilateral efforts to manage chemicals of concerns also continued.

Through the Substance Groupings Initiative and rapid screening, the program is well on its way to reaching the overall goal of the second phase of the CMP of assessing and managing the potential health and ecological risks associated with approximately 1,500 substances. In 2014-15, draft risk assessments for 1,057 substances (107 azos, 50 cobalt containing substances, seven MDIs/MDAs (Methylenediphenyl Diisocyanate and Diamine), six International substances, 612 RS (Rapid Screening) III, 275 RS Polymers), and final risk assessments for 47 substances (azos) were published as part of these initiatives. The program also addressed 248 substances that were determined to already have been assessed or managed. In addition, the program published final risk assessments for 40 substances initially considered during the first phase of the CMP, including Challenge, legacy, F&DAs and petroleum, as well as draft risk assessments for 15 petroleum substances.

In 2014-15 Environment Canada and Health Canada also jointly performed the screening assessment of micro-organisms listed on the Domestic Substances List (DSL). Draft Screening Assessments for 19 microorganisms were published in the Canada Gazette, Part I for a 60-day public comment period. The final Screening Assessment for three micro-organisms was also published in the Canada Gazette, Part I. Work continues on the remaining screening assessments for several other Domestic Substances List micro-organisms of high and medium priority.

Targeted risk management (RM) activities were taken to address four Challenge substances and three legacy substances. Six final RM instruments were published for these seven substances. The instruments covering the Challenge substances are:

  • Under CEPA 1999: Code of Practice for 2-Butanone, oxime (Butanone oxime) Associated with the Interior Application of Consumer Alkyd Paint and Coating Products.
  • Under the Food and Drugs Act: Adding to Cosmetic Hotlist - (Solvent Red 23 & DEHA) Regulations Amending Schedule 2 to the Canada Consumer Product Safety Act.
  • Regulations Amending Schedule 2 to the Canada Consumer Product Safety Act (TCEP).

The instruments under CEPA 1999 covering legacy substances are:

  • Regulations Amending the PCB Regulations and Repealing the Federal Mobile PCB Treatment and Destruction Regulations.
  • Regulations Amending the 2-Butoxyethanol Regulations.
  • Products Containing Mercury Regulations.

There were also five RM Scope documents published, covering 61 substances, most of which were part of the Substance Groupings Initiative:

  • PSSA (Petroleum Sector Stream Approach) Stream 4 - Liquefied Petroleum Gases (two substances).
  • PSSA Stream 4 - Natural Gas Condensates (three substances).
  • Carbamic acid, ethyl ester - from the Internationally Classified substance grouping (one substance).
  • Cobalt-containing substances grouping (50 substances).
  • MDI/MDA substance grouping (five substances).

During the same time period, there was also one Risk Management Approach document published for a PSSA substance - Fuel Oil no. 2.

All 501 new substance notifications received in 2014-15 were assessed, including those for living organisms. Of the 501 substances, 425 were chemicals and polymers, 18 were products of biotechnology, 6 were nanomaterials, and 52 were substances regulated as F&DA products. Two Significant New Activity (SNAc) Notices and five Ministerial Conditions were issued in 2014-15, with no prohibitions. A notice of intent to apply the SNAc provisions was published for one existing living organism.

Environment Canada and Health Canada are conducting a review of all Significant New Activity (SNAc) notices and orders in force. Since publication of the first order in 2001, policies and practices have evolved, particularly with respect to the nature and scope of SNAcs, as well as the wording used to identify "significant new activities". The review is being undertaken to ensure that everything is in step with current policies, including the Policy on the Use of Significant New Activity Provisions of the CEPA 1999 (published in December 2013). SNAc Notices and Orders will be reviewed between 2014 and 2017 in groups of similar chemistry (for example, nanomaterials) or common elements (for example, notices and orders with consumer product references). As a result of the review, SNAc notices or orders may be rescinded, amended or left unchanged.

Nine nominations to the Revised "In Commerce List" (R-ICL) (substances in products regulated under the F&DA that were in Canadian commerce between January 1, 1987 and September 13, 2001), were received and seven substances were added. The list, which is available on the Health Canada website, was updated three times in 2014-15 in order to capture additions to the list and to correct errors. A total of 1,017 substances on the R-ICL have undergone prioritization.

Information gathering activities (voluntary data requests) were initiated for three groups of substances that will be addressed in the third phase of CMP, including Polymers (303 substances), Petroleum substances (70 substances) and Nanomaterials (208 substances). Voluntary data requests were launched for Polymers and Petroleum substances in February 2015, and will follow this request with the publication of CEPA section 71 Notices in the summer of 2015 to complete the data gathering needs for all three initiatives.

Information received by Health Canada and Environment Canada during the second phase of the Domestic Substances List Inventory Update (DSL IU), has been used to inform priority setting for the next phase of the CMP, help align with international initiatives applicable in a Canadian context, support subsequent risk assessment and risk management activities, where appropriate; and continue to help improve supply chain awareness, support the development of the next phase of the IU and inform the Rapid Screening and Polymer Approaches. In an effort to increase public awareness and to facilitate access to information on manufactured and/or imported substances in Canada, a non-confidential summary of information received from the second phase of the DSL IU was published in December 2014. The Government of Canada is committed to continuing to communicate results of future DSL inventory updates in order to increase transparency and public knowledge of chemicals in commerce in Canada.

The program also contributed to risk management activities related to water quality in 2014-15. These activities are described elsewhere under Section II, Sub-Program 2.3.3: Water Quality in the 2014-15 DPR, as well as under Goal 3, Target 3.2: Drinking Water Quality, in the 2014-15 Sustainable Development Supplementary Table.

Highlights for consumer products and cosmetics in 2014-15 included: completing method development and testing of CMP substances (incl. Benzene, Toluene, Ethyl-Benzene and Xylenes (BTEX), Polycyclic aromatic hydrocarbons (PAHs), flame retardants and phthalates) to support risk management actions and risk assessment activities. Consumer Product Safety risk assessors reviewed assessment documents from Petroleum Streams 1-4, legacy substances and Challenge substances. Risk assessors also completed product risk assessments, such as completing the draft risk assessment for diethyl phthalate, which will feed into the second phase of CMP Phthalate grouping, and the review of the Cosmetic Hotlist restriction for boric acid in cosmetic products.

Highlights for food and food packaging include completing analytical method development for 20 phthalates using Total Diet Study samples and initiating the development of risk management strategies for ethyl carbamate. Food risk assessors reviewed screening assessment criteria for several substances and provided statistical support for dietary intake analysis where appropriate, such as for boric acid and its precursors and selenium. In addition, Food Consumption Tables for use in dietary exposure assessments were developed using more recent Canadian food consumption data [from the Canadian Community Health Survey (Cycle 2.2)Footnote 1] than has been previously available to risk assessors.

In 2014-15, Health Canada also completed the re-evaluation of 10 active ingredients used in previously approved pesticides according to the re-evaluation work plan, focusing on only those aspects of the health and environmental risk assessments that needed to be updated. Health Canada also initiated the special review for 26 active ingredients used in pesticides in response to an Organisation for Economic Co-operation and Development (OECD) member country prohibiting all uses of a specific pesticide, or in cases where there were reasonable grounds that the health or environmental risks or value of a registered pesticide were unacceptable.

Stakeholder Engagement

The CMP Stakeholder Advisory Council met twice in 2014-15. The purpose of the council is to get stakeholder input on the implementation of the CMP, and to foster dialogue on issues pertaining to the CMP between stakeholders and government, and among different stakeholder groups. Issues may include risk assessment, risk management, risk communications, monitoring, research, indicators of success, chemical policy and other cross-cutting integrated activities. Some examples of topics that were discussed in 2014-15 include: alternative assessments; findings of the Domestic Substances List Inventory Update; update on work carried out under the Regulatory Cooperation Council and under the Strategic Approach to International Chemicals Management; and the CMP Stakeholder Engagement and Public Outreach Framework.

The CMP Science Committee held its second meeting in Ottawa on November 4-5, 2014. The Science Committee ensures a strong science foundation to CMP by providing external and scientific expertise to Health Canada and Environment Canada on scientific issues. The Terms of Reference for the committee were endorsed at the meeting and members were asked to provide input on 'Best Practices for Deriving a Sufficient Rationale for Read-across in Screening Assessment Reports under the CMP'. Members engaged in constructive discussions as they began developing the committee's scientific input for the Government of Canada. Next steps were also identified for formulating the Committee Report.

Public outreach, compliance promotion and stakeholder awareness activities were undertaken in 2014-15, focusing on targeted stakeholders, in order to facilitate information sharing. These activities included 59 cross-Canada general public outreach events, distribution of CMP communications tools such as Hazardcheck, Facebook and Twitter posts, and News Canada articles for web and print. The renewal of regional stakeholder inventories was also undertaken to enhance information gathering, compliance promotion and industry outreach.

In 2014-15, regions delivered 140 stakeholder engagement activities related to chemical effects on health and approximately 58,800 brochures were distributed. The number of interactions with stakeholders was approximately 11,900 throughout the country. Regions delivered 33 chemical awareness learning sessions, with a total of 616 participants. Feedback results found that 95% of participants reported that their understanding of the subject had improved as a result of attending the session.

In June 2014, the government hosted a multi-stakeholder workshop to discuss early thinking and next steps for the inventory update. The development of the third phase of the inventory update is underway and will be based on lessons learned and successes, as well as stakeholder feedback from the second phase. The government will continue to facilitate and expand supply chain awareness and information-sharing.

In June and October 2014, the government hosted multi-stakeholder workshops to engage and receive input from stakeholders on the planning for the next steps of the CMP. Topics discussed included remaining priorities for risk assessment and risk management in the next phase of the CMP, research and monitoring, stakeholder engagement and risk communications and early thinking and next steps for the Domestic Substances List inventory update. The development of the third phase of the inventory update is underway and will be based on lessons learned and successes, as well as stakeholder feedback from the second phase. The government will continue to facilitate and expand supply chain awareness and information-sharing.

Two issues of the CMP Progress Report were published in July and December 2014. The CMP Progress Report has been created to keep stakeholders and other interested parties up to date on the activities and programs related to the CMP. The report is produced jointly by Environment Canada and Health Canada and is published twice a year. It reports on advances in major initiatives and highlights key activities related to the Government of Canada's recent work under the CMP. It provides information about up-coming events, dates of interest and how to get involved.

Research

Research in support of CMP themes continued, in order to better understand the exposure and effects of chemicals and to contribute to the development of better methods for chemical hazard and exposure assessment. Research also focused on the development of novel methods to investigate toxicity and mechanisms of action of chemicals in order to support the use of new scientific approaches as lines of evidence in risk assessments. Additional CMP research was also directed towards providing information on some of the remaining information gaps.

Following the identification of new research priorities and completion of three-year research projects in 2013-14, Health Canada launched a competitive internal process to allocate research funds to new CMP research projects, initiated in 2014-15, for the final two years of the second phase of the CMP program. Research priorities were shared between Environment Canada and Health Canada to support research program synergies. The resulting 23 new research projects addressed priorities, identified under the following themes: a) Effects, b) Exposure, and c) Methods and Tools Development, in order to better understand the exposure and effects of chemicals and to contribute to the development of better methods for chemical hazard and exposure assessment. Research was initiated on the exposure and toxicity of CMP priority chemicals such as potential reproductive and endocrine-disrupting compounds, metals, flame retardants and nanomaterials. Health Canada nanomaterial research (five projects) addressed knowledge gaps on the chemical properties, health effects and methods for exposure assessment for manufactured nanomaterials.

Some examples of Health Canada research areas include: exposure to inorganic and organic chemicals of emerging concern in utero and in children under three years of age, development of concepts and tools to evaluate the ability of environmental toxicants to induce heritable genetic effects, computational toxicology modelling, nationally representative levels of exposure to metals and chemicals through phase 2 of the Canadian House Dust Study, health effects of complex mixtures, and the development of methods to interpret the results of genetic toxicity assessments employed to screen new and existing substances.

Environment Canada initiated sixteen chemicals research projects addressing data gaps on priority substances including: flame retardants, benzotriazoles and benzothiazoles, antioxidants, phthalates, platinum group elements, lanthanides and organometalics. Environment Canada also continued five nanomaterials research projects to address chemical-physical properties characterization and toxicity data gaps for manufactured nanomaterials. Environment Canada scientists published approximately 31 research papers related to these projects in 2014-15.

Data analysis is also ongoing for the Maternal-Infant Research on Environmental Chemicals (MIREC) cohort study. Seven additional research journal articles were published, including results for bisphenol A, phthalates, triclosan, perfluorinated chemicals, and phenols exposure in pregnant women. In addition to focusing on the analysis and dissemination of the results of the MIREC study, work is also underway on the extension of the cohort for early childhood biomonitoring (age three) and an examination of neurodevelopment at the same age.

Monitoring and Surveillance

Health Canada and Environment Canada continued to conduct monitoring programs to address existing and emerging chemicals of concern, and to inform risk assessment needs and risk management activities. At Health Canada, in total, 13 two-year monitoring and surveillance studies were initiated under the themes of targeted population, biomonitoring supportive research, and targeted environmental monitoring. Health Canada is on track to release The Third Report on Human Biomonitoring of Environmental Chemicals: Results of the Canadian Health Measures Survey (CHMS) Cycle 3 (2012-13) in July 2015. This report presents national biomonitoring data on the Canadian population's exposure to chemicals. The fourth cycle (2014-15) of the CHMS began sample collection in January 2014 and its sample size, number of sites, and the chemicals measured mirror those of Cycle 3. In addition, planning continued for Cycles 5 and 6 of the CHMS (including laboratory method development). Other monitoring activities included measurement of chemicals in household dust, volatile organic compounds in drinking water and a selection of chemicals in indoor air. Health Canada also supported eight biomonitoring, health effects and risk communications projects related to heavy metals (e.g., mercury) and persistent organic pollutants (e.g., PCBs) in the Canadian Arctic. Health Canada also completed 9 research projects and 14 monitoring and surveillance projects on CMP substances with food implications in 2014-15, including on phthalates and organic flame retardants.

Environment Canada also continued to conduct a broad range of chemical monitoring activities in ambient air, surface water, sediments, fish, bird eggs and municipal wastewater, in support of the CMP. In total, Environment Canada undertook integrated environmental monitoring and surveillance of approximately 130 priority chemicals in various environmental media to detect and characterize environmental change. Some of the priority substances monitored include: polybrominated diphenyl ethers (PBDEs), other flame retardants, perfluorinated compounds (including PFOS and PFCAs), siloxanes, triclosan, bisphenol A (BPA), nonylphenol and ethoxilates (NP/NPEs), phthalates, short chain chlorinated paraffins, and metals.

Compliance and Enforcement

Environment Canada continued to develop compliance strategies, compliance promotion plans and deliver related activities, to promote regulatees' awareness and understanding of, and compliance with, regulatory requirements for CMP substances. Focusing on small- to medium-sized enterprises, compliance promotion activities reached around 9,325 regulatees regarding six priority regulations, as determined by the compliance priority setting process. The six regulations were:

  • Chromium Electroplating, Chromium Anodizing and Reverse Etching Regulations.
  • PCB Regulations.
  • Perfluorooctance Sulfonate and its Salts and Certain Other Compounds Regulations.
  • Prohibition of Certain Toxic Substances Regulations.
  • Solvent Degreasing Regulations.
  • Tetrachloroethylene (PERC) Regulations (Use in Dry Cleaning and Reporting Requirements).

In order to increase compliance with the dry cleaning regulations, all PERC dry cleaners across Canada were contacted and provided promotional materials (fact sheets and a video) in their preferred language (English, French, Chinese, Korean, Punjabi, or Persian) and by their preferred delivery method (email, letter, or fax). This campaign resulted in 100% of PERC dry cleaners in Canada being aware of the Regulations. Communication with regulatees prompted additional questions and dialogue, which supported a greater understanding of the Regulations' requirements.

Enforcement completed 27 investigations and 3,254 inspections related to the CMP regulations. As planned, Enforcement focused its efforts on the Tetrachloroethylene (PERC) Regulations (Use in Dry Cleaning and Reporting Requirements), by completing 869 inspections and 14 investigations in order to continue the efforts to increase the compliance rate amongst dry cleaners. The targeting of high risk sites and storage tanks was also accomplished as planned, by completing a total of 527 inspections and 7 investigations under the Storage Tanks Systems for Petroleum Products and Allied Petroleum Products Regulations (STSR); a total of 933 inspections and three investigations under the Polychlorinated biphenyls (PCB) Regulations; and, a total of 400 inspections and one investigation under the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations. All the enforcement activities related to the CMP regulations resulted in a detection of 2,803 violations leading to 2,027 written warnings and 665 environmental protection compliance orders.Footnote 2

Cyclical Enforcement (CE) CMP-related projects were put in place to determine compliance levels for Toys and Children's Jewellery. For the products tested, there was 100% compliance to the Toys Regulations and Consumer Products Containing Lead (Contact with Mouth) Regulations. There was 95% compliance to the Children's Jewellery Regulations. A recall for the non-compliant children's jewellery product was not required, as it was determined that it had not been distributed to consumers.

AR 2.1 - Actual Results: Public Health Agency of Canada

The Public Health Agency of Canada continued to work with passenger conveyance industry stakeholders, including airlines, railways, cruise ships, ferries, buses, and ancillary services such as flight kitchens and terminals, in order to identify and address potential risks to travellers. Activities were targeted using a public health risk assessment tool, and the Public Health Agency of Canada completed 459 public health inspections, 25 outbreak investigations, 90 outreach and awareness activities, and took 1,222 water samples. When public health risks were identified, PHAC worked with operators to mitigate them. For example, conveyance and facility operators successfully resolved 92% of critical public health violations that were identified, above the target of 90%. The Agency continues to work with operators to address public health risks and to achieve compliance under a voluntary program.

Comments on variances
Health Canada
The variance is mainly due to higher than anticipated spending related to the costs incurred to carry out the additional unforeseen work, additional program requirements, and a required electrical upgrade not originally included in the initial cost estimate and scope of the Banting Lab Retrofit project. An internal reallocation from existing reference level was made to support the required activities.
Public Health Agency of Canada
The variance is mainly due to the delays in staffing actions.
Environment Canada
The variance is mainly due to funds that have been allocated to other priorities within the department.
Results achieved by non-federal partners (if applicable)

N/A

Federal Strategy on Early Childhood Development for First Nations and Other Aboriginal Children

General Information

Name of lead department

Health Canada

Federal partner organization(s)
  • Employment and Social Development Canada (ESDC)
  • Public Health Agency of Canada (PHAC)
  • Aboriginal Affairs and Northern Development Canada (AANDC)
Non-federal and non-governmental partner(s)

N/A

Start date of the horizontal initiative

October 2002

End date of the horizontal initiative

Ongoing

The Federal Strategy on Early Childhood Development (ECD) for First Nations and Other Aboriginal Children will no longer be reported as a horizontal initiative. This initiative has been reported as such since the launch of the Strategy in 2002. At this stage, the ECD is a part of the on-going program funding base of Health Canada, ESDC, and PHAC. As such, it will be reported on as part of the Analysis by Program in Section 2 of the Reports on Plans and Priorities and Departmental Performance Reports of each department. Past horizontal reports on this initiative can be found in the Horizontal Initiatives database.

Total federal funding allocated (start to end date) (dollars)
  • ECD: $817,908,369 for the first 13 years; and ongoing $52,602,748.
  • Early Learning and Child Care (ELCC): $142,047,000 for the first 10 years; and ongoing $13,046,774.
Description of the horizontal initiative

The goal of the Federal Strategy on ECD for First Nations and Other Aboriginal Children, announced in October 2002, was to address the gap in life chances between Aboriginal and non-Aboriginal children. The shared initiative between Health Canada, ESDC, AANDC and PHAC received $320 million over the first five years and continues to receive $52.6 million annually as ongoing funds. AANDC's portion of the funding ended on March 31, 2013.

In December 2004, Cabinet approved an additional $45 million over three years (beginning fiscal year 2005-06) and Health Canada and ESDC continue to receive $13 million annually as ongoing funds for the ELCC component to improve integration and coordination of two ECD programs: Aboriginal Head Start On Reserve (AHSOR-Health Canada) and the First Nations and Inuit Child Care Initiative (FNICCI-ESDC).

Shared outcome(s)

The ECD component complements the September 2000 First Ministers Federal/Provincial/Territorial ECD Agreement. It seeks to address the gap in life chances between Aboriginal and non-Aboriginal children by improving the developmental opportunities to which Aboriginal children (and their families) are exposed at an early age (0-6 years).

The ELCC component complements funding released to provinces and territories under the March 2003 Multilateral Framework for Early Learning and Childcare to improve access to ELCC programs and services.

Governance structures

Each federal department is responsible for their specific program activities.

Performance highlights

In collaboration with partners and stakeholders, federal departments will continue to build on evidence to inform programming, and enhance linkages between programs and services to better support Aboriginal children and families.

Contact information

Halina Cyr, MHSc, RD
Director, Population Health and Wellness Division
First Nations and Inuit Health Branch, Health Canada
200 Eglantine Driveway
Address Locator: 1920A
Ottawa, ON, K1A 0K9
Tel: 613-948-6412
E-mail: halina.cyr@hc-sc.gc.ca

Performance Information

Federal organizations Link to department's Program Alignment Architecture Contributing programs and activities Total allocation (from start to end date)
(dollars)
2014-15 Planned spending
(dollars)
2014-15 Actual spending
(dollars)
2014-15 Expected Results 2014-15 Actual results achieved against targets
Health Canada First Nations and Inuit Primary Health Care a) AHSOR 277,226,092Table 2 - Footnote 1 from 2002-03 to 2014-15 18,997,000 14,975,067 ER 1 AR 1
ELCC
75,547,000Table 2 - Footnote 1 from 2005-06 to 2014-15
6,547,000 5,336,685
b) Fetal Alcohol Spectrum Disorder - First Nations and Inuit Component 188,166,000Table 2 - Footnote 1 from 2002-03 to 2014-15 13,166,000 9,332,763 ER 2 AR 2
c) Capacity Building 11,166,661Table 2 - Footnote 1 from 2002-03 to 2012-13 0 0 N/A N/A
ESDC Skills and Employment d) FFICC 118,820,520 from 2002-03 to 2014-15 9,140,040 9,127,680 ER 3 AR 3
ELCC
66,500,000 from 2005-06 to 2014-15
6,500,000 6,500,000
Social Development e) Research and Knowledge 43,610,000Table 2 - Footnote 1 from 2002-03 to 2014-15 400,000 400,000 ER 4 AR 4
AANDC The People - Social Development f) Capacity Building 11,110,000 from 2002-03 to 2012-13 0 0 N/A N/A
PHAC Health Promotion and Disease Prevention g) Aboriginal Head Start in Urban and Northern Communities 161,609,096Table 2 - Footnote 1 from 2002-03 to 2014-15 10,700,000 10,556,979 ER 5 AR 5
h) Capacity Building 6,200,000 from 2002-03 to 2014-15 200,000 162,465 ER 6 AR 6
Sub-Total for All Federal Partners ECD
817,908,369 from 2002-03 to 2014-15
52,603,040 44,554,954
ELCC
142,047,000 from 2005-06 to 2014-15
13,047,000 11,836,685
Total for All Federal Partners 65,650,040 56,391,639 N/A
Table 2 - Footnote 1

Total allocation (from start to end date) differs from the RPP 2014-15 to reflect funds transferred to support the British Columbia Tripartite initiative and the government-wide reductions.

Return to footnote 1 referrer

2014-15 Expected results (ER) and Actual results (AR) against targets:

Aboriginal Head Start on Reserve (AHSOR)

ER 1: First Nations and Inuit have access to healthy child development programs and services.

AR 1

  • Target: 9,000 First Nations children on-reserve access AHSOR.
  • Result Achieved: 13,981 children accessed early literacy and learning through the AHSOR program, representing an increase of nearly 5,000 children since 2009.
Fetal Alcohol Spectrum Disorder (FASD) - First Nations and Inuit Component

ER 2: Maintaining the number of First Nations and Inuit communities served by FASD Programming.

AR 2

  • Target: 36Footnote * mentoring sites, 17 community coordinators, and program supports in over 400 First Nations communities.
  • Results Achieved: 29 mentoring sites and 17 community coordinators, reached over 1,000 First Nations and Inuit women.

Variance explanation: The variance between planned and actual spending is mainly due to a reallocation of funding between First Nations and Inuit Health programs to address needs and priorities.

First Nations and Inuit Child Care Initiative (FNICCI)

ER 3: The FNICCI supports First Nations and Inuit communities in developing and implementing child care programs designed to address their local and regional needs. The main objective of the initiative is to increase the supply of quality child care services in First Nations and Inuit communities, with a secondary objective being to support parents or child care providers who are working or participating in job training programs. FNICCI is a labor market support program that is currently administered under the Aboriginal Skills and Employment Training Strategy (ASETS).

AR 3

  • Target: 8,500 child care spaces available at First Nations and Inuit sites in over 450 sites in First Nations and Inuit communities.
  • Results Achieved: At 423 child care centers, 13,662 child care spaces were available (# of spaces is based on the current Standard Data File results).

Variance Explanation: The variance between planned and actual spending is mainly due to project expenditures being lower than previous planned as a result of an amendment to a project.

Research and Knowledge

ER 4: Providing information on early learning and child care from the First Nation Regional Education and Employment Survey (FNREES).

AR 4

  • Target: Aboriginal children living on-reserve.
  • Results Achieved: FNREES completed the data collection.
Aboriginal Head Start in Urban and Northern Communities (AHSUNC)

ER 5: Aboriginal children and families living off reserve have access to quality healthy child development programs and services.

AR 5

  • Target: 4,500 off reserve children enrolled in the AHSUNC program.
  • Results Achieved: The Agency continued to reach more than 4,500 Aboriginal children; a total of 4,832 children were enrolled in the AHSUNC program in 2014-15. The majority (80%) of those children are between three and five years of age. Children with diagnosed or suspected special needs represent 19% of all children enrolled in the AHSUNC program. Most sites are able to refer these children to health professionals (74%) and/or assist families in accessing other services (66%) while AHSUNC Early Childhood Educators provide early learning supports through program activities.
Capacity Building

ER 6: Organizations from various sectors collaborate with AHSUNC projects to support the needs of AHSUNC participants.

AR 6

  • Target: 70% of AHSUNC sites leverage multi-sectorial collaborations.
  • Results Achieved: A total of 84% of the AHSUNC projects leveraged multisectoral collaborations with a broad range of local stakeholders such as health organizations, other Aboriginal organizations, educational institutions, other local early childhood or family services, etc. Together, these multisectoral collaborations enhance the local capacity to better meet the needs of Aboriginal children and their families.

Additionally, the Steering Committee on Aboriginal Maternal and Child Health has expanded beyond Health Canada and PHAC (Agency) to include AANDC and ESDC to enhance horizontal collaboration and provide a forum for shared policy development, planning and knowledge development and exchange. The Agency continues to work with stakeholders and provincial/territorial governments to enhance coordination on Aboriginal early childhood education. AHSUNC sites continue to be very successful in collaborating with a broad range of partners in their community.

Variance explanation: Program results were achieved with fewer resources as a result of continuing and on-going efficiencies created through historical government-wide reductions to departmental operating budgets.

Federal Tobacco Control Strategy

General Information

Name of lead department

Health Canada

Federal partner organizations
  • Canada Border Services Agency (CBSA)
  • Canada Revenue Agency (CRA)
  • Public Health Agency of Canada (PHAC)
  • Public Safety Canada (PSC)
  • Royal Canadian Mounted Police (RCMP)
Non-federal and non-governmental partner(s)

N/A

Start date of the horizontal initiative

April 2012

End date of the horizontal initiative

March 31, 2017

Total federal funding allocated (start to end date) (dollars)

$225,331,254

Description of the horizontal initiative

The Federal Tobacco Control Strategy (FTCS) was initiated in 2001. In 2012, the Strategy was renewed for five years to provide a focused federal presence to preserve the gains of the past decade and continue the downward trend in smoking prevalence. The renewed strategy focuses on the core areas of federal responsibility and invests in new priorities including populations with higher smoking rates.

Shared outcome(s)

To preserve the gains made over the past decade, and to continue the downward trend in smoking prevalence.

Governance structure(s)

Health Canada remains the lead department with responsibility for the coordination and implementation of the FTCS. As part of the Health Portfolio, the PHAC will deliver a contribution program that will fund tobacco-related interventions that aim to reduce tobacco use as a chronic disease risk factor.

Federal partners manage the control of tobacco products through monitoring and assessing the illicit and licit tobacco markets.

  • Public Safety Canada (PSC) - monitors contraband tobacco activity and related crime.
  • Royal Canadian Mounted Police (RCMP) - works with federal partners to identify and investigate criminal activities and to coordinate information on national and international contraband tobacco issues.
  • Canada Border Services Agency (CBSA) - increases knowledge of contraband domestically and internationally by liaising with tobacco authorities at all levels and by monitoring and providing regular reports on both national and global contraband tobacco. The CBSA provides reports, information and guidance to the Department of Finance Canada on matters that will impact the future tax structure of tobacco.
  • Canada Revenue Agency (CRA) - administers the Excise Act 2001, which governs federal taxation of tobacco products and regulates activities involving the manufacture, possession and sale of tobacco products in Canada.
  • Public Prosecutions Service Canada - monitors federal fines imposed in relation to tobacco and other types of offences in order to enforce and recover outstanding fines. FTCS funding for the Office of the Director of Public Prosecutions ended 2012-13.
Performance highlights

Few other countries have been as successful as Canada in lowering smoking rates and shifting public attitudes about tobacco. Smoking prevalence is now at its lowest-ever overall rate. As of 2013, 15% of Canadians were current smokers, down from 22% in 2001 and the lowest national smoking rate ever recorded. Further, 6% of teens aged 15-17 are current smokers.

Working in its core area of responsibility, and building on past activities, the federal government has refocused the 2012-17 Strategy to concentrate on two groups with higher rates of smoking than most Canadians - on-reserve First Nations and Inuit people and young adults (aged 20-24) - as well as tobacco as a risk factor for serious disease.

Results achieved by non-federal partners

N/A

Contact information

Suzy McDonald
Associate - Director General
Controlled Substances & Tobacco Directorate Health Canada
Tel: (613) 941-3202

Performance Information

Federal organizations Link to department's Program Alignment Architecture Contributing programs and activities Total allocation (from start to end date)
(dollars)
2014-15 Planned spending
(dollars)
2014-15 Actual spending
(dollars)
2014-15 Expected results 2014-15 Actual results achieved against targets
Health Canada Substance Use and Abuse FTCS 180,899,699 35,189,041 31,096,367 Link 17.1 Link 18.1
Public Health Agency of Canada Health Promotion and Disease Prevention FTCS 10,884,958 2,414,958 1,412,856 Link 17.1 Link 18.1
Public Safety Canada Countering Crime FTCS 3,050,000 610,000 605,360 Link 17.2 Link 18.2
Royal Canadian Mounted Police Police Operations (Tech Ops) Criminal Intelligence FTCS 8,859,820 1,700,000 1,723,480 Link 17.3 Link 18.3
Canada Border Services Agency Criminal Investigations FTCS 15,192,277 3,677,265 3,677,265 Link 17.4 Link 18.4
Canada Revenue Agency Taxpayer and Business Assistance FTCS 4,444,500 888,900 913,058 Link 17.5 Link 18.5
Public Prosecutions Service Canada Regulatory offences and economic crime prosecution program FTCS 2,000,000 Nil Nil
Total 225,331,254 44,480,164 39,428,386
Health Portfolio figures include EBP and PWGSC accommodation costs. The five year window in this Departmental Performance Report (DPR) is different from that of the 2014-15 Report on Plans and Priorities (RPP) due to the refocused FTCS.

Expected Results

Link 17.1
  • Regulations and Compliance - Conducting compliance monitoring activities and undertake enforcement measures with respect to the Tobacco Act and its regulations.
  • Research - Conducting research and surveillance to support decision making and the development of anti-tobacco policies and programs.
  • Policy - Leading the development of policies supporting the FTCS and facilitating stakeholder engagement. This includes coordinating and supporting policies associated with Canada's membership in the World Health Organization Framework Convention on Tobacco Control (WHO FCTC), as well as collaborating with provinces and territories in tobacco control activities.
  • Litigation - Providing base funding for tobacco litigation and for the defense of the Tobacco Act and its regulations.
  • Community interventions - Funding will be used to leverage existing networks and seek innovative partnerships that contribute to an integrated approach to chronic disease prevention; to support interventions and programming that aim to reduce tobacco use, particularly among young adults, First Nations on-reserve and Inuit in recognized Inuit communities; and to work with partners from the public and private sectors to promote healthy living and prevent chronic diseases caused by risk factors such as tobacco use.
Link 17.2
  • Enhanced partnership arrangement with Akwesasne Mohawk Police through the administration of contribution funding for monitoring activities in connection with determining levels of contraband activity.
  • Provision of policy leadership and development of strategies to support law enforcements efforts to combat organized crime in the trade of contraband tobacco.
Link 17.3
  • RCMP Police Operations (Tech Ops): Improved border security through the use of sophisticated technology which permits detection and monitoring of illegal border intrusions, resulting in intelligence that supports criminal investigations. Investigators use this technology in the fight against organized crime networks that move illicit tobacco products across shared borders.
  • RCMP Criminal Intelligence: Regular reports on the illicit tobacco situation provided to the Department of Finance Canada and Health Canada, including data on seizures, organized crime involvement and trends. Reports and presentations provided to other partners and key Ministerial entities upon request, such as the Senior Revenue Officials Conference and the Interprovincial Investigations Conference. Participation in information sharing sessions with American Law Enforcement partners. Delivery of presentations at law enforcement courses/workshops in Canada and the United States of America on the subject of contraband tobacco.
Link 17.4
  • Provide advice to Department of Finance on matters that will impact the future tax structure on tobacco.
  • Monitor and report on the contraband tobacco situation in Canada.
  • Expand cooperation with international and national law enforcement partners.
  • Collection of the tobacco duties imposed on personal importations of returning Canadians.
Link 17.5
  • Verification of export activity.
  • Ensuring compliance with legislative requirements imposed on the manufacture, possession and sale of tobacco products in Canada.
  • Working with stakeholders to monitor and assess the effectiveness of measures used to reduce contraband tobacco.
  • Supporting RCMP/CBSA enforcement activities.
  • Maintaining accounts and providing services related to transactions (including refunds) and producing reports of tobacco-related activities.

Results Achieved

Link 18.1

The FTCS continued to support domestic and international tobacco policy development; research and surveillance; public education; stakeholder engagement and regulation of the manufacture, sale, labelling and promotion of tobacco products by administration of the Tobacco Act. In 2014-15 select activities included:

Health Canada reports that the manufacturing sector was 100% compliant regarding minimum packaging requirements, the presence of prohibited additives, and the promotion of prohibited additives. Compliance with tobacco product labelling requirements was 91%.

Health Canada continues to support interventions and programming that aim to reduce tobacco use, particularly among young adults.

Marketing activities and results for 2014-15 included:

  • 60 experiential engagement events were implemented from August 2014 to January 2015.
  • Over 75,000 young adults were engaged on the topic of tobacco cessation.
  • Over 3,000 young adults participated in a collective video.
  • 764 post-event surveys were completed (out of 4,151 requested).
    • 73% of survey respondents reported that information received at events motivated them to consider quitting smoking.
  • Over 38,000 web visits to the Breakitoff.ca/jetelaisse.ca site.
  • Over 2,000 downloads of the Break It Off and Je te laisse mobile applications.
  • A Facebook events page was developed to provide information on the events and the web site; a total of 53 posts garnered a reach of over 2,000 people.

Over 16 million impressions were achieved through community newspaper/web articles, a radio broadcast segment and online videos about smoking cessation and the Break It Off campaign, a digital campaign to promote tobacco cessation in partnership with the Canadian Cancer Society. Impressions refer to how often the article/video/radio segment was shown or heard and the possible number of people that were reached.

The First Nations and Inuit component of the FTCS is supporting First Nations and Inuit communities and organizations to undertake comprehensive tobacco control strategies aimed at reducing and preventing tobacco misuse. In 2014-15, resources were transferred to the British Columbia First Nations Health Authority, and the governments of Nunavut and the North West Territories to enhance tobacco control strategies for First Nations and Inuit within these jurisdictions. A call for proposals was also launched in June 2014, which funded 16 comprehensive projects aimed at reducing smoking rates in First Nations and Inuit communities in Alberta, Saskatchewan, Manitoba, Ontario, Quebec and Atlantic regions.

The PHAC has successfully put in place three projects that will build professional competencies amongst health professionals to enable better, more consistent and integrated cessation resources into community and healthcare settings. A new project this year - MANTRA - complemented the work of the Canadian Partnership Against Cancer to better integrate tobacco cessation into cancer care settings. The Agency also negotiated two cessation projects with public and private sector partners, including Run to Quit, a program to help smokers quit by incorporating running into their daily lives. These projects, which will begin in 2015-16, address cessation directly, and in conjunction with other risk factors for chronic disease prevention, will significantly increase the resources being allocated to tobacco cessation in Canada.

The Health Portfolio strengthened its tobacco control efforts and advanced policy positions consistent with Canada's tobacco control agenda through membership in the WHO FCTC.

As Party to the Convention, Canada's contribution to the WHO FCTC helped advance the implementation of an international program of work. In 2014-15, this included the adoption of guidelines for the implementation of Article 6 of the FCTC (Price and tax measures to reduce the demand for tobacco) and guidance on smokeless tobacco products. In addition, as a key facilitator to the Articles 9 and 10 (Regulation of tobacco products) Working Group, Canada contributed to the advancement of this work.

Canada also participated in bilateral meetings with like-minded countries to exchange information on lessons learned and current challenges, including working with tobacco control partners in the Americas region.

Link 18.2

PSC managed the Akwesasne Partnership Initiative (API) contribution agreement to support Akwesasne Mohawk Police Service in combating organized crime in and around Akwesasne Mohawk Territory.

In addition, PSC continued to lead the development of domestic and international policy initiatives, to further address the contraband tobacco market, along with negotiations with First Nations Band Councils to build on existing law enforcement partnerships to address organized crime activities, as well as contraband tobacco.

Link 18.3

The RMCP Technical Operations Unit collaborated with domestic and international partners to enhance border security through the testing, development and the use of sophisticated technologies to detect illegal border intrusions. The RCMP Federal Coordination Centre provided regular reports and presentations on the illicit tobacco situation to its various partners. In 2014, 50 additional RCMP personnel dedicated to contraband tobacco enforcement were reallocated from within Federal Policing - these resources were fully deployed to areas with the highest contraband tobacco activity.

While there was a steady decline in contraband tobacco seizures from 2009-13, the RCMP was involved in 223 seizures in 2014, representing a 10% increase over 2013. Specifically, the RCMP interdicted and seized approximately 94,000 cartons or unmarked bags of cigarettes and seized 55,400 kilograms of fine-cut tobacco.

Bill C-10 (Combatting Contraband Tobacco Act) received Royal assent.

Link 18.4

The CBSA provided status updates on the contraband tobacco market, as well as seizure statistics, at the Department of Finance chaired Tobacco Enforcement meetings. An annual assessment was produced of Canada's contraband tobacco market detailing characteristics and trends encountered by CBSA that year. The Agency continued to collaborate with other Agencies, namely the RCMP and the Akwesasne Mohawk Police, which resulted in an increase in referrals for examination for both commercial and domestic travellers. Indicators were identified and modus operandi not previously known, in addition, emerging trends and threats were identified and shared with CBSA Regional Offices, and with domestic and international partners, including the World Customs Organization. CBSA continued to collect duties and taxes at Ports of Entry on all personal importations of tobacco.

Link 18.5

The CRA processed returns and refunds to ensure correctness and maintained systems and reporting capabilities to meet program requirements. In addition, audits and regulatory reviews were performed to ensure compliance with legislative requirements imposed on the manufacture, possession and sale of tobacco products in Canada.

The Agency provided information about specific tobacco transactions, as well as expert testimony and affidavits, as required to support RCMP/CBSA enforcement activity and participated in a number of committees dealing with the monitoring and control of tobacco products including those dealing with interprovincial issues.

Notes

Comments on variances:

Health Canada

The variance between planned and actual spending is mainly due to lower than anticipated provincial and territorial funding requirements for the pan-Canadian Quitline. The First Nations and Inuit component of the FTCS is a proposal based initiative, geared toward selecting high capacity community projects. In 2014-15, funding was spent on launching and implementing a number of initiatives with different start dates throughout the year. As a result, funds for some initiatives that began later in the year were not fully dispersed in 2014-15.

PHAC

Given the complex nature of the projects and partnerships funded under the Agency's Multi-sectoral Partnership approach, not all funds were expended in 2014-15 due to the required timelines to negotiate projects with matched funds and pay for performance milestones. The figure from PHAC Office of International Affairs reflects a payment of 216,000 dollars for Canada's membership in the WHO FCTC under the International Health Grants Program.

RCMP

As Noted in Chapter 5 of the June 2011 Status Report of the Auditor General of Canada, the RCMP has had to reallocate funding internally from all programs in order to meet the increased demands for National Policing Services. Furthermore, various Federal and Protective policing priorities have created additional requirements resulting in the reallocation of funding and resources.

Food and Consumer Safety Action Plan

Name of lead department(s)

The lead is shared between Health Canada, the Canadian Food Inspection Agency (CFIA), the Public Health Agency of Canada (PHAC), and the Canadian Institutes of Health Research (CIHR).

Start date of the horizontal initiative

2008-09

End date of the horizontal initiative

Ongoing started in 2013-14

In January 2015, Treasury Board Secretariat (TBS) approved that this initiative is no longer required to be separately reported under the Reports on Plans and Priorities (RPPs) and the Departmental Performance Reports (DPRs) Supplementary Information Tables. Instead, it will be included as part of the Section II: Analysis of program(s) by Strategic Outcome(s) in the RPPs and DPRs where applicable to individual organizations. The historical reports related to this initiative can be found on the TBS website.

Total federal funding allocation (start to end date)

$488.5M for 2008-09 to 2012-13 and $125.0M ongoing

Description of the horizontal initiative

The federal government is responsible for promoting the health and safety of Canadians. A key part of this role is to assess that the food, health and consumer products used by Canadians are safe. Adverse consequences associated with unsafe products impact not only the Canadian public, but also the Canadian economy. The Food and Consumer Safety Action Plan (FCSAP) is a horizontal initiative aimed at modernizing and strengthening Canada's safety system for food, health and consumer products. A number of high-profile incidents, such as lead and ingestible magnets in children's toys, food borne illness outbreaks, and the global withdrawal of some prescription medicines, have underscored the need for government action.

The FCSAP includes efforts to modernize Canada's regulatory system to enable it to better protect Canadians from unsafe food, health and consumer products in the face of current realities and future pressures. The FCSAP bolsters Canada's regulatory system by committing to amending or replacing outdated health and safety legislation with new legislative and regulatory regimes that respond to modern realities, and by enhancing safety programs in areas where modern legislative tools already exist. The FCSAP helps to ensure that Canadians have the information they need to assess the risks and benefits associated with the consumer and health products they choose to use, and to minimize risks associated with food safety.

The FCSAP is an integrated, risk-based plan and includes a series of initiatives that are premised on three key areas of action: active prevention, targeted oversight and rapid response. We focus on active prevention to avoid as many incidents as possible and work closely with industry to promote awareness, provide regulatory guidance, and help identify safety concerns at an early stage. Targeted oversight provides for early detection of safety problems and further safety verification at the appropriate stage in a product's life cycle. To improve rapid response capabilities and ensure the government has the ability to act quickly and effectively when needed, we work to enhance health and safety risk assessments, strengthen recall capacity, and increase the efficiency in responding and communicating clearly with consumers and stakeholders.

Shared outcomes

  • Increased knowledge of food risks and product safety (scientific and surveillance/monitoring).
  • Increased industry awareness and understanding of regulatory requirements.
  • Increased industry compliance with safety standards.
  • Increased consumer awareness and understanding of safety risks associated with health and consumer products and food.
  • Strengthened oversight and response to safety incidents.
  • Increased consumer confidence in health and consumer products and food.
  • Increased trade-partner confidence in Canadian controls, which meet international standards.
  • Increased availability of safe and effective products.
  • Level playing field where imports can be demonstrated to meet Canadian requirements.

Governance Structure

The Minister of Health has responsibility and accountability for results, and for providing information on progress achieved by the FCSAP.

Health Canada's Health Products and Food Branch (HPFB) has primary responsibility for implementing FCSAP activities related to health products along with the Regions and Programs Bureau (RAPB) with support from Health Canada's Strategic Policy Branch (SPB) and CIHR on one initiative (increased knowledge of post-market drug safety and effectiveness).

Health Canada's Healthy Environments and Consumer Safety Branch (HECSB) and the Pest Management Regulatory Agency (PMRA), along with RAPB and PHAC, work together to implement FCSAP activities related to consumer products.

CFIA, HPFB and the PHAC work together to implement FCSAP activities related to food.

Health Canada's Communications and Public Affairs Branch (CPAB) provides communications support for all of the above activities and coordinates or leads many of the horizontal Departmental activities.

Performance Highlights

The FCSAP reflects the need to modernize and sharpen the focus of Government action to protect Canadians and responds to the economic realities and new technologies of the 21st century, such as globalization and the introduction of more complex products. The FCSAP is an integrated, risk-based plan with the streams of initiatives (premised on the three key areas of action: active prevention, targeted oversight and rapid response) aligned to meet these needs.

Contact Information

Deryck Trehearne
Director General, Resource Management and Operations Directorate
Health Products and Food Branch
Health Canada
250 Lanark Ave., Ottawa ON K1A 0K9
7th Floor, Graham Spry Building
Address Locator: 2007D
Telephone number: 613-957-6690
E-mail address: deryck.trehearne@hc-sc.gc.ca

Performance Information

Federal Organization Link to department's Program Alignment Architecture Contributing programs and activities Total allocation 2008-09 to 2012-13 (dollars) 2014-15
Planned spending (dollars)
2014-15
Actual spending (dollars)
2014-15
Expected results
2014-15
results achieved against targets
Health Canada Health Products Active Prevention 17.1 56,800,000 9,959,078 9,024,663 17.1a 17.1b
Targeted Oversight
17.2
34,456,257 10,186,807 7,030,631 17.2 a 17.2 b
Rapid Response
17.3
Existing Resources Existing Resources
Consumer Product and Workplace Chemical Safety Active Prevention
18.1
41,020,000 13,660,000 7,698,050 18.1 a 18.1 b
Targeted Oversight
18.2
15, 700,000 4,900,000 8,102,235 18.2 a 18.2 b
Rapid Response
18.3
17, 900,000 4,400,000 7,277,514 18.3 a 18.3 b
Pesticides Active Prevention
19.1
6,880,000 1, 640,000 1,640,000 19.1 a 19.1 b
Rapid Response
19.2
8,000,000 2,100,000 2,100,000 19.2 a 19.2 b
Food Safety and Nutrition Active Prevention
20.1
29,600,000 7,510,328 7,318,229 20.1 a 20.1 b
Rapid Response
20.2
1,300,000 389,672 473,756 20.2 a 20.2 b
Canadian Food Inspection Agency Food Safety Program and Internal Services Active Prevention
21.1
114,200,000 27,400,000 25,200,000 21.1 a 21.1 b
Targeted Oversight
21.2
77,000,000 18,800,000 14,200,000 21.2 a 21.2 b
Rapid Response
21.3
32,200,000 8,700,000 8,200,000 21.3 a 21.3 b
Public Health Agency of Canada Health Promotion and Disease Prevention Active Prevention
22.1
1,000,000 1,637,647 831,001 22.1 a 22.1 b
Targeted Oversight
22.2
8,000,000 2,305,340 1,397,521 22.2 a 22.2 b
Public Health Infrastructure Active Prevention
22.1
17,316,020 2,280,444 2,833,802 22.1 a 22.1 b
Canadian Institutes of Health Research Health and Health Services Advances Targeted Oversight
23.1
27,143,743 9,013,657 9,933,230 23.1 a 23.1 b
Total for all federal organizations 488,516,020 124,882,974 113,260,631

Variance explanations:

Health Canada
  • Health Products
    The variance is mainly due to projects being postponed and staffing processes being delayed.
  • Consumer Products and Workplace Chemical Safety
    The deficits are offset by reallocations from the Active Prevention program.
  • Food Safety and Nutrition
    The variance is mainly due to the delays in staffing.
CFIA
  • Food Safety Program and Internal Services
    The variance is mainly due to the delay in the finalization of proposed regulations to support importer licensing impacting the roll-out of new program requirements and the timing of training and utilization of inspection staff to carry-out verification of regulated parties' adherence to these new requirements, most specifically in Targeted oversight.
PHAC
  • Health Promotion and Disease Prevention
    The surplus was mainly due to the delays in staffing actions and the contracting processes.
CIHR
  • Health and Health Services Advances
    CIHR has managed the DSEN funding between implementation years to best align the DSEN budget with the DSEN mandate and objectives, and has met the 2014-15 DSEN grants target. The variance is mainly due to the planned spending not including the reprofiled funds from previous years.

Health Products

17.1 Active Prevention

In 2014-15, the Health Products program will continue to engage stakeholders in the modernization of Canada's regulatory system. Health Products and Food Branch is taking a phased approach to implementation as described in the Regulatory Roadmap.

In an effort to improve the safety, quality and efficacy of health products, Health Canada will continue to focus on enhancing the integrity of the health product supply chain in Canada by educating stakeholders and improving the oversight of the ingredients found in health products as per the new Active Pharmaceutical Ingredients (API) regulations which came into force on November 8, 2013. Health Canada will continue to implement the new regulations with the full implementation of the API licensing and inspection programs.

Health Canada is committed to enhancing the transparency of regulatory decision-making related to pharmaceutical and biological products and medical devices. The Summary Basis of Decision (SBD) project provides information about Health Canada's decision to authorise applicable products for sale in Canada. Phase II of the project was launched in 2012, where SBD documents were redesigned into a question and answer format that is more easily navigable and user-friendly. Information on post-authorisation activities is now included, allowing Canadians to get up-to-date information on products which have SBDs. The SBDs will continue to include regulatory, safety and effectiveness considerations with an increased focus on Health Canada's risk/benefit analysis.

Health Canada also reviews Product Monographs (PM) produced by Market Authorization Holders that are factual, scientific documents on a drug product that describes the properties, claims, indications and conditions as well as information that may be required for the optimal, safe and effective use of the drug. The PM consists of three sections: Part I - Health Professional Information; Part II - Scientific Information; and Part III - Consumer Information. Health Canada has drafted plain language labelling improvements to PM Part III (now called Consumer Medication Information).

As part of the lifecycle approach, Health Canada will continue reviewing Risk Management Plans (RMP) for therapeutic products. The RMPs provide information related to both identified and potential risks, strategies to characterize the risks in question, and a risk minimization plan.

RMPs are submitted as part of a submission package or upon request from Health Canada (HPFB).

To increase awareness and compliance with regulatory requirements, Health Canada will continue to engage in pre-submission meetings with industry to ensure higher quality submissions and to provide valuable scientific and regulatory guidance to stakeholders. These meetings provide the opportunity to monitor and evaluate the exchange of information as well as obtain feedback regarding areas of concern prior to filing a submission.

With the age of blockbuster drugs coming to an end, Health Canada will experience a paradigm shift towards niche market drugs of high complexity such as combination products, orphan drugs, personalized medicines and cancer drugs. Pre-submissions meetings with industry will be of even more importance to ensure appropriate guidance to different sets of regulations are provided to the sponsor. As well, since Health Canada's mandate is the review and authorization of drug products, increased collaboration with the Canadian Agency for Drugs and Technologies in Health may be needed to ensure speedier access to these niche drug products.

The Government of Canada has made a number of commitments to involve the public in its decision-making processes. Health Canada is putting these commitments into effect through a variety of public involvement opportunities. External advisory bodies are one mechanism that Health Canada is using to receive public input and advice on scientific, technical, policy, and program matters. Currently, an initiative to incorporate observers in advisory body meetings has been undertaken in order to increase openness and transparency.

17.1 a Expected Results

Increased industry awareness and knowledge of regulatory requirements; enhancement of knowledge of post-market health products safety risks to inform decisions; increased oversight of the risk management and risk mitigation strategies for health products; increased safety of APIs through industry compliance with the Food and Drugs Act and its regulations; improved timeliness of pre-market reviews; and increased awareness and understanding of the safe use of health products by consumers and health care professionals.

Performance Indicator

Number of engagement opportunities with industry, international collaborations; number of guidance/educational tools developed; number of standards, frameworks and policies developed or modified; and number of consultations/engagement activities with Canadians and target populations; improved timeliness of pre-market reviews; number risk management and mitigation plans received, reviewed and implemented; percent of API firms in compliance as determined through the inspection program (once established)Footnote 3.

17.1 b Results Achieved
Summary Basis of Decisions (SBD)

Given the importance of the government's openness and transparency agenda, and Health Canada's commitment to being more open and transparent, the evaluation of Phase II of the SBD project was deferred. The SBD unit focussed its efforts instead on increasing transparency as described in Vanessa's Law and the Regulatory Transparency and Openness Framework. The first Regulatory Decision Summaries were posted to the Health Canada website in May 2015, and the first list of Submissions Under Review is planned for publication in June 2015.

Additionally, Health Canada published on its website, 27 SBD documents and 104 Post-Authorization Activity Table (PAAT) (for pharmaceutical drugs (14 SBDs; 69 PAATs), biologics (8; 32) and medical devices (4; 3)).

Product Monographs (PM)

Under the HPFB's Plain Language Labelling Initiative, Health Canada continued to make improvements to drug labels. The aim of the initiative was to provide more relevant and easier to understand drug information on labels in order to help Canadians make better informed decisions about their medications. As part of this initiative, changes to PMs were also required. The PM Guidance Document provides direction for industry stakeholders concerning preparation of the three sections of the Product monograph: Part I - Health Professional Information; Part II - Scientific Information; and Part III - Consumer Medication Information (now called Patient Medication Information). The following progress was made:

Under Part III - Patient Medical Information:

  • Health Canada published the final Guidance for Industry and Templates for the Product Monograph Part III - Patient Medication Information. (April 2014).
  • Developed training material and delivered training to its scientific review staff on the changes and new requirements (April 2014).
  • Launched the first phase of the implementation of the Part III Patient Medication Information changes (June 2014).
  • Revised internal standard operating procedures based on results from consultations on the Product Monograph Guidance.

Under Part I - Health Professional Information; Part II - Scientific Information:

  • Health Canada released for consultation, proposed plain language labelling and general improvements to its draft Guidance Document - Product Monographs, Parts I (Health Professional Information) and II (Scientific Information). (December 2014-March 2015).
  • Comments received during the consultation are under analysis and will be considered in the development of final revisions to the guidance document. The target approval for the final version of the guidance document is the end of 2015-16.

Additionally, Health Canada continued to process and published 3,853 product monographs to the Health Canada website this year (for pharmaceutical drugs (3,370), biologics (372) and veterinary drugs (111)). This is a slight increase from last year's 3,834.

External Advisory Bodies

Health Canada continues to permit external stakeholders and the public to observe in person or by telecom at its open Advisory Body meetings to increase openness and transparency.

Pre-submission Meetings

Health Canada's Pharmaceutical Drugs Program continues to receive a high volume of pre-submission requests. During 2014-15, the HPFB received a total of 120 requests and coordinated 52 pre-submission meetings, including: 36 pre-New Drug Submission meetings, 14 pre-Supplemental New Drug Submission Meetings, and two pre-Clinical Trial Application Meetings. The Branch allows sponsors to request meetings at any time, and every effort is made to accommodate the meeting dates proposed, however, our ability to address all requests is dependent on the workload at the time of the request. Health Canada encourages sponsors to submit meeting requests and material well in advance of their drug development process to ensure that all regulatory requirements are addressed. By doing so, Health Canada has the potential to uncover unresolved problems or issues early in the submission process, and in turn would help provide the Branch with an opportunity to re-align resources or expertise, if necessary, to prepare for the arrival of the submission. The meetings continue to provide a forum to discuss the data in a submission to facilitate its review and identify whether the studies the sponsor is relying on are adequate and well controlled in establishing the effectiveness of the drug.

Health Canada is committed to remaining open and transparent to the public and therefore began posting Safety Summary Reviews (SSRs) in 2014-15. The summaries which are posted provide an overview of safety reviews completed by Health Canada, as well as the action taken, thereby helping Canadians to make informed decisions. In 2014-15, 28 SSRs were posted on Health Canada's website. Health Canada also posts lists of ongoing safety reviews initiated on a quarterly basis so that Canadians are aware of safety issues being looked at.

Health Canada developed the following Guidance documents for industry which are anticipated to be posted in 2015-16:

  • Submission of Risk Management Plans and Follow up commitments.
  • Preparation and Submission of Summary Reports for Marketed Health Products.

There has been an increase in industry submitted Risk Management Plans (RMP) and of RMP follow-up activities to Health Canada. In 2014-15, there were 156 RMPs and 76 RMP follow-up activities submitted by industry. Health Canada completed 155 RMPs and 74 RMP follow-ups in 2014-15. This represents an increase over the 150 RMPs and 40 RMP follow-ups completed in 2013-14. In 2014-15, 98% of the RMP reviews were completed within the ninety-day performance standard.

In 2014-15, the HPFB coordinated a total of 86 pre-submission meetings, including; 32 pre-New Drug Submission meetings, 22 pre-Supplemental New Drug Submission meetings, 29 pre-Clinical Trial Application meetings, two pre-Notifiable Change meetings, one pre-Notice of Deficiency meetings. Minutes were approved for 100% of these meetings, and the interactions resulted in increased industry awareness of submission filing expectations and industry understanding of new or proposed legislation and regulations. Furthermore, the HPFB allows sponsors to request meetings at any time during the year, and every effort is made to accommodate the meeting dates proposed. As a result, meeting requests are processed within two weeks of receipt.

The Active Pharmaceutical Inspection (API) Program

In 2014-15, Health Canada continued the implementation of the amended Food and Drug Regulations which extended regulatory oversight to APIs. During the year, efforts were focussed on adopting and implementing a risk-based phased-in approach to compliance and enforcement with respect to APIs.

Making information available to regulated parties and encouraging compliance through education is an important element of Health Canada's compliance approach. Health Canada participated in a total of 17 stakeholder engagement events, providing valuable information and regulatory guidance for APIs. Health Canada conducted several compliance promotion visits with industry to inform them of the amended regulatory framework and provide guidance on GMP inspections.

In 2014-15, Health Canada implemented the API inspection program prioritizing inspections based on factors such as complexity of the activity undertaken (such as fabrication, importing, etc.). During this period, Health Canada conducted 26 domestic inspections and took compliance and enforcement action where non-compliances were identified. The non-compliant establishments did not receive establishment licences and API related activities were halted.

Health Canada conducted a total of eight foreign building inspections including two API inspections. As part of their establishment licence applications, importers are required to provide Health Canada with information on foreign buildings conducting API related activities. Efforts were focussed on determining and implementing strategies to assess evidence demonstrating compliance of foreign establishments with good manufacturing practices (GMP) regulations.

Recognizing the complexity and interconnectedness of API global supply chains, Health Canada continues to collaborate with regulatory partners to harmonize strategies, share best practices and conduct joint inspections. These joint initiatives include the Canada-United States Regulatory Cooperation Council, the Canada-Australia Regulatory Cooperation Initiative and the Pharmaceutical Inspection Co-operation Scheme. In addition, Health Canada, as an active member of the International Conference on Harmonization (ICH) Implementation Working group for Good Manufacturing Practice Guide for API, has contributed to the development of a question and answer document that provides interpretation and clarifies expectations regarding ICH Q7 Guideline adopted by the World Health Organization and regulatory partners internationally.

17.2 Targeted Oversight

Through the National Border Integrity Program, Health Canada's ability to make and support admissibility decisions at the border as they relate to health products will be strengthened. The program will continue to advance its ability to monitor and control the importation of health products by addressing challenges involved in reducing the health and safety risk for products entering Canada through the following initiatives: a national standardized process for the handling of health products at the border; establishment of service standards between Canada Border Services Agency (CBSA) and Health Canada to improve the ability to respond when safety incidents occur; and, undertaking public education activities to inform Canadians of risk associated with the importation of non-compliant health products. The program intends to further expand its work on the Single Window Initiative (SWI).

Health Canada will continue to enhance the post-market surveillance elements of the program through increased efforts focused on review of Periodic Safety Update Reports (PSURs) and the Periodic Benefit-Risk Evaluation Report (PBRER), which are documents that summarize the worldwide safety experience of a health product at pre-established post-authorization times.

In addition, Health Canada has enhanced the post-market surveillance elements of the program through the request of issue related summary reports from the manufacturer for the purpose of assessing the safety and effectiveness of a drug. Furthermore, Health Canada will continue to seek opportunities to expand and enhance the Post Market Reporting Compliance Inspection Program, such as through a review of international best practices and the incorporation of additional elements to its inspections.

Health Canada will be exploring new ways to enhance the quality and reporting of adverse reaction reports. With this in mind, the Canada Vigilance eHealth Project will determine the feasibility of developing an eHealth-based adverse reaction reporting system to leverage the eHealth tools used by healthcare professionals, including electronic medical records, electronic health records and related data repositories such as provincial Drug Information Systems, for adverse reaction reporting to Health Canada.

The Department has worked with Accreditation Canada to develop adverse reaction reporting and monitoring standards as part of their accreditation program for hospitals. These standards will complement the Department's many efforts to encourage and facilitate adverse reaction reporting. Health Canada also promotes adverse reaction reporting through the Canada Vigilance Regional Offices, by way of outreach and promotional activities, as a way to increase health professional and consumer awareness of, and participation in, the Canada Vigilance Program.

In partnership with the Canadian Institute for Health Research (CIHR), Health Canada has implemented the Drug Safety and Effectiveness Network (DSEN): a pan-Canadian virtual network of centres of excellence in post-market pharmaceutical research.The evidence generated by DSEN funded studies is intended to inform pharmaceutical decision-making across the health care system. The CIHR and Health Canada will work collaboratively to streamline the DSEN processes and procedures (e.g., the framework to prioritize DSEN research queries, query submission, etc.) to make these tools as responsive as possible to the needs of the Federal Regulator, Federal/Provincial/Territorial (F/P/T) drug plans and organizations mandated to support F/P/T decision making while broadening the Health Portfolio's engagement and increasing program transparency. The DSEN evaluation is scheduled for 2019 and the portfolio partners will work collaboratively to ensure the required data are available to complete a comprehensive evaluation to confirm that the DSEN is delivering on the key policy objectives - increasing the availability of post-market drug safety and effectiveness evidence for health care decision makers and increasing Canadian capacity to undertake high quality research in this area.

Please refer to Section 23.1 for DSEN's Expected Results and Performance Indicators.

17.2 a Expected Results

Enhance capacity of Health Canada and the pharmaceutical/biotech industriesFootnote 4 to identify and respond to risk issues; increase capacity to identify safety issues with health products on the market; increase knowledge of post-market drug safety and effectiveness to inform decisions and increase capacity to address priority research on post-market drug safety and effectiveness; improve ability to monitor and control importation of health products.

Performance Indicators

Year-over-year increase in PSUR submitted by industry; number new safety signals generated through PSUR reviews per year; percent of safety issues identified by Market Authorization Holders (MAH) resulting in product monograph changes or regulatory action to mitigate risk; percent of adverse reactions addressed within service standards; number of import alerts resulting in detecting/stopping non-compliant products at the border; number/percentage of health product admissibility determinations that recommend refusal of entry into CanadaFootnote 5.

17.2 b Results Achieved

Health Canada has completed legislation for the mandatory reporting of adverse reactions for certain Health Products. The development of regulations and guidance to implement this new authority is currently in progress.

In addition Health Canada has developed business requirements to access adverse reaction information from electronic medical records and electronic health records. Specific projects were initiated with Canadian Primary Care Sentinel Surveillance Network and British Columbia PharmaNet.

There has been a reduction in unsolicited voluntary industry submitted PSUR and PBRER to Health Canada.

In 2014-15, there were a total of 273 pharmaceutical and biologic PSURs/PBRERs submitted to Health Canada compared to 340 submitted in 2013-14.

In 2014-15 Health Canada conducted 283 PSUR/PBRER level one reviews and 84 PSUR/PBRER full reviews. Of those level one PSUR/PBRER reviews, 95% were completed on target and 96% of the PSUR/PBRER full reviews were completed on target.

In 2014-15, Health Canada requested the MAH to prepare 42 issue related summary reports on specific safety issues.

The partner organizations (CIHR and Health Canada's SPB and HPFB) continued to collaborate on a number of DSEN processes:

  • Collaboration to streamline processes and improve the responsiveness of the DSEN query process to better meet decision-makers' needs for pan-Canadian evidence on post-market safety and effectiveness (HPFB and SPB).
  • Participation in the DSEN Science Advisory Committee (HPFB).
  • Coordination of the DSEN Operational and DSEN Executive Working Group meetings, to maintain and strengthen the working partnership (SPB).
  • Coordination of the Health Canada DSEN Implementation Project Team (HPFB) and participation and contribution to this team (SPB). The Team was established by HPFB in 2009, with representatives from HPFB and First Nations and Inuit Health Branch.
  • Liaising with the Canadian Agency for Drugs and Technologies in Health (CADTH) to enhance engagement of provincial drug plans in DSEN; and facilitation of communication with Provincial and Territorial government drug plan managers to identify opportunities for collaboration (SPB).
  • HPFB's collation, review and forwarding of research queries from the Health Canada DSEN Team members to the DSEN Coordinating Office (within CIHR) for consideration as part of the Network's prioritized national research agenda. Health Canada continues to forward proposed research queries for the DSEN to investigate.
  • Critical review of findings from DSEN-funded research studies in working towards contributing to Health Canada drug regulatory and/or policy development, decision-making activities (HPFB).
  • Ongoing dialogues between Health Canada staff and DSEN researchers to refine queries and to discuss methodologies. This engagement fosters communication and understanding between both parties on DSEN capability and the needs of the regulator. Ultimately this will improve how Health Canada can leverage DSEN capacity (HPFB).
  • Exchange of information on DSEN development and Health Canada research queries with the European Medicines Agency (HPFB).
  • Engagement with international partners implementing related initiatives (e.g., ENCePP in EU; Sentinel in United States) to share best practices and explore opportunities for data sharing (HPFB);
  • Support of DSEN Steering Committee representatives (e.g., preparation of briefing material, presentations etc.) (SPB and HPFB).
  • Active participant in CIHR-led DSEN activities (SPB and HPFB).
  • Active contributor and participant in DSEN's annual Knowledge Translation meeting, to develop the guiding principles of transparency within DSEN, and for communicating DSEN findings (HPFB and SPB).
  • Active participation in the semi-annual DSEN Network operational meetings, which bring together DSEN decision makers and researchers to advance their working relationships (SPB and HPFB).
Good Pharmacovigilance Practices previously Post Market Reporting Compliance Inspection Program

In 2014-15, work continued on enhancing the efficiency and effectiveness of the Good Pharmacovigilance Practices. The continuous application of Good Pharmacovigilance Practices serves an important role in the overall system to verify that marketed drugs remain safe and effective well after their market authorization. During the year, the program continued to use a risk-based approach for the selection of establishments to inspect. The guiding principle in the selection process is the safety and efficacy of drugs marketed in Canada. Over 45 Good Pharmacovigilance Practices inspections were conducted in 2014-15.

In order to promote compliance, two presentations were provided to stakeholders on most common deficiencies noted during inspections. Those presentations also served as a reminder for stakeholders of Health Canada's expectations about processes and systems for pharmacovigilance.

Border Integrity

The National Border Integrity Program achieved several successes in the year 2014-15. For example, the D-19-9-1 Memorandum to CBSA on how to handle Health Products was published in August. In addition, service standards were established with the CBSA. Health Canada was also a key participant in the launch of the SWI in March 2014 including the development of guidance and stakeholder engagement sessions. In 2014-15, over 54,000 admissibility recommendations of imported health products were made by Health Canada. Of these, over 60% were either refused or seized due to non-compliance.

Consumer Product and Workplace Chemical Safety

18.1 Active Prevention

The Canada Consumer Product Safety Act and the Food and Drugs Act and its Cosmetics Regulations provide the authorities for the Consumer Product Safety Program to support industry's responsibility for the safety of their products and consumers' responsibility to make informed decisions about product purchases and use.

The program will work with industry, standard setting bodies and international counterparts to develop standards and guidelines and share best practices as appropriate. The program will also promote consumer awareness of the safe use of consumer products and cosmetics to support informed decision-making.

18.1 a Expected Results

Industry is informed/aware of regulatory requirements related to consumer products and cosmetics.

Performance Indicator

% of Canadian industries informed/aware of regulatory requirements.

18.1 b Results Achieved

Health Canada developed and made available online numerous guides for industry to help them better understand their obligations under the Canada Consumer Product Safety Act and its regulations.

Evaluation forms were sent to industry members following presentations and following the distribution of new industry guidance. According to the evaluation forms, industry respondents somewhat/strongly agreed that, the presentations had increased their awareness (100%) and understanding (88%) of their obligations under the Act. A survey of industry on the new industry guidance indicated that 100% of respondents agreed that the guidance increased their understanding of their obligations and 91% agreed that the information was presented in a clear and organized manner.

In the spirit of international cooperation, in September 2014, Health Canada along with consumer product safety regulators from the United States and Mexico made a trilateral presentation to an estimated 80 industry members on strollers at the ABC Kids Expo in Las Vegas. This Expo was attended by over 14,000 people from 66 countries. This was the first time the three agencies have partnered on a technical presentation to industry members.

All three countries also participated in an Organisation for Economic Co-operation and Development international outreach campaign on button batteries and laundry detergent packets.

Also, in February 2015, Health Canada and the Consumer Product Safety Commission partnered in a presentation to an estimated 70 members of industry on toy safety requirements at the 112th North American International Toy Fair in New York City. This event is the largest toy fair in the western hemisphere, attracting approximately 30,000 members of the global toy industry and featured 1,064 exhibitors.

With respect to radiation emitting devices regulated under the Radiation Emitting Devices Act, Health Canada responded to 230 enquiries from stakeholders for elaboration/interpretation of regulatory requirements under Radiation Emitting Devices Act. In addition, Health Canada responded to 654 public enquiries associated with questions related to the safety of radiation emitting devices. Many of the enquiries related to the potential health effects of electric and magnetic fields, ultraviolet, infrared and visible light radiation, acoustics from consumer devices and manmade environmental sources and radiation protection, regulatory requirements for x-ray screening devices.

In support of increasing Canadian's awareness and understanding of risks related to radiation emitting devices Health Canada updated the following Safety Codes and guidelines:

18.2 Targeted Oversight

The Program undertakes regular cycles of compliance and enforcement in selected product categories as part of the cyclical enforcement plan and responds to issues identified through mandatory incident reporting, market surveys, lab results and other means. Under the Canada Consumer Product Safety Act, the program has improved authorities to ensure investigative actions are being taken to determine the safety profile of products and to verify that preventative measures are being implemented.

18.2 a Expected Results

Early detection of potentially unsafe consumer products and cosmetics.

Performance Indicator

% of incident reports received and triaged within service standard

18.2 b Results Achieved

Health Canada continued the implementation of the Canada Consumer Product Safety Act, which came into force on June 20, 2011.

The risk-based approach across all program activities was advanced. The Consumer Product Safety Risk Assessment Framework was developed in December 2014 and the summary was posted on the Health Canada website in March 2015.

The program continues to strengthen its surveillance reports and ad hoc analytical activity requests to inform its outreach and compliance and enforcement activities.

Health Canada triaged mandatory and voluntary reports to detect potentially unsafe consumer products and cosmetics at the earliest stage possible. These reports were then sent for appropriate risk assessment, risk management or placed under surveillance. In 2014-15, Health Canada received 1,924 reports (61% from industry, 39% from consumer) and triaged 99% of these reports within the service standard.

In the spirit of regulatory openness and transparency, the program published the first Quarterly Consumer Product Safety Incident Report Summary in March 2015.

Increased sharing of information with international regulators

Health Canada scientists provide ongoing scientific support and advice in the areas of Electromagnetic Fields (EMF), Noise and Electro-optics, participate in meetings on international standards for non-ionizing radiation emitting devices (e.g., noisy machinery, ultraviolet, lasers, microwave, radiofrequency and ultrasound) and supports the development of international standards for medical imaging equipment. Some of the international organizations include:

  • World Health Organization (WHO) International EMF project Advisory Committee and the WHO Noise Guidelines Working Group.
  • American National Standards Institute S12 Noise Working Group.
  • International Commission on Illumination Division 6 Working Group (Photochemistry and Photobiology).
  • Canadian Standards Association (national organization with linkages to international organizations);
  • International Organization for Standardization.
  • International Electrotechnical Commission.
  • Canadian General Standards Board.
18.3 Rapid Response

The Government of Canada is equipped to respond rapidly to remove unsafe consumer products from shelves, preventing them from reaching consumers. While the Department continues to operate with a step-wise approach to compliance and enforcement by working with industry to voluntarily take corrective actions, the Canada Consumer Product Safety Act includes measures to protect Canadians from unsafe consumer products. Under Rapid Response, when an unacceptable risk from consumer products and cosmetics is identified, the program can act quickly to protect the public and take appropriate enforcement actions - including issuing consumer advisories, working with industry to negotiate recalls or other corrective measures.

18.3 a Expected Result

Risks associated with consumer products and cosmetics in the Canadian marketplace are appropriately managed.

Performance Indicator

% of non-compliant products identified through the Cyclical Enforcement Plan and incident reporting, for which risk management action is taken in accordance with established operating procedures and timelines.

18.3 b Results Achieved

In 2014-15, Health Canada took action on non-compliant consumer products and cosmetics approximately 96% of the time within the service standard.

Health Canada continued to monitor the efficiency of its risk management operational procedures to ensure prompt action is taken to reduce the risks posed by dangerous consumer products and cosmetics in the Canadian marketplace.

In the spirit of regulatory openness and transparency, the program published the first Quarterly Consumer Product Safety Incident Report Summary in March 2015.

Additionally, a new enforcement approach was piloted at Canada's ports of entry to implement more active prevention techniques in the compliance and enforcements projects and new inspection approaches were initiated to further evaluate the ability of industry to meet Canada Consumer Product Safety Act requirements.

Health Canada published new Exemptions Regulations (Consumer Products). Under the Exemption Regulations, charitable organizations and retailers that sell second-hand consumer products that they obtained from donation will be exempt from certain Canada Consumer Product Safety Act record keeping requirements except where the donation is from a business. The Regulations will also allow Health Canada to implement a commitment made during the development of the Canada Consumer Product Safety Act, in which the department communicated to Parliament and Canadians that certain charitable activities were not intended to be captured by the Act's record keeping requirements.

A Forward Action Plan was developed for the systematic review and update of the highest priority regulations under the Canada Consumer Product Safety Act.

Health Canada completed 87 assessments as requested by institutions and other government departments. In addition, a cyclical enforcement plan for radiation emitting devices regulated under the Radiation Emitting Devices Act was developed and implemented based on a risk evaluation of these products. The first cycle was completed in 2014-15.

Pesticide Safety

19.1 Active Prevention

The Pesticide Program encourages and facilitates industry development and adoption of quality assurance and stewardship programs for the safe manufacture and subsequent selection and use of pesticides and other consumer products containing pesticides. Retailers of pest control products often rely on their distributors for validation of access to registered products. Work under this strategy fosters an increased knowledge of the requirements under the Pest Controls Products Act and related regulations and an awareness of the tools available to validate the status of the pest control products and their label information.

Health Canada will continue to provide information to consumers through outreach programs related to the responsible use of pesticides. This includes dissemination of material through media, booths, the web, and Pest Management Information Service, which every year responds to a wide range of queries from the public on the safe and proper use of pesticides. The compliance strategies under active prevention aim to engage stakeholders in order to test assumptions about the ability and will to comply in a timely and effective manner with enforcement actions.

19.1 a Expected Results

Increased industry (manufacturers, distributors, retailers and vendors) awareness of risks and related regulatory requirements.

Performance Indicators

Number of active prevention activities (e.g. booths, visits, presentations, surveys, workshops) conducted.

19.1 b Results Achieved

Health Canada conducted approximately 133 active prevention activities, including the dissemination of outreach material and information to various targeted populations as well as to the general public through Pest Management Information Service and in on-line and print publications throughout Canada.

Support was also provided to facilitate participation at fairs, exhibits, and consumer-oriented events, in order to promote pesticide safety and responsible pesticide use.

19.2 Rapid Response

Under rapid response, the Pesticide Program will enhance compliance monitoring of pest control products at the retail or marketplace level as a strategy for early detection of any pesticide safety issues.

19.2 a Expected Results

Improved monitoring of pest control products using a risk-based management approach.

Performance Indicators

Number of targeted inspections conducted (marketplace, manufacturers, retailers, distributors and vendors of consumer pesticides; number and type of enforcement responses initiated in situations of non-compliance.

19.2 b Results Achieved

Health Canada undertook several initiatives to monitor and enforce industry compliance with the Pest Controls Products Act. The Agency delivered programs in the marketplace, as well as with pest control operators and registrants to ensure that only registered consumer pest control products were imported, sold and used in accordance with the conditions of registration.

For 2014-15, 74 inspections were delivered for the Pest Control Operators Program, focussed on residential structural pests such as bedbugs. In response to situations of non-compliance, 16 enforcement letters and nine education letters were issued. 219 marketplace inspections of suspected retailers, distributors and vendors of neem, naphthalene and citronella pest control products were conducted to identify companies that are supplying them. 246 enforcement actions were taken on 139 non-compliant vendors and distributors. Enforcement actions consisted of removal/disposal of non-compliant products, and education letters to non-compliant vendors. And, 51 samples of consumer insecticides/insect repellents were submitted to the laboratory for analysis to ensure product integrity. Sample analysis continues for this program.

Inspections of registrants of consumer products revealed minor label deficiencies that were addressed through verbal and written education.

Consumer pest control products were also monitored at the border. Of the 56 confirmed instances of non-compliance related to consumer pesticides, actions taken included 29 requests to cease activity or remove products from the marketplace, eight requests to return products to distributor, six requests to dispose of the products, one denial of entry into Canada and one order to return product to distributor. There was no action required for the remaining cases. Two border targets related to consumer pest control products are in effect.

Furthermore, Health Canada continued to verify compliance when non-compliance was previously identified through its surveillance program. Of the ten surveillance inspections related to consumer products, half were of retailers; there was one each for manufacturers, distributers, registrants and users, and one where the responsible party could not be identified. Education letters were issued following six of these inspections and enforcement letters were issued for two. Most cases involved insecticides, herbicides or insect repellents. As of 31 March 2015, 76 % of these inspections found a return to compliance. Health Canada is taking active steps, including application of escalated enforcement measures, to compel the remaining regulated parties and individuals to fully comply with the Pest Control Products Act.

Food Safety and Nutrition

20.1 Active Prevention

Health Canada's Food Safety and Nutrition program will continue to enhance risk management measures for priority food safety hazards in foods, implement Food Allergy Incident Prevention Measures, consult with industry and stakeholders on key files, and engage with international standards bodies while developing standards, policies, regulations and processes.

20.1a Expected Results

Increased effective assessment and mitigation strategies of food safety risks.

Performance Indicators

Number of risk modelling activities conducted, number and type of involvement in International initiatives that support industry, number and type of involvement with international standard setting initiatives, percent and range of new submissions addressed within time standards, research in policy and Regulatory Impact Analysis Statement, as well as the considerations of consumer and stakeholder feedback documented in decision-making.

20.1b Results Achieved:
Better understanding of food safety risks

In order to better identify food safety risks, Health Canada developed and/or validated many analytical methods such as the review by the joint Health Canada-CFIA Allergen Method Committee of allergen testing methods used in compliance programs and health risk assessments to ensure that they are fit-for-purpose.

Health Canada continued to assess microbiological, chemical and nutritional risks in food such as the prevalence and persistence of various foodborne pathogens in raw foods of animal origin, the prevalence of verotoxin subtypes in Canadian verotoxin producing E. coli isolates, the transmission dynamics of parasites in foods, and the presence of hepatitis E virus in retail food products, the levels of specific components such as the level of gluten, soy and mustard in various products such as naturally gluten-free products, infant cereals, wheat containing products, products made from naturally gluten-free flours and starches.

Health Canada also continued to investigate intervention strategies, such as high pressure processing, for various foodborne pathogens.

Engage Canadians in food safety decision-making

Health Canada consulted with stakeholders on Category Specific Guidance for Temporary Marketing Authorization: Beverages, Beverage Mixes and Concentrates, Powder, Bars and Confectionaries and an updated Classification of Products at the Food-Natural Health Product Interface: Products in Food Format.

A number of consultations were also held with industry, consumer, and health stakeholders on nutrition labelling modernization, including public and web-based consultations, technical consultations, consumer engagement sessions held across the country in September 2014 and bilateral meetings with specific industry associations and key stakeholders.

Broader engagement with stakeholders on food regulatory modernization were held to seek their views and feedback on potential guiding principles and conceptual elements, such as: a consultation with Canadian stakeholders in the development of Canadian positions for proposed Mycotoxins—Deoxynivalenol (DON) Maximum Levels, and a consultation on the food colour labelling as part of the proposed changes to nutritional labelling.

A face to face meeting of the Federal/Provincial/Territorial Food Safety Committee was held in Ottawa, Ontario on the 25 -26 November 2014. Topics considered during the meeting included the Strategic Work Plan 2014-17, Regulatory Modernization, pathogen reduction (including control safe cooking and handling labelling), Food Retail and Food Service Sectors, Non-Federally Registered Sector, foodborne illness surveillance, and antimicrobial resistance.

Strengthened standard setting and appropriate regulatory backstops

Health Canada continued to lead and leverage international food standards development and risk management standards through her engagement in subsidiary bodies of the Codex Alimentarius Commission (Codex). For example, Health Canada led the Canadian delegation at the 36th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses, where Canada continued to lead efforts to revise the Codex General Principles for the Addition of Essential Nutrients to Foods in order to reflect the latest scientific evidence and current global market trends while ensuring rational and safe addition of essential nutrients to foods.

Canada also contributed to:

  • Proposed amendments to the Codex Guidelines on Nutrition Labelling, encouraging the use of accurate and informative labelling to support informed food choices and encourage the formulation of foods which would benefit public health.
  • The World Health Organization (WHO) on the issues of maternal, infant, and young child nutrition.
  • The World Trade Organization (WTO), in particular the Committee on the Application of Sanitary and Phytosanitary Measures (SPS Committee) in order to ensure that any agreements reached with respect to trade did not compromise Health Canada's ability to set standards to protect the health of Canadians.
  • The Pan American Health Organization (PAHO) on building regulatory capacity to address risk factors for non-communicable diseases and providing input on the PAHO Plan of Action for the Prevention of Obesity in Children and Adolescents. Health Canada also contributed to the Rome Declaration on Nutrition and the Framework for Action, an outcome of the Second International Conference on Nutrition.
  • The on-going collaboration with international agencies such as the United States Government agencies on the development of a framework for using chronic disease endpoints in setting Dietary Reference Intake (DRI) values, which underpin national nutrition standards and policies in Canada and the United States. Health Canada and the United States Government agencies established an expert panel and hosted a workshop to look at options for consideration of chronic disease endpoint for DRIs.

Health Canada advanced policy development and risk management of various categories of supplemented food products with added nutrients and other "functional" components. Health Canada issued Temporary Marketing Authorization (TMA) for 93 new foods and extended TMA for over 100 supplemented foods.

A regulatory proposal was developed to modernize the regulatory system for contaminants and adulterating substances in foods through the use of incorporation by reference.

Health Canada undertook efforts to update policy related to vitamin D fortification of foods to reflect the most up to date health and nutritional advice, including modelling a number of fortification scenarios using various foods and conducting exposure assessments to determine the health impact on Canadians. Health Canada also held a workshop to seek constructive advice on an expanded vitamin D fortification policy with vitamin D experts from across the world. This work will contribute to a final proposal for amending the Food and Drug Regulations.

The Department's scientific research continued to integrate the nutritional and metabolic aspects of foods, which underpins evidence-based policy development. Health Canada led or contributed to six publications in scientific peer reviewed journals that contribute to the body of knowledge and inform policies on the role of folic acid and vitamin B12 in population health, including maternal, prenatal and infant health.

Working with industry to implement effective risk mitigation

Health Canada developed and published the following advisories, risk profiles, guidance documents and standards such as the safety of Human Donor Milk in Canada, the risk Profile on Non-O157 Verotoxin-Producing Escherichia coli in Produce, Beef, Milk and Dairy Products in Canada, an additional industry guidance on safe cooking and handling labelling for raw ground meat and raw ground poultry, the National Strategy for the Control of Poultry-Related Human Salmonella Enteritidis Illness in Canada, Health Canada's Guidance Document on Unpasteurized Fruit Juice and Cider. Health Canada also promulgated new regulatory requirements for the mandatory labelling of mechanically tenderized beef which came into force on August 21, 2014 and published a companion interpretive guidance document for industry ("Guidance on Mandatory Labelling for Mechanically Tenderized Beef").

Targeted Oversight

The Food Safety and Nutrition Program has no targeted oversight funding under this stream.

20.2 Rapid Response

Under the rapid response pillar the Food Safety and Nutrition program will continue its participation in the Partnership for Consumer Food Safety Education with the goal of promoting the "Be Food Safe" campaign and will continue to develop new education materials for consumers to promote food safety in an effort to reduce foodborne disease outbreaks in Canada.

20.2 a Expected Results

Consumers make informed decisions about food.

Performance Indicators

Number of safe food handling web pages that were viewed (Health Canadians web site and Health Canada web site).

20.2 b Results Achieved:

As a member of the Canadian Partnership for Food Safety Education, Health Canada contributed to the Be Food Safe Website during 2014-15. Social media engagement continued through Twitter, Facebook, Pinterest and Instagram in an effort to communicate focused risk communication messages.

With the support of Health Canada, Canada Beef organised an educational campaign on the use of food thermometers where demonstrations took place in several grocery stores across the country showing the importance of using those thermometers to ensure that foods are cooked at the proper internal temperature for safety.

Health Canada continued to participate in consumer education activities such as the "Thelfie (Thermometer + Selfie = Thelfie)" campaign, "Food Safety Wheel" and the "Science Funfest".

Health Canada published safe food handling guidance for vulnerable populations (i.e., adults ages 60 and over, children ages 5 and under, pregnant women, people with weakened immune systems).

Food Safety Program and Internal Services

21.1 Active Prevention

The Canadian Food Inspection Agency's (CFIA) food safety initiatives continue to ensure active prevention include measures to enable government to better understand and identify food safety risks and to work with industry to implement effective food safety risk mitigation strategies. The CFIA, along with its federal partners, will strive to strengthen food safety standards and regulations and will engage Canadians in making decisions with respect to food safety.

The CFIA will continue the redesign of its food safety regulatory framework to support the implementation of the Safe Food for Canadians Act, In light of these regulatory changes, the CFIA will continue to revise its food safety programming for verification of industry food safety systems in high-risk sectors and complete the administrative infrastructure for importer licensing, including the information management, information technology component.

The CFIA will continue to work with Health Canada on data collection and risk mapping towards identification and characterization of areas of concern, including imported food ingredients, fresh produce, mycotoxins in cereals and undeclared allergens. Risk mapping will identify additional gaps in standard-setting and policy development and will assist in focusing operational efforts on areas of greatest risk. Data collected through baseline surveillance will serve to fill information gaps.

The CFIA will continue engagement with counterparts in foreign countries to enhance food safety information exchange and identify best practices to inform risk management approaches.

As well, the CFIA will also continue to inform consumers and industry on the use of Product of Canada and Made in Canada claims on food products.

Internal Services (Communications Services)

Health Canada's Communications and Public Affairs Branch (CPAB) will continue to focus on increasing industry and consumer awareness of food, health and consumer product safety.

As technology advances and consumption habits change, Canadians will increasingly expect information to be when and where they need it. Health Canada will continue to offer information in a variety of new and traditional ways to meet this need. CPAB will continue to focus on ensuring that Canadians have easy access to health and safety information in order to make informed health and safety decisions. In collaboration with Treasury Board of Canada Secretariat (TBS), Health Canada is leading the development of the Health theme on Canada.ca. The Health theme will be a user-centric website populated by information and services most used by Canadians. With the Healthy Canadians social media channels, Health Canada will increase the reach of food, consumer and health product messaging, including risk communications. Health Canada will expand the content delivered through these platforms, explore additional channels to reach Canadians and update innovative tools such as the Recalls and Safety Alerts web and mobile applications. Additionally, food, consumer and health product web content will be developed to provide consumers friendly information to Canadians and to raise awareness of food, consumer and health product responsibilities among industry.

As outlined in TB policy directives, Health Canada will continue to produce electronic formats first and ensure value when producing printed publications. CPAB will ensure that Canadian consumers continue who wish to receive information in print will continue to receive accurate and reliable information related to food, health and consumer product safety by streamlining the distribution process, focusing on inventory management and reducing storage costs by using "just in time" delivery of print products.

CPAB continues to manage the Service Level Agreement (SLA) put into place in May 2012. This SLA increases efficiencies with telephone inquiries by providing extended hours of service to Canadians, fielding a larger volume of calls and responding more efficiently to email inquiries. This streamlined approach also provides a more consistent response to consumer-related inquiries.

21.1 a Expected Results

To better identify, assess, and prioritize potential food safety hazards through risk mapping, information gathering, and sampling and testing of foods on the Canadian marketplace and to inform the relevant Agency stakeholders on relative risk in order to influence decisions and priorities for different food/hazard combinations; improved industry compliance; industry implementation of preventive food safety systems; provide data to Health Canada to be used in the establishment of standards, regulations, and policies that contribute to the prevention of food safety issues through the product lifecycle.

Expected Result (Internal Services)

Increased consumer awareness and understanding of the safe use of health, food and consumer products. Increased industry awareness and knowledge of regulatory requirements.

Performance Indicators

The following were used as guidance for data collection: percent completion of regulatory approval process; number of planned and percent completed commodity/hazard targeted surveys to address information gaps; number of risk profiles completed; number and percent of high risk/priority areas for which CFIA has the requisite tools and processes to identify, assess and prioritize potential food safety risks, percent completion of revised approaches to food safety system verification; number of industry awareness sessions delivered versus planned, ability to report on the number and nature of inquiries regarding the Product of Canada guidelines; percent completion of the supporting information management, information technology infrastructure and tool for importer licensing management; evidence of new/ongoing engagement on food safety with international regulatory counterparts.

As the FCSAP initiative has become entrenched in the Agency's on-going food safety programming, attribution of food safety results to specific Active Prevention activities has become complex. Performance indicators and targets are transitioning from those used to report progress on the FCSAP to those to measure holistic food safety outcomes under the CFIA's systems performance framework.

Performance Indicators (Internal Services)

Increase in the number of followers on Healthy Canadians social media channels; increase in the number of web visits and engagement levels.

21.1 b Results Achieved

CFIA Active Prevention activities included:

  • Risk ranking food-hazard combinations.
  • Using risk profile reports, influence diagrams, and/or farm-to-fork food process flow charts to examine gaps along the farm-to-fork continuum to firmly establishing linkages between risk profiling and risk prioritization.
  • Using iRisk, an automated science-based risk ranking tool which comparatively ranks food/hazard combinations, to assess chemical hazards that appear in multiple food sources.
  • Conducting targeted surveys for microbiological and chemical hazards: undeclared allergens, bacteriology, and chemistry.
  • Amalgamating the regulatory proposal for the Imported Food Sector Products Regulations in the regulatory proposal to support implementation of the Safe Food for Canadians Act.
  • Re-designing Release 1 of the Licence Management System (LMS) to support the Safe Food for Canadians Act.
  • Continuing engagement with regulatory counterparts on food safety to enhance regulatory cooperation and relationship building (i.e. United States, New Zealand, European Union, India).
  • Continuing participation in Codex Working Groups.
  • Responding to requests for ongoing program guidance and policy clarification, from internal, other government departments, industry, and media sources on Product of Canada guidelines; and conducting labelling investigations related to Product of Canada, while continuing to monitor compliance with the guidelines through its inspection and label verification activities and responding to complaints and referrals related to the interpretation and implementation of the revised policy.
Results Achieved (Internal Services)
Marketing
  • Healthy Canadians Facebook, Twitter and YouTube had over 60,000 fans/followers/subscribers and a reach of over 27 million an increase of 232% over the prior year.
  • Social Media efforts generated over 220, 000 visits to web.
  • Major recalls for consumer products, vehicles, food and health products that are relevant to Healthy Canadians' target audience are posted on both our Facebook pages and Twitter feed shortly after they've been posted on the Recalls and Safety Alerts website. In 2014-15 we posted 80 recalls on Facebook and Twitter.
Web Development

The Healthy Canadians website (now named Canada.ca/Health) and the Recalls and Safety Alerts (RSA) web and mobile presences continue to be widely sought, visited and referenced information, with over 7.7 million visits to the website and 2.7 million visits to the RSA April 2014 to March 2015. That represents a 50% increase in visits for Canada.ca/Health and a 10% increase for the RSA compared to the previous fiscal. Visitors to the site browsed for an average of 1 minute 28 seconds and visitors to the RSA stayed for an average 1 minute 13 seconds. Given that the Recalls and Safety Alerts are generally concise, this indicates that users were highly engaged, reading the information fully. The Recalls and Safety Alerts mobile application had over 4,461 downloads last year, allowing users to access recall information on their mobile devices.

Health Canada's web writers and editors provided substantial input to, and edited the Canada.ca Web Content Style Guide. This guide details how web content should be written and presented on Canada.ca. This consistent, plain language approach enhanced user-experience and the ability to find the information more easily on the web.

Publication/Distribution

Calls received:

  • Food safety - 1,162
  • Consumer product safety - 4,977

Food Safety Publications

  • 3,638 orders
  • 179,182 copies shipped

Consumer Product Safety

  • 2,910 orders
  • 2,543,261 copies shipped
21.2 Targeted Oversight

Targeted oversight initiatives include enhanced inspection of identified high-risk food sectors and targeted import control measures. The CFIA will continue to adapt its food safety inspection practices for high-risk sectors, including the implementation of an importer licensing regime and provide training to inspection staff on revised procedures. Evaluation and verification of industry's food safety control systems in both fresh fruit and vegetable and non-federally registered sectors will take place with a focus on imported products. Method development and testing in targeted areas will continue. Enhanced tracking of imported food products will continue and border blitzes will be conducted.

21.2 a Expected Results

Improved industry compliance with food safety standards; modern tools and new risk-based approaches contribute to improved safety of imported foods.

Performance Indicators

The following were used as guidance for data collection: number and percent of total required inspectors trained on revised procedures, number and percent of planned high-risk food safety inspections and verifications completed; number of border blitzes conducted versus planned; number and percent of new testing methodologies developed and implemented.

As the FCSAP initiative has become entrenched in the Agency's on-going food safety programming, attribution of food safety results to specific Targeted Oversight activities has become complex. Performance indicators and targets are transitioning from those used to report progress on the FCSAP to those to measure holistic food safety outcomes under the CFIA's systems performance framework.

21.2 b Results Achieved

CFIA activities included:

  • Conducting inspections in the non-federally registered sector in the four identified priority areas of greatest risk (produce, mycotoxins in cereal, imported ingredients, undeclared allergens).
  • Conducting Fresh Fruit & Vegetable Establishment inspections.
  • Conducting Border Blitz inspections and import surveillance activities in continuing targeted oversight of imported products.
  • Developing and enhancing a number of laboratory methods for analysis of chemical and microbiological hazards.
21.3 Rapid Response

Towards ensuring rapid response to food safety issues and emergencies, enhanced recall capacity will enable the Government of Canada to effectively respond to and conduct investigations for an anticipated increased number of food recalls resulting from targeted oversight activities. Targeted consumer risk communication activities and products will also provide Canadians with more information to help consumers better protect themselves and their families.

The CFIA will continue to implement and to improve recall and policies and procedures to support effective and efficient food safety recall and investigation methodologies. This will include development and delivery of training to Agency staff and provide awareness sessions to industry associations.

21.3 a Expected Results

Timely and efficient recall capacity in the face of increased identification of potential risks through targeted testing and other information; better public understanding of food safety risks; increased consumer use of various food safety alert systems; and increased public trust and confidence in the food safety system.

Performance Indicators

The following were used as guidance for data collection: number of personnel trained and available to support recall activities; number of recalls and percent conducted in accordance with CFIA standards; number of and percent of required investigations conducted in accordance with CFIA standards; number of communications initiatives aimed at increasing consumer awareness of food safety issues and recall; percent of consumers aware of food safety issues.

As the FCSAP initiative has become entrenched in the Agency's on-going food safety programming, attribution of food safety results to specific Rapid Response activities has become complex. Performance indicators and targets are transitioning from those used to report progress on the FCSAP to those to measure holistic food safety outcomes under the CFIA's systems performance framework.

21.3 b Results Achieved

CFIA Rapid Response activities included:

  • Managing recalls related to non-federally registered and fresh fruit and vegetable products, which resulted in a total of 565 recalls (primary and secondary combined).
  • Continuing its efforts to enhance food safety recall and investigation methodology, by delivering sessions across Canada on revised materials for Food Recall.
  • Using social media as a communications tool and publishing postings of food recalls and allergy alerts.
  • Posting targeted surveys reports to the CFIA's website. These reports, which summarize the findings of CFIA's targeted surveys, present information regarding the occurrence of contaminants in the food supply. Posting the results of these reports on the CFIA website is an important step in raising consumer awareness about food safety risks and issues.

Health Promotion and Disease Prevention

22.1 Active Prevention

PHAC will modernize and strengthen Canada's food safety systems by use of innovative laboratory tests (molecular typing), by expanding integrated surveillance systems (Canadian Integrated Program for Antimicrobial Resistance Surveillance (CIPARS) and C-EnterNet), use of decision making models in priority areas and dissemination of outbreak investigation results to provincial and territorial partners through the web-based Outbreak Summaries system.

22.1 a Expected Results

Increased understanding of food-borne illness risks by Health Canada, CFIA and the Public Health Agency of Canada.

Performance Indicators

% of reports tracked, # of peer-reviewed publications, # of issue papers provided to departmental colleagues and stakeholders, and # of provinces/territories using the Outbreak Summaries system.

22.1 b Results Achieved

In order to better identify and understand food safety risks, the PHAC was engaged in several activities, including surveillance, sharing of outbreak information, detection technologies, and development of risk assessment tools. Significant achievements to date include the following:

Surveillance

FCSAP funding has maintained and enhanced the Canadian Integrated Program for Antimicrobial Resistance Surveillance (CIPARS) and the National Integrated Pathogen Surveillance Program (FoodNet Canada). These surveillance programs consistently contributed valuable population-based information not available from any other sources on antimicrobial resistance in the food chain and augmented data on food-borne and gastrointestinal pathogens from FoodNet Canada. CIPARS information supported the creation and evaluation of policies to contain antimicrobial resistance and to better manage antimicrobial use in human medicine, veterinary medicine, and agricultural sectors. FoodNet Canada provided information on source attribution to identify targets for food safety interventions and to determine effectiveness of interventions. Data from both these programs were accessed to look for potential sources in provincial and national food-borne illness outbreaks.

FoodNet Canada operated in three sentinel sites in 2014-15, in British Columbia, Alberta and Ontario. Key achievements included:

  • Analysis of survey data on foodborne, waterborne and environmental exposures provided important information about potential sources of enteric pathogens.
  • In collaboration with the CFIA, information on the occurrence of enteric pathogens on bagged leafy greens and herbs was generated, to identify ongoing issues and opportunities for interventions.
  • Following an outbreak involving E. coli O157 in pork in 2014, FoodNet Canada initiated testing of ground pork and pig manure to assess the potential for this as an emerging food safety issue.
  • Sampling of sliced fruits was completed in 2014, to determine the occurrence of viruses, parasites and Listeria on the products.
  • The most likely sources of human infection for salmonellosis, verotoxigenic E. coli (VTEC) infection, and campylobacteriosis in the FoodNet Canada sites were published.
  • Analysis of domestically acquired foodborne disease data was used to provide information on sources related to gastrointestinal disease in Canada.
  • Data from FoodNet Canada provided information on severity of illness to support the development of hospitalizations and deaths estimates associated with domestically-acquired foodborne illness.

CIPARS achievements related to FCSAP funding in 2014-15 included the following:

  • Retail sampling continued in seven provinces and targeted sampling in an eighth province. Sampling included beef, pork, chicken, chicken nuggets, turkey, imported seafood and produce, in collaboration with CFIA.
  • Through retail chicken meat testing augmented by on-farm antimicrobial use and antimicrobial resistance data from the CIPARS/FoodNet Canada on-farm component, CIPARS began to monitor the impact of a national voluntary ban on ceftiofur initiated by the broiler chicken sector in the Spring of 2014 (partly in response to CIPARS data).
  • CIPARS similarly continued monitoring and communicating changes in the prevalence of Campylobacter resistant to fluoroquinolones in retail chicken meat and this was communicated at the fall CIPARS stakeholder meeting and in the CIPARS Annual Report.
  • A scientific manuscript version of the "Risk Profile of Ceftiofur-Resistant Salmonella Heidelberg of Poultry Origin", based on Codex Guidelines for Risk Analysis of Foodborne AMR and developed in part using CIPARS retail meat data, was finalized for publication. The Risk Profile shows the current state of knowledge and the risk management options for ceftiofur-resistant Salmonella Heidelberg of poultry origin.
  • CIPARS retail data continued to be regularly used by Health Canada in conducting safety evaluations to authorize the sale of antimicrobials for animal use, including post-market safety assessments of certain antimicrobials. This has resulted in label changes and a 2012 claim withdrawal of a particular use of an antimicrobial in a class considered very important to human medicine.
  • Using molecular methods, the occurrence of genes that are associated with resistance to antimicrobials of very high importance to human health (extended spectrum beta-lactamase (ESBL) and carbapenemase genes) in bacteria from animals and meat was examined using samples collected through CIPARS, including the CIPARS retail component. ESBL-producing bacteria isolated from agri-food sources are very rare in Canada but they occur in a variety of commodities and sources, including retail meat. No carbapenem resistant isolates were identified through routine surveillance.

There were seven peer-related publications relating directly to CIPARS' FCSAP activities. In addition, in 2014-15, the Agency produced Chapters 1 (Design & Methods) and Two (Antimicrobial Resistance) of the CIPARS 2012 and 2013 Annual Reports. CIPARS also presented the 2013 retail data and other surveillance findings at a multi-commodity stakeholder meeting in November 2014.

There were eight peer-reviewed publications from FoodNet Canada in 2014-15. The Agency produced the FoodNet Canada 2012 Short Report, 2013 Short Report and 2010 Long Report. In addition, data from FoodNet Canada provided information on severity of illness for generating the hospitalizations and deaths estimates of food-borne diseases in Canada, to be released in the summer 2015.

Outbreak Summaries Application

The PHAC has led the development and implementation of a platform for summarizing outbreak information. The Outbreak Summaries Application is a secure, web-based application for documenting and disseminating outbreak data in a standardized manner, which can then be used for monitoring trends in sources and risk factors, evaluating public health interventions, and informing risk assessments.

Outbreak Summaries:
  • In January 2014, PHAC developed, in collaboration with the Provincial and Territorial partners, an analysis plan for the two reports that will be published from Outbreak Summary data: a short annual report and a multi-year report.
  • In March 2015, the first report of data compiling the outbreak investigations reported through the enteric, food-borne and waterborne diseases module of the Outbreak Summary (OS) application between 2008 and 2012 was finalised and shared with Provincial and Territorial partners.
  • The application has been implemented in six provinces. Discussions are ongoing to have additional provinces and territories implement the application. In March 2015, PHAC visited Alberta and North-West Territories to promote the platform.
  • As of March 31, 2015, there were over 3,500 outbreak summaries in the system.
  • In April 2015, Ontario implemented Outbreak Summary application and uploaded their provincial outbreak investigations from 2014.
Detection

The PHAC had the capacity and continued to conduct molecular fingerprinting using Pulsed Field Gel Electrophoresis for Listeria, Salmonella spp., Shigella spp., E. coli O157:H7 and non-O157:H7 VTEC isolated by surveillance programs. As noted in previous years, the Agency also optimized and evaluated the effectiveness of next generation molecular typing methodology (Multilocus Variable Number Tandem Repeat Analysis (MLVA)).

MLVA training and certification were made available to federal, provincial, and territorial partners in 2014-15. The National Microbiology Laboratory (NML) provided on-site training to the Canadian Food Inspection Agency. Internally, six additional NML staff became certified in MLVA (E. coli O157:H7, Salmonella Enteritidis and Salmonella Typhimurium). The Agency detected and evaluated 193 separate clusters, based on real-time molecular testing and comprising both single and multi-jurisdictional postings to the PulseNet Canada discussion board (135 clusters of Salmonella, 31 clusters of E. coli O157:H7, 1 cluster of Shigella, and 26 clusters of listeriosis), which enabled follow-up and outbreak investigations to be initiated at the earliest possible stage. In 2014-15, 70% of all E. coli O157:H7 isolates were characterized by MLVA, comprising most cases and food isolates captured in the PulseNet Canada surveillance system. Genomics (DNA sequencing and genetic mapping) has been used to develop novel laboratory fingerprinting methods for Campylobacter. Testing for Campylobacter using these methods has been implemented at three sentinel sites. The Agency also continued to implement whole genome sequencing as the next generation method to further improve surveillance and outbreak detection; during 2014-15, whole genome sequencing was used to support 10 food-borne disease investigations.

Risk Assessment

The PHAC conducted quantitative risk assessment modelling to identify and compare public health risks and evaluated potential mitigation measures to prevent foodborne illness. Key 2014-15 activities included:

  • A cross-contamination model for bacteria in poultry processing chilling tanks was developed, which was published in a peer-reviewed journal. Expansions to the model are planned to broaden its application to evaluate processing practices' impacts on public health.
  • Systematic review for poultry chilling interventions to reduce Campylobacter contamination was completed and published in a peer-reviewed journal. Results will be incorporated into a risk assessment model to identify interventions to reduce public health impacts.
  • A draft model for exposures to VTEC through consumption of food and water, and direct contact with the animals and the environment was completed. This model can be used to compare relative risks among exposure routes using farm-specific information, and to compare efficacies of on-farm interventions. Model development is ongoing to incorporate FoodNet Canada data.
  • A literature review on co-morbidity and risk factors for listeriosis was completed, and will inform a risk assessment model under development to rapidly identify vulnerable subpopulations.
  • Ongoing collaboration is underway with federal and provincial partners to model risks from Salmonella in poultry in Canada and identifies potential interventions for public health.

As part of the Agency's risk assessment activities under the FCSAP, there were two peer-reviewed publications and three papers issued to departmental colleagues and stakeholders.

22.2 Targeted Oversight

Through ongoing and expanded data collection, analysis and reporting on the rates, patterns and circumstances of unintentional injury to Canadians, the PHAC will contribute to the evidence base supporting injury prevention and control.

22.2 a Expected Results

Data on accidents, injuries, illnesses and deaths due to consumer products, engagement of injury prevention stakeholders.

22.2 b Results Achieved

The Agency improved injury data by launching a real-time secure surveillance system to identify emerging hazards, injury trends, illnesses and deaths related to consumer products and other risk factors. This system operates in 17 hospitals across the country and the data collected was made available to the public through the Government of Canada's Open Data Initiative. Development of injury syndromics and identification of emerging hazards through its electronic Canadian Hospitals Injury Reporting and Prevention Program (eCHIRPP) was pilot tested and the electronic analytical query tool (eCHRIPP) was released.

As part of the continued collaboration with Health Canada, the Agency analyzed and disseminated data on select consumer products (e.g., toboggans, helmets, concussions, poisonings, scooters, detergent packets, toys, baby products, etc.) in order to strengthen the evidence base for action.

The Agency and its partners and stakeholders have published peer-reviewed journal articles using Canadian Hospitals Injury Reporting and Prevention Program (CHIRPP) data for many injuries, including those related to consumer products and worked with the Canadian Paediatric Surveillance Program to release a report from Paediatricians across Canada on injuries related to detergent packets.

The Agency developed and released a series of training webinars for query builder and an in depth site data entry manual to help improve the quality of the data collected and updated the coding manual for eCHIRPP. These documents have been rolled out and are available for sites across Canada on the eCHIRPP Collaboration Centre.

Collaboration with injury prevention NGOs (e.g. Parachute) on a series of injury products, some of which are related to consumer products such as the Cost of Injury In Canada, the development of Canadian Injury Prevention Curriculum Resource (to be launched 2015-16), both the Ontario and Canadian Injury Compass Reports.

Horizontal Health Research Initiatives

23.1 Targeted Oversight

The Canadian Institutes of Health Research (CIHR) will make investments and focus efforts in advancing the Drug Safety and Effectiveness Network (DSEN) to increase the evidence on drug safety and effectiveness available to regulators, policy-makers, health care providers and patients and to increase capacity within Canada to undertake high-quality post-market research in this area.

Work will continue on refining the DSEN Query management process, engaging decision makers, delivering on peer reviewed funding opportunities for the initiative and responding to strategic direction received from the DSEN Steering Committee.

23.1a Expected results

Increased knowledge of post-market drug safety and effectiveness to inform decisions and increased capacity in Canada to address priority research on post-market drug safety and effectiveness.

Performance Indicators

Increased knowledge of post-market drug safety and effectiveness to inform decisions.

23.1 b Results Achieved

The DSEN Coordinating Office (CO) has continuously taken action to improve program efficiency.

In 2014-15, particular considerations focused on the availability and dissemination of the results of DSEN's funded research.

The DSEN CO has published the Knowledge Translation Guidance Document for DSEN Researchers and Stakeholders. This document has been prepared to assist the DSEN community (researchers and stakeholders alike) in understanding the translation and dissemination of research results to Query Submitters and other audiences. It is intended to provide clarity and transparency on the process and make tools available in the form of adaptive procedures and templates. This, in turn, is expected to promote the dissemination, application, and impact of DSEN research results.

DSEN has also developed "DSEN Abstracts" which are high level summaries of key findings to disseminate research results to Canadian. Eight summaries are presently available on the CIHR website, in both French and English, and DSEN Researchers are preparing those for other completed projects.

The DSEN CO continued engaging with decision-makers at the provincial and territorial levels to grow and strengthen relationship with the CADTH, the Institut national d'excellence en santé et services sociaux, the Pan-Canadian Oncology Drug Review (pCODR) and provincial governments. This engagement facilitated the identification and submission of queries by the provinces, brings scientific support to the provincial drug plans and facilitates the dissemination of DSEN research outputs. Resulting from those efforts, six new queries were submitted in the first quarter of 2015 by CADTH, pCODR and provincial decision makers.

In consideration of the results of the 2013-14 evaluation of DSEN's implementation phase, DSEN renewed four of the DSEN Research Teams (i.e. SEARCH, PREVENT, CAN-AIM and MAGIC) in September 2014 in order to keep the ongoing momentum of the DSEN research capacity. The last team's renewal (CNODES) is scheduled for July 2016. Collectively the research teams for a tightly coordinated national network of over 200 researchers committed to the highest excellence in post-market drug safety and effectiveness research. Together, they create the research platform which enabled the DSEN program to respond in a timely manner to the queries as proposed by decision makers.

The Research Teams continued working to respond to priorities on the DSEN research agenda and to disseminate their research results. In 2014-15, DSEN communicated the results of 21 queries regarding specific request for drug safety and effectiveness evidence, to federal regulator or federal/provincial decision makers and 23 other queries are under research.

To support research capacity development in post-market drug safety and effectiveness, DSEN invested $315,000 over four fiscal years in the career development of two doctoral trainees, starting in 2015-16 and launched a $1,375,000 training grant, starting on November 2015, to support a national training program relevant to drug safety and effectiveness research for five years.

The seventh semi-annual DSEN meeting, held on January 23rd, 2015, focused on a review of the current strengths and limitations in responding to queries under the theme "The Canadian Mosaic of Drug Safety and Effectiveness Strategy Strengths and Limitations: Increasing Efficiency and Effectiveness". The network meetings are held to maintain and stimulate the collaboration necessary for optimal network operations and to discuss evidence needs with the research teams, Health Canada, provincial / territorial decision-makers and other organizations mandated to support federal/provincial decision making with respect to drugs.

DSEN's investments in research and capacity development mirror its two objectives. DSEN is funding research projects in response to queries proposed by decision makers but also training awards (PhD, postdoctoral and new investigator awards) and open grants to stimulate research in the specific areas of drug safety and effectiveness. As of the end of the year, the DSEN has funded over 132 projects including projects responding to queries (62 projects responding to 48 queries), 41 open grants that were not linked to specific queries and 29 capacity building activities, mostly training awards and operating grants reserved for new investigators.

Based on the results of the 2013-14 evaluation, the DSEN Steering Committee is working to develop an Action Plan to 2020 to guide DSEN's further developments.

Evaluation of the Food and Consumer Safety Action Plan

The evaluation of the FCSAP (August 2014) covers the five years of the plan. The evaluation was undertaken to fulfill the requirements of the Treasury Board of Canada's Policy on Evaluation (2009). The purpose of the evaluation was to assess the relevance and performance of the FCSAP.

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