CFIA Framework for Food Safety Investigation and Response

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Office of Food Safety and Recall
Approved by: Stephen Baker, Vice President Operations Branch
Date: July 3, 2012

Table of Contents

1. Background

The Canadian Food Inspection Agency (CFIA) is dedicated to safeguarding food, animals and plants, which enhances the health and well-being of Canada's people, environment and economy. One of CFIA's top priorities in carrying out its mandate is to contribute to protecting Canadian consumers from preventable health risks such as risks associated with exposure to hazardous food. The ability to prevent or respond to food safety incidents in a timely and appropriate manner is a critical component. It also contributes to safeguarding the economic well being of Canada by maintaining trust and credibility with trading partners.

2. Amendments and Revisions

The CFIA is committed to a process of continuous improvement and will review the CFIA Framework for Food Safety Investigation and Response (the framework) every two years with the aim of continuously meeting the current operating environment. The CFIA's Office of Food Safety and Recall (OFSR) will lead this review and make revisions to the document as appropriate.

3. Scope

This framework has been developed to provide guidance with respect to the CFIA operational activities relating to food safety investigation and response. CFIA's food safety investigation and response system is activated by various triggers including consumer and trade complaints, inspection or audit findings, laboratory results or referrals from other regulatory organizations.

While the Agency's food safety investigation procedure and associated processes are consistent regardless of the trigger or event, the governance and management structures may be different, depending on the complexity, magnitude, and potential impact of the event. The decision process is outlined in Appendix 1: Food Safety Issues - Decision Process Flow.

The framework applies to CFIA food safety investigations and response and some non food safety investigations, such as extensive food spoilage or foreign material contamination, where the potentially implicated food product is in the Canadian market place. Other governance and management processes may be added to the structure during a declared food safety emergency, high profile food safety issue, or the activation of the Canada's Foodborne Illness Outbreak Response Protocol (FIORP) to guide a multi-jurisdictional response.

The framework is part of a suite of CFIA guidance documents including: the Area Operations Framework for Food Safety Investigation and Response, the Food Investigation and Response Manual, the Compliance and Enforcement Operational Policy, the Food Complaint Policy and the Food Complaint Manual (the latter under development).

4. Purpose

The purpose of this framework is to describe the Agency's overall approach to food safety investigations and response. It describes the governance and the roles and responsibilities of CFIA Branches.

5. Guiding Principles

The following principles will guide the CFIA's activities related to food safety investigation and response. The CFIA will:

  • Conduct food safety investigations thoroughly, identifying affected or potentially affected product(s), and use a systematic approach for tracing product (traceback and trace forward);
  • Respond appropriately; the depth and breadth of a food safety investigation and response will be proportional to the nature of the hazard and likelihood of occurrence;
  • Conduct food safety investigations consistently and in accordance with policies, procedures, guidelines and standards;
  • Incorporate the weighting of evidence and the precautionary principle in the assessment of risk and decision making pertaining to risk mitigation;
  • Take actions to remove risk exposure from the consumer, both immediate exposure (product in distribution) and potential exposure (product not yet in distribution) in a timely manner;
  • Verify the implementation of corrective actions by manufacturers and/or importers of non-compliant product;
  • Document information, evidence and decisions taken to support the response, ensuring transparency with partners and stakeholders;
  • Ensure appropriate engagement with partners, as early as possible, during a food safety investigation and response event;
  • Ensure transparency with the public through timely communication which identifies hazardous situations and/or affected products; and
  • Contribute to the continuous improvement of program design.

6. Definitions

Food Safety Investigation (FSI)
is an investigation into a food safety related issue. It is not a regulatory investigation which is conducted in response to non compliance in order to recommend further compliance measures or enforcement action. A food safety investigation includes inspection and related activities undertaken by regulatory officials to verify whether or not a food hazard which could cause human illness exists and to determine the nature and extent of the problem which includes the determination whether there is additional affected product that may be on the market, i.e. scoping.
Recall (verb tense)
means for a firm to remove from further sale or use, or to correct, a marketed product that poses a risk and/or contravenes a legislation administered or enforced by the CFIA.
Recall (noun tense)
denotes the process of recalling the affected product and encompasses all tiers of the affected product distribution system.
Mandatory recall
means a recall undertaken with a recall order as per Section 19 of the Canadian Food Inspection Agency Act. Subsection 19.(1) reads: "Where the Minister believes on reasonable grounds that a product regulated under an Act or provisions that the Agency enforces or administers by virtue of Section 11 poses a risk to public, animal or plant health, the Minister may, by notice served on any person selling, marketing or distributing the product, order that the product be recalled or sent to a place designated by the Minister."
Voluntary recall
means a recall that is initiated and carried out by the recalling firm without ministerial order.

7. CFIA Roles and Responsibilities

7.1 Operations Branch

The accountability for food safety investigations and responses, including recalls, rests with the Vice-President of Operations.

The functions and duties of the Vice-President Operations, relating to food safety investigations are exercised by the CFIA Area Executive Directors (ED) through personnel authorized by legislation. The Area Executive Directors ensure that food safety investigations adhere to established policies and procedures; effective measures are implemented to reduce or remove exposure by consumers to hazardous food products; and appropriate actions are taken to prevent reoccurrence.

When an issue is referred to the OFSR, the Executive Director of the OFSR is responsible and accountable for the coordination and consistency of decision-making related to the outcome of the food safety investigation. The ED, OFSR works in collaboration with the Area Executive Director(s) and consult with other CFIA Branches as required during the food safety investigation. This includes areas such as scoping, sampling, and recall activities. Coordination is achieved by using an inter-branch collaborative approach which is explained in Section 9, and as seen in the Decision Process Flow for Food Safety Issues in Appendix I.

The Executive Director of OFSR is responsible for consistent decision-making for food safety recalls.

Additionally, as the primary point of contact with Health Canada (HC) during a food safety investigation, the OFSR is responsible for formulating requests for Health Risk Assessments, Hazard Characterizations and Advisory Opinions from Health Canada.

7.2 Policy and Programs Branch

The Vice-President of Policy and Programs Branch has accountability for the role of his/her organization, throughout the food safety investigation and response process. The Branch is responsible for providing program advice and guidance; interpreting program requirements to facilitate corrective action activities conducted by operations staff; assisting the OFSR in collecting information related to international food safety investigations and recalls; and disseminating information to countries that have received recalled product produced in Canada.

7.3 Science Branch

Science Branch provides scientific leadership, advice and laboratory services. CFIA laboratories operate under ISO Quality Systems and are accredited to ISO/IEC 17025:2005. They possess a wide array of analytical technologies that ensure that analytical results are valid and accurate. In support of food safety investigation and response, the Science Branch:

  • Provides scientific advice and testing capacity for food and food environmental samples, which includes when necessary, the use of other approved laboratories;
  • In the case of microbiology and chemistry, uses the methodology most appropriate to the investigation (i.e., pathogen/contaminant and food matrix combination);
  • Identifies and characterizes micro-organisms using Pulsed Field Gel Electrophoresis (PFGE) testing for Salmonella, Listeria, E. coli O157 and Shigella isolates when requested by the OFSR or Commodity Programs;
  • Interprets and communicates laboratory results of planned sampling plans as well as for food borne illness outbreaks and food safety investigations; and
  • Provides testing support for other agencies on a case by case basis during food safety investigations.

7.4 Communications and Public Affairs

Communications and Public Affairs is responsible for providing strategic risk communication advice and communication tools; recommending appropriate vehicles for dissemination of information; assisting, when required, in the preparation of public warning and arrange for appropriate media distribution; and working with their counterparts at Health Canada, Public Health Agency of Canada (PHAC), and provincial/territorial governments as required.

7.5 Legal Services

CFIA Legal Services provide legal advice upon request to CFIA officials during both mandatory and voluntary recall processes. This includes the interpretation and application of legislation, the application of common law principles, the review of external communications, and representation of the CFIA in communications with third party lawyers.

8. External Accountabilities and Responsibilities

In 2008, a Memorandum of Understanding (MOU) between Health Canada, the PHAC and the CFIA was finalized. The trilateral MOU outlines the roles and responsibilities of the CFIA, HC, and PHAC as they relate to the common issues that have an impact on human health including food safety and nutrition, infectious disease outbreak management and emerging zoonotic diseases. The MOU also refers to the FIORP as a guide to the roles of federal, provincial and territorial partners during the investigation and response to foodborne illness outbreak events.

8.1 Health Canada (HC)

Health Canada's Health Products and Food Branch (HPFB) is responsible for establishing health, safety and nutritional standards for foods and provides Health Risk Assessments associated with microbiological, chemical, extraneous material, nutritional and allergen hazards to the CFIA. The Food Directorate within the HPFB provides scientific advice and analytical surge capacity for analyzing microbiological contaminants, chemical contaminants, food additives, food packaging materials and incidental additives, and food allergens in food and clinical samples. The Food Directorate also provides national reference diagnostic services for food-borne botulism, listeriosis and viruses as well as risk management advice, including public communication.

8.2 Public Health Agency of Canada (PHAC)

PHAC is responsible for the coordination and provision of leadership during investigations of multi-jurisdictional human illness outbreaks involving more than one province and/or territory. PHAC also provides, as required, technical expertise in outbreak investigations and interprets and provides feedback on the strength of evidence collected during the epidemiological investigation of a food-borne illness outbreak. PHAC maintains strong linkages with the OFSR, especially during foodborne illness outbreak investigations. Complete details of the role of PHAC are outlined in the Foodborne Illness Outbreak and Response Protocol (FIORP).

8.3 Federal Government Departments and Agencies

During food safety or foodborne illness outbreak investigations there are various federal government departments and agencies that may be involved in a collaborative response depending on the issue and jurisdiction. Some of the federal departments or agencies that may be involved are: Agriculture and Agri-food Canada (AAFC), Canada Border Services Agency (CBSA), Public Safety Canada (PS), Fisheries and Oceans Canada (DFO), Natural Resources Canada (NRCAN), Environment Canada (EC) and Department of Foreign Affairs and International Trade (DFAIT).

8.4 Provincial/Territorial Government Authorities (P/T)

Local and/or regional health officials in the provinces or territories have the mandate to investigate human illness outbreaks that occur within their boundaries. In this case, the local or regional medical officer of health will take a leadership role. The role of provincial, territorial and municipal governments is further outlined in the FIORP.

9. Governance Structures

9.1 Food Safety Investigation and Response

The governance structure identifies the decision making points and the linkages during a food safety investigation where a potential health risk has been identified and the product is in distribution. The structure also applies to non-food safety investigations into issues such as extensive food spoilage or foreign material contamination. See the Decision Process Flow in Appendix I.

The inter-branch consultative process and governance formalizes the discussions among Agency colleagues during routine food safety investigations and subsequent development of risk management options. The process is represented in Figure 1.

In the event that the routine inter-branch collaborative process is not sufficient to address a complex food safety issue, the Food Safety Investigation Review Committee (FSIRC) is engaged and, in circumstances requiring sustained engagement by CFIA's senior management, the Senior Food Safety Committee (SFSC) is engaged.

9.1.1 Food Safety Investigation Review Committee (FSIRC)

The FSIRC, chaired by the ED, OFSR, may be convened in the event of a complex food safety issue requiring additional effort to ensure a common understanding and agreement on the risk management options and decisions. The FSIRC's role is to discuss the issue and ensure appropriate discussion among Agency members to arrive at a collective agreement on actions to be taken during these time sensitive incidents or events. The Committee membership list is found in Appendix II.

If an agreement is not reached on an issue, the issue will be referred to the SFSC for a decision.

9.1.2 Senior Food Safety Committee

The SFSC, chaired by the Chief Food Safety Officer, may be convened in the event of a high profile or complex food safety issue requiring the attention of the Office of the President. The role of the SFSC is to discuss the issue, provide advice to the President as well as collective, strategic decision and direction during time sensitive incidents or events. The SFSC is a forum for enhanced coordination across the Agency and provides final rulings on issues. The committee membership list is found in Appendix II.

Figure 1: The inter-branch consultative process and governance for food safety investigation and response
Flowchart - Figure 1. Description follows.
Description for Figure 1

This diagram is a flow chart showing the inter-branch consultative process and governance that occurs among Agency colleagues that may be utilized, as needed, during routine and non-routine food safety investigations. This diagram lists the key contacts and offices and shows how the information flows among them for both routine and non-routine events. The following outlines how communication occurs simultaneously in the both the Office of Food Safety and Recall (OFSR) and the Area during a routine event. Communication occurs between the Vice-President, Operations Branch, the Executive Director, OFSR and the Area Executive Director (AED), Operations Branch. The AED is in communication with the Area Food Safety Investigation Team, the Area Recall Coordinator as well as the Executive Director, Office of Food Safety and Recall. Communication then occurs between the Area Food Safety Investigation Team/Area Recall Coordinator (ARC) and the Food Safety Investigation and Recall Unit, Enforcement and Investigation Services (EIS), Industry and the Laboratories. The laboratories communicate with Science Branch. Concurrently, the ED, OFSR communicates with the AED and two units within OFSR: the Food Safety Investigation and Recall Unit as well as the Technical Assessment Unit. The Food Safety Investigation and Recall Unit remains in contact with all of the following parties throughout the investigation: Policy and Programs Branch, Science Branch, Communications and Public Affairs Branch, Legal Services, International Policy Directorate, International Authorities, the Public Health Agency of Canada (PHAC), the Provinces, the Area Food Safety Investigation Team/ARC and the Technical Assessment Unit. The Technical Assessment Unit liaises with Health Canada (HC) for health risk assessments. HC also exchanges information with the PHAC and the Provinces. In the case of a non-routine event, where the inter-branch collaborative process is not sufficient to address a complex food safety issue, the Food Safety Investigation Review Committee and the Senior Food Safety Committee may be engaged, and the Incident Command Structure/National Emergency Operations Centre can be invoked.

9.2 Incident Command Structure (ICS)

In the event of a national food safety emergency or high profile issue, the CFIA may activate an Incident Command Structure (ICS) with the Incident Commander as the primary point of contact with federal partners, including Health Canada and PHAC.

ICS is an international model for the command, control, and coordination of a response to an emergency or significant food safety issue. It combines facilities, equipment, personnel, procedures and communications operating within a common organizational structure.

A national ICS may be invoked when there are multiple partners and/or provinces involved in a response, or there are other factors that meet the assessment criteria for national activation. According to the CFIA Emergency Response PlanFootnote 1, the following criteria are assessed to determine the level of response required:

  • There are a significant number of people, animals, plants, or resources at risk;
  • Response coordination is required because of a large or widespread event, multiple emergency sites, or several responding agencies;
  • There is significant media/public and/or political interest;
  • Resource coordination is required because of limited local resources or significant need for outside resources; and
  • There are uncertain conditions such as possible escalation of the event, unknown extent of damage, or potential threats to people, property, animal or plant health, trade, or the environment.

During these events,

  • The National Emergency Response Team (NERT) will be mobilized. The NERT is an expansion of the Food Safety Investigation and Response governance structure;
  • A National Emergency Operations Center (NEOC) will be activated;
  • The Food Safety Emergency Response Functional Plan (currently in draft) will be applied; and
  • The Food Investigation Response Manual (FIRM) will continue to be utilized to guide the food safety investigation activities.

Detailed information on the ICS and process can be found in the CFIA's Emergency Response Plan.

9.3 Foodborne Illness Outbreak Response

When a situation arises involving a multi-jurisdictional food-borne illness outbreak, the CFIA response to the food safety investigation will be part of the PHAC led multi-jurisdictional response as defined in the Foodborne Illness Outbreak Response Protocol (FIORP). The FIORP was collectively developed by the PHAC, Health Canada, and the CFIA, in consultation with provincial/territorial stakeholders, to enhance the collaboration and overall effectiveness of response during multi-jurisdictional food-borne illness outbreaks.

The purpose of the FIORP is to set out the key guiding principles and operating procedures for the identification and response to multi-jurisdictional foodborne illness outbreaks in order to enhance collaboration and coordination among partners, establish clear lines of communication, and improve the efficiency and effectiveness of response, thereby protecting the health of Canadians. This document describes activities beginning with the determination of a potential for multi-jurisdictional foodborne illness outbreak and ending with either the containment of the risk or resolution of the outbreak.

Appendix I: Food Safety Issues – Decision Process Flow

Click on image for larger view
Flowchart - Appendix 1. Description follows.

Description for Appendix I

This diagram is a flow chart that outlines the decision making points and linkages used by the Canadian Food Inspection Agency in handling food safety issues where the product is in distribution and either a potential health risk or no potential health risk has been identified. The structure also applies to certain non-food safety issues (yeast, moulds, etc.). Inspectors also receive support from within the area structure, as required. A food safety trigger (complaint, inspection finding, etc.) would lead to an inspection by a field inspector and either an Area or Regional food safety investigation. The Area/National Program Specialist, Science Branch, the Area Recall Coordinator (ARC) and the Office of Food Safety and Recall (OFSR) can provide input, as necessary. The following outlines the steps taken for a food safety issue with no potential health risk and a food product that is in compliance with legislation. If it is determined that the product is in on hold, the product can be released. The following outlines the steps taken for a food safety issue with no potential health risk and the product is not in compliance with legislation. After determining that the product is in non-compliance with legislation, with input from an Area/National Program Specialist, as required, the OFSR is notified and a compliance action is issued by the inspector. An action plan to address the non-compliance is developed by the regulated party, which is then reviewed/approved by the inspector. If approved, the inspector will monitor the implementation of the action plan; however, if the plan is not approved, the inspector will seek input from the Area/National Program Specialist. Feedback can then be given to improve program design or to adjust inspection frequency. The following outlines the steps taken for a food safety issue with a potential health risk when the product is in or potentially in the market. After determining the potential risk and that the product is in or potentially in the market, the OFSR is notified. Notification can also occur from other jurisdictions. A food safety investigation is conducted by the inspector with input from the OFSR, Science Branch and Policy and Programs Branch, in consultation with the Food Safety Investigation Review Committee and the Senior Food Safety Committee, as appropriate. When appropriate, Health Canada provides a Health Risk Assessment (HRA). If the HRA finds no potential health risk, then the steps as outlined above for a compliance or non-compliance issue are followed. If the HRA finds a potential health risk, then a risk category and recall class are given to the food safety issue by the Executive Director, OFSR and, as required, with consultation from Legal Services and Communications and Public Affairs. The regulated party then develops a product disposition plan and the implementation is monitored by the inspector. The inspector also performs a recall follow-up. Feedback can then be given to improve program design or to adjust inspection frequency. The following outlines the steps taken for a food safety issue with a potential health risk when the product is under control. After determining the potential risk and that the product is under control, the regulated party develops a product disposition plan. The inspector reviews and evaluates the plan with input from the Area/National Program Specialist, Science Branch, Operations Branch, and in consultation with the Senior Food Safety Committee and the Food Safety Investigation Review Committee, as required. The inspector then monitors the implementation of the product disposition plan and completes any follow-up actions. Feedback can then be given to improve program design or to adjust inspection frequency.

Appendix II: Inter-branch Consultative Process and Committee Structure

Flowchart - Appendix 2. Description follows.
Description for Appendix II

This diagram is a flow chart showing the inter-branch consultative process and committee structure that is used during food safety investigation and response activities. It outlines committee governance and membership as well as the purpose for each committee or consultative process. In response to a food safety situation, the Food Safety Investigation Team at the Area level is initiated. Once a food safety investigation has been launched, the inter-branch consultation process can begin and communication occurs between branch staff and the members of the Food Safety Investigation Team to arrive at more robust and formalized collaboration during risk management decision making. When the routine process does not resolve concerns or issues, the Food Safety Investigation Review Committee is convened and communication occurs between its members and branch staff within the inter-branch consultation process for further consultation. The Food Safety Investigation Review Committee supports the Senior Food Safety Committee, which provides strategic guidance and direction and is convened during high profile or complex food safety issues. The Senior Food Safety Committee liaises with the Incident Command Structure/National Emergency Operations Centre, when it is invoked. The consultative structure consists of the following committees: The Food Safety Investigation Team: participants are area specific; The Inter-branch consultation process: participants include Recall Specialists from the Office of Food Safety and Recall, Technical Specialists, National Commodity Program Specialists, representatives from Science Branch and Area, Regional and/or field representatives; The Food Safety Investigation Review Committee: participants include the Executive Director and a Manager/Officer/Technical Specialist from the Office of Food Safety and Recall, Executive Directors from Policy and Programs Branch, Science Branch and the Area as well as representatives from International, Domestic and Legal, where necessary; and The Senior Food Safety Committee: participants include the Chief Food Safety Officer for Canada, the Executive Vice President, the Vice President or Associate Vice President of Operations Branch, the Executive Director, Office of Food Safety and Recall, the Vice President or Associate Vice President of Policy and Programs Branch, the Vice Presidents of Science Branch and Communications and Public Affairs, the General Counsel and Head of Legal Services and the Executive Director, Corporate Secretariat.

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