ARCHIVED - Health Canada - Supplementary Tables

Name of Horizontal Initiative:

Food and Consumer Safety Action Plan (the Action Plan)

Name of Lead Department(s):

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

Lead Department Program Activity:

• HC: Health Products, Consumer Products, Food and Nutrition, and Pesticide Regulation
• CFIA: Food Safety
• PHAC: Health Promotion, Chronic Disease Prevention and Control, and Infectious Disease Prevention and Control
• CIHR: Strategic Priority Researc

Start Date of the Horizontal Initiative:

Fiscal Year 2008-2009

End Date of the Horizontal Initiative:

Fiscal Year 2012-2013 (and ongoing)

Total Federal Funding Allocation (start to end date):

$489.4 million over five years ending in Fiscal Year 2012-2013 (and $126.7 million ongoing)

Description of the Horizontal Initiative (including funding agreement):

The federal government is responsible for promoting the health and safety of Canadians. A key part of this role is ensuring that the 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 (Action Plan) is a horizontal initiative aimed at modernizing and strengthening Canada's safety system for food, health and consumer products. A number of recent high-profile incidents, such as lead and ingestible magnets in children's toys, contaminants in imported food products, and the global withdrawal of some prescription medicines, have underscored the need for government action.

The Action Plan modernizes Canada's regulatory system to enable it to better protect Canadians from unsafe consumer products in the face of current realities and future pressures. The Action Plan bolsters Canada's regulatory system by amending or replacing outdated health and safety legislation with new legislative regimes that respond to modern realities, and by enhancing safety programs in areas where modern legislative tools already exist. The Action Plan ensures 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 Action Plan is an integrated, risk-based plan and includes a series of initiatives that are premised on three key pillars: 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 risk assessments, strengthen recall capacity, and increase the efficiency in responding and communicating clearly with consumers and stakeholders.

In addition to addressing the concerns outlined above, the Action Plan provides a platform for Canada to actively participate in the Security and Prosperity Partnership (SPP), in particular by supporting commitments to increase the safety of imported products within North America. It also enables Canada to better align with US standards, which will have a positive impact on consumer confidence and the business climate.

Shared Outcome(s):

• 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(s):

The Minister of Health and the Minister of Agriculture and Agri-Food Canada have joint responsibility and accountability for results, and for providing information on progress achieved by the Action Plan.

A Governance Framework has been established and endorsed by all of the partner departments/agencies. To facilitate horizontal coordination, the following Director General (DG)/Executive Director (ED) level Task Forces have been established: Health Products Task Force, Consumer Products Task Force, Food Task Force, Communications Task Force, and the Legislative and Regulatory Task Force. The Task Forces report to a DG/ED level Coordinating Committee. An Assistant Deputy Minister (ADM)/Vice President (VP) level Steering Committee provides direction to the Coordinating Committee. An Oversight Committee of Deputy Heads facilitates the provision of high level guidance to the Steering Committee.

Health Canada's Strategic Policy Branch (SPB) provides the Secretariat function for the Action Plan and plays an integral role in supporting the ongoing operation and decision-making of the governance committees, oversight and integration of performance against commitments, and advice to senior management. SPB is also the lead for coordinating the implementation of the legislative and regulatory initiatives.

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

Health Canada's Health Products and Food Branch (HPFB) has primary responsibility for implementing Action Plan activities related to health products with support from Health Canada's Strategic Policy Branch (SPB) and the Canadian Institutes of Health Research (CIHR) on one initiative (increased knowledge of post-market drug safety and effectiveness).

The Canadian Food Inspection Agency (CFIA), Health Canada's Health Products and Food Branch (HPFB) and the Public Health Agency of Canada (PHAC) work together to implement Action Plan activities related to food safety.

The Public Affairs, Consultation and Communications Branch (PACCB) provides communications support for all of the above activities and will coordinate or lead many of the horizontal Departmental activities under the Consumer Information Strategy.

($ millions)

Federal Partners	Federal Partner Program Activity (PA)	Names of Programs for Federal Partners	Total Allocation (from Start to End Date)	Planned Spending for 2009-10	Actual Spending for 2009-10	Expected Results for 2009-10	Results Achieved in 2009-10
Health Canada	Health Products	Active Prevention	57.6	10.80	10.88	Increased industry awareness and knowledge of regulatory requirements	109 pre-submission meetings for biologics and pharmaceuticals. 59 pre-submission meetings with industry were held for biologics and radiopharmaceuticals. 11 oncology pre-submission meetings were held. 5 oncology submissions that had a pre-submission meeting have been received. 2 are in screening and 3 have been accepted for review. Survey not yet planned for - too early to report on this indicator. Post Market Reporting Compliance = 100% of establishments inspected were found to be at an acceptable level of compliance to the Food and Drugs Act (FDA). Human = 96.3% of clinical trials inspected were found to be at an acceptable level of compliance to the FDA. Good Clinical Practice = 90% of clinical trials inspected were found to be at an acceptable level of compliance to the FDA.
						Enhanced knowledge of post-market health product safety risks to inform decisions	Pharmacovigilance Plans (PvP) received and reviewed for 2009-10 Received: 30 Reviewed: 25 Service Standards for PvP are being developed and being piloted. No PvP were rejected, although deficiencies (if present) were noted and passed on to the Market Authorization Holders (MAH).
						Increased oversight of the risk management and risk mitigation strategies for health products	Guidance Documents specifically on Risk Management Plans - 4: Questions and Answers regarding the Implementation of Risk Management Planning Notice Regarding Implementation of Risk Management Planning including the adoption of International Conference on Harmonisation (ICH) Guidance Pharmacovigilance Planning - ICH Topic E2E Description of Current Risk Communication Documents for Marketed Health Products for Human Use Standard Operating Procedure (SOP) - Issuance of Health Professional Communications Public Communications by Sponsors Risk Management Mitigation Plan (RMMP) Received: 30 Risk Management Program (RMP) Reviewed: 25 100% of RMMP received were considered satisfactory, after clarification received from Market Authorization Holders (MAH)
						Increased safety of Active Pharmaceutical Ingredients (API) through industry compliance with the FDA and its regulations	Consultation with industry and other government departments completed on proposed regulatory framework. API inspections on hold pending regulatory amendment Stakeholder consultations on the proposed framework on Schedule - Consultation with industry and other government departments completed.
						Improved timeliness of pre-market reviews	Human Drugs - New Drug Submissions (NDS), Supplemental New Drug Submissions (SNDS), Abbreviated New Drug Submissions (ANDS), and Supplemental Abbreviated New Drug Submissions (SANDS) combined - 63% of decisions made met 90% performance target. Alternatively, when reported as new drugs vs. generics, performance was much better for new drugs with 80% meeting target (NDS (72%), SNDS (83%)). For generic drugs, 44% met target (ANDS (36%) and SANDS (71%)). The Pharmaceutical Human Drugs program continues to focus its efforts on increasing the timeliness of its pre-market decisions while targeting reduction of backlogs in both Clinical and Generic Reviews. This fiscal year, efforts were made to find efficiencies in-house, and by applying strategic use of external scientific contracting. Note: *No new hires. Funding is for review staff hired under Therapeutic Access Strategy (TAS). In addition, TAS funding was lower in FY 2009-10. BGTD maintained its target of 90% of decisions issued within target for all submission types except NDS. Type # reviewed % within target ANDS 1 100% NDS 18 66.7% SNDS 76 89.5% CTA 245 99.2% CTA-A 471 99.8% NC 433 93.8% DIN B 37 91.9%
						Increased awareness and understanding of the safe use of health products by consumers and health care professionals	A total of 52 stakeholders met with the ADM in a series of six bilateral and multilateral meetings held under the ADM Stakeholder Meeting Program. Evaluation performed and follow-up action tracked. Performance evaluation of paediatric cough and cold outreach campaign completed and shared with stakeholders. Research, internal and external consultations and needs analysis completed towards the development of a proposal to create a patient and consumer pool from which the Branch can draw engaged and informed stakeholders to participate in decision-making. E-learning module for patient and consumer stakeholders drafted. Establishing baseline data and developing tracking tools to determine number of consumers aware of risks associated with health products imported for personal use. 1. General Documents Posted by MHPD on HC Website in 3 - Risk Management & Intervention 2 - Info Gathering, Monitoring & Processing 2 - Other 2. Risk Communication Advisories/Warnings posted to HC Website (MedEffect Canada): HC issued: 108 MAH issued: 60 TPD notes that no new hires due to budgetary constraints. Creation of a Health Products Web content safety map identifying all health product Web information in preparation for adding new and revised content to the Consumer Safety Portal. An analysis of all Public Opinion Research related to consumer, food and health product safety completed. Development of a consumer-friendly advisory template and a department-wide standard operating procedure for the production of risk communications; improved use of social media (particularly Twitter) for the dissemination of advisories, warnings and recalls.
Health Canada	Health Products	Targeted Oversight	34.6	3.90	2.07	Enhanced capacity of HC and industry to identify and respond to risk issues	Periodic Safety Update Reporting (PSUR) received/reviewed 2009-2010 Marketed Health Products Directorate (MHPD) Level I (Screening) - 104/68 + 71/71 = 175/139 MHPD Level II (Full/Targeted) - 37/37 + 56/56 = 93/93 TPD (PSUR C) - 20 # of new safety signals generated through PSUR reviews: A total of 4 new signals were specifically derived from PSUR review in 2008-09. More complete statistics will be available for 2010-11, as until recently the process has been to review PSURs for which we already suspect some potential issues and that review takes the format of an "improved" Level II review. For the purpose of setting up a tracking system for PSUR, funding from HPFB- MHPD was transferred to HPFB-Therapeutic Products Directorate (TPD). TPD's Submission Processing unit in turn developed a process for putting PSURs into docuBridge� (an electronic based viewing tool) so that these safety reports could be reviewed electronically. The unit also established PSUR tracking capabilities within its Drug Submission Tracking System (DSTS) database. The unit will then provide MHPD with DSTS training and ongoing maintenance/volume reporting as required.
						Increased capacity to identify safety issues with health products on the market	Relevant legislation regarding Mandatory Reporting (MR) has not yet been passed, therefore, no adverse reactions (AR) have been received under MR. 100% of priority AR reports (outcome of death or life threatening and reports of interest) addressed within established service standard (15 days). Performance standards for all other reports have been implemented for FY 2010-11. Performance standards are being piloted. Results to be analyzed 2010-11 (Note - new legislation is required in order to make reporting mandatory) Some data for Q4 not yet available Pharmaceutical AR Reports received YTD: 11,759 Note that a breakdown of completion by product line is not yet available from the Canada Vigilance system Total Domestic AR Reports received (all product lines): 27,139 (increase of 20.7% from previous fiscal year) Domestic AR Reports Completed Workflow: 30,314 100% of AR Reports received are processed, additional reports completed includes reports previously pending workflow completion. Signal Assessment & Review: Signals Prioritized: 29 Signals Completed: 54 Remaining outstanding: 11 Note that a breakdown of Risk Communications by Product Line is not yet available Total Risk Communications Issued: HC Issued: 108 Previous FY: 102 Market Authorisation Holders (MAH) Issued: 60 Previous FY: 60
						Increased knowledge of post-market drug safety and effectiveness to inform decisions Increased capacity in Canada to address priority research on post-market drug safety and effectiveness	Also see: Canadian Institute for Health Research, Strategic Priority Research, Targeted Oversight DSEN partners have engaged international partners implementing related initiatives (e.g. EnCepp in EU; Sentinel in U.S) to share best practices and explore opportunities for data sharing. Health Canada (HC) and CIHR collaborated to develop the DSEN Performance Measurement and Evaluation Framework which will be submitted for approval by senior HC and CIHR management in Spring 2010. HC and CIHR collaborated to hold a Best Brains Exchange in March 2010 titled "The Methods Gap: What Can Pharmacoepidemiology Tell Decision Makers About Drug Safety and Effectiveness?" This one day event brought together Canadian and international drug policy decision makers (including senior officials from HPFB) and scientific researchers to discuss and promote international collaboration on actions to improve the availability and quality of information required to make evidence-based decisions. Based on survey, overall participant satisfaction for the event was 84%, with an average score in meeting participants' top two expectations at an average of 76. The Health Canada DSEN Implementation Project Team was established by HPFB. One goal of this Team (composed of representatives from HPFB and FNIHB) is to collate research questions from HC staff for consideration as part of the DSEN's national research agenda. Two calls for HC research questions for the DSEN to undertake were made during this period with questions from the first round submitted to Canadian Institute for Health Research (CIHR) for consideration in the launch of the first DSEN funding opportunity.
						Improved ability to monitor and control importation of health products	National Customs Refusal Database in final stages of development and planned to be rolled out early FY 10/11. This will permit tracking of shipments refused entry that were referred to Health Canada due to an import alert. Once a database is implemented a target can be established in FY 11/12. All importers of inadmissible health products notified of the violation. Health Canada "Its Your Health" information sheet regarding dangers of buying drugs over the Internet, letter from RCMP regarding counterfeit drugs, copies of Public Warnings/Advisories and/or refusal notices sent to personal use importers as appropriate. Health Canada is looking at other communications pieces to warn Canadians of dangers of counterfeit drugs and medical devices.
Health Canada	Health Products	Rapid Response	Existing Resources	0.00	0.00	Improved ability to respond with better tools when safety incidents occur	New tools on hold due to delay in new legislation.
Health Canada	Consumer Products	Active Prevention	41.0	4.16	2.47	Increased awareness and understanding of product safety obligations by consumer products industry	Key to supporting industry awareness of product safety obligations is the development of industry guides for consumer products. In 2009-10 a number of guides were completed (e.g. lighter requirements, children's jewellery, tents, second hand products) Included were updates to the following publications: Guide to Cosmetic Ingredient Labelling Quick Reference Guide to the Hazardous Products Act for Manufacturers, Importers, Distributors and Retailers, 2009.
						Increased awareness and understanding of standards by consumer products industry	A Memorandum of Agreement with Standards Council of Canada in place to support consumer & small business participation in the National Standards System Implementation and support of ISO product safety standard with Canadian Safety Association Trilateral collaboration between Health Canada, the US Consumer Product Safety Commission (CPSC) and the European Union has begun to identify solutions for addressing corded window covering products. Crib standards and test methods are in the process of being adopted by US CPSC and the American Society for Testing and Materials (ASTM). Machinery Noise Declaration standards have been drafted. Second draft document completed of revisions to the Canadian Mammography Quality Guidelines. Ongoing lead of, and participation in, standards committees, e.g. International Electrotechnical Commission & Organization for International Standardization in areas of acoustics, electromagnetics, X-ray devices & laser and electro optics.
						Increased awareness and understanding of consumer product safety issues by consumers	Consumer Product Safety publications continue to be popular with stakeholders and the public in general. Is Your Child Safe is the most popular and covers many common subjects relevant to homes with children. Just under 200,000 copies were circulated in both official languages. Second on the list is Safety with Radar - popular for children's events - approximately 50,000 copies were circulated. Launch of the online consumer safety portal with a complete user-friendly section on children's products, social media features, a survey and easy-to-navigate design. Development of a consumer-friendly advisory template and a department-wide standard operating procedure for the production of risk communications; improved use of social media (particularly Twitter) for the dissemination of advisories, warnings and recalls. Promotion of the new consumer product safety online complaint/incident form. Safety Code 6 (2009) associated communications products, such as fact sheets & FAQs have been developed. The following Its Your Health documents were published on the HC Internet: 1) Airport Body Scanners 2) the Safety of Compact Fluorescent Lamps. Drafting of revisions to It's your Health documents 1) Community Noise Annoyance, 2) Aircraft Noise & 3) Personal Stereo Systems Noise (awaiting publication). Updated the HC Internet page on sun safety. Complete analysis of Web sections for Consumer, Food and Health product safety pages (800+ Web pages) was completed New Web page dedicated to showcasing Health Canada's social media Four social bookmarking sites added to the Health Canada site (Digg, Delicious, Facebook and Twitter) New YouTube channel created just for Health Canada and launched December 23, 2009. More than 2,000 followers on Twitter receiving instant updates on consumer recalls, advisories and warnings. Horizontal development of a clear writing guide for the department. Launch of the department's first widget, allowing users to attach a self-updating feed to their own websites for news on Health Canada's advisories, warnings and recalls. The Contact Centre put in place a new software system designed to track and consolidate consumer inquiries (2009 statistics: approximately 22,224 calls and 28,536 emails were handled by the Contact Centre)
Health Canada	Consumer Products	Targeted Oversight	15.7	2.10	1.15	Improved timeliness and quality of information on consumer product safety	In 2009-10 Health Canada, Consumer Product Safety had a total of 7,844 unique subscribers. Consumers are now able to subscribe to product safety information being published (e.g. advisories, warnings and recalls) in both official languages. Product safety complaints/incidents have been steadily increasing over the last four years (2006-07 567 complaints; 2007-08 - 672; 2008-09 - 944; 2009-10 - 1102). Of the 1,102 complaints received in 2009-10, Health Canada met its service targets, responding to 100% of complainants and met its service standard following-up with 100% of companies. Depending on the severity of the incident reported, actions could include product inspection with follow-up and enforcement actions, including recall or public advisory, as appropriate. In addition, follow-up with the companies in question to ensure appropriate actions have been completed. Data suggests the increase in reporting by consumers is linked to the increase in subscriptions to the recall website and is an indicator of increased consumer awareness of risks associated with consumer products.
						Improved Cosmetic Regulations under the FDA	Amendments to the Cosmetic Regulations under the Food and Drugs Act were drafted, however; amendments were not introduced into the House due to the prorogation of Parliament. Work was initiated on the use of Sunscreen by consumers (for purposes of classification regulation). Through increased capacity and improved efficiency the notification process for cosmetics resulted in the reduction of the backlog to almost zero. Future improvements to IT systems will further improve the processing of notifications.
						Increased sharing of information with international regulators	Continued implementation of the Memorandum of Understanding with China on the safe manufacturing of consumer products. A number of technical working group meetings were completed. Preliminary discussions have occurred with Vietnam. MOU with EU being addressed under FT negotiations. Ongoing bilateral discussions with the US and Australia. Continued participation as a member of the Scientific Oversight Committee, which oversees the International Electromagnetic Frequency (EMF) Project (World Health Organization). This project gathers information regarding completed, active and proposed research into the effects of electromagnetic radiation on human health. Ongoing lead of, and participation in, standards committees, e.g. International Electrotechnical Commission & Organization for International Standardization in areas of acoustics, electromagnetics, X-ray devices & laser and electro optics.
Health Canada	Consumer Products	Rapid Response	17.9	3.40	3.95	Improved legislative authority and regulatory tools for consumer products	Due to the prorogation of Parliament in 2009-10 the Canada Consumer Product Safety Act (CCPSA) did not receive Royal Assent. The CCPSA (Bill C-36) was re-tabled in the House of Commons on June 9, 2010.
						Improved legislative authority and regulatory tools for radiation-emitting devices	Completed international environmental scan, and held a consultation workshop with internal Health Canada collaborators. Review and analysis of existing public opinion research and stakeholder concerns listed on the PWGSC web site concerning radiation emitting devices. Developed proposal outlining evidence needed to summarize health and safety risks associated with radiation emitting devices to feed into the Issue Analysis Summary. Legal analysis of REDA authorities is ongoing. Developed work plan for enhanced collaboration with the Medical Devices Bureau and the HPFB Inspectorate.
						Improved monitoring of consumer and cosmetic products	In 2009-10 compliance and enforcement activities continue as per cyclical enforcement plan: Toys - heavy metals: 2009-2010: 55 samples- 89% compliant (2008-09: 95%) Toys - noise: 2009-2010: 120 samples - 100% compliant (2005-06: 96%) Utility Lighters: 2009-2010: 15 samples- 7% compliant Halloween costumes: 2009-2010: 22 samples- 95% compliant (2008-09: 84.2%) Glazed Ceramics: 2009-2010: 121 samples- 92% compliant (2004-05: 67%) Children's products e.g. furniture, learning products: 2009-2010: 31 samples- 90% compliant (2007-08: 79%) Children's Jewellery: 2009-2010: 107 samples- 60% compliant (2008-09: 74%)
Health Canada	Pesticide Regulation	Active Prevention	6.9	1.34	1.15	Increased industry (manufacturers and retailers) awareness of risks and related regulatory requirements	Completed analysis of information relevant to program design/delivery to be initiated in 2010-11 related to quality assurance for pesticide manufacturing. Contributed to ongoing internal discussions relating to treated articles policy/regulatory approach that included some discussions vis a vis compliance approach. Ongoing work related to vendor knowledge of and related capacity to comply with legislation e.g., only offer for sale registered products. New program methodology for active prevention related to the use of structural pest control products by property managers was developed to provide further insight into causality i.e., why compliance exists/does not exit. Ongoing discussions with FPT on possible consumer product related programs/activities. Some interest related to Active Prevention related to the use of unregistered non conventional products e.g., garlic. Additional work completed aimed at creating further transparency related to compliance work and decisions.
Health Canada	Pesticide Regulation	Rapid Response	8.0	1.00	0.76	Improved monitoring of pest management products using a risk management approach	Targeted inspections were conducted of manufacturers and vendors of consumer products. More than 200 vendors of pet products inspected nationally - with lack of knowledge of regulatory requirements being the key reason for non-compliance. Some work done in relation to border integrity (under HC Improving Together pilot project). Consultations held with US EPA colleagues in relation to common challenges related to imported unregistered products, false and misleading product claims, best practices. In BC, Quebec and Ontario, a number of detected situations of non-compliance resulted in follow up. Many non-compliant consumer products were for use on pets.
Health Canada	Food Nutrition	Active Prevention	29.6	4.90	4.78	Establishment of the appropriate instrument or mix of instruments, including regulatory and non-regulatory measures (standards, policies, etc.) to address immediate areas of concern	HC developed and published several guidance documents that provided Canadians with better information on what they are eating and how to handle food safely, e.g., caffeine, allergens, fresh produce and powdered infant formulas. As part of its Amendments to the Food Additive Tables, Health Canada published 9 Interim Marketing Authorization notices in Canada Gazette Part I. Health Canada published in Canada Gazette Part II three regulatory amendments for food additives for a total of 13 submissions. Amendments have been drafted for several other additives and publication is expected in Summer 2010.
						Increased understanding of food safety risks by HC, PHAC & CFIA	Risk mapping model and tool has been developed and implemented. Risk profiling & prioritization activities underway.
						Increased engagement by Canadians in the regulatory system Increased industry knowledge regarding food labelling	Public consultations, including an on-line consultation were completed on the enhancement of the system for precautionary labelling of allergens in food. The purpose of the consultations was to provide stakeholders the opportunity to comment on whether and how precautionary labelling on food should be regulated. As well, HC hosted two technical consultations 1-to permit the use of the enzyme asparigenese -2- Proposed maximum limits for the presence of Mycotoxin Ochratoxin A in foods. Contribution to the Nutrition Facts Education Initiative (NFEI), a collaboration between Health Canada and the food industry's trade association - Food and Consumer Products Canada (FCPC), to help further nutrition labelling education with Canadians. A three-year food safety campaign was launched, starting with relevant Public Opinion Research, development of creative aspects, media planning, printing, and Web development. A radio ad campaign promoting Safe Food Handling for Adults 60+ ran nationally from March 22nd - 31st. More than 90,000 safe food handling HC publications shipped from the distribution centre in 2009-2010.
						Increased industry understanding of and engagement in the development and implementation of food safety risk mitigation processes Improved international collaboration in addressing common import risks	The departmententered into a number of formal arrangements (Letters of Understanding, Memoranda of Understanding) with major International regulatory counterparts to enhance collaboration (e.g., European Food safety Authority (EFSA), Australian National Measurements Institute (NMI).) to support rapid information sharing and to facilitate work sharing opportunities. The department formed collaborations with several national and international partners to validate, develop, disseminate and advise on laboratory testing methods related to the four FCSAP priority areas (allergens, natural toxins, emerging foodborne pathogens and bioactives). The Executive Board of the World Health Organization (WHO) adopted the resolution Advancing Food Safety Initiatives. The resolution, led by HC and other Canadian partners, aims to advance global food safety initiatives and augments the recommendations in earlier resolutions. HC has begun to increase its engagement of stakeholders and the public. Most importantly, it has established a Food Regulatory Advisory Committee to provide broad expert advice on matters related to the safety and nutritional quality in food.
Health Canada	Food Nutrition	Rapid Response	1.3	0.20	0.17	Increased public understanding of food safety risks, alert systems and safety systems	A survey was conducted in February 2010 by Ekos for HC, the conclusions of which provided useful information regarding Canadians' knowledge and behaviours related to food safety.
Canadian Food Inspection Agency	Food Safety	Active Prevention	114.2	20.10	16.40	Increased understanding of food safety risks by HC, PHAC & CFIA	Risk mapping model and tool has been developed and implemented. Risk profiling & prioritization activities underway.
						Establishment of the appropriate instrument or mix of instruments, including regulatory and non-regulatory measures (standards, policies, etc.) to address immediate areas of concern	Development of proposed regulatory regime for the imported food sector.
						Increased industry understanding of and engagement in the development and implementation of food safety risk mitigation processes Improved international collaboration in addressing common import risks	Importer licensing policy approved. Engagement of international partners specifically with through agreements with China, enhancement to Mexico agreement, and with the US. Requirements documentation for identification & verification of IMFS drafted. Internal & government partners consultation complete on Guide to Food Safety.
						Increased engagement by Canadians in the regulatory system Increased industry knowledge regarding food labelling	Consultations planned for the purposes of regulatory amendments. CFIA conducted consultations with stakeholders on Guide to Food Safety.
Canadian Food Inspection Agency	Food Safety	Targeted Oversight	77.0	13.20	8.30	Increased verification of industry food safety measures	9 new inspector training courses are in various stages of development to support enhanced inspection.
						Improved ability to monitor and control importation of food	Preliminary Project Approval (PPA) for the IM/IT Enabled Business Projects granted by Treasury Board. Implementation of foundational elements under PPA continues. Development of EPA submission for functional enhancements continues. 40 port of entry investigations completed. 107 post-entry verifications conducted. 6 targeted inspections since December 1st (BC West).
Canadian Food Inspection Agency	Food Safety	Rapid Response	32.2	6.00	8.60	Timely and efficient recall capacity	Increased hiring and training of inspection staff.
						Increased public understanding of food safety risks, alert systems and safety systems	Farm to Fork and Safe Food Handling videos were recorded in February. The public opinion research campaign was launched in February with the goals of identifying the public's confidence in food safety in Canada and other countries, of reporting on awareness of food recalls, and of identifying the resources the public use to gather information on food safety. Brochures for at-risk populations (the elderly, pregnant, and immuno-suppressed) are in progress, and may be released in collaboration with Health Canada, who are working on a similar initiative. The Food Safety Portal has begun to be communicated to establishments such as restaurants and retirement homes, and a social networking strategy is coming into effect. The CFIA is responding to public and industry queries as a result of increased awareness of the FCSAP. A number of stakeholder outreach initiatives, including industry and consumer conferences, information sessions, and workshops.
Public Health Agency of Canada	Infectious Disease Prevention and Control	Active Prevention	18.3	4.00	3.20	Increased understanding of food safety risks by HC, PHAC, & CFIA	Surveillance (C-Enternet) activities were expanded to include sampling/testing to identify high risk imported products to target for prevention. Identification of pathogens; also established MoA and started activity at a second sentinel site in BC. Next-generation laboratory method (MLVA) jointly developed and evaluated for E. coli and Salmonella by PHAC with US CDC. PulseNet Canada is nearing rollout of the E. coli MLVA method to all PulseNet Canada members. New technology platforms have been assessed for future use in increasing capacity for real time surveillance of enteric bacterial disease. Expansion of the capacity of PHAC's web-based outbreak summary reporting system, developed with P/T input, which allows standardized dissemination of the results of disease outbreak investigations. Following the 2008 launch of an Enteric Module of the application in BC, both the Enteric Module and the Respiratory and Vaccine Preventable Disease Module were launched in NS in October 2009. PHAC is working with partners towards the launch of the application in other P/Ts throughout 2010. PHAC - New technology platforms have been assessed for future use in increasing capacity for real time surveillance of enteric bacterial disease.
Public Health Agency of Canada	Health Promotion/Chronic Disease Prevention and Control	Targeted Oversight	8.0	1.00	0.47	More and better data on accidents, injuries, illnesses and deaths due to consumer products Engagement of risk assessment stakeholders	CCMED database development continued CHIRPP expansion Knowledge translation and dissemination through CHIRPP reports and Injury in Review - focus on Consumer Product Safety
Canadian Institute of Health Research	Strategic Priority Research	Targeted Oversight	27.1	2.30	1.90	Increased knowledge of post-market drug safety and effectiveness to inform decisions Increased capacity in Canada to address priority research on post-market drug safety and effectiveness	Also see: Health Canada, Health Products, Targeted Oversight The establishment of the DSEN Coordinating Office at CIHR was completed with the appointment of the DSEN Executive Director in January 2010. CIHR opened nominations for membership to the DSEN Steering Committee (DSC) in February 2010. The DSC membership is targeted to be named in Spring 2010. The DSC will advise on the strategic direction and research priorities of the DSEN. Senior management from SPB and HPFB (three members) will represent HC on this committee. CIHR launched the Catalyst Grant: Drug Safety and Effectiveness in Aug 2009 resulting in 14 research projects being funded in March 2010 using the $1 million DSEN grants and an additional $0.33 million funded through partnerships with 5 CIHR Institutes/Initiatives valuing $0.33 million for a total research investment of $1.33 million. The first DSEN research is anticipated to be completed in the spring of 2011, and dissemination of the research evidence and knowledge translation will start after the spring of 2011.
Total			489.4	78.40	66.23

Comments on Variances:

Health Products	In 2009-10 the pre-submission meeting with industry target was not achieved. This was due primarily to backlog and other work load pressures. Additionally, the process has been in place for a number of years, hence there might be an understanding as to when to request a meeting and the type of questions and information that would require a meeting. The target for mandatory reports processed was not achieved as a result of staff turnover and Branch budget limitations in the Pharmacovigilance unit. Limited staffing now initiated within 2010-11 budget allocations. With Border Integrity two performance measures listed are not the most representative of the programs success. As the program develops and evolves in 2010/11, the available tools will be reviewed and more representative performance measures will be developed.
Consumer Products	Due to the prorogation of Parliament in 2009-10, Royal Assent of the proposed Canada Consumer Product Safety Act did not take place. Several planned activities, including staffing, were deferred which resulted in a variance of ~1M. The planning schedule for the development of IT systems for Mandatory Reporting of Product Safety Incidents was amended due to delays in the passage of the proposed Canada Consumer Product Safety Act, which includes provisions for mandatory reporting. This resulted in a planned transfer of 1M in O&M funds for system development to be deferred until 2010-11.
Food Safety	The second year of the Food and Consumer Safety Action Plan for the CFIA saw a continued effort to provide the necessary training to enhance the capability of for the additional capacity acquired in year one . Additionally, foundational work in a number of areas (e.g. establishment of policies) was completed, which will facilitate achievement of expected outcomes. Funds lapsed are being carried forward.

Results to be achieved by non-federal partners (if applicable):

N/A

Contact information:

H�l�ne Quesnel, Director General
Policy Development Directorate
Strategic Policy Branch
Health Canada
Telephone: (613) 952-3484
E-mail: helene_quesnel@hc-sc.gc.ca

Weblinks

• Healthy Canadians
• Consumer Product Safety
• Consumer Product Recalls
• Advisories, Warnings & Recall-Food &Nutrition
• Avis, mises en garde et retraits - Aliments et nutrition
• Allergy Alerts-Food Allergies and Intolerances
• Alertes � l'allergie - Les allergies alimentaires et les intol�rances alimentaire
• Produce Safety
• Salubrit� des fruits et l�gumes frais
• Safe Food Handling
• � bas les BACt�ries! - Manipulation hygi�nique des aliments
• Manipulation hygi�nique des aliments
• Food Allergen Labelling - Health Canada
• �tiquetage des allerg�nes alimentaires - Sant� Canada
• Safe Food Handling Guide
• Consumer Safety Portal

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Name of Horizontal Initiative:

Early Childhood Development and Early Learning and Child Care

Name of Lead Department(s):

Health Canada (HC)

Lead Department Program Activity:

First Nations and Inuit Health Programming and Services

Start Date of the Horizontal Initiative:

ECD - October 2002
ELCC - December 2004

End Date of the Horizontal Initiative:

ECD Strategy - ongoing.
ELCC Single Window - ongoing.

Total Federal Funding Allocation (start to end date):

$365 million 2002-03 to 2006-07 (ECD $320 million and ELCC $45 million). ECD $65 million and ELCC $14 million/year on going.

ECD: $320 million 2002-03 to 2006-07 ($60 million in 2002-03 and $65 million thereafter). $65 million per year ongoing.

ELCC: $45 million 2005-06 to 2007-08 ($14.5 million in 2005-06; $15.3 million in 2006-07; $15.2 million in 2007-08). $14 million/year ongoing.

Description of the Horizontal Initiative (including funding agreement):

The ECD Strategy for First Nations and Other Aboriginal Children was announced on October 31, 2002. The strategy provides $320 million over five years to: improve and expand existing ECD programs and services for Aboriginal children; expand ECD capacity and networks; introduce new research initiatives to improve understanding of how Aboriginal children are doing; and work towards the development of a "single window" approach to ensure better integration and coordination of federal Aboriginal ECD programming.

In December 2004, as first phase of a "single window", Cabinet approved an additional $45 million over three years ($14 million ongoing) to improve integration and coordination of two ECD programs-- Aboriginal Head Start on Reserve and the First Nations and Inuit Child Care Initiative-- beginning in 2005-06.

The objectives of these funds are to increase access to and improve the quality of ELCC programming for First Nations children on reserve, and improve integration and coordination between the two programs through joint planning, joint training and co-location.

Joint planning will also include INAC-funded child/day care programs in Alberta and Ontario.

Shared Outcome(s):

The federal ECD Strategy complements the September 2000 First Ministers F/P/T 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 funding approved in December 2004 for ELCC for First Nations Children Living on Reserve and Working Towards the First Phase of a Single Window" complements funding released to provinces and territories under the March 2003 Multilateral Framework for Early Learning and Childcare (ELCC) to improve access to ELCC programs and services.

Governance Structure(s):

• Interdepartmental ECD ADM Steering Committee;
• Interdepartmental ECD Working Group.

($ millions)

Federal Partners	Federal Partner Program Activity (PA)	Names of Programs for Federal Partners	Total Allocation (from Start to End Date)	Planned Spending for 2009-10	Actual Spending for 2009-10	Expected Results for 2009-10	Results Achieved in 2009-10
1. Health Canada	First Nations and Inuit Health Programming and Services	a. Aboriginal Head Start on Reserve (AHSOR)	107.595 (2002-03 through to 2006-07; 21.519/year). 21.519/year ongoing. Committed in 2002. 24.000 (2005-06 through to 2007-08, 7.500 in 2005-06, 8.300 in 2006-07; 8.200 in 2007-08). 7.500 in 2008-09 and ongoing Committed in 2005.	21.519 7.500	27.293 (ECD and ELCC)	Program support and enhancement Increase integration, coordination, access, and quality	Approximately one third of AHSOR sites across Canada use outreach/home visiting as a way of increasing the number of children that they are able to serve, and a significant number of these sites rely on outreach/home visiting as the sole means of providing services to children. In 2009-10, a review of AHSOR Community Exchange Program was completed which provided a clear picture of the progress of the program, the perceived benefits and challenges for participants, the lessons learned to date and recommendations for future improvements. The program objective is to provide an opportunity to AHSOR community workers to share their knowledge and experiences and to explore how other First Nations communities operate their AHSOR sites. Work continues with partner departments to improve integration and coordination among AHSOR, Human Resources and Skills Development Canada's (HRSDC) FNICCI, and INAC funded daycares in Alberta and Ontario.
		b. Fetal Alcohol Spectrum Disorder - First Nations and Inuit Component (FASD-FNIC)	70.000 (2002-03 through to 2006-07; 10.000 in 2002-03 and 15.000 thereafter). 15.000/ year ongoing. Committed in 2002.	15.000	13.272	Complete the Mentoring Project Special Study to guide mentoring projects and to provide further training and support Support and evaluate FASD Community Coordinator pilot projects towards the development of an evidence-based project framework Develop strategies to incorporate findings on support for FN/I women with addictions	The FNIHB FASD Mentoring Program Special Study was completed in March 2010. Nine FASD Community Coordinator pilot projects have been completed. Eight of the projects participated in a group review process and three have completed their individual consultations. The remaining individual consultations will be completed by June 2010. Year one of the two year project was successfully completed.
		c. Capacity Building	5.075 (2002-03 through to 2006-07; 1.015/year). 1.015/ year ongoing. Committed in 2002.	1.015	0.868	Increase capacity with National Aboriginal Organizations Enhance capacity of community ECE practitioners	As part of the 2002 Federal Strategy's capacity-building component, Health Canada provides funding to build capacity and expertise relating to early childhood development to National Aboriginal Organizations. In 2009-10, funds were provided to the Assembly of First Nations (AFN), the Inuit Tapiriit Kanatami (ITK), and the Native Women's Association of Canada (NWAC). As well, Indian and Northern Affairs Canada is providing annual funding to Pauktuutit Inuit Women of Canada. In 2009-10, funding enabled these organizations to contribute to the development of the Federal Strategy through strategic planning and capacity building in their own organizations. Funding from the Federal Strategy also continued to support the development of an Aboriginal service providers' network named the Aboriginal Children's Circle of Early Learning (ACCEL). During 2008-09, ACCEL was updated and maintained by the National Aboriginal Health Organization (NAHO). Horizontal training funding was provided to regions to support training for ECD workers in AHSOR and FNICCI sites. HC is working to develop a training strategy for ECD and other community workers that will lead to culturally appropriate training and certification of providers of healthy child development programming on reserve, and support coordination between HC, HRSDC and INAC programs.
2. PHAC	Child and Adolescent Health Promotion	a. Aboriginal Head Start in Urban and Northern Communities (AHSUNC)	62.880 (2002-03 through to 2006-07; 12.576/ year and ongoing. Committed in 2002.	12.576	10.788	Enrolment in the AHSUNC program has increased by almost 10%. Program expansion and enhancement will address the increasing special needs requirements of children and provide staff with the tools to address these needs.	AHSUNC program has maintained enrolment levels (i.e. 6.1% increase of children since 2004). Expansion of services and support for at-risk children and their families includes increased use of assessment tools to screen for special needs and developmental delays.
	Child and Adolescent Health Promotion	b. Capacity Building	2.500 (2002-03 through to 2006-07; 0.500/year) and ongoing Committed in 2002	0.500	0.236	Increased capacity	Capacity building and increased capacity in early child development program evaluation through training workshops (Evaluation and Brigance Screen overview) and meetings in Halifax and Ottawa.
3. HRSDC	Lifelong Learning- Health Human Resources (HHR)	a. First Nations and Inuit Child Care Initiative (FNICCI)	45.700 (2002-03 through to 2006-07; 9.140/year) and ongoing. Committed in 2002 21.000 (2005-06 through to 2007-08; 7.000/year). 6.500/ year ongoing. Committed in 2005	9,140 and on-going 6,500 and on-going	9,140 6,500	Program expansion and enhancement Increase program integration, coordination, access and quality	Approximately 8,500 child care spaces supported in 462 First Nations and Inuit sites and administered through 58 Aboriginal Human Resource Development Agreement (AHRDA) holders.
	Lifelong Learning- HHR	b. Research and Knowledge	21.200 (2002-03 through to 2006-07); 4.240/year and ongoing. Committed in 2002.	4,240 and on-going	0,900 for ACS 0,700 for AUEY	Information on the well-being of Aboriginal children through an Aboriginal Children's Survey (ACS) and the Aboriginal component of "Understanding the Early Years" (EUY).	Data from the 2006 Aboriginal Children's Survey were released in October 2008 and made available to the policy research community. Series of papers, profiles and presentations on well-being of First Nations, M�tis and Inuit children have been produced or are under preparation. The project with the Prince Albert Grand Council, under the Understanding the Early Years initiative (UEY), engaged the community and completed its data collections. Several other UEY projects included activities for Aboriginal children and their families.
4. INAC	The people- social development	a. Family Capacity Initiatives	5.050 (2002-03 through to 2006-07; 1.010/year 2007-2008 and ongoing. Committed in 2002.	1.010 and on-going	0.999	Partnerships with other government departments and First Nations to support increased coordination/integration of ECD programs and services	Provided capacity funding to Pauktuutit Inuit Women of Canada, supported Health Canada and the Public Health Agency of Canada to fund research, and supported Inuit Tapiriit Kanatami for a National Inuit Gathering.
Total			ECD: 320.000 (60.000 in 2002-03 and 65.000/year through to 2006-07); 65.000/year ongoing. ELCC: $45.000 (14.500 in 2005-06; 15.300 in 2006-07; 15.200 in 2007-08); and $14.000/year ongoing.	ECD: 65.000/ year ongoing. ELCC: 14.000/ year ongoing.

Comments on Variances:

HRSDC is currently evaluating the possibility of merging data collections on Aboriginal adult and children within an overall Aboriginal data strategy, in which INAC will assume the leadership.

The Aboriginal component of Understanding the Early Years initiative: While the planned spending column reflects an ongoing allocation of $800,000, the actual spending column reflects the actual funds ($700,000) transferred annually to the Initiative.

PHAC planned spending represents the total program budget including departmental corporate costs. Actual expenditures are net of corporate costs (EBP and salary), resulting in an over-estimation of variances.

Results to be achieved by non-federal partners (if applicable):

N/A

Contact information:

Cathy Winters
Senior Policy Coordinator
Children and Youth Division
First Nations and Inuit Health Branch, Health Canada
Postal Locator: 1920D Tunney's Pasture, Ottawa
Telephone: (613) 952-5064
Fax: (613) 952-5244
E-mail: cathy.winters@hc-sc.gc.ca

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Name Horizontal Initiative:

Federal Tobacco Control Strategy 2007-2011

Name of Lead Department(s):

Health Canada (HC)

Lead Department Program Activity:

3.4 Substance Use and Abuse

Start Date of the Horizontal Initiative:

2001-02

End Date of the Horizontal Initiative:

2007-08 and ongoing

Federal Funding Allocation:

$368.5 M

Description of the Horizontal Initiative (including funding agreement):

The FTCS establishes a framework for a comprehensive, fully-integrated, and multi-faceted approach to tobacco control. It is driven by the longstanding commitment of the Government of Canada to reduce the serious and adverse health effects of tobacco for Canadians. It focuses on four mutually reinforcing components: prevention, cessation, protection, and product regulation.

Shared Outcome(s):

The long-term outcome of the FTCS is to reduce tobacco-related disease and death in Canada.

To pursue this long-term outcome, the FTCS will contribute the following tobacco control goal and objectives for April 1, 2007 to March 31, 2011.

Goal: Reduce overall smoking prevalence from 19% (2005) to 12% by 2011.
Objectives:

• Reduce the prevalence of Canadian youth (15-17) who smoke from 15% to 9%;
• Increase the number of adult Canadians who quit smoking by 1.5 million;
• Reduce the prevalence of Canadians exposed daily to second-hand smoke from 28% to 20%;
• Examine the next generation of tobacco control policy in Canada;
• Contribute to the global implementation of the World Health Organization's Framework Convention on Tobacco Control; and
• Monitor and assess contraband tobacco activities and enhance compliance.

Governance Structure(s):

Resources for the implementation of the FTCS were allocated to a number of departments and agencies. HC is the lead department in the FTCS and is responsible for regulating the manufacture, sale, labelling, and promotion of tobacco products as well as developing, implementing and promoting initiatives that reduce or prevent the negative health impacts associated with smoking.

The partner departments and agencies are:

• Public Safety Canada (PSC): administers contribution funding for monitoring activities in connection with determining levels of contraband tobacco activity. PS also provides policy advice and support on smuggling issues and leads Canada's delegation that is negotiating an international protocol on illicit trade in tobacco products
• Office of the Director of Public Prosecutions (ODPP): responsible for monitoring federal fines imposed in relation to tobacco and other types of offences, and for enforcing and recovering outstanding fines
• Royal Canadian Mounted Police (RCMP): responsible for the enforcement of laws in relation to the international movement of tobacco products (including the illicit manufacture, distribution or possession of contraband tobacco products)
• Canada Revenue Agency (CRA) (formerly the Canada Customs and Revenue Agency): responsible for ensuring the assessment and collection of tobacco taxes and monitoring tobacco exports.
• Canada Border Services Agency (CBSA) (previously part of the former Canada Customs and Revenue Agency): responsible for monitoring and assessing of the contraband tobacco market in Canada and internationally, as well as improving the administration of assessment and collection of new tobacco taxes on imported tobacco.

($ millions)

Federal Partners	Federal Partner Program Activity (PA)	Names of Programs for Federal Partners	Total Allocation (from Start to End Date)	Planned Spending for 2009-10	Actual Spending for 2009-10	Expected Results for 2009-10	Results Achieved in 2009-10
HC	Substance Use and Abuse	FTCS	$287.34	$52.88	$49.51	The FTCS has set a 4-year goal to: Reduce overall smoking prevalence from 19% (2005) to 12% by 2011. All activities are expected to contribute towards achieving this result.	Latest available data (2008) reported a 17.9% overall smoking prevalence. The results below contribute to Health Canada's efforts to reduce the overall smoking prevalence to 12% by 2011. 84.3% of tobacco retailers are in compliance with regulations restricting underage youth from purchasing tobacco products, marking a significant increase from 69.8% in 2000. A step forward in improving the regulatory framework controlling tobacco was Health Canada's support to the Government for the passage of Bill C-32, Cracking Down on Tobacco Marketing Aimed at Youth Act, which received Royal Assent in October 2009 and will help to reduce the use of tobacco products by Canadian youth. Program results show that Health Warning Messages on tobacco product packaging are effective, and retail compliance continues to be high.
PSC	N/A	FTCS	$3.05	$0.61	$0.61	Enhanced partnership arrangement with Akwasasne Mohawk Police. Leading in preparation and participation in the World Health Organization Framework Convention on Tobacco Controls.	See results achieved by Non-federal Partners below. Public Safety leads the Canadian Delegation in the preparation and participation to negotiate a global Protocol to reduce illicit tobacco which takes place in Geneva. Two sessions of the Intergovernmental Negotiating Body (INB) took place in 2009-10, in June/July and in March. These were the third and fourth negotiating sessions, respectively.
RCMP	N/A	FTCS	$8.6	$1.72	$1.038	Provide the Department of Finance, Health Canada and other partners with current updates on illicit tobacco trade activities. The RCMP monitors illegal activities at and along the CAN/U.S. border through the use of strategic detection and surveillance equipment. Expand cooperation with international and national law enforcement partners. Complete the first Progress Report for the Contraband Tobacco Enforcement Strategy implementation.	Regular reports on the illicit tobacco situation were provided to Finance and Health Canada. Side bar reports and presentations provided to other partners and key Ministerial entities upon request, such as the Government of Canada Task Force on Illicit Tobacco, the Senior Revenue Officials Conference and the Interprovincial Investigations Conference. The Tobacco Analysts also attend regular meetings to brief the Department of Finance. Continued border security through the use of sophisticated technology which permits detection and monitoring of illegal border intrusions, resulting in vital intelligence. Co-hosted the 2009 Joint U.S./Canada Tobacco Diversion Workshop with American and Canadian agencies and presently preparing the 2011 Workshop to be held in April 2011. This event brings together members of Canadian and American law enforcement and regulatory agencies who have a vested interest in the illicit tobacco market whether it pertains to smuggling, counterfeit, stolen or other illegal activities. In recent events, the TDW has also included an increasing number of international guests as participants and speakers also involved in tobacco enforcement efforts. The workshop is part of an ongoing commitment by all of the above noted agencies to address the growing illicit tobacco market and its cross-border flow through an integrated policing and intelligence sharing approach. Released the first Progress Report for the implementation of the Contraband Tobacco Enforcement Strategy, which has been made public and in available online at the RCMP Customs & Excise website. The two (2) national tobacco analysts have attended several training courses regarding contraband tobacco as both students and presenters; they include: Interprovincial Investigations Conference: The aim is to develop, increase and maintain cooperation among all those who are involved in combating the contraband tobacco market by providing current information and contacts in other jurisdictions IBET Analyst/Intelligence Officer Workshop: This provided an overview on Crime trends, technology strategy and regional overviews. ATF Alcohol & Tobacco Diversion School: The purpose of the course is to provide instruction on the many various aspects of contraband trafficking, covers topics such as U.S. laws and regulation, sources of intelligence and information; current contraband trafficking trends and schemes. In 2009, the RCMP seized approximately 975,000 cartons of illicit cigarettes, and approximately 34,000kgs of contraband fine cut tobacco.
ODPP	N/A	FTCS	$12.22	$2.44	$2.35	Expected results for 2009-10 will be reported through the ODPP's Report on Plans and Priorities.	Approximately $6M has been recovered for all fines as of YE 2010 an increase of 16% over the previous year. Over 1,700 files were settled. This concerns all fines, not only tobacco related. Due to the substantial increase policing and border patrol efforts, the number of convictions in cigarette contraband and other tobacco related fines, the inventory of fines is now at 872 files of which 658 are solely contraband. The recoverable amount for these fines is at $15.6M. Implementation of set-off with CRA alone has accounted for almost 800K in fines (this is included in point # 1. Set-off is one of the most cost effective methods of recovery. This Of 2,253 fines paid in set-off, the majority of fines fully satisfied were in the $0 to $10K range. This inventory comprised of old fines where individuals could not be located. Reduction of this inventory will permit units to concentrate their efforts on larger fines. Registration of native fines with CRA's set-off program is bearing fruit. While we are unable to seize native assets on reserves, we are allowed to seize any GST or income tax refunds to an individual via set-off as long as they file a return. Over 7200 interventions were registered during this period. 268 individuals were incarcerated for failure or refusal to pay their fines during this period, of which 27 opted to pay their fines in lieu of remaining in custody.
CRA Assessment and Benefit Services (previously Assessment and Collections) Excise and GST/HST Directorate/ Legislative Policy and Regulatory Affairs Branch	N/A	FTCS	$4.44	$0.89	$.2 $.69	Systems adjustments and maintenance to reflect the legislative changes that affect rates, reporting and refunds as well as program changes to include duty-free shops and ships stores. Verify Export activity. Expand cooperation with international and national law enforcement partners. Work with stakeholders to monitor and assess the effectiveness of measures used to reduce contraband tobacco. Provide the Department of Finance with advice in the development of policy and the determination of the magnitude and timing of future tax increases. Support RCMP enforcement activity.	Systems and reporting capabilities were maintained as required to meet program requirements. The Tobacco Enforcement Verification Program (field) effectively monitored the movement of exported tobacco products. Excise duty officers performed audit and regulatory reviews of licensed manufacturers to ensure compliance with legislative requirements. Participated on a number of committees dealing with the monitoring and control of tobacco products, including those dealing with interprovincial issues. Co-hosted the Tobacco Diversion Workshop with Canadian and U.S. participation. Met with the Department of Finance as required. Provided industry and product information. Supported RCMP enforcement activity by providing information about specific tobacco transactions as well as expert testimony and affidavits.
CBSA	Risk Assessment	a. FTCS b. Loss of Duty Free Licensing	$52.8	$10.56	6.15	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.	Attended monthly meetings with Department of Finance and partners to discuss and serve as a reference for questions on tobacco issues. Provided monthly analysis of the national contraband situation by compiling reports received from the Regions. Partnered with RCMP in annual risk assessment of the nature and extent of tobacco contraband activity. Coordinated development of tobacco intelligence in the Regions. The capabilities of our officers and analysts to infiltrate the marketplace, gather intelligence, liaise with other agencies and process their files has resulted in: an increase in targets for examination, for both companies and individuals; identification of possible risk elements not previously perceived; awareness of emerging trends and threats. Actively participated in Joint Force Operations with law enforcement partners across the Regions. Developed and maintained contact with international tobacco enforcement personnel. In 2009-2010, CBSA front line officers collected duties and taxes from previously exempted personal importations of tobacco
Grand Total:			$368.47	$69.10	$60.55

Comments on Variances:

In 2009-10, $2.5 million in Tobacco contributions were transferred from the Regions and Program Branch's Tobacco Program to cover Departmental funding pressures.

Results to be achieved by non-federal partners (if applicable):

Health Canada works with a variety of partners (e.g. Provinces, Territories, NGOs) to achieve results in reductions in tobacco control.

Contact information:

Brenda Paine, Director
Office of Policy and Strategic Planning
Controlled Substance and Tobacco Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Telephone: (613) 941-9826
E-mail: brenda_paine@hc-sc.gc.ca

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Name of Horizontal Initiative:

Chemicals Management Plan

Name/ 3. PAA of Lead Department(s):

Health Canada/Environment Canada

Start Date of the Horizontal Initiative::

FY 2007-2008

End Date of the Horizontal Initiative:

FY 2010-2011

Total Federal Funding Allocation:

$299.2 M

Description of the Horizontal Initiative:

The Chemicals Management Plan (CMP) is part of the Government's comprehensive environmental agenda and is managed jointly by Health Canada (HC) and Environment Canada (EC). The activities identified in this plan build on Canada's position as a global leader in the safe management of chemical substances and products, and focus upon timely action on key threats to health and the environment. It includes risk assessment, risk management, monitoring and surveillance, as well as research on chemicals which may be harmful to human health or the environment.

The CMP also puts more responsibility on industry through realistic and enforceable measures, stimulates innovation, and augments Canadian competitiveness in an international market that is increasingly focused on chemical and product safety.

HC and EC collectively manage the CMP funding and ensure that it is aligned with human health and environmental priorities.

The following program areas were involved in CMP activities in 2009-2010:

In Health Canada:

• Health Products and Food Branch:
  • Food Directorate
  • Biologics and Genetic Therapies Directorate
  • Natural Health Products Directorate
  • Office of Science and Risk Management
  • Therapeutic Products Directorate
  • Veterinary Drugs Directorate
• Healthy Environments and Consumer Safety Branch:
  • Consumer Product Safety Directorate
  • Safe Environments Directorate
  • Environmental and Radiation Health Sciences Directorate
• Pest Management Regulatory Agency

In Environment Canada:

• Environmental Stewardship Branch
  • Chemicals Sector Directorate
  • Legislative and Regulatory Affairs Directorate
  • Public and Resources Sectors 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

Shared Outcome(s):

High-level outcomes for managing the CMP include:

• Canadians and their environment are protected from the harmful effects of chemicals;
• identification, reduction, elimination, prevention or better management of chemicals substances and their use;
• direction, collaboration and coordination of science and management activities;
• understanding of the relative risks of chemicals substances and options to mitigate;
• biomonitoring and environmental monitoring of substances;
• risk assessment and risk management; and
• informed stakeholders and the Canadian public.

Governance Structure(s):

HC shares the lead on the CMP with EC. The CMP consists of five inter-related program elements to be planned, delivered and evaluated within an integrated framework, managed jointly by HC and EC.

Governance is assured through a joint HC/EC Assistant Deputy Ministers Committee (CMP ADM Committee) and the Interdepartmental Chemicals Management Executive Committee (CMEC). These Committees were established to maximize the coordination of efforts, while minimizing duplication between the two departments.

The CMP ADM Committee provides strategic direction, coordination and a challenge function for the overall implementation and review of results and resource utilization on CMP initiatives. The Committee serves as a high-level forum for making recommendations on chemicals management to respective Deputy Ministers.

The CMEC is the key management committee at the Director General level to support the development of joint EC-HC strategic directions. It is also a formal body for joint consultations and cooperation to ensure timely and concerted actions in implementing the CMP work activities in an integrated fashion. The CMEC reports to the ADM Committee, providing recommendations on program implementation, results and resource utilization.

Federal Partners	Program Activity	Names of Programs	($ millions)
			Total Allocation (from Start to End Date)	Planned Spending 2009-10	Actual Spending 2009-10
Health Canada	Sustainable Environmental Health (Chemicals Management Sub-Activity)	a. Risk Assessment	$9.9	$2.5	$ 2.5
		b. Risk Management	$50.1	$14.0	$ 11.91
		c. Research	$26.6	$10.9	$ 10.6
		d. Monitoring & Surveillance	$34.0	$11.5	$ 11.5
		e. Program Management	$5.4	$1.4	$ 1.32
	Consumer Products	a. Risk Management	$12.6	$3.4	$ 3.03
	Pesticide Regulation	a. Risk Assessment	$9.9	$3.1	$ 3.1
		b. Risk Management	$13.6	$4.2	$ 4.2
	Health Products	a. Risk Assessment	$3.3	$0.8	$ 0.8
		b. Risk Management	$12.5	$4.3	$ 4.3
		c. Research	$2.5	$0.5	$ 0.5
		d. Monitoring & Surveillance	$1.1	$0.3	$ 0.3
		e. Program Management		$0.1	$ 0.12
	Food & Nutrition	a. Risk Assessment	$3.8	$1.2	$ 1.51
		b. Risk Management	$6.2	$1.9	$ 0.91
		c. Research	$1.2	$0.3	$ 1.11
		d. Monitoring & Surveillance			$ 2.11
Environment Canada	Risks to Canadians, their health and their environment posed by toxic and other harmful substances are reduced	a. Research	$2.1	$0.0	$ 0.0
		b. Monitoring & Surveillance	$26.4	$7.3	$ 7.3
		c. Risk Assessment	$13.1	$3.1	$ 3.1
		d. Risk Management	$64.9	$19.3	$ 17.04
Sub-Total (Environment Canada)			$106.5	$29.7	$ 27.4
Sub-Total (Health Canada)			$192.7	$60.4	$ 59.7
Grand Total:			$299.2	$90.1	$ 87.1

Expected Results for 2009-2010 (From 2009-2010 Report on Plans and Priorities):
Health Canada:

• Increase level of Canadian public awareness of chemical management issues and actions being taken, including risks related to food chemical contamination, pesticides and consumer products.
• Risk assessments are conducted and risk management objectives are met for regulations and other control instruments for substances and the products of biotechnology, including risks related to food contamination, pesticides and consumer products.
• Declining trends in levels of risk, adverse reactions, illnesses and injuries from toxic chemical substances in the environment and their use and/or the risk of exposure to Canadians, including the use of pesticides, consumer products and items regulated under the Food and Drugs Act.
• Enhanced knowledge of chemical contaminants of environmental origin and their impacts on human health with targeted risk assessment and regulatory decisions to reduce Canadians' exposure to these substances, including risks related to food chemical contamination, pesticides and consumer products.

Environment Canada:

• Risks to Canadians and impacts on their environment posed by toxic and other substances of concern are reduced.
• Direction, collaboration and coordination of science and management activities
• Increased knowledge of the risks of toxic chemical substances through research and options to mitigate
• Risk assessments conducted in a timely fashion as required
• Risk management objectives are met, e.g. effective controls identified and implemented

Enhanced knowledge of stakeholders and the Canadian public regarding risk assessment/management activities, including knowledge on the effectiveness of control actions.

Results Achieved in 2009-2010:

A key component of the CMP is taking immediate action on the 200 highest priority chemicals identified in the Challenge program. Through the "Challenge to Stakeholders", information is collected and used to inform decisions regarding the best approach to protect Canadians and their environment from risks that certain substances may pose. These 200 substances were divided up into a number of Batches, to be assessed sequentially by 2010. As of March 31, 2010, all of the 12 batches under the CMP have been launched, and draft or final assessment decisions have been published for the 151 substances in Batches 1 through 9. 

All of the CMP risk assessments that were scheduled for publication during 2009-2010 were completed. These included the release of the final Screening Assessment Reports for Batches 4 to 7 and the draft Screening Assessment Reports for Batches 6 to 9. In total, draft risk assessment reports were published for 63 substances, or classes of substances, and final assessment reports were published for 65 substances, or classes of substances. In addition, a final assessment report on Aluminum salts, a substance on the second Priority Substances List, was published as well as assessment reports for six pesticide substances, 104 organotin substances and chlorinated naphthalenes as well as two substances from a pilot project for screen assessments initiated in 2001.

During 2009-2010, the assessment of approximately 160 chemicals that are primarily of interest to the petroleum industry gained momentum under the Petroleum Sector Stream Approach.Assessment work continued on approximately 70 petroleum substances (heavy fuel oil, gas oils, low boiling point naphthas and petroleum gases) that have been identified as being restricted to petroleum refineries and upgrader facilities (these are referred to as "site-specific" or "industry-restricted" petroleum substances). Strategies and methods to assess the remaining substances (or groups of substances) that require a risk assessment in the future, where the amount of scientific information on most substances is poor to very poor, continue to be explored and tested.

Under the Challenge, the launch of section 71 notices under the Canadian Environmental Protection Act (CEPA, 1999) took place to collect information for Batches 10, 11 and 12 (the final batches of substances in the Challenge). A Compliance Promotion Plan for information gathering initiatives under the CMP continued and stakeholder information sessions were held in Toronto and through a series of webinars offered in June 2009 and January 2010. These sessions explained the Challenge and provided stakeholders with guidance on how to submit information.

A section 71 notice was also launched for data collection on approximately 500 chemicals as part of the Domestic Substances List (DSL) Inventory Update. The information should complement information collected or generated as part of the DSL categorization process to inform prioritization of these substances and subsequent risk assessment and management activities.

As part of the Challenge, risk management approaches were published for 9 substances in batches 4 to 7 that met section 64* of CEPA, 1999 and risk management scopes were published for 13 substances in batches 6 to 9 that were proposed to meet section 64 of CEPA, 1999. This year, actions taken or proposed for substances assessed under the Challenge included proposed additions to Health Canada's Cosmetic Ingredient Hotlist (published October 23, 2009), proposed amendments to the registration of Naphthalene as an active ingredient in moth ball preparations (published December 15, 2009), and final regulations prohibiting the advertisement, sale or import of polycarbonate baby bottles containing Bisphenol A (BPA) - published March 31, 2010.

For substances where current exposure is not of concern, but where there are concerns that additional exposure could harm human health or the environment, the Significant New Activity (SNAc) regulatory instrument under CEPA, 1999 provides for information gathering and assessment prior to this significant new activity or use being initiated. SNAcs were either proposed or implemented for 42 Challenge substances concluded to either not meet section 64 of CEPA, 1999 or to not be in commerce in Canada. The implementation of SNAcs for approximately 153 non-Challenge high priority substances continued.

The Government of Canada continued to seek advice and input from the CMP Stakeholder Advisory Council (members include non-governmental organizations and industry). HC and EC co-managed three face-to-face meetings where the Council provided advice and input on CMP related activities. The Government also sought advice from the Challenge Advisory Panel on the application of precaution and weight of evidence in assessments under the CMP Challenge (Batches 6 to 9) and for one non-Challenge chemical.

Under the HC CMP Monitoring and Surveillance Fund, 19 multi-year projects are ongoing with 7 initiated in the 2009-10 fiscal year.  A call for proposals for the remaining 2010-2011 funds was launched and resulted in the allocation of the remaining $500K across the existing 19 projects. Preliminary results from the Canadian Health Measures Survey (CHMS) were released, showing a significant decrease in blood lead levels since 1978. Background material for the CHMS Exposure Report is under development. CHMS Cycle 2 was launched in September 2009 with younger children included in the survey.

The Maternal-Infant Research on Environmental Chemicals (MIREC) Study is monitoring environmental chemicals in mothers and newborns. Recruitment for the MIREC study is underway at several sites across Canada. Results of the study will inform risk management decisions and identify potential sources of exposure and predictors of exposure to environmental chemicals.

Environmental monitoring programs have been integrated and augmented under the CMP to provide a truly National program, capable of meeting the government's existing monitoring commitments as well as being responsive to emerging chemicals of concern. These include environmental monitoring and surveillance of chemicals in air, water, sediments, fish and birds, as well as releases form wastewater and landfills.

To better understand the exposure and effects of a variety of chemicals that were identified as priorities under the CMP, an extensive, competitive research program on CMP priorities has continued. The CMP themes and priorities addressed the following areas: effects, exposure, tool/model development, endocrine disrupting compounds, metals, mixtures, perfluorinated alkyl compounds, and the approximately 3000 remaining priority substances. In addition, work continued on a directed research program to address gaps in regulatory knowledge of BPA.

Other CMP activities undertaken in FY 2009-2010 included:

• The Northern Contaminants Program (NCP), which receives additional funds through the CMP for human health monitoring in the North, released its 3rd NCP Human Health Assessment Report in June 2009. This work was part of on the circumpolar Arctic Monitoring and Assessment Programme's corresponding Human Health Assessment Report.
• The scope of the environmental health indicators program was re-oriented to serve the needs of users across Canada and a needs assessment was finalized.
• Strategies to address medium priority substances are being developed. Strategies are being tested through the information collected on 500 substances representing a subset of the 3000 remaining priorities post March 2010. In addition, a plan to address certain azo or benzidine based substance linked to the colourant sector has been prepared.
• Update of the CMP website was completed. All website information was posted as scheduled.
• Outreach activities, including the preparation and publication of fact sheets on the CMP and ongoing headquarter and regional activities in support of risk management and risk communication such as workshops for stakeholders, continued on schedule.
• Preparation continued for the draft lead toxicology review along with a draft risk management approach and recommendations for Blood Lead Guidance Revisions.
• Working closely with stakeholders, finalization and implementation of a framework to revise the list of more than 9,000 substances used in products regulated under the Food and Drugs Act (F&DA) that were in commerce between January 1987 and September 2001, known as the In Commerce List (ICL). Substances on the revised ICL will be categorized, prioritized and undergo health and environmental risk assessments.
• Consulting with stakeholders to develop Environmental Assessment regulations to address the potential environmental and human health impact of new substances contained in products regulated under the F&DA.
• A cost benefit analysis was carried out for the regulations prohibiting BPA in baby bottles.
• The results of three BPA monitoring studies (survey of BPA in bottled water products, survey of BPA in baby foods pre-packaged in glass jars with metal lids, survey of BPA in canned powered infant formula) have been completed and published on HC's website.
• New risk management strategies for food were explored for CMP high profile chemicals, including examination of regulatory changes such as updating tolerances for contaminants in foods based on current science, delisting food additives in the Food and Drugs Regulations, collaborating with stakeholders to develop industry guidance documents or encouraging industry to develop/use safer alternatives, providing advice to consumers on substances of concern, performing health risk assessments and adding substances of concern to the Total Diet Study
• A draft guidance document on health risk assessment of foodborne genotoxic carcinogens was completed.
• Advice was provided to the Canadian Food Inspection Agency on additions of substances to the compliance- based National Chemical Residue Monitoring Program, based on the findings of the CMP, and ways of improving the enforceability of administrative guidelines for environmental contaminants in food were explored.
• As part of its commitment under 'Developing a Risk Management Strategy for Acrylamide in food', HC implemented an Acrylamide Monitoring Plan.
• Canadian data on hazards and exposure to foodborne acrylamide was submitted to the Joint FAO/WHO Expert Committee on Food Additives to support the February 2010 international evaluation of acrylamide.
• Stakeholder calls were held outlining food implications from the substances in batches 6 through 9.
• Accelerating the re-evaluation of older pesticides, to determine if these pesticides meet today's health and environmental standards. As of March 31, 2010, 360 (90%) of the 401 older pesticides active ingredients have been addressed.
• In FY 2009-2010, 9 new pesticide active ingredients were registered, one of which was a joint review or work share with other jurisdictions.
• As a result of CMP funding, Health Canada has established a mandatory health and environmental pesticide incidents reporting program, where trends are assessed and regulatory action is taken when necessary. The evaluations of serious incidents and the first annual report have been published on Health Canada's Website.This year, the incident reports helped identify potential adverse reactions in cats and dogs from the use of flea and tick control products. Health Canada is now taking action to prevent overdosing in small animals and to address improper use or misuse of these pesticides.

* A substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that:

1. have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
2. constitute or may constitute a danger to the environment on which life depends; or constitute or may constitute a danger in Canada to human life or health." (Section 64)

Comments on Variances:

• $2M was transferred from Sustainable Environment Health (Risk Management) to the Food and Nutrition program. These funds were intended to increase capacity to perform food related assessment of CMP priority chemicals.
• $100K was transferred from Sustainable Environment Health (Program Management) to Health Products to support coordination of input into CMP risk assessments.
• $400K was transferred from Consumer Products to Sustainable Environmental Health Research. Planned Spending changed to reflect re-profiled resources under Risk Management ($17M vs. $19.3M before re-profile).

Results Achieved by Non-federal Partners:

N/A

Contact Information:

Suzanne Leppinen, Director
Horizontal and International Programs
Safe Environments Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Ph: (613) 941-8071
E-mail: suzanne_leppinen@hc-sc.gc.ca

Mark Cuddy, Director
Environmental Stewardship Branch Coordination
Environmental Stewardship Branch
Environment Canada
Ph: (819) 994-7467
E-mail: Mark.Cuddy@ec.gc.ca