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Health Canada Policy

Food Safety Assessment Program

Preamble

Health Canada recognizes that a safe and nutritious food supply is a major contributory factor to the health of Canadians and that there is a need to maintain a reputation nationally and internationally as a supplier of safe food products. Programs that ensure safe and nutritious food are receiving renewed attention in other countries - for example, a major food safety initiative was launched in the United States and a new Food Standards Agency was formed in UK.

Food safety is a concern shared by consumers, industry and governments. Food Safety programs are facing significant challenges. The food industry is constantly changing with new and evolving technologies being implemented, distribution systems are becoming much broader, and accessibility to a wider variety of food products including imported foods is increasing. Other challenges include the emergence of new food-borne pathogens, known pathogens becoming more resistant or virulent, and the susceptibility of certain people to food-borne infections. Every year in Canada approximately 10,000 cases of foodborne diseases are reported and it is estimated that the actual number is around 2 million. About 30 of these are believed to result in death.

In 1997, the Canadian Food Inspection Agency was established and consolidated all food inspection related resources at the federal level. Health Canada and the CFIA share the common objective of enhanced food safety and share unique and complementary roles and responsibilities in the federal food safety system. Health Canada (reporting to the Minister of Health) is responsible for establishing policies and standards related to the safety and nutritional quality of the food supply and the CFIA (reporting to the Minister of Agriculture and Agri-Food) is responsible for the enforcement of these policies and standards and for the delivery of all federal food inspection activities. More specifically, Health Canada is responsible for the administration (setting policies and standards) of the Food and Drugs Act the core federal legislation which regulates the safety and nutritional quality of food sold in Canada. The CFIA is responsible for the enforcement of the health and safety provisions of the Food and Drugs Act and the administration and enforcement of the non-health and safety aspects (such as composition and economic fraud).

In addition, the CFIA Act provides an additional responsibility to the Minister of Health, namely to assess the effectiveness of the Agency's activities related to food safety. The intent of explicitly assigning an assessment role to the Minister of Health was to assure Parliament and the Canadian public, as well as our international trading partners, that the realignment and consolidation of the federal food inspection resources into one alternative service delivery agency would enhance food safety. This legislated provision does not create a responsibility or accountability obligation for the Minister of Health with respect to the actions or performance of the CFIA. Therefore, in the context of this additional responsibility, the obligation incumbent on the Minister of Health is to implement a process to conduct assessments of CFIA's food safety activities.

This Policy has been developed to describe how the Minister of Health's responsibility to assess the effectiveness of the CFIA activities related to food safety will be administered. It will be reviewed on a regular basis.

Authority

By virtue of section 11(4) of the Canadian Food Inspection Agency Act, the Minister of Health has the statutory responsibility to establish policies and standards relating to the safety and nutritional quality of food sold in Canada and to assess the effectiveness of the Canadian Food Inspection Agency's activities related to food safety.

Mandate and Objectives

The mandate of the Food Safety Assessment Program (FSAP) is to assess the effectiveness of CFIA's activities related to food safety with the objectives of

• providing advice and guidance to CFIA on its food safety activities; and
• providing feedback to Health Canada to assist in carrying out its role of developing food safety and nutrition policies and standards (regulations, guidelines, etc).

This Policy has to be read in conjunction with other existing or future Health Canada policies in the food safety area. This Policy is not intended to substitute for the on-going relationship between Health Canada and the Canadian Food Inspection Agency necessary to discharge other responsibilities and manage issues as they arise.

Scope

The Food Safety Assessment Program covers all of CFIA's activities related to food safety and nutritional quality. In this context, "activities" is interpreted to include food safety and nutrition policies, programs and initiatives delivered by the Agency in accordance with its legislative mandate.

The words "assessing the effectiveness" in the CFIA Act were deliberately chosen to reflect an evaluation approach as described in the Treasury Board Evaluation Policy. In the context of the Food Safety Assessment Program, this covers assessing:

• the rationale and design of CFIA's activities;
• their implementation; and
• their success in meeting objectives and achieving results including compliance with health and safety standards.

It is clear that CFIA is not the only organization with responsibilities for the safety and nutritional quality of the Canadian food supply. Health Canada shares that responsibility by setting policies and standards and by gathering health surveillance information that can be used to anticipate, prevent and respond to health risks posed by food. As a result, there is on-going interaction between the two organizations. Furthermore, other agencies, especially provincial agencies, have a role to play depending on the food product and context.

Definitions

The food safety assessments provide objective and credible information on the effectiveness of CFIA's activities related to food safety.

A further explanation of the key terms in this definition follows:

Objective: The FSAP is part of the Food Directorate at Health Canada and not part of the CFIA. The assessments are conducted with an objective state of mind, with impartiality and without any pre-conceptions. Professional judgements are made based solely on the evidence gathered.

The work is effectively planned to cover important questions and issues for Health Canada and for CFIA, including those involving key performance expectations, and to allow useful information to be gathered at the most appropriate time to respond to these questions. Teams carrying out the assessments possess the knowledge and competence necessary to fulfill the requirements of the assessments including skills in such scientific disciplines as food microbiology, food chemistry and epidemiology and skills in evaluation methods and practices. The work incorporates sufficient and appropriate consultation and, where appropriate, applies the advice and guidance, of experts from the Food Directorate or any other relevant directorate of Health Canada. Expertise from outside the Department can also be called upon. Team members are properly trained and supervised. They act with integrity in their relationships with CFIA officials and any stakeholders.

Credible: Information, findings and conclusions are based on the application of sound research design; and on the collection and analysis of valid and reliable quantitative and qualitative data. Multiple lines of evidence are used wherever possible. Findings are relevant to the issues and follow from the evidence. In other words, the evidence is based on clear and current facts and on sound, thorough and rigorous analysis that can stand up to strenuous scrutiny. It is appropriate in quality and in quantity to make a convincing case.

Various national and international sources of information on the safety of the food supply and related public health outcomes, such as Food Bureaux of the Food Directorate, the Center for Infectious Disease Prevention and Control, the Pest Management Regulatory Agency, the CFIA and the World Health Organization, may be used for the food safety assessments. Information is used after ensuring it is complete and reliable.

Effectiveness: The effectiveness of programs is the extent to which they achieve their objectives. The food safety assessments are assessing the extent to which the CFIA's activities are contributing to the safety and nutritional quality of food sold in Canada. The assessments can also cover unintended effects. Specific objectives may have been established by the CFIA or by Health Canada in their programs or policies and standards. When objectives are not clearly articulated, these would be identified and agreed upon as part of the design phase of the assessment.

Roles and Responsibilities

The Director, Bureau of Food Safety Assessment is responsible and accountable to the Director General, Food Directorate, Health Products and Food Branch, for the leadership and overall management and delivery of the Program, including addressing all Human Resources issues and co-ordinating the food safety assessment efforts with those of other organizations. The Director is a member of the FSA Advisory Committee. The Director is supported by Senior Project Managers who lead the specific assessments.

The Director General (DG), Food Directorate, Health Products and Food Branch, provides leadership and overall direction for the Food Safety Assessment Program (FSAP). The DG also encourages the cooperation and participation of other members of the Food Directorate. The DG co-chairs the FSA Advisory Committee.

The Assistant Deputy Minister, Health Products and Food Branch supports the FSAP, provides direction as needed and encourages the cooperation and participation of other members of the Branch or Department.

The FSA Advisory Committee, which includes equal representation from Senior Management of Health Canada and CFIA, provides corporate guidance for the food safety assessments, including overseeing the Program planning process, providing advice as needed throughout the conduct of individual food safety assessments and reviewing the final assessment reports. The Committee is co-chaired by the DG, Food Directorate (Health Canada) and the Executive Director, Corporate Audit and Review Directorate (CFIA). If consensus is not achieved by the committee on any significant matters, these matters will be forwarded to Health Canada's Assistant Deputy Minister HPFB and CFIA's Executive Vice-President for resolution. If needed, matters can also be raised with Health Canada's Deputy Minister and CFIA's President.

Health Canada ultimately remains responsible for implementing its assessment responsibility under section 11(4) of the CFIA Act.

Program Planning

The main purpose of Program planning is to develop a strategically-focussed, risk-based plan for the conduct of food safety assessments. Over time, the mix of assessments should cover a range of CFIA food safety activities. The assessments are intended to be demonstrably useful to management in both organizations and be conducted at the most appropriate time to aid decision-making.

Every year, an environmental scan is conducted. Views from officials of Health Canada and CFIA as well as views from various stakeholders including the public can be taken into consideration. Proposals for assessments are developed, on behalf of Health Canada, by the BFSA in consultation with CFIA. The proposals will relate to existing policies (Health Canada or CFIA), programs (CFIA), or initiatives (CFIA or joint Health Canada and CFIA). Topics that are not clearly linked to existing policies, programs or initiatives but are considered relevant by the co-chairs of the Food Safety Assessment Advisory Committee can also be considered during the Program planning process.

Ranking of proposals is guided by the following criteria:

(1) An estimation of the relative food safety risk associated with CFIA's activities;

(2) Priorities identified by Health Canada where the conduct of a food safety assessment would add value in terms of providing information on the implementation and effectiveness of Health Canada policies and standards;

(3) Priorities identified by the CFIA where the conduct of a food safety assessment would add value in terms of providing information on the effectiveness of particular CFIA activities; and

(4) Areas that would complement and not duplicate similar work (audits, evaluations, etc) that is being conducted by the CFIA or other organizations such as the Office of the Auditor General.

The FSA Advisory Committee meets to review proposals and preliminary rankings with a view to establish priorities and timing for the future food safety assessments. An Annual Plan for the FSAP will then be developed with the list of activities to be assessed in the period covered along with the proposed scope, objectives, preliminary assessment questions, timeframe and resources required. The Annual Plan is approved as part of Health Canada resource allocation process.

In developing the Annual Plan, where appropriate, the Office of the Auditor General and Health Canada's Internal Audit and Program Evaluation units will be consulted to ensure effective coordination of efforts. The Annual Plan will be provided to the CFIA.

Approach

Establishment of an Assessment Committee. An Assessment Committee will be established at the beginning of each approved food safety assessment. The purpose of the Committee is to provide appropriate representation and input and to help resolve issues throughout the assessment process. It includes responsible program managers and/or subject matter experts from both Health Canada and CFIA. The Committee also includes representatives from CFIA's Corporate Audit and Review and Health Canada's BFSA, as well as other personnel relevant to the scope of the assessment. The Committee is co-chaired by Health Canada and CFIA.

The Assessment Committee will meet at each phase of the assessment process or more often if needed. If the Assessment Committee does not come to agreement at any phase of the assessment process, the outstanding issues of substance or process will be brought to the attention of the FSA Advisory Committee for resolution. If necessary, a meeting of the FSA Advisory Committee will be held.

The food safety assessments will be performed in the following four phases: terms of reference, design, implementation and reporting.

Terms of Reference. Terms of reference for approved food safety assessments will be developed by the BFSA and provided to the Assessment Committee. The terms of reference will include the proposed scope, objectives, preliminary assessment questions, timeframe and resources required as set out in the Annual Plan. They will also describe the approach to be taken for the conduct of the design phase. The Assessment Committee will review the Terms of Reference for the assessment and agree on a plan for the conduct of the design phase.

Design. The purpose of the design phase is to gain a good understanding of the activity selected for assessment, and to gather sufficient information to clarify the logic model or performance framework for the activity, identify and prioritize questions and issues to assess, consider methods to collect and analyse the necessary information and develop a detailed plan for the implementation phase. At the end of the design phase, the scope, objectives, assessment questions and methods for the assessment will be finalized and reviewed by the Assessment Committee. A possible outcome of this phase could be a decision that no further data gathering is necessary and that the assessment could proceed directly to the reporting phase.

Implementation. The purpose of the implementation phase is to gather sufficient evidence to answer the assessment questions and conclude on the objectives. Communication will be maintained with the CAR contact during the implementation and any changes to the scope, objectives, questions or methods will be discussed. Observations and findings along with supporting evidence will be discussed as they arise with relevant officials. Any issue of high significance or where imminent health risks are identified will be communicated immediately to the appropriate authorities so that they can take appropriate and timely action. At the end of the implementation phase, the Assessment Committee will be debriefed on the key findings.

Reporting. Assessment reports will present the information gathered, findings and conclusions in a clear and objective manner. If recommendations are included they will respect the distinct accountabilities of Health Canada and CFIA. The reports will be written so that senior managers can readily focus on and understand the important issues being reported.

The assessment reports will:

• be concise and clearly written;
• include only information that is needed for a proper understanding of the findings, conclusions and recommendations when provided;
• provide appropriate context by describing the objectives and timing of the assessment, the activities assessed, their importance and how they fit into the overall operations of the Agency;
• clearly expose the limits of the assessment in terms of scope, methods and conclusions;
• provide an accurate presentation of the findings; and
• present the conclusions and recommendations, when provided, so that they flow logically from the findings.

The Agency will respond to the overall findings of the report in a CFIA management response, which will provide information on how CFIA plans to address key findings, conclusions and recommendations when provided. CFIA management response will be included in the final report.

For each assessment, a draft report will be prepared after the implementation phase is completed. It will be reviewed according to the criteria set above with the Assessment Committee and modified, if required. Once the Assessment Committee agrees with the facts, findings and conclusions, CFIA will prepare a draft management response to be reviewed by the Committee. The draft report along with the draft CFIA management response will be submitted to the Food Safety Assessment Advisory Committee for their review. It will then be reviewed by Health Canada's Assistant Deputy Minister, HPFB, and CFIA's Executive Vice-President and signed off by Health Canada's Deputy Minister and CFIA's President.

The final report will be forwarded by the Deputy Minister, Health Canada, to the Minister of Health and to the President of CFIA. It will then be posted in both official languages on Health Canada's Website.

The Minister of Health may report on the effectiveness of the CFIA's activities related to food safety by including results emanating from the FSAP annually in Health Canada's performance report to Parliament.

Follow-up. The purpose of the follow-up is to review the actions taken to address the findings, conclusions and recommendations, when provided, of the assessment reports. CFIA is responsible and accountable for implementing the management response included in the final assessment reports. CFIA will conduct follow-ups for each of the assessment reports. These follow-up reports will be provided to the Bureau of Food Safety Assessment and may be included in CFIA's Annual Report or in its Performance Report to Parliament. The timing and the extent of the follow-up activities will be based on the nature and complexities of the issues raised in the assessment reports and their relative health and safety importance.

The BFSA may be involved in different other projects within the Food Directorate. For example, a performance framework will be developed for all new food safety policies adopted by Health Canada. The BFSA will participate in the development of these performance frameworks to ensure that the objectives and expected results are clearly articulated and are measurable. This will facilitate the food safety assessments of these policies for the future.

The Food Safety Assessment Program is breaking new ground being the first in the world with such an assessment of food safety function independent of the actual delivery of the programs. Traditional program evaluation techniques and methods have been and will continue to be adapted to fit in the food safety environment. Procedures are established to ensure the assessments are carried out in a timely, efficient and effective manner. Quality assurance measures are an integral part of the process. Feedback on the assessments conducted and areas for improvement to the Program will be sought regularly.

A Memorandum of Understanding between Health Canada and CFIA on the Food Safety Assessment Program contains further details on the implementation of this Policy and the specific arrangements made with CFIA so that it can be implemented in an efficient and effective manner.