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Risk Analysis Framework to address Animal Health, Plant Health and Food Safety Risks within the Canadian Food Inspection Agency

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Executive Summary

As part of an Integrated Risk Management Framework (as defined by Treasury Board¹) Government organizations have been requested to establish a systematic and holistic approach to manage risks. This Risk Analysis Framework has been developed to address Animal Health, Plant Health and Food Safety Risks within a broader Risk Management Framework for the Canadian Food Inspection Agency (CFIA).

As reported in the 2003-2004 Report on Plans and Priorities², the Agency (CFIA) is mandated to safeguard Canada's food supply and the plants and animals upon which safe and high-quality food depends. In carrying out this mandate, it directly contributes to the Government of Canada's priorities as well as the public good by protecting Canadians from preventable health risks, providing a fair and effective regulatory regime that contributes to the growth of Canada, contributing to sustainable natural resources and promoting the security of Canada's food supply. The development and implementation of "risk-based inspection systems" to address these activities require an understanding of and capability for risk analysis within the CFIA. Inspection Systems, in this context, refers to all of the activities involved in the development and implementation of policies and programs related to animal and plant health and food safety. Import, Export and Domestic programs are included as are all activities in support of these programs, e.g., laboratory support, scientific support, audits, etc.

Risk Analysis, as defined by the Codex Alimentarius Commission, the Office Internationale des Épizooties and the International Plant Protection Convention, involves three major activities - Risk Assessment (being the determination of the degree of risk involved); Risk Management (establishing if and what measures are required to mitigate the risk); and Risk Communication (ensuring that stakeholders are involved in the process). A graphical representation of this framework (based on guidelines and recommendations of these three international standard setting bodies) is included in the document along with definitions for terms commonly used in Risk Analysis. Other Risk Analysis or Risk Management models have been developed which incorporate all of the above elements, e.g. Health Canada's Decision Making Framework for Identifying, Assessing and Managing Health Risks. While there may be some differences in terminology used in these frameworks, reflecting the diversity of activities of the parent organizations, the activities and the principles described therein tend to be the same. This Risk Analysis Framework has been developed to ensure that it reflects the approaches taken by these international standard setting bodies.

Risk analysis activities have been applied both formally and informally in the development of inspection systems across all disciplines within the CFIA. These systems are designed to meet CFIA's objectives - safe food, consumer protection and the protection of plants and the health of animals in Canada. This document separates the various programs into three main categories - Animal Health, Plant Health and Food Safety. Fish Inspection programs are included in the Food Safety category, as matters related to fish health are not normally part of the Animal Health responsibilities and remain the mandate of the Department of Fisheries and Oceans. Feed and fertilizer programs are included in the plant and animal risk analysis activities as appropriate. Issues related to biotechnology are addressed within their respective areas of animal health, plant health or food safety.

This Risk Analysis Framework may be used to estimate the human, animal or plant health risks associated with the scenario being evaluated and to select and implement appropriate measures to control such risks as effectively as possible. While the impact on plant, animal or human health is the primary consideration in the risk analysis process, there are often a number of other values that are potentially placed in jeopardy as risk management policies are developed. For example, the economic impact of risk management decisions on persons, groups or agricultural sectors can be significant, while other values such as basic human rights or legal rights, animal or environmental welfare, etc. can also be significantly impacted. In this Risk Analysis Framework, the Risk Assessment phase estimates the health risks associated with the scenario being evaluated; the Risk Management process selects the most appropriate option to satisfactorily deal with the health risks while considering the impact of such decisions on the other values; and Risk Communication occurs throughout the process to ensure appropriate involvement of stakeholders at various steps in the process.

This document establishes a strategy or framework to deal with situations which are best resolved using a formal risk analysis process, and describes the roles and responsibilities of the various participants within such a framework. Such situations may include a desire for a risk assessment of a particular product or process to determine the need for risk mitigation; a desire to develop risk management options for the control of a particular hazard; the need to identify or quantify a critical limit for a critical control point in an HACCP plan; or the need to establish a standard for the importation of an animal, plant, food or product derived therefrom.

The principles and methodology described in this framework are applicable to a wide range of animal health, plant health and food safety issues for which the Agency must make decisions. As part of a proactive, formal change mechanism, considerable time may be allocated to the thorough application of all aspects of this framework. In a reactive, emergency mode, e.g., in a potential recall situation, the same types of activities may occur, however they are often performed over a compressed period of time. Protocols have been established for specific activities, such as an emergency response to an outbreak of a foreign animal disease or a food safety recall. These protocols clearly delineate the responsibilities of key stakeholders, including the Office of Food Safety and Recall, Operations Branch staff, Commodity Program Divisions and Technical specialists. The framework can be adapted to situations involving major projects with several stakeholder groups involved, or it may be applied to smaller risk analysis projects involving two or more CFIA staff.

The application of this framework within each of the commodity sectors may vary, reflecting the need to respect various international agreements, as well as agreements with other government organizations, e.g., Health Canada, Environment Canada, and other stakeholders. The framework has been developed taking into consideration current structure and function of the Agency, and as such, its formal application should not result in significant resource requirements.

This document has been prepared in consultation with the Bureau of Food Safety & Consumer Protection; Animal Health & Production Division; Fish & Seafood Production Division; Food of Animal Origin Division; Plant Health & Production Division; Food of Plant Origin Division and staff within the Operations Branch.

The Risk Analysis Process - A Brief Overview

The following briefly describes the Risk Analysis Process to be applied. Each step is described in greater detail later in the document along with a description of the roles of the key players in each activity.

International standard setting bodies for Animal Health, Plant Health and Food Safety describe Risk Analysis as a process consisting of three separate but integrated components - Risk Assessment, Risk Management and Risk Communication (see Figure 1). Within each of these components are a number of elements that are interactively and iteratively applied at various stages of the process. To facilitate the development of this Risk Analysis Framework, these elements have been organized in a chronological fashion as per Figure 2.

The process of Risk Analysis normally begins with the identification and description of issues, problems or scenarios potentially posing a risk to human, animal or plant health. These arise through a variety of means, e.g., program review, incident reports, audit results, international activity. While many of these issues are easily and quickly resolved, others may require a more extensive application of this framework. A priority is assigned to each, and further activity is initiated according to this priority. A Risk Assessment is then undertaken to answer three basic questions - what could go wrong? how likely is it to happen? and, what would be the consequence if it did happen? The results of the Risk Assessment are evaluated and a decision made respecting the need for risk mitigation or changes to existing risk mitigation approaches. While human, animal and plant health are the primary determinants for decisions regarding Risk Management, such decisions must clearly delineate their impact on other values placed at risk. Elements of the Risk Management component are applied to define, evaluate and eventually select the appropriate risk management option(s) for implementation and evaluation. Throughout the above listed activities, effective Risk Communication is maintained to ensure that stakeholders are involved and informed.

While this Risk Analysis process is depicted in Figure 2 as a linear process, it should be emphasized that at each arrow, a decision is made to repeat one or more of the preceding steps; to proceed on to the next step; or to stop the process. In the evaluation of risk management options and the evaluation of the implementation of the selected option(s), risk assessment activities are required to determine how the risk has been modified, including an assessment of new risks introduced with the risk management activity. Risk analysis is truly an iterative process. Even after completion of the risk analysis process and implementation of specific risk mitigation activities, reevaluation of the situation is justified to review the impact of new information. 

The Risk Analysis Process in Detail  - Problem Identification and Definition

Issues or problems involving Plant Health, Animal Health or Food Safety are normally identified by Programs or Operations staff. These arise from a variety of internal and external sources, including the results of program review, from specific requests from importers, the need to identify or quantify a critical limit in an HACCP program, the requirement for a standard subsequent to an incident, etc. Not every issue needs to go through a formal risk analysis process, and some, e.g., emergency response or food safety recall issues have a separate process by which they may be addressed. Many day to day decisions are made using less formal risk analysis approaches that are completely adequate to consistently control the risks for which the various programs have been established.

Risk Analysis Profile

Regardless of the issue or problem, it is necessary to clearly define it and establish its relative importance. To assist in this process, a Risk Analysis Profile is developed. The Risk Analysis Profile is designed to provide information regarding the commodity, product or scenario of concern, the values placed at risk in the scenario described, the distribution of risks and benefits, management characteristics of the hazard or stakeholders, commodity profile--basically a what, where, when, how and why description of the situation requiring risk analysis support. The Risk Analysis Profile is developed by Commodity Program and/or Operations staff and is based on their current knowledge of the situation. Risk Analysis personnel either within or outside of CFIA may be contacted to provide input into these profiles.

It should not be construed that the Risk Analysis Profile is an in-depth literature review of the issue, nor should it be perceived as a laborious undertaking. The intent of the issue profile is to describe what the initial identifier (and/or the appropriate program officer) knows about the issue, of course with scientific substance. It should be specific in describing the issue, the reason for concern, and context for the evaluation by others involved in further determining the appropriate management of the issue. Where appropriate, the originators may seek input from scientists, risk assessors and stakeholders as they compile this information, however, this activity should not be an overwhelming task in itself.

The Risk Analysis Profile is considered a "living document," in that it is updated throughout the Risk Analysis process as information is gathered and analysed. It is considered the starting point for a more in-depth examination of the issue. Risk Assessors are required to verify that, to their knowledge, all hazards are identified. Risk Managers are responsible for reviewing Risk Profiles to ensure that, to their knowledge, stakeholders are identified.

The Risk Analysis Profile assists Commodity Program or Operations staff to determine the need for a more formal approach to resolve the issue, i.e., in many cases, the issue may be resolved using information in the Risk Analysis Profile alone. The Risk Analysis Profile is also useful to identify specific information gaps for inclusion in the annual research planning process.

Appendix I outlines a Risk Assessment Request Form that may be used to initiate a risk assessment. The Preliminary Risk Analysis Profile and Commodity Profile are the two major components of this document.

Process Initiation:

Not every plant health, animal health or food safety issue or problem requires a formal risk analysis approach. Many issues are resolved by the appropriate Commodity Program staff with minimal or no involvement of others within or outside of CFIA. As industry is currently being charged a fee for certain animal and plant health risk assessment activities, it is important that such decisions are consistent and transparent to avoid criticism from those stakeholders experiencing these charges.

As a formal risk analysis is resource intensive, it is necessary to prioritize such requests. The CFIA has developed a priority setting process which considers both the immediate impact on human, animal or plant health and the impact on other values, as appropriate. Priority will be based first on estimations of the immediate impact on health. Where there is no immediate impact on health, the priority assigned to the risk analysis request will then be determined by examining other relevant factors, e.g., the impact on proponent and opponent industries, economic and social impacts on the general public, trade impacts, urgency and other factors which may be identified. Where an emergency exists placing human, animal or plant health at immediate risk without appropriate action, such issues would be given immediate priority and managed through such systems as the Food and Agriculture Emergency Response System³.

Appendix II provides a process which may be used to assist in the prioritization of requests for risk analysis.

Risk analysis priorities are determined by commodity program staff in an effort to implement the appropriate allocation of resources. A mechanism has also been established to permit ad hoc, urgent requests to be processed as required. A log of risk analysis requests is completed to ensure that requests are processed according to established priorities.

Once priorities have been established and a list of projects generated, formal risk assessment and risk management procedures are initiated.

Risk Assessment

Using the Risk Assessment models of the Animal, Plant and Food Risk Analysis Network (APFRAN)⁴, staff within the Science Branch will undertake the requested risk assessments. In the case of risk assessments related to human health and safety, such risk assessments will directly involve Health Canada staff⁵. Other government departments may be involved, as appropriate, e.g., Environment Canada. The outcome of the risk assessment is an estimate of the animal, plant or human health risk associated with the product or process--this may be qualitative or quantitative depending on the situation and the information available.

Risk Assessment basically answers three questions - what could go wrong? how likely is it to happen? and, what would be the consequence if it did happen? These questions are addressed through four related procedures - Hazard Identification, Hazard Characterization, Exposure Assessment and Risk Characterization (see definitions at the end of this section). The application of these four procedures varies slightly, depending on the commodity or scenario being assessed. Such variations reflect slightly different international approaches to the risk analysis process, however these four components are completed regardless of the approach taken. The output of the Risk Assessment may be expressed in terms of the number of animals, plants or humans experiencing specific adverse events over a specific period of time; or the direct and indirect costs associated with these adverse events over the same period of time, e.g., direct animal health or productivity losses plus indirect losses associated with the loss or reduction in domestic or international trade.

It is possible, following a preliminary review of the Risk Profile and review of appropriate literature, that sufficient information is available for the development of risk management approaches without further risk assessment activity. Such decisions are made keeping in mind international concerns regarding the transparency of the process, and the need to take international norms into consideration in the assessment and/or decision making process. As information is obtained regarding the scenario, the Risk Analysis Profile is modified to reflect new information obtained, e.g., hazards not previously identified, potential factors influencing mitigation of risk, etc.

Where value judgements and policy choices are required in the risk assessment process, e.g., what population should be considered at risk, how specific safety standards should be applied, reference is made to established Risk Assessment Policy. In order to maintain the scientific integrity of risk assessments, Risk Assessment Policy is established and appropriately documented with full collaboration between staff responsible for development of risk management approaches and staff responsible for the risk assessment.

Evaluation of Results

The risk assessment delivers a quantitative or qualitative estimate of the plant, animal or human health risk associated with a particular scenario. By itself, this estimate is not judgmental, i.e., it does not indicate whether the risk is too high, acceptable, etc. Where applicable, these results are compared to existing standards established to determine the requirement for further Risk Analysis activity. Alternatively, staff responsible for introducing the question review the results of the Risk Assessment to determine if further Risk Analysis activity is required. In the case of Food Safety issues, results may be reviewed with appropriate Health Canada staff to establish the need for further action.

In some cases, it is appropriate to maintain the status quo with respect to programs and policies currently in place to deal with the situation. If, however, such an approach is not appropriate, formal Risk Management procedures are initiated to examine and select appropriate measures to be implemented. A more complete description of the Risk Management Framework is given in Appendix III.

Risk Management Options

Risk Management is the process of weighing policy alternatives in the light of the results of risk assessment, and, if required, selecting and implementing appropriate control options, including legislative, regulatory and policy measures. Given the mandate of CFIA (to safeguard Canada's food supply and the plants and animals upon which safe and high-quality food depends), human, animal and plant health are the primary determinants for decisions regarding Risk Management. However, such decisions must also reflect the impact on other values placed at risk.

While many of the issues addressed by this framework are resolved with the involvement of two or three CFIA representatives, management of more complex issues requires greater involvement by various stakeholders. In such cases, the establishment of a Risk Management Working Group is recommended. In both cases, it is necessary to determine the level of consultation required and develop protocols for information exchange. Should a Risk Management Working Group be set up, terms of reference for the group are established using information arising from risk profiles, risk assessments and other information. With clear definition of the problem, the working group establishes specific, concrete, measurable management goals or objectives and looks for risk management options that will aid in meeting these objectives.

Application of Precaution in the Risk Analysis Process

CFIA believes that the "Canadian Framework for the Application of Precaution in Decision Making"⁶ reflects current practice within the Agency. This Framework outlines guiding principles for the application of precaution to science-based decision making in the areas of health and safety, environment and natural resources. The application of precaution recognizes that the absence of full scientific certainty shall not be used as a reason for postponing decisions where there is a risk of serious or irreversible harm.

CFIA applies precaution in all of its risk management decision making and supports the Framework as described. CFIA activities in risk analysis reflect fundamental policy positions espoused over the years by a number of international regulatory fora, e.g., World Trade Organization, OIE, Codex Alimentarius, IPPC. The Agency continues to participate in discussions within these fora regarding the application of precaution. It will also continue to take advantage of relevant opportunities, both internally and with stakeholders, to discuss the use of precaution within the Agency.

Option Selection

A number of decision making techniques are available to assist in determining which option or set of options best addresses the objectives of the group while meeting specific criteria established for such a decision. The application of risk management measures for one hazard often has an inadvertent impact on other risks, resulting in their increase or decrease. For each risk management option, not only is the planned reduction of risk estimated, but potential changes in other risks are also estimated. The impact of risk management options on other areas of concern, e.g., economic impact on an agricultural sector, are also evaluated. Where risk management options involve various levels of risk to human health, and questions arise regarding acceptable limits of risk, Health Canada is involved--the lead department ultimately responsible for setting Canadian health and food safety standards. The final decision regarding the preferred option and the implementation of this option is left with the appropriate program/operations staff.

Implementation and Evaluation

Once the choice of appropriate option(s) is made, an implementation plan with specific action items, responsibility and time frame for the completion of each is drafted and implemented. As with any other program, evaluation of the risk control program provides feedback not only on the effectiveness of the program itself, but also on the process used to develop and implement the program.

Risk Communication

An integral part of the risk analysis framework is the involvement of stakeholders at appropriate points in the risk analysis. A more complete framework for the application of Risk Communication within CFIA is included in Appendix IV⁷.

As mentioned previously, many issues are easily resolved with the involvement of a Programs representative with input from Operations and/or scientific support staff. At a minimum, stakeholders should be kept informed of such activities through appropriate communication activity, e.g., direct or indirect notification of the intent to begin a specific risk assessment . Where more complex issues are being addressed, the number of stakeholders involved will obviously increase and a more formal approach may be required. Stakeholders include all those who have a significant and legitimate interest in the risk management issue and the decisions which may be made. They include not only regulatory staff (CFIA Programs and Operations staff as well as other Government agencies at the international, federal, provincial and municipal level), but also a myriad of industry groups and the general public. The involvement of stakeholder groups early in the risk analysis process is important to obtain their insight into the issue and input into the development of the most feasible and cost-effective options so that they have ownership in the regulatory decisions made. Failure to do so may undermine the credibility of the initiative and may result in political (high visibility) crisis at a time when risk management decisions are being applied. The challenge, therefore, is to establish a risk communication framework that effectively involves the stakeholders while ensuring timely and efficient resolution of the issue.

The following table illustrates where in the Risk Analysis framework stakeholder consultation would be appropriate:

Roles and Responsibilities in Risk Analysis

This Risk Analysis framework involves staff from Science Branch, Programs Branch and Operations Branch. Programs staff includes Commodity Program staff (staff within the Animal Products Directorate and Plant Products Directorate, including Program Network staff) and staff within the Food Safety Directorate; Science Branch staff include Laboratory staff and Science Strategies Directorate staff; and staff within the Operations Branch include those at both the headquarters and Area levels. Among other duties, the Science Strategies Directorate has been tasked with providing risk analysis support to the CFIA in the area of Animal and Plant Health. Health Canada plays a major role in providing risk assessment support and establishing food safety standards for issues impacting on human health and safety.

Most frequently, Commodity Program and Operations staff initiate the process, through the identification of problems that require resolution using the Risk Analysis framework. Coordination of Risk Assessment activity is the responsibility of the Science Strategies Directorate with appropriate support provided by Laboratory staff and Programs and Operations staff as appropriate. Risk Assessments are undertaken within a framework that takes into consideration international and domestic agreements or arrangements. Where evaluation of human health risks is required, CFIA staff work closely with Health Canada staff, keeping in mind Health Canada's role in the conduct of human health risk assessment and setting of food safety and nutrition policy (for additional information, see "Health Canada/Canadian Food Inspection Agency Linkage in Policy Development and Management of Food Safety and Nutrition Issues - A Framework"⁸) . Commodity Program and Operations staff are involved in the development and delivery of Risk Management options, with Commodity Program staff responsible to incorporate risk mitigation activities in the development of specific policies and procedures for food safety, animal health or plant health programs. Where in-depth evaluation of economic and/or social impacts of the proposed options is required, other CFIA staff or other Departmental staff (e.g., Market and Industry Services Branch of Agriculture and Agri-Food Canada) may become involved in the process. The use of formal risk communication approaches, e.g., Consultative Committees, ensures the involvement of stakeholders throughout the process.

DEFINITIONS

Risk - a function of the probability of an adverse health effect⁹ and the magnitude of that effect, consequential to a hazard; the likelihood of the occurrence and the magnitude of the consequences of an adverse event.

Hazard - A thing or action that can cause adverse health effects in animals (including fish), plants or humans.

Risk Analysis - a process consisting of three components: risk assessment, risk management and risk communication (see Figure 1)

Risk Assessment - the scientific evaluation of the probability of occurrence and severity of known or potential adverse health effects resulting from exposure to hazards. The process consists of the following steps: (i) hazard identification (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization. The definition includes quantitative risk assessment, which emphasizes reliance on numerical expressions of risk, and also qualitative expressions of risk, as well as an indication of the attendant uncertainties.

Hazard Identification - the identification of known or potential health effects associated with a particular agent in a given scenario.

Hazard Characterization - the qualitative or quantitative evaluation of the nature of the adverse effects associated with the hazard. Where data is available, a dose-response assessment should be performed.

Exposure Assessment - the qualitative or quantitative evaluation of the degree of exposure likely to occur in a given scenario.

Risk Characterization - the integration of hazard identification, hazard characterization and exposure assessment into an estimation of the adverse health effects likely to occur in a given population, including attendant uncertainties.

Risk Communication - the interactive exchange of information and opinions concerning risks and risk-related factors among risk assessors, risk managers and other interested parties, with one objective being the achievement of better understanding of risk and risk related issues and decisions.

Risk Management - the process of weighing policy alternatives in the light of the results of risk assessment and, if required, selecting and implementing appropriate control options.

¹ Integrated Risk Management Framework, April 2001. Treasury Board of Canada Secretariat.
² 2003-2004 Estimates, Part III : Report on Plans and Priorities. Treasury Board of Canada Secretariat, 2003.
³ More information regarding the Food and Agriculture Emergency Response System by be found at the following Website: http://www.inspection.gc.ca/english/anima/heasan/fad/faers99e.pdf
⁴ Details of the Animal Health and Production Risk Analysis Framework may be found on the CFIA Website at http://www.inspection.gc.ca/english/sci/ahra/rianfrwk/rianfrwke.shtml
⁵ Details of the Health Canada Decision Making Framework for the Identification, Assessment and Management of Risks to Health may be found on the Health Canada Website at http://www.hc-sc.gc.ca/hpfb-dgpsa/hcrisk_cp_e.html
⁶ This document is available on the Canadian Food Inspection Agency Website at the following address: http://www.inspection.gc.ca/english/reg/precaut/precaute.shtml
⁷ See also “Risk Communication and Government: Theory and Application for the Canadian Food Inspection Agency” on the CFIA Website: http://www.inspection.gc.ca/english/corpaffr/publications/riscomm/riscomme.shtml
⁸ Draft prepared for the HC/CFIA Sub-committee on Food Safety and Nutrition Standards and Policies, March 5, 2003.
⁹ In this and subsequent definitions, health refers to human, animal or plant health. While other values may be placed at risk, e.g., economic and social values, such values are considered when evaluating options for management of the health risks.

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