Food Investigation Response Manual
4.0 Food Safety Investigation
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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
188.8.131.52 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.
184.108.40.206 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.
220.127.116.11 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.
18.104.22.168 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.
22.214.171.124 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.
126.96.36.199 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.
188.8.131.52 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.
184.108.40.206 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.
220.127.116.11 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:
18.104.22.168 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.
22.214.171.124 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
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).
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.
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
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.
126.96.36.199 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
188.8.131.52 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;
- Storage of incoming material;
- Product processing;
- 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.
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.
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.
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