Food Investigation Response Manual
5.0 Decision Making
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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
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.
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:
- 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.
- 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
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.
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