Food Investigation Response Manual

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PLEASE NOTE: The Food Investigation Response Manual is currently under revision to update its public warning and recall templates. In the interim, visit the Food recall Warnings – High Risk page for examples of the wording and formats necessary for Public Warnings and Recalls.

1.0 Introduction

Preamble

This manual was developed to provide guidance with respect to the Canadian Food Inspection Agency (CFIA) operational activities relating to food safety investigation and recall. It 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.

This manual is supported by the CFIA Framework for Food Safety Investigation and Response (the FSIR Framework), which describes the Agency's overall approach to food safety investigations and response, the governance and the roles and responsibilities of CFIA Branches, and the Area Operations Framework for Food Safety Investigation and Response. Other governance and management processes are added during a declared food safety emergency, high profile food safety issue, or during the activation of Canada's Foodborne Illness Outbreak Response Protocol (FIORP) to guide a multi-jurisdictional response.

This manual is currently going through a review initiated in 2013.

1.1 Scope of the Food Investigation Response Manual

References:

The purpose of this manual is to provide direction, operational guidance, definitions and policy and procedures for the CFIA with respect to:

  • roles and responsibilities;
  • investigation of food safety and non-food safety issues and food emergency situations;
  • risk management strategies; and
  • implementation of food safety recalls.

This manual will also delineate the roles of Health Canada (HC), the Public Health Agency of Canada (PHAC) and the CFIA with respect to food safety investigations, recalls and emergencies, as well as the relationship between the Office of Food Safety and Recall (OFSR) and other partners within the CFIA. Industry also has key roles and responsibilities in the recall process and to address this, CFIA has developed Industry Recall Guides.

1.2 Amendments and Revisions

As the custodian of the document and to ensure information remains current, the OFSR will lead and coordinate the review of the FIRM every two years.

1.3 Stages of a Food Safety Investigation and Recall

Reference:

Food safety issues require investigation to confirm whether a hazard (physical, chemical, and/or biological) or contravention exists. Where it is determined that a hazard exists, various risk management options may be implemented including, but not limited to, recall, detention, seizure, public advisories, letter of non-compliance, opportunity to be heard, informal meetings, cancellation/suspension of registration or license, prosecution, border lookouts, re-export of the affected product(s), prosecution, etc.

Recall is an effective method of removing food products that pose a risk from the marketplace. It is an action usually taken by manufacturers, distributors, retailers or importers to fulfill their responsibility to protect the public health. They may also carry out recalls to meet regulatory requirements for food products.

The food safety investigation and recall process can be broken down into the following stages:

  • Trigger: The initial cause of an issue;
  • A Food Safety Investigation (FSI): An issue or product where a health and safety concern and/or a contravention of legislation enforced by the CFIA is suspected. Operations staff in the Areas/Regions take the lead in the food safety investigation, supported as necessary by the OFSR;
  • Decision-making: When a health risk has been established, the OFSR coordinates the development of the most appropriate risk management strategy in consultation with internal CFIA sections, such as Technical and Program Specialists, and external departments and agencies for the issue such as HC, PHAC, law enforcement agencies, the Ministry of Environment, Provincial/Territorial Governments, etc. The Executive Director (ED) of the OFSR is responsible and accountable for risk management decisions for potential recalls, with the level of action being appropriate to the health risk. OFSR decision-making includes recall requests for health and safety issues and recall recommendations for some non-health and safety issues. A recall recommendation may be conveyed to the industry when it is deemed that is an appropriate strategy (i.e. extensive spoilage, infestation);
  • Recall Implementation: Where it is determined that the appropriate risk management strategy is to recall the affected product, the recalling firm is advised and CFIA staff work with the recalling firm to implement a recall. A public warning may be issued depending on the circumstances;
  • Verification of Recall Effectiveness: The recalling firm is responsible for effectively removing the affected product from the market. CFIA Operations monitor the effectiveness of the recall;
  • Follow-up: CFIA Operations staff, in consultation with Programs staff, conduct follow- up activities with the recalling firm during/following the recall to ensure that issues are handled consistently and appropriately. Follow up activities may include determining the disposition of returned product and product in storage, evaluation of the corrective action implemented for the recalled product and evaluation of the corrective action implemented to reduce the likelihood of reoccurrence of the issue. Technical Specialists will provide advice, where necessary, in support of Operations and Programs staff. It is important to note that scoping (i.e. the determination whether additional product is on the market place) is not part of the follow-up phase, even though the two activities often occur simultaneously. Programs will track recall trends and take appropriate actions as required.

2.0 Roles and Responsibilities

Scope

This section includes a brief overview of the roles and responsibilities of the internal and more frequently involved external partners in the implementation of a food safety investigation and the recall process. Roles and responsibilities specific to each stage of the food safety investigation and recall process are included in the respective sections of this manual.

2.1 Canadian Food Inspection Agency (CFIA) and Internal Sections

2.1.1 Canadian Food Inspection Agency

The role of the CFIA is to enforce food safety legislation. To this end, the CFIA implements activities which contribute to a safe food supply and accurate product information. Within the context of this manual and the food recall process, this objective is supported by several activities, such as: investigations of food safety related issues and food emergency situations; providing scientific, technical and operational guidance; supporting internal and external working relationships; and monitoring the implementation of recommended risk management strategies by responsible firms. These activities are conducted/supported by several CFIA directorates at the Headquarters and Area levels as follows.

2.1.2 Office of Food Safety and Recall (Headquarters, OFSR)

The OFSR, in partnership with the Area Executive Director (ED), is responsible and accountable for the coordination and consistency of decision making on food safety investigations, including scoping, sampling and recalls at the point of time when an issue is referred. The OFSR is responsible for issues that are referred to them and CFIA operational and program staff have the responsibility to refer any issues to the OFSR where product may possibly be on the market and pose a potential health risk. The OFSR is involved at different levels in the food safety investigation, Health Risk Assessment process, decision making and communications of food safety issues.

The Executive Director, OFSR is responsible for the decision to determine the risk management strategy (i.e. to request a firm to initiate a recall) to be utilized to reduce or eliminate exposure of the public to a hazardous food product. The decision making process includes the review of health risk assessment/information related to incident, classifying the level and depth of a recall or identifying another appropriate risk management strategy. When a decision to request a recall is reached, the request will be conveyed to the recalling firm. For situations where a firm is not initiating a voluntary recall, the ED, OFSR may make a recommendation for the Minister to issue a recall order or may identify other risk management strategies.

The OFSR works with the Area Recall Coordinators and with Technical Specialists, Program Branch Specialists, Science Branch, International Policy Directorate, Legal Services Unit, Public Affairs and other Area staff throughout the process, as appropriate.

The OFSR is the single point of contact for both domestic and international food-related issues and food-related emergencies. In situations where there is a food safety issue related to an exported food product, the OFSR would notify the receiving country of the food safety concern. The OFSR will be the investigational contact with the foreign manufacturer when there is more than one Canadian importer of the affected product(s).

2.1.3 Technical Specialists (Headquarters, OFSR)

CFIA Technical Specialists provide OFSR with Health Risk Assessments (HRAs) for food safety issues linked to a food product. The Technical Specialists utilize food policies and standards in determining the risk and may interface with Health Canada (HC), requesting formal HRAs when required. The Technical Specialists for microbiology, chemical, marine biotoxins, extraneous material, nutrition and allergen issues are located in the Office of Food Safety and Recall, Food Safety Assessment and Recall Operations.

2.1.4 Area Executive Director/ Regional Director (Area)

The Area Executive Director has been delegated the authority for food safety investigations to ensure that the established policies and procedures are adhered to as well as the implementation of effective measures to reduce or remove exposure of consumers to hazardous food products and to take appropriate actions to prevent re-occurrence.

The Regional Director is responsible and accountable to the Area Executive Director for ensuring that food safety investigations and recall activities are carried out in a timely, appropriate and effective manner. They establish and maintain relationships with the Provinces and Territories and ensure that Headquarters is advised of potential food emergencies.

Area Executive Directors or Regional Directors take the lead to establish a liaison network with regional hospitals, police authorities and related public health partners or appropriate provincial authorities to ensure prompt sharing of information and coordination of the food safety investigation or tampering incidents, as per area procedures. The Regional Director (or designate) is to immediately advise the local police and the manufacturer, importer or distributor in the region, the Area Recall Coordinator (ARC) and the OFSR of any tampering incident associated with the company’s products.

2.1.5 Enforcement and Investigation Services

Enforcement and Investigative Services (EIS) provides advice on enforcement options and strategies as required. Requests for assistance usually originate directly from Area Operations.

2.1.6 Area Recall Coordinator / Regional Recall Coordinator

The ARC is the key communication link and primary contact between Area Operations staff and the OFSR. They coordinate and monitor the food safety investigation, the implementation of the recall and the recall verification. The ARCs liaise with Regional Directors, Inspection Managers/Supervisors, Program Network staff, Supervisors, other ARCs, Provincial/Territorial personnel and Inspectors on recalls and emerging issues to ensure the necessary information is collected and communicated to the appropriate components in a timely manner.

Note: Areas may have slightly different structures and all of the above roles and responsibilities may be carried out by Regional Recall Coordinators or some of the roles by Area or Regional Operations Coordinators.

2.1.7 Inspection Manager/Supervisor

The Inspection Manager/Supervisor oversees the activities of the field staff and is responsible and accountable to the Regional Director to coordinate, lead and direct all food safety investigations of food emergency situations, food safety issues and recall activities through the Area field staff.

2.1.8 Lead Investigator

These are food safety investigators located in the regional or district offices of an Area. They are designated inspectors who may be Commodity or Food Safety Inspectors. The Lead Investigator is responsible for the completeness and accuracy of the food safety investigation and the firm’s implementation of the recommended risk management strategy. The Lead Investigator coordinates the verification and follow-up activities. The Lead Investigator also has the primary responsibility to ensure that the food safety investigation is expanded to its fullest and that all products which may pose a potential health risk to the public are investigated and assessed.

In certain situations, responsibilities for the recall implementation do not fall in the region/area responsible to conduct the food safety investigation (i.e. the firm’s headquarters is located in another location), in this case a second lead investigator is assigned to work on the recall.

2.1.9 Area Field Staff / Food Safety Investigation Team

Within the Areas are various field staff who contribute to the food safety investigation of food safety related issues and the verification and follow up activities of the recall process. Their roles and responsibilities are dependent upon their commodity / technical expertise.

The Area may engage a Food Safety Investigation Team (FSIT), dependent on the circumstances and complexity of an issue being investigated and the requirements for resources.

2.1.10 Other CFIA Branches

The details of the roles and responsibilities of: Policy and Programs Branch; Legal Services; Public Affairs; and Science Branch, are found in the FSIR Framework.

2.2 CFIA Governance

The details of CFIA governance and supporting committees, such as the Senior Food Safety Committee and the Food Safety Investigation Review Committee, are found in the FSIR Framework.

2.3 External Partners

2.3.1 Industry

It is the responsibility of the recalling firm to ensure the product that is sold is safe, assist the CFIA in the food safety investigation and to recall product effectively from the marketplace. The Industry should inform the CFIA when they are removing a food product from the marketplace. Recall guidelines for industry are available on the CFIA website.

2.3.2 Foreign Country Governments

The CFIA has several agreements with government officials from foreign countries that are generally commodity specific and include the exchange of information related to food safety issues and recalls. For countries where an agreement is absent, the OFSR will notify the receiving country’s officials of a food safety related recall when necessary.

2.3.3 Other External Partners

The details of the roles and responsibilities of other external partners, such as Health Canada, the Public Health Agency of Canada and Provincial/Territorial/Municipal Governments, can be found in the FSIR Framework.

3.0 Triggers for Food Safety Investigations

Types of Triggers

The Canadian Food Inspection Agency (CFIA) receives information regarding food safety concerns from all types of sources. These sources are termed "Triggers" and they include:

  • Consumer complaints;
  • Trade complaints;
  • Foodborne illness outbreaks or epidemiological information;
  • Unsatisfactory lab results;
  • Media;
  • Company initiated product removals or product correction: i.e. recalls, stock recovery, product withdrawal, export refusal;
  • Referrals from other government departments (either domestic or international), law enforcement, medical community, industry and consumer associations; and
  • Food safety and non-food safety investigations resulting from product inspection or inspection/audit/assessment/evaluation results that have the possibility of affected product being on the market.

3.1 Referring Food Safety Incidents to the Office of Food Safety and Recall (OFSR)

3.1.1 Definitions

Referral:
The step to formally engage the OFSR for coordination and guidance with respect to a food safety investigation or a recall.
Early Referral:
An immediate referral to the OFSR that is done during the preliminary assessment of a food safety incident or in the early stages of a food safety investigation, even though available information may still be limited. Please refer to Annex A for a list of types of food safety incidents that require an early referral.
High Priority Food Safety Incident:
An incident that takes precedence over all other work by Operations Branch. Please refer to Annex A for a list of high priority food safety incidents.
Normal Priority Incident:
A food safety incident that is not a high priority.
Outbreak:
An incident in which two or more persons experience similar illness after a common source exposure. An outbreak is identified through laboratory surveillance or an increase in illness that is unusual in terms of time or geography. An outbreak is confirmed through laboratory and/or epidemiological evidence (Source: Canada's Food-borne Illness Outbreak Response Protocol).

3.1.2 Documentation

All activities and decisions are recorded in the Issues Management System (IMS).

3.1.3 Procedure

The Process for Referring Food Safety Investigation Incidents to the OFSR is illustrated in Annex B and starts when an incident is triggered. The inspectorate conducts a preliminary assessment which includes assigning one of the following priorities to the food safety incident:

  1. High Priority with an Early Referral
  2. High Priority
  3. Normal Priority

The priority assigned to a food safety incident may change during the course of an investigation.

At any time during a food safety investigation (i.e. before or after notification to the ARC/RRC or referral to the OFSR), the inspectorate can seek advice and guidance from the ARC/RRC to determine whether there is a potential health risk and on appropriate next steps. The ARC/RRC can also seek advice and guidance from the OFSR at any time.

A. High Priority with an Early Referral

Please refer to Annex A for a list of types of food safety incidents that require an early referral.

The OFSR's responsibility for coordinating food safety investigations and recalls at the national level includes communication with internal and external partners. Some types of food safety incidents require the CFIA to engage with partners at an early stage. An early referral to the OFSR enables timely engagement with these partners.

A.1 Notify the ARC/RRC

The Lead Investigator immediately notifies the ARC/RRC, as per the Area's communication protocol, regardless of the amount of information available on the food safety incident. The Lead Investigator provides the following information:

  • Area of concern;
  • Trigger;
  • Summary of information available to date;
  • If illness, injury or reaction has been reported, the number of cases under investigation and the cases' health status, if known;
  • IMS number, if available; and
  • Brief summary of actions taken to date together with the next actions to be taken

The ARC/RRC reviews the information received in the notification. Where necessary, the ARC/RRC requests additional data or information from the Lead Investigator. If the incident does not require an early referral, the ARC/RRC informs the Lead investigator.

A.2 Early Referral to the OFSR

The ARC/RRC immediately refers the incident to the OFSR by telephone using the emergency number (613-720-5087), followed by an e-mail flagged as "urgent" to CFIA.OFSR-BSRA.ACIA@inspection.gc.ca. The subject line of the e-mail should state "Early Referral". The email should include the information that was provided by the Lead Investigator in step A.1, including actions taken to date and proposed next steps.
Once an incident is referred to the OFSR, a Food Safety Recall Specialist is assigned to the file.

B. High Priority

Please refer to Annex A for a list of high priority food safety incidents.

B.1 a) Determine if Affected Product is Potentially in Distribution

The Lead Investigator, in consultation with their Supervisor, evaluates food safety investigation findings as they are being collected. The Lead Investigator notifies the ARC/RRC as soon as the information indicates that the affected product is in distribution or potentially in distribution. A product is considered to be in distribution when it has left the direct control of the regulated party responsible for that product.

When it is not possible for the Lead Investigator to confirm whether the affected product is under control or on hold by the regulated party, the Lead Investigator will consider the product to be distributed.

If the affected product is in distribution or is potentially in distribution, the Lead Investigator proceeds to B.2 Notify the ARC/RRC

If the affected product is confirmed to be not in distribution, the Lead Investigator proceeds to B.1.b) Determine if Other Affected Products are Potentially in Distribution

B.1 b) Determine if Other Affected Products are Potentially in Distribution

The Lead Investigator, in consultation with their Supervisor, evaluates food safety investigation findings and notifies the ARC/RRC as soon as:

  • the information indicates that other affected products have been distributed or could have been distributed; and/or
  • the affected product was imported and there could be other shipments distributed by the same importer or other shipments distributed by other importers that could be affected by the same problem.

The Lead Investigator will notify the ARC/RRC before taking any sample.

If it is determined that no other affected products could have been distributed, the Lead Investigator follows the established procedures to verify compliance and take appropriate compliance measures.

B.2 Notify the ARC/RRC

The Lead Investigator immediately notifies the ARC/RRC as per the Area's communication protocol and provides the following information:

  • Area of concern;
  • Trigger;
  • A summary of the food safety incident and their findings to date;
  • IMS number; and
  • Brief summary of actions taken together with the next actions to be taken.

Once the ARC/RRC is notified of an incident, the ARC/RRC becomes engaged and provides guidance to the inspectorate, as required.

B.3 Refer to the OFSR

The ARC/RRC immediately refers the incident to the OFSR by sending an e-mail flagged as "urgent" to CFIA.OFSR-BSRA.ACIA@inspection.gc.ca. After regular OFSR working hours (i.e. after 5:00 pm ET), the referral should be done by telephone using the emergency number (613-720-5087), followed by an email. The subject line of the e-mail should state "High Priority Referral". The email should include the information that was provided by the Lead Investigator in B.2, including actions taken to date and proposed next steps.

Once an incident is referred to the OFSR, a Food Safety Recall Specialist is assigned to the file. At this stage, the Lead Investigator and the ARC/RRC may not have all the information required for the OFSR to initiate its activities. The Lead Investigator will continue to lead the food safety investigation and the ARC/RRC will continue to provide guidance and advice as necessary. The OFSR will provide guidance and will initiate its activities when required.

C. Normal Priority

C. 1 a) Determine if Affected Product is Potentially in Distribution

The Lead Investigator, in consultation with their Supervisor, evaluates food safety investigation findings as they are being collected and notifies the ARC/RRC as soon as the information indicates that the affected product is in distribution or potentially in distribution. A product is considered to be in distribution when it has left the direct control of the regulated party responsible for that product.

When it is not possible for the Lead Investigator to confirm whether the affected product is under control or on hold by the regulated party, the Lead Investigator will consider the product to be distributed.

If the affected product is in distribution or is potentially in distribution, the Lead Investigator proceeds to C.2 Notify the ARC/RRC

If the affected product is confirmed to be not in distribution, the Lead Investigator proceeds to C.1.b) Determine if Other Affected Products are Potentially in Distribution

C.1 b) Determine if Other Affected Products are Potentially in Distribution

The Lead Investigator, in consultation with their Supervisor, evaluates food safety investigation findings and notifies the ARC/RRC as soon as:

  • the information indicates that other affected products have been distributed or could have been distributed; and/or
  • the affected product was imported and there could be other shipments distributed by the same importer or other shipments distributed by other importers that could be affected by the same problem.

The Lead Investigator will notify the ARC/RRC before taking any sample.

If it is determined that no other affected products could have been distributed, the Lead Investigator follows the established procedures to verify compliance and take appropriate compliance measures.

C.2 Notify the ARC/RRC

The Lead Investigator immediately notifies the ARC/RRC as per the Area's communication protocol and provides the following information:

  • Area of concern;
  • Trigger;
  • A summary of the food safety incident and their findings to date;
  • IMS number; and
  • Brief summary of actions taken together with the next actions to be taken.

Once the ARC/RRC is notified of an incident, the ARC/RRC becomes engaged and provides guidance to the inspectorate.

C.3 Determine When to Refer to the OFSR

The ARC/RRC evaluates the information received in the notification, and determines when to refer the file to the OFSR.
The file should be referred when:

  • Advice or coordination from the OFSR is required to advance the food safety investigation
  • Sampling advice or sampling coordination from the OFSR is required
  • Hazard is in the process of being confirmed (i.e. laboratory results are pending) and product core information (i.e. product details and distribution) is available
  • Presence of a hazard has been confirmed in a product in distribution. For example through:
    • Unsatisfactory laboratory results
    • Inspection observations (e.g. insect infestation, extraneous material)
    • Document review (e.g. calculations of levels of allergens based on formulations and known percentage of ingredient)

If it is determined that the file is not ready to be referred, the ARC/RRC reevaluates the file on an ongoing basis. The ARC/RRC may determine that the file does not need to be referred to the OFSR as no hazard was identified in products in distribution or potentially in distribution.

C.4 Refer to the OFSR

The ARC/RRC immediately refers the incident to the OFSR by sending an e-mail to CFIA.OFSR-BSRA.ACIA@inspection.gc.ca. After regular OFSR working hours (i.e. after 5:00 pm ET), the referral should be done by telephone using the emergency number (613-720-5087), followed by an email. The subject line of the e-mail should state "Referral". The email should include the information that was provided by the inspector in C.2, including actions taken to date and proposed next steps.

Once an incident is referred to the OFSR, a Food Safety Recall Specialist is assigned to the file.

Annex A: High Priority Food Safety Incidents with Requirements for Early Referral

A high priority food safety incident requires immediate and sustained attention. Work on these incidents takes precedence over all other work and may continue after-hours where necessary.

Notifications for both high priority incidents that do not require an early referral and normal priority incidents will be made to the ARC/RRC as soon as it is determined that affected products have been or could have been distributed. The ARC/RRC will refer high priority incidents immediately to the OFSR to initiate collaboration and gain efficiency in the resolution of the incident.

This table outlines types of high priority food safety incidents and identifies the ones that require an early referral.
Type of High Priority Food Safety Incidents Early Referral Required?
Suspected or confirmed foodborne illness outbreak situation Yes
Hospitalization or death related to food Yes
Reported Table Note 1 illness, injury or reaction related to food Yes
Pathogen detected in food or on direct food contact surface (e.g. Listeria monocytogenes detected on a slicer) No
Undeclared priority allergen No
Toxin in food (e.g. marine biotoxins and Staphylococcus toxins) No
Injurious extraneous material in beverages No
Multiple complaints involving the same product or incident No

Hazard in products targeted at a vulnerable population, i.e.:

  • the elderly or the immunocompromised
  • infants and young children
Yes
Tampering incident (suspected or confirmed) Yes

Food safety incident that may generate or has generated public attention through traditional or social media. Includes:

  • evidence of extensive extraneous contamination or spoilage in a food
  • chemical in a widely consumed product
  • where a complainant has indicated their intention to contact the media
  • any incident considered controversial (i.e. incidents that may be low risk but have high sensitivity from the public such as food irradiation or biotechnology)
Yes
Company initiated (includes foreign companies) product recall, removal or correction of a marketed product for food safety incidents Yes
Public warning issued by other government departments Yes
Food safety incident involving shellfish exported to the United States Table Note 2 Yes

Table Notes

Table Note 1

When reported by a doctor, a public health authority representative or considered valid or potentially valid by the inspector/ARC/RRC. Includes reported allergic reactions to non-priority allergens.

Return to table note 1  referrer

Table Note 2

To enable timely notification by OFSR of the incident to the United States.

Return to table note 2  referrer

Notes:

  • The priority assigned to a food safety incident may change during the course of an investigation.
  • In all situations, but particularly complex ones, the Lead Investigator can consult with the ARC/RRC to determine whether a situation should be treated as high priority. The OFSR is available to assist the ARC/RRC in the determination.

Annex B: Process for Referring Food Safety Incidents to the OFSR

Click on image for larger view
Flowchart - Process for Referring Food Safety Incidents to the Office of Food Safety and Recall. Description follows.

Description of Annex B Process for Referring Food Safety Incidents to the OFSR

This annex illustrates a flow chart that describes the steps for referring food safety incidents to the Office of Food Safety and Recall. The process starts with a trigger followed by a step where the Lead Investigator determines the priority of the food safety incident. The Lead Investigator assigns one of the three following priorities: A) high priority and early referral required; B) high priority; or C) normal priority. Each of these priorities has its own set of steps to follow, which are outlined below.

A) High priority and early referral required

When the Lead Investigator determines that the food safety incident is a high priority and requires an early referral to the Office of Food Safety and Recall, he/she follows step A.1 and immediately notifies the Area Recall Coordinator/Regional Recall Coordinator. In step A.2, the Area Recall Coordinator/Regional Recall Coordinator reviews the information and immediately refers the incident to the Office of Food Safety and Recall.

B) High priority

When the Lead Investigator determines that the food safety incident is a high priority and does not require an early referral, he/she follows step B.1 a) and determines if the affected product is in distribution or potentially in distribution. If the Lead Investigator determines that the affected product is in distribution or potentially in distribution, he/she follows step B.2, and immediately notifies the Area Recall Coordinator/Regional Recall Coordinator.

If the Lead Investigator determines that there are no affected products in distribution, he/she follows to step B.1 b) and determines if there are other affected products that are potentially in distribution. If the Lead Investigator determines that there are other affected products potentially in distribution, he/she follows step B.2 and immediately notifies the Area Recall Coordinator/Regional Recall Coordinator. If the Lead Investigator determines that there are no other affected products potentially in distribution, he/she will verify compliance and follow appropriate procedures.

In step B.3, when the Area Recall Coordinator/Regional Recall Coordinator receives a notification from the Lead investigator, he/she immediately refers the incident to the Office of Food Safety and Recall.

C) Normal priority

When the Lead Investigator determines that the food safety incident is normal priority, he/she follows step C.1 a) and determines if the affected product is in distribution or potentially in distribution. If the Lead Investigator determines that the affected product is in distribution or potentially in distribution, he/she follows step C.2, and immediately notifies the Area Recall Coordinator/Regional Recall Coordinator.

If the Lead Investigator determines that there are no affected products in distribution, he/she follows step C.1 b) and determines if there are other affected products that are potentially in distribution. If the Lead Investigator determines that there are other affected products potentially in distribution, he/she follows step C.2 and immediately notifies the Area Recall Coordinator/Regional Recall Coordinator. If the Lead Investigator determines that there are no other affected products potentially in distribution, he/she will verify compliance and follow appropriate procedures.

In step C.3, when the Area Recall Coordinator/Regional Recall Coordinator receives a notification from the Lead investigator, he/she determines when it should be referred to the Office of Food Safety and Recall. The Area Recall Coordinator/Regional Recall Coordinator will refer the file when advice is needed for coordination and sampling; when product core information is available and laboratory results are pending; and when hazard is confirmed.

In step C.4, the Area Recall Coordinator/Regional Recall Coordinator immediately refers the incident to the Office of Food Safety and Recall.

4.0 Food Safety Investigation

Scope

This section includes those activities implemented from the initial trigger activity up to, but not including, the formation of the recommended risk management option.

4.1 Goal of Food Safety Investigations

The Canadian Food Inspection Agency (CFIA) investigates many types of issues related to food, including food safety, nutrition, tampering, quality and non-compliance with regulatory requirements. Authority for these activities is provided by the various Acts and Regulations administered and enforced by the CFIA.

The goal of the food safety investigation is to verify whether or not a food safety related hazard or contravention exists as well as to determine the nature and extent of the problem. They are to be done in a thorough, consistent and timely manner. Information obtained through the food safety investigation provides the basis for risk assessment and for the development of appropriate risk management strategies to control affected products. Several key activities included in this process are:

  • Identify complaints associated with the incident;
  • Identify product(s) associated with the incident;
  • Obtain a detailed description of the suspect affected product(s);
  • Acquire information about the causative agents and their sources;
  • Evaluate the affected product(s) for risk;
  • Investigate to determine the root cause of the issue; and
  • Expand the food safety investigation where it is determined that the root cause of the issue may affect the safety of other food products or when the root cause remains unknown.

4.2 Roles and Responsibilities

4.2.1 Canadian Food Inspection Agency

4.2.1.1 Office of Food Safety and Recall (Headquarters, OFSR)

During this phase, after a referral, the OFSR coordinates food safety investigations, including scoping, sampling and provides the communication interface between the Area staff and the appropriate National Headquarters staff. Requests by the Program and Technical Specialists for further information about the area of concern and the suspect food are directed to the Areas through the OFSR. During food safety investigations, requests from the Areas are directed to the Headquarters staff through the OFSR. The Food Safety Investigation Recall (FSIR) National Manager or the OFSR Recall Specialists are the primary contact with the Public Health Agency of Canada (PHAC) in foodborne illness outbreak investigations.

The OFSR is the primary contact with international regulatory authorities and foreign manufacturers and importers.

The OFSR during a food safety investigation will seek guidance from the appropriate commodity and program specialists through an inter-branch consultation process, as required.

4.2.1.2 Technical Specialists (Headquarters, OFSR)

The Technical Specialists:

  • Provide Health Risk Assessments (HRAs) to OFSR;
  • Provide scientific advice and guidance to OFSR and Program Specialists;
  • Request and maintain on file HRAs from Health Canada when required; and
  • Liaise with OFSR, Program Specialists at Headquarters and laboratory staff.
4.2.1.3 Area Executive Director/ Regional Director (Area)

The Area Executive Director has been delegated the authority for food safety investigations to ensure that the food safety investigation adheres to the established policies and procedures and the implementation of effective measures to reduce or remove exposure of consumers to hazardous food products and to take appropriate actions to prevent re-occurrence.

The Regional Director is responsible and accountable to the Area Executive director for ensuring that food safety investigations are carried out in a timely, appropriate and effective manner. They establish and maintain relationships with the Provinces and Territories and ensure that Headquarters are advised of potential food emergencies.

Regional Directors shall take the lead to establish a liaison network with regional hospitals, police authorities, and related public health partners to ensure prompt sharing of information and coordination of investigation of tampering incidents. During an actual tampering event the Regional Director (or designate) is to immediately advise the local police and the manufacturer, importer or distributor in the region, ARC and OFSR of any tampering incident associated with the company’s products.

4.2.1.4 Area Recall Coordinator (ARC) / Regional Recall Coordinator (RRC)

It is the responsibility of the ARC to coordinate Area Operations staff, ensuring the food safety investigation is conducted in a timely manner and the information gathered is complete and accurate. The ARC is the communication link between the Area staff and the OFSR. Their responsibilities include:

  • Provide the OFSR with a referral immediately by phone and in writing;
  • Provide advice on food safety and food emergency response to the Area Operational staff at every stage of the food safety investigation;
  • Monitor the food safety investigation process and advise on additional actions to be taken when necessary (i.e. document collection and review);
  • Ensure that all information required to request an HRA is collected and collated;
  • Liaise with Regional Directors, Inspection Managers/Supervisors, Program Network staff, Supervisors and field staff on the food safety investigations and emerging issues;
  • Liaise with the OFSR providing the necessary information in a timely manner; and
  • Liaise with Provincial / Territorial health partners as necessary.

Note: Areas may have slightly different structures and all of the above roles and responsibilities may be carried out by Regional Recall Coordinators or some of the roles by Area or Regional Operations Coordinators.

4.2.1.5 Inspection Manager/Supervisor

During the food safety investigation process, the Inspection Manager/Supervisor will:

  • Provide advice and guidance to the field staff;
  • Liaise with the ARC;
  • Ensure that food safety and food emergency investigations are carried out in a timely, appropriate and effective manner;
  • Ensure timely and accurate IMS data entry; and
  • Ensure staff availability and provide contact names and numbers.
4.2.1.6 Lead Investigator

The responsibilities of the Lead Investigator during this phase include:

  • Be the primary contact with the manufacturer/importer;
  • Investigate the issue at the suspect root source (i.e. collect information/documents);
  • Determine the root cause;
  • Determine the scope of the product(s) that may be affected;
  • Obtain additional information as requested by the OFSR; and
  • Ensure that the issue is entered into the Issues Management System (IMS) in accordance with IMS business rules, including the root cause if it has been determined.
4.2.1.7 Area Field Staff / Food Safety Investigation Team

In a general context, these staff:

  • Assist in food safety investigations, working with the Lead Investigator, to collect information and verify accuracy and completeness of the facts; and
  • Enter pertinent information into the IMS in accordance with IMS business rules.

The Area may engage a Food Safety Investigation Team, dependent on the circumstances and complexity of an issue being investigated and the requirements for resources.

4.2.1.8 Other CFIA Branches

The details of the roles and responsibilities for other CFIA Branches, such as Science Branch or Policy and Programs Branch, are found in the FSIR Framework.

4.2.1.9 CFIA Governance

The details of CFIA governance and supporting committees, such as the Senior Food Safety Committee and the Food Safety Investigation Review Committee, are found in the FSIR Framework.

4.2.2 External Partners

The external partners most frequently involved in the food safety investigation process are:

4.2.2.1 Industry - Suspect Root Source

It is the responsibility of the suspect root source facility to:

  • Provide all pertinent information related to the food safety investigation of the suspect food to the Lead Investigator in a timely manner;
  • Determine the root cause of the issue;
  • Accurately define the affected product, i.e. products, codes, sizes; and
  • Provide CFIA with after-hour contacts and their coordinates (E-mail, phone, etc. ) during a food safety investigation.
4.2.2.2 Other External Partners

The details of the roles and responsibilities for other external partners, such as Health Canada, the Public Health Agency of Canada and Provincial / Territorial / Municipal Governments, can be found in the FSIR Framework.

4.3 Food Safety Investigation Approaches

4.3.1 Key Principles

Food safety investigations should follow these key principles:

  • Timeliness - incidents involving actual or alleged illness, injury or high visibility issues should be investigated promptly and given a high priority. Time frames should be proportional to the potential risk;
  • Appropriateness - the depth of a food safety investigation should be appropriate to the hazard and the likelihood of its occurrence. The food safety investigation should cover all relevant levels at which the product has been manufactured, imported, distributed, sold or consumed;
  • Consistency - the investigative procedures applied both within a specific food safety investigation and to all food safety investigations should be congruent and consistent with internal policies, procedures, guidelines and standards;
  • Thoroughness - food safety investigations should identify all affected or potentially affected product. Utilize a systematic approach for tracing products forward and backward within the distribution system;
  • Accuracy - food safety investigations should strive to detect and identify the specific hazard in all affected or potentially affected product(s) that has created, or has the potential to create, an elevated food safety risk to the Canadian public. All efforts must be deployed to precisely identify the hazard which will be the base of the food safety investigations. Information collected should facilitate decision making by being as exact and concise as possible;
  • Partnership - collaboration and cooperation between stakeholders is necessary to ensure food safety investigation (FSI) activities are performed in a timely, effective and appropriate manner; and
  • Transparency - disclosure of information pertinent to the FSI is needed to ensure all stakeholders are able to perform their duties and fulfill their responsibilities to best of their abilities. However, the CFIA must adhere to access to information and privacy laws.

The above principles should be followed by all those who are involved in the various stages of the food safety investigation and recall process.

4.3.2 Follow the Food

This is the process of following the suspect food through the distribution chain to ensure complete and accurate verification of the issue, affected products(s), root cause and the root source of the issue.

Where the food safety investigation is triggered at some down-stream point in the distribution chain, i.e. consumer, vendor, distributor, and/or wholesaler, the food safety investigator should follow the food backwards from the last point of distribution to the product origin, etc.

consumer level → vendor level → distribution level → firm level.

Where the food safety investigation is being conducted at the point of manufacture (suspect root source), the process of production should be followed from start to finish, as applicable. In those circumstances in the manufacturing plant where cross-contamination may occur, the product should be investigated from the finished state backwards to the source of input.

4.3.3 Food Safety Investigation Verification Process

Reference:

The food safety investigation should include verification (if possible) of:

  • The issue;
  • The affected product(s);
  • The firm(s) associated with the product(s);
  • The root cause; and
  • The scope of issue

4.3.4 Scoping and Root Cause Analysis

Every food safety issue must be fully explored to identify all products, either under control or already distributed, which may pose a potential health risk to the public. Scoping is necessary for issues in which the root cause has been identified and also for those situations where the root cause is unknown. Two questions need to be addressed:

  • Could any other products have been affected?
  • Could any other manufacturers/importers have been affected?

The identification of the root cause of the hazard/contravention is very important in answering the above two questions as well as to assist in preventing the reoccurrence of a similar situation. The Lead Investigator has the primary responsibility to ensure that the food safety investigation is expanded to its fullest and that all products which may pose a potential health risk to the public are investigated. The ARC should provide a complimentary role in the scoping of an issue. The Lead Investigator (through the ARC as appropriate) may require assistance in this determination, while the coordination and assistance is provided by the OFSR.

As required, there are four main areas of scoping:

  • Same product - The same product was packaged and/or labeled with other codes, other brands, and/or packaged in other sizes of containers;
  • Other products - The root cause or possible root cause originated in a process, common equipment or employee practice which are used or come in contact with other products manufactured at the plant;
  • Other processes - The root cause or possible root cause may be affecting other processes in the establishment; and
  • Other Firms - The root cause may have originated with contaminated raw materials from another supplier or manufacturer and these materials may have been used in other products manufactured by other firms. Affected product may be shipped and processed at another facility. Affected imported products may be imported by several Canadian firms.

Product traceback is a systematic approach for determining the source and location of a suspect product and is a valuable tool in scoping a potential recall situation. This step is undertaken to identify at what level of distribution the problem occurred and/or to rule out the problem at the specific distribution chain level being investigated.

Scoping usually involves additional sampling and analysis for supporting evidence to confirm the presence of a hazard. Scoping is a critical aspect of the OFSR decision making process and subsequent risk management of any food safety hazard.

The responsibility for the root cause analysis process is dependent on the specific issue and capabilities of the involved firms. The analysis process, regardless of which party leads, must adhere to and take into account the food safety investigation guiding principles of timelines, thoroughness, appropriateness and consistency, as well as the investigation priority based on the established hazard and assigned profile status.

Dependent on the capabilities of the involved firms, understanding the variety of science- based control systems that are in place in specific aspects of the food industry and taking into account the variety of policies covering specific commodity groups, the following options exist for the group responsible for the root cause analysis:

  • The affected firm takes the lead and the CFIA Area provides oversight and root cause verification;
  • The CFIA Area and affected firm together; or
  • The CFIA Area (due to lack of firm capability or adherence to guiding principles).

4.3.5 Sampling

Product and equipment sampling and testing is an important tool for food safety investigations. In many cases, it is the only mechanism available to collect the evidence necessary for HRAs. Sampling can have limitations, for example, when the prevalence is very low or the hazard is not uniformly distributed. To optimize the sampling procedure, advice may be required regarding methodology and sampling size. The Science Branch will provide advice on methodology and the OFSR Technical Specialists and/or Health Canada may be requested to provide advice in selecting the best sample site and sample size in order to enhance the determination whether a hazard is present in the food.

The OFSR frequently requests the sampling of products and environmentals in order to collect the evidence required for an HRA. The sample results may also assist in the root cause analysis process as it may provide evidence which can be interpreted to confirm or identify the root cause and assist in the direction of the food safety investigation.

Reference:

This document describes a comprehensive process for determining the requirements for sampling during the scoping and verification activities of the food safety investigation.

While open sample testing is a valuable tool for food safety investigations, their results may not be sufficient, on an individual basis, to allow for a recall decision to be taken; however, their analysis and results can be essential in the following manner:

  • Identify the presence and level of a hazard; and
  • Two independent open sample results are considered in the HRA process and can be considered the equivalent of one closed sample.

Type of Samples and Reliability

The CFIA usually accepts results from external accredited laboratories; however, the level of confidence provided by these results must be carefully determined with the assistance of the Food Safety Science Directorate and the OFSR Technical Specialists.

The most reliable samples for food safety investigation purposes are those that are sampled, collected and tested by CFIA Area staff. Retention samples and firm sample test results can be used in the food safety investigation process in situations where there is no other practical alternative. It is recommended that these samples be supported by independent and unbiased CFIA samples whenever possible. A food safety investigation should not rely solely on a firm’s sampling and testing results.

4.4 Food Safety Investigation Process

4.4.1 Pre-Investigation Activities

Prior to initiating the on-site food safety investigation at any level of distribution, the food safety investigator should complete the following activities:

  • Determine the nature of the issue or complaint and the area of concern;
  • Determine the urgency of the complaint or issue;
  • Inform the complainant/responsible firm that the results of the food safety investigation will be provided to them;
  • Notify the appropriate Districts/Regions/Areas/Program Network staff/OFSR;
  • Notify appropriate laboratory if samples may be submitted;
  • Review technical information as necessary;
  • Review suspect firm history (profile, audits, inspections, etc. );
  • Review IMS for any similar issue in the firm’s past;
  • Record all preliminary details in the IMS;
  • Review pertinent legislation, guidelines, policies & procedures as necessary; and
  • Gather the necessary tools for the food safety investigation, i.e. sampling equipment, notepad, pen, etc.

4.4.2 Complainant / Consumer Level

The following are some of the factors which should be considered to ensure the completeness of the food safety investigation at the complainant level:

  • Complainant details;
  • Product details;
  • Product storage/handling;
  • Retail details;
  • Product sampling;
  • Illness or reaction details;
  • Allergen details; and
  • Injury details.

4.4.3 Vendor Level

The following are some of the factors which should be considered to ensure the completeness of the food safety investigation at the vendor level:

  • Vendor details;
  • Product details;
  • Product transportation/storage/handling;
  • Product history;
  • Sanitation; and
  • Sampling.

Vendors include retailers, distributors, institutions such as hospitals, nursing homes, etc.

4.4.4 Importer / Manufacturer Level

During food safety investigations at the manufacturer or importer level, it is important to document the non-compliant conditions and to describe how these conditions may result in the hazard or problem under food safety investigation. Direct on site visits, observations, interviews, recording of information immediately (i.e. note-taking), document review and verification of information are key tools in conducting a thorough food safety investigation. Where the information is obtained through interview(s) of firm personnel and/or document review, the information must be verified by observation and documentation.

4.4.4.1 Importer Level

The following are some of the factors which should be considered to ensure the completeness of the food safety investigation at the importer level:

  • Importer details;
  • Product details;
  • Product history;
  • Product transportation / storage / handling;
  • Importer knowledge / assessment of product; and
  • Sampling.
4.4.4.2 Manufacturer Level

The following are some of the factors which should be considered to ensure the thoroughness of the food safety investigation at the manufacturer level:

  • Transportation of incoming materials;
  • Inputs;
  • Storage of incoming material;
  • Product processing;
  • Packaging;
  • Storage of finished product; and
  • Transportation of finished product.

4.5 Note Taking

Detailed, accurate and complete notes are essential for ensuring correct transposing of the information into the IMS. This detailed information will form the basis of the HRA Requests, HRAs, decision making process and risk management strategy development.

4.6 Reporting

Documenting and reporting the activities and findings of a food safety investigation is essential in ensuring that the risk associated with the issue is properly assessed and that the appropriate risk management strategy is developed. The IMS is the database that is to be used as the tool to record and communicate this information.

4.7 Conclusion

The food safety investigation will continue until complete and adequate information is gathered to support an accurate health risk assessment and/or to develop an appropriate risk management strategy. The food safety investigation may be ongoing even when the other stages of the recall process have been initiated. Once a recall has been initiated the food safety investigation continues to determine whether there are other affected products that may pose a risk through scoping activities coordinated by the OFSR.

5.0 Decision Making

Scope

Once all of the pertinent information on the issue of concern has been collected and submitted to the Office of Food Safety and Recall (OFSR), a risk management strategy is developed. This strategy may include a single or series of activities. In many situations the decision making process includes a request for a Health Risk Assessment (HRA).

This section provides an overview of the risk management decision making process.

5.1 Roles and Responsibilities

Reference:

Throughout the food safety investigation process, information is exchanged between various internal and external partners to ensure that all of the pertinent facts are collected and verified.

5.1.1 Office of Food Safety and Recall

The OFSR is responsible for:

  • Coordinating the collection of food safety investigation findings and providing them to technical specialists;
  • Requesting Health Risk Assessments, when appropriate;
  • Considering various risk management strategies and making the decision to request a recall;
  • Providing the appropriate risk management decisions for the responsible firms to the Areas;
  • Determining the classification and depth of a recall; and
  • Making decisions on non-health and safety issues leading to recalls.

The Executive Director (ED), OFSR is responsible for the decision to request a firm to initiate a recall and the classification of the recall, i.e. the Class and depth of the recall.

5.1.2 Technical Specialists (Headquarters, OFSR)

The Technical Specialists are responsible for providing HRAs based on a Health Canada (HC) food safety standard or guideline, or by a requesting HC to conduct a Health Risk Assessment for situations where no standard exists. The OFSR may occasionally ask for a risk management recommendation for situations that are new or unique in nature. An Advisory Opinion will be issued if the specifically affected product has not been distributed.

Reference:

5.1.3 Area Recall Coordinator (ARC) / Lead investigator

The ARC/Lead Investigator should request the firm for after-hours contact (E-mail, phone, etc. ) to be available while the Health Risk Assessment is in progress.

The ARC/Lead Investigator will be responsible for the communication of the recall decision to the recalling firm and will oversee the implementation of the recall.

5.2 Office of Food Safety and Recall

The ED, OFSR is responsible for the decision to request a firm to initiate a recall and for decisions on the issuing of public warnings.

The ED, OFSR generally makes the final decision with regards to the issuing of public warnings. In exceptional circumstances, the ED, OFSR makes the final decision to issue a public warning/advisory after consultation with senior executives.

5.2.1 Classification of the Recall

A Recall Incident is the initial recall situation (Primary Recall) that may lead to additional recalls (Secondary Recall) and is related to the original/same/parent issue. The initial recall incident and secondary recalls have a common factor(s) such as product, cause, process deviation, etc. The cause of the secondary recall is the primary recall.

Once the decision to recall has been made, recalls will be classified according to the relative degree of health risk presented by the product being recalled. Recall classification follows the numeric designation which outlines the consequences of exposure.

Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death.

Class II is a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III is a situation in which the use of, or exposure to, a product is not likely to cause any adverse health consequences; the product is in contravention of an Act or Regulation enforced by the CFIA.

The classification of the recall will also include the depth of the recall, which refers to the extent to which the recall has been extended into the food distribution system, i.e., manufacturer/importer, distributor, retail, or consumer levels. The "retail" level of a recall includes hotels, restaurants and institutions (HRI). Factored into the classification decision is the target population for the product (i.e., children, elderly, general public), whether any illnesses have occurred from use of the product, the ease of product identification and the amount of product that is presumed to be in the market place.

There are two other types of product removal or disposition actions:

  1. Product Withdrawal is a firm's removal from further sale or use of a marketed product that does not contravene legislation administered or enforced by the CFIA. It is not considered to be a recall. Most product withdrawals are for quality reasons.
  2. Stock Recovery is a firm's removal or correction of a violative product that has not been marketed or that has not left the direct control of the recalling firm. It is not considered a recall.

5.2.2 Basis for Recall Decisions

The basis for the OFSR to make the decision to request a recall can vary depending on various factors including the type of trigger, the food safety investigation findings, the HRA and other factors. Closely linked to this decision is the determination of the depth of the recall (i.e. consumer, retail, warehouse). The following scenarios represent some of the more common situations that are encountered, on which a recall decision is based:

  • HRAs provided by Health Canada;
  • HRAs provided by CFIA Technical Specialists based on a Health Canada standard or guideline;
  • Legal Advice;
  • Canadian Firm initiated a recall. When a Canadian Firm decides to conduct a recall with a public warning, the OFSR will consider providing assistance in the issuing of the public warning while the company proceeds with the recall process. For situations where the company does not want to issue a public warning, the OFSR may request a Health Risk Assessment to confirm that the level of product action taken by the company is appropriate to the risk;
  • Out of country manufacturer recalls, publicly, a product that is sold in Canada. The request for a recall in Canada would be based on the out of country recalling firm's decision and depth of the recall (i.e. consumer level). A Food Safety Alert may be initially issued by the CFIA until such time that the Canadian importer(s) can be identified and the recall process can be initiated;
  • Public Warnings may be issued for secondary recalls based on an HRA from a primary recall where the product has not been manipulated in a manner that has reduced the original health risk; and
  • The basis for Class III recalls varies depending on the type of Class III recall that is conducted. Section 5.2.3 outlines the various scenarios that are normally encountered.

5.2.3 Class III Recalls

The OFSR recognizes three types of Class III recalls. They are as follows:

  • Recalls associated with a Health Canada HRA assessed Health 3 risk level where it is not likely that there will be adverse health consequences. Examples would be Listeria in Category 3 products, certain Allergen issues, etc;
  • Recalls that are not health and safety in nature, associated with a contravention of an Act or Regulation and a program recommendation for a recall action. Examples would be not permitted colour or additive or levels of E. coli exceeding program requirements but not posing a health risk; and
  • Recalls that involve extensive product spoilage or foreign material contamination that are not a health and safety concern, but are associated with a contravention of an Act or Regulation enforced by the CFIA. Examples: fermented or mouldy fruit juices, or insect contamination of a food product.

5.2.4 OFSR Decision to Issue a Public Warning

The CFIA uses a variety of public warnings/advisories to inform consumers, retailers and media of various health and safety concerns. Please refer to section 7 for a description of the various communication tools.

5.3 Recall Authorization

Each recall is classified in writing by the ED, OFSR or his/her delegate. The ED, OFSR is responsible for the decision to request a firm to initiate a recall and the classification of the recall. i.e. The Class and depth of the recall. Copies of the recall authorization for all classes of recalls are distributed internally within the CFIA. This document provides written confirmation of the ED, OFSR's decision to Operations Staff.

5.4 Risk Management Options

Each food safety issue is evaluated on its own merits. Based on the information received from the Areas and the HRA, the OFSR makes the decision whether a recall is appropriate and to what level. Recommendations on additional risk management strategies to be implemented can be developed by Technical and/or Commodity Specialists in collaboration with Operations Branch. Additional risk management options, which may be recommended, include but are not limited to the following and may be implemented singularly or in combination:

  • Increased audit frequency;
  • Border lookouts;
  • Seizure of products;
  • Detention of products;
  • Informal meeting of CFIA and Firm representative(s);
  • License suspension/cancellation;
  • Registration suspension/cancellation;
  • On site education;
  • Over stickering of non-compliant labels;
  • Re-labelling of products;
  • Reworking the affected product;
  • Increased sampling frequency;
  • Destruction of product;
  • Letter of non-compliance; and
  • Prosecution.

For larger food safety concerns, the OFSR may refer the issue to Program Specialists and Public Affairs for consideration of general strategies such as:

  • Development of consumer fact sheets;
  • Development of guidelines/policies;
  • Industry sector audits;
  • Industry sector education;
  • Additional media relations and outreach activities to targeted groups; and
  • Review and update of current program guidelines/policies/regulations.

6.0 Implementation

Scope

This section will describe the process of implementing a voluntary recall. Where the recalling firm does not agree to conduct a voluntary recall, other actions will be considered by the Canadian Food Inspection Agency (CFIA) and are described in section 10.

The implementation of a recall to the consumer level requires the preparation of several communication documents, namely the public warning and in some instances a Memorandum to the Minister or Memorandum to the Vice President of Operations. The scope, content, procedure for development and approval, and distribution of these documents is described in section 7.

6.1 Roles and Responsibilities

6.1.1 Office of Food Safety and Recall (OFSR)

In the implementation stage of the recall process, the OFSR is responsible for:

  • The coordination of the information required for a public warning;
  • Preparation and distribution of recall information; and
  • Issuing the recall authorization.

6.1.2 Public Affairs

Please refer to section 7 for more details on their roles and responsibilities.

6.1.3 Canadian Food Inspection Agency Area Operations - General

The Area Executive Director, Regional Director(s), and the Inspection Manager(s), are responsible and accountable for the implementation of the recommended risk management option in their Area and Regions.

The Area Recall Coordinator (ARC) is responsible for coordinating and providing advice and guidance to all area staff on food safety issues and recalls.

The Lead Investigator is the primary contact with the recalling firm that is responsible for implementing the recall in a timely, appropriate, consistent and thorough manner. In some situations, the recalling firm request that their head office coordinate the recall and in that case the Lead Investigator roles may be shared. Where there are multiple recalling firms in more than one province, various Lead Investigators may be assigned from each Area/Region.

6.1.4 Recalling firm

The recalling firm is responsible for the effective implementation of the recall.

6.2 Communication of Decision and Recall Process

References:

Immediately following the decision to request a recall of the affected product(s), the following activities are implemented to ensure timely notification of all partners:

  • The OFSR will inform the ARC (or Lead Investigator) of the decision to request a recall and its classification and depth;
  • The OFSR will complete and distribute the public warning/advisory to various groups for further distribution;
  • The ARC will activate the Area's recall management procedures, which may include informing the Area Executive Director, Regional Directors, Inspection Managers/Supervisors, Operations/Issues Coordinator and Program Networks, Communications Officer, etc. ;
  • The Lead Investigator will contact the responsible firm to request a voluntary recall. A letter confirming these discussions should then be prepared and sent to the recalling firm. This letter should include the recall classification, the regulatory contravention (when applicable), the time frames for action, a summary of the discussion and the Firm's agreement to voluntary recall the product, etc. (refer to Appendix 4A);
  • The ARC will coordinate the recall effectiveness verification strategy with other Regions and ARCs; and
  • The Lead Investigator provides the OFSR with the following information on the affected product(s) as per Appendix 4B (if not already provided):
    • The name and address of the recalling firm;
    • The company spokesperson for the media (if company wishes);
    • Area of distribution of the product;
    • Distribution date;
    • Copies of the product label (enlarged in French and English);
    • Brand name;
    • Common name;
    • Package type, net content, size, weight and/or special marks or features
    • date codes, lot codes, product or UPC codes, GTIN;
    • Expiry / best before / use by (dates); and
    • Any reported complaints, of illnesses or reactions made to the recalling firm.

The Lead Investigator will also:

  • Establish the plan to verify the effectiveness of the recall implemented by the recalling firm and associated responsible firms in consultation with the Inspection Manager/Supervisor and/or the ARC; and
  • Evaluate the recalling firm's strategy to be applied to effectively recall the product.

6.3 Verification of the Firm's Recall Plans and Activities

Reference:

The Lead Investigator will review the firm's recall plan to ensure that all necessary components are included. An on-site visit by an inspector is preferable to conduct a review of the following information but due to the urgency of the recall at this point, the Lead Investigator may find it more expedient to have the information E-mailed or faxed:

  • The notice of recall to the firm's accounts;
  • The news release (if applicable);
  • The distribution list specific for the affected product(s);
  • The firm's plans for conducting effectiveness checks (if applicable); and
  • The firm's plans for correcting or disposing of the affected product.

Note: A checklist to assist the Lead Investigator in gathering all necessary information and to assist in verifying the firm's recall plan can be found in Appendix 4C.

6.3.1 The Notice of recall

6.3.1.1 Purpose

For all classes of recalls, the recalling firm is responsible for promptly notifying each of its affected accounts about the recall. The format, content, and extent of a recall notice should be appropriate with the risk management strategy developed for that recall. In general terms, the purpose of a recall notice is to convey:

  • That the product in question is subject to a recall;
  • That further distribution or use of any remaining product should cease immediately;
  • Reason for the recall (identify the specific area of concern);
  • Where applicable, that the consignee should in turn notify the accounts to whom some or all of the product was further distributed of the recall; and
  • Instructions regarding what to do with the product.
6.3.1.2 Contents

The Lead Investigator will verify that the recall notice is written in accordance with the following criteria:

  • Brief and to the point;
  • Clearly identifies the product, size of the affected lot(s), lot number(s), package and case code(s), and/or UPC codes and any other pertinent descriptive information to enable accurate and immediate identification of the product;
  • Concisely explains the reason for the recall and the hazard involved;
  • Provides specific instructions on what must be done with respect to the recalled products;
  • Provides a ready means for the recipient to contact the recalling firm to confirm receipt of the information, to report how much of the product remains in the consignee's possession, the action taken on the product and how much of the product had been further distributed; and
  • Clearly states that the consignees should, in turn, notify their accounts that a recall is being conducted, where appropriate.

The recall notice should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message. Where necessary, follow up communications should be sent to those who fail to respond to the initial recall communication.

6.3.1.3 Transmission

As determined by the recall plan, a recall notice can be communicated by telephone, fax, E-mail or other appropriate measure after consultation with the CFIA. Telephone calls or other personal contacts should be documented in an appropriate manner. The communication of the recall notice should be initiated immediately after the recalling firm has agreed to conduct a recall.

6.3.2 The News Release (Public Warning)

Reference:

Where a public warning is required, the Lead Investigator coordinates the sharing of the recall notice with the recalling firm to verify that the facts are accurate.

In certain situations such as a foodborne illness outbreak, food safety investigations resulting in a recall, the public warning may be a joint release with a municipality, province, the Public Health Agency of Canada (PHAC) or Health Canada.

The scope, content, procedure for development and approval, time standard and distribution of these documents is described in section 7.

6.3.3 Distribution list

The recalling firm must develop and provide to the CFIA, as soon as possible, an accurate consignee list specific for the affected product. This distribution list must include the following information in a clear and legible form:

  • The names of consignees, addresses and telephone numbers. (If a product specific distribution list is not available, the firm should provide a list of its accounts who may have received the products); and
  • A contact person for each consignee (if available).

Additional information such as the quantity of the product and the date shipped to each consignee are also requested; however, more time may be permitted to the recalling firm to submit this information.

The Lead Investigator should also request that the recalling firm provide a separate list of wholesale, distributor or manufacturer type accounts. All distributors should be contacted by the CFIA office in their Area/Regions and requested to also provide their distribution lists.

6.3.4 Affected Product Correction / Destruction

The recalling firm should be advised of the specific requirements of the applicable CFIA legislation and policy. The Lead Investigator must verify that the recalling firm has an appropriate strategy for dealing with the affected product.

The recalling firm's plan to dispose of the affected product is to be verified by the applicable Program Specialist. An OFSR Technical Specialist may assist the Program Specialist as deemed necessary.

7.0 Communication

Introduction

Where a public warning is required, the Canadian Food Inspection Agency (CFIA) coordinates the preparation, translation and transmission of the public warning to the news wire. In certain circumstances, Public Affairs will also provide additional communication products and services.

Public warning documents include Food Recall Warnings, Food Recall Warnings (Allergen), Food Safety Warnings and Mandatory Recalls, all of which are issued to the news wire and posted on the CFIA website.

  • A Food Recall Warning is a warning to consumers advising them not to consume a recalled product that poses a health risk (except allergens).
  • A Food Recall Warning (Allergen) is a warning to consumers advising them not to consume a recalled product because it may contain an undeclared allergen.
  • A Food Safety Warning is a warning to consumers of a health and safety issue where there is no recall. This is for situations in which a recall has not yet been conducted or cannot be conducted. The decision to prepare these documents is made by the Food Safety Communications Manager with input from the OFSR, Media Relations and the Executive Director, Strategic Communications. Advice will also be sought from Health Canada (HC) and the Public Health Agency of Canada (PHAC).

Mandatory Recall Alerts occur when a company is unable, or refuses, to voluntary recall a product. The Minister of Health has the power to order a mandatory recall if he/she has reasonable grounds to believe that the product poses a health risk to the public. Prior to a mandatory recall, the OFSR may decide to issue a consumer advisory.

A General Advisory can be issued by a program in situations where consumers should be aware of an industry-wide issue or a safety recommendation relating to a food product. This type of advisory is generally not as urgent as a public warning.

7.1 Guiding Principles

  • Food recalls and food related emergencies are a key priority of Public Affairs.
  • Information provided to the public must be timely, accurate, clear, objective and complete.
  • Public Affairs will work in collaboration with our communication partners in food safety, including, but not limited to Agriculture and Agri-Food Canada, the Public Health Agency of Canada and Health Canada to achieve coherent and effective communications with the public.
  • Public Affairs will work to foster open dialogue with the public on issues involving risk and build a climate of trust, credibility and understanding by being open and transparent about food safety issues and recalls, including facts, evidence and information.

7.2 Process, Roles and Responsibilities

References:

Public Warning Templates:

CFIA Website

7.2.1 Public Warning Process

  1. The OFSR
    • Notifies the Recall Communications Advisor that there is a recall and provides background information; and
    • Prepares and forwards a draft public warning.
  2. The Recall Communications Advisor:
    • Sends a "heads up" E- mail to the Privy Council Office, Health Canada, the Public Health Agency of Canada and Public Affairs staff including: Media Relations, Ministerial and Corporate Communications, the Surge Capacity Unit, the Manager of Food Safety, the Executive Director, Strategic Communications and Web Operations;
    • Reviews the draft public warning and provides strategic communications advice on messaging;
    • Determines, in cooperation with the Food Safety Manager, whether additional communications products are required;
    • Works with the OFSR to revise the public warning as appropriate;
    • Incorporates changes and forwards a copy of the revised public warning to the OFSR;
    • Forwards the revised public warning to the translator; and
    • Once the translation is completed, forwards the English and French drafts to the OFSR for review and approval.
  3. The OFSR sends the public warning to the Lead Investigator, The Lead Investigator:
    • Reviews the public warning and liaises with the recalling firm to determine if any corrections are necessary;
    • Requests that the recalling firm initials and dates the news release when possible, upon review of the public warning; and
    • Forwards a copy of the initialed and dated public warning to the OFSR when applicable.
  4. When changes are requested by the lead investigator, which are approved by the OFSR:
    • The OFSR incorporates the changes and sends the revised version to the Recall Communications Advisor; and
    • The Recall Communications Advisor reviews the draft to ensure the appropriate messaging and sends the revised version to the translator to make the required adjustments.
  5. The OFSR approves the final English and French public warning.
  6. Distribution of the public warning is as follows:
    • The Recall Communications Advisor sends the public warning to the newswire.
    • The release is distributed across the country, to specific provinces, and/or selected media outlets depending on where the product has been sold;
    • The Recall Communications Advisor sends the public warning to Web Operations and the CFIA Webmaster. The CFIA Webmaster posts the public warning on the CFIA's website and sends it electronically to list serve subscribers for food recalls;
    • The OFSR distributes the public warning to its list of contacts; and
    • The Recall Advisor may send the final public warning to the "heads-up" lists in the event of a high profile recall.

In cases where the recalling firm decides to draft their own release, the OFSR will communicate with the firm and forward the public warning to the Recall Communications Advisor for review to ensure that promotional languages do not deter from the warning. If the recalling firm's public warning does not communicate the appropriate messages, the OFSR will draft a new separate public warning.

7.3 Public Warning Content

The standard content for a public warning includes:

  • Brand name;
  • Common name;
  • Size;
  • Lot, best before date, code;
  • UPC code, where possible;
  • Photo of label, if available;
  • Description of the problem;
  • Illnesses, if there have been any;
  • Media relations contact information;
  • Distribution;
  • The name of the manufacturer, importer and/or distributor, if deemed to be beneficial information;
  • Consumer information contact number;
  • Information on the recall database; and
  • The CFIA website address.

Note: Where the distribution of the affected product is unknown a statement such as "may have been distributed across Canada" may be substituted to allow for timely distribution of the public warning.

7.4 Supporting Communications Products

7.4.1 Media Lines and Questions and Answers

Most recalls do not require media lines since the public warning provides the necessary information; however, media lines and/or questions and answers (Q&As) may be required for high profile or complex issues.

These would be used as guidance for the OFSR spokesperson and media relations to respond to media queries and public enquiries received via the 1-800 number of the CFIA web site.

In such cases, the Food Safety Communications Manager makes the recommendation that media lines and Q&As be prepared, and decides whether they are needed at the time of the recall or the next day. The Recall Communications Advisor prepares the media lines and Q&As, if they are needed urgently. Otherwise, the Food Safety Communication Advisor responsible for the issue will prepare them the next business day.

The National Manager of the Food Safety Investigation Recall (FSIR) can also request media lines to help determine messaging on high profile or complex food recalls.

Media Lines and questions and answers relating to recalls are approved by the Food Safety Communications Manager and the Executive Director, Strategic Communications. They are then provided to the Manager, Media Relations and the Manager, Web Operations for dissemination.

High profile or complex issues for which media lines and Q&As should be considered include, but are not limited to:

  • A mandatory recall;
  • The recall of a product that is consumed by an at-risk population;
  • An expanded recall or outbreak;
  • Reports of serious illness, injury, adverse reactions or death; and
  • Consumer advisories on food safety risks.

7.4.2 Media Queries and Spokespersons

When media contacts the CFIA Media Relations Office regarding a food safety recall, Media Relations will:

  • List the reporter's questions and contact information; and
  • Inform the applicable CFIA senior executives and managers, the Minister's Office and the Privy Council Office of the media request.

If the reporter's questions are related to a specific recall, Media Relations will contact the OFSR at their emergency on-call telephone number to respond to the reporter. If a request for interview volume for a certain recall is high, Media Relations may organize a conference call with several media at once and sit in on that conference call along with the OFSR. Media Relations may also be present for the OFSR interviews that are on-camera.

If questions relate to policy around recalls or other regulatory policy questions, the Media Relations Officer will manage the query in cooperation with the appropriate subject matter expert in the Policy and Programs Branch.

7.4.3 Public Inquiries

  1. Upon final receipt of the public warning, the communications advisor who is on recall duty sends the final English and French versions to the original "heads-up" list as noted in Section 7.2.1.
    • In situations where media lines, Q&As, or other relevant communications products have been developed, the communications advisor on recall duty also sends those products to the "heads-up" list along with the public warning.
  2. The Web Operations sends the public warning and all other relevant communications products (in both languages) to their point of contact at Service Canada, which manages the CFIA 1-800 public inquiries line.
  3. Web inquiries through the CFIA Webmaster account are handled as follows, depending on the nature of the inquiry:
    • Routine questions are answered through the CFIA Webmaster within 24 hours, using approved messaging from the public warning or other relevant communications products; and
    • Detailed questions that go beyond the scope of the approved communications products are forwarded by the CFIA to the Area Recall Coordinator. The spokesperson answers the E-mail inquiry directly within 48 hours, copying the CFIA Webmaster and the Manager of Food Safety Communications.

Public Affairs will coordinate the development of information for the 1-800 and web inquiries with input from the OFSR. In an outbreak or other high profile situation, the viability of using existing 1-800 lines and the need for additional staff resources and expanded hours of service will be considered. Depending on the issue's scope and duration and the volume of enquiries received, Public Affairs may make the decision to hire additional staff for Service Canada or develop a dedicated 1-800 line.

7.4.4 Other Communications Products

In extraordinary circumstances, other communications products and activities may be considered by Public Affairs. These could include:

  • Website landing page;
  • Direct communication to at-risk populations;
  • On-line fact sheets;
  • News releases;
  • Frequently asked questions;
  • Translation into languages other than English and French; and
  • Media teleconference or press conference.

The decision to prepare these products is made by the Food Safety Communications Manager with input from the OFSR, the Manager, Media Relations, and the Executive Director, Strategic Communications. Advice will also be sought from Health Canada and the Public Health Agency of Canada.

7.4.5 Class II and III Recalls

As of November 16, 2009, the CFIA began putting information on Class I, II and III recalls in a Food Recall database on its website.

This information includes:

  • CFIA reference number;
  • Name of recalling firm;
  • Date of recall;
  • Recall classification;
  • Distribution;
  • Extent of distribution;
  • Brand name;
  • Common name;
  • Size;
  • UPC codes;
  • Other codes; and
  • Reason for recall.

This information is available and searchable, similar to public recall alerts. The data remains on the CFIA website for a five year period.

It is the responsibility of the Food Safety Recall Specialist, OFSR, to enter this information in the food recall data base within one business day of the initiation of the recall.

7.4.6 Class II and III Allergen Recalls

As of February 24, 2011, the CFIA began sending e-mail notification for Class I, II and III allergen recalls to e-mail subscribers. Prior to this, the CFIA posted information on all Class I, II and III recalls in a food recall database on its website.

The body of the email includes:

  • Recall classification;
  • Reason for recall (allergen);
  • Product(s);
  • Name of recalling firm;
  • Distribution; and
  • Hyperlink to web posting.

This information is available and searchable, similar to public recall alerts. The data remains on the CFIA website for a three year period.

It is the responsibility of the Food Safety Recall Specialist, OFSR, to enter this information in the food recall database within one business day of the recall.

8.0 Verification

Scope

The purpose of the verification process is to assess the effectiveness of the recall measures taken by the recalling firm and other associated firms (i.e. distributors and retailers).

8.1 Roles and Responsibilities

8.1.1 Industry

The recalling firm not only has the responsibility for conducting the recall but also for ensuring that its actions have been effective in removing the product from the marketplace. To ensure the effective removal of the products, the recalling firm needs to advise its accounts to remove the product from sale and/or to further notify their accounts down the distribution chain as appropriate to the recall depth.

Note: The procedures outlined in this section are designed only for the Canadian Food Inspection Agency's (CFIA) verification activities. The time standards and sample sizes identified in the procedures do not directly apply to the verification activities conducted by a recalling firm; therefore, it is the responsibility of the recalling firm to apply appropriate procedures.

8.1.2 Canadian Food Inspection Agency

8.1.2.1 Office of Food Safety and Recall (OFSR)

Throughout the verification process, the OFSR may provide advice to the Area field staff involved in the verification activities.

8.1.2.2 Area Recall Coordinator (ARC) / Regional Recall Coordinator (RRC)

The Area Recall Coordinator is responsible for providing guidance and support on the verification process. The ARC is also responsible for receiving requests for verification activities from other Areas and ensuring that they are acted upon in a timely manner.

8.1.2.3 Lead Investigator

The Lead Investigator is responsible for gathering the information necessary to initiate the recall verification activities from the recalling firm and in consultation with the Supervisor and/or Inspection Manager, is responsible for planning, coordinating, reporting and closing the CFIA recall verification process.

8.1.2.4 Area Field Staff

CFIA Area field staff verify whether consignees to whom a product has been sold have been notified of the recall and whether the implicated product has been removed from sale and properly segregated pending disposition.

8.1.3 Provincial/Territorial/Municipal Governments

Where agreements are in place with other government departments or agencies to assist with verification activities, the ARC will forward to the appropriate department the necessary information. The ARC will also forward to the appropriate CFIA office the results of the verifications conducted by an external partner. Please refer to appendices 6A, 6B, 6C and 6D for example documents that may be used for preparing and recording such requests.

8.2 Verification Process

The CFIA works with the recalling firm on the strategy developed by the firm to recall products from sale and verifies the effectiveness of the recalling firm in completing and assessing its own recall. Using a statistical sampling plan, the CFIA identifies a sample of consignees to verify the recall's effectiveness. If the CFIA determines that the recalling firm has not been successful in conducting an effective recall, it will take appropriate actions to ensure the safety and well-being of the consumer.

The following describes the procedures which are applied by the CFIA to verify the effectiveness of food recalls. Additional procedures such as 100% checks may also be applied as considered necessary, for example, in case of a food borne illness outbreak or distribution targeted to institutions such as day care centres or retirement homes. Further deviations with the established procedures may also occur in exceptional circumstances. With the agreement of his/her Supervisor and/or Inspection Manager and in consultation with the ARC and the OFSR, the Lead Investigator may modify the approach proposed in this section provided that the CFIA has sufficient confidence and evidence that the recalled product has been taken off the market.

Notes:

  1. An example of the latter situation is when the recalling firm or distributor conducts effectiveness checks immediately following the start of the recall and the checks are deemed satisfactory by the CFIA. With the approval of his/her Supervisor and/or Inspection Manager, the ARC and the OFSR, the Lead Investigator may modify the current approach by reducing the number of establishments to be verified. Such a practice would apply only to single-circuit distributions where the success of an effective recall is not dependent upon another distributor.
  2. For Class III recalls, two approaches for verifications are available:
    • The primary approach is to verify removal or correction of a recalled product by the recalling firm by obtaining (via E-mail, fax or visit) necessary documents such as a recall notice and other company documents which show the removal/correction of a recalled product. This verification should be completed within a suitable time (Table 1). Since products under Class III are "not likely to cause any adverse health consequences," this approach is considered acceptable and should be used to verify the removal or correction of recalled products for Class III recalls.
    • The secondary approach is to employ the procedure outlined in the following sections. The secondary approach is for recalls where the primary approach is considered less effective or efficient. This approach should be used only in exceptional circumstances and only in consultation with the Supervisor/Manager/ARC/OFSR.

8.2.1 The Lead Investigator will:

For a Class I and Class II recall:

  1. Immediately request a detailed list of consignees from the recalling firm. The list of consignees should contain sufficient details to allow the CFIA inspectors to understand the distribution patterns and make contacts without further delay;

    Note: It is anticipated that the majority of recalling firms would immediately start the recall activities and provide a list of accounts to the CFIA for the verifications process. However, in some cases of a Class I recall or a recall with a public announcement, where a recalling or an associated firm is slow to respond, the CFIA may use previously available lists to initiate a verification process.

  2. The list should have sufficient details including:
    • Names, addresses including postal codes and phone numbers of all consignees who are notified by the recalling firm;
    • Separation of consignees within the list by geographical regions (as applicable); and
    • Separation by consignee within the list type - hospitals, chains, independents etc. , (as applicable). See Suggested Procedure for Obtaining List(s) of Consignees for the recommended procedures.

    Notes: Preferably the list should have the names of all consignees who received the recalled product. However, the list often includes the names of all of the recalling firm's consignees, some of which may not have received the recalled product.

    Preferably the list of all retail consignees should be available. However, often the list includes both retailers and distributors consignees and in some cases some further manufacturers.

    The Lead Investigator should at the time of the initial request determine the types of consignees included in the list. If the list contains further distributors or manufacturers, appropriate CFIA offices should be immediately notified, so that distributors can be contacted to obtain a detailed list of retailers. If there are further manufacturers in the original list, separate recall food safety investigations would be initiated.

  3. In consultation with the Supervisor and/or Inspection Manager and appropriate CFIA offices, determine the best estimate of the number of consignees, sampling interval and the random starting point sample for verification (refer to section 8.2.3 for details), while the recalling firm is compiling the list;
  4. Prepare a plan, including the sampling interval and the random starting point, the recommended time frames for completion, the related IMS number and any other details which may help conduct the verification activities more effectively. The plan will then be forwarded to the ARCs in those areas where products have been distributed. Attached to the plan will be copies of the lists, product/carton labels, recalling firm's notice of recall, and copies of corrected labels and the public warning (if applicable);
  5. Ensure that the recalling firm and appropriate associated firm(s) including distributor, chain store head office or a store are notified and that the corrective action is initiated, when informed of a deviation; and
  6. Review the results of the recalling firm's recall activities; this activity is most effective when conducted on-site and is likely to include a review of documentation such as confirmed recall notices, receipts of returned product, telephone call reports and email confirmations.

For a Class III recall in consultation with Supervisor/Manager and as needed with ARC/OFSR initiate the most efficient/effective approach (see note 2, section 8.2).

8.2.2 The Inspectors Assigned the Verification Activities Will:

  1. Ensure receipt of the recalling firm's distribution list as well as the distribution list from other distributors involved;

  2. Assist the Lead Investigator, while the distribution list is being compiled, in determining the best estimate of the number of consignees and the provinces where the product has been distributed (refer to section 8.2.3 for details);

  3. Ensure that copies of the recalling firm's Notice of Recall, and as applicable, copies of the public warning and labels are on hand when conducting verification activities; these documents can then be referenced and/or left with consignees if required;

  4. Bring the issue to the attention of the recalling firm, where there is suspicion that the distribution list is not accurate or complete (i.e. a generic list of chain stores is missing a few known stores); and where necessary, evidence will be gathered and a list will be prepared, identifying other potential retailers and/or distributors who may carry the recalled products, but are not included on the distribution list.

  5. Select the consignees, after receiving the actual copy of a distribution list, and identify the type of check to be conducted for the selected consignees, for verification (see section 8.2.3) and inform the appropriate ARC (or the CFIA office as per area protocol) to conduct the checks;

  6. Conduct checks to determine if the consignees have received a Notice of Recall from their supplier and have taken the prescribed action. Conduct checks by on-site visits or phone according to the provisions in notes below;

    Notes:

    1. Telephone checks should be done according to the method listed in the Recommended Telephone Verification Procedure. On-site visit checks should be done according to the method listed in the Recommended On-site Verification Procedure.

    2. For checks, Chain Stores are defined as two or more retail outlets under a common system. These would include company owned stores as well as franchised stores. These include outlets such as gas stations, hardware stores etc. where food items are sold. Independent Stores are defined as all non-chain outlets where food items are sold.

    3. For chain stores, checks by telephone and by visits are considered equally effective.

    4. At independent stores conduct 75% checks by on-site visits and 25% by phone.

    5. For independent stores, checks by visit are more effective than the checks by telephone. Therefore, using telephone checks in lieu of on-site visits for independent stores is considered acceptable only in exceptional circumstances and only after consultation with ARC.

  7. Request immediate compliance with the instructions if the recalled product is being held for sale or used against directions provided in the Notice of Recall;
  8. Immediately advise the Lead Investigator and any other inspector responsible of the deviations encountered and assist the Lead Investigator and/or ARC in contacting the appropriate recalling firm to notify the observed deviation and take necessary corrective action; and
  9. Enter the data electronically in the Issues Management System (IMS) and include a summary of the verification results in the Task / Activity log before closing the assignment.

8.2.3 Determining the Consignees to be Contacted (the Sample):

The consignees to be contacted will be determined by the Lead Investigator and the appropriate Regional Inspectors. The verification process uses a statistical approach that incorporates a systematic sampling method. The verification activities should be timely and should include sufficient numbers of checks at appropriate consignees.

The Lead Investigator will:

  1. Determine the actual or the best estimate of the number of consignees, (e.g. 1200);

    Notes:

    • The Lead Investigator should attempt to obtain the entire distribution list within the appropriate time lines (see Table 1). If such a list is available in time, the actual number of consignees is determined from that list.
    • In order to ensure timely response, the CFIA cannot wait for the entire list to be available before the checks are initiated; therefore, at the very beginning, the Lead Investigator should, in discussion with the recalling firm and as needed (if there are distributors on the list) through other CFIA offices, determine the best estimate of the number of actual retailers (who received the recalled product or who will be notified of the recall). Example: If the recalling firm has 50 retailers and 5 distributors and the 5 distributors in turn have 400, 200, 300, 100 and 150 retailers, the best estimate of the number of consignees on the list is 1200 retailers. The effectiveness check is done from the list of 1200 names.
    • The best estimate is not the "customer" list of a recalling firm. It is rather the estimate of retailers which would have received the recalled product or would receive the recall notification from the recalling firm. The best estimate can be determined via phone/E-mail without obtaining actual copies of the lists; however, care must be taken that the estimate would not significantly differ from the actual list(s) (See the Suggested Procedure for Obtaining List(s) of Consignees).
    • The Lead Investigator should use the actual number or the best estimate and Tables 2 and 3, 4, 5 or 6 to determine the sufficient numbers of checks.
  2. Determine if the distribution is a multi-channel or a single channel distribution. For example, where distribution is by one source/location or only within a chain system, it can be classified as a single channel distribution, (i.e. distribution to1200 stores including a few distributors and various chain and independent stores, would be multi-channel, while distribution to 1200 stores all within one chain store or from one distribution point would be a single channel);

  3. Determine the appropriate sampling rate, using Table 2. For example, for a Class I recall and the list of 1200 consignees in a multi-channel distribution, the appropriate table is table 3 and the sampling rate is 160. On the other hand for a Class I recall and the list of 1200 consignees in a single distribution system, the appropriate table is table 4 and the sampling rate is 87;

  4. Determine a sampling interval by dividing the total number of actual or estimated consignees (example 1200) by the minimum sample size (160 for the multi-channel list and 87 for the single channel list). In this example, sampling intervals would be 7 (1200/160 = 7.50 rounded to the lower whole number) or 13 (1200/87 = 13.79 rounded to the lower whole number);

  5. Randomly select a number between 1 and the sampling interval to determine the starting point. For example, say 3 for a sampling interval of 7 or 2 for a sampling interval of 13;

  6. Provide the sampling interval and the random starting point along with any available lists to the applicable area(s); and

  7. Provide the ARC with the number of verification requests to be expected.

    The inspectors assigned the verification activities after receiving the actual copy of the distribution list will:

  8. Select the consignees for verification, using the predetermined sampling interval and the random starting point;

    Notes:

    • Put the distribution list in any order, count from the top until you reach the starting point 3rd name on the list in the example. Select 3rd name, then go down the list and select every 7th as an example to 10th, 17th and further (according to the predetermined sampling interval) until the list is exhausted. From any grouping (such as all stores in Ontario or BC; or a group of all hospital accounts) within the list which has fewer consignees than the predetermined sampling interval, at least one name should be randomly chosen.
    • If there are groupings of consignees which sell to susceptible populations likely to be affected by the recalled product (such as a list of day care centers, hospital cafeterias, retirement homes, etc. ), they must be included and checked at higher frequency on case-by-case basis.
  9. separate selected consignees into chain and independent stores. Provide appropriate office(s) details (names, phone numbers, addresses and the type checks) of the consignees to complete the checks according to section 7.2.1; and
  10. Continue with all the assigned checks even though, regionally, a recall may appear ineffective.

8.2.4 Verification Result Summaries

The Lead Investigator will prepare and enter in the IMS the summary of recall activities. The focus of the summary should be to:

  • Determine how many consignees still have the product(s) on sale;
  • Identify reasons for continued sale;
  • Identify other deficiencies;
  • Assign an overall effectiveness rating to the recalling firm's recall activities; and
  • Summarize corrective actions.

The summary should include a description of the corrective actions taken to correct each identified deficiency (i.e. the product removed and segregated in shipping area, re- notification was issued for all convenience stores including names of affected distributors, as applicable, etc.).

The IMS should be updated with the summary and complete the item Satisfactory under Action Taken.

8.3 Time Frames for Initiating and Reporting on Verification Activities

Recall verification activities are to be considered a high priority by receiving Areas, Regions or Districts. Table 1 describes the recommended time frames for the initiation of verification activities and for the submission of results of these activities. It is recognized that each recall is accompanied by its own risk management strategy; therefore, specific circumstances may affect the time frames presented in this table. It is the responsibility of the receiving Area to notify the Lead Investigator of circumstances which may delay the verification and/or reporting activities.

The time standards presented in Table 1 are for the CFIA's verification activities. It should not be misunderstood that for a Class I recall a recalling firm has 3 days to initiate and 10 days to complete a recall. Recall activities by firms should be immediate upon deciding a recall or receiving notification of a recall. During this time, the Lead Investigator will also have an oversight function to assess whether the recall activities have in fact been initiated by the recalling firm.

Table 1 - Recommended time frames for initiating and reporting verification activities within the CFIA
Recall classification Following the initiation of a recall, the verification activities must begin within a period of: Following their initiation, verification activities must be completed within a period of:
Class I 3 days Table Note 1 10 days
Class II 5 days 12 days
Class III 10 days 17 days

Table Notes

Table note 1

Working days: working days may include Saturday and Sunday, depending upon the risk associated with a recalled product.

Return to table note 1 referrer

Verification results should be submitted to the Lead Investigator via fastest possible means E-mail, fax, phone or IMS as soon as possible.

8.4 Concluding the Verification Activities

The objectives of verification activities are to evaluate:

  • The overall effectiveness of the recall;
  • The recalling firm's process; and
  • The actions taken by the consignees when advised of the recall.

8.4.1 Deviations

Deviations are those occurrences where unfavorable results are encountered. Two types of deviations may be encountered:

  1. Product deviations are defined as those occurrences where the affected product remains available to the consumer.
  2. Process deviations are related to the overall recall strategy or process and may include:
    • The Notice of Recall was not received by all consignees within the established time frames;
    • Effectiveness checks were not properly conducted;
    • Problems encountered were not adequately addressed; and
    • A break-down in the notification process by a secondary distributor.

The Lead Investigator must be advised immediately when deviations are encountered so that the recalling firm and/or appropriate consignee can be informed.

Also, the Lead Investigator must determine if the deviations follow a pattern or trend, thus allowing for a focused and appropriate application of corrective measures. During the evaluation of the deficiencies and associated reasons, it is important to distinguish between isolated reasons (i.e. the product was removed in a store but was re-shelved by mistake) and widespread systemic reasons (i.e. breakdown in the notification process or delay caused by the schedule of sales personnel).

The Lead Investigator, in consultation with the Supervisor and/or Inspection Manager, will assess if the verification process has been found to be effective and will communicate their decision via E-mail/IMS, etc.

Note: Depending upon the actual sampling calculations, the final sample count would likely differ (generally be higher) from the count listed in the tables, therefore, caution should be used in the interpretation of the critical numbers. The recall activities should be classified as effective or ineffective, after considering both the number and the nature of the deviations.

8.4.2 Determining the Overall Effectiveness of the Recall

Was the recall process effective in removing the product from sale?

For a recall to be deemed effective, the number of consignees checked that are found to have the product available to the public must be equal to or less than the critical number in the sampling plan.

Where a product has been removed from sale but process deviations are identified (i.e. the consignee did not receive the Notice of Recall but became aware of the recall by the media), the Lead Investigator must still be advised as soon as possible.

8.4.3 Determining the Overall Effectiveness of the Recalling Firm's Process

Was the recalling firm's strategy implemented properly and effectively?

Where the process deviations are encountered, it may be concluded that the recalling firm did not properly carry out its recall process or that the firm's recalling strategy may be inappropriate. The CFIA will take the appropriate measures and provide needed guidance to ensure the recalling firm addresses the deviations.

8.4.4 Determining if the Appropriate Actions were Taken by the Consignees when Advised of the Recall

Did the distributors / consignees take the appropriate product action when advised of the recall?

Deviations will be recorded where it is found that the consignees (retailers, wholesalers, etc. ) along the distribution chain were properly advised of the recall but did not take the appropriate actions. The CFIA will take the appropriate measures to ensure the product is removed from sale. In such instances, inspectors may seek advice, guidance and assistance from an investigation specialist within the Enforcement and Investigation Services.

Where it is found that the consignees (distributor or other resaler) along the distribution chain were properly advised of the recall but did not properly carry out the recall to the next level of distribution as requested by the recalling firm, the CFIA will take appropriate measures to ensure that the recall is properly carried out by the affected consignee.

Examples/Scenarios of Effective and Ineffective Recalls:

Note: Only the Lead Investigator assigns this (effective or ineffective) classification. Inspectors conducting checks would need to continue with all the assigned checks even though, regionally, a recall may appear ineffective.

Using the example of 1200 consignees on a list for a Class I recall, with verification done at 160 randomly selected consignees where critical number is seven.

  1. All consignees checked have received the Notice of Recall from the recalling firm and have removed the product from sale.

    Action: None, recall is effective.

  2. Eight consignees (1 more than critical number) checked are found to have deviations. Four have not received the recall notice and still offering the product for sale; four have received the notice but have not taken the requested product action. Therefore, the product remains available to the consumer at 8 locations, exceeding the critical number.

    Action: Recall is deemed ineffective (a total of eight consignees still have the product available). Product action will be taken and a recall may need to be repeated, in the appropriate area/region. Measures will be applied against those consignees who received the information but did not take appropriate action.

  3. Ten consignees checked are found to have deviations. Seven are found to have process deviations and 3 have product deviations.

    Action: Overall recall would appear effective as the product deviations are less than the critical number; however, the recalling firm may have an inappropriate recalling strategy. The recall may be ineffective if the reason(s) for the deviations was systemic or effective if the reason(s) was isolated. The CFIA will take the appropriate measures to ensure the recalling firm and/or consignees address the deviations and will provide the guidance as required.

    Product action will be taken and a recall may need to be repeated, in the appropriate area/region. Measures will be applied against those consignees who received the information but did not take appropriate action.

8.4.5 Ineffective Recall

If at any time during the verification of the recall, the CFIA determines that the recall effort is ineffective, the OFSR should be notified. The CFIA will assess the root cause of the failure and determine which actions are appropriate to the situation. The CFIA will discuss the situation with the responsible firm to determine what action the responsible firm intends to take to improve its recall effort, such as issuing additional recall communications, etc.

A letter should be written by the Lead Investigator detailing the reasons why the recall has been found to be ineffective. The Lead Investigator should request a written response from the responsible firm confirming the actions that will be taken to address the situation.

If, after having been formally notified by the CFIA of the ineffectiveness of their recall, the responsible firm is unwilling or incapable of extending or modifying its recall, the Inspection Manager/Supervisor/ARC will forward the recommended actions to be taken by the CFIA, to the OFSR. Risk management options to be considered may include public warnings issued by the CFIA, product seizures or other appropriate legal and/or compliance actions.

Table 2: Selection of Appropriate Sampling Table for Recall Effectiveness Verifications
Recall Distribution Class I Class II Class III
Multi-channel Table 3 at prescribed rate Table 4 at prescribed rate Table 5 at prescribed rate
Single channel Table 4 at prescribed rate Table 5 at prescribed rate Table 6 at prescribed rate
Table 3. Class I Multi-Channel Selection of Consignees for Recall Effectiveness Verifications
Consignees Select Critical #s
> 10000 200 9
5000 - 9999 195 9
3500 - 4999 190 9
2600 - 3499 180 8
2000 - 2599 175 8
1600 - 1999 170 8
1150 - 1599 160 7
1000 - 1149 155 7
850 - 999 150 7
750 - 849 145 6
650 - 749 135 6
550 - 649 130 6
500 - 549 120 5
400 - 499 115 5
350 - 399 110 4
290 - 349 95 4
255 - 289 85 3
230 - 254 80 3
175 - 229 75 3
150 - 174 65 2
125 - 149 60 2
100 - 124 50 1
90-99 45 1
75-89 35 1
65-74 30 0
< 65 25 or 100% 0

Note: Irrespective of the classification of the recall, corrective actions are taken, even if only one consignee is found to be selling the product. There is no tolerance for a consignee selling a recalled product.

Table 4. Class I Single Channel, Class II Multi-Channel Selection of Consignees for Recall Effectiveness Verifications
Consignees Select Critical #s
> 5000 110 5
3000 - 5000 105 5
2000 - 2999 100 4
1600 - 1999 95 4
1250 - 1599 90 4
1000 - 1249 87 4
850 - 999 84 3
750 - 849 80 3
650 - 749 77 3
550 - 649 74 3
500 - 549 70 3
400 - 499 69 3
350 - 399 65 2
300 - 349 61 2
250 - 299 58 2
225 - 249 55 2
200 - 224 52 2
175 - 199 50 2
150 - 174 45 1
125 - 149 40 1
115 - 124 35 1
100 - 114 32 1
80-99 30 1
< 80 25 or 100% 0

Note: Irrespective of the classification of the recall, corrective actions are taken, even if only one consignee is found to be selling the product. There is no tolerance for a consignee selling a recalled product.

Table 5. Class II Single Channel, Class III Multi-Channel Selection of Consignees for Recall Effectiveness Verifications
Consignees Select Critical #s
> 2000 70 3
1000 - 2000 65 3
750 - 999 55 2
600 - 749 50 2
400 - 599 45 1
350 - 399 40 1
325 - 349 35 1
100 - 324 30 1
< 100 25 or 100% 0

Note: Irrespective of the classification of the recall, corrective actions are taken, even if only one consignee is found to be selling the product. There is no tolerance for a consignee selling a recalled product.

Table 6. Class III Single Channel Selection of Consignees for Recall Effectiveness Verifications
Consignees Select Critical #s
> 2000 50 2
1500 - 2000 45 2
1000 - 1499 40 1
750 - 999 35 1
500 - 749 30 1
400 - 499 28 1
300 - 399 26 1
< 300 25 or 100% 0

Note: Irrespective of the classification of the recall, corrective actions are taken, even if only one consignee is found to be selling the product. There is no tolerance for a consignee selling a recalled product.

Suggested Procedure for Obtaining List(s) of Consignees

Steps:

  • Prepare by reading the recalling firm file to understand its clients and distribution system.
  • Have reference documents ready, i.e., news release, Memorandum to the Minister (MTM), Recall Authorization, the label, etc.
  • First try by phone and if no or limited cooperation, visit the recalling firm. Identify yourself and ask to speak with the owner/manager/supervisor/person in charge. Ensure that the person you are speaking with has the authority to respond to product recall activities and/or was involved in recall activities.
  • Explain the general purpose of requesting distribution lists and clarify the role of the CFIA (the recalling firm is responsible for removing recalled product off the shelf, the CFIA only does the monitoring). Inform the recalling firm how the recall effectiveness would be verified - not all accounts checked, only random checks are done etc.

Questions to consider:

Prepare your questions ensuring they are such that they avoid leading the respondent to answering what they think we want to hear.

  • "Please describe how your product is distributed including - how orders are taken?" "How does the product flow from your location to the stores?" "Is product sold to retail stores only by the case or the case is broken?"
  • "How far is your product distributed?" "Clarify the geographical distribution by provinces?" "Do you export the affected product?" If yes. "To which countries?"
  • "Do you directly sell to retailers?" "Do you sell to cash and carry outlets?" "Do you wholesale to distributors?" Do any recalling firms buy a recalled product to make its own products? If there are distributors/manufacturers involved, immediately request lists of those accounts.
  • "Was this product sold to day care centers, hospital cafeterias, school cafeterias, retirement homes, kids camps or other institutional accounts?" "Was the product sold or otherwise provided to food banks?"
  • "Do or can you know which of your customers received this product?" If yes. "How would you be preparing the list of your accounts for this product?" "How do you track your batches when selling?" If no. "Would you be contacting ALL your clients and how?" "How would you be narrowing the list for notification?"
  • "How quickly you can get the list of your accounts to us?" Determine if an actual list can be obtained within time lines (Table 1).
  • "Approximately how many retailers sell the recalled product?" "How did you determine this number?"

Outcome:

At the end of the request and discussion regarding distribution and accounts, you should know:

  1. If the recalling firm is capable of providing a detailed list (names, phone numbers etc.) within the time lines;
  2. the estimated number of consignees who are selling or could have received the recalled product;
  3. Area/regions where the product was distributed;
  4. If the product was distributed to locations frequented by susceptible population;
  5. If there are any distributors/manufacturers who bought the product, their names and contacts; and
  6. You would have made a request to obtain a detailed list including - names, addresses and phone numbers, with consignees grouped by geographical location/provinces and/or types (see section 8.2.1).

Recommended Telephone Verification Procedure

Steps:

  • Have reference documents ready, i.e., news release, Memorandum to the Minister (MTM), Recall Authorization, the label, etc. Have a blank effectiveness form ready for use.
  • Print from the IMS, to ensure the use of the latest version.
  • Identify yourself and ask to speak with the owner/manager/supervisor/person in charge.
  • Ensure that the person you are speaking with has the authority to respond to product recall notifications and/or was involved in recall activities.
  • Explain the general purpose of your call - "A product recall has been initiated; the CFIA is conducting verification activities to determine the effectiveness of the recalling firm's recall efforts. Your store (recalling firm) was included in the distribution list provided to us by the recalling firm."

Questions to consider:

Prepare your questions ensuring they are such that they avoid leading the respondent to answering what they think we want to hear.

  • "Please tell me about the recall notice?" Let the person describe the situation and follow-up with specific questions, e.g. "Are you aware of a product recall conducted by recalling firm x of product y?" "When, how and whom did you become aware of this recall?" - If notified by fax or letter, ask if a copy can be faxed or read to you. Verify the date of receipt. If by telephone, "who called you?" Information on the notice of recall should be reviewed for accuracy of information on product, risk and clarity (i.e., no promotional information etc.).
  • "What happened at the store once the notice was received?" Again let the person describe the activities and follow-up with the specific questions, e.g., "What quantity of the product was on your store shelves when the notice was received from the recalling firm?" "What action was taken with this product?" "What quantity of the product was in your storage area or stockroom?" "What action was taken with this stored product?" Physically verify the disposition of the product.
  • "What happens to the product which is removed?" Once again let the person describe the activities and follow-up with specific questions, e.g., "While the product is segregated, until final disposal, how will you ensure that the product is not mistakenly returned to the store shelf?"
  • "What happens after the recall work is done?" Do you and how will you inform your head office/Manager/Owner once the product has been removed/disposed?
  • "Other than retail sales to individual consumers, do you further distribute this product (act as a wholesaler...)? If so, have you taken any measures to relay the recall information to your clients? When, how and by who was this done?" If the client was notified by fax or letter - "Could a copy be faxed to me or read over the telephone?" "The CFIA will need to follow up with these accounts as well, when could we receive a copy of your distribution list?"

Outcome:

At the end of the check make sure you have answers to all questions on the form and if there was a problem - cause is known and that the corrective action has been taken/initiated.

Recommended On-Site Verification Procedure

Steps:

  • Bring copies of the news release (if applicable) or other reference documents, and copies of News Release can be left with the store/consignee if requested. Have a blank effectiveness form ready for use. Print the effectiveness form from the IMS, to ensure the use of the latest version.
  • Before approaching a representative, the inspector should see if the recalled product is on the shelf.
  • Identify yourself and ask to speak with the owner/manager/supervisor/person in charge. Ensure that the person you are speaking with has the authority to respond to product recall notifications and/or was involved in recall activities.
  • Explain the general purpose of your visit- "A product recall has been initiated; the CFIA is conducting verification activities to determine the effectiveness of the recalling firm's recall efforts. Your store (recalling firm) was included in the distribution list provided to us by the recalling firm."

Questions to consider:

Prepare your questions ensuring they are such that they avoid leading the respondent to answering what they think we want to hear.

  • "Please tell me about the recall notice?" Let the person describe the situation and follow-up with specific questions, e.g.,"Are you aware of a product recall conducted by recalling firm x of product y?" "When, how and from whom did you become aware of this recall?" - If notified by fax or letter, ask to review the copy. Verify the date of receipt. If by telephone, "who called you?" Information on the notice of recall should be reviewed for accuracy of information on product, risk and clarity (i.e., no promotional information etc.).
  • "What happened at the store once the notice was received?" Again let the person describe the activities and follow-up with the specific questions, e.g., "What quantity of the product was on your store shelves when the notice was received from the recalling firm?" "What action was taken with this product?"
  • "What quantity of the product was in your storage area or stockroom?" "What action was taken with this stored product?" Physically verify the disposition of the product.
  • "What happens to the product which is removed?" Once again let the person describe the activities and follow-up with specific questions, e.g., What measures are taken to ensure the affected product is not mistakenly returned to store shelves?
  • "What happens after the recall work is done?" Do and how you inform your head office/Manager/Owner once the product has been removed/disposed?
  • "Other than retail sales to individual consumers, do you further distribute this product (act as a wholesaler...)?" If so, have you taken any measures to relay the recall information to your clients? When, how and by who was this done? If the client was notified by fax or letter, ask to see a copy. "The CFIA will need to follow up with these accounts as well, when could we receive a copy of your distribution list?"

Outcome:

At the end of the check make sure you have answers to all questions on the form and if there was a problem - cause is known and that the corrective action has been taken/initiated.

9.0 Follow-Up

Scope

This section of the manual describes the follow-up stage and the roles and responsibilities of the Canadian Food Inspection Agency (CFIA) and the recalling firm. Follow-up actions described here generally affect product that is not in the marketplace or new production after a recall. Scoping activities are not considered as part of the follow up as scoping activities affects product that is or may be in the marketplace. Scoping is associated with the food safety investigation stage.

9.1 Purpose

Follow-up activities, which include immediate/short term and long term, are key to both the recalling firm and the CFIA. Follow up activities include:

  • Verification that the affected product has been controlled by removal from distribution and recovered;
  • Verification that the corrective/disposition action for the affected product(s) has been evaluated and appropriate and acceptable, i.e. destruction, disposal, re-label, oversticker, rework;
  • Development and implementation of an appropriate risk management strategy where it is determined that the suspect/determined root cause may affect future production;
  • Verification that the recalling firm's recall strategy/plan/procedure is revised, as required and reviewed by the CFIA to determine its acceptability;
  • Where the recall identifies a new issue involving other manufacturers or need for policy/standard revision; and
  • Where trends on food safety concerns or recalls are identified related to an industry sector or country.

9.2 Roles and Responsibilities

9.2.1 Office of Food Safety and Recall (OFSR)

While the OFSR is involved in the food safety investigation and recalls, during the follow-up activities its role shifts. The OFSR is not involved in the follow up activities after the recall; however, the OFSR may be concurrently coordinating the scoping activities to determine if additional affected product is on the market.

9.2.2 Recalling Firm

The recalling firm is responsible to:

  • Control recalled product to ensure it does not re-enter the market;
  • Verify that all recalled product has been removed from the market;
  • Ensure correction or disposition (rework, re-label, export, destruction, etc. ) of the recalled product at the appropriate levels of distribution (consumer, retail, distributor, manufacturer) and which is under the recalling firm's control;
  • Evaluate, correct and/or dispose of other products produced under the same conditions, process, packages, ingredients, etc. ;
  • Examine difficulties encountered during the recall process which may require special efforts to recover the product;
  • Develop, implement, monitor and verify the effectiveness of corrective action taken on current and future production; and
  • Conduct a review of the recall strategy and adjust where appropriate.

9.2.3 Lead Investigator

The lead investigator is responsible to:

  • Monitor the recalling firm's actions on recovery, reconciliation, control, correction and disposition of recalled product;
  • Monitor the corrective action on current and future production of the product by the root source;
  • Enter follow up reports into the Issue Management System (IMS) in a timely manner; and
  • Provide advice and recommendations to programs where required.

9.2.4 Inspection Manager/Supervisor

  • The Inspection Manager/Supervisor is responsible to ensure that the CFIA has conducted the appropriate short term and long term follow-up activities. In some situations consultation with the Area/region Program and Technical Specialists will be necessary.

9.2.5 Other CFIA Branches

The details of the roles and responsibilities of other CFIA Branches, such as Operations Branch, Science Branch or Policy and Programs Branch, are found in the FSIR Framework.

9.3 Follow-Up Activities

Follow-up activities can be broken into the following categories:

  • Follow-up to a recall at an establishment (includes repeat offenders)
    • Objective: corrective action to prevent reoccurrence
    • Lead: Area Operations
    • Complimentary Role: advice from Programs and Laboratory support from Science
  • Recall identifies a new issue or need for policy/standard/guideline revision
    • Objective: Review of policy/standard/guideline to verify risks are effectively and consistently addressed
    • Lead: Programs and Policy Branch (with Health Canada as appropriate)
    • Complimentary Role: Operations advice on policy/standard/guideline implementation and advice from Science
  • Trends associated with food safety concerns and recalls may identify that some form of follow-up activity with an industry sector or country is required
    • Objective: Work with sector or foreign country to address trend that goes beyond one company or sector
    • Lead: Programs and Policy Branch
    • Complimentary Role: Advice from Operations on industry/importer and from Science Branch

9.4 Hot Wash

Dependent on the nature, profile and complexity of a food safety investigation, CFIA management will have the discretion to request a "hot wash".

This informal post food safety investigation process is used to identify which processes worked well and where improvements can be made. It is a critical step to ensuring continual improvement in the Agency's response to food safety incidents.

A more formal Lessons Learned review process may be conducted by the Audit, Evaluation and Risk Oversight (AERO) Branch at the request of senior management.

10.0 Recall Orders

Scope

A recall order may be issued by the Minister of Health in circumstances where a recalling firm is unknown, unavailable or unwilling to conduct a voluntary recall. In these circumstances the Canadian Food Inspection Agency Act provides the Canadian Food Inspection Agency (CFIA) with a legislative base for taking appropriate action to remove the product from sale or use.

This section includes:

  • The description and conditions for use (10.1);
  • The legal authority for a mandatory recall (10.2);
  • The decision process to implement a mandatory recall (10.3); and
  • The Roles and Responsibilities: the implementation process (10.4).

10.1 Description and Conditions for Use

A recall order is signed by the Minister and served on a person(s) or recalling firm(s) who sells, markets or distributes a product that is believed, on reasonable grounds, to pose a risk to public, animal or plant health. This order is in effect a mandatory recall; it is designed to address the situation where the regulated party cannot be located, communicated with or does not wish to issue a voluntary recall. In order for a recall to proceed, the product must be:

  1. specific and identified; and
  2. regulated under any of the following Acts:

    Canada Agricultural Products Act, Health of Animals Act, Plant Protection Act, Meat Inspection Act, Fish Inspection Act, Feeds Act, Fertilizers Act, Seeds Act, Food and Drugs Act (in relation to food only), Consumer Packaging and Labelling Act (in relation to food only).

10.2 Legal Authority

Section 19 of the CFIA Act sets out the legal authority for a mandatory recall.

10.2.1 Recall order:

19. (1)
Where the Minister believes on reasonable grounds that a product regulated under an Act or provision that the CFIA 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.

10.2.2 Contravention of recall order:

(2)
Any person who contravenes a recall order referred to in subsection (1) is guilty of an offence and liable on summary conviction to a fine not exceeding $50,000 or to a term of imprisonment not exceeding six months or to both.

10.2.3 Notification of order:

(3)
For greater certainty, a recall order is not a statutory instrument for the purposes of the Statutory Instruments Act, but no person shall be convicted of an offence referred to in subsection (2) unless the person was notified of the order.

10.3 Decision to Implement a Mandatory Recall

A mandatory recall order is a risk management option which can be implemented when the recalling firm is not willing or able to recall a product that is considered to pose a risk to public, animal or plant health.

CFIA senior executives and the Senior Food Safety Committee must be kept informed of a potential recall order early in the process and updated as often as necessary. Key contacts should be identified and consulted throughout the decision making process. CFIA Legal Services provides advice on whether the legal conditions for a recall order have been met and the mandatory recall can proceed.

10.4 Mandatory Recall Procedure

  • The Executive Director, Office of Food Safety and Recall (ED, OFSR) initiates the process.
  • The OFSR provides information to CFIA Legal Services.
  • The OFSR reviews and updates CFIA Legal Services and requests a legal opinion.
  • The ED, OFSR decides to proceed with a mandatory recall.
    • The OFSR consults with (for support and execution):
      • CFIA Legal Services;
      • Ministerial and Parliamentary Affairs;
      • Media Relations;
      • Communications;
      • Program Specialist;
      • Area Recall Coordinator (ARC) / Regional Recall Coordinator (RRC);
      • Lead Investigator;
      • Technical Specialist;
      • Operation Strategy and Delivery;
      • Senior Management including the Senior Food Safety Committee.
  • Inspection staff inform the firm that the recall process has been started.
  • CFIA Legal Services drafts the order.
  • CFIA Legal Services assists in dealing with firm's lawyers.
  • The OFSR drafts a Memo to Minister (MTM) that includes the risk assessment and the legal opinion.
  • The OFSR sends the MTM to the President for signature. The President recommends the recall order to the Minister of Health and sends the MTM.
  • CFIA Legal Services completes the draft recall order and sends it for translation.
  • Ministerial and Parliamentary Affairs deliver the recall order "hard copies" (EN and FR) to the Minister for signature.
  • Ministerial and Parliamentary Affairs return the signed copies of the recall order to Legal Services for certification.
  • The OFSR keeps the signed recall order (certified signed copies).
  • The OFSR prepares and issues the public warning/press release.
  • The OFSR faxes the certified signed recall order to the Lead Investigator.
  • Inspection staff "serve/deliver" the recall order:
    1. When the company is available: the company does the recall.
    2. When the company is not available or is unknown, the CFIA serves the order to distributors and/or retailers.
  • CFIA Legal Services and Area EIS are consulted if there is any refusal to implement the recall order.
  • The CFIA might be required to "implement" the recall and can request assistance from Provincial authorities including Municipal Public Health Units, if needed.
  • CFIA Area operation inspection staff monitor the progress of the recall and assesses its effectiveness. The CFIA verification process is modified as required.
  • At any time, the mandatory recall process can be stopped with the approval of the ED, OFSR.

11.0 Tampering

Scope

Over the years, there have been sporadic incidents of tampering, tampering threats, and deliberate contamination of food products regulated under legislation administered by the Canadian Food Inspection Agency (CFIA). For the purposes of this document, the term "tampering incident" will be used to represent tampering, threats of tampering and deliberate contamination (sabotage) of food products.

11.1 Background

Tampering is defined as deliberate or intentional altering of a product, its container or label with the intent to harm.

Although tampering is often random and violent in nature, it can occur for other reasons:

  • Extortion;
  • For the personal gain of the perpetrators;
  • Promotion of political objectives;
  • By obtaining free publicity; or
  • Revenge, by causing financial damage to a recalling firm through lost sales.

Product tampering may be prosecuted as an offence under the Criminal Code of Canada. The Code does not contain specific provisions that relate directly to product tampering, although sections such as public mischief, uttering threats, extortion, etc. , may apply.

Several instances of product tampering and threats in Canada, in recent years have occurred, which resulted in extensive investigations, product recalls, and public advisories in some cases.

The following questions may be useful in deciding whether an issue should be treated as a tampering incident.

  1. Is there visible evidence that the integrity of the package has been compromised? (i.e. tears, perforations, loss of vacuum, open or broken seal)
  2. Does the food appear to have been altered or replaced?
  3. Was harmful foreign matter found in the package or product?
  4. Does the orientation of the foreign material in the package indicate whether the foreign material was introduced deliberately or accidentally?
  5. Could the foreign material (type, dimensions, condition) make it through the manufacturing process intact?
  6. Does the foreign material seem consistent with the product/manufacturing process?
  7. Have other similar complaints been received by the importer, retailer or manufacturer?
  8. Has anyone indicated that the food has been tampered with or threatened to tamper with the food?
  9. Does the source of information and related details appear credible?
  10. Are there similar complaints in the Issue Management System (IMS)? Do the complaints appear to be related?
  11. Is the complainant an employee or former employee of the manufacturer/importer?
  12. Has there been recent labour unrest, disgruntled employees or layoffs/dismissals at the manufacturer/importer?
  13. Has the retailer or manufacturer been associated with a previous tampering incident?

11.2 Process, Roles and Responsibilities

The key to the overall management of food tampering investigations is working with police authorities at the local, provincial and national levels.

Local police conduct investigations at the local level, the Provincial Police and the Royal Canadian Mounted Police (RCMP) are responsible for investigating incidents that may have province-wide or national implications. The primary responsibility for the investigation of perpetrators of tampering incidents rests with local police authorities.

The RCMP maintains information that may be helpful in identifying individuals who may have been involved in incidents elsewhere.

The CFIA plays an important role in the initial identification of tampering incidents and in their ultimate resolution, from a food safety perspective.

In the event of reported cases of food tampering or tampering threats, the OFSR will coordinate the emergency response on behalf of the CFIA in collaboration with the appropriate Regional Director and Area Operations Coordinator.

In cases where industry sectors have established emergency response and / or tampering protocols, the CFIA will work with the sector to coordinate overall response to address public health and security concerns. Area CFIA offices have ensured that local contacts with police jurisdictions are current, in the event that police advice with respect to tampering threats is required on a priority basis.

The following operational procedure is intended to address the CFIA's role in the coordination of an expeditious response to tampering incidents:

  1. The investigation of tampering incidents shall be given the highest priority. Whether received directly from the public or by referral (from another health agency, a poison control center, or the police), care must be taken to follow proper investigational procedures. Particular attention must be given to any report of atypical injury or illness directly attributable to a food product.
  2. Area Executive Directors and Regional Directors shall take the lead to establish a liaison network with regional hospitals, police authorities, and related public health partners to ensure prompt sharing of information and investigation of tampering incidents.
  3. Area operations may have a tampering protocol based on the Incident Command System (ICS) which clearly delineates the roles and responsibilities of each participant, and the resources, expertise and laboratory capabilities available to assist in the investigation. Where the tampering incident contaminant is unknown, unusual or requires specialized analysis, the laboratory capability will be coordinated nationally by the Executive Director, Food Safety Science Directorate. This information should be included in the CFIA Area response procedures and updated as necessary.
  4. The OFSR is to be advised immediately of all tampering incidents (potential and confirmed) during and after business hours, and shall coordinate notification of international food regulatory agencies, as appropriate.
  5. Where tampering incidents involve a food product originating outside the region where the incident occurred, the ARC/RRC, of the Area of product origin, is to be notified immediately on receipt of the first indication of the incident. This action is to be taken by the Area initially receiving the information. The OFSR will ensure communications protocols are followed.
  6. The Regional Director is to immediately advise the local police and the manufacturer, importer or distributor in the region of any tampering incident associated with the company's products. Key industry associations will be advised by the OFSR and / or National Program Directors, as appropriate.
  7. The expertise and resources of the CFIA shall be made available to other public health partners, the police authorities and the manufacturer / distributor / importer in tampering incidents where significant adverse effect is possible. This includes, as may be appropriate, the request for provision of a Health Risk Assessment by Health Canada, participation in the investigation to define the origin and characteristics of the tampering, the analysis or screening of product to identify contamination, the invoking of the CFIA's emergency response procedures for food recall to ensure the effective and efficient removal of product from the marketplace, and the consideration of public warnings to alert the public. The OFSR will coordinate the request for a Health Risk Assessment from Health Canada as required.

11.3 Public Warning

The CFIA will give consideration to a public warning in the following circumstances:

  • A threat assessment to determine the validity of tampering allegations is unavailable or incomplete; and
  • Tampering investigations have confirmed the possibility of contamination of food products in distribution to the consumer level, and the health risk posed warrants a public alert.

In the above circumstances, a general public warning through the news media, either national or local as appropriate, through specialized news media, e.g. professional or trade press, or to specific segments of the population such as physicians, hospitals, pharmacists, etc. will be given consideration. It is the policy of the CFIA to encourage the manufacturer, importer or distributor of the food products in question to issue such an advisory. Existing communications protocols, such as Health Canada's physician, hospital and pharmacy emergency communications protocols will be accessed, where appropriate.

Appendix 1A - Definitions

Area of Concern
is the specific nature of an issue, i.e. non-declared allergens, microbiological contamination, chemical contamination, tampering, nutritional concerns, inaccurate labelling or net weight declarations, etc.
Correction
means taking appropriate measures/actions on the affected product to bring it into compliance without its physical removal to some other location.
Emergency
is an abnormal situation which requires prompt action beyond normal procedures to limit damage to persons, property or the environment.
Food
includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatsoever, under the Food and Drugs Act.
Food Emergency
is broadly defined as any situation involving or potentially involving food which may pose a high health and safety concern to humans. Emergencies usually involve significant resources and require the coordination of a timely and/or extraordinary operational response.
Food Investigation
is broadly defined as an investigation of either a food safety or non-food safety issue.
Food Recall Warning
is a warning to consumers advising them not to consume a recalled product that poses a health risk (except allergens).
Food Recall Warning (Allergen)
is a warning to consumers advising them not to consume a recalled product because it may contain an undeclared allergen.
Food Safety Investigation
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. It is also to determine the nature and extent of the problem, which includes the determination of whether there is additional affected product that may be on the market, i.e. scoping.
Food Safety Warning
is a warning to consumers of a health and safety issue where there is no recall. This is for situations in which a recall has not yet been conducted or cannot be conducted. The decision to prepare these documents is made by the Food Safety Communications Manager with input from OFSR, Media Relations and the Executive Director, Public Affairs. Advice will also be sought from Health Canada and the Public Health Agency of Canada.
General Advisory
is generally issued by a program when the consumers should be made aware of an industry wide issue or of safety recommendations pertaining to a commodity.
Health Risk Assessment
is a scientifically based process which determines the likelihood that a specific adverse effect will occur in an individual or a population, following exposure to a hazardous agent. The following steps are used in the development of a Health Risk Assessment: 1) hazard identification; 2) hazard characterization; 3) exposure assessment; and 4) risk characterization.
Issue
is an incident that requires documentation and/or investigation into food safety, quality, labelling or fraud concerns within the CFIA's program's priorities and mandate.
Mandatory Recall
refers to a recall as per Section 19 of the Canadian Food Inspection Agency Act.
Notice of Recall
means a notice that is issued by the recalling firm to its accounts to inform them of the product recall, identify the product to be recalled and provide instructions on disposition of the recalled product.
Product
refers to any food that is or may be the subject of trade or commerce.
Product Withdrawal
means a firm's removal from further sale or use of a marketed product that does not contravene a legislation administered or enforced by the CFIA. It is not considered to be a recall.
Public Warning
is the communication document issued by the CFIA to inform the public of various health and safety concerns. Public warning documents include Food Recall Warnings, Food Recall Warnings (Allergen), and Food Safety Warnings.
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.
Recall Incident
is the initial recall situation (primary recall) that may lead to additional recalls (secondary) related to the original issue. The initial recall incident and secondary recalls have common factors such as product, cause, process deviation, etc. The cause or trigger of secondary recalls is the original recall incident. E.g. an out of country manufacturer recalls product that was shipped to multiple Canadian importers.
Recall Classification
refers to the numerical designation, i.e. Class I, Class II or Class III, assigned by the OFSR to a particular product recall to indicate the relative degree of health risk presented by the product being recalled.
  1. Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death.
  2. Class II is a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.
  3. Class III is a situation in which the use of, or exposure to, a product is not likely to cause any adverse health consequences; the product is in contravention of an Act or Regulation enforced by the CFIA.
Recall Depth
refers to the level to which a recall is conducted (i.e. consumer, retail, distribution).
Recalling Firm
denotes a responsible firm that is accountable for the implementation of a recall.
Recall Plan
means a planned course of action in conducting a specific recall prepared and executed by the recalling firm under CFIA supervision.
Recall Verification
denotes the monitoring conducted by the CFIA of the effectiveness of a recall.
Responsible Firm
is the manufacturer, importer, distributor and/or vendor who sells, markets, and /or distributes the affected product and is subject to compliance with all or part of the recommended risk management strategy(ies).
Root Cause Analysis
refers to the determination of the original source or reason of the food contamination or hazard (e.g. inadequate sanitation, failure of process, etc.).
Root Source
is the responsible firm where the issue originated or the firm responsible for the importation of the affected product. Not every recall may have a domestic root source, e.g. direct shipment of imported affected product from a foreign distributor/manufacturer to customer.
Scoping
is a part of the food safety investigation process in which CFIA staff determine if there is any other additional affected product on the market beyond the product initially investigated or recalled.
Stock Recovery
means a firm's removal or correction of a product in contravention that has not been marketed or that has not left the direct control of the recalling firm. It is not considered to be a recall.
Suspect Product
refers to the product which triggers the food safety investigation or the product which through further food safety investigation has determined to be the most likely cause of the issue.
Trigger
is any specific source of information that prompts CFIA staff to initiate a food safety investigation, e.g. a laboratory analysis, a consumer or trade complaint, a referral from another government department, an inspection finding, a report from a foreign government, a manufacturer-initiated product action or withdrawal, epidemiological evidence, etc.
Vendors
includes retailers, distributors and institutions such as hospitals, nursing homes, etc.
Product in Contravention
is product that contravenes a legislation administered or enforced by the CFIA.
Voluntary Recall
means a recall that is initiated and carried out by the recalling firm without ministerial order.

Appendix 1B - Commonly Used Acronyms

AERT
Area Emergency Response Team
ARC /RRC
Area Recall Coordinator / Regional Recall Coordinator
CAP
Corrective Action Plan
CFIA
Canadian Food Inspection Agency
CVS
Compliance Verification System
ED
Executive Director
EIS
Enforcement and Investigative Services
FIORP
Foodborne Illness Outbreak Response Protocol
FSI
Food Safety Investigation
FSIRC
Food Safety Investigation Review Committee
FSIT
Food Safety Investigation Team
GMP
Good Manufacturing Practices
HC
Health Canada
HPFB
Health Products and Food Branch
HRA
Health Risk Assessment
ICS
Incident Command System
IMS
Issues Management System
MCAP
Multi Commodity Audit Program
MTM
Memorandum to Minister
MTVOP
Memorandum to the Vice President of Operations
NEOC
National Emergency Operations Center
NERT
National Emergency Response Team
NHO
National Head Office
OFSR
Office of Food Safety and Recall
PHAC
Public Health Agency of Canada
PMRA
Pest Management Regulatory Agency
RCA
Root Cause Analysis
SFSC
Senior Food Safety Committee
TS
Technical Specialist

Appendix 1C - Food Investigation Response Process

Flowchart - Food Investigation Response Process
Flowchart - Food Investigation Response Process
Flowchart - Food Investigation Response Process
Flowchart - Food Investigation Response Process
Flowchart - Food Investigation Response Process
This flow chart outlines the stages of the food safety investigation and recall process

The first stage is the trigger. The trigger is any specific source of information such as a company initiated recall, a consumer or trade complaint, an audit or inspection finding, an analytical result, epidemiology, information from other government departments, etc. The trigger prompts the initiation of a food safety investigation when the issue is within the scope of legislation that is administered or enforced by the CFIA.

The second stage is the food safety investigation where a health and safety concern and/or a contravention of legislation enforced by the CFIA is suspected. This can occur at different levels in the supply chain such as the consumer, the retailer, the distributer, the manufacturer or the importer. The following outlines the steps taken during a Food Safety Investigation: confirm hazard; investigate suspect root cause; identify affected products to confirm whether a possible health risk or regulatory violation exists; scoping; and determine if additional affected products are in the market place. If a possible health risk or violation is determined, based on legislation administered or enforced by the CFIA, then the investigation proceeds to the next stage (decision making) for the food safety issue. If there is no health risk or violation, then no further regulatory action is needed.

The third stage is decision making. It is first determined whether the situation represents a food safety issue, with or without a Health Risk Assessment. Health risk issues can be physical, chemical, biological or allergen. The Office of Food Safety and Recall coordinates the development and consideration of risk management options and strategies as well as assigns the recall a class I, II, III or provides a referral for other risk management options. If the issue does not represent a health risk (non-health risk issues could include deceptive practices, misrepresentation, quality, spoilage, wholesomeness and labelling), the Office of Food Safety and Recall coordinates the development and consideration of risk management options and strategies as well as assigns the recall a class III or a referral.

The fourth stage is the implementation of the recall. When it is determined that the appropriate risk management strategy is to recall the affected product, the recalling firm is advised and CFIA staff work with the recalling firm to implement the recall. The recalling firm is responsible for preparing the recall plan, initiating the recall, preparing distribution lists, warning the public, notifying and reconciling accounts, collecting and controlling the recalled product, controlling returns, assessing the safety of current and future production as well as conducting an internal review, as appropriate. The CFIA will warn the public, report in the Issues Management System, obtain a copy of the product label, describe the product, determine the area and level of distribution, request distribution lists, review the firm's recall plan and notice to accounts, send a confirmation letter to the firm and detaining the product, if required. Where it is determined that the appropriate risk management strategy does not involve a recall, some possible follow-up activities include inspection, sampling, sending a letter of non-compliance, scheduling a meeting, creating a public advisory, seizure or detention of the affected product and prosecution.

The fifth stage is the verification of recall effectiveness to ensure that the recalling firm has effectively removed the affected product from the market. The firm is responsible for controlling the affected product and its return, and monitoring and assessing the effectiveness of the recall. The CFIA will verify the clarity of the firm's recall notice, create a statistical plan to select account samples, review the firm's data on recall effectiveness, ensure the accounts were notified of the recall, remove product from sale, control the affected product, ensure that verification was conducted on product further distributed or used for manufacturing as well as decide the overall effectiveness of the recall.

The sixth and final stage is the follow-up. The CFIA conducts follow-up activities with the recalling firm during and following the recall to ensure that issues are handled consistently and appropriately. The recalling firm is responsible for disposing of recalled product, controlling warehouse stock, implementing corrective actions, monitoring future production, conducting an internal review as well as analyzing trends. The CFIA will monitor the firm's actions on returns and warehouse stock, supervise the disposition of recalled product, enforce corrective action on current and future production, analyze trends as well as develop and revise codes and standards.

Appendix 2A – Investigation Verification Process

  1. Verify the Issue – Link the issue to the product
  2. Verify the Product – Link the product to the Firm
  3. Verify the Firm – Link the Firm to the Cause
  4. Verify the Cause – Link the Cause to the Product
  5. Scoping – Is there any other affected product on the market:
    1. Same Product; other codes/ brands/sizes
    2. Other Products (common process, equipment, behaviors)
    3. Other Processes (errors in general processing practice)
    4. Other Firms (e.g. incoming materials)

Appendix 2B - Scoping and Verification during a Food Safety Investigation

Background

The scoping and verification component of a food safety investigation contributes to the public health outcome by identifying foods that may be or already are in distribution that contain a hazard to human health. This component also helps the CFIA meet its objective during a food safety investigation to determine if a food safety hazard exists as well as the source and extent of the problem.

In order for the CFIA to fulfill its stated objectives, when the CFIA becomes aware that a hazard exists in a product/lot, two sets of questions must be answered:

    1. Is the contaminated product in distribution?
    2. Is it at risk?
    3. What risk management actions are required?
    1. Are there other associated products (common raw ingredients, production processes and/or environment) that are in distribution?
    2. Are any contaminated?
    3. Are any at risk?
    4. What risk management actions are required?

Answers to the first set of questions come from standardized steps of risk assessment and recall decisions. Answers to the first two questions of the second set come from scoping and the verification component that is followed by risk assessment and recall decisions.

Comprehensive and properly conducted scoping of verification activities assists the CFIA to identify products in the market that are risk to consumers.

If the second set of questions are not asked and/or properly answered, potentially contaminated products that pose a risk to human health could remain in the marketplace.

It is for the reason of human health that appropriate, consistent, thorough and timely completion of scoping and verification activities during a food safety investigation is necessary.

This document summarizes the scoping and verification steps conducted during a food safety investigation procedures.

Scoping and Verification Process

The following is a stepwise description of scoping and verification activities:

Steps: (1) Compile Basic Information, (2) Develop Scoping Objective, (3) Determine Scoping Frame and (4) Food Safety Verification: (4.1) Documentary Verification and (4.2) Product Verification.

Note: These steps are mostly concurrent and build on each other.

  1. Compile Basic Information
    1. Fully identify the main product(s) that triggered the food safety investigation (FSI). (i.e. frozen raw ground beef burger without binders/spices; lot x);
    2. Fully identify the hazard. (i.e. E. coli O157:H7);
    3. List known or estimated risk level (i.e. Risk 1); and
    4. Determine from current or previous FSIs the likely cause or route of contamination (i.e. ground meat; lot y) that was made from trims, lot z, that were generated from carcasses slaughtered on date 1x).
    As the first step, item A will likely be most advanced and items B, C and D may still be developing. The final Health Risk Assessment may still be pending or in-depth characterization of microbial hazards such as Pulsed-field gel electrophoresis (PFGE) and details of various lots of raw materials may not be known. The next steps are continued while this information is developed and/or collected.
  2. Develop Main Scoping Objective

    Using the best available basic information, develop the main scoping objective. The main scoping objective should be stated incorporating all four basic components: product, hazard, risk and source of contamination. The main scoping objective is always to determine what additional products are associated with the source of contamination being considered, are these products still in distribution and what additional products are non-compliant and/or a health risk due to the presence of the identified hazard.

  3. Determine Scoping Frame

    This is a crucial activity and requires a thorough understanding of the industry practices, manufacturing processes and the likely causes. Usual contamination routes are:

    • Raw material;
    • Environment and/or equipment;
    • Process break down (insufficient cooking, cooling, sealing, etc. );
    • Packaging Materials (chemical leaching, extraneous materials); and
    • Tampering.

    The scope/extent of the concern will depend upon the likely cause, when the deficiency started and when/if it was corrected and it may also be influenced by common industry practices.

    For example:

    • An oven breakdown that was fixed at 10 am may only impact a few hours of product made during the morning period;
    • Presence of metal pieces in baked products though the flour has resulted in numerous recalls at various companies that used the flour from the same supplier;
    • Continuous contamination of meat cuts through the slicer that harbour Listeria is known to have caused the recent outbreak from products made over a few weeks;
    • Undeclared milk in dark chocolate has resulted in recalls, downstream in the distribution chain; and
    • The industry practice of identifying dairy based creamers as non-dairy creamers.

Using the determination of the likely cause develops a scoping frame, which includes all marketed products that are associated with the likely cause or the source. In cases of outbreaks, more than one associated date/lot that are a likely risk may be already known/suspected and scoping frame(s) can be developed for each and combined into a larger frame.

While the scoping frame is being developed, the status of the controls and any sampling and technical details about the products and processes are also collected and understood.

By the end of this step there will be a list of suspected products with the best available information on the quality controls, distribution and location of those products.

Food Safety Verification

The final step is food safety verification of products identified within the scoping frame.

Verification has two parts:

Documentary Verification

Documentary verification collects and analyzes all Quality Control/Quality Assurance (QC/QA) data within the scoping frame. Procedures and data are collected from various companies to develop a better understanding of the manufacturing process and various observations that are available to provide confidence in the safety of products.

Documentary verification helps to determine if the product(s) within the scoping frame were made under normal conditions and to understand the limitations, if any, and if there were any incidents / events of interest that show point(s) of possible contamination.

Product Verification

Product verification builds on documentary verification and attempts to obtain sufficient and direct observations related to suspected products within the scoping time frame.

It can:

  1. Support the conclusion that the issue was isolated;
  2. Provide evidence that the issue is more wide-spread; or
  3. Supplement a lack of documentation leading to either 1) or 2).

It is crucial that all attempts be made to conduct the product verification across the scoping frame at the same time. Comprehensive and concurrent product verification reduces the chance of repeated and multiple recalls occurring over a several week period.

Product Verification has three components: lots to sample, sample size per lot and sampling.

Lots to Sample

Number of lots to include in verification is determined using Table 1.

If documentary evidence shows time periods or events of interest as the likely source/points of contamination; then lots around those time periods / events are preferentially used for product verification. As a basic principle, safety buffers both before and after the suspected spots/events are included in the scoping frame. If however, documentary evidence reveals no pattern or spots/events as the likely source/point of contamination, a more generic spread across the shelf-life of the product is used for product verification.

Table 1: Maximum Table Note 2 number of lots to verify by Class and Hazard
HazardRisk IRisk IIRisk III
Microbial 12 6 2
Extraneous Matter 10 5 0
Chemical/Nutrition 10 5 0
Allergen 6 3 2

Table Notes

Table note 2

Table 1 will likely provide sufficient observations for the Health Risk Assessment that when combined with documentary verification can provide a basis for a larger and wider assessment, if applicable. If however, after combining documentary and product verifications only lot by lot assessments are possible, additional lots should be sampled.

Return to table note 2 referrer

Sample Size Per Lot

It is recognized that sampling a lot has its limitations even with larger numbers. However, as internationally accepted, it is also recognized that "the protection conferred on the consumer for a particular lot is seriously limited when using small number of sample units such as n=5; hence the recommendation is use large values of n when a direct hazard is recognized". (ICMSF Vol 7, 2001, pg 161). It is considered that in such situations the decision tree similar to an outline by ICMSF (ICMSF Vol 7, 2001, pg 153) will result in a more reliable assurance of safety.

Product verification involves sampling of suspected product lots within the scoping frame to obtain direct evidence. The total observations or sample results that are used in verification will include samples/tests done by the company, trade, or other government agencies and will/must include more than 50% of observations from reliable independent government agencies including the CFIA (more than 25%).

The points and/or products for verification will change for each food safety investigation. However, within the scoping frame samples that are to be taken for product verifications can be determined using the Table 1 and/or ICMSF guidelines (ICMSF Vol 7, 2001, pg 165).

Sampling

Once the numbers of lots and samples have been decided, the CFIA must ensure that those samples represent the lot and scoping frame being verified.

To take a sample that properly represents a lot: the quantity, distribution and locations of units produced and available is obtained from the company. Based on the known distribution, sample units are proportionally spread across the distribution area(s) and obtained randomly. Verification samples are taken at warehouses as well as retail locations.

In summary, the product verification step attempts to obtain sufficient, representative and direct observations.

In a comprehensive analysis, the product testing results from industry sources are also included. It is therefore essential that complete sampling and testing details are obtained from companies and /or other agencies. Before external results can be included in the information for a request for a Health Risk Assessment (HRA), the CFIA must be satisfied that samples represent the lot and that testing methods and laboratories are accredited/equivalent to the Canadian standards.

Appendix 3A - Communication Flow Chart - Food Safety and Recall Response System

Communication Flow Chart - Food Safety and Recall Response System
Communication Flow Chart – Food Safety and Recall Response System

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, 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.

Appendix 3B - Health Risk Assessment Process

A Health Risk Assessment (HRA) is one of the three components of a Health Risk Analysis, with the other two components being Risk Management and Risk Communication. The HRA is essential in assuring that sound science is used to establish standards and guidelines to facilitate food safety. The CODEX standard (CAC/GL-30) is used as a guideline for microbiological risk assessments.

Basic Steps of a Health Risk Analysis

  1. Identify issue and context (Health Risk Assessment)
  2. Assess risks and benefits (Health Risk Assessment)
  3. Identify and analyze options (Health Risk Management)
  4. Select strategy (Health Risk Management)
  5. Implement strategy (Health Risk Management & Communication)
  6. Evaluate (Health Risk Communication)

An HRA addresses the questions: What is the likelihood of harm? What is the potential degree of harm? The HRA process should utilize as much quantitative information as possible in order to estimate risk. To promote an unbiased process, it should be functionally distinct from Risk Management, operational and resource issues.

The HRA process involves (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization.

All stakeholders should contribute to this process, in order to facilitate transparency, utilize available expertise, ensure the inclusion of relevant information, enhance communication, and ensure a credible/accepted outcome.

During the HRA process it is important to use credible information to reduce uncertainty and increase reliability of the assessment. In the presence of incomplete or conflicting information, well-informed decisions may be needed to complete the assessment. In such cases these decisions need to be well researched, supported and documented.

The HRA process which currently exists between the Office of Food Safety and Recall (OFSR), Canadian Food Inspection Agency (CFIA) and Health Canada (HC) is as follows:

  1. A formal, written request for an HRA is submitted by a Technical Risk Assessor (CFIA), and may be referred to a Scientific Evaluator (Health Canada), if no guidelines exist.
    1. Completion of part A of HRA Request form.
    2. Inclusion of all available relevant information.
  2. All information is reviewed by the assessor.
    1. Assessor may request additional information.
    2. Assessor will search for similar issues in departmental database or literature.
  3. The HRA is performed by the assessor.
  4. The Completed HRA is returned to the requester.

Basic Steps of a Health Risk Assessment

  1. Clearly define purpose:
    1. What is the trigger?
    2. What is the scope of product(s) to be covered by the HRA?
  2. Preliminary investigation (usually completed before the HRA request):
    1. Collect pertinent information to assist in completion of the HRA.
    2. Summarize details surrounding the product of concern.
    3. Analysis of information, if available.
    4. Reported illnesses/reactions?
  3. Hazard Identification – Predominantly a qualitative process to determine which potential hazard(s) identified present a significant health risk to consumers:
    1. Identify biological, chemical or physical agent which may be present and capable of causing adverse health effects.
    2. Determine whether a health hazard exists or has the potential to exist.
  4. Hazard Characterization:
    1. What is the potential severity of adverse health effects?
    2. What is the potential duration of adverse health effects?
  5. Evidence – Scientific evidence which contributes to exposure assessment:
    1. Positive lab results.
    2. Strong epidemiological link between product and human illness.
    3. Product attributes which may be amenable to pathogen proliferation.
    4. Other supportive information.
  6. Exposure Assessment:
    1. Dose-Response Assessment.
    2. Level of contamination.
    3. Likelihood of Occurrence.
    4. Hazard Exposure Characterization: Quantitative/qualitative evaluation of potential exposure (dietary information, level of contamination).
    5. Information on product distribution, intended use, consumer habits, target populations, high-risk populations, etc.
  7. Risk Characterization:
    1. Determine likelihood of occurrence of illness as a result of consumption of the product.
    2. Based on steps 2 to 5, classify the level of risk as Health 1, Health 2, Health 3, or Other (no risk).
  8. Complete documentation:
    1. If applicable, support the HRA by indicating the Act, Regulation, Policy or Guideline that was used.
    2. Identify which section of the Act or Regulation that was violated.
    3. Identify any unknowns.
  9. Potential re-assessment of issue, if new relevant information becomes available.

Appendix 4A - Standardized CFIA Recall Confirmation Letter to Recalling Firm

(Date)

(Address of the Recalling Firm)

Attention: (Name of Recalling Firm Contact)

RE: Recall of (brand name, common name, size, lot code of affected product. Where there are several products, state a general description, e.g. product type)

Dear (Name of Recalling Firm Contact):

This letter will confirm our discussion held on (date), at which time you agreed to immediately initiate recall action on the following product(s):

(List - brand name, common name, size, lot code)

The details of the recall are as follows:

  • Recall Classification: (I, II, or III. Include "with a Public Warning" where applicable)
  • Depth of Recall: (distributor, institutional, retail, consumer)
  • Reason for Product Recall: (state the reason, e.g. undeclared milk protein, and the name of the legislation/regulation and section of the legislation/regulation contravention, e.g. contravention of subsection 5(1) of the Food and Drugs Act)

(Choose the appropriate paragraph)

(For Class I and II recall situations) In the event that your firm fails to immediately initiate recall action, the CFIA will recommend to the Minister of Health to sign a mandatory recall order pursuant to subsection 19(1) of the Canadian Food Inspection Agency Act.

(For a Class III situation) In the event that your firm fails to immediately initiate a recall, the CFIA will take appropriate action which may include detention, seizure, prosecution or other enforcement action.

In the implementation of the recall your firm will prepare a notice of recall for review by the undersigned, produce a list of accounts who received the product in the (time period, e.g. last year, last 3 months, etc.), and immediately advise each account in writing, where possible, of the recall and the action to be taken on the product. An example of a Notice of Recall to be sent to your accounts is attached.

Action to be taken on product subject to recall action: (state the agreed upon action, e.g. re-labelling, reworking, etc.) upon approval and verification by the CFIA. All returned products will be segregated from other products in order to prevent inadvertent use of shipment of the recalled product back to the market.

You are requested to provide the undersigned with a distribution list of your firm's accounts which received the recalled product by (date). This list should include the following information for each account:

  • name of firm
  • street address, unit number, city/town, province
  • telephone number
  • name of contact
  • date product was shipped to the firm
  • amount of product shipped

As discussed, your firm will maintain records confirming that each account was contacted including:

  • the date contacted, the method of contact, e.g. by telephone, fax and/or E-mail, and the name of the contact
  • the amount of product on site at each account at the time of the recall
  • the action taken by each account, e.g. returned product to your firm's warehouse

This information should be summarized in a report and forwarded to the undersigned by (date). Canadian Food Inspection Agency staff will be contacting a selected number of accounts to verify the effectiveness of the recall. If you require any additional information, please contact the undersigned at (phone number).

Yours truly,

(Name of Lead Inspector)
Attachment: Notice of Recall Template

Appendix 4B - Standardized CFIA Letter to Distributors Requesting Recall Action

(Date)

(Address of Distributor)

Attention: (Name of Distributor Contact)

RE: Recall of (brand name and common name of affected product. Where there are several products, state a general description, e.g. product type) Dear (Name of Distributor Contact):

As per our conversation on (date of conversation), (name of recalling firm) is conducting a recall of the above-noted product(s). The details of the recall are as follows:

Recall Classification: (I, II, or III. Include "with a Public Warning" where applicable) Depth of Recall: (distributor, institutional, retail, consumer)

Reason for Product Recall: (state the reason, e.g. undeclared milk protein, and the name of the legislation and section of the legislation to which the product is in contravention)

Product(s) Recalled: (brand name, common name, size, lot code)

Action to be taken on recalled product: (state the agreed upon action, e.g. re-labelling, reworking, etc.) upon approval and verification by the CFIA. All returned products will be segregated from other products in order to prevent inadvertent use of shipment of the recalled product back to the market.

(Name of Recalling Firm)'s records indicate that your firm is a distributor of the product subject to recall action. Therefore, it is expected that you will prepare a notice of recall for review by the CFIA, produce a list of accounts who received the product in the (time period, e.g. last year, last 3 months, etc.), and immediately advise each account in writing, if possible, of the recall and the action to be taken on the product. An example of a Notice of Recall to be sent to your accounts is attached. It is expected that the list of accounts be forwarded to the undersigned by (date). This list should include the following information for each account:

  • firm name
  • street address, unit number, city/town, province
  • telephone number
  • name of contact
  • date product was shipped to the firm
  • amount of product shipped

As discussed, we expect that your firm will maintain records confirming that each account was contacted including:

  • the date contacted, the method of contact, e.g. by telephone, fax and/or E-mail, and the name of the contact
  • the amount of product on site at each account at the time of the recall
  • the action taken by each account, e.g. returned product to your firm's warehouse, returned directly to the recalling firm, etc.

This information should be summarized in a report and forwarded to the undersigned by (date). Any problems experienced during the recall should be addressed with corrective actions to prevent future occurrences.

Canadian Food Inspection Agency staff will be contacting a selected number of accounts to verify the effectiveness of the recall. If you require any additional information, please contact the undersigned at (phone number).

Yours truly,

(Name of Responsible Inspector)

Attachment: Notice of Recall Template

Appendix 4C - Checklist for Gathering Implementation Information and Verifying the FIRM’s Recall Plan

General information on the recalling firm:

  • Box proper name and address of recalling firm
  • Box after hours contact name and telephone number (cell phone number, if applicable)
  • Box company spokesperson for the media

Information on the implicated product:

  • Box area and where appropriate, specific store names and locations of distribution of the product
  • Box distribution date
  • Box copies of the product label (enlarged)
  • Box brand name
  • Box common name
  • Box package type, net content, size, weight and/or special marks or features
  • Box Date codes ("packaged on", "best before" as applicable to the product), lot codes, Global Trade Item Number(s) (GTIN)* (presented on package as UPC or EAN) cases codes/multi-pack codes/SKUs (all to be provided as applicable to the product)*Note: When all digits of the GTIN are printed on the product, the complete GTIN (i.e. the GTIN 8, 12, 13 or 14, as applicable, is to be provided. When the UPC E (8 digit, zero suppressed) format is printed on the product, the complete GTIN (12 digits) plus provide the human readable UPC E (8 digits)
  • Box expiry dates/best before dates/use by
  • Box any reported complaints or illnesses or reactions made to the recalling firm
  • Box storage conditions
  • Box product preparation instructions
  • Box quantity produced
  • Box how it is packaged (i.e. units per case)
  • Box warehouse stock
  • Box amount in distribution
  • Box target population (i.e. infants, elderly, special dietary needs)
  • Box country of origin
  • Box association with any other recall (e.g. originally recalled product used as an ingredient in other secondary store made products (e.g. sandwiches, pizza, etc.)
  • Box if the product(s) has/have already been removed from sale/distribution and the date of remove from sale/distribution

Notice of recall

  • Box brief and to the point
  • Box name of recalling firm initiating the recall to appear first with information re: where sold stated later in notice
  • Box identifies the product, size, lot numbers, brand name, common name, package type, net content, size, weight, date codes, lot codes, GTIN (plus UPC E if used), case code/SKU, packaged on/best before dates as applicable, storage conditions, country of origin, where to look for the code on the package, etc.
  • Box area and where appropriate specific store names and locations of distribution of the product
  • Box reason for recall
  • Box if the product(s) has/have already been removed from sale/distribution and date of removal
  • Box instructions on what must be done with the affected product
  • Box describes the means for contacting the recalling firm to confirm receipt, advise on quantities on hand and/or further distribution
  • Box request the recipient advise any accounts they may have forwards the product to

Distribution list

  • Box name, address and telephone number of the consignee
  • Box contact persons
  • Box type of consignee
  • Box the product brand, package type
  • Box GTIN (plus UPC E if used, case code/SKU)
  • Box lot, date or production code
  • Box expiry or best before dates
  • Box quantity shipped
  • Box date shipped

Effectiveness check plan

  • Box number of consignees to be contacted meets or exceeds requirements of the appropriate sampling plan
  • Box date of initiation
  • Box date of completion
  • Box plan for addressing deviations

Product action

  • Box clearly described in the plan

Appendix 5A - Food Recall Warning - Allergens

For immediate release

[DRAFT] Food Recall Warning (Allergen)

(Product) recalled due to undeclared (allergen)

OTTAWA, (Date) – (Company) is recalling (product) from the marketplace because (it/they) (may) contain(s) (allergen) which is not declared on the label. People with an allergy to (allergen) should not consume the recalled product(s) described below.

[Or when the company/importer cannot be named]

Industry is recalling (product) from the marketplace because (it/they) (may) contain(s) (allergen) which is not declared on the label. People with an allergy to (allergen) should not consume the recalled product(s) described below.

The following product(s) (has/have) been sold in (province(s) of distribution).

Recalled product(s)

Brand Product Size UPC Codes

What you should do

Check to see if you have recalled products in your home. Recalled products should be thrown out or returned to the store where they were purchased.

If you have an allergy to (allergen), do not consume the recalled product as it may cause a serious or life-threatening reaction.

If you have an allergy to (allergen) do not consume the recalled product as it may cause a serious or life-threatening reaction.

Background

This recall was triggered by (the Canadian Food Inspection Agency's (CFIA) inspection activities/ Canadian Food Inspection Agency (CFIA) test results/ a consumer complaint/ a recall in another country/ findings by the Canadian Food Inspection Agency (CFIA) during its investigation into a foodborne illness outbreak/ the company). The (CFIA/ Canadian Food Inspection Agency (CFIA)) is conducting a food safety investigation, which may lead to the recall of other products. If other high-risk products are recalled, the CFIA will notify the public through updated Food Recall Warnings.

The CFIA is verifying that industry is removing recalled product from the marketplace.

Reactions

There have been no reported illnesses associated with the consumption of (this/these) product(s).

[or when there is a reaction]

There (has been one reported reaction/have been reported reactions) associated with the consumption of (this/these) product(s).

More information

  • (Company name): (Company contact information)
  • CFIA: www.inspection.gc.ca/contactus

Media enquiries

CFIA Media Relations
613-773-6600

Appendix 5B - Food Recall Warning - E. coli O157:H7

For immediate release

[DRAFT] Food Recall Warning

(Product) recalled due to E. coli O157:H7 / NM

OTTAWA, (Date) – (Company) is recalling (product) from the marketplace due to possible E. coli O157:H7 / NM contamination. Consumers should not consume the recalled product(s) described below.

[Or when the company/importer cannot be named]

Industry is recalling (product) from the marketplace due to possible E. coli O157:H7 contamination. Consumers should not consume the recalled product(s) described below.

The following product(s) (has/have) been sold in (province(s) of distribution).

Recalled product(s)

Brand Product Size UPC Codes

What you should do

Check to see if you have recalled products in your home. Recalled products should be thrown out or returned to the store where they were purchased.

Food contaminated with E. coli O157:H7 / NM may not look or smell spoiled but can still make you sick. Symptoms can include nausea, vomiting, mild to severe abdominal cramps and watery to bloody diarrhea. In severe cases of illness, some people may have seizures or strokes, need blood transfusions and kidney dialysis or live with permanent kidney damage. In severe cases of illness, people may die.

Background

This recall was triggered by (the Canadian Food Inspection Agency's (CFIA) inspection activities/ Canadian Food Inspection Agency (CFIA) test results/ a consumer complaint/ a recall in another country/ findings by the Canadian Food Inspection Agency (CFIA) during its investigation into a foodborne illness outbreak/ the company). The (CFIA/ Canadian Food Inspection Agency (CFIA)) is conducting a food safety investigation, which may lead to the recall of other products. If other high-risk products are recalled, the CFIA will notify the public through updated Food Recall Warnings.

The CFIA is verifying that industry is removing recalled product from the marketplace.

Illnesses

There have been no reported illnesses associated with the consumption of (this/these) product(s).

[or when there is illness]

There (has been one reported illness/have been reported illnesses) associated with the consumption of (this/these) product(s).

More information

  • (Company name) : (Company contact information)
  • CFIA: www.inspection.gc.ca/contactus

Media enquiries

CFIA Media Relations
613-773-6600

Appendix 5C - Food Recall Warning – Listeria monocytogenes

For immediate release

[DRAFT] Food Recall Warning

(Product) recalled due to Listeria monocytogenes

OTTAWA, (Date) – (Company) is recalling (product) from the marketplace due to possible Listeria monocytogenes contamination. Consumers should not consume the recalled product(s) described below.

[Or when the company/importer cannot be named]

Industry is recalling (product) from the marketplace due to possible Listeria monocytogenes contamination. Consumers should not consume the recalled product(s) described below.

The following product(s) (has/have) been sold in (province(s) of distribution).

Recalled product(s)

Brand Product Size UPC Codes

What you should do

Check to see if you have recalled products in your home. Recalled products should be thrown out or returned to the store where they were purchased.

Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still make you sick. Symptoms can include vomiting, nausea, persistent fever, muscle aches, severe headache and neck stiffness. Pregnant women, the elderly and people with weakened immune systems are particularly at risk. Although infected pregnant women may experience only mild, flu-like symptoms, the infection can lead to premature delivery, infection of the newborn or even stillbirth. In severe cases of illness, people may die.

Background

This recall was triggered by (the Canadian Food Inspection Agency's (CFIA) inspection activities/ Canadian Food Inspection Agency (CFIA) test results/ a consumer complaint/ a recall in another country/ findings by the Canadian Food Inspection Agency (CFIA) during its investigation into a foodborne illness outbreak/ the company). The (CFIA/ Canadian Food Inspection Agency (CFIA)) is conducting a food safety investigation, which may lead to the recall of other products. If other high-risk products are recalled, the CFIA will notify the public through updated Food Recall Warnings.

The CFIA is verifying that industry is removing recalled product from the marketplace.

Illnesses

There have been no reported illnesses associated with the consumption of (this/these) product(s).

[or when there is illness]

There (has been one reported illness/have been reported illnesses) associated with the consumption of (this/these) product(s).

More information

  • (Company name) : (Company contact information)
  • CFIA: www.inspection.gc.ca/contactus

Media enquiries

CFIA Media Relations
613-773-6600

Appendix 5D - Food Recall Warning - Salmonella

For immediate release

[DRAFT] Food Recall Warning

(Product) recalled due to Salmonella

OTTAWA, (Date) – (Company) is recalling (product) from the marketplace due to possible Salmonella contamination. Consumers should not consume the recalled product(s) described below.

[Or when the company/importer cannot be named]

Industry is recalling (product) from the marketplace due to possible Salmonella contamination. Consumers should not consume the recalled product(s) described below.

The following product(s) (has/have) been sold in (province(s) of distribution).

Recalled product(s)

Brand Product Size UPC Codes

What you should do

Check to see if you have recalled products in your home. Recalled products should be thrown out or returned to the store where they were purchased.

Food contaminated with Salmonella may not look or smell spoiled but can still make you sick. Young children, pregnant women, the elderly and people with weakened immune systems may contract serious and sometimes deadly infections. Healthy people may experience short-term symptoms such as fever, headache, vomiting, nausea, abdominal cramps and diarrhea. Long-term complications may include severe arthritis.

Background

This recall was triggered by (the Canadian Food Inspection Agency's (CFIA) inspection activities/ Canadian Food Inspection Agency (CFIA) test results/ a consumer complaint/ a recall in another country/ findings by the Canadian Food Inspection Agency (CFIA) during its investigation into a foodborne illness outbreak/ the company). The (CFIA/ Canadian Food Inspection Agency (CFIA)) is conducting a food safety investigation, which may lead to the recall of other products. If other high-risk products are recalled, the CFIA will notify the public through updated Food Recall Warnings.

The CFIA is verifying that industry is removing recalled product from the marketplace.

Illnesses

There have been no reported illnesses associated with the consumption of (this/these) product(s).

[or when there is illness]

There (has been one reported illness/have been reported illnesses) associated with the consumption of (this/these) product(s).

More information

  • (Company name) : (Company contact information)
  • CFIA: www.inspection.gc.ca/contactus

Media enquiries

CFIA Media Relations
613-773-6600

Appendix 5E - Public Warning Template - C. botulinum

For immediate release

[DRAFT] Food Recall Warning

(Product) recalled due to potential presence of dangerous bacteria

OTTAWA, (Date) – (Company) is recalling (product) from the marketplace because they may permit the growth of Clostridium botulinum. Consumers should not consume the recalled product(s) described below.

[Or when the company/importer cannot be named]

Industry is recalling (product) from the marketplace because they may permit the growth of Clostridium botulinum. Consumers should not consume the recalled product(s) described below.

The following product(s) (has/have) been sold in (province(s) of distribution).

Recalled product(s)

BrandProductSizeUPCCodes

What you should do

Check to see if you have recalled products in your home. Recalled products should be thrown out or returned to the store where they were purchased.

Food contaminated with Clostridium botulinum toxin may not look or smell spoiled but can still make you sick. Symptoms can include nausea, vomiting, fatigue, dizziness, blurred or double vision, dry mouth, respiratory failure and paralysis. In severe cases of illness, people may die.

Background

This recall was triggered by (the Canadian Food Inspection Agency's (CFIA) inspection activities/ Canadian Food Inspection Agency (CFIA) test results/ a consumer complaint/ a recall in another country/ findings by the Canadian Food Inspection Agency (CFIA) during its investigation into a foodborne illness outbreak/ the company). The (CFIA/ Canadian Food Inspection Agency (CFIA)) is conducting a food safety investigation, which may lead to the recall of other products. If other high-risk products are recalled, the CFIA will notify the public through updated Food Recall Warnings.

The CFIA is verifying that industry is removing recalled product from the marketplace.

Illnesses

There have been no reported illnesses associated with the consumption of (this/these) product(s).

[or when there is illness]

There (has been one reported illness/have been reported illnesses) associated with the consumption of (this/these) product(s).

More information

  • (Company name): (Company contact information)
  • CFIA: www.inspection.gc.ca/contactus

Media enquiries

CFIA Media Relations
613-773-6600

Appendix 5F - Food Recall Warning - Unspecified hazard

For immediate release

[DRAFT] Food Recall Warning

(Product) may be unsafe due to (hazard)

OTTAWA, (Date) – (Company) is recalling (product) from the marketplace due to (hazard). Consumers should not consume the recalled product(s) described below.

[Or when the company/importer cannot be named]

Industry is recalling (product) from the marketplace due to (hazard). Consumers should not consume the recalled product(s) described below.

The following product(s) (has/have) been sold in (province(s) of distribution).

Recalled product(s)

BrandProductSizeUPCCodes

What you should do

Check to see if you have recalled products in your home. Recalled products should be thrown out or returned to the store where they were purchased.

Food contaminated with (hazard)...

Background

This recall was triggered by (the Canadian Food Inspection Agency's (CFIA) inspection activities/ Canadian Food Inspection Agency (CFIA) test results/ a consumer complaint/ a recall in another country/ findings by the Canadian Food Inspection Agency (CFIA) during its investigation into a foodborne illness outbreak/ the company). The (CFIA/ Canadian Food Inspection Agency (CFIA)) is conducting a food safety investigation, which may lead to the recall of other products. If other high-risk products are recalled, the CFIA will notify the public through updated Food Recall Warnings.

The CFIA is verifying that industry is removing recalled product from the marketplace.

Illnesses

There have been no reported illnesses associated with the consumption of (this/these) product(s).

[or when there is illness]

There (has been one reported illness/have been reported illnesses) associated with the consumption of (this/these) product(s).

More information

  • (Company name): (Company contact information)
  • CFIA: www.inspection.gc.ca/contactus

Media enquiries

CFIA Media Relations
613-773-6600

Appendix 5G - Updated Food Recall Warning - Allergens

For immediate release

[DRAFT] Updated Food Recall Warning (Allergen)

(Product) recalled due to undeclared (allergen)

OTTAWA, (Date) – The food recall warning issued on (date), has been updated to include additional (distribution/product) information. This additional information was identified during the Canadian Food Inspection Agency's (CFIA) food safety investigation.

(Company) is recalling (product) from the marketplace because (it/they) (may) contain(s) (allergen) which is not declared on the label. People with an allergy to (allergen) should not consume the recalled product(s) described below.

[Or when the company/importer cannot be named]

Industry is recalling (product) from the marketplace because (it/they) (may) contain(s) (allergen) which is not declared on the label. People with an allergy to (allergen) should not consume the recalled product(s) described below.

The following product(s) (has/have) been sold in (province(s) of distribution).

Recalled product(s)

BrandProductSizeUPCCodes

What you should do

Check to see if you have recalled products in your home. Recalled products should be thrown out or returned to the store where they were purchased.

If you have an allergy to (allergen) do not consume the recalled product as it may cause a serious or life-threatening reaction.

Background

This recall was triggered by (the Canadian Food Inspection Agency's (CFIA) inspection activities/ Canadian Food Inspection Agency (CFIA) test results/ a consumer complaint/ a recall in another country/ findings by the Canadian Food Inspection Agency (CFIA) during its investigation into a foodborne illness outbreak/ the company). The (CFIA/ Canadian Food Inspection Agency (CFIA)) is conducting a food safety investigation, which may lead to the recall of other products. If other high-risk products are recalled, the CFIA will notify the public through updated Food Recall Warnings.

The CFIA is verifying that industry is removing recalled product from the marketplace.

Reactions

There have been no reported reactions associated with the consumption of (this/these) product(s).

[or when there is a reaction]

There (has been one reported reaction/have been reported reactions) associated with the consumption of (this/these) product(s).

More information

  • (Company name): (Company contact information)
  • CFIA: www.inspection.gc.ca/contactus

Media enquiries

CFIA Media Relations
613-773-6600

Appendix 5H - Updated Food Recall Warning - Pathogens

For immediate release

[DRAFT] Updated Food Recall Warning

(Product) recalled due to (pathogen)

OTTAWA, (Date) – The food recall warning issued on (date) has been updated to include additional (distribution/product) information. This additional information was identified during the Canadian Food Inspection Agency's (CFIA) food safety investigation.

(Company) is recalling (product) from the marketplace due to (pathogen). Consumers should not consume the recalled product(s) described below.

[Or when the company/importer cannot be named]

Industry is recalling (product) from the marketplace due to (pathogen). Consumers should not consume the recalled product(s) described below.

The following product(s) (has/have) been sold in (province(s) of distribution).

Recalled product(s)

BrandProductSizeUPCCodes

What you should do

Check to see if you have recalled products in your home. Recalled products should be thrown out or returned to the store where they were purchased.

Food contaminated with (pathogen)...

Background

This recall was triggered by (the Canadian Food Inspection Agency's (CFIA) inspection activities/ Canadian Food Inspection Agency (CFIA) test results/ a consumer complaint/ a recall in another country/ findings by the Canadian Food Inspection Agency (CFIA) during its investigation into a foodborne illness outbreak/ the company). The (CFIA/ Canadian Food Inspection Agency (CFIA)) is conducting a food safety investigation, which may lead to the recall of other products. If other high-risk products are recalled, the CFIA will notify the public through updated Food Recall Warnings.

The CFIA is verifying that industry is removing recalled product from the marketplace.

Illnesses

There have been no reported illnesses associated with the consumption of (this/these) product(s).

[or when there is illness]

There (has been one reported illness/have been reported illnesses) associated with the consumption of (this/these) product(s).

More information

  • (Company name): (Company contact information)
  • CFIA: www.inspection.gc.ca/contactus

Media enquiries

CFIA Media Relations
613-773-6600

Appendix 5I - Food Safety Warning - Allergen

For immediate release

[DRAFT] Food Safety Warning (Allergen)

(Product) recalled due to undeclared (allergen)

OTTAWA, (Date) – The Canadian Food Inspection Agency (CFIA) is warning people with an allergy to (allergen) not to consume (and retailers, restaurants and institutions not to sell or use) the product(s) described below because (it/they) (may) contain(s) (allergen) which is not declared on the label.

The following product(s) (has/have) been sold in (province(s) of distribution).

Product(s)

BrandProductSizeUPCCodes

What you should do

Check to see if you have the product in your home. Recalled products should be thrown out or returned to the store where they were purchased.

If you have an allergy to (allergen), do not consume the recalled product as it may cause a serious or life-threatening reaction.

Background

This warning was triggered by (the Canadian Food Inspection Agency's (CFIA) inspection activities/ Canadian Food Inspection Agency (CFIA) test results/ a consumer complaint/ a recall in another country/ findings by the Canadian Food Inspection Agency (CFIA) during its investigation into a foodborne illness outbreak). The (CFIA/ Canadian Food Inspection Agency (CFIA)) is conducting a food safety investigation, which may lead to the recall of these or other products. If products are recalled, the CFIA will notify the public through a Food Recall Warning.

Reactions

There have been no reported illnesses associated with the consumption of (this/these) product(s).

[or when there is a reaction]

There (has been one reported reaction/have been reported reactions) associated with the consumption of (this/these) product(s).

More information

  • CFIA: www.inspection.gc.ca/contactus

Media enquiries

CFIA Media Relations
613-773-6600

Appendix 5J - Food Safety Warning - Pathogens

For immediate release

[DRAFT] Food Safety Warning

(Product) may be unsafe due to (pathogen)

OTTAWA, (Date) – The Canadian Food Inspection Agency (CFIA) is warning the public not to consume (and retailers, restaurants and institutions not to sell or use) the product(s) described below due to (pathogen).

The following product(s) (has/have) been sold in (province(s) of distribution).

Product(s)

BrandProductSizeUPCCodes

What you should do

Check to see if you have the product in your home. If the product is in your home do not consume it.

Food contaminated with (pathogen)...

Background

This warning was triggered by (the Canadian Food Inspection Agency's (CFIA) inspection activities/ Canadian Food Inspection Agency (CFIA) test results/ a consumer complaint/ a recall in another country/ findings by the Canadian Food Inspection Agency (CFIA) during its investigation into a foodborne illness outbreak). The (CFIA/ Canadian Food Inspection Agency (CFIA)) is conducting a food safety investigation, which may lead to the recall of these or other products. If products are recalled, the CFIA will notify the public through a Food Recall Warning.

Illnesses

There have been no reported illnesses associated with the consumption of (this/these) product(s).

[or when there is illness]

There (has been one reported illness/have been reported illnesses) associated with the consumption of (this/these) product(s).

More information

  • CFIA: www.inspection.gc.ca/contactus

Media enquiries

CFIA Media Relations
613-773-6600

Appendix 5K - Food Safety Warning - Unspecified Hazard

For immediate release

[DRAFT] Food Safety Warning

(Product) may be unsafe due to (hazard)

OTTAWA, (Date) – The Canadian Food Inspection Agency (CFIA) is warning the public not to consume (and retailers, restaurants and institutions not to sell or use) the product(s) described below due to (hazard).

The following product(s) (has/have) been sold in (province(s) of distribution).

Product(s)

BrandProductSizeUPCCodes

What you should do

Check to see if you have the product in your home. If the product is in your home do not consume it.

Food contaminated with (hazard)...

Background

This warning was triggered by (the Canadian Food Inspection Agency's (CFIA) inspection activities/ Canadian Food Inspection Agency (CFIA) test results/ a consumer complaint/ a recall in another country/ findings by the Canadian Food Inspection Agency (CFIA) during its investigation into a foodborne illness outbreak). The (CFIA/ Canadian Food Inspection Agency (CFIA)) is conducting a food safety investigation, which may lead to the recall of these or other products. If products are recalled, the CFIA will notify the public through a Food Recall Warning.

Illnesses

There have been no reported illnesses associated with the consumption of (this/these) product(s).

[or when there is illness]

There (has been one reported illness/have been reported illnesses) associated with the consumption of (this/these) product(s).

More information

  • CFIA: www.inspection.gc.ca/contactus

Media enquiries

CFIA Media Relations
613-773-6600

Appendix 6A - Example Template - Letter to Public Health Agencies for Requesting Assistance for Conducting Recall Effectiveness Checks

Canadian Food Inspection Agency
Street Address; City, Prov; Postal Code

(Date)

Ministry of
space

Street Address; City, Prov; Postal Code

Attention: (Name of Contact)

RE: (Voluntary/Mandatory) RECALL OF (brand name, common name, size, lot code of affected product. Where there are several products, state a general description, e.g. Product type) BY (Name of Recalling Firm)

Dear (Name of Contact):

This letter will confirm our discussion held on (date), at which time the CFIA advised it is requesting the assistance of the space and the affected Local Boards of Health (LBH) in conducting recall effectiveness checks at (the accounts listed/independent retail stores/healthcare facilities/food premises) to verify the effectiveness of the above-mentioned recall. The CFIA is requesting your assistance because (of the widespread distribution of this product/because there have been a number of illnesses associated with this product/because there is an urgent need to remove this product from the market, etc. ). The CFIA will also be monitoring the effectiveness of the recall by conducting checks at (both chain and independent retail stores, distributors, etc. on the recalling firm's distribution list).

The following product(s) are affected:

(List - brand name, common name, size, lot code OR Please visit the following links to the CFIA website for a complete list of affected brands: English and French links) The details of the recall are as follows: Recall Classification: (1, or 2, with a Public Warning) Depth of Recall: (distributor, institutional, retail, consumer) Reason for Product Recall: (state the reason, e.g. undeclared milk protein, and the name of the legislation/regulation and section of the legislation/regulation violated, e.g. contravention of subsection 5(1) of the Food and Drugs Act)

Please request inspectors to do the following:

  1. Conduct on-site visits to each of the (accounts listed/stores/facilities/food premises) to determine if they have received (the Notice of Recall from the recalling firm/any notification about the recall from their supplier) and have taken the prescribed action. On-site visit checks should be done according to the procedure outlined in the attached instructions. If the recalled product is being used against the directions provided (in the Notice of Recall/by their supplier), inspectors may request immediate compliance by the account(s). (If no distribution list is provided, include the following: Please note: As there is no specific distribution list of accounts to check, inspectors may be visiting accounts that may not have received any of the affected product).
  2. Record the information obtained on the Effectiveness Checks for Food Recall Recording form as per the attached instructions.
  3. If any deviations are encountered with the CFIA recall, (CFIA to insert applicable comments). It is considered a deviation if product is found offered for sale or notification was not received in any form from the (recalling firm/supplier). (If no distribution list is provided, include the following: Please provide the undersigned with the name of the account's supplier and the method of purchase, e.g. cash sale.)
  4. Upon completion of all recall effectiveness checks, please complete the Recall Effectiveness Checks Summary Report for each health unit.

Please confirm receipt of this request and advise me of the names of the LBHs that will be assisting the CFIA with this request and those that will not as soon as possible so that the CFIA can take appropriate action. (Due to the short shelf life of this type of product/urgency of this issue/extensive media coverage) please have this request initiated immediately and have as many (accounts/stores/facilities/food premises) as possible visited by (date). Should you wish to amend the CFIA request for assistance, please consult with the CFIA Area Recall Coordinator (ARC) prior to doing so.

You may recommend additional enforcement action to the LBHs to protect the health of the people. Should the additional enforcement action be beyond the CFIA's legal mandate or not deemed required by the CFIA, it is understood that you will act based on your legislative powers, identify the request as such, and answer any questions resulting from such action.

Please return all reporting forms (i.e. Effectiveness Checks for Food Recall recording forms and Recall Effectiveness Checks Summary Reports) by fax or e-mail to (the undersigned/designate) within (X) business days of (insert date as specified on page 2). Once all Recall Effectiveness Check recording forms are returned from all health units to the undersigned, feedback will be provided to you on the effectiveness of the recall.

If there are any questions/concerns, please do not hesitate to contact the undersigned at space

Thank you for your assistance.
Regards,
Name ARC Contact Information
List of attachments:

Appendix 6B - Example Template - Effectiveness Checks for Food Recall Form

 
Page space of space
Class: space Public Health Unit: space Inspector's Name: space
Name of Recalling Firm: space Product Information: space Recall Reason: space
1.
Name and Address of Food Premise (with City/Town)
2.
Date of Visit
(yyyy/mm/dd)
3.
Contact Name and Phone Number
4.
Notification Received from Recalling Firm/Supplier (Y/N)
5.
Supplier's Name and Phone Number
6.
Recalled product offered for sale at time of visit (Y/N) (If yes, how many?)
7.
If offered for sale, date of notification to the CFIA (yyyy/mm/dd)
8.
If not offered for sale, indicate disposition of recalled product by food premise:
  1. segregated by retailer
  2. returned to supplier
  3. sold out at time of recall
  4. did not receive the product
9.
Distributes further (Y/N) (If yes, notify the CFIA and obtain list)

Notes / Other comments:

Appendix 6C - Example Instructions for Completing Effectiveness Checks for Food Recall

  1. Name and Address of Food Premise: Record the name and address of the food premise visited. Please include city / town.
  2. Date of Visit (yyyy/mm/dd): Record the date on which you conducted the visit. If a visit was not done, record "phone" and the date on which you made the phone call.
  3. Contact Name and Phone Number: Record the name and phone number of the person you spoke to at the food premise visited who has the authority to respond to product recall notifications.
  4. Notification received from recalling firm/supplier (Y/N): Ask the responsible person "Are you aware of a product recall conducted by recalling firm X of product Y?" If they received notification by phone, fax or e-mail, record "Yes". If notification was not received in any form, record "No".
  5. Supplier's Name and Phone Number: Record the name and phone number of the supplier of the recalled product to the food premise visited.
  6. Recalled product offered for sale at time of visit (Y/N) (If yes, how many): Examine the store shelves to determine if the product is offered for sale at the time of your visit.
    1. If product is offered for sale, record "Yes" and the number of units found. Ask the store to remove the product from sale and segregate it appropriately. Proceed to question 7.
    2. If product is not offered for sale, record "No." Proceed to question 8.
  7. If offered for sale, date of notification to the CFIA (yyyy/mm/dd): If product was offered for sale at the time of your visit, notify the CFIA contact by phone fax, or email ASAP. Record the date on which you contacted the CFIA.
  8. If not offered for sale, indicate disposition of recalled product by food premise (a. segregated by retailer; b. returned to supplier; c. sold out at time of recall; d. did not receive the product): If product was not offered for sale at the time of your visit, ask the responsible person "What action was taken with this product?"
    1. If product was removed by the retailer and set aside, physically verify that the product was segregated and will not be mistakenly returned to the store shelves. Record "a".
    2. If product was removed by the retailer and already returned to the supplier, verify by reviewing invoices/written documents. Record "b".
    3. If product was sold out at the time of notification, record "c".
    4. If the food premise did not receive the recalled product, record "d".
  9. Distributes further (Y/N) (If yes, notify CFIA. Obtain list): Ask the responsible person "Other than retail sales to individual consumers, do you further distribute this product (act as a wholesaler…)?" If the account further distributes, ask them to prepare a distribution list. Notify the CFIA contact by phone, fax or email ASAP and forward the distribution list to the CFIA contact. The CFIA will continue the follow up.

Notes/Additional Comments: Inspectors may add any additional comments at the bottom of the page.

** CFIA Contact:

Appendix 6D - Example Recall Effectiveness Checks Summary Report

Upon completion of all recall effectiveness checks, please complete this form for each health unit and submit to the CFIA contact indicated below.

General Information

Recall information (indicate recall that form is pertaining to): space
Date report was prepared: space
Name of Health Unit: space

Contact Information for Person who Prepared the Report

Name: space
Telephone number: space
E-mail address: space

Recall Effectiveness Checks Information
Total number of effectiveness checks requested to complete (if provided a distribution list by the CFIA):
Total estimated number of effectiveness checks to complete (based on health units knowledge of potentially affected food premises, when no distribution list is available from the CFIA): If information is not available, please check one:
  • Box Cannot be estimated
  • Box Unavailable information
  • Box Other, please specify space
Total number of effectiveness checks (number of premises) completed:
Total number of effectiveness checks (number of premises) not completed:
If there are any effectiveness checks still outstanding, please indicate a) if they will be completed; and b) by what date the checks will be completed:
  1. Check one:
    • Box Outstanding checks will be completed
    • Box Outstanding checks will not be completed
  2. Estimated completion date:
Total number of inspectors involved in completing the effectiveness checks:
 
Deviations
Total number of food premises at which product was found for sale:
 
Please add any additional comments on a separate page
 
CFIA Contact:
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