ARCHIVED - Risk Categorization Model for Food Retail / Food Service Establishments - Second Edition

Second Edition - Prepared for: - Federal/Provincial/Territorial Committee on Food Safety Policy - Approved May 9, 2006 - Revised May 4, 2007

Table of Contents

• Preamble
• Contact
• 1. Definitions
• 2. Introduction
• 3. Purpose
• 4. Scope
• 5. Considerations
• 6. Description of the Risk Categorization Model Questionnaire
• 7. Summary
• 8. Bibliography
• Table 1: Regulatory Agencies using Risk Factors to determine Frequency of Inspection
• Appendix 1: Risk Categorization Model Questionnaire
• Appendix 2: Guide for Use of the Risk Categorization Model Questionnaire

Preamble

The Second Edition of the Risk Categorization Model was prepared by a Working Group of the Federal/Provincial/Territorial Food Safety Policy Committee (FPTCFSP) and was endorsed by the latter on May 9, 2006 . The Second Edition represents a modification of the First Edition (2001) based on the knowledge acquired through pilot studies conducted to finalize the model. The contributions of all the individuals who participated in the development of both editions are greatly appreciated.

Second Edition Working Group Members:

Mark Durkee (Chairman), Nova Scotia Department of Agriculture
Karen Wong-Petrie, Nova Scotia Department of Agriculture
Eric Bergsma , Yukon Health and Social Services
Beth Junkins, Health Canada
Doris Miller, Health Canada
Lucie Olson, Health Canada

Contact

Interagency Program
Bureau of Regulatory, International and Interagency Affairs
Health Canada
(613) 957-0906

1. Definitions

Definitions of common terms contained in this document are listed below.

Critical items : Specific requirements that, when in violation, may result in foodborne illness if not corrected immediately. These would include temperature control (e.g., hot holding, refrigerator temperatures), food handler handwashing, and food/ water sourcing.

Epidemiological Evidence: Epidemiological evidence: In the absence of other types of evidence, epidemiological evidence must show a statistically significant association between human illness and consumption of specific food(s).

Food Handler: Individual working with unpackaged food, food equipment, utensils, or food contact surfaces.

Hazard : means, as set out in the General Principles of Food Hygiene (CAC/RCP 1 - 1969, Rev. 4 - 2003), a biological, chemical or physical agent in, or a condition of, food with the potential to cause an adverse health effect.

High risk establishment: An establishment which represents a high likelihood of occurrence of a foodborne illness outbreak, based on theevaluation of the eight risk factors provided in the Risk Categorization Questionnaire.

High risk food : Foods or groups of foods that are frequently the cause of microbial foodborne illness. Foods may contain and support the growth of microorganisms and are intended for consumption with or without further treatment to destroy microorganisms.

Laboratory evidence: Evidence shown by the isolation/identification of the same pathogen, toxin or contaminant from cases of human illness and the suspect food.

Low risk establishment : An establishment which represents a low likelihood of occurrence of a foodborne illness outbreak, based on the evaluation of the eight risk factors provided in the Risk Categorization Questionnaire.

Low risk food : Foods or groups of foods that are seldom the cause of foodborne illness. Foods are unlikely to contain pathogenic microorganisms or will not support growth of pathogenic microorganisms due to food characteristics.

Medium risk food : Foods or groups of foods that are less frequently the cause of microbial foodborne illness. Foods may contain microorganisms but will not normally support their growth due to food characteristics OR are unlikely to contain pathogenic microorganisms due to their processing but may support their growth.

Moderate risk establishment : An establishment which represents a moderate likelihood of occurrence of a foodborne illness outbreak, based on the evaluation of the eight risk factors provided in the Risk Categorization Questionnaire.

Non-Critical Items: Requirements that, when in violation do not meet regulatory standards, but are not likely to pose an immediate health hazard. These would include structural issues (floors, walls, ceilings), solid waste management and pest management.

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 and/or place. An outbreak is confirmed through laboratory and/or epidemiological evidence.

Ready-to-eat (RTE) foods : Foods that do not need any further preparation before being consumed, except perhaps washing, thawing or moderate reheating if the food in question is customarily eaten hot.

Risk : An estimate of both the harm to human health that results from being exposed to a hazard, together with the likelihood that the harm will occur. In order for a health risk to exist, three things must be true: there must be exposure to a hazard; there must be a health effect; and there must be some likelihood that the health effect will occur.

Risk factor : Something that can increase the likelihood that adverse health effects will occur following exposure to a hazard.

Risk-based inspection : An inspection approach focussed on identifying significant behaviours and practices inherent to the food establishment operations with particular emphasis on Food Retail and Food Services Code interventions and risk factors.

Risk management : The process that includes identifying, evaluating, selecting and implementing alternatives for mitigating risk.

2. Introduction

The Federal/Provincial/Territorial Committee on Food Safety Policy (FPTCFSP) established a Working Group to develop a national risk categorization model for food retail and food service establishments. This undertaking was prompted by the publication of the FoodRetail and Food Services Code and the commitment of federal, provincial, territorial and municipal governments to pursue the goals of the Blueprint for the Canadian Food Inspection System. The Risk Categorization Model (RCM) presented in this document was pilot tested in Nova Scotia and the Yukon to provide reasonable assurance that the categorization rankings obtained with its use reflect the rankings that would be given by inspectors based on the factors outlined in the model.

The RCM Questionnaire and Guide contained in Annexes 1 and 2, respectively, are provided for the voluntary use by regulatory authorities across Canada .

3. Purpose

The purpose of the RCM is to provide a risk management tool that will allow food regulatory authorities to provide a consistent approach to inspection planning and resource allocation, giving greater attention to higher risk establishments and therefore improving public health protection through food safety. Implementation of the RCM by all levels of government is encouraged, as it will provide a common approach for interpreting the Food Retail and Food Services Code.

4. Scope

The RCM is a tool to consistently evaluate the risk of food borne illness outbreak occurrence originating from individual food retail and food service establishments, which should be used during on-site visits. By determining if an establishment poses a "high", "moderate" or "low" risk, a manager can then determine the resource requirements for a given period of time (e.g., on a yearly basis).

The RCM is not intended to serve as an in-depth inspection procedure to assess compliance with jurisdictional requirements and determine appropriate enforcement activities. It should be used as a complement to existing inspection procedures to evaluate the overall risk, based on current conditions at the time of the visit as well as previous conditions or incidents since the last evaluation took place.

The RCM should therefore be used to assess establishments that were inspected at least twice in the past, since it is expected that new establishments would be inspected more frequently at the onset regardless of the risk that they may pose.

The RCM is not intended to assign inspection frequencies that parallel the risk ranking, as frequency is dependent on available resources within a jurisdiction. For instance, a jurisdiction could decide that it has sufficient resources to inspect all "high risk" establishments on a monthly basis, while another jurisdiction may only have sufficient resources to inspect these establishments on a quarterly basis. Inspection frequency may also be affected by the results of a particular inspection. An establishment that encountered poor inspection results may be subject to a re-inspection within a short time frame, even if the overall risk posed by that establishment may not have changed. Although the RCM does not assign an inspection frequency, its use throughout a jurisdiction should improve consistency in the assignment of inspection frequencies within that jurisdiction.

5. Considerations

Risk categorization is a complex process that may be influenced by a number of factors. The RCM Questionnaire uses a linear process based on the total score of the identified risk factors and pre-determined cut-off values. It is recognized at the outset that no one combination of factors is expected to uniquely or comprehensively capture the complexities of the human decision making process. However, the two pilots conducted to refine the RCM showed that it provides a good approximation of how inspection staff categorize establishments, based on identified risk factors and the likelihood of occurrence of a fooborne illness outbreak. While the RCM uses a prudent and sensible approach, the results that it provides need to be evaluated, especially for establishments with scores near the cut-off values. Managerial discretion should be exercised to assign a different risk categorization if needed. Such a decision should take into consideration any significant risk factors that may not have been captured in the Questionnaire and the consequences of over-categorizing (cost of increased inspection frequency) versus under-categorizing (increased public health risk) establishments. It is for this reason that the RCM Questionnaire provides the opportunity to assign a final risk categorization that differs from the one obtained using the Questionnaire, with documentation of the additional factors considered in reaching the decision.

6. Description of the Risk Categorization Model Questionnaire

6.1 Risk Factors and Corresponding Scores

The purpose of the RCM Questionnaire (Annex 1) is to assess the following eight risk factors:

• Types of food and intended uses
• Food preparation and processing
• Equipment and facility
• Management and employee food safety knowledge
• Food safety management program
• Regulatory compliance
• Volume of food
• Typical patronage

These factors were selected during the development of the First Edition of the Risk Categorization Model, based on a review of factors that contributed to foodborne illness in Canada (Todd, E.C.D., 1983) as well as factors used by some jurisdictions to determine inspection frequency (Table 1).

Each risk factor has corresponding weighted values (e.g. scores) based on the level of risk posed by the situation noted during an inspection.

The RCM Guide (Annex 2) provides an explanation for each risk factor, along with direction on how to determine the corresponding score. Following is a description of the eight risk factors.

1) Type of Food and Intended Uses

Epidemiological evidence shows that foodborne illnesses occur most frequently from microbiological hazards. Some types of food are more likely to be contaminated with microbial organisms and support their growth. The types of foods being handled in a food establishment are important in identifying the hazards likely to be associated with that establishment.

High or medium risk foods which receive no further heat treatment have a greater likelihood of being implicated in a foodborne illness than foods which undergo additional steps to reduce or control microbial growth. High or medium risk foods which receive further heat treatment or undergo other methods to reduce microbial pathogens are at a reduced risk. Low risk foods are less likely to be involved in a foodborne illness.

2) Food Handling, Preparation and Processing

The amount of handling which a food undergoes during preparation is a determinant of the risk posed by a food establishment. Foods that are extensively handled are more likely to be contaminated with microbial organisms. Establishments handling uncooked and unpackaged foods have a greater potential for contaminating these foods than if they are prepackaged.

Food systems within food establishments such as cook/chill processes, commissaries, and catering away from the location where food is prepared, provide added risk to food safety. Foods in these systems may receive less heat treatment during preparation and may be held hot or chilled for longer periods of time. This presents more opportunity for microbial contamination and growth requiring greater control over the food system

3) Equipment and Facility

The layout and design of food establishments should allow for the flow of food to be in one direction from receiving to service or sale. The flow pattern should ensure that raw, unprocessed high or medium risk foods are adequately separated from cooked, ready to eat foods. Dishwashing, waste storage and other non food activities should be separated from food preparation and processing areas. Food establishments that do not provide for the safe flow and separation of foods are at greater risk of contamination of foods.

Water at a foodservice establishment may be used for direct consumption (i.e., drinking, ice manufacturing). Water as a food ingredient and as a part of many necessary processes at an establishment (i.e., handwashing, ware washing and sanitizing), can also impact the health of patrons at the facility. Establishments not able to provide potable water on repeated occasions pose a greater likelihood of illness to the end consumer.

Food equipment must be constructed of suitable, non toxic materials that are easily cleanable. The design, structure and location within an establishment must allow easy accessibility for cleaning and sanitizing.

Equipment must be adequate to the volume of food preparation or processing. Refrigeration must be appropriate to its intended use and capable of maintaining required temperatures. Use of commercial equipment built to international standards and certified by third parties such as NSF International and Underwriters Laboratories of Canada (ULC) should be used.

As equipment ages and becomes worn through use, it becomes less efficient than when new. Food establishments may add used equipment to their facility. Kitchen layouts evolve over time as a result of changes in activities and added equipment. What was once a well planned and equipped food establishment may now be less efficient and contribute to an increased risk of foodborne illness.

4) Management and Employee Food Safety Knowledge

Knowledge of food safety principles is essential in the control and reduction of risks of foodborne illness in food service. Those employees who are in direct contact with food should be trained to a level appropriate to the operation they perform. Managers and supervisors must have added knowledge to ensure that safe food handling practices are being followed and capable of undertaking corrective actions when practices pose a risk to food safety. Certification must be current as studies indicate that the level of knowledge of food safety practices deteriorates over time.

Food safety knowledge can be acquired through formal training or informal experiential exposure. The Canadian Food Retail and Food Services Code can be used as a guide to determine levels of food safety knowledge in a food retail or food service establishment as it outlines food handler training program expectations, expiration of training programs, and learning outcomes of training program participants.

Having a certification from a recognized training program in itself is not sufficient to ensure safe food handling practices are being employed. Trained managers and employees must demonstrate to the regulatory agency that they are following safe practices. This may be demonstrated by observations during routine inspection of establishments.

Food establishments that do not have trained employees or practice safe food handling principles are at greater risk of being implicated in a foodborne illness.

5) Food Safety Management Programs

Control of food processing and preparation stages is best offered through a food safety management program such as Hazard Analysis Critical Control Point (HACCP). Establishments that have such a program in place would be at less risk that those that have no controls.

Development and implementation of a food safety management program requires the commitment and involvement of both management and employees. It also requires full implementation of pre-requisite support programs such as facility maintenance and sanitation, and personal hygiene of foodservice workers. The implementation of these programs must be done prior to implementation of the food safety management program. The effectiveness of the system depends on how it is practiced in the establishment for identifying and controlling hazards. The commitment to the program and its appropriateness to the establishment must be demonstrated to the regulatory authority when carrying out a risk categorisation of the establishment.

Documentation of the food safety management program used by the establishment is critical in demonstrating conformity with the program. In the absence of record-keeping, management and employees are not able to demonstrate control of Critical Control Points (CCPs). A formal auditing process is recognized to further confirm adherence to the documented food safety program.

The operation of a food service establishment may be very different from one type of foodservice to another. These differences may require modification of food safety management plans. The technical knowledge and abilities of the facility manager and employees to develop and implement the plan must be considered. For some small establishments with low risk foods, detailed documented plans may not be necessary.

6) Regulatory Compliance

Historical information about regulatory compliance with critical items can provide data of value when determining risks. "Compliance" in this factor refers to past and current compliance inspections. There is a relationship between a pattern of non-compliance with critical items and association with foodborne illness. The most often observable critical items found to be in non-compliance are temperatures of cold holding and rapid cooling of foods. When assessing past compliance particular attention should be given to temperature violations. Consumer complaints should also be reviewed when assessing the risks associated with specific establishments as they can indicate non-compliance with critical items. Appreciation of hazards presented by non-compliance, and willingness of management to act on previous advice must also be considered.

The occurrence of an outbreak at a foodservice establishment is an indication that food safety principles were not followed prior to the outbreak. Even after regulatory agencies investigate an outbreak, and targeted food safety education with establishment managers/ operators and employees takes place, enhanced monitoring through inspection to ensure adherence to food safety principles should be considered a significant part in food borne illness risk reduction.

Non-compliant issues identified during a compliance inspection may detect deficiencies in pre-requisite programs if a food safety management program has been implemented.

7) Volume of Food

The number of people served or provided food, or the number of employees at an establishment at a given time (i.e., shifts) is used as a determinant of the volume of foods sold or prepared. Higher volumes of foods, which require additional handling, and the added potential of temperature abuse increase risk of foodborne illness.

8) Typical Patronage

Segments of the general population - the young, the elderly, and immuno-compromised are most vulnerable to foodborne illness and can become very ill after exposure to low doses of pathogens. The likelihood of a foodborne illness outbreak occurrence in food service establishments that provide food directly to these high risk populations (i.e. daycare centres, health care facilities, etc.), would increase.

6.2 Assignment of Risk Categories

The risk categorization for the establishment (e.g. high, moderate or low risk) is determined based on the total score for the eight factors and pre-assigned cut-off values.

Food establishments should be assigned a risk category as follows:

1. One of the three categories provided in the RCM Questionnaire should be selected based on the total score for the eight factors.
   
2. If the risk categorization obtained with the RCM Questionnaire does not adequately take into account other significant risk factors posed by the establishment, an administrator or manager may assign a final categorization that differs from the one obtained with the Questionnaire. This re-assignment is to be properly documented noting the additional factors instrumental in the change from the original risk categorization
   
3. The categorization should be reviewed at pre-determined intervals as the operational conditions within the establishment may change.

7. Summary

The RCM is intended as a national tool that can contribute to the protection of public health through risk-based inspections of food retail and food service establishments across Canada. It is based on the evaluation of eight risk factors that may be present in an establishment. Each factor has corresponding scores that correlate with the severity of the situation encountered during the inspection. The total score for the eight risk factors as well as pre-established cut-off values are used to determine if the establishment represents a high, moderate or low risk with respect to the likelihood of occurrence of a foodborne illness outbreak.

The RCM Questionnaire and Guide were pilot tested in Nova Scotia and the Yukon to gain confidence in their ability to estimate risk. As these tools become used more widely by jurisdictions across Canada, they may be reviewed and modified periodically to reflect comments and suggestions from users. Comments and suggestions can be submitted to the Working Group through the contact provided at the beginning of the document.

8. Bibliography

Blueprint for the Canadian Food Inspection System, 1995, Joint Steering Committee, Federal/Provincial/Territorial Agri-Food Inspection Committee and Federal/Provincial/Territorial Committee on Food Safety Policy

Canada Foodborne Illness Outbreak Response Protocol to Guide a Multi-Jurisdictional Response, July 2006. Federal/Provincial/Territorial Committee on Food Safety Policy.

Food Quality and Safety Systems - A Training Manual on Food Hygiene and the Hazard Analysis Critical Control Point (HACCP) System, 1998, Food and Agriculture Organization of the United Nations, Rome.

Food Retail and Food Services Code, 2004, Canadian Food Inspection System Implementation Group.

Manuals of Food Quality Control #5 Food Inspection, 1984, Food and Agriculture Organization of the United Nations, Rome.

Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1 - 1969, Rev. 4 - 2003).

Todd, E.C.D., 1983. Factors that contribute to Foodborne disease in Canada , 1973-1977, J. of Food Protection Vol.16, Pages 737-747.

Source: Risk Categorization Model, First Edition (October 2001)

Acronyms used in Table 1:

USFDA: United States Food and Drug Administration
Ont (MoH): Ontario Ministry of Health (the current name is Ontario Ministry of Health and Long-Term Care)
BC: British Columbia
NS: Nova Scotia
MAPAQ: Ministère de l'Agriculture, des pêcheries et de l'alimentation du Québec

Appendix 1 - Risk Categorization Model Questionnaire¹

Risk categorization obtained with questionnaire:

• High Risk: 165 points or more
• Moderate Risk: between 110 and 160 points
• Low Risk: 105 points or less

Document any additional risk factors noted during the visit that should be taken into consideration:

Evaluation prepared by:

Date:

Evaluation reviewed by:

Date:

Final categorization assigned by manager or administrator (if different than above):

• High Risk
• Moderate Risk
• Low Risk

Rationale for changing risk categorization obtained with the Questionnaire

(if applicable):

Appendix 2 - Guide for Use of the Risk Categorization Model Questionnaire

Purpose

This guide is intended to be used by Environmental Health Officers and Food Safety Specialists to evaluate the risk of food borne illness outbreak occurrence originating from food retail and food service establishments. For the purpose of the Risk Categorization Questionnaire, "food borne illness" refers to illness from microbial hazards. The Questionnaire takes into account eight risk factors with corresponding scores. The guide provides an explanation for each risk factor, along with direction on how to determine the corresponding score. The risk categorization for the establishment is then determined based on the total score for the eight factors.

It may be difficult to assess all eight factors for a given establishment due to the nature of the situation. For instance, a banquet hall may be used by various community groups, which makes it difficult to assess the types of food and their intended use, or the food safety knowledge of management and employees. If there is insufficient information to determine the appropriate score of a risk factor, then the recommended approach is to err on the side of safety and assign the highest score.

Compliance history is one of the eight factors considered within the Risk Categorization Questionnaire. Therefore, it is recommended the Questionnaire not be used to the determine risk categorization of a new food retail or food service establishment until at least two inspections are performed at the facility. It is assumed that a compliance inspection is routinely carried out after a pre-opening inspection, after which it would be appropriate to use the Risk Categorization Questionnaire. The guide is to be used as a complement to properly interpret the Questionnaire and is not designed to serve as a procedural inspection/inspector-oriented document.

Identified Risk Factors

The following table defines and provides direction on assessing each of the risk factors used in the Questionnaire.

¹ - Footnote: This Questionnaire should be used with the companion Risk Categorization Model Guide (Appendix 2).