Our Science, Our Health - A Report from the Health Products and Food Branch - 2003

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© Her Majesty the Queen in Right of Canada, 2004

CAT. No. H43-5/2003E-PDF
ISBN: 0-662-36150-4
Publication No. 1188

Our Science, Our Health
2003 Report - Health Products and Food Branch

I am pleased to present Our Science, Our Health, the first report on the science and research activities of the Health Products and Food Branch.

Science and research are of critical importance to the work of the Branch. They are at the base of our mandate which is to take an integrated approach to the management of the risks and benefits to health related to health products and food by minimizing health risk factors for Canadians while maximizing safety provided by the regulatory system for health products and food; and by promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health.

It has been three years since the Health Products and Food Branch was formed. Changes have happened and will continue to happen to best position the Branch for today's challenges and those to come. Our scientists and researchers are an integral part of that change as science is constantly evolving, bringing with it new developments in the fields of drugs, biologics and genetic therapies, medical devices, food and natural health products, as well as challenges such as society's acceptance of scientific advances.

This report highlights the wide range and complexity of the science and research activities carried out by the Branch in support of its mandate, and reflects the excellent work of a dedicated scientific staff. It is intended to foster a better understanding of the work we do and its contribution to the health of Canadians.

I encourage you to understand more about our science and research and our role as regulator and supporter of public health.

Diane C. Gorman
Assistant Deputy Minister Health Products and Food Branch

Acknowledgements

The office of biotechnology and science, science coordination division, would like to thank the branch members who contributed. thanks are also extended to colleagues at Statistics Canada for their valuable contribution.

Particular thanks go to Dr W. L. Wilson, who prepared the first draft of the report based on information available up to april 30, 2003.

Table of Contents

Overview
Introduction

Foreword
How the Report is Structured

1. Science in Health

On the Road to the 21^st Century

Science at Health Canada Today
Science and the Federal Government
Science in HPFB
HPFB and the Canadian Public

2. Mandates, Missions, Roles and Responsibilities

Major Roles and Activities

Food Directorate
Therapeutic Products Directorate
Biologics and Genetic Therapies Directorate
Natural Health Products Directorate
Veterinary Drugs Directorate
Health Products and Food Branch Inspectorate
Marketed Health Products Directorate
Policy and Strategic Planning Directorate
Office of Nutrition Policy and Promotion
Office of Consumer and Public Involvement
Office of Regulatory and International Affairs
Office of Biotechnology and Science
Senior Director General's Office - Office of Information Management and Technology
Office of Management Services
Health Products and Food Litigation Secretariat
Regional Operations

3. Laboratory-Based Science in HPFB

Biologics and Genetic Therapies Directorate Laboratories

Centre for Biologics Research Laboratory
Biologics and Radiopharmaceuticals Evaluation Centre Laboratories

Health Product and Food Branch Inspectorate Laboratories

Longueuil Laboratory
Toronto Laboratory

Food Directorate Laboratories

Toxicology Research Division Laboratory
Food Research Division Laboratory
Microbiology Research Division Laboratory
Animal Resources Division Laboratory
Nutrition Research Division Laboratory
Quebec Region Food Laboratory
Ontario & Nunavut Region Food Laboratory
Manitoba & Saskatchewan Region Food Laboratory
British Columbia & Yukon and Alberta & Northwest Territories Region Laboratory

Therapeutic Products Directorate Laboratories

Medical Devices Laboratory
Office of Science Laboratory
Research Laboratory

Others

4. Non-Laboratory-Based Science in HPFB

R&D
RSA

Regulatory Studies, Risk Assessment and Standard Setting
Policy Studies
Product Evaluation/Pre-Market Review
Data Collection and Surveillance
Inspection, Investigation and Compliance
Information Services
Education, Training and Development

Appendix I - Definitions

Federal Government Definitions (Statistics Canada)
HPFB's Related Scientific Activities (RSA) Definitions

Appendix II - HPFB Organization Chart

Appendix III - HPFB Laboratories

Appendix IV - HPFB Laboratory Locations

Acronyms

Overview

This report provides a description of the many diverse and complex science activities undertaken by the Health Products and Food Branch (HPFB). It is the first such report since the creation of the Branch in 2000, and it comes at a time of change both globally and nationally.

The events of September 11, 2001, the more recent incidences of the Severe Acute Respiratory Syndrome (SARS), West Nile virus and Bovine Spongiform Encephalopathy (BSE), and the tremendous advances in genomics/proteomics - all the 'omics' in fact - and nanotechnology as well as the impacts of these events and technologies and the public's expectations, bring to the fore the need to reassess what the Branch does and the way it does it.

At the federal level, senior officials recently made a strong commitment to implement a new framework and governance process for crossdepartmental and agency science and technology. Many collaborations already exist between science-based departments and agencies, but many of them are ad hoc. The new approach garners all available expertise to advance national issues from a science perspective.

The report was prepared to address a need identified by HPFB's Science Community Committee to identify and describe the Branch's science activities and their important contribution to the health of Canadians as well as to Canada's Innovation System. By providing the narrative behind the numbers, this report will also help to increase awareness of the science conducted in the Branch among HPFB and departmental staff, other government departments and agencies, international organizations, stakeholders, and the public.
The science done in the Branch, as exemplified in this document, is in support of the Department's vision for the health agenda, namely to

• maintain and improve the health of Canadians, and therefore their quality of life;
• reduce the risks to the health of Canadians; and
• maintain confidence in the health system.

The report provides the evidence-base for the four themes that help move these objectives forward: Building a Modern Regulatory System, Sustaining Health Care Reform, Towards a 21st Century Public Health System, and Improving First Nations and Inuit Health.

Health Canada (HC), under the leadership of the Office of the Chief Scientist, embarked on a new initiative - the development of HC's Framework for Science - with the objective "to ensure that Health Canada performs, and has access to, critically important science needed to fulfil its mandate and contribute to the government's overarching priorities." One of the main elements of the Framework is the development of a Departmental Science Plan, which sets out the Department's science requirements and activities based on a set of principles and criteria.

It has been seven years since the publication of the Science and Technology Action Plan of the Federal Health Portfolio, S&T at Work for the Health of Canadians¹. A new Departmental Science Plan - to which all science-based branches and agencies contributed - is expected in early 2004. The Science Plan is intended to reflect the goals and objectives of HPFB's Business Plan 2003-2006.

As is apparent every day to the staff conducting the Branch's science-based activities, science is constantly evolving - scientific data will never be complete or perfect, technology is always improving and new scientific advancements are being made every day. As such, this report captures the work carried out in the Branch today. The next iteration of this report will reflect the changes that are sure to come; these changes will impact on Branch priorities as well as on how the Branch carries out its work.

Introduction

Foreword

Science and technology (S&T) are essential in the delivery of the Health Products and Food Branch's (HPFB's) regulatory and public health mandates. Science is used in the Branch on a daily basis - from policy development, the scientific evaluation of health products and food dossiers, risk assessments, compliance testing, and nutrition surveillance to research on food pathogens and pharmacogenomics. In fact, science is implicit in most of the work conducted by HPFB.

S&T encompasses both Natural Sciences and Engineering (NSE) and Social Sciences and Humanities (SSH). Each area includes research and development (R&D) and related scientific activities (RSA). Refer to Appendix I for federal government and Branch definitions of some terms used in this report.

The Branch conducts laboratory- and non-laboratory-based science in Natural Sciences (this includes Natural Sciences and Engineering) and Social Sciences (this includes Social Sciences and Humanities). The Branch carries out research and development (R&D) and other science activities - referred to as related scientific activities (RSA) - within the context of the guiding principles of the federal strategy, Science and Technology for the New Century², and in support of the Science and Technology Action Plan of the Federal Health Portfolio, S&T at Work for the Health of Canadians.

This report highlights the many diverse and complex science activities the Branch undertakes in support of its mandate.

How the Report is Structured

The following outlines the major topics included in each of the report's chapters:

Chapter 1 - provides a historical context by outlining the evolution of health-related science, pertaining to health products and foods, within the federal government.

Chapter 2 - describes the activities conducted in the Branch's directorates, offices, secretariat and regions.

Chapter 3 - the laboratory-based science conducted in the 16 laboratories across the country.

Chapter 4 - describes the non-laboratory-based science conducted throughout the Branch.

In addition, the appendices provide federal government and Branch definitions, a Branch organizational chart, and a list of HPFB laboratories and their addresses.

Chapter 1
Science in Health Canada

For over 125 years, science and government scientists have played an important role in the health and safety of Canadians. The following provides an overview of the evolution of health-related science, pertaining to health products and foods, within the federal government.

This chart is a summary of key historical events between 1875 and 1972.

Year	Milestone
1875	Inland Revenue Act passed; intended to prevent the adulteration of food, drinks and drugs; the Act provided for the appointment of analysts to examine samples
1884	Adulteration Act passed; defined more specifically what constituted the adulteration of food and drugs; appointment of the first Chief Analyst to corroborate the findings of local analysts; the Chief Analyst standardized the components and methods of analysis as well as the interpretations of results
1919	Federal Department of Health established and the Food and Drugs Division created; the Division was responsible for administering the Adulteration Act
1920	Adulteration Act repealed and replaced with the Food and Drugs Act, which also covered the misbranding of foods along with adulteration
1927	Food and Drugs Act extended to cover drugs
1937	Scientific Advisory Committee on Nutrition appointed
1938	Canadian Council on Nutrition established; Council spearheaded the development of the first (and subsequent revisions to) Dietary Standards for Canada, which underpin food guide recommendations
1943	The Canada Nutrition Program was launched by the Nutrition Division of the Department of Pensions and Natural Health; the Program was a long-term and comprehensive approach to help people eat the right foods; Canada's Official Food Rules developed
1946	Authority established in the Food and Drugs Act to make regulations defining the conditions of sale of any food or drug in the interest of protecting public health
1954	Food and Drugs Act amended to include the manufacture, preparation and storage of food for sale under unsanitary conditions
1955	The Food and Drugs Division became the Food and Drug Directorate
1950-1970	Science and research within the health portfolio shifted from primary care to preventative care and curative medicine; Department staff nearly tripled; stringent new drug testing programs emerged
1972	The Health Protection Branch (HPB) was formed; it consisted of six directorates: Food, Drugs, Environmental Health, Laboratory Centre for Disease Control, Administration and Field Operations

On the Road to the 21^st Century

The 1970s and 1980s saw periods of expansion to address new public health concerns, followed by consolidation as the government of the day instituted a series of across-the-board cutbacks and program reviews.

Beginning in 1993, the federal government began an extensive review of all its S&T activities. The most important product of this review was the 1994 Auditor General's Report, which devoted three chapters to a critical review of the management of federal S&T. In the 1994 budget, the government announced that it was going to conduct a fundamental review of S&T. In June of that same year, the S&T Review was launched with a series of public consultations across Canada. As well, the National Advisory Board on Science and Technology (NABST) conducted an independent review (the NABST Report).

In March of 1996, the government set out its response in the document titled Science and Technology for the New Century. The strategy provided direction to federal departments and agencies and set out the elements of a federal governance system for S&T activities. In response to the recommendations contained in this report, each department produced a document outlining its own plans for the renewal of S&T activities. HC's report was titled Action Plan of the Federal Health Portfolio, S&T at Work for Canadians (1996).

In 1997, HPB initiated a process of transition in order to respond to the emerging challenges to public health. The objectives of this transition included

• strengthening the science that underlies decision making in order to meet current and emerging public health risks,
• improving and modernizing Canada-wide health surveillance capacity, and
• improving the delivery of health protection programs.

HC's realignment was initiated to meet the challenges of the 21st century advances in health knowledge and technology along with changing public expectations and an increasing need for partnership, collaboration and horizontality. Important steps had already been taken to address some of these issues, including the following:

• resources were reallocated to strengthen surveillance, monitoring, and disease prevention and control;
• telehealth was tested to improve health care delivery and access to information; and
• a Science Advisory Board was established in 1997.

However, more needed to be done. As part of the realignment, the health protection program was re-engineered. This entailed increasing its science capacity, focusing its programs more effectively, improving horizontal management and putting more emphasis on accountability. In the realigned Department, health promotion and community action were integrated with health surveillance and disease prevention and control.

Science at Health Canada Today

HC had one major science-based Branch until 2000 (HPB) and one science-based Agency (the Pest Management Regulatory Agency (PMRA)).

Today, in addition to the PMRA, the Department has three science branches:

• Health Products and Food Branch (HPFB) - responsible for policies, standards and pro grams related to the health determinants, benefits and risks associated with products that are ingested or put into the human body;
• Healthy Environments and Consumer Safety Branch (HECSB) - responsible for the safety and efficacy of producer and consumer products in the marketplace as well as the promotion of a healthy living, working and recreational environment; and
• Population and Public Health Branch (PPHB) - responsible for policies, programs and research relating to disease surveillance, prevention and control, health promotion, and community action.

Realignment also resulted in the creation of the Office of the Chief Scientist. The role of the Chief Scientist is to bring greater leadership, coherence and expertise to the overall strategic direction of the Department's scientific responsibilities, activities and needs.

Overall, the Department's science and research environment has improved dramatically over the past three years, in part because of the creation of the Office of the Chief Scientist and the substantial infusion of external funding for biotechnology.

Science and the Federal Government

HC science is conducted within the context of broader federal government priorities. The 2002 Speech from the Throne reiterated the federal government's commitment to science. As stated, the Government of Canada "will strengthen government science, integrating its efforts across departments and disciplines, and focusing on the priorities of Canadians." This builds upon an earlier commitment to double the Government of Canada's present funding for R&D by 2010, to strengthen the capacity of government laboratories as well as those of universities and institutions to carry out research activities, and to accelerate Canada's ability to bring research discoveries out of the laboratories and into the marketplace.

A recent Federal Science and Technology Forum - Transforming Federal Science and Technology for the Future: Achieving a Vision for Excellence - initiated a dialogue on a vision for S&T in the federal government. Among the many points raised was the need for horizontality.

Working horizontally in the federal government is not new. Since the early 1980s, the federal S&T community has come together to address biotechnology. More recently, members of that same community came together to strengthen their response to chemical, biological, radiological and nuclear (CBRN) threats. The CBRN Research and Technology Initiative (CRTI) was created to provide S&T solutions to national security and CBRN preparedness. Efforts are now being made to develop a framework for collaboration and integration to more efficiently address other crosscutting issues that are important to Canadians (e.g. water, northern S&T).

Science in HPFB

More than 1,700 employees work in HPFB. They play direct or supporting roles in helping to ensure that food products are safe and that therapeutic products, biologics, radiopharmaceuticals and veterinary drugs as well as natural health products are safe and effective. To do that, HPFB members operate in a scientific environment that is characterized by the following:

• Science in HPFB is widespread - From the laboratory researcher to the scientists reviewing new health product submissions to the inspectors in the regions and the researcher generating the evidence base to create appropriate policies, Branch science covers all aspects of Canadian food, drugs, medical devices, natural health products and nutrition. Because the science encompasses various disciplines and diverse levels of technical knowledge, HPFB scientists cannot rely on being an expert solely in one area. Instead, they need to have a good grasp of a large amount of information that affects many areas.
• Science in HPFB is dynamic - In an ever-changing environment, scientists must work to improve their skills and knowledge to keep pace with the latest national and international research developments. Because science at HPFB occurs in a public forum, decisions must be defensible, not only to peers but also to the general public. For instance, the general public may not understand the science behind a certain decision, but will often put blind trust in the decision because "Health Canada has said so, and we trust them." Conversely, peers have the scientific knowledge to judge the validity of the research being conducted. Branch scientists must be respectful of the differing information needs of these two diverse groups and tailor their messages accordingly.
• Science in HPFB is constantly evolving - Scientists have to stay up to date on the new technologies and scientific advancements that affect their field of interest.

HPFB and the Canadian Public

By providing quality and safety guidelines and information, HPFB helps Canadians make informed choices on food and health products. HPFB scientists are responsible for evaluating, regulating and monitoring drugs, biologics and medical devices. Before a product is launched on the Canadian market, law requires that it be reviewed to ensure that it is safe, effective and of high quality.

The scientists also work to ensure that Canadians have access to safe and nutritious food - and they promote nutritional well being - by developing policies, procedures, regulations and guidelines that will impact on the health of Canadians. Regulating enhanced food labelling, establishing maximum residue limits for veterinary drugs in food-producing animals and developing Canada's Food Guide to Healthy Eating - which identifies and promotes a pattern of eating that meets nutrition needs and reduces the risk of chronic conditions - are just three concrete examples of how the work undertaken by the HPFB has a direct impact on Canadians and their health.

The Branch also sets standards and researches and evaluates health risks for food, veterinary drugs, therapeutic products and natural health products. The policies that the Branch develops in all of these areas are grounded in a strong scientific foundation. HPFB uses the full range of life sciences to make informed recommendations and to properly analyze health risks and benefits.

The Branch works not only for Canadians but also works with them. With a recognition that the values of Canadians are relevant and that their willingness to accept or tolerate risk is something that must be considered, the Branch tries to gather a balanced view of the various issues - one that is based on all of the available information from the people it serves. This knowledge helps to ensure that the Department's policies and actions have the best possible impact on the lives of Canadians.

When it comes to health matters, Canadians do not want to be passive observers - their active participation is important. Moreover, sharing views, concerns and the results of scientific research is essential to reach a common understanding and produce sound decisions that are acceptable to all. HPFB has established an Office of Consumer and Public Involvement (OCAPI) (see page 12 for more information) as well as a Public Advisory Committee (PAC). The Branch is commited to improving public involvement and to that end is continuously looking at new innovative approches.

Chapter 2
Mandates, Missions, Roles and Responsibilities

HC's mission is to help the people of Canada maintain and improve their health. With that mission in mind, HPFB's mandate is to take an integrated approach to the management of the risks and benefits to health related to health products and food by:

• minimizing health risk factors for Canadians while maximizing safety provided by the regulatory system for health products and food; and
• promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health.

Major Roles and Activities

HPFB consists of six product directorates, an inspectorate, a secretariat, five regional offices, several supporting offices and one supporting directorate. The following outlines the roles and activities of these groups. In addition, an organizational chart is included as Appendix II.

Food Directorate

Much of HC's focus on food safety is managed by the Food Directorate. In support of HC's mission to help Canadians maintain and improve their health, the Food Directorate is the federal health authority responsible for establishing policies, setting standards, and providing advice and information on the safety and nutritional value of food.

The vision of the Directorate is to be Canada's most trusted authority on food safety. The Directorate strives to attain this vision by providing policies, standards, advice and information on the safety and nutritional value of food.

The Directorate has over 400 employees located in Ottawa and in the five regions. Most of these employees are scientists and technicians who perform a variety of specialized activities in support of the mission and vision described above.

These activities include the following:

• evaluation of industry submissions for new food additives, food packing materials, infant formula and genetically modified foods;
• surveillance of nutrition and monitoring of chemical contaminants in the food supply;
• research into microbial and chemical hazards in foods as well as nutritional quality; and
• participation in national and international standard setting.

Therapeutic Products Directorate

The Therapeutic Products Directorate (TPD) is responsible for the regulation of pharmaceutical drugs, medical devices and other therapeutic products available to Canadians. This includes evaluating the safety of Clinical Trial Applications (i.e., the review of clinical protocols used to study new therapeutic products or new indications in humans). The Directorate is also responsible for assessing the safety, efficacy and quality of the products within its mandate and determining appropriate risk management strategies to minimize risk and maximize benefits for these products.

Biologics and Genetic Therapies Directorate

The Biologics and Genetic Therapies Directorate (BGTD) is responsible for regulating biological and radiopharmaceutical drugs, including blood and blood products, viral and bacterial vaccines, biotechnology and genetic therapeutic products, human cells, tissues and organs, and xenografts. This includes evaluating the safety of Clinical Trial Applications (i.e., the review of clinical protocols used to study new biological and radiopharmaceutical drugs or new indications in humans). It also includes the pre-market and post-market assessment of the safety, efficacy and quality of biologics and radiopharmaceutics as well as participation in the development of risk management strategies, including risk-benefit assessments, for these products. In addition, research is being undertaken in emerging scientific areas that are associated with the development of policies and appropriate new regulations to provide Canadians with safe, effective and high-quality innovative new products, promote Canadian health, and keep pace with national and international developments and the evolving biotherapeutics industry.

Natural Health Products Directorate

The Natural Health Products Directorate (NHPD) is responsible for regulating natural health products in Canada. As such, the Directorate's mandate is to ensure that Canadians have ready access to a range of natural health products that are safe, effective and of high quality, while respecting freedom of choice as well as philosophical and cultural diversity. The Natural Health Products Regulations, which will come into effect on January 1, 2004, set out the requirements for the manufacture, packaging, labelling, storage, importation, distribution and sale of natural health products in Canada as well as for clinical trials involving human subjects.

The Directorate is also dedicated to research in the field of natural health products. Through its Natural Health Products Research Program, the Directorate, in partnership with the Canadian Institutes of Health Research (CIHR), has committed five million dollars over the next five years in support of community-based initiatives involved in the area of natural health products.

Veterinary Drugs Directorate

The Veterinary Drugs Directorate (VDD) ensures the safety of foods such as milk, meat, eggs, fish and honey from animals treated with veterinary drugs. VDD also ensures that veterinary drugs sold in Canada are safe and effective for animals. The Directorate is staffed by a multi-disciplinary team of people with skills and experience specific to their job functions. This includes program staff with backgrounds in veterinary medicine, biology, microbiology, toxicology, pharmacology, epidemiology, parasitology, animal sciences, aquaculture, environmental health safety and chemistry, IT/knowledge management, communications, policy, accounting, and administration.

In support of its regulatory activities, the Directorate funds monitoring and surveillance work and several research projects at various laboratories within the Department. It also funds the following studies: the Risk Assessment of Human Health Impact of Antimicrobial Use and Resistance in Agri-Food, alternative research on probiotics, and Human-Enterics Resistance studies conducted at universities.

Health Products and Food Branch Inspectorate

Approximately 200 dedicated professionals work at the Health Products and Food Branch Inspectorate (HPFBI) to deliver a national compliance and enforcement program. The Inspectorate manages the licensing processes for regulated establishments as well as the industry inspection, product investigation and enforcement activities related to the manufacture, importation and sale of marketed health products. In addition, the Inspectorate maintains a laboratory program that supports these activities.

The Inspectorate contributes actively to policy and planning processes and to the setting of and performance measures at the Branch level. In particular, the Inspectorate participates in risk management strategies - including benefit/ risk assessments, communication, and other compliance and enforcement activities - as part of the management of emergency situations. Inspectorate staff work together and collaborate with other areas of the Branch to ensure that Canadians have timely access to safe and effective health products.

The Inspectorate has nine centres within Canada: five Operational Centres and two laboratory facilities located in the regions, the National Coordination Centre located in Ottawa, and the Director General's Office. It has also established a broad and strong network of partners outside the Department. At the international level, the Inspectorate is involved in Mutual Recognition Agreements and Memoranda of Understanding with more than 20 countries. The Inspectorate is also an active member of international organizations that foster the harmonization of standards and practices, including the Global Harmonization Task Force for Medical Devices and the Pharmaceutical Inspection Cooperation Scheme.

Marketed Health Products Directorate

The Marketed Health Products Directorate (MHPD) is responsible for coordinating the delivery of post-market surveillance-related functions in a consistent manner across the whole spectrum of marketed therapeutic health products, including biologics and biotechnology products, food interactions with other health products, medical devices, medical incidents/ errors, natural health products, pharmaceuticals, radiopharmaceuticals, and veterinary health products.

In general terms, MHPD provides medical and other scientific support concerning the safety and therapeutic effectiveness of marketed health products to other directorates and bureaus within HPFB, and it supports the policy development initiatives by other branches within HC. MHPD also coordinates risk management activities (e.g., risk expectation, monitoring, risk mitigation, mutually agreed risk communication) within HPFB to ensure timeliness and consistency of approach. In collaboration with other HPFB directorates, MHPD anticipates safety concerns and facilitates the identification, selection and implementation of risk management options, including the crafting, coordinating and disseminating of risk communications to consumers, health care professionals, foreign regulatory bodies and industry.

MHPD also has the lead within HPFB for product advertising complaint assessment and policy, and it coordinates relations with the delegated pre-clearance agencies. MHPD also leads the Canadian Coalition for Medication Incident Reporting and Prevention (CCMIRPs) - a group of 12 health care organizations and consumers. The Coalition's mandate is to develop options, in the form of a business plan, for a comprehensive, viable, sustainable and affordable medication incident reporting and prevention system for Canadians. The desired outcome is a program that manages the risks inherent in medication use and moves toward a goal of risk prevention.

Finally, MHPD is HPFB's lead in the development of adverse reaction regulations and adverse reaction coding terminology conventions. The Directorate also has the Branch lead for the international post-market surveillance framework.

Policy and Strategic Planning Directorate

The Policy and Strategic Planning Directorate (PSPD) provides leadership and an integrated approach to policy and strategic planning in support of HPFB, HC and government-wide objectives and priorities.

The Directorate champions the development of a policy agenda and policy planning process for the Branch, including policy analysis, research, integration, capacity building and environmental scanning. To support an integrated approach to planning, reporting and performance measurement in the Branch, PSPD facilitates a robust annual business cycle and develops key products such as the Branch's strategic priorities and Business Plan, departmental plans and reports, and the performance management framework.

The Directorate leads and supports horizontal policy initiatives and networks at the Branch and departmental and interdepartmental levels, including those related to government priorities and Cabinet business. To strengthen policy and planning linkages, PSPD collaborates with key partners within HC as well as with central agencies and other federal departments and agencies. The Directorate provides leadership and support to the development of policy and planning capacity and culture in the Branch. PSPD also provides high-quality and timely advice and service for the ADM and Branch Executive Committee.

Office of Nutrition Policy and Promotion

The Office of Nutrition Policy and Promotion's (ONPP's) mission is to promote the nutritional health and well being of Canadians by collaboratively defining, promoting and implementing evidence-based nutrition policies and standards. Taking advantage of research from various sources in Canada and abroad, the ONPP acts as a central hub for current, reliable nutrition information.

Office of Consumer and Public Involvement

The Office of Public Involvement (OCAPI) provides expertise and coordination for public involvement activities in the Branch. It helps to develop information and opportunities for Canadians - especially the consumers of the products regulated by HC - to become meaningfully involved in the decision-making process. The Office's main objective is to support and encourage effective public participation in decision making on the Branch's priorities, policies and programs. OCAPI has recently supported the implementation of a significant agreement between the government and the voluntary sector
- An Accord Between the Government of Canada and the Voluntary Sector was signed in December 2001 - and "A Code of Good Practice on Policy Dialogue" was completed in 2002/03.

The Office has significantly increased the number of consultations with Canadians and stakeholders on key health products and food-related initiatives in the past two years. Some of these consultations include the Use of Placebos in Clinical Trials, a Proposal on Legislative Renewal, Communicating Drug Safety Information and Environmental Assessment Regulations.

The Office also produces a quarterly newsletter
- Involving You - that informs Canadians about Branch work and encourages public involvement in helping to determine Branch priorities, policies and programs.

Office of Regulatory and International Affairs

The Office of Regulatory and International Affairs (ORIA) improves HPFB's ability and capacity to implement regulatory policy, increases knowledge and public involvement, and develops consistent approaches to regulating risks. It also promotes HPFB's interests internationally. The Office influences international standards, negotiates international agreements with Canada's trading partners or with other regulatory agencies, addresses issues that cut across borders, and develops US/Canada relations. This Office works with other groups within HPFB to develop Branch positions on the various issues that arise.

HPFB requires a core regulatory capacity to ensure coherence to quality approaches and to support Branch regulatory programs. As such, ORIA focuses on the procedures and capacities needed to develop, administer and gauge the impact of regulations and HPFB's regulatory programs. The Office also influences Branch regulatory activities by adopting best practices and helping to build capacity. Best practices include the use of the Regulatory Process Management Standards, standard operating procedures, and training and professional curricula for regulatory professionals.

Office of Biotechnology and Science

The Office of Biotechnology and Science (OBS) serves both a corporate and Branch function. At the corporate level, the Office coordinates both the science and regulatory components of the departmental biotechnology programs in a manner that is consistent with the Canadian Biotechnology Strategy. The Office is also responsible for corporate services related to library sciences. At the Branch level, the Office provides science coordination and policy advice, and actively promotes a science culture within the organization. It is the Branch focal point for cross-directorate/office science issues and is the contact point for the Office of the Chief Scientist.

The Office provides support as needed to HPFB programs, advises the Assistant Deputy Minister (ADM), maintains strong linkages between the Branch and other areas within the Department, and maintains interdepartmental and other external linkages (e.g., CIHR, Organisation for Economic Co-operation and Development) on all science and biotechnology matters.

Senior Director General's Office - Office of Information Management and Technology

The Office of Information Management and Technology (OIMT) provides Branch-wide information management/information technology (IM/IT) services focused on supporting HPFB science and business objectives and deriving increased productivity and utility out of available IM/IT tools. Key services include

• applications development and support (Lotus Notes, Oracle, QSI, etc.),
• Internet dynamic Web applications,
• business systems analysis and project management services,
• information/records management support, and
• equipment infrastructure support.

The OIMT mission is to provide affordable, effective and efficient IM/IT services that support the HPFB work environment and help the Branch and Directorate realize its business objectives and mandate for service to the Canadian public.

Office of Management Services

HPFB's Office of Management Services (OMS) is responsible for providing overall support, issue management and policy advice to the Branch in meeting its corporate objectives and improving management practices in the areas of people management, financial management, records management, and emergency preparedness and business continuity planning.

Within the framework of people management in HPFB, the Office of Continuing Education's learning and development activities support HC's goal of becoming a "learning organization". The Office is also in line with and supports HC's Learning and Development Policy, which reflects the Continuous Learning Policy of the Public Service.

Health Products and Food Litigation Secretariat

The Health Products and Food Litigation Secretariat (HPFLS), in collaboration with Legal Services and the programs, provides expertise, leadership and coordination in managing litigation and legal risks in HPFB.

Regional Operations

Branch activities are carried out in the National Capital Region (NCR) and in five other regions: Atlantic; Quebec; Ontario & Nunavut; Manitoba & Saskatchewan; and British Columbia & Yukon and Alberta & Northwest Territories. The regional activities are a geographical extension of the NCR activities. The regions are equal partners in many of the Branch's research, surveillance, policy, standard setting, and risk evaluation projects and activities. In addition, they respond to regional needs and address regional issues through liaison with provincial and regional partners.

Atlantic Region

In this region, responsibilities include enforcement programs for drugs, medical devices, blood, biologics and natural health products from offices in Halifax and Moncton. The region also distributes information, liaises with government and private organizations, and supports policy development and consultation activities.

Quebec Region

In this region, responsibilities include enforcement programs for drugs, medical devices, blood, biologics and natural health products delivered from the Regional Operations Centre in Longueuil. The programs are supported by a laboratory. The region also operates a Food Laboratory that contributes to the development of food safety standards by conducting analytical surveillance of selected food products and by developing analytical methods for analyzing chemicals at the trace and ultra-trace levels in food. It specializes in the field of nitrosamines, metal, environmental pollutants, pesticides, vitamin D and nutrient analysis, and pathogen analyses of various food commodities.

Ontario & Nunavut Region

In this region, responsibilities include enforcement programs for drugs, medical devices, blood, biologics and natural health products delivered from the Regional Operations Centre in Toronto. A laboratory supports the programs. The region also operates a Food Laboratory that contributes to the development of food safety standards by conducting analytical surveillance of selected food products and by developing analytical methods for analyzing chemicals at the trace and ultra-trace levels in food. It specializes in the field of mycotoxins, environmental pollutants and pesticides.

Manitoba & Saskatchewan Region

This region maintains enforcement programs for drugs, medical devices, blood, biologics and natural health products from the Regional Operations Centre in Winnipeg. It also operates an analytical chemistry lab program for food risk assessment, policy development and standard setting. In addition, the region supports policy development and consultation activities.

British Columbia & Yukon and Alberta & Northwest Territories Region

This region, headquartered in Burnaby, BC, supports the Branch's risk-management approach to decision making by conducting research, analysis, inspection and surveillance of food and health products to determine their compliance with regulations. The region also promotes conditions that enable Canadians to make healthy choices and informed decisions.

Chapter 3
Laboratory-Based Science in HPFB

The Branch has sixteen laboratories, nine of which are managed by the Food Directorate. The other seven are split between the BGTD (2), HPFBI (2) and TPD (3). Ten of the laboratories are in the NCR. Of the six in the regions, four are food laboratories - which are closely linked to the food laboratories in Ottawa - and two are Inspectorate laboratories. A list of the HPFB laboratories and their addresses is included in Appendices III and IV. The laboratories' science activities are reported based on the categorization developed by the HPFB Quality Management Council. The text box that follows outlines this categorization.

RSA

Compliance Testing - A laboratory science activity enforcing an act or regulation (e.g., pharmaceutical product testing).

Reference Services - A laboratory science activity whose data, services or products are intended to be used by internal or external clients for identification/confirmation of potential public health risks related to infectious diseases and bacterial toxins.

Surveillance - A laboratory science activity whose data are used by internal or external clients to assess or develop regulations (policy development) or to facilitate decision making regarding public health issues.

R&D

Applied Research - A laboratory research activity whose data, information or knowledge is intended to address, improve or resolve specific problems of practical significance in an applied field or area (note that some types of "surveillance" may fall within the definition of applied research (e.g., method development)).

Anticipatory Research - A laboratory research activity whose data or information is intended to address longer-term science and policy issues.

The following provides a description of the laboratories and their activities by directorate.

Biologics and Genetic Therapies Directorate Laboratories

Centre for Biologics Research Laboratory

Mandate

The Centre's mandate is to maintain and enhance research capacity in order to provide a synergistic and proactive group capable of addressing scientific issues (policy, risk assessment) and regulatory challenges in BGTD and HC.

Description

Research at the Centre for Biologics Research (CBR) is focused in two major areas: cellular and molecular biology and biomolecular and structural chemistry. The Centre also has a biostatistics group that supports not only the research activities of the Centre but also contributes to the Directorate's other related scientific activities, namely review and compliance testing.

The CBR provides both anticipatory research (to provide scientific advice for risk assessment and the development of policy and regulations) and more applied research (to address regulatory, analytical and product-specific concerns). It is also involved in international harmonization efforts, efforts to decrease animal testing for health products, and work to develop novel techniques and approaches for the evaluation of therapeutic products. When necessary, the Centre conducts research on adverse reactions to licenced products and/or analyzes products post-market.

Anticipatory Research

The primary activity of the Centre is in the area of anticipatory research. Its activities/projects are as follows:

• blood thrombosis and homeostasis,
• immunological risks associated with new drugs/biologicals,
• analytical separation techniques for bio-molecules,
• molecular basis for anti-cancer therapeutics,
• protein folding,
• bio-spectroscopy,
• cytokine/antigen signalling and transduction pathways,
• molecular and biochemical basis for risk assessment, and
• pharmacogenomics and nucleic acid screening.

Applied Research

The Centre's applied research activities are focused on enhancing the Directorate's expertise in biotechnology, integrating genomic and proteomic research approaches to the study of product safety, efficacy and quality, and enhancing the Directorate's scientific reputation and credibility nationally and internationally. The following activities are currently being undertaken to enhance biotechnology expertise:

• chemical and conformational stability of recombinant therapeutic proteins,
• quantitative marker of potency and toxicity,
• structural characterization with nuclear magnetic resonance (NMR) and mass spectrometer (MS),
• international harmonization of methods,
• drug metabolizing enzymes, and
• inactivation of endogenous retroviruses and prions.

Genomic and proteomic approaches are being integrated into safety, efficacy and quality evaluation by the following activities:

• development of new techniques and methods for proteome analysis, and
• development of genomic and proteomic approaches to the study of drug-induced changes and their biological significance.
• The Directorate's scientific credibility and reputation nationally and internationally is enhanced by the following:
• participation of Centre scientists on international committees such as the various biological working groups of the European Directorate for Quality Medicines (EDQM); and
• laboratory participation on numerous World Health Organization (WHO) and EDQM international collaborative studies to establish standards, methods and approaches for the control and regulation of biologicals, vaccines, blood and other biotherapeutic products.

Biologics and Radiopharmaceuticals Evaluation Centre Laboratories

Mandate

The Centre's mandate is to support the pre-market review and post-market Lot Release Program activities by carrying out product testing, reviewing manufacturers' test methods, reviewing manufacturers' test results, and developing methods and standards.

Description

The Biologics and Radiopharmaceutical Evaluation Centre houses the laboratories used in the compliance testing of biologics, including vaccines, blood products and biotechnology products. These laboratories contribute to the evaluation of biologics for safety, effectiveness and quality; the development of new methods for analysis of biologics; the development of standard test methods; and the establishment of standards via collaborative studies.

Compliance Testing

The Centre's primary activity is the laboratory assessment of biologics used in clinical trials and the pre-market testing of consistency lots for new biologic products and for approved biologic products following a change in manufacturing processes or in the manufacturing site. The testing is carried out as part of the review process to independently assess the consistency of manufacture as well as to analyze the critical test methods used by the manufacturer.

The post-market lot release program is a tool used to manage the risk of biologic drugs on the Canadian market. At the end of the pre-market review, products are assigned to a lot release category based on the inherent level of risk of the product, the global and HC market experience, and the level of process and product consistency observed during the review. Depending on the lot release category, critical release tests (i.e., potency, quality) may be repeated in HC laboratories, the Certificate of Analysis might be reviewed, or the annual notification of lots released may be required.

Applied Research

The Centre's applied research focuses on

• participating in collaborative studies to establish product standards or test methods (e.g., development and potency assignment for international standards for biologics);
• adapting newer techniques and methods to assay methodology; and
• maintaining expertise through, for example, participation in the international harmonization of methods.

Health Product and Food Branch Inspectorate Laboratories

Mandate

The Inspectorate Laboratory Programme is mandated to provide inspectors with the timely and reliable results of microbiological and chemical analyses of health products as well as scientific expertise on these analyses in order to support inspections and investigations related to drugs, medical devices and natural health products.

Description

Laboratories, which are located in Toronto and Longueuil, provide analytical services to inspectors located in the five Inspectorate Operational Centres across the country and to the National Coordination Centre (NCC) located in Ottawa. The samples analyzed include drugs for human or veterinary use (testing according to specifications for chemistry and microbiology: assay, purity, uniformity of dosage, sterility, pathogens, etc.), medical devices (sterility testing and testing of latex gloves) and natural health products. Approximately half of the samples analyzed are related to investigations (screening for active ingredients, chemical or microbiological contaminants, etc.).

The Inspectorate Laboratory Programme is a member of the Network of Official Medicine Control Laboratories (OMCL) of the EDQM. Both laboratories were accredited to ISO/IEC 17025 by the Standards Council of Canada on June 17, 2002. The current scope of accreditation includes chemical techniques only. The laboratories will be applying to expand the scope of accreditation to include microbiological techniques in 2003. The Inspectorate Laboratory Programme participates in and meets the requirements of the external international proficiency testing program of the EDQM. It has recently agreed to participate in the US Food and Drug Administration's proficiency testing program.

Compliance Testing

Compliance testing accounts for approximately 95% of laboratory activity. This testing is done in support of the following:

• drug good manufacturing practices (GMP) inspections, including analytical surveys; and
• investigations related to drugs, medical devices and natural health products.

Applied Research

Applied research accounts for less than 5% of laboratory activity. It includes participation in the development of compendial methods or monographs (i.e., United States Pharmacopoeia (USP), European Pharmacopoeia (EP), AOAC International) and the establishment of pharmacopoeial reference standards (i.e., EP, USP) through collaborative studies or membership on pharmacopoeial committees.

Applied research also involves the development of screening methods for adulterants or undeclared active ingredients in drugs or natural health products.

Longueuil Laboratory

Description

In addition to the activities described above (which are common to both Inspectorate laboratories), the following are activities performed exclusively in the Longueuil Laboratory:

• analyses of antineoplastics (products inhibiting or preventing the growth and spread of neoplastic or malignant cells),
• particulate matter in injections,
• screening by inductively coupled plasma mass spectrometer (ICP-MS).

Toronto Laboratory

Description

In addition to the activities described above (which are common to both Inspectorate laboratories), the following are activities performed exclusively in the Toronto Laboratory:

• microbial assays of antibiotics, and
• testing of latex condoms.

Food Directorate Laboratories

Toxicology Research Division Laboratory

The Toxicology Research Division Laboratory is one of two laboratories in the Food Directorate's Bureau of Chemical Safety. The mandate of these laboratories is to ensure that chemicals are not present in foods at levels that would pose an unacceptable risk to human health. This assessment requires both a toxicological and an exposure component.

Mandate

The Toxicology Research Division Laboratory is focused on the toxicological aspect of the assessment. It is responsible for identifying and investigating potential health hazards associated with novel foods, food-borne chemical contaminants (including those of environmental origin), agriculturally used chemicals and natural food toxicants.

Description

Research is carried out to characterize the organ-and disease-specific effects of these substances. The focus of the research is on filling knowledge gaps regarding the toxicity of these chemicals, particularly as they relate to Canadians' health and the safety of the Canadian food supply. The resulting data are provided to the Chemical Health Hazard Assessment Division of the Bureau of Chemical Safety to assist them in their risk assessment activities.

Other major activities include refining classical toxicological methods and applying molecular toxicology, molecular pathology, genomics and proteomics as tools to develop and identify sensitive and early biomarkers of genotoxicity, mutagenicity, cancer, endocrine disruption, neurotoxicity and immune dysfunction in order to facilitate the enhanced health risk assessment of food-borne chemicals and novel foods. The Pathology Section also provides pathology support to other scientists in the Department.

Applied Research

Applied research, which comprises approximately 95% of laboratory activities, includes the following:

• animal and cell culture studies to identify and characterize organ- and disease-specific effects associated with ingestion of novel foods and food-borne chemical contaminants;
• tissue processing, slide preparation and immunohistochemical staining for pathological (light and electron microscopic) evaluation of tissues from animal studies;
• biochemical, immunological, mutagenicity and genotoxicity assays; and
• application of molecular toxicology, molecular pathology, genomics (DNA micro arrays) and proteomics (protein arrays) as tools to develop and identify sensitive, early toxicity and disease-specific biomarkers for enhanced health risk assessment of food-borne chemicals and novel foods.

The laboratory participates in the International and North American Collaborative Immunotoxicity Studies.

Food Research Division Laboratory

This is the second laboratory in the Food Directorate's Bureau of Chemical Safety.

Mandate

The Food Research Division Laboratory provides dietary exposure data - as well as ways of mitigating this exposure - through its research and surveillance programs.

Description

The Laboratory engages in a range of research activities related to the identification, determination, distribution and sources of potentially hazardous chemicals in the food supply. Major activities are the development of methods of analysis for such chemicals and the conduct of targeted surveys to determine the levels and extent of contamination of food as well as the conduct of national surveys to determine human exposure to these chemicals.

Applied Research

Applied research, which comprises approximately 80% of laboratory activities, includes the following:

• utilization of a multi-element screening method, based on solid-phase micro extraction (SPME) and aqueous phase ethylation for the speciation of lead, mercury and tin in wines; and
• research on rapid screening, immunologically based methods for priority allergens in foods and liquid chromatograph-mass spectrophotometer (LC-MS-MS) techniques for confirmation of allergenic proteins.

Surveillance

Surveillance activities (approximately 18% of total laboratory activity) include planning, coordinating and conducting national surveys of foods for potentially hazardous chemicals (in collaboration with HPFB regional laboratories).

Compliance Testing

Compliance testing (approximately 2% of total laboratory activity) includes certifying that synthetic food colours imported into Canada meet the requirements described in the Food and Drugs Act and regulations.
The Food Research Division Laboratory is a contributor to the AOAC International and it adheres to AOAC International processes for method development and validation.

Microbiology Research Division Laboratory

Mandate

The mandate of the Microbiology Research Division Laboratory in the Bureau of Microbial Hazards is to ensure the microbiological safety of the Canadian food supply by providing expert advice and research data to support the development of policies, standards and regulations.

Description

The Microbiology Research Division Laboratory is a prominent centre of research expertise in microbial food safety. It conducts a variety of research and advisory activities such as the development of novel and rapid methods for the detection, identification, and molecular characterization of bacterial, viral and parasitic food-borne pathogens; research in support of qualitative and quantitative risk assessments and policy development; validation of the safety of novel foods and of new food processing technologies; and research on natural antimicrobials and microbial antibiotic resistance. Reference services include maintaining the National Reference Centres for Botulism and Listeriosis.

Applied Research

Applied research, which comprises approximately 80% of laboratory activity, focuses on method development for the detection of bacterial, viral and parasitic microbial agents in foods. One example is the Microbial Method Evaluation for Development of Nationally Accepted Standard Methods. The impact of this project is in providing appropriate methodology for the analysis of food by all stakeholders, especially the Canadian Food Inspection Agency (CFIA) and accredited laboratories. The main output is a recommendation to HC's Microbiological Methods Committee (MMC) on the appropriateness of specific novel techniques (rapid biotechnical methods for detecting bacteria) and in-house improvements to standard methods.

Reference Services

Reference services, which comprise 20% of laboratory activity, include the following:

• the National Botulism Reference Laboratory - examines suspect foods and clinical specimens submitted for analysis, assists physicians and provincial health departments when botulism is suspected, and alerts the appropriate agencies when commercial foods are involved. The Laboratory maintains reference cultures of Clostridium botulinum.
• the Listeriosis Reference Laboratory - examines suspect foods and clinical specimens submitted for analysis, assists physicians and provincial health departments when food-borne listeriosis is suspected, and alerts the appropriate agencies when commercial foods are involved. The Laboratory maintains reference cultures of Listeria monocytogenes.

The Laboratory also organizes and participates in national and international collaborative studies on methodology and food safety assessments, and it maintains the Compendium of Analytical Methods, which is used by the CFIA and the food industry in Canada.

Animal Resources Division Laboratory

The Laboratory is managed by the Food Directorate on behalf of HC.

Mandate

The Animal Resources Division (ARD) Laboratory's mandate is to supply expert services in animal care and use in relation to authorized research and regulatory and diagnostic testing protocols using animals approved by the HC-Ottawa Animal Care Committee under the auspices of the Canadian Council on Animal Care.

Description

The Division is made up of two interlocked entities: the animal facility and the Laboratory.

Animal Facility
Four floors of state-of-the-art animal facilities (biosafety containment Levels II and III) house a number of special breeding colonies, from Spontaneously Diabetic Rats to transgenic mouse strains and Non-Human Primates (NHP). All of these animals (except the NHPs) are "purposebred". The other parts of the ARD animal facilities are used for a variety of testing and regulatory purposes. The results of the tests are used to manage and evaluate the risks attached to various chemicals that are used in daily life and to help determine whether or not they should be used. For instance, a diesel fuel additive was denied permission to be used in Canada as it proved too toxic in animal experiments. Other protocols might be for the purpose of studying the benefit or risk attached to nutritional supplements, etc. A large part of the work (40%) resides in the testing of biological products (mostly vaccines) in co-operation with BGTD to ensure that they are safe and efficacious (lot by lot release) following HC and WHO regulations.

The Veterinary Pathology Laboratory
This Laboratory is comprised of five distinct units: Flow Cytometry (a technique for measuring and characterizing particles, usually cells suspended in fluids); Clinical Biochemistry and Urinalysis; Hematology; Microbiology and Immunology; and Histopathology. Each component of the Laboratory is run by a technologist and is under the general supervision of the veterinary pathologist.

Applied Research

The applied research conducted by the Laboratory varies with the specific laboratory component. For instance, flow cytometry and clinical biochemistry (80% research), hematology (50% research), microbiology (50% research), and histopathology (50% research) mainly service a variety of research protocols dealing with everything from food safety to radiation protection (e.g., microbial hazards, chemical toxicology, environmental protection).

The balance of the activity in all of the laboratory components is the support of ARD breeding colonies through the periodic performance of quality control procedures as well as diagnostic procedures, which are done on demand.

Nutrition Research Division Laboratory

Mandate

The Nutrition Research Division is mandated to carry out research and surveillance. Research activities focus on ensuring that the Canadian food supply is safe from nutritional hazards and that it meets nutritional requirements. Surveillance activities provide important information about food consumption by Canadians. The Division is responsible for studying the relationship between certain aspects of diet and disease conditions and it maintains and markets the Canadian food composition table: the Canadian Nutrient File.

Description

The Nutrition Research Division consists of the Research Section and the Survey Section. Expertise covers the areas of lipids, carbohydrates, protein, dietary fibre, energy, minerals, vitamins, nutritional genomics, nutritional molecular biology, food composition databases and survey methodology. Activities, except for those undertaken by the Survey Section, are laboratory-based.

Applied Research

As its primary activity (80%), the Division has the responsibility for carrying out research that integrates the nutritional and metabolic aspects of foods. It develops and evaluates analytical methods for nutrients and recommends standards for nutrient intakes and the nutritional adequacy of the food supply.

Division work focuses on the following:

• determining the level and metabolic effect of both naturally occurring and introduced food constituents,
• identifying and understanding the metabolic effects of nutrient interactions,
• studying factors affecting the bioavailability of nutrients,
• developing biomarkers of nutritional status, and
• developing analytical methods.

Method development is often driven by CFIA requirements. Examples of the research conducted include determining the safety of phytosterols and assessing the impact of higher fibre levels in the diet on mineral bioavailability.

Surveillance

Laboratory-based surveillance activities, such as the monitoring of iodine levels in retail milk samples or the determination of various nutrients in the Total Diet samples, comprise approximately 20% of laboratory activity.

The Total Diet Study (TDS) involves the purchasing of foods at the retail level, processing the foods for consumption (Kemptville Community College), combining the foods into about 140 food composites (each one a separate food), homogenizing the composites, analyzing the composites for background concentrations of various potential toxicants, calculating the dietary intake of each chemical toxicant by different age/gender groups (this information is used by the Nutrition Research section), and posting the results on the Food Directorate Web site. Foods from one city are sampled from four different supermarkets once a year.

Reference Services

The Canadian Nutrient File (CNF) is a computerized database of the nutrient values of over 4,000 foods. The File is required to support the survey work undertaken by the Division but is also essential for other activities (e.g., risk assessments). The File is widely used by various government departments, food industries, marketing agencies, hospitals, universities, private nutrition consultants, the media and the general public, and it is the basis of the popular publication Nutrient Value of Some Common Foods. Standards (i.e., number of samples required and number of locations from which they must be gathered) exist for the generation of data for the CNF.

Anticipatory Research

Anticipatory research conducted by the Division includes the following:

• developing biomarkers of nutritional status, and
• identifying transporter proteins involved in the regulation and distribution of cellular levels of copper (the concentration of these transporters can be used as a measure of copper status).

Quebec Region Food Laboratory

Mandate

The Food Laboratories Division contributes to the development of food safety standards by conducting analytical surveillance of selected food products, developing analytical methods for analyzing chemicals at the trace and ultra-trace levels in food, and validating microbiological methods. The Laboratory also participates in national surveys (e.g., TDS) to determine human exposure to these chemicals.

Description

The Laboratory specializes in the field of nitrosamines, elements, environmental pollutants and pesticides. Ultra-trace analyses are conducted in a Level III chemical containment facility. The Division conducts food composition analyses for nutrition and specializes in Vitamin D analyses and nutrients analyses. The microbiology section conducts pathogen analyses on various food commodities, while the chemistry and microbiology sections conduct drinking water analyses on all regulated water parameters.

Surveillance

Surveillance is one of the Laboratory's primary activities. It includes

• surveillance of chemicals (e.g., lead and cadmium) in food to validate levels for Codex compliance as well as of another 16 toxic elements for the TDS, and
• surveillance of enteric pathogens in various food types and of antimicrobial resistance.

Applied Research

Applied research - which is another of the Laboratory's primary activities - includes the following:

• methods development for the detection of microbial pathogens in foods,
• microbial evaluation for the development of nationally accepted standard methods, and
• methods development for the analysis of Vitamin D in fish to collect reliable data for the CNF.

Compliance

Laboratory compliance activities include analyses of

• microbial and chemical contaminants in water (drinking and recreational waters), and
• water quality parameters (drinking and recreational waters).

The Laboratory is participating in national inter-laboratory studies on foods and is currently participating in international inter-laboratory studies on water analysis.

Ontario & Nunavut Region Food Laboratory

Mandate

The Food Laboratories Division contributes to the development of food safety standards by conducting analytical surveillance of selected food products and by developing and validating analytical methods for analyzing chemicals at the trace and ultra-trace levels in food.

Description

The Food Laboratories participate in national surveys such as the TDS to determine human exposure to chemicals. The programs are coordinated through the Food Directorate planning process. The Food Chemistry Laboratory has specialized in the field of mycotoxin analysis over the last decade. Work has included several toxins such as Ochratoxin A and Aflatoxin in a variety of matrices, infant cereals and grains, beverages, and juices. The Organic Residue Laboratory has many years of experience in the field of pesticide analysis and the ultra-trace analysis of dioxins, furans and PCBs. The ultra-trace work is carried out in a four zone chemical containment facility. The Division has also done some work in the field of nutritional analysis, specifically trans fatty acids in frying oils from commercial operations.

Surveillance and Applied Research

Work under these primary activities includes surveillance of mycotoxins in grain-based commodities as well as the trace and ultra-trace analysis of organic residues, including pesticides, dioxins, furans and dioxin-like PCBs.

The entire Laboratory works under the ISO 17025 quality management system, and it was accredited by the Standards Council of Canada in 2001 for two methods. As the surveillance work of the Division changes over time, the scope of accreditation will be adjusted accordingly.

The Laboratory participates in international proficiency sample programs suitable to meet accreditation requirements. In addition, it recently participated in the 3rd Round of Interlaboratory Comparison on Dioxins in Food 2002, organized by the Department of Chemical Analysis at the Division of Environmental Medicine, Norwegian Institute of Public Health. When possible, the Laboratory also participates in international AOAC International collaborative studies.

Manitoba & Saskatchewan Region Food Laboratory

Mandate

The mandate of this Laboratory is to maximize the safety of foods in the Canadian marketplace.

Description

The Manitoba & Saskatchewan Region Food Laboratory contributes to risk identification and assessment by developing, modifying and validating analytical methods of analysis for trace levels of hazardous contaminants (primarily naturally occurring mycotoxins) in retail foods. The methods are then used in national surveillance projects (e.g., TDS, Child Health Initiative) to determine the incidence and levels of the contaminants in the Canadian food supply. The data are also used by other Branch staff to develop dietary exposure estimates, risk assessments and risk management strategies.

The program is conducted in close collaboration and partnership with the Food Research Division, the Chemical Health Hazard Assessment Division, the Toxicology Research Division and the CFIA.

Surveillance

Surveillance comprises half of the work undertaken by the Laboratory. It includes surveillance of the incidence and levels of contaminants in the Canadian food supply.

Applied Research

Applied research comprises the other half of the work undertaken by the Laboratory. It includes the development, modification and validation of methods of analysis for trace levels of hazardous contaminants (primarily mycotoxins) in retail foods.

The Laboratory operates under the principles of ISO 17025. Methods are validated in-house, following the principles of the International Union of Pure and Applied Chemistry (IUPAC) Harmonized Guidelines for Single-Lab Validation of Methods of Analysis. The Laboratory uses Quality Systems International (QSI) software in the management and administration of its quality documents.

The laboratory participates in two international check series programs for mycotoxins in cereal grains: Food Analysis Performance and Assessment Scheme (FAPAS), administered by the Department of Environment, Food and Rural Affairs, UK, and the American Association of Cereal Chemists (AACC).

British Columbia & Yukon and Alberta & Northwest Territories Region Laboratory

Mandate

The mandate of the British Columbia & Yukon and Alberta & Northwest Territories Region Laboratory is to conduct issue-oriented research and surveillance activities related to chemical and biological aspects of food safety by focusing on specific aspects of the food supply in the region with nationwide implications. This supports the mandate of both the Food Directorate and the VDD.

Description

The British Columbia & Yukon and Alberta & Northwest Territories Region Laboratory conducts issue-oriented research as well as some surveillance activities in support of regional and national surveys. The biotechnology group conducts research to address food safety and human health issues related to the consumption of genetically modified fish. Major activities are the investigation of the potential linkage of the use of antibiotics in food and animal feeds to the occurrence of antimicrobial resistant bacteria and the impact to human health. In support of regional and national surveillance studies, the chemistry group develops methods of analysis for chemicals such as PCBs, dioxins and drug residues in various food and environmental matrices, and conducts targeted surveys to determine the levels and extent of contamination in food in order to determine human exposure to these chemicals and drugs.

Applied Research

Applied research comprises half of the Laboratory activity. It includes

• developing detection methods for genetically modified fish in the Canadian food supply and assessing potential toxic effects and suitability for human consumption;
• investigating veterinary drug use as growth promoters in food animal production, the occurrence of antimicrobial resistant bacteria and the impact on human health; and
• determining human exposure to chloroform during a typical shower (HECSB project).

Surveillance and Support Activities

These activities, which comprise the other half of the Laboratory activities, include the following:

• TDS,
• Aquaculture Survey,
• avermectins in food matrices, and
• toxic constituents of herbal and plant products sold as food.

Therapeutic Products Directorate Laboratories

Medical Devices Laboratory

Mandate

The Laboratory is mandated to conduct studies of the physical, chemical and biomedical aspects of medical devices in support of post-market surveillance and pre-market review.

Description

The Laboratory has scientists and engineers with expertise in physics, biophysics, chemistry, electrophysiology, biomedical engineering, materials science and biotechnology. The Laboratory has instruments and facilities for a number of scientific areas, including the analysis of the surface properties of biomaterials, the assessment of biomaterials, the testing of anaesthetic and respiratory devices, and the measurement of electromagnetic interference.

The Laboratory research studies are used to develop policies on the safety of devices and materials and to improve the protocols used by the Branch to review licence applications for new devices.

Applied Research

This primary activity includes the following key undertakings:

• studies in support of the pre-market review and post-market surveillance activities of the Bureau;
• as part of post-market surveillance, evaluation of hazards posed by devices that failed or malfunctioned and the identification of corrective action to be taken by a manufacturer to improve the safety of the device or the issuance of a HC advisory to users of the device; and
• research on generic safety issues, such as the bio-compatibility of the polyurethanes and plasticizers used in medical devices or safety issues such as electromagnetic interference with pacemakers and other medical devices.

Office of Science Laboratory

Mandate

The Laboratory is mandated to conduct studies on the factors affecting the safety and efficacy of therapeutic products in support of post-market surveillance and pre-market review.

Description

The Laboratory is a joint HC-University of Ottawa partnership that brings together scientists and clinicians from across Canada and the US with expertise in antibiotic resistance, chemical analysis, drug disposition, ethno botany, HIV/AIDS, molecular biology, pharmacokinetics and pharmacogenetics. Through this partnership, the Laboratory has access to a wide range of analytical equipment and technical expertise to conduct work on interactions affecting drug safety and efficacy.

The studies conducted are used to develop public communication documents for patients and their health care professionals as well as guidelines and policies on drug-drug, drug-food and drug-natural product interactions to support the regulatory process.

Applied Research

Applied research - the Laboratory's primary activity - includes the following:

• studies in support of pre-market and post-market activities, and
• research, mainly on drug-natural product interactions that could affect drug metabolism and transport as well as on the pharmacogenetic factors affecting the expression and catalytic function of these pathways.

The Laboratory's research studies have been funded directly by the Branch and Directorate and through grants from the Office of the Chief Scientist, the Canadian Foundation for HIV/AIDS Research and the Ontario HIV/AIDS Treatment Network. Indirect support has come through partnerships with scientists and clinicians funded by these granting agencies, CIHR, and the National Science and Engineering Research Council of Canada (Strategic Program).

Research Laboratory

Mandate

The Laboratory's mandate is to maintain a laboratory facility and to conduct research studies in support of drug submission evaluations. The Laboratory also participates in national and international collaborative studies for developing internationally harmonized standards and guidelines.

Description

Laboratory activities focus on assessing the quality of pharmaceutical products by conducting

• studies for enhanced international scientific collaboration,
• research to support and develop policies for the evaluation of pharmaceutical products (innovator and generic drugs),
• research for the assessment of generic and innovator products, and
• other laboratory projects of national and international relevance.

One of the studies' anticipated outcomes is better predictability/reproducibility of drug release characteristics with respect to product formulation, manufacturing attributes and in vivo or clinical results and, thus, expeditious drug submissions reviews.

Applied Research

The Laboratory's primary activity includes the development of in vitro drug release (dissolution) methods for the improved characterization of pharmaceutical products. The Laboratory maintains analytical equipment and expertise for the testing of pharmaceutical products following recognized world standards such as those of the USP.

Others

In addition to HPFB's in-house laboratory-based research, the Branch also funds research undertaken by other branches and universities.

The VDD funds several research projects at various laboratories within HC to ensure the continued safety of Canada's food supply. It also funds HC's Laboratory for Food Borne Zoonoses at Guelph, Ontario, to develop an integrated national surveillance system on antimicrobial resistance (AMR) and antimicrobial use monitoring.

The Directorate's AMR research activities are ongoing in various laboratories across Canada. It also funds alternative research on probiotics as well as human-enterics resistance studies.

Chapter 4
Non-Laboratory-Based Science in HPFB

In addition to the laboratory-based science outlined in the previous chapter, HPFB conducts non-laboratory-based R&D and RSA in both Natural Sciences and Social Sciences.

R&D

Non-laboratory based research is conducted in a number of areas in the Branch.

In terms of food, the Directorate undertakes research in the following areas:

• method development for analysis and inference of food consumption surveys,
• validation of new complex survey methodologies,
• development of methodologies for the quantitative assessment of nutrition policies,
• dose response modelling and exposure modelling for food safety risk assessment,
• statistical meta-analysis techniques,
• methods for probabilistic risk assessment in food safety and nutrition,
• decision analysis modelling for policy analysis, and
• quantitative performance measurement modelling.

In terms of nutrition, research is undertaken into the following:

• Canadians' broad perceptions of healthy eating concepts,
• factors influencing their food choices, and
• an exploration of the language and terminology related to nutrition and healthy eating.

Research is also being conducted to look at Canadians' perceptions of the Food Guide as well as the determinants of healthy eating among seniors, children, youth and low-income Canadians. Research priorities are also being set with stakeholders on determinants of healthy eating and interventions to address them.

In terms of marketed health products, the Directorate conducts research into how best to optimize surveillance strategies for obtaining safety and effectiveness data regarding marketed health products, and into communication strategies for effectively influencing the use of therapeutic products by consumers and health care providers.

Research is also being conducted in a number of other areas (e.g., the impacts of Direct To Consumer Advertising (DTCA) on the health care system, public opinion, public involvement and consultation activities, research aimed at mobilizing social sciences to address HPFB issues).

In terms of natural health products, the Branch funds research performed by academia and other stakeholders that is related to the four pillars of the CIHR (i.e., basic biomedical; clinical; health systems and services; and social, cultural and other factors that affect the health of populations) and to HC as a regulator. It also supports research in effective knowledge translation and transfer.

RSA

By far the most important (in terms of personnel allocation) work undertaken by the Branch is the category of activities defined by the federal government as Related Scientific Activities (RSA). While some of these activities were captured under Laboratory-Based Science (e.g., Compliance Testing, Reference Services and Surveillance) in Chapter 3, many are non-laboratory-based and are mandated by law under the Food and Drugs Act. Seven science activities, each with distinct characteristics, were identified and definitions were developed based on the Statistics Canada requirements for annual reporting. The seven activities are

• regulatory studies, risk assessment and
• standard setting;
• policy studies;
• product evaluation/pre-market review;
• data collection and surveillance;
• inspection, investigation and compliance;
• information services; and
• education, training and development.

The following is a description of the Branch's work under these activities.

Regulatory Studies, Risk Assessment and Standard Setting

Regulatory Studies

Regulatory Framework Development for Biologics

Projects underway in the BGTD regarding regulatory framework development are as follows:

• Plasmapheresis - A project is ongoing to update the regulations (currently under part C, Division 4 of the Food and Drugs Regulations) respecting the collection of human plasma by plasmapheresis to be used for the manufacturing of blood products. Updates to these regulations are needed because of advances in technology and new infectious disease testing requirements.
• Blood and blood components - A project is underway to develop a comprehensive regulatory framework for the blood and blood components used for transfusion. This initiative is required to respond to changes in the health care system, and it allows for a comprehensive approach to safety issues around blood. This initiative will include
  • developing national standards for blood safety;
  • drafting regulations based on the standards;
  • establishing a well-adapted framework for regulatory oversight and control of parts of the system that are not currently addressed (e.g., hospital blood banks);
  • conducting uniform, high-quality and internationally competitive risk-based inspections to evaluate establishments' handling of blood, safety information and reporting of adverse transfusion events;
  • conducting high-quality investigations when notified of a potential problem; and
  • implementing appropriate corrective and preventative compliance and enforcement actions.
• Cells, tissues and organs for transplantation - The objective of this work is to develop a comprehensive regulatory framework for cells, tissues and organs used for transplantation. The implementation of new regulations for the safety of cells, tissues and organs used for transplantation in Canada will focus on establishments involved in the procurement, testing and processing of cells, tissues and organs. This initiative will include:
  • publication of national standards for cell, tissue and organ safety;
  • development of regulations based on the requirements of the standards;
  • establishment of a registration mechanism for such establishments;
  • periodic information gathering and analysis from such establishments in order to determine the level of compliance with the regulations;
  • risk assessments for practices found not to be in compliance with the regulations and for new emerging issues brought to HC's attention; and
  • compliance and enforcement activities, surveillance, and a targeted research program to develop internal expertise related to new risk areas for cell, tissue and organ transplantation.
• Xenotransplantation - The development of a comprehensive and appropriate regulatory framework for clinical trials in xenotransplantation is required to address the unique safety issues associated with xenotransplantation in order to maximize the safety, efficacy and quality of xenografts intended for use in clinical trials. Of particular concern is the potential for transmission of animal viruses across the species barrier to patients receiving animal cells, tissues and organs, and the subsequent possible transfer to close contacts and other third parties. This proposed new framework will result in new regulations under the Food and Drugs Act as well as revised safety standards for xenotransplantation, accompanied by new policies and guidelines for xenotransplantation.
• Positron-emitting radiopharmaceuticals (PERs) - An initiative is underway to develop a regulatory framework for PERs. This initiative will include an examination of the current regulatory framework applicable to Schedule C drugs, which includes PERs for use with Positron Emission Tomography (PET); recommendations on whether or not an amendment to the regulatory framework is required based on the current state of knowledge and use of PERs with the PET technology in Canada; and the development of policies and guidelines for PER manufacturing and use.

Clinical Trial Regulations for Biologics and Therapeutic Products

Before an application for marketing is filed, much work goes into the development of a new drug product. Studies are conducted in vitro and in animal models, and the toxic potential for the drug/biologic is thoroughly investigated. Regulatory Process steps in at the point when the product is ready to be tested in humans. There are pertinent, stringent and extensive regulations and guidelines in place to ensure that human subjects of research are protected, and that all provisions of good clinical practice are respected. Division 5 of the Drug Regulations outlines in detail all of the requirements. In addition to clarifying the regulations, applicable guidelines exist to outline good clinical practice in full detail. Finally, an inspection program is aimed at further ensuring that all protections are in place at each investigational site, that they are respected and that the integrity of the information obtained during the course of a clinical trial is maintained, so that the outcome of these trials can be considered valid. In all respects, Canadian Regulations on Clinical Trials are considered to be "state of the art".

Clinical Trials of Natural Health Products

NHPD is preparing a scientific framework and guidance document that focuses on the specific issues of the clinical trial approval of natural health products. This would differ from and be in addition to the internationally accepted requirements for all conventional medicine clinical trial approvals. Examples include proper characterization of the typically complex nature of natural health products and the unique aspects of complementary and alternative health care paradigms requiring expertise in the supervision and conduct of a clinical trial involving a natural health product that is not usually associated with conventional clinical trials.

Environmental Assessment Regulations

The ORIA is developing environmental assessment regulations for substances in products currently being regulated under the Food and Drugs Act. These products include pharmaceuticals, veterinary drugs, biologics, genetic therapies and radiopharmaceuticals, natural health products, cosmetics, medical devices, food additives, and novel foods. The Office works horizontally with other federal departments (specifically the Department of Fisheries and Oceans, Agriculture and Agri-Food Canada, and Environment Canada) as well as with the provinces and academics to coordinate and collaborate on research activities focusing on the environmental exposure and effects of substances included in the Food and Drugs Act.

Regulation Development in the Area of Food

In keeping with new national and international developments in relation to allergens in foods, work will be undertaken to develop a regulation on the labelling of food ingredients to protect allergen-sensitive consumers.

A Regulatory Framework for the product-specific authorization of health claims for foods is also being developed.

Risk Assesment

Risk Assessment Related to Biologics and Radiopharmaceuticals

BGTD provides medical, scientific and technical support concerning the safety and effectiveness of biologics and radiopharmaceuticals to other directorates within the HPFB. The Directorate also participates in risk management activities and performs risk assessments in support of investigations triggered by the potential violation of the Food and Drugs Act and Regulations that could compromise product safety.

Risk Assessment Related to Marketed Health Products

For marketed health products such as pharmaceuticals, biologics, medical devices, natural health products and veterinary drugs, post-market assessments of the benefits and risks are conducted, and the appropriate risk management and communication strategies are recommended. Some of the assessments also respond to requests from provincial governments and other federal government departments.

Risk/Benefit Assessments Related to the Food Supply

Determining health risks associated with the food supply and developing national strategies to manage them is one of HC's primary responsibilities. Determining health benefits that may accrue by consuming certain foods and developing strategies to encourage consumers to adopt practices that lead to those benefits is another. The process of determining the health risks and benefits associated with food is fundamental to the development of public health policies related to foods. Risk/benefit assessments are generally carried out by multi-disciplinary teams that consider toxicological and epidemiological studies, surveillance information, data from food-borne illness outbreak investigations, and data from compliance and monitoring. Examples of risk/benefit assessments conducted by the Food Directorate include health risk assessments in response to situations regarding allergens, organic and inorganic contaminants, natural toxins, and microbial contaminants. Some assessments are conducted in response to requests from CFIA, other federal government departments and the provinces.

Health Risk Assessments Related to Veterinary Drugs

VDD provides health risk assessments to CFIA upon request when CFIA inspectors find residues in food derived from animals treated with veterinary drugs. This activity provides sound scientific advice upon which CFIA is able to decide how to proceed with compliance actions to ensure that the food consumed by Canadians is safe.

Standard Setting

Standards in Biologics and Genetic Therapies

BGTD plays a key role in developing safety standards for biologics, including participation on technical committees responsible for the development of national safety standards for blood and blood components, human cells, tissues and organs, and xenografts as well as international committees (e.g., International Conference on Harmonization) involved in developing standards for other biological products.

Standard Setting in Food and Nutrition

The setting of standards is critical to the achievement of the Food Directorate's public health objectives. Canadian standards are based on risk/benefit assessments and reflect, in many cases, established international standards. Standard setting is undertaken using a multidisciplinary approach that addresses nutritional, chemical and microbiological considerations. Examples include the recommended nutrient intake for the establishment of the safety of a novel food.

Veterinary Drug Standards

The VDD sets the standards and guidelines for the human safety evaluation, clinical evaluation, and manufacturing and quality control of veterinary drugs. This also includes medicated feeds and assay methodology for detecting veterinary drug residues in food.

VDD has the crucial responsibility of ensuring the safety of food produced from food-producing animals treated with veterinary drugs through the establishment of Maximum Residue Limits (MRLs). An MRL is an amount of a residue that could remain in the tissue or food derived from a food-producing animal that has been treated with a veterinary drug. This maximum level of residue is considered to have no adverse health effects if ingested daily by humans over a lifetime.

The establishment of MRLs is a complex process, and it is done only after an extensive review of data demonstrates food safety. VDD uses a scientific multi-step health risk assessment process that is internationally recognized. Once the evaluation of a drug is complete, the proposed MRL must go through a consultative review with stakeholders. The proposed MRL then goes through the regulatory process before it can be promulgated into the Food and Drugs Act and Regulations. Following the approval of products, the CFIA undertakes monitoring and compliance activities to make sure that MRLs are adhered to.

Standards in Natural Health Products

NHPD is currently preparing a Compendium of Product Monographs containing approximately 300 monographs on natural health products that are based on critically evaluated scientific information. The types of health products being monographed include those derived from plant, algal, fungal, bacterial or non-human animal materials, extracts or isolates of the above, most vitamins, amino acids, essential fatty acids, synthetic duplicates of the above natural compounds, minerals, and probiotics. Excluded are injectable drugs, tobacco, antibiotics, biologics such as vaccines, prescription medicines and controlled substances.

The monographs contain the proper and common names of the natural health product, its source, routes of administration, dosage forms, uses or purposes, dose, duration of use, risk information, including cautions or warnings and adverse reactions and contraindications, and the references from which this information was obtained. The standards of evidence being applied in the evaluation of the literature correspond to those established by the US Agency for Health Care Research and Quality. Claims for safety and effectiveness of natural health products must correspond to the level of evidence available that relates to the claim, with safety taking precedence.

NHPD is reviewing the scientific literature to establish GMP and Good Agricultural Practice Guidance Documents that contain detailed specifications for the production of high-quality natural health products. Conformance to GMPs to assure product quality will be a requirement for the issuance of a site licence to a manufacturer, packager, distributor or importer.

Policy Studies

Novel Foods and Biotechnology

The Food Directorate engages in various activities to ensure that Canada's approach to the safety assessment of novel foods, including foods derived from biotechnology, evolves with the science. These activities include participating in international fora such as Codex Alimentarus and the Organisation for Economic Co-operation and Development and incorporating advice from expert advisory committees (e.g., Canadian Biotechnology Advisory Committee (CBAC), Royal Society of Canada).

Nutritional Quality of Foods

HC policies regarding the nutritional quality of foods are based upon risk assessments using modelling techniques and pooled provincial survey databases, the integration of the recommendations of an external advisory committee, the scientific review and evaluation of scientific data and existing regulations in other countries, the development of standards of evidence for evaluation of health claims, and adherence to Codex General Principles. Policy work in the areas of generic health claims, product-specific health claims, and the addition of vitamins and minerals to food will complement the recently implemented mandatory nutrition labelling regulations and help Canadians improve their health and make informed choices.

Highest-Risk Food-Borne Pathogens

The Food Directorate is concerned with mitigating the risks associated with food-borne microbial hazards, including those of the highest risk: Salmonella, Verotoxigenic E. coli, Listeria and Campylobacter. The development of comprehensive government policies to reduce the risk of food-borne illness needs to ensure that appropriate and feasible measures are taken at each step in the food chain where hazards are present. Comprehensive policies will cut across many jurisdictions and regulatory authorities. This work requires extensive consultation and collaboration with partners and stakeholders in the preparation, review and communication of risk assessments, the development of appropriate risk management strategies, and communication with industry, regulatory authorities and consumers.

Prions

Key Transmissible Spongiform Encephalopathy (TSE) issues relevant to human health, as they relate to food, are being addressed with the goal of developing integrated policies across HC and CFIA program areas to prevent the entry of TSE into and along the food chain in Canada.

Other Food Policy Studies

Policy studies are also being undertaken in areas such as food irradiation in support of the new enabling regulatory provisions and food fortification. These studies include statistical modelling to illustrate the impact of discretionary fortification options.

CFIA Food Safety Activities

Subsection 11(4) of the Canadian Food Inspection Agency Act provides HC with the mandate to assess the effectiveness of the CFIA's activities related to food safety with the objectives of providing

• advice and guidance to CFIA on its food safety activities, and
• feedback to HC to assist in carrying out its role of developing food safety and nutrition policies and standards.

The approach used in HC's Food Safety Assessment program is based on Treasury Board's Evaluation Policy. The findings and conclusions of a food safety assessment are based on sound research design as well as the collection and analysis of valid and reliable quantitative and qualitative data. Food safety assessments can examine both the intended and unintended outcomes of a program.

Food Policy Liaison

Effective consultation and liaison strategies are being developed and conducted with respect to the HPFB food program between federal interests and provincial/territorial governments, health professionals, industry, consumer associations and special interest groups.

Nutrition-Related Policy

To ensure that policies and programs to support healthy eating and enhance population health are scientifically sound, the ONPP draws on relevant and current national and international research from a range of disciplines, including medical and biological sciences as well as social, economic, political and environmental sciences. A review of Canada's Food Guide to Healthy Eating and related dietary guidance is being undertaken as a result of new scientific knowledge about the relationships between diet and health. In addition, relevant scientific background information is being collected and synthesized, and options are being developed for the implementation of the Food and Nutrition Surveillance System (FNSS).

The strength of ONPP's capacity to create a solid evidence base is multiplied through collaborative efforts with partners and the involvement of expert advisory groups, including respected researchers, non-governmental organizations, and representatives from relevant ministries at the federal, provincial and territorial levels. ONPP provides leadership in bringing partners together and identifying information needs and research as well as by advocating for efforts to fill in these gaps (e.g., by influencing national health survey content or research agendas of the CIHR). Dissemination of this work is a priority because providing the appropriate information to stakeholders will enable planning and action by all sectors to meet the needs of Canadians.

Inspection-Related Policy

The Policy and Regulations Division supports the core function requirements of the Inspectorate, the Branch and HC by contributing to the development of a strategic, science-related public policy framework that is based on a comprehensive regulatory strategy across all product classes. Multi-disciplinary collaboration between inspectors, laboratory analysts, managers and policy analysts ensures that policy development is grounded in valid scientific data and robust analyses utilizing a risk management approach to decision making. By harnessing the full range of life sciences - complemented by social science perspectives and tools - the Inspectorate is able to deliver an informed, effective and efficient national compliance and enforcement program in furtherance of HPFB's mandate.

Antimicrobial Resistance (AMR)

The development of AMR poses a serious threat to public health. VDD is leading the federal and interdepartmental efforts on the science and policy aspects of AMR from both a human and animal health perspective. The interdepartmental work has led to the development of an AMR Issue Identification Paper.

HC's Advisory Committee on Animal Uses of Antimicrobials and Impact on Resistance and Human Health was formed in 1999 to provide advice on the development of policies on AMR associated with the use of antimicrobials in food-producing animals. This Committee submitted its final report to HC in June 2002.

A consultation with provincial and territorial representatives was held in Ottawa on February 7, 2003, to discuss some of the Advisory Committee's recommendations, namely those that require provincial action. Background documents on this consultation as well as other AMR publications can be found on the VDD Web site. A public consultation with a broad cross-section of stakeholders was held on May 22-23, 2003. All of this input will inform policy development and other activities with regards to AMR.

Product Evaluation/Pre-Market Review

Safety, Efficacy and Quality of Biologics, Radiopharmaceuticals and Therapeutic Products

No drug is 100% effective and/or 100% safe. Indeed, the more potent and effective a drug product, the higher the probability of its having significant side effects. The purpose of the review of each product file is, in part, to conduct a benefit/risk assessment in order to ensure that the benefits of the product outweigh its risks. To arrive at a decision, staff from the regulatory areas consider the full range of the known properties of a product (its profile) and balance that against the disease it intends to treat. Depending on the circumstances, the evaluator must ensure that consideration has also been given to information on the full range of therapeutic options for the disease to be treated, their known properties and whether they represent an advance on existing treatment options. The exercise is both qualitative and quantitative, and it requires training, experience, and an intimate knowledge of clinical and medical sciences.

The following example illustrates the three steps required in the product evaluation/pre-market review of biologics: Clinical Review Process, Quality Review Process and Review of Product Monographs.

Clinical Review Process

The Clinical Review Process is a synthesis of an evaluation of the in vitro data, the animal data that support future and potential claims in man, and the human clinical studies.

• Evaluation of the in vitro data in a submission - This consists of an evaluation of the in vitro information that forms part of the regulatory submissions that are filed by manufacturers or non-commercial sponsors in support of their initial pharmacodynamic studies in animal models. These studies provide a significant foundation that will allow the prediction of effects (including toxicity) in animal models. Specific expertise in basic medical and other sciences is required.
• Evaluation of the animal data that support future and potential claims in man - These studies can be pharmacodynamic, pharmacokinetic, toxicokinetic or immunogenicity studies in an animal model or in models that are best suited to the human situation. There may also be special studies that examine the behaviour of the biologic in females, juvenile animals or in the aged as well as specific studies targeted at elucidating properties of the products that are expected to have direct relevance in the clinic.
• Evaluation of human clinical studies - These extensive clinical studies carried out in human subjects - either healthy volunteers or patients - validate the use of the new product in the human therapeutic situation. Studies are of variable size and design depending upon the disease, its prevalence in the population and whether special subgroups, including women, children or the aged, need to be targeted.

Quality Review Process

The quality review for biologics is a synthesis of the following: an indepth analysis of the paper submission, a laboratory evaluation of both the product and the key test methods used to control it, and an on-site evaluation (inspection) of the facilities and the personnel involved in its production.

The process involves an evidence-based, case-by-case, risk/benefit assessment that considers the product in the context of its intended use.

• In-depth analysis of the paper submission - This step in the quality review process includes an analysis of the following:
  • characterizaion of the active biological ingredient,
  • the biological starting materials,
  • the production methods used to produce the active ingredient and drug product,
  • process validation,
  • viral safety,
  • biologic test methods and test method validation,
  • specifications for the active ingredient and the final drug,
  • stability of the drug substance and final product, and
  • comparability of material manufactured at small scale versus commercial scale.
• Laboratory evaluation of both the product and the key test methods used to control it - During this stage in the process, the degree of laboratory evaluation to which a biologic product is subjected is linked to a risk/benefit assessment of the intended use of the product. In addition, before a Notice of Compliance is issued, the adequacy and reproducibility of critical control test(s) are assessed using the standard operating procedures provided by the sponsor.
• On-site evaluation (inspection) of the facilities and the personnel involved in production - On-site evaluations look at the level of control of the production facility, the production process, the active ingredient and the drug product. These evaluations also examine the quality of the personnel who produce the active ingredient and drug product as well as the documentation systems in place in the production facility.

Review of Product Monographs

Information to professionals and the public on the products that are evaluated and made available through the drug development and evaluation process generates the knowledge and intelligence that is reflected in the Product Monograph. The Product Monograph is a scientific and practical document that describes the entire profile of a drug at the time it is approved and issued. It is a living document, the intent of which is to provide information and manage the risks inherent in the use of a product.

Other Issues on Access to Drug Products

In addition to the regulatory processes described so far, in cases of emergency or in urgent situations in which a physician has exhausted all other therapeutic means, the regulations allow for the provision on an individual basis of the release of products that are not yet marketed. This is called the Special Access Programme. It allows, under certain defined conditions, the compassionate release of therapies after consideration of the information available on the product on a case-by-case basis. This ensures that the product is used legally; however, the requesting physician and the patient have to take full responsibility for the use of the drug.

Miscellaneous Drug Regulatory Matters

Before filing a submission, a sponsoring manufacturer may wish to determine the extent and scope of the information that is required before the product can be reviewed and approved. The sponsor might wish to know, for example, whether the product is a drug (a chemical or a biologic drug), a device, a combination of a drug and a device or a natural health product. The sponsor might also wish to determine whether or not the product is in new drug status. The regulatory implications of these decisions are varied, and they result in diverse information and regulatory requirements depending upon how the decision is rendered.

Safety and Efficacy Evaluation of Veterinary Drugs

Veterinary drugs are being assessed for safety and efficacy from both an animal and human perspective. This entails the scientific and technical evaluation of the chemistry and manufacturing information, the review of animal safety studies, human safety studies and adverse drug reaction information, and an environmental review. Veterinary drugs sold in Canada are safe for the animals, effective for the purpose for which they are being marketed, manufactured according to strict specifications and remain stable up to the expiry date. A veterinary drug is approved for sale in Canada only if HC is satisfied that following the evaluation the drug is in compliance with the Food and Drugs Act and Regulations.

Pre-Market Assessment of Genetically Modified Foods and Other Novel Foods

The pre-market assessment of genetically modified foods and other novel foods is required under Section B.28.001 of the Food and Drugs Regulations. The science-based safety and nutritional assessment includes a review of the molecular biological data that characterize the genetic change, the composition of the novel food compared to non-modified counterpart foods, the nutritional information compared to non-modified counterparts, the potential for introducing new toxins and the potential for causing allergic reactions.

Pre-Market Notification Related to Infant Formulas

The pre-market notification of HC by manufacturers of new infant formulas and of infant formulas that have undergone major changes to their formulation, manufacturing process or packaging is mandated by the Food and Drugs Regulations. Infant formulas are generally the sole source of nutrition for infants during a critical phase and, as such, they must be nutritionally adequate to promote acceptable growth and development. Infant formulas must also be chemically and microbiologically safe.

Evaluation of Manufacturers' Submissions Related to Food Irradiation

Prior to irradiating a food that is not listed in the Table of Division 26 of the Food and Drugs Regulations, manufacturers must provide submissions to HC. These submissions must be evaluated pursuant to the statutory requirements of Section B.26.005 and an amendment made to the Table to enable the food to be irradiated at the specified dose.

Evaluation of Food Additives

Section B.16.002 of the Food and Drugs Regulations requires an evaluation of food additives prior to use. HC's process involves an evaluation of the microbiological effects and safety of the additive, the effect on the nutritional quality of the food, and a chemical assessment for safety and efficacy.

Data Collection and Surveillance

Post-Market Monitoring of Marketed Health Products

The safety and therapeutic effectiveness of marketed health products, including pharmaceuticals, biologicals, food interactions with other health products, medical incidents/errors, natural health products, radiopharmaceuticals and medical devices is monitored by HC. The aim is to respond consistently, effectively and in a timely manner when further attention and/or intervention is required. MHPD monitors most of the therapeutics regulated and evaluated by HPFB, with the exception of vaccines, blood, tissues and organs. These are monitored by the PPHB, where further levels of interaction and collaboration exist. HPFB also promotes and facilitates pharmacovigilance activities in Canada and internationally by liaising with stakeholders and other regulatory authorities and conducting regulatory oversight of drug advertising.

Food and Nutrition Surveillance Activities

Surveillance activities are part of a complete policy and standard-setting program for food safety and nutrition.

The Food Directorate's surveillance activities are focused on chemical and microbiological hazards in food as well as the nutritional value of foods. The Directorate uses an integrated approach to data collection and synthesis that incorporates data from various forms of surveillance such as market basket surveys, food consumption survey data, the CNF, product/food additive post-market surveillance, food inspection data, disease data, health status data, sentinel studies, and health determinants such as food-borne disease statistics and the incidence of low birth weight in infants.

In the last three years, through an inter-branch working group with provincial representation, HC has built the case for enhanced food and nutrition surveillance in Canada and has identified the benefits of an FNSS - including its key elements and core components. HC has also initiated a process to move forward on the FNSS. The ONPP chairs this internal working group, and it has been designated to coordinate the development of an FNSS. The system involves the collection, integration, analysis, interpretation and dissemination of data, and it relies on a number of activities as well as a comprehensive range of data sources. Its centerpiece is an ongoing program of major national population surveys to gather data on food and nutrient intakes, food safety and environmental exposures, nutritional status, nutrition-related health outcomes, knowledge, attitudes and practices for healthy eating, anthropometrics, and individual and collective health determinants, including factors affecting food security.

Examples of food and nutrition surveillance activities include the following:

• gathering data on calcium in calcium-added beverages to assure the safety of these products;
• gathering data on nutrients (12 elements) and toxic chemicals (16) in the TDS;
• conducting studies on iodine contamination in milk-based food as well as lead and cadmium in infant formula;
• conducting market basket surveys, including food consumption surveys;
• undertaking product/food additive post-market surveillance;
• monitoring enteric pathogens;
• collecting food-borne disease statistics and health status data;
• undertaking sentinel studies and health determinant studies such as food-borne disease statistics and the incidence of low birth weight in infants; and
• conducting consumer surveys regarding knowledge, attitudes and opinions about food.

Veterinary Drugs and AMR Surveillance Activities

Monitoring activities related to veterinary drugs and AMR are being undertaken to ensure that their levels in food and their use as growth promoters do not pose unacceptable risks to the health of Canadians. This involves the gathering of data on antibiotic resistance of major human pathogens in retail food in Canada; the development of an integrated national surveillance system on AMR and antimicrobial use monitoring; the establishment of a database of adverse reactions to veterinary drugs to track adverse drug reactions and inform the scientific evaluation of new veterinary drugs; and the post-market surveillance of veterinary drugs (pharmacovigilance).

Inspection, Investigation and Compliance

Drug Investigation Activities

The primary role of the HPFB inspectors is to monitor compliance and enforcement of the relevant legislative requirements for health products regulated under either the Food and Drugs Act or the Controlled Drugs and Substances Act and their Regulations. An investigation is conducted when real or perceived violations of these two laws and regulations are brought to the attention of the Inspectorate through complaint or enquiry.

Investigations may be initiated at any stage of a product's life cycle, and each new investigation, depending on its source, the product, or the aspect subject to complaint, may require a customized approach selected from a common set of actions. Drug products that are investigated include pharmaceuticals, narcotics, controlled and restricted substances, biologics such as viral or bacterial vaccines, radiopharmaceuticals, natural health products, veterinary drug products, medical gases, disinfectants and plasma derivatives (blood products).

Problems investigated may include any of the following:

• labelling and advertising violations;
• quality and compositional issues, including contamination, tampering allegations, product ineffectiveness and product failure;
• recalls and withdrawals;
• complaints such as the sale of drugs without drug identification numbers (DIN);
• adverse reactions reporting where a product is concerned (e.g., reactions not mentioned in the product monograph);
• follow-up to Customs surveillance;
• complaints relating to the diversion or inappropriate use of controlled drug substances; and
• collaboration with foreign authorities relating to counterfeit drugs or fraudulent products.

The Inspectorate Laboratory Program supports drug investigation activities by providing inspectors with chemical, physical and microbiological analytical services. At the national and international levels, investigations are conducted in partnership with other organizations such as the CFIA, the Royal Canadian Mounted Police, and the Canada Customs and Revenue Agency.

Clinical Trials for Human Drugs

The Inspectorate conducts inspections and investigations related to clinical trials as part of a national initiative to ensure compliance to the Good Clinical Practices (GCP) that are integrated in the Clinical Trial Regulations. Selection of sites for inspections is made in consultation with other directorates of the Branch.

Inspections of clinical trials are conducted at either the qualified investigator's site or sponsor site. A determined percentage of all sites is inspected each year, as is the customary practice in other jurisdictions. The current target is to do up to 80 inspections per year. The scope of inspections includes the thorough assessment of compliance to pre-approved protocols, best practices in obtaining informed consents, GCP and other important elements in the conduct of clinical trials.

In addition to inspections, investigations are initiated whenever a complaint or concern is relayed. These investigations can be triggered by either external sources (e.g., subjects enrolled in a clinical trial, sponsors, qualified investigators, Research Ethics Boards, other regulatory agencies) or internal sources (e.g., other Branch directorates).

The Inspectorate collaborates with all Canadian stakeholders in communicating expectations vis-à-vis the requirements of GCP within the Canadian context. As GCP was developed in the international forum and has been widely implemented in other jurisdictions, harmonization with similar activities in other jurisdictions is maintained. This is particularly important as clinical trials are frequently conducted simultaneously across many jurisdictions.

Activities Related to Blood, Tissues, Organs and Xenografts

The Inspectorate conducts activities in the area of blood, tissues, organs and xenografts (BTOX) so that Canadians are not put at undue risk by these health products. The Inspectorate also provides information about the risks and benefits of these health products.

Regional BTOX compliance specialists assess the compliance of blood establishments to the applicable regulatory requirements in order to minimize the risk of transmission of infectious agents and diseases. Issues of non-compliance by establishments and individuals in Canada handling and/or processing human cells, tissues and organs for transplantation are investigated. BTOX compliance specialists inspect establishments that process, import and distribute donor semen according to a specific inspection plan and cycle. The Inspectorate's main partners within HPFB are the BGTD and the TPD.

Establishment Licencing Activities

The purpose of Drug Establishment Licensing is to provide licences to establishments that deal with drugs and that are involved in the licensing framework for all drug products on the Canadian market. All establishments engaged in the fabrication, packaging/labelling, importation, distribution, wholesale and operation of a testing laboratory relating to drugs are required to hold a drug establishment licence unless expressly exempted under the Food and Drugs Regulations. The basis for the issuance of an establishment licence is GMP compliance as determined by an inspection conducted by the HPFB Inspectorate. Foreign sites whose products are being imported by Canadian importers for distribution on the Canadian market also fall under the umbrella of establishment licensing and are therefore evaluated for GMP compliance.

The purpose of Medical Devices Establishment Licensing is to confirm that procedures are in place to protect the public should a problem with a medical device be identified. A Medical Device Establishment License is required to sell or import a medical device in Canada. The basis for the issuance of the licence is the attestations made by the establishment's senior executive officer that all of the procedures required by the Medical Device Regulations have been followed.

Certificates of a Pharmaceutical Product (CPP) are issued in the WHO-standardized format by the Inspectorate as a service to industry. No requirement exists to do so under the Food and Drugs Act and Regulations. The scope of this initiative covers drug products (pharmaceutical, biological and radiopharmaceutical) for human use. A CPP provides a formal attestation regarding a drug product's marketing status in Canada as well as the manufacturer's GMP compliance status. International certification is supported and promoted by the WHO in an effort to provide countries with reliable levels of drug quality assurance not normally available to them.

GMP Inspection Activities

The Inspectorate conducts inspections of companies that manufacture, package/label, distribute, import, analyze or wholesale pharmaceuticals, radiopharmaceuticals or biologic products. The purpose of the inspections is to determine whether the sites comply with the GMP guidelines set out in the Food and Drugs Regulations. Inspections are preliminary to the issuance of an establishment licence or to the incorporation of a foreign site into a current establishment licence.

Under the Inspectorate's inspection cycle, inspections of manufacturing, packaging/labelling and laboratory facilities are conducted every two years, while distributors, importers and wholesalers undergo inspections every three years. To ensure more consistent application of regulatory requirements and to enable industry to comply more easily, the Inspectorate has also developed a series of guidelines and related documents that are available on its Web site.

The Inspectorate has established Mutual Recognition Agreements with other countries with respect to GMP compliance programs. The agreements ensure ongoing access to quality products for Canadians and facilitate the exportation of products manufactured in Canada. Moreover, Canada is a member of the Pharmaceutical Inspection Cooperation Scheme - an international association of more than 25 countries whose purpose is to harmonize the GMPs of member countries.

Medical Devices Activities

The Medical Devices staff in the Inspectorate protect the health and safety of Canadians by enforcing the Medical Devices Regulations that govern the sale, importation and advertisement of medical devices in Canada. Medical devices covered by the Regulations include complex electronic equipment such as defibrillators and X-ray machines, implants such as cardiac pacemakers and hip prostheses, and even simple products such as sutures and disposable gloves. There are about 70,000 types of devices sold in Canada that must comply with the Medical Devices Regulations, and of those about 40,000 require a device licence. There are approximately 2,000 companies in Canada that either import, distribute or manufacture medical devices.

The Inspectorate conducts inspections of medical device manufacturers, importers and distributers. It investigates and responds to national and international complaints and problems; this sometimes results in product modifications, redesigns or recalls as well as packaging, labelling and manufacturing changes. The Inspectorate also monitors medical device recalls conducted by foreign or domestic manufacturers in Canada. When necessary, a Medical Device Advisory may be issued to ensure that the Canadian public, medical professionals, institutions and distributors are aware of product problems, corrections and recalls made by manufacturers. The result is a high standard of medical device safety, effectiveness and quality in Canada.

Within the HPFB, the Inspectorate maintains an ongoing partnership with the Medical Device Bureau; at the international level, it is an active member of the Global Harmonization Task Force for Medical Devices.

Information Services

Science Library Network

The OBS of HPFB has responsibility for corporate services related to science libraries. The Office heads the Science Library Network (SLN), which supports the research and regulatory activities in the HECSB, PPHB and HPFB. The SLN offers a number of services, including reference and literature searches, training and orientations, acquisitions, awareness building (e.g., helping clients stay up to date in their field, disseminating information), and document delivery services.

National and International Communication and Collaborations Related to Food

HC's participation in international fora helps ensure that Canada takes full advantage of opportunities for coordination with food safety regulators from governments and agencies in other countries. International activities include participation in the following:

• Codex Alimentarius,
• Joint Expert Committee on Food Additives,
• WHO/Pan American Health Organization,
• Organisation for Economic Co-operation and Development, and
• Global Forum of Food Safety Regulators.

To advance food safety issues from a departmental perspective, the Food Directorate also fosters strong inter-departmental and intra-departmental relationships. Mechanisms are in place to facilitate HC/CFIA activities, including information gathering and the analysis of food safety priorities.

Mechanisms are also in place to facilitate communication and collaboration with federal/ provincial and territorial partners in food safety. These mechanisms facilitate the development of national food safety standards and policies within a public health context as well as the development of model regulations and codes of practice to move Canada toward a more unified food inspection system.

Networks and Information Dissemination and Exchange Related to Biologics and Therapeutics

Activities related to the networks and information dissemination and exchange related to biologics and therapeutics include the following:

• coordinating national networks, secretariats and councils (e.g., organs and tissue transplantation, blood and blood products);
• managing expert advisory bodies such as panels, committees, boards and contract reviewers;
• harmonizing activities with international agencies;
• preparing and posting on the Internet Dear Health Care Professional Letters, public advisories, Adverse Reaction Newsletter, fact sheets and It's Your Health publications;
• undertaking risk assessment and emergency preparedness activities (flu pandemic, molecular pharming biologicals, blood substitutes, threats of bioterrorism, health- or health product-related emergencies); and
• staffing booth displays at health professional conferences to raise awareness of the adverse reaction and medication incident reporting program.

Consumer and Public Involvement

Involving You is a quarterly newsletter that is published by OCAPI. It plays a key role in encouraging the more informed involvement of Canadians in decisions about health priorities, policies and programs of the HPFB and other HC branches with similar regulatory responsibilities. It is mailed to health-related organizations and individuals across the country and is posted on the OCAPI Web site.

The OCAPI Web site provides information and opportunities for Canadians - especially consumers of the products the Branch regulates - to become meaningfully involved in the decision-making processes of the HPFB regarding priorities, policies and programs. The Web site also serves as an Internet billboard for Branch public involvement activities and related information.

Information Management and Technology

The scientific community within HPFB has been quick to realize the important role of IM/IT in the development of systems to support scientific research, information gathering and analysis. OIMT divisions have developed numerous tools to increase the productivity and effectiveness of HPFB scientific operations.

The following is a list of the IM/IT contributions to HPFB science:

• HPFB Web site - This is a portal developed for all HPFB program Web sites; the Web sites provide important announcements on HPFB activities as well as on the PAC. Program Web sites are also created and maintained through OIMT groups.
• Laboratory Sample Tracking System - Implemented in the Food Directorate, this application captures, tracks and reports on samples of potential outbreaks of botulism in Canada, the results of tests performed in Food Directorate labs, and the suspected causes of the outbreaks. The application facilitates a prompt national response to large outbreaks and policy changes.
• Canadian Adverse Drug Reaction System - Implemented in the MHPD, this database is a repository for adverse drug reactions. The database facilitates the monitoring and collection of adverse reactions and medication incident data and the communication of product-related risks to health care professionals and the public.
• Drug Product Database - Implemented in the Therapeutic Drugs Directorate and the BGTD, the database contains product-specific information on drugs approved for use in Canada and it is accessible by the Canadian public.
• Stock Culture Collection - Implemented in the Food Directorate, this application captures, tracks and reports on Salmonella bacteria food samples received from external and internal parties. The application facilitates the provision of accurate and timely data on the prevalence of Salmonella in the Canadian food chain and decreases the response time for regulatory actions.
• Environmental Assessment Regulations Web Site - Implemented for the ORIA, the Web site enhances visibility, openness, public involvement, accountability, dialogue and good business practices.

Education, Training and Development

Education

The NHPD has established a liaison with the CIHR to facilitate the peer review of grant applications that include aspects of natural health products research. NHPD can also provide seed funding through its Natural Health Products Research Program, which encompasses both grants and contributions. For example, the Branch recently co-funded an Interdisciplinary Capacity Enhancement (ICE) Grant with the Institutes of Health Services and Policy Research, Immunity and Infection, and Musculoskeletal Health and Arthritis. Given to support a Complementary and Alternative Health Care Team, the ICE Grant will extend over the next four years. Grantees belong to several institutions across Canada, including the Universities of Toronto, Laval, Calgary and Saskatchewan as well as the Canadian Memorial Chiropractic College. NHPD has also initiated discussions with the National Science and Engineering Research Council of Canada regarding similar collaborations. Research priorities for NHPD's program were established in consultation with a broad spectrum of stakeholders.

HPFB participates in government-wide PDFs, Post-Secondary Co-operative Education and Internship Programs (Co-op), and the Federal Student Work Experience Program, and it has established a TPD scholarship program.

OCAPI has been instrumental in the creation of a 16-member PAC, which is consulted by HPFB to gain the perspective of the general public and consumers on the Branch's policies and issues. In its first six months, PAC offered input and has already influenced decisions.

Training and Development

Since September 1994, the OCE has been developing and delivering a comprehensive, operationally based continuing education program within some directorates that are now part of HPFB.

In 2000, the Branch Executive Committee endorsed OCE's program and expanded OCE's responsibility to include meeting the scientific and operational learning needs of all HPFB staff. The Branch's Continuing Education and Training Programme (CETP) is intended to contribute to the Branch's capacity to achieve its mission. The CETP is designed to

• provide a core curriculum for new staff in order to orient them and provide key scientific and operational competencies as quickly as possible;
• maintain the scientific and operational competencies of existing staff;
• develop new skills for employees to meet the evolving challenges of their jobs; and
• develop partnerships and liaisons with external organizations and institutions, such as other regulatory agencies, universities, the pharmaceutical industry, and professional associations, to acquire learning programs and avoid duplication of effort as well as to increase the area of mutual benefit.

OCE activities include the development, management, coordination and promotion of all specialized operational learning activities, including those intended for scientific and medical professionals.

The International Association for Continuing Education and Training has approved the OCE as an authorized provider of continuing education units. OCE has also been approved by the Royal College of Physicians and Surgeons of Canada to issue continuing education units for courses under the College's Framework for Maintenance of Certification.

In addition to the above, the Branch provides funding and support for its employees to attend many professional, management and administrative courses of a more generic nature; these courses are offered by HC's Learning Centre.

Attendance at scientific conferences and other meetings - both domestically and internationally - ranks prominently as a key learning and development activity for HPFB staff and accounts for a considerable investment by the Branch.

Appendix I - Definitions

Federal Government Definitions (Statistics Canada)

1. Natural Sciences and Engineering (NSE)

Consists of disciplines concerned with understanding, exploring, developing or utilizing the natural world. Included are life sciences, mathematical, physical sciences, and engineering.

1.1. Scientific Research and Experimental Development (R&D)

Creative work undertaken on a systematic basis in order to increase the stock of scientific and technical knowledge and to use this knowledge in new applications. The central characteristic of R&D is an appreciable element of novelty and of uncertainty.

1.2. Related Scientific Activities (RSA)

Those activities which complement and extend R&D contributing to the generation, dissemination and application of scientific and technological knowledge. Examples: scientific data collection (results from surveys, routine laboratory analyses, compilation of operating records), information services (recording, classifying, translating and disseminating scientific and technological information, operations of scientific and technical libraries, S&T consulting and advisory services, publications of scientific journals and monographs, and organizing scientific conferences are also included), special services and studies (testing and standardization - work towards the establishment of international, national and provincial standards for materials, devices, products, non-routine quality testing, feasibility studies and demonstration projects), education support (grants to individuals or institutions).

2 Social Sciences and Humanities (SSH)

The social sciences and humanities (SSH) field embraces all disciplines involved in studying human actions and conditions and the social, economic and institutional mechanisms affecting humans. Included are disciplines such as economics, law, library sciences, philosophy, political sciences, psychology, social work, history, geography, sociology, urban and regional studies, languages, anthropology and demography.

2.1. Scientific Research and Experimental Development (R&D)

Creative work undertaken on a systematic basis in order to increase the stock of knowledge, including knowledge of humans, culture and society and the use of this stock of knowledge to devise new applications. R&D requires the acquisition of knowledge and not just information.

2.2. Related Scientific Activities (RSA)

Those activities which complement and extend R&D contributing to the generation, dissemination and application of scientific and technological knowledge. The kinds of related scientific activities for the social sciences and humanities are, general purpose data collection, information services, special services and studies, economic and feasibility studies, operations and policy studies (the analysis and assessment of departmental programs, policies, and operations) and education support.

HPFB's Related Scientific Activities (RSA) Definitions

Regulatory Studies, Risk Assessment, Standard Setting

Activities directed towards the establishment of regulations, national science-based standards and guidelines for health products and food as required under the Food and Drugs Act and Regulations. Scientific risk assessments and sound scientific advice for regulatory decisions. Work in support of international science-based standards and harmonization.

Policy Studies

Analysis and assessment of departmental/branch policies, programs and operations. Feasibility studies and policy studies focusing on protecting and improving the well-being of Canadians by reducing the incidence of disease, illness, injury, and death.

Product Evaluation/ Pre-Market Review

Process by which an application for approval
to market a pharmaceutical, biologic, veterinary drug, food, medical device or natural health product is reviewed by scientists in the Branch, and on occasion, by outside experts, to assess the product's safety, efficacy ( except food) and quality. Scientific assessments are conducted using a risk-based approach and supported by a significant component of research, data collection and surveillance, inspection and investigation, regulatory and policy development. For some products, this assessment may also include laboratory evaluation of both the product & the key test methods used to control it and an on-site evaluation (inspection) of the facilities and the personnel involved in production.

Data Collection, Surveillance

Gathering, processing, collating and analysis of scientific data resulting from surveys, or compilations of operating and other records. Examples include statistical and epidemiological studies as part of dietary reference intake, post-market surveillance of health products (pharmaceuticals, radiopharmaceuticals, biologics, medical devices, natural health products, and veterinary health products) and antibiotic resistance of food pathogens. It also includes the monitoring and collection of adverse reactions, medication incident/error, food interactions with other health products, the review and analysis of safety data, and compilation of records.

Inspection, Investigation, Compliance

All work directed toward the delivery of a national compliance and enforcement program for all products, except food, under the mandate of the Branch. Activities include inspection, investigation and monitoring related to the fabrication, packaging/labelling, importation, distribution and wholesaling of regulated health products for human and veterinary use. Examples include quality and compositional issues including contamination, product ineffectiveness and product failure, assessment of clinical trials to pre-approved protocols and compliance with GMP guidelines.

Information Services

All work directed to recording, classifying, translating and disseminating scientific and technological information, operations of scientific and technical libraries, S&T consulting and advisory services, publications of scientific journals and monographs, and organizing scientific conferences.

Education, Training and Development

Grants to individuals or institutions on behalf of individuals which are intended to support the post-secondary education of students in technology and the natural sciences and branch's participation in federal summer student programs, CIHR and university research collaborations.
All training and conferences, attended or arranged, that are not project-specific. This includes the delivery of training courses, research of subject matter, preparation of training materials, collaboration with others, training delivery and evaluation.

Appendix II - HPFB Organization Chart

*as of December 1^st, 2003

Assistant
Deputy Minister
Diane C. Gorman

Senior Director General
Janet King

Issues Management
Executive Director
Cecilia Muir

Therapeutic Access Strategy Secretariat
Executive Co-ordinator
Pharmaceuticals Management Strategies
Abby Hofmann

Office of Management Services Director
Ginette Workman

Strategic Outreach and Partnerships Director
Susan Gardner-Barclay

Therapeutic Products Directorate
Director General
Robert Peterson

Biologics and Genetic Therapies Directorate
Director General
Julia Hill

Health Products and Food Branch Inspectorate
Director General
Jean Lambert

Natural Health Products Directorate
Director General
Philip Waddington

Office of Consumer and Public Involvement
Director General
Roger Farley

Policy and Strategic Planning Directorate
Director General
Stephen Lucas

Health Products and
Food Litigation Secretariat A/Director
Susan Padmos

Office of Nutrition Policy and Promotion
Director General
Mary Bush

Marketed Health Products Directorate
Director General
Chris Turner

Atlantic Region
Regional Director
Annette Daley

Quebec Region
A/Regional Director
Denise Côté

Ontario and Nunavut Region
Regional Director
Colin Broughton

Office of Regulatory and International Affairs
Director General
Judith Lockett

Alberta, B.C., N.W.T. and Yukon Region
Regional Director
Brian Mori

Veterinary Drugs Directorate
Director General
Diane C. Kirkpatrick

Office of Biotechnology and Science
Director General
Pierre Charest

Manitoba and Saskatchewan Region
Regional Director
Robert Scales

Food Directorate
Director General
Karen Dodds

*This organizational chart reflects changes in HPFB which occured subsequent to the preperation of the report.

Appendix III - HPFB Laboratories

Health Product and Food Branch (HPFB)

Health Products and Food Branch Inspectorate (HPFBI)

• Longueuil Laboratory
• Toronto Laboratory

Biologics and Genetic Therapies Directorate (BGTD)

• Biologics and Radiopharmaceuticals Evaluation Centre Laboratory
• Centre for Biologics Research Laboratory

Therapeutic Products Directorate (TPD)

• Medical Devices Laboratory
• Office of Science Laboratory
• Research Laboratory

Food Directorate (FD)

• Toxicology Research Division Laboratory
• Food Research Division Laboratory
• Microbiology Research Division Laboratory
• Animal Resources Division Laboratory
• Nutrition Research Division Laboratory
• Quebec Region Food Laboratory (Longueuil, QC)
• Ontario & Nunavut Region Food Laboratory (Toronto, ON)
• Manitoba & Saskatchewan Food Laboratory (Winnipeg, MB)
• British Columbia & Yukon and Alberta & Northwest Territories Regions Laboratory (Burnaby, BC)

Appendix IV - HPFB Laboratory Locations

Food Directorate Laboratories

Toxicology Research Division Laboratory

Sir Frederick G. Banting Research Centre
A.L. 2202Dl Tunney's Pasture Ottawa, Ontario K1A 0L2 Tel.: (613) 957-0938 Fax: (613) 954-4674

Microbiology Research Division Laboratory

Sir Frederick G. Banting Research Centre
A.L. 2204A2 Tunney's Pasture Ottawa, Ontario K1A 0L2 Tel.: (613) 957-0908 Fax: (613) 941-0280

Nutrition Research Division Laboratory

Sir Frederick G. Banting Research Centre
A.L. 2203C Ottawa, Ontario K1A OL2 Tel.: (613) 957-0919 Fax: (613) 941-6182

Food Research Division Laboratory

Sir Frederick G. Banting Research Centre
A.L. 2203D Ottawa, Ontario K1A 0L2 Tel.: (613) 957-0944 Fax: (613) 941-4755

Animal Resources Division Laboratory

Sir Frederick G. Banting Research Centre
A.L. 2203E Ottawa, Ontario K1A 0L2
Tel.: (613) 957-0917
(613) 952-6815 Fax: (613) 948-6139

Quebec Region Food Laboratory

1001, Saint-Laurent Street West Longueuil (Quebec) J4K 1C7 Tel.: (450) 646-1353 Fax: (450) 928-4480

British Columbia & Yukon and Alberta & Northwest Territories Food Laboratory

3155 Willingdon Green Burnaby, BC V5G 4P2 Tel.: (604) 666-3581 Fax: (604) 666-3149

Manitoba & Saskatchewan Food Laboratory

510 Lagimodière Blvd., Winnipeg, MB R2J 3Y1 Tel.: (204) 983-5490 Fax: (204) 983-5547

Ontario & Nunavut Food Laboratory

2301 Midland Ave. Scarborough, Ontario M1P 4R7 Tel.: (416) 973-1600 Fax: (450) 973-1559

Inspectorate Laboratories

Toronto Laboratory

2301 Midland Avenue Toronto, (Ontario) M1P 4R7 Tel.: 416-973-1572 Fax: 416-954-8599

Longueuil Laboratory

1001 St-Laurent West Longueuil (Québec) J4K 1C7 Tel.: (450) 646-1353 Fax: (450) 928-4455

Biologics and Genetic Therapies Directorate Laboratories

Centre for Biologics Research Laboratory

Sir Frederick G. Banting Research Centre Tunney's Pasture Ottawa, ON K1A 0L2 Tel.: (613) 957 1061 Fax: (613) 941 8933

Biologics and Radiopharmaceutical Evaluation Centre Laboratory

Building 6 Tunney's Pasture Ottawa, ON K1A 0L2 Tel.: (613) 952 0237 Fax: (613) 948 3655

Therapeutic Products Directorate Laboratories

Medical Devices Laboratory

775 Brookfield Road
A.L. 6302B Ottawa, ON K1A 1C1 Tel.: (613) 954-0288 Fax: (613) 993-0281

Research Laboratory

Sir Frederick G. Banting Research Centre A/L 2202C1 Ottawa, ON K1A 0L2 Tel.: (613) 957-3728 Fax: (613) 341-8932

Office of Science Laboratory

University of Ottawa 2215 Guindon Hall 451 Smyth Road Ottawa, Ontario K1H 8M5 Tel.: (613) 562-5800, ext. 8165 Fax: (613) 562-5434

Acronyms

The following acronyms and abbreviations are used throughout this report. (Several abbreviations also appear throughout the text.)

AACC
American Association of Cereal Chemists

ADM
Assistant Deputy Minister

AMR
Antimicrobial Resistance

AOAC
Association of Official Analytical Chemists

ARD
Animal Resources Division

BEC
Branch Executive Committee

BGTD
Biologics and Genetic Therapies Directorate

BREC
Biologics and Radiopharmaceuticals Evaluation Centre

BSE
Bovine Spongiform Encephalopathy

BTOX
Blood, Tissues, Organs and Xenografts

CBAC
Canadian Biotechnology Advisory Committee

CBR
Centre for Biologics Research

CBRL
Centre for Biologics Research Laboratories

CBRN
Chemical, Biological, Radiological and Nuclear

CCMIRP
Canadian Coalition for Medication Incident Reporting and Prevention

CETP
Continuing Education and Training Programme

CFIA
Canadian Food Inspection Agency

CIHR
Canadian Institutes of Health Research

CNF
Canadian Nutrient File

Co-op
Co-operative Education and Internship Programs

CPP
Certificates of a Pharmaceutical Product

CRTI
CBRN Research and Technology Initiative

DTCA
Direct To Consumer Advertising

EDQM
European Directorate for Quality Medicines

EP
European Pharmacopoeia

FAPAS
Food Analysis Performance and Assessment Scheme

FD
Food Directorate

FDA
Food and Drug Administration

FNSS
Food and Nutrition Surveillance System

GCP
Good Clinical Practices

GMP
Good Manufacturing Practices

HC
Health Canada

HECSB
Healthy Environments and Consumer Safety Branch

HPB
Health Protection Branch

HPFB
Health Products and Food Branch

HPFBI
Health Products and Food Branch Inspectorate

HPFLS
Health Products and Food Litigation Secretariat

ICE
Interdisciplinary Capacity Enhancement

ICP-MS
Inductively Coupled Plasma Mass Spectrometer

IM/IT
Information Management/Information Technology

IUPAC
International Union of Pure and Applied Chemistry

LC-MS-MS
Liquid Chromatograph-Mass Spectrometer

MHPD
Marketed Health Products Directorate

MMC
Microbiological Methods Committee

MRL
Maximum Residue Limits

NABST
National Advisory Board on Science and Technology

NCC
National Coordination Centre

NCR
National Capital Region

NHP
Non-Human Primates

NHPD
Natural Health Products Directorate

NMR-MS
Nuclear Magnetic Resonance - Mass Spectrometer

NSE
Natural Sciences and Engineering

OBS
Office of Biotechnology and Science

OCAPI
Office of Consumer and Public Involvement

OCE
Office of Continuing Education

OCS
Office of the Chief Scientist

OECD
Organisation for Economic Co-operation and Development

OIMT
Office of Information Management and Technology

OMCL
Official Medicine Control Laboratories

OMS
Office of Management Services

ONPP
Office of Nutrition Policy and Promotion

ORIA
Office of Regulatory and International Affairs

PAC
Public Advisory Committee

PDF
Post-doctoral fellow

PERs
Positron-emitting radiopharmaceuticals

PET
Positron Emission Tomography

PMRA
Pest Management Regulatory Agency

PPHB
Population and Public Health Branch

PSPD
Policy and Strategic Planning Directorate

QMC
Quality Management Council

QSI
Quality Systems International

R&D
Research and Development

ROC
Regional Operations Centre

RSA
Related Scientific Activities

S&T
Science and Technology

SAB
Science Advisory Board

SARS
Severe Acute Respiratory Syndrome

SCC
Science Community Committee

SCD
Science Coordination Division

SDGO
Senior Director General's Office

SLN
Science Library Network

SPME
Solid-Phase Micro Extraction

SSH
Social Sciences and Humanities

TDS
Total Diet Study

TPD
Therapeutic Products Directorate

TSE
Transmissible Spongiform Encephalopathy

USP
United States Pharmacopoeia

VDD
Veterinary Drugs Directorate

WHO
World Health Organization

Footnotes

1. Science and Technology Action Plan for the Federal Health Portfolio, S&T at Work for the Health of Canadians, Minister of Supply and Services Canada, 1996, Cat. No. H21-129/199.

2. Science and Technology for the New Century - A Federal Strategy, 1996, Minister of Supply and Services Canada, 1996, Cat. No. C2-
290/1996