Guidance for the Application of Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods

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Table of Contents

1.0 Introduction

The goal of Health Canada's Policy on Listeria monocytogenes (Lm) in Ready-to-Eat (RTE) Foods (the "Policy") is to protect the health of Canadian consumers, to provide guidance to industry and regulatory authorities regarding the verification and control of Lm in RTE foods, and finally to provide guidance to regulatory authorities regarding oversight and compliance activities of RTE foods contaminated with Lm. Processors, packers, and importers of RTE foods are responsible for complying with all applicable legislation and regulatory requirements, including Sections 4 and 7 of the Food and Drugs Act (FDA).

The RTE food industry is encouraged to be aware of and familiar with the recommended food safety practices detailed in the Policy. Processors and packers of RTE foods are also encouraged to implement effective Good Manufacturing Practices (GMPs) and/or a Hazard Analysis Critical Control Points (HACCP) system to minimize all potential sources of Lm and to verify that sanitation and other controls are effective (whereby their effectiveness can be verified by end product sampling, and environmental sampling of food contact surfaces (FCS), non-food contact surface (non-FCS)). Importers of RTE foods are encouraged to obtain information from their foreign supplier(s) related to the imported food products and/or verify compliance of end products by sampling and testing.

Although condensed explanations of the Policy are stated in this document, the Policy itself should be the official reference.

To access the Policy, go to: Policy on Listeria Monocytogenes in Ready-to-Eat Foods

2.0 Purpose

Since many Agrifood and Import and Manufactured Food Program (IMFP) inspectors are responsible for the delivery of multi-commodity programs, this document will serve to:

  1. Outline Lm oversight and rationale for Agrifood and IMFP;
  2. Develop consistent follow-up activities by these program groups when Lm is detected in the environment or the product by either industry or CFIA.

Please refer to Program manuals or procedures for specific details.

3.0 Scope

  • Agrifood Programs (Dairy, Egg, Fresh Fruit and Vegetables, Processed Products)
  • IMFP

4.0 Legal Authorities

A summary of legal authorities is available in Appendix A.

5.0 Product Risk Categories

For the purposes of the policy, RTE foods have been classified into two categories, based on health risk. Industry is responsible for generating validation data (to be assessed by the CFIA) to support the risk categorization of their RTE foods, when applicable. If insufficient, inadequate or no data is provided, products are considered category 1 by default.

Category 1 RTE foods are those which can support the growth of Lm throughout the shelf life and should therefore receive a high priority for industry verification and control as well as regulatory oversight. This category also includes any other RTE products for which validation studies, when required, are insufficient, inadequate or not provided.

Category 2 RTE foods are subdivided into two subgroups:

  • Category 2A products can support limited growth of Lm (no greater than 100 cfu/g) throughout their stated shelf life. In addition, these RTE products:
    • Are known to occasionally contain low levels of Lm and do not have a kill step (validation studies required); and/or
    • Have a refrigerated shelf life of ≤ 5 days (validation studies not required).

These products should receive medium-to-low priority for industry verification and control as well as regulatory oversight;

  • Category 2B products do not support the growth of Lm throughout shelf life and should therefore receive low priority for industry verification and control as well as regulatory oversight. Validation studies are required for this category of products, unless products are frozen or meet the specified physicochemical properties (i.e., pH and/or aw) stated in the policy.

The table below provides some examples of product categorization within each program.

Examples of products
Program Category 1 Category 2A Table Note 1 Category 2B Table Note 1 Exempted Products
Dairy Cheeses, fluid milks, cultured dairy products n/a Ice cream, hard cheese (MFFB <50%) Milk and whey powders, canned milks (evaporated, sweetened and condensed), sterilized and Ultra-high temperature (UHT) milks
Egg Pasteurized liquid egg (whole egg, yolk and albumen), egg mixes, cooked egg products n/a Frozen egg (whole egg, yolk and albumen), Omelette blends (heated before consumption), boil-in-bag products, Dried egg (albumen, yolk and whole egg)
IMFP Intraprovincially traded RTE meats (deli meats, hot dogs, pâté), fish, dairy, as well as their analogues e.g., simulated meat, simulated dairy, etc. irrespective of trade (intra/inter provincial) with a shelf life of > 5 days without validation data Intraprovincially traded fresh-cut produce, RTE meats, fish and dairy with shelf life ≤ 5 days or validation studies required Intraprovincially traded ice cream, hard cheeses, dry salami/varieties of prosciutto etc., dry salted fish, refrigerated pickles, sauerkraut Cereals, dried herbs, dried spice mixtures, dry pasta, bread, etc.
Fresh Fruit & Vegetables RTE Fresh-cut fruits and vegetables with a shelf life > 5 days without validation data RTE Fresh-cut fruits and vegetables
(with shelf life ≤ 5 days or validation studies required)
n/a n/a
Processed Products n/a n/a Refrigerated pickles, olives, and sauerkraut, frozen fruit, and frozen vegetables without cooking instructions Maple products, hermetically sealed juices, fruit and vegetable products

Table Note

Table note 1

When validation data is required but data is insufficient, inadequate or not available, Category 2A and 2B products are considered Category 1 by default.

Return to table note 1  referrer

6.0 Strategies

The inspection activities presented in this document are based on the program's legal authorities, policies, guidelines, and product risk. They include both proactive and reactive activities. Specific activities may differ for each program.

A general summary of these activities is found in the tables of this section and in Appendix A. As well, Figure A outlines the activities which should be conducted when Lm is detected in the finished product and/or when environmental sampling results demonstrate the presence of Lm.

6.1 Proactive Activities

Proactive activities can include industry communication, environmental sampling (monitoring), product sampling and assessment of industry's controls. Refer to specific program references for further information.

6.1.1 Industry Communication

Communication can occur with industry by various means on issues related to the Policy and its implementation. For example, communication can occur through website postings, letters, meetings, information sessions, symposia, and direct dialogue during routine inspection activities and correspondence.

6.1.2 Environmental Sampling

As part of their regular microbiological monitoring program, the Dairy and Processed Egg programs will use the environmental sampling plans outlined in the following table. The purpose of these plans is to monitor the effectiveness of a plant's sanitation and GMPs in preventing contamination of processing environments.

Program Description
Dairy Lm environmental monitoring program for cheese establishments. Swabs taken of FCS during production.
Egg Environmental monitoring of FCS and Non-FCS will continue; the plan now includes Lm testing. There is no additional work for Operations.

6.1.3 Product Sampling

As part of regular microbiological monitoring programs, products samples are planned under the following sampling plans:

Program Product Description
Dairy Domestic Cheese To monitor dairy products for Lm and other pathogens
Dairy Imported dairy To monitor dairy products for Lm and other pathogens
Dairy Domestic fluid milk To monitor dairy products for Lm and other pathogens
Dairy Domestic acid & rennet coagulated dairy products To monitor dairy products for Lm and other pathogens
Dairy Special plan for domestic cheese To monitor the safety of the cheese produced on the same packaging lines where FCS swabs are taken under environmental plan.
Egg Domestic processed egg Domestic product monitoring for all regulatory microbiological standards (already includes testing for Lm)
Egg Imported processed egg Import product monitoring for all regulatory microbiological standards (already includes testing for Lm)
Fresh Fruit & Vegetables Domestic RTE Fresh-cut fruit & vegetables To monitor RTE Fresh-cut fruit & vegetables for pathogens, including Lm.
Fresh Fruit & Vegetables Imported RTE Fresh-cut fruit & vegetables To monitor RTE Fresh-cut fruit & vegetables for pathogens, including Lm.
IMFP RTE Fermented Meat Directed sampling to support inspection findings
Samples will be taken at the discretion of the inspector to verify inspection observation.
IMFP RTE Non-Fermented Meat Directed sampling to support inspection findings
Samples will be taken at the discretion of the inspector to verify inspection observation.
IMFP RTE Fish Directed sampling to support inspection findings
Samples will be taken at the discretion of the inspector to verify inspection observation.
IMFP RTE FFV Directed sampling to support inspection findings
Samples will be taken at the discretion of the inspector to verify inspection observation.
IMFP Soft & semi-soft cheese Directed sampling to support inspection findings
Samples will be taken at the discretion of the inspector to verify inspection observation.
Processed Products Domestic frozen fruit To monitor frozen fruit for Lm
Processed Products Imported frozen fruit To monitor frozen fruit for Lm
Processed Products Domestic frozen vegetables without cooking instructions To monitor frozen vegetables without cooking instructions for Lm
Processed Products Imported frozen vegetables without cooking instructions To monitor frozen vegetables without cooking instructions for Lm
Processed Products Domestic refrigerated pickled products To monitor refrigerated sauerkraut, refrigerated pickles, and refrigerated olives for Lm
Processed Products Imported refrigerated pickled products To monitor refrigerated sauerkraut, refrigerated pickles, and refrigerated olives for Lm

6.1.4 Assessment of Industry's Controls

CFIA's inspection activities, including sampling activities, will assess industry's controls; however, Dairy and Egg have the following specific directions in their Inspection Manuals:

Dairy – The Dairy Program has enhanced its establishment and product inspection activities for domestic and import in order to reflect the HC Lm Policy. Additional requirements for registered establishments are described in the Dairy Establishment Inspection Manual tasks 1.10.07.01 and 1.10.07.03 in Chapter 10 and 1.13 in Chapter 9. Additional tasks have also been added for dairy importers (Dairy Product Inspection Manual, Chapter 16.6.3.1).

Egg – As part of the Processed Egg Inspection Program Activities, a Registration file review is conducted periodically, which includes a review of the stations pre-requisite programs such as the Quality Assurance program. If a deviation is noted, it is recorded on the "Processed Egg Station - Sanitation and Inspection Report (CFIA/ACIA 1082)". Depending on the severity of the deviation or non-compliance, the processed egg station is to come up with an action plan.

6.2 Reactive Activities

Reactive activities can include Industry communication, environmental sampling, product sampling and assessment of industry's controls. These activities may occur when Lm is detected in the finished product and/or when environmental sampling results demonstrate the presence of Lm. Figure A outlines the activities which should be conducted when Lm is detected in the finished product and/or when environmental sampling results demonstrate the presence of Lm. Program specialists should be consulted for further guidance.

6.2.1 Environmental Sampling

The purpose of the directed sampling plans is to follow up on previous unsatisfactory results, GMP concerns or other triggers.

Program Description
Dairy Taken from establishments exhibiting poor control over their sanitation program, with a poor compliance history or undergoing renovations.
Dairy Used as a follow-up sample when a monitoring sample is unsatisfactory.
Egg Used as a follow-up sample when a monitoring sample is unsatisfactory.
Fresh Fruit & Vegetables Food Contact Surface (FSC) samples will be collected on a case by case basis only.
IMFP On a case by case basis. These samples are collected on special request e.g. complaints/investigations.
Processed Products On a case by case basis. These samples are collected on special request e.g. complaints/investigations.

6.2.2 Product Sampling

The following sampling plans should be used for follow up to positive Lm results from monitoring sampling, complaints, illnesses, recalls etc.

Program Product Description
Dairy Domestic frozen dairy products Used for directed samples taken as follow-up to unsatisfactory monitoring samples when the inspector detects possible non-compliance.
Dairy Domestic milk powders Directed samples are taken under these plans when the inspector detects possible non-compliance.
Dairy Domestic cheese Used for directed samples taken as follow-up to unsatisfactory monitoring samples.
Dairy Imported dairy Used for directed samples taken as follow-up to unsatisfactory monitoring samples.
Dairy Domestic fermented dairy Directed samples are taken under these plans when the inspector detects possible non-compliance.
Dairy Domestic Butter Directed samples are taken under these plans when inspection detects possible non-compliance.
Dairy Domestic fluid milk Used for directed samples taken as follow-up to unsatisfactory monitoring samples.
Dairy Domestic acid & rennet coagulated dairy products Used for directed samples taken as follow-up to unsatisfactory monitoring samples.
Dairy Special plan for domestic cheese Used for directed samples taken as follow-up to unsatisfactory monitoring samples.
Dairy Domestic dairy Products Special requests for consumer/ trade complaints, illnesses, recalls etc.
Dairy Imported dairy products Special requests for consumer/ trade complaints, illnesses, recalls etc.
Egg Domestic Processed Egg Directed samples stemming from unsatisfactory monitoring samples.
Egg Imported Processed Egg Directed samples stemming from unsatisfactory monitoring samples.
Egg Special Requests Special requests such as consumer/ trade complaints, illnesses, recalls.
Fresh Fruit & Vegetables Domestic RTE Fresh-cut fruit & vegetables Directed samples stemming from monitoring sampling.
Fresh Fruit & Vegetables Imported RTE Fresh-cut fruit & vegetables Directed samples stemming from monitoring sampling.
Fresh Fruit & Vegetables Domestic Fruit & vegetables Special requests of microbiological concerns such as consumer, trade complaints, illnesses, recalls.
Fresh Fruit & Vegetables Imported Fruit & vegetables Special requests of microbiological concerns such as consumer, trade complaints, illnesses, recalls.
IMFP Fermented Meat Follow-up samples taken in response to unsatisfactory/investigative results from pro-active sampling.
IMFP Non-Fermented Meat Follow-up samples taken in response to unsatisfactory/investigative results from pro-active sampling.
IMFP RTE Fish Follow-up samples taken in response to unsatisfactory/investigative results from pro-active sampling.
IMFP RTE FFV Follow-up samples taken in response to unsatisfactory/investigative results from pro-active sampling.
IMFP Soft & semi-soft cheese Follow-up samples taken in response to unsatisfactory/investigative results from pro-active sampling.
IMFP Domestic Manufacturer Compliance Follow-up samples taken in response to unsatisfactory/investigative results from pro-active sampling.
Processed Products Domestic frozen fruit When the result of a monitoring plan is unsatisfactory, follow-up samples may be submitted.
Processed Products Imported frozen fruit When the result of a monitoring plan is unsatisfactory, follow-up samples may be submitted.
Processed Products Domestic frozen vegetables without cooking instructions When the result of a monitoring plan is unsatisfactory, follow-up samples may be submitted.
Processed Products Imported frozen vegetables without cooking instructions When the result of a monitoring plan is unsatisfactory, follow-up samples may be submitted.
Processed Products Domestic refrigerated pickled products When the result of a monitoring plan is unsatisfactory, follow-up samples may be submitted.
Processed Products Imported refrigerated pickled products When the result of a monitoring plan is unsatisfactory, follow-up samples may be submitted.
Figure A. Follow-up procedure when Lm is detected in finished product / environment
Flowchart - Follow-up procedure when Lm is detected in finished product / environment. Description follows.
Description for Follow-up procedure

Figure A outlines the activities which should be conducted when Lm is detected in the finished product and/or when environmental sampling results demonstrate the presence of Lm. Figure A outlines the activities which should be conducted when Lm is detected in the finished product and/or when environmental sampling results demonstrate the presence of Lm. Program specialists should be consulted for further guidance.

1 Evidence of persistent findings of Listeria spp. on a FCS (2 or more successive positive results from the same production line, i.e. Using the same equipment) in a short time frame should also be communicated to the CFIA.

2 Some CFIA programs may implement environmental monitoring programs.

3 As per the guidelines in Figure 1 (Step B) and Figure 2 (Step C) of the Policy.

Appendix A: Guide to the Application of HC's Listeria monocytogenes Policy for Agrifood and IMF Programs

Category/Legal Authority Dairy Processed Egg RTE Fresh-cut Fruits and Vegetables IMF Processed Products
Listeria Food Category 1 & 2B 1 & 2B 1 by default or 2A (with validation) 1, 2A, 2B 2B
Legal Authority CAPA
DPR, Part I, s 2.2(1); Part II, s 27
CAPA
PER, Part I, s 4(3)(h)
CAPA
FFVR, Part I.1, s 3.1
CAPA
PPR, Part I, s 2.1
Legal Authority FDA, s 4.1 (1) & 7 FDA, s 4.1 (1) & 7 FDA, s 4.1 (1) & 7 FDA, s 4.1 (1) & 7 FDA, s 4.1 (1) & 7
Activities by Program
Activities Dairy Processed Egg RTE Fresh-cut Fruits and Vegetables IMF Processed Products
Proactive: Industry communication Yes Yes Yes Yes Yes
Proactive: Assessment of industry's controls Yes Post processed egg approved only As per IMFP Work Specification FS338, through routine inspection activity When conducting inspection activities No
Proactive: Environmental sampling Cheese plants only Yes No No No
Proactive: Product sampling Yes Yes Yes When conducting inspection activities Frozen fruits; frozen vegetables without cooking instructions; refrigerated pickles, olives, and sauerkraut
Reactive: Industry communications Yes Yes Yes Yes Yes
Reactive: Environmental sampling Activities will be determined on a case by case basis Activities will be determined on a case by case basis Activities will be determined on a case by case basis Activities will be determined on a case by case basis Activities will be determined on a case by case basis
Reactive: Product sampling Yes Yes Yes Yes Yes
Reactive: Assessment of industry's controls Yes Yes With IMFP collaboration,
on a case by case basis
On a case by case basis Yes
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