Annex H: Policy on the Control of Listeria monocytogenes in Ready-to-Eat (RTE) Meat and Poultry Products

This page is part of the Guidance Document Repository (GDR).

Looking for related documents?
Search for related documents in the Guidance Document Repository

1.0 Listeria monocytogenes

1.1 Description

Listeria monocytogenes (L. monocytogenes) is a Gram-positive, non-spore forming, rod-shaped bacterium. It is very hardy, resistant to drying, freezing, and high salt concentrations. It can grow readily at refrigeration temperatures and in vacuum-packaged meat and poultry products. Listeria can be destroyed by thoroughly cooking meat and poultry products.

1.2 Occurrence

L. monocytogenes is widely distributed in nature, occurring in soil, sewage, vegetation, water, silage, livestock, and humans. It is well adapted to survival in cold, moist environments commonly found in meat and poultry processing establishments. Meat and poultry products most commonly associated with outbreaks of listeriosis include hot dogs, deli-meats, jellied pork tongue and pâté. Cooked meat and poultry products can be contaminated from equipment, from the handling of raw products by personnel, or from reservoirs of Listeria in the post-lethality ready-to-eat environment.

1.3 Concern

Immunocompromised individuals, pregnant women, neonates, and the elderly are most susceptible to infection. L. monocytogenes most often causes symptoms such as vomiting, nausea, cramps, diarrhoea, severe headache, constipation and persistent fever. In some instances, these symptoms may be followed by septicaemia, miscarriages, meningitis and encephalitis. Death is rare in immunocompetent persons affected with listeriosis, but is approximately 30% in the high-risk group. The infective dose for L. monocytogenes in humans is not exactly known, but may be less than 1,000 organisms/g of food consumed by some susceptible people.

This policy outlines the control measures required in meat and poultry establishments producing RTE products in order to control the risk posed by this pathogen. To understand the terminology used throughout the policy, please consult the glossary section provided at the end of this document.

2.0 Ready-to-eat meat and poultry products

Processed meat and poultry products that do not require any further preparation before consumption, except washing/ rinsing, thawing or warming, are considered RTE foods. The following definition applies to RTE meat and poultry products according to the "Meat Inspection Regulations (MIR), 1990":

"Ready-to-eat means, in respect of a meat product, a meat product that has been subjected to a process sufficient to inactivate vegetative pathogenic microorganisms or their toxins and control spores of food borne pathogenic bacteria so that the meat product does not require further preparation before consumption except washing, thawing or exposing the product to sufficient heat to warm the product without cooking it."

Warming is heating the product to a temperature that is lower than the Health Canada recommended "Safe internal cooking temperature" or other validated cooking temperature for the given product.

Products that are fully cooked in hermetically-sealed containers and are not exposed to the environment after a validated heat treatment (e.g., canned) or aseptically processed and packaged products (e.g. hot filled at lethality temperatures) and cook-in-bag products which have achieved a minimum 5-log reduction in numbers of L. monocytogenes and are not post- lethality exposed, are excluded from sampling requirements of this policy with the exception of CFIA product sampling plan (M200).

It is the responsibility of the operator to determine whether the meat product produced in the establishment is RTE or Non-RTE (NRTE) unless there is a standard of identity prescribed for the product in Schedule 1 of the MIR. A careful evaluation of an operator's Hazard Analysis Critical Control Points (HACCP) plan and validation results, as well as on-site process and product labelling verification by the Inspector-in-Charge (IIC) and/or the Food Safety Enhancement Program (FSEP) or the Area Operations Specialist, may be required to confirm classification of products into RTE or NRTE categories.

In general, if a meat or a poultry product has received a heat treatment to achieve 6.5 or 7.0 D lethality of Salmonella spp., respectively, according to time and temperature parameters listed in Manual of Procedures (MOP) Chapter 4 (Section 4.4 and Annex D) or has received a processing intervention step(s) (e.g., fermentation, dry curing, etc.) according to MOP Chapter 4, then the product is classified as RTE. If further preparation of a meat and poultry product is required (e.g., cooking) before consumption, then the product is considered as NRTE.

An assembled convenience food is a product containing meat and non-meat components. Such products are classified into RTE and non-RTE categories according to the following criteria:

Ready-to-Eat (RTE) meat products:

  1. The assembled food undergoes a full lethality step post-assembly at the establishment, e.g., fully cooked pizza, meat spaghetti sauce, frozen entrees.
  2. The meat and non-meat components of the assembled food are in RTE stage prior to their assembly at the establishment and none of them will receive further lethality treatment for pathogens before consumption, e.g., sandwiches, chicken salad, frozen entrees.

Non Ready-to-Eat (NRTE) meat products:

  1. The meat components of the assembled food have not received a full lethality treatment for pathogens of concern at the establishment, e.g., par-fried breaded chicken nuggets, par-fried pork nuggets.
  2. The meat component in the assembled food is in the RTE stage while at least one other non-meat ingredient is in the NRTE stage and will require further cooking before consumption, e.g., pizza with raw dough, frozen entrees with NRTE ingredients which require lethality treatment before consumption.

Heat-treated products or assembled convenience foods which are considered NRTE but may be mistaken as RTE products, must be labelled according to the "MIR" section 94 (6.1), i.e.,

"If any meat product is not a ready-to-eat meat product but has the appearance of or could be mistaken for a ready-to-eat meat product, the meat product shall bear the following information on its label:

  1. the words "must be cooked", "raw product", "uncooked" or any equivalent words or word as part of the common name of the product to indicate that the product requires cooking before consumption; and
  2. comprehensive cooking instructions such as an internal temperature-time relationship that, if followed, will result in a ready-to-eat meat product."

Such heat-treated meat and poultry products do not fall under this policy, and should not be tested for L. monocytogenes.

Frozen cooked meat and poultry products and frozen cooked assembled convenience foods (containing meat and poultry ingredients) that are customarily cooked before consumption will be evaluated on case-by-case basis by the IIC and the FSEP Specialist and/or Area Operations Specialist, as required, and may be considered NRTE (e.g., commercially prepared filled and non-filled refrigerated and frozen cooked pasta products). These products must be labelled with a declaration (e.g., cook and serve, cook and eat, cook thoroughly) and validated cooking instructions, such as an internal temperature-time relationship, that will result in a RTE product.

3.0 Control procedures for Listeria and classification of establishments producing RTE products

3.1 RTE product categories

Based on the health risk and the potential for the growth of L. monocytogenes, the RTE meat and poultry products are divided into the following two risk categories as per Health Canada's (HC) "Policy on Listeria monocytogenes in Ready-to-Eat Foods - 2011".

Category 1: Includes RTE products that support the growth of L. monocytogenes. These products receive highest priority for industry verification and control, and for the Canadian Food Inspection Agency (CFIA) oversight and compliance activities.

Category 2: Category 2 RTE products are further divided into two sub-categories:

Category 2A: Includes RTE products in which limited growth of L. monocytogenes to levels not greater than 100 CFU/g can occur throughout the stated shelf-life of the product. This category is meant to include RTE products which are known to occasionally contain low levels of L. monocytogenes and do not have a kill step and/or RTE refrigerated foods with a shelf-life of ≤ 5 days. For RTE products not subjected to a kill step that achieves a ≥ 5-log reduction in numbers of L. monocytogenes (i.e., achieving < 5-log reduction from non-thermal process or no kill step altogether), operators can choose to classify such products as Category 2A refrigerated RTE products with shelf-life > 5 days. When this option is chosen, operators must validate and regularly monitor that the levels of L. monocytogenes do not exceed 100 CFU/g throughout the stated shelf-life of the product. For RTE refrigerated foods with a shelf-life of ≤ 5 days, no validation is required. The validation must be conducted as per HC's guidance document "Validation of Ready-to-Eat Foods for Changing the Classification of a Category 1 into a Category 2A or 2B Food – 2012." This guidance document is available at the following site: https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/policies/validation-ready-foods-changing-classification-category-1-into-category-food-relation-policy-listeria-monocytogenes-ready-foods-2011.html

If insufficient, inadequate or no validation information is provided or the product categorisation has not been confirmed by the CFIA, the RTE product(s) will be considered, by default, as Category 1 product(s) for all sampling, verification and compliance purposes.

Category 2B: Represents RTE products in which the growth of L. monocytogenes cannot occur throughout the stated shelf-life of the product(s) i.e., a RTE food in which L. monocytogenes numbers do not increase by 0.5 log CFU/g, throughout the stated shelf-life is considered not to support growth of the organism. Growth of L. monocytogenes is assumed not to occur in RTE foods, if the physico-chemical parameters fall within the following range:

  1. pH < 4.4, regardless of aw
  2. aw < 0.92, regardless of pH
  3. Combination of factors (e.g., pH < 5.0 and aw < 0.94)
  4. Frozen RTE foods (i.e., products that are kept frozen throughout the distribution chain from the federally registered establishment to the consumer)

Scientific studies have demonstrated that products which meet these criteria are stable with respect to the growth of L. monocytogenes throughout their stated shelf-life. Therefore, validation studies are not required when Category 2B products meet the above-mentioned criteria (i.e., pH, aw, freezing). However, operators must include reference(s) to these criteria in their HACCP system and must ensure, through regular monitoring and verification, that the parameters are achieved during production.

Validation studies are required when operators choose to re-classify products that do not meet the above-mentioned criteria but apply other controls (e.g., use of antimicrobials) to re-classify products into Category 2B. If insufficient, inadequate or no validation is provided to demonstrate that there is no growth of L. monocytogenes throughout the stated shelf-life of the product, or the product categorisation has not been confirmed by the CFIA, the RTE product(s) will be considered, by default, as a Category 1 RTE product(s) for all sampling, verification and compliance purposes.

3.2 Antimicrobial agents and post-lethality procedures

Operators can employ antimicrobial agents/processes and/or post-lethality procedure(s) to suppress or limit growth of L. monocytogenes in RTE products. When such procedures are used to determine the Relative Risk Level (RRL) of a product, they must be validated by the operators and accepted by the CFIA. The operator must validate any change in the procedure to ensure the effectiveness and consistency.

Antimicrobial agents

Antimicrobial agents are food additives that are approved by Health Canada. Examples of currently approved antimicrobial agents which can be used to potentially control the growth of L. monocytogenes in RTE meat and poultry products are: Carnobacterium maltaromaticum CB1, potassium lactate, sodium acetate, sodium diacetate and sodium lactate.

RTE meat and poultry products produced using antimicrobial agent(s) which allow no more than 2 log CFU/g increase in L. monocytogenes throughout their stated shelf-life may qualify to a lower Relative Risk Level (RRL) for sampling purposes within their respective RTE product category but cannot be moved to a lower risk RTE product category.

However, Category 1 RTE products can be moved to Category 2B when permitted antimicrobial agents are used to limit the growth of L. monocytogenes to < 0.5 log CFU/g throughout the stated shelf-life of the product. When they are used to determine the category of a RTE product, operators must validate and present data to demonstrate that the growth of L. monocytogenes will be < 0.5 log CFU/g throughout the stated shelf-life.

The table of food additives that may currently be used as Class 2 preservatives to potentially control the growth of Listeria monocytogenes in ready-to-eat foods sold in Canada is available at the following site:
http://www.hc-sc.gc.ca/fn-an/legislation/pol/listeria_monocytogenes-addit-eng.php

Post-lethality procedures

Post-lethality procedures refer to procedures implemented by operators in the post-lethality processing environment to reduce or eliminate L. monocytogenes in RTE meat and poultry products. Operators can employ validated post-lethality treatment(s) to reduce the levels or inactivate any L. monocytogenes found on the surface of RTE products due to post-lethality contamination or can simply rely on sanitation measures alone (no post-lethality treatment).

RTE meat and poultry products produced using a post-lethality treatment achieving at least 3-log reduction in number of L. monocytogenes, e.g., High-Pressure Processing (HPP) at 87000 psi for 3 minutes (maximum three cycles of 3 to 9 minutes each), may qualify to a lower RRL for sampling purposes within their respective RTE product category, but cannot be moved to a lower risk RTE product category.

Novel technologies should be assessed by HC before use. Improved food processing technologies proposed by industry (e.g., steam pasteurization, hot water treatment, radiant oven heating, infrared heating) should be assessed by the CFIA, in consultation with HC as required.

3.3 Alternative methods to control L. monocytogenes in RTE products

Operators may identify the alternative method(s) under which the establishment is operating for effective control of L. monocytogenes in RTE products and environment:

Alternative 1: Employ both post-lethality treatment, that achieves at least 3-log reduction in number of L. monocytogenes, and an antimicrobial agent or process, that allows no more than 2 log CFU/g increase in L. monocytogenes throughout the stated shelf-life of the product, for the control of L. monocytogenes in RTE products.

Alternative 2A: Employ a post-lethality treatment that achieves at least 3-log reduction in number of L. monocytogenes in RTE products.

Alternative 2B: Employ an antimicrobial agent or process for control of L. monocytogenes on RTE products that allows no more than 2-log increase throughout the stated shelf-life of the product.

Alternative 3: Employ only sanitation measures to control L. monocytogenes.

The alternative methods have been designed following Food Safety and Inspection Services (FSIS) guidelines, however, the minimal L. monocytogenes reduction requirements for post-lethality treatment(s) under various alternatives have been chosen as per HC recommendations. The validation and effectiveness of antimicrobial agents/processes and post-lethality treatments must be accepted by the CFIA.

Based on available scientific information and HC's "Policy on Listeria monocytogenes in Ready-to-Eat Foods-2011," a risk-based approach is followed to further sub-classify risk within each RTE product category and alternative. The frequency of sampling of environment and RTE products produced under each Category and alternative is determined according to the RRL assigned to an establishment.

3.4 Classification of establishments

Establishments producing RTE meat and poultry products may be classified according to the RTE product risk categories (1, 2A or 2B) and the alternative methods (1, 2A, 2B or 3). All establishments must determine the RRL under which they are operating. The RRL is the overall L. monocytogenes associated risk as determined according to the following factors:

  1. RTE meat and poultry product category
  2. Antimicrobial agents/ processes, and
  3. Post-lethality procedures

Based on these factors, the following RRLs are assigned to establishments:

Table 1: Relative Risk Levels (RRL)
RTE product category Table Note 1 Alternative method 3: Sanitation/ GMP's alone Alternative method 2B: Antimicrobial(s) Table Note 2 Alternative method 2A: Post-lethality Treatment Alternative method 1: Antimicrobial(s) Table Note 2 and Post-lethality treatment
Category 1 High Medium High Medium High Medium
Category 2A Medium Medium Low Medium Low Low
Category 2B Low Very Low Negligible Negligible

Table Notes

Table Note 1

As per HC's "Policy on Listeria monocytogenes in Ready-to-Eat Foods-2011"

Return to table note 1  referrer

Table Note 2

Antimicrobial agent allowing no more than 2 log CFU/g increase in L. monocytogenes throughout the stated shelf-life of the product.

Return to table note 2  referrer

The testing frequency of an establishment is based on the RRL under which its products are produced (Negligible to High). For an establishment producing RTE products under more than one RRLs, the establishment's sampling frequency will default to the RRL under which the highest risk category RTE product(s) is produced except where there are dedicated and segregated production lines for a lower RRL. Therefore, irrespective of the product risk categories and the alternative methods, all establishments must identify their RRL for sampling, verification and compliance purposes.

Overall, establishments producing RTE products are classified into the following seven RRL groups in order of decreasing risk:

  • High
  • Medium High
  • Medium
  • Medium Low
  • Low
  • Very Low
  • Negligible

Note: For US export, there is zero tolerance for L. monocytogenes in all Categories of RTE products. All establishments eligible to export RTE products to the US will perform Food Contact Surface (FCS) and RTE product testing, assessment and follow-up procedures as described for Category 1 RTE products (i.e., Appendix 1 or 2 for FCS and Appendix 4 for RTE products testing). The sampling frequencies for an US export eligible establishment can be determined according to the criteria described for Category 1 products in section 3.4. These criteria can be assessed on case-by-case basis for establishments using dedicated and segregated production line(s) to prevent cross-contamination of products produced for export to the US.

4.0 CFIA testing program

The following programs have been designed for Listeria monitoring/verification in federally registered establishments producing RTE meat and poultry products:

  1. M205: This is a RTE environmental FCS monitoring plan for L. monocytogenes and other Listeria species in post-lethality areas. This sampling plan is linked to the random RTE product sampling plan M200 except for RTE products which are not exposed to the environment after processing.
  2. M200: This is a random RTE meat and poultry product sampling plan for monitoring of L. monocytogenes and Salmonella spp. in RTE products, as well as for E. coli O157:H7 in uncooked dry or semi-dry fermented products containing beef. The sampling plan is linked to M205 FCS monitoring plan. M200 may be conducted without a linked M205 where products are not exposed in the post lethality environment.
  3. M205RB: This is a RTE environmental (FCS) monitoring plan for L. monocytogenes and other Listeria species in post-lethality areas, and is linked to the risk based RTE meat and poultry products sampling plan M200RB.
  4. M200RB: This is a targeted risk-based RTE meat and poultry products sampling plan for L. monocytogenes. This sampling plan is linked to M205RB FCS sampling plan.
  5. The Risk-based Verification Sampling of RTE meat and poultry products: This is a CFIA sampling plan implemented by operators under CFIA supervision (Section 5.3) to monitor L. monocytogenes and Salmonella spp. in RTE products, as well as for E. coli O157:H7 in uncooked dry or semi-dry fermented products containing beef.

Note: Risk Based product sampling plan (M200RB) and FCS (M205, M205RB) apply only where product is exposed in the post lethality environment.

The sampling of FCS and/or RTE product(s) under respective sampling plans should be evenly distributed throughout the production year. Establishments engaged in seasonal manufacturing of RTE products shall be tested during the production period with the number of samples prorated accordingly.

In establishments operating with multi-commodity production lines, sampling of FCS and product(s) under CFIA or operator's sampling plans must be performed when RTE meat and poultry products are being produced. Any unsatisfactory test result originating from non-meat product(s) may have an impact on RTE meat and poultry product(s), as per the CFIA's "lot" definition, if full sanitation is not performed in-between and will impact the operators trend analysis (section 5.5).

4.1 Tracking Listeria test results by the CFIA

All Listeria test results from CFIA and operator's FCS and RTE product testing, including result(s) from follow-up testing, are tracked by the IIC. Appropriate Compliance and Verification System (CVS) tasks are rated as "satisfactory" or "unsatisfactory" based on the laboratory results. The IIC shall verify and track results of Listeria testing until the establishment has corrected the problem. The CFIA supervisor, Area Operations Specialist and the Inspection Manager are to be informed of all unsatisfactory results.

4.2 M205: Listeria environmental monitoring of FCS

All federally registered meat and poultry establishments producing RTE meat or poultry products that are exposed in the post-lethality environment shall be tested by the CFIA under this sampling plan. The purpose is to monitor the effectiveness of sanitation and Good Manufacturing Practices (GMP) in preventing contamination of RTE processing environment and products by L. monocytogenes.

The M205 sampling is conducted at the same time as the random RTE product sampling under the M200 sampling plan. Operators must be informed 24 hours in advance of sampling so that they can hold the product affected by the sampling. In multi-line operations, a production line is selected randomly on the day of sampling.

4.2.1 Sampling Frequency

Sampling frequency is stated in the "National Microbiological Sampling Guidelines and Assessment Criteria" under sampling plan M205.

4.2.2 Sampling procedures

The operational centre in each area supplies Listeria environmental sampling kits to the IIC. Instructions on sanitary sampling techniques are available in the training material "Sampling for M205". Any problems with the sampling kits should be immediately reported to the Area Operations Specialist.

Samples shall be collected and submitted to the CFIA laboratory according to the instructions provided for sampling plan M205. Pre-moistened swabs will be used to sample FCS (any surface or object that comes into contact with the RTE meat or poultry product) in the post-lethality treatment areas of the establishment. For fermented or dry-cured products, FCS should be swabbed after the point in the process where the product has achieved RTE status as per the operator's written program. Ten swabs are provided in each kit to swab 10 different FCS sites. If 10 sites are not available, a minimum of five sites must be swabbed. A 900 cm2 surface should be swabbed whenever possible. Surfaces should be swabbed three hours (T3) or more after the start of the operations. If the time of production is less than three hours, the samples should be taken in the second half of the production period. The sampling sites should be documented on Laboratory Sample Tracking System (LSTS) CFIA/ACIA 5165 Food Environmental Sampling Submission Form which accompanies the shipment to the CFIA lab. Samples should be submitted to CFIA labs as soon as possible after collection. The CFIA labs will test the composite samples for the presence of L. monocytogenes and other Listeria species.

4.2.3 CFIA Follow-up on unsatisfactory results

The IIC must inform the operator (or representative) as soon as possible, either in person and/or electronically, if L. monocytogenes or any other Listeria species has been detected (Appendix 1). The test result is unsatisfactory when L. monocytogenes is detected under M205 and, therefore, the establishment is not considered to be operating according to GMPs. The appropriate CVS sampling task(s) will be rated as "Unsatisfactory" and a Corrective Action Request (CAR) will be issued to the operator. When any other Listeria species is detected the result is assessed by CFIA laboratories as "investigative" and the follow-up actions must be performed as per section 4.2.5.

The IIC will examine the test results of the product that was sampled simultaneously under the M200 random product sampling plan from the same production lot and line that revealed unsatisfactory M205 results.

The IIC will receive a corrective action plan from the operator within 5 working days of the notification of an unsatisfactory test result. The IIC and/or the CFIA complex supervisor will review the action plan, verify the on-site activities proposed in the action plan, and oversee the operator's follow-up actions. The IIC may consult the Area Operations Specialist when required for program clarification and advice. To verify compliance, the IIC will collect a verification sample from the same FCS within three production days (Table 2) after the satisfactory completion of operator's three follow-up testing on the affected production line (i.e., after three Listeria spp. negative test results from the same FCS on three consecutive production days).

4.2.4 Operator's follow-up on unsatisfactory results

Operators receiving a CAR because of an unsatisfactory result under sampling plan M205 are required to take immediate corrective actions. The operator must also submit an action plan to the IIC within 5 working days of the notification of the unsatisfactory result. The action plan must indicate all the corrective measures that will be implemented to eliminate Listeria spp. from the RTE environment. This includes the requirement to test the same FCS free of Listeria spp., including L. monocytogenes, on three consecutive production days (Appendix 1, 2 or 3 as applicable). The operator must take corrective action(s) as soon as possible after the notification of the test result. The first follow-up sample from the same FCS must be taken on the first production day after the appropriate corrective action. The RTE product(s) produced on the affected production line must be held pending test result(s) of follow-up FCS sampling for Listeria spp. The product(s) can be released when the follow-up FCS test result is negative for Listeria spp. For more information on follow up procedures, please refer to Appendix 2 or 3.

Notes:

  1. When the product tests satisfactory under M200 (or M200RB) sampling plan and the FCS tests unsatisfactory under the linked M205 (or M205RB) sampling plan, the product can be released into the domestic market if operator's risk assessment is satisfactory.
  2. The product from a lot which came in contact with FCS contaminated with L. monocytogenes, including product which tested negative for L. monocytogenes under M200 or M200RB, is not eligible for export to the United States unless the product has undergone a process that is destructive of L. monocytogenes and acceptable to FSIS.

4.2.5 Operator's follow-up to Listeria species other than L. monocytogenes

The confirmation of Listeria species, other than L. monocytogenes, will be considered as the first detection of Listeria spp. on FCS. The operator must take appropriate corrective actions and perform follow-up testing of the same FCS for Listeria spp. on the first production day after the corrective action (Appendix 1, 2 or 3).

4.3 M200: Random RTE product testing for L. monocytogenes

This is a random sampling plan for RTE meat and poultry products. This plan applies to all RTE meat and poultry products (Category 1, 2A and 2B), whether or not they are exposed to the environment after being processed. Only one type of RTE product is randomly selected on a given production day. The RTE product is tested for L. monocytogenes, Salmonella spp., as well as for E. coli O157:H7 if it is an uncooked dry or semi-dry fermented product containing beef.

The M200 sampling plan is linked to the M205 sampling plan. In multi-line operations, a production line is randomly selected on the day of sampling. The IIC must inform operators 24 hours in advance of sampling so that they can hold the product affected by the sampling.

Table 2 a): Follow-up samples collected by the CFIA in response to unsatisfactory test results obtained under CFIA random sampling plans

RTE product testing: M200 FCS testing: M205 CFIA Verification sampling on RTE Product under the following plan Table Note 3: CFIA Verification sampling on FCS under the following plan Table Note 3:
Unsatisfactory Unsatisfactory M200D M205D
Satisfactory Unsatisfactory M200I M205D
Unsatisfactory Satisfactory M200D M205I

Table Notes

Table Note 3

The IIC must obtain a sample submission number from the Area Operations Specialist. Verification sampling is performed by CFIA within three production days after satisfactory completion of operator's follow-up testing.

Return to table note 3  referrer

Note: D is "Directed sampling", and I is "Investigative sampling."

Table 2 b): Follow-up samples collected by the CFIA in response to unsatisfactory test results obtained under CFIA risk-based sampling plans

RTE product testing:
M200RB
FCS testing:
M205RB
CFIA Verification sampling on RTE Product under the following plan Table Note 4: CFIA Verification sampling on FCS under the following plan Table Note 4:
Unsatisfactory Unsatisfactory M200RBD M205RBD
Satisfactory Unsatisfactory M200RBI M205RBD
Unsatisfactory Satisfactory M200RBD M205RBI

Table Notes

Table Note 4

The IIC must obtain a sample submission number from the Area Operations Specialist. Verification sampling is performed by CFIA within three production days after satisfactory completion of operator's follow-up testing.

Return to table note 4  referrer

Note: D is "Directed sampling", and I is "Investigative sampling."

4.3.1 Sampling frequency

The sampling frequency is stated in the "National Microbiological Sampling Guidelines and Assessment Criteria" under sampling plan M200.

4.3.2 Sampling procedures

The RTE product samples must be collected by the IIC using aseptic techniques. Five intact sample units of 250 g each are collected and submitted to the CFIA laboratory under conditions required to maintain the sample integrity. Please refer to the training module "Control measures for Listeria in RTE meat products" for information on sample collection procedures as well as the "National Microbiological Sampling Guidelines and Assessment Criteria" under sampling plan M200.

It is strongly recommended to hold the product affected by the sampling pending the receipt of the laboratory Report of Analysis (ROA). As a minimum, all products produced under the same conditions as the tested lot are considered implicated (e.g., products processed on the same day on the same processing line, or using the same equipment, between two full sanitation cycles) in the event of unsatisfactory test result. Distributed product may be subjected to a Health Risk Assessment (HRA) and a possible recall.

4.3.3 CFIA Follow-up on unsatisfactory results

The IIC must inform the operator (or representative) of the unsatisfactory test result as soon as possible, either in person and/or electronically. An establishment receiving an unsatisfactory M200 test result is not considered to be operating according to GMPs. The IIC will rate the appropriate CVS task as "Unsatisfactory," and will issue a CAR to the operator. The IIC will examine the results of M205 sampling associated with the unsatisfactory M200 product test result and rate the results according to section 4.2.3.

A composite sample (composite of 5 sub-units) is tested and the following assessment criteria are used to interpret ROA or laboratory test results:

Category 1 products:

Unsatisfactory: L. monocytogenes is detected.
Satisfactory: L. monocytogenes is not detected.

Category 2 products:

Unsatisfactory: L. monocytogenes counts >100 CFU/g in any of the five sub-units.
Investigative: L. monocytogenes is detected and counts are ≤100 CFU/g in all five sub-units. As per HC recommendations, a HRA may be required if the intended product is produced for high-risk population (Appendix 5).
Satisfactory: L. monocytogenes is not detected.

A "hold-and-test" procedure for end product testing will be initiated immediately on the affected production line by the operator under CFIA supervision (section 4.3.4). The IIC and/or the CFIA complex supervisor will review the action plan submitted by the operator and verify on-site activities proposed in the action plan. The IIC may consult the Area Operations Specialist for program clarification and advice. The IIC will collect follow-up product (five intact sample units of at least 100 g each) verification samples within three production days after the satisfactory completion of operator's hold-and-test procedure (Table 2).

4.3.4 Operator's follow-up on unsatisfactory results

Operators receiving a CAR because of an unsatisfactory result under sampling plan M200 are required to take immediate corrective actions and to submit an action plan to the IIC within 5 working days of the unacceptable test result. The action plan must indicate all the corrective measures that will be implemented to prevent product contamination by L. monocytogenes. This includes the "hold-and-test" procedure for end-product testing that must start immediately on all new production lots produced on the affected line after the notification of the unsatisfactory test result.

For follow-up actions to an "investigative" test result in category 2 product(s), please refer to Appendix 5.

Hold-and-Test procedure for RTE products:

Operators must implement hold-and-test end-product testing whenever a RTE meat and poultry product (Category 1, 2A and 2B) tests unsatisfactory for L. monocytogenes for any reason (e.g., CFIA sampling, Operator's testing, process control, client initiated testing, etc.). This is to ensure that the new product lots produced on the affected line are safe prior to their distribution. The same product that was assessed unsatisfactory under the original sampling plan should be sampled under hold-and-test. If the same product is not being produced on the sampling day, a similar product or another high-risk product can be selected from the affected line in consultation with the IIC. Five sample units, each weighing a minimum of 100 g, should be sampled by the operator and submitted to an accredited laboratory for L. monocytogenes analysis.

The product must be sampled from five consecutive production days. The product(s) can be released when the follow-up test result is reported as "satisfactory" (refer to Appendix 4 or 5). The CFIA will collect follow-up product verification sample within three production days after the satisfactory completion of operator's hold-and-test procedure. If a sample tests unsatisfactory during the follow-up testing, including CFIA verification testing, the "hold-and-test" procedure starts from the beginning.

4.4 M205RB: Listeria environmental monitoring of FCS associated with risk-based product testing under M200RB plan

This environmental sampling plan is linked to the risk based M200RB RTE product sampling plan. All federally registered establishments producing RTE meat or poultry products that are exposed in the post-lethality environment are sampled under this plan to monitor the effectiveness of sanitation and GMPs in the RTE processing environment. The FCS are tested for L. monocytogenes and other Listeria species.

Under M200RB, the highest risk product produced on the sampling day is selected and FCS are swabbed from the same production line under the M205RB plan. Where the highest risk RTE product is produced on multiple lines, a production line is selected at random. Operators must be informed 24 hours in advance of sampling so that they can hold the product affected by the sampling.

4.4.1 Sampling Frequency

The frequency of FCS sampling is based on the RTE product category and the alternative methods under which these products are produced. Refer to section 4.5.2.

4.4.2 Sampling and follow-up procedures

The FCS sampling procedures, CFIA and operator's follow-up procedures on unsatisfactory results are similar to those described under sampling plan M205 (Section 4.2).

CFIA follow-up verification sampling is performed, under the appropriate sampling plan, i.e., M205RBD, M205RBI (Table 2), within three production days after the satisfactory completion of three consecutive Listeria spp. negative tests on the same FCS by the operator.

4.5 M200RB: Risk-based RTE meat and poultry product sampling

This is a targeted risk-based monitoring plan for RTE meat and poultry products. The highest risk product produced in the establishment on the sampling day is selected for testing under M200RB. The product is tested only for the presence of L. monocytogenes. RTE meat or poultry products that are not exposed to the post-lethality environment (e.g., cooked-in-bag products which achieve a minimum 5 log reduction in numbers of L. monocytogenes) products are not sampled under this plan.

This sampling plan is linked to the M205RB environmental sampling plan. The highest risk product produced on the sampling day is selected under M200RB plan according to section 4.5.1 and the same production line is sampled under M205RB. Where the highest risk RTE product is produced on multiple lines, a production line is selected at random for sampling. The operator must be informed 24 hours in advance of sampling so that they can hold the product affected by sampling.

4.5.1 Risk prioritization of RTE products

In establishments producing more than one types of RTE product on the day of sampling, the highest risk post-lethality exposed RTE product must be sampled according to these guidelines. The products are listed in decreasing order of risk:

  1. Deli-meats that are sliced in a federally registered establishment
  2. Deli-meats shipped whole from the federal establishment (This does not include cook-in-bag products; only those exposed post-lethality)
  3. Hotdog products
  4. Deli-salads, pâtés, and meat spreads
  5. Fully cooked type products (other than cooked products in 1-4 above)
  6. Fermented products
  7. Dried products
  8. Salt-cured products
  9. Products labelled as "Keep Frozen"

Note: All these products will be considered as Category 1 products if they do not meet the physico-chemical and other relevant processing parameters of Categories 2A or 2B products as per section 3.0. Any deviation in the key processing parameter must be corrected and verified to confirm compliance and classification of product(s) into Category 2A or 2B.

4.5.2 Sampling frequency

The sampling frequency is determined according to the RRL under which products are produced as per section 3.4. The following guidelines are used to determine the sampling frequency of an establishment under M200RB and M205RB plans:

Table 3: M200RB and M205RB sampling frequencies based on RRL (samples per year)
RTE product Category Table Note 5 Alternative method 3: Sanitation/ GMP's alone Alternative method 2B: Antimicrobial(s) Table Note 6 Alternative method 2A: Post-lethality Treatment Alternative method 1: Antimicrobial(s) Table Note 6 and Post-lethality treatment
Category 1 4 3 3 2
Category 2A 2 1 1 1
Category 2B 1 1 0 0

Table Notes

Table Note 5

As per HC's "Policy on Listeria monocytogenes in Ready-to-Eat Foods-2011"

Return to table note 5  referrer

Table Note 6

Antimicrobial agent allowing no more than 2 log CFU/g increase in L. monocytogenes throughout the stated shelf-life of the product.

Return to table note 6  referrer

4.5.3 Sampling procedures

The RTE product samples must be collected using aseptic techniques by the IIC. Five intact sample units of at least 100 g each are collected and submitted to a CFIA laboratory under conditions required to maintain the sample integrity. Please refer to the training module "Control measures for Listeria in RTE meat products" for information on sample collection procedures.

It is strongly recommended to hold the product affected by the sampling pending laboratory result. In the event of an unsatisfactory test result, all products produced under the same conditions as the tested lot may be considered implicated.

4.5.4 Follow-up procedures

CFIA and operator's follow-up procedures on unsatisfactory results are similar to those described under M200 sampling plan (Section 4.3).

CFIA follow-up verification sampling is performed within three production days after the satisfactory completion of hold-and-test procedure by the operator (Section 4.3) under the appropriate sampling plan, i.e., M200RBD, M200RBI (Table 2).

4.6 CFIA's action during extended non-compliance

Operators producing RTE meat and poultry products must implement control measures when there are ongoing findings of any Listeria spp. on FCS or L. monocytogenes in the product. CFIA inspection staff will take appropriate actions, such as intensified inspection, in-depth review, etc., when the continuous presence any Listeria spp. on FCS or L. monocytogenes in the product is encountered. The situations that warrant immediate action are:

  1. Repetitive: Two consecutive unsatisfactory sampling events from samples taken from the same production line for either the product or FCS, regardless of the sampling plan, i.e., operator's sampling (mandatory or not), CFIA sampling or follow-up sampling, etc.
  2. Recurrent: Two unsatisfactory sampling events from samples taken from the same production line for either the product or FCS in a moving window of the five latest sampling events on that line, regardless of the sampling plan.
  3. Systemic: Multiple unsatisfactory sampling events from samples taken from different production lines for either the product or FCS. For example:
    • Three or more production lines have unsatisfactory results from samples taken during the same week;
    • Two or more production lines have recurrent problems.

Note: Only one sampling event can take place on a production line between two complete sanitation cycles, i.e., one sampling event/production line/day.

4.6.1 Intensified CFIA inspection

Intensified CFIA inspection is described as the extra oversight/ follow-up measures CFIA inspectors will perform during a situation of extended non-compliance by an operator. Intensified CFIA inspection is required whenever a repetitive, recurrent or systemic problem is identified. The inspector must closely monitor the implementation of an operator's action plan and take additional action(s) where necessary. Such actions may include additional verification sampling for FCS or product(s); intensified follow-up to verify implementation and effectiveness of the corrective actions and preventative measures; a reassessment of operator's action plan; and/or additional CVS tasks related to Critical Control Points (CCPs), equipment design, process validation, maintenance and calibration, sanitation, GMPs, employee/product traffic pattern, ventilation, etc., beyond the prescribed frequency.

The intensified inspection continues until compliance is achieved and the CAR is closed.

4.6.2 CFIA's in-depth review

The in-depth review is triggered when intensified inspections do not resolve the situation. The goal of an in-depth review is to identify deficiencies that may be responsible for the unsatisfactory conditions and continuing presence of Listeria in either the post-lethality processing environment or the product. An in-depth review will also assess if the operator's HACCP system:

  • Is designed to effectively control Listeria hazards;
  • Meets the FSEP and program requirements; and
  • Is reassessed to ensure Listeria hazards remain under control.

The protocol for conducting the in-depth review is available in MOP Chapter 18 (Section 18.7.1.3).

5.0 Operators program

Operators producing RTE meat and poultry products must implement adequate controls in their establishments to mitigate the risk posed by L. monocytogenes. Their HACCP system must therefore include, without being limited to, the following information as it pertains to controlling L. monocytogenes:

  1. Procedures and validation of an antimicrobial agent or a post-lethality treatment or process as per section 3.2, when used
  2. Sanitation guidelines:
    • General cleaning
    • Determining the effectiveness of Sanitation Standard Operating Procedures (Visual examination and testing)
    • Procedures (Sanitation Standard Operating Procedures (SSOP))
    • Employee/product traffic control (including prevention of cross-contamination)
    • Employee hygiene
    • Sanitizers

    Note: Cleaning and repairing of equipment(s) during operation should be avoided unless the work can be done without creating a hazard from cross-contamination.

  3. Equipment design and maintenance: Particular attention must be paid to the equipment used in the RTE processing area. More precisely, the equipment must be fit for the proposed use, and be well designed for easy cleaning and evaluation after sanitation. Operators must provide a detailed description of procedures that will ensure proper disassembly, maintenance and sanitation of the inner gear-housings for all equipment used for slicing and/or cutting RTE products.
  4. Extra precautions are necessary to control employee traffic, product flow and environment during construction and maintenance activities.
  5. Take into consideration the end-user of the RTE products.
  6. For processes which do not include a kill step (such as the production of prosciuttos or uncooked fermented products), control of the microbiological quality of the incoming raw ingredients, including microbiological specifications for the raw meat.
  7. All establishments using the same facility or common equipment to produce Category 1 and 2 (2A or 2B) RTE products must have controls within their HACCP system, including plans, GMPs, control documents, product segregation and sanitation steps to prevent cross-contamination. For example, the cross-contamination can be prevented by using dedicated production line/equipment or by processing Category 1 products at the beginning of the operation or after full clean-up and sanitation.
  8. Validate and regularly monitor the appropriate product parameters to confirm and justify the classification of RTE products into Category 2A or 2B according to section 3.0.

In order to demonstrate product compliance, operators have to verify the effectiveness of their HACCP controls by implementing the following mandatory sampling procedures:

  1. Mandated environmental sampling of FCS as per section 5.2.
  2. The Risk-based Verification Sampling of RTE Meat and Poultry Products according to section 5.3.

In addition, it is recommended that operators implement environmental sampling of non-food contact surfaces (NFCS) as per section 5.4.

5.1 Laboratory procedures

The following requirements are applicable to both the mandated environmental FCS testing as well as any product testing performed by operators as part of the Listeria verification:

  1. All samples have to be analyzed in an accredited laboratory, except non-mandated FCS and NFCS samples.
  2. The methods of analysis to be used by the laboratories have to be within the scope of their accreditation or evidence must be available to demonstrate that the process is underway for adding the method to the scope of accreditation with the accrediting body (e.g., Standards Council of Canada [SCC], Canadian Association for Laboratory Accreditation [CALA]). However, this does not apply to operator's non-mandated FCS and non-mandated NFCS samples.
  3. The operator shall indicate, for each sample submitted, the method of analysis that is to be used by the laboratory. Acceptable methods can be obtained from the HC's "Compendium of Analytical Methods" at the following site. The "application" section of the method chosen must be appropriate for the intended purpose.

    Other methods of analysis (e.g., AOAC, ISO, NMKL, FSIS, BAM etc.), for both L. monocytogenes in food product and environmental samples and Listeria spp. in environmental samples, will be considered with the provision of validation data acceptable to the CFIA to support the requested method. For consideration of alternative methods, please contact the CFIA Food Safety Science Directorate (FSSD), Executive Director.

    Positive results from any rapid screening methods are considered presumptive. Listeria spp. confirmation and speciation of L. monocytogenes can be accomplished by using motility agar, hemolysis and carbohydrate testing as a minimum, as described in MFHPB-30.

  4. The operator must inform the CFIA of all L. monocytogenes and/or Listeria spp. test results by a written or electronic notification as soon as possible, as per the written program.
  5. The CFIA will verify compliance to these criteria.

Notes:

  1. Any follow-up testing required by the operator in response to an unsatisfactory test result is considered mandatory testing.
  2. Category 2 products submitted for testing must meet specific criteria (e.g., pH, aw, freezing, antimicrobials, etc.) which must be verified by operators, as applicable, to confirm and justify their classification into Category 2A or 2B according to section 3.0.

5.2 Operator's mandated sampling of Food Contact Surfaces

Operators must design, implement and maintain environmental sampling programs for testing FCS for the presence of L. monocytogenes or Listeria spp. Testing of FCS for Listeria spp. and reacting to positive results as if they were L. monocytogenes (e.g., intensive cleaning and sanitation) provides a more sensitive and broader Listeria control program in RTE meat processing establishments than would testing for L. monocytogenes alone (HC's Policy on Listeria monocytogenes in Ready-to-Eat Products, 2011; Industry Best Practices - Draft, 2012 - PDF (670 kb))

The testing frequencies specified below (Section 5.2.3) for FCS must be met or exceeded.

5.2.1 Target organism for operator's mandated sampling of FCS

Operators may test FCS for L. monocytogenes or Listeria spp. as per (Appendix 2 or 3). The first detection of Listeria spp. on a FCS will trigger corrective actions, such as intensive cleaning and sanitation, but 2 and 3 consecutive findings of Listeria spp. on the same FCS for Category 1 and 2 production lines, respectively, will be considered "unsatisfactory" and follow-up procedures are required as per Appendix 2 and 3. The product produced on those unsatisfactory FCS sampling days must be tested for L. monocytogenes.

Operators can opt to test FCS for L. monocytogenes or to confirm a presumptive positive Listeria spp. test result at the time of first testing of FCS. When this option is chosen, it is recommended to hold the product pending lab results. If L. monocytogenes is confirmed on FCS and the result is considered "unsatisfactory," the product must also be tested for L. monocytogenes. The confirmation of Listeria species, other than L. monocytogenes, will be considered as the first detection of Listeria spp. on FCS and follow-up sampling of the same FCS is required for Listeria spp. (Appendix 2 and 3).

5.2.2 Sample collection for operator's mandated sampling of FCS

Operators must follow industry best practices when implementing FCS sampling programs in the post-lethality processing environment. Operators should collect samples from ten (10) different FCS sites from each production line. This will be considered as one sampling event for the selected production line. If 10 FCS sites are not available, a minimum of 5 sites must be sampled. Operators must also provide a rationale to the IIC for testing less than ten (10) sites. No more than ten (10) samples should be composited, as this process makes it more difficult to trace the source of the contamination. Operators should not mix FCS samples with NFCS samples. Should the operator decide to mix different sites the result will be considered as affecting a FCS, but will not count toward the minimum number of tests required for FCS. The individual locations for the composite sample should be noted to assist in determining the site of contamination when an unsatisfactory result is obtained.

The surfaces must be swabbed three hours (T3) or more after the start of the operation. This will provide a reliable assessment of the working conditions as the elapsed time will have allowed surfaces to be inoculated. If the time of production is less than three hours, the samples must be taken in the second half of the production shift. Should operators wish to specifically verify the sanitation of a specific structure or equipment, additional samples may be taken prior to start-up (T0). The CFIA strongly encourages this practice. A 900 cm2 surface should be swabbed whenever possible.

When testing for Listeria spp. on a FCS (Appendix 2 or 3, as applicable) and when the next sampling is scheduled before the results of the previous FCS test are received, it is strongly recommended to hold the product, pending the laboratory report, since an unsatisfactory result may trigger the need to test this product.

Please refer to section 5.1 for sampling methodology requirements.

5.2.3 Testing frequency for operator's mandated sampling of FCS

Food contact surfaces on each production line must be tested at the following minimum frequencies. The sampling frequency is determined according to the RRL under which RTE products are produced as per section 3.4. For an establishment producing more than one category of RTE products under different RRLs, the establishment's sampling frequency will default to the RRL under which the highest risk RTE product(s) is produced. A dedicated production line used exclusively for the production of a lower risk RTE product may be sampled at a lower frequency; however, a written proposal must be submitted to the IIC for approval. Sampling of FCS must be evenly distributed throughout the prescribed period. In certain situations the production line(s) may be out of production for part of the specified period of time (e.g., one or more weeks in a month). In such instances, it is not necessarily expected that the sampling be compressed into the remaining portion of the period. The operator identifies the production line, the time period for which the line is out of operation and provides the reason as to why the line is out of operation. Samples which would normally have been collected during this period of inactivity would not need to be collected. When the line returns to normal operation, sampling of FCS for the remaining week(s) of that month is performed at regular frequency.

Table 4a): FCS testing frequency per production line per year according to RRL
RTE product Category Table Note 7 Alternative method 3: Sanitation/ GMP's alone Alternative method 2B: Antimicrobial(s) Table Note 8 Alternative method 2A : Post-lethality Treatment Alternative method 1: Antimicrobal(s) Table Note 8 and Post-lethality treatment
Category 1:
Non-deli, non-hot Dogs
12 (1/month) 6 (1/2 month) 6 (1/2 month) 4 (1/3 months)
Category 2A 4/year 2/year 2/year 1/year
Category 2B 2/year 1/year 0 0

Table Notes

Table Note 7

As per HC's "Policy on Listeria monocytogenes in Ready-to-Eat Foods-2011"

Return to table note 7  referrer

Table Note 8

Antimicrobial agent allowing no more than 2 log CFU/g increase in L. monocytogenes throughout the stated shelf-life of the product.

Return to table note 8  referrer

Table 4b) FCS testing frequency per production line per year according to RRL for Category 1: Deli products and Hot-dogs
Plant Production Volume Table Note 9 Alternative method 3: Sanitation/ GMP's alone Alternative method 2B: Antimicrobi-al(s) Table Note 10 Alternative method 2A : Post-lethality Treatment Alternative method 1: Antimicrobial(s) Table Note 10 and Post-lethality treatment
Very small 12 (1/month) 6 (1/2 month) 6 (1/2 month) 4 (1/3 months)
Small 24 (2/month) 12 (1/month) 12 (1/month) 6 (1/2 month)
Medium 36 (3/month) 18(3/2month) 18(3/2month) 12 (1/month)
Large 48 (4/month) 24(2/month) 24(2/month) 12 (1/month)

Table Notes

Table Note 9

Antimicrobial agent allowing no more than 2 log CFU/g increase in L. monocytogenes throughout the stated shelf-life of the product.

Return to table note 9  referrer

Table note 10

Very small: up to 100,000 kg of deli and hot-dogs products produced per year

Small: from more than 100,000 kg to up to 2,000,000 kg of deli and hot-dogs products produced per year

Medium: from more than 2,000,000 kg to up to 6,000,000 kg of deli and hot-dogs products produced per year

Large: more than 6,000,000 kg of deli and hot-dogs products produced per year

Return to table note 10  referrer

Note: Deli products include sliced and un-sliced deli meats, deli-salads, pâtés, and meat spreads.

5.2.4 Results and follow-up for operator's sampling of FCS

As indicated under section 5.1, operators must inform the IIC of any L. monocytogenes and Listeria spp. test results as soon as possible, including non-mandated FCS test results, as per their written program. The IIC must inform the CFIA complex supervisor and the Area Operations Specialist of any unsatisfactory test results.

RTE product(s) from lines that have tested positive for Listeria spp. at any time, may not be eligible for export until the follow-up sample from the same FCS reveals a negative test result for Listeria spp. Refer to additional country specific export requirements in MOP Chapter 11.

The first detection of Listeria spp. on a FCS must trigger corrective actions by the operator as soon as possible after the notification of the test result. These actions must include but are not limited to intensive cleaning and sanitation. The follow-up sample must be taken on the first production day after the appropriate corrective action as per Appendix 2 or 3.

The operator must ensure, in addition to the immediate corrective actions, that full HACCP deviation procedures are implemented in accordance with the FSEP Manual. The detection of Listeria spp. on FCS is an indicator of poor GMPs and/or sanitation procedures. CFIA inspector will issue a Verification Report and follow up as required.

The FCS test result is considered unsatisfactory when:

  1. L. monocytogenes is detected on a FCS at any time
  2. Two consecutive test results reveal Listeria spp. on a line producing Category 1 product
  3. Three consecutive test results reveal Listeria spp. on a dedicated line producing Category 2 product

For a production line producing Category 1 products, two consecutive tests, including the original and the follow up test, confirming Listeria spp. on the same FCS is considered unsatisfactory (Appendix 2). This will trigger the same follow-up actions as if L. monocytogenes was detected on the FCS, including RTE product testing for L. monocytogenes.

For a dedicated production line producing Category 2 products, three consecutive tests, including the original and follow-up tests, confirming Listeria spp. on the same FCS will be considered unsatisfactory (Appendix 3). This will require the same follow-up actions as if L. monocytogenes is detected on the FCS, including RTE product testing for L. monocytogenes.

Unsatisfactory FCS test results will trigger the following actions:

  1. The IIC will issue a CAR to the operator under the applicable CVS task. The operator must present an action plan to the IIC within 5 working days.
  2. The operator must take corrective action(s) as soon as possible after the notification of the test result. The first follow-up sample from the same FCS must be taken on the first production day after the appropriate corrective action(s).
  3. The same FCS that were included in the original FCS sample must be tested, either individually or as a composite sample, on three consecutive production days. The product(s) produced on the affected line must be held pending laboratory test results of follow-up FCS sampling.
  4. The follow-up test results must be negative for Listeria spp. on three consecutive production days.
  5. If any follow-up FCS test is positive for Listeria spp., test the held product from the same lot for L. monocytogenes (alternatively, operators can start FCS follow-up testing and product testing simultaneously) and restart the FCS test sequence from the beginning.
  6. If the product on hold tests positive for L. monocytogenes, operator will either condemn the product or rework on the product as per the HACCP system.

The IIC and the CFIA complex supervisor shall ensure that results of Listeria testing are tracked until the establishment has corrected the problem. To verify compliance, the IIC will collect FCS verification sample within three production days after the completion of three consecutive Listeria spp. negative FCS tests by the operator (Table 5). An evaluation may be done to determine whether or not intensified CFIA inspection or an in-depth review should be conducted.

Table 5: Follow-up samples collected by the CFIA for unsatisfactory test results obtained under an operator's FCS and product sampling plans
RTE product testing FCS testing CFIA Verification sampling on RTE Product Table Note 11 CFIA Verification sampling on FCS Table Note 11
Unsatisfactory Unsatisfactory MX200 MX200
Unsatisfactory Satisfactory MX200 MX200
Satisfactory Unsatisfactory None If needed Table Note 12

Table Notes

Table note 11

Verification sampling is performed by the CFIA under the following plan within three production days after satisfactory completion of operator's follow-up testing.

Return to table note 11  referrer

Table Note 12

FCS samples are collected under MX200 based on previous history or trend analysis. Consult Area Operations specialist.

Return to table note 12  referrer

5.3 CFIA's Risk-Based Verification Sampling of RTE Meat and Poultry Products performed by operators

All operators producing RTE meat or poultry products that are exposed to the environment after processing must implement the CFIA's "Risk-Based Verification Sampling of Ready-to-Eat (RTE) Meat and Poultry Products". This sampling plan targets all RTE meat and poultry products that are exposed to the processing environment after the lethality step or after achieving the RTE status.

5.3.1 Frequency of testing

The testing frequency increases as the level of associated food safety risk increases. The testing frequency of an establishment is based on the RRL under which products are produced (Refer to section 3.4). For an establishment producing products under different RRLs, the establishment's sampling frequency will default to the RRL under which the highest risk category product(s) is produced. The following product sampling frequencies must be followed:

Table 6: Product sampling frequencies based on RRL (samples per year)
RTE product Category Table Note 13 Alternative method 3: Sanitation/GMP's alone Alternative method 2B : Antimicrobial(s) Table Note 14 Alternative method 2A: Post-lethality Treatment Alternative method 1: Antimicrobial(s) Table Note 14 and Post-lethality treatment
Category 1 12 9 9 6
Category 2A 6 4 4 2
Category 2B 2 1 1 1

Table Notes

Table note 13

As per HC's "Policy on Listeria monocytogenes in Ready-to-Eat Foods-2011"

Return to table note 13  referrer

Table Note 14

Antimicrobial agent allowing no more than 2 log CFU/g increase in L. monocytogenes throughout the stated shelf-life of the product.

Return to table note 14  referrer

5.3.2 Sample collection

The operator is responsible for the sample collection process that includes the following steps:

1. Appropriate training of the designated employee(s).

2. Collection of RTE product samples is done under direct CFIA supervision and according to the product risk prioritization (section 4.5.1).

3. Operators must have a written sampling program for risk-based testing of RTE products that covers sample collection, preparation and shipping procedures. It shall also cover means to ensure tamper-evidence (e.g., sealing samples under CFIA supervision), to protect the integrity of samples and to maintain the chain of custody (e.g., how samples are handled, packaged and shipped).

The shipping procedures shall specify:

  1. who packages the samples and where the packaging is done;
  2. where samples are kept pending shipment;
  3. who ships the samples; and
  4. where (laboratory) and how samples are shipped (shipping agent).

The general guidelines for the sample collection, shipping and integrity protection are provided in section 5.3.8.

4. The VIC/IIC (Veterinarian/Inspector-in-Charge) will review and approve the establishment's written program. The VIC/IIC will verify the sampling activities and will complete the appropriate CVS task.

It is recommended to hold the sampled "lot" pending laboratory result.

5.3.3 Target Pathogens

The samples will be analysed for L. monocytogenes and Salmonella spp. If the product is an uncooked dry or semi-dry fermented sausage and contains beef, it will also be analysed for E. coli O157:H7.

5.3.4 Methods of analysis

From sub-samples submitted as per section 5.3.8, five 25 g test portions/samples for a total of 125 g sample size will be analysed for L. monocytogenes using an acceptable cultural (presence/ absence) method. Enumeration must be performed on any Category 2A or 2B sample that is presumptive or confirmed positive by presence / absence testing. Enumeration will be performed on five 10 g test portions/samples for a total of 50 g sample for L. monocytogenes using an acceptable quantitative method. Sample units must be analysed individually.

Furthermore, five 65 g test portions/samples for a total of 325 g sample size will be analysed for Salmonella spp. The analysis for E. coli O157:H7, when required, will be conducted on five 65 g test portions/samples for a total of 325 g sample size.

Guidance on whether sample units may be composited or not can be found within the analytical method chosen for testing. The following analytical methods are to be used:

  • Listeria monocytogenes

The operator shall indicate, for each sample submitted, the method of analysis that is to be used by the laboratory. Acceptable methods can be obtained from the HC's "Compendium of Analytical Methods" at the following site. Note that the most recent published version of the method should be used. The "application" section of the method chosen must be appropriate for the intended purpose.

  • Salmonella spp.

The operator shall indicate, for each sample submitted, the method of analysis that is to be used by the laboratory. Acceptable methods for Salmonella spp. testing are as follows:

MFLP-06: Detection of Salmonella spp. in foods using the 3M™ Molecular Detection System Test Kit.

MFLP-20: The Genequence® Salmonella Microwell Assay for the Detection of Salmonella in a Variety of Foods

MFLP-29: The Qualicon Bax® System Method for the Detection of Salmonella in a Variety of Food and Environmental Samples

MFHPB-24: Detection of Salmonella spp. in Foods by the Vidas SLMTM Method™

MFLP-32: Identification of Salmonella species using the Adiafood rapid pathogen detection system, a real-time PCR technique

MFLP-38: Detection of Salmonella spp. from all foods and selected environmental surfaces using iQ-Check™ Salmonella Real-Time PCR Test Kit

MFLP-49: Detection of Salmonella spp. in foods bythe VIDAS® UP Salmonella (SPT) method.

MFHPB-20: Methods for the Isolation and Identification of Salmonella from Foods and Environmental Samples

The above listed methods can be obtained from the HC's "Compendium of Analytical Methods" at the following site. The most recent published version of the method should be used and the "application" section of the method chosen must be appropriate for the intended purpose:
https://www.canada.ca/en/health-canada/services/food-nutrition/research-programs-analytical-methods/analytical-methods/compendium-methods.html

  • E. coli O157:H7

The operator shall indicate, for each sample submitted, the method of analysis that is to be used by the laboratory. Acceptable methods for E. coli O157:H7 testing can be obtained from the HC's "Compendium of Analytical Methods" at the following site. The most recent published version of the method should be used and the "application" section of the method chosen must be appropriate for the intended purpose:
https://www.canada.ca/en/health-canada/services/food-nutrition/research-programs-analytical-methods/analytical-methods/compendium-methods.html

The samples must be analysed in an accredited laboratory, i.e., a laboratory that is formally recognized by the SCC, CALA, or another accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement (MRA) as conforming to the requirements of ISO/IEC 17025:2005. Approved methods must be included in the laboratory scope of accreditation.

Note: Operators must follow MOP Chapter 11 for guidance on export to the US. Alternate methods identified in Chapter 11 will be considered acceptable only for products that are exclusively exported to the United States

5.3.5 Laboratory reports

  1. The laboratory report must clearly indicate the common name of the product tested as well as the date on which the sample was collected by the operator.
  2. The laboratory report must be sent simultaneously to both the operator and the CFIA's Food Safety Division in Ottawa by email or fax:
    email: RTE-PAM@inspection.gc.ca, or fax: 613-773-5959
  3. The laboratory report must be assessed for L. monocytogenes, Salmonella spp. and, if applicable, for E. coli O157:H7 as per the criteria provided in section 4.3.3.
  4. The operator must also advise the IIC upon reception of the laboratory analysis.

Please note that if, for whatever reason, the laboratory is unable to analyse and make an evaluation of the sample submitted for analysis, a replacement sample must be sent as soon as possible.

5.3.6 Follow-up on positive results

  1. CFIA and operator's follow-up procedures to unsatisfactory test results for RTE meat and poultry products (Category 1 or 2A or 2B), including hold-and-test, are similar to those described under M200 sampling plan (Section 4.3) and appendix 4 or 5 as appropriate. CFIA will collect follow-up product samples under sampling plan MX200 (Table 5), Special Request Microbiological Testing- Red Meat and Poultry Products.
  2. The CFIA notification procedures must be clearly outlined in the written sampling program (e.g., who in the company will notify the VIC/IIC when the analysis is completed and the result is unsatisfactory, e.g., L. monocytogenes is detected in a sample).
  3. When pathogens other than L. monocytogenes are detected, the follow-up procedures will be determined on a case-by-case basis in consultation with the Area Operations Specialist.
  4. The sampled lot must remain under operator's control. In the unlikely event that the sampled lot was distributed before the positive result was received or if it is determined that there are other products in distribution that are implicated or potentially implicated by the positive result, the CFIA will immediately notify the Area Recall Coordinator. If any of the involved product was exported, the regulatory authority of concerned countries would also be immediately notified. For example, FSIS would be informed and provided with the distribution details of products that had been exported to the United States.

5.3.7 Record keeping

All laboratory reports should be kept for at least one year after the end of the sampled product's shelf-life. Other records should be kept as per the operator's HACCP plan.

5.3.8 General guidelines for sample collection, shipping procedure, and for the maintenance of the integrity of samples:

  1. Sample collection must be performed on a RTE product.
  2. Sample collection will be carried out by the individual who is designated in the establishment's written protocol and has received the required training. Sampling supplies, such as sterile gloves, sterile sampling solutions, hand soap, sanitizing solution, etc., as well as specific materials needed for sampling, will need to be assembled prior to beginning sample collection.
  3. A sample consisting of five sample units shall be drawn at random from each lot selected for sampling. Each sample unit shall consist of 250 g or five intact units weighing at least a total of 1250 g. Do not sample the same lot(s) which has been sampled by CFIA under M200 or M200RB sampling plans.
  4. Unopened, original containers shall be sampled, when possible.
  5. If the product is in bulk, several sample units can be collected from one container, while ensuring that the total number of sample units is not collected from one container. More than one sample unit may also be collected from large institutional or bulk containers when the total number of sample units required exceeds the number of containers in the lot. The collected sample units shall be placed in sterile containers. A sample unit will consist of more than one container when the lot consists of containers smaller than 150 g (e.g., six - 25 g containers in each sample unit).
  6. Aseptic techniques shall be employed in collecting the sample units.
  7. The samples must be properly identified. This includes the name of the product, the production date or code, and the lot of production they represent (in the event that the laboratory results should be unsatisfactory). The production lot must be identified and acceptable according to CFIA policy (please refer to the glossary for lot definition).
  8. Depending on the nature of the product, the sample units must either be kept refrigerated (0-4°C) or frozen at all times. The temperature of refrigerated samples must not exceed 7°C upon their arrival at the laboratory.
  9. The operators must have a written procedure explaining how they ensure that samples are protected from temperature abuse during sampling, storage and transportation to the laboratory, as well as from potential tampering.
  10. Samples must be sent to a laboratory accredited to perform the analysis by the methods considered acceptable (refer to section 5.3.4).

5.4 Operator's sampling of Non-Food Contact Surfaces (NFCS)

The primary purpose of environmental sampling in RTE establishments is to verify the effectiveness of the sanitation procedures and GMPs. All establishments producing RTE meat and poultry products should implement sampling programs to monitor NFCS for Listeria spp. Operators should perform investigative NFCS sampling when there are repetitive, recurrent or systemic non-compliances or as a part of intensified inspections and in-depth reviews (section 4.6). If Listeria spp. is present, this should be taken as an evidence of the need to improve the control of Listeria spp. in the processing environment.

The sampling frequency can be determined according to Industry Best Practices and should be evenly distributed throughout the year. The recommended procedure and follow-up actions for testing NFCS for Listeria spp. are described in Appendix 6.

NFCS samples can be analysed by using methods deemed appropriate for the purpose by the industry. It is not mandatory to use an accredited laboratory for analysis of NFCS samples. All sampling results must become part of the operator's Listeria trend analysis and must be available to the CFIA upon request.

Note: Implementation of a sampling program for NFCS is mandatory in federal establishments eligible to export RTE meat and poultry products to the US. Please refer to MH MOP Chapter 11 for detailed information.

5.5 Operator's trend analysis of results

Performing trend analysis on test results is an essential component of any sampling program designed to monitor a microbiological risk. Operators are therefore required to include this procedure in their HACCP system. They must also indicate the parameters that they will use to assess whether or not the risk is controlled. When the risk is not controlled, corrective actions must be implemented.

All test results (e.g. mandated testing, non-mandated testing, client initiated testing, non-meat commodity testing, NFCS, FCS or product,) must be included in the trend analysis. Particular attention must be paid to the follow-up actions taken when the number of unsatisfactory results obtained is either high or on the increase, as well as, when the Listeria detection is moving from a NFCS to a FCS. The operator must react to these situations in a rapid and efficient way. In addition, if the establishment often finds itself in such a situation, it would indicate that the provisions of the HACCP system are not stringent enough to control the risk posed by Listeria. All pertinent aspects of the HACCP system must then be re-evaluated and the required adjustments implemented.

Appendix 1. Procedures when Food Contact Surfaces (FCS) are tested for Listeria spp., including L. monocytogenes, on production lines used for Category 1 and 2 products (M205 and M205 RB).

Click on image for larger view
Procedures when Food Contact Surfaces (FCS) are tested for Listeria spp., including L. monocytogenes, on production lines used for Category 1 and 2 products (M205 and M205 RB). Description follows.

Description for image: This flow chart shows the procedures when Food Contact Surfaces (FCS) are tested for Listeria spp., including L. monocytogenes, on production lines used for Category 1 and 2 products (M205 and M205 RB).

It is recommended to hold the product pending test results when Food contact surface is tested (Test 1)

There are three possible results and procedures for each:

  • Positive for L. monocytogenes,
  • Positive for other Listeria spp.; and,
  • Negative for all Listeria spp.

Positive for L. monocytogenes, (Test 1)

  • The result is considered Unsatisfactory. For follow-up actions operators must refer to “Unsatisfactory result” box on Appendix 2 or 3 as appropriate.
  • Examine product test results sampled under M200 or M200RB
    • Product test result positive for L. monocytogenes is Unsatisfactory result
    • Product test result negative for L. monocytogenes
      • Release the product

Positive for other Listeria species (Test 1)

  • Investigative result: For follow-up actions operators must refer to ”investigative result” box on Appendix 2 or 3 as appropriate.
  • Release the product if product test result is satisfactory

Negative for all Listeria species. (Test 1)

  • Release the product if product test result is satisfactory
  • Continue normal sampling schedule

Appendix 2. Operator's procedures when Food Contact Surfaces are tested for Listeria spp. or L. monocytogenes on production line(s) used for Category 1 products (dedicated or non-dedicated lines).

Click on image for larger view
Operator's procedure when Food Contact Surfaces are tested for Listeria species on production line(s) used for Category 1 products (dedicated or non-dedicated lines). Description follows.

Description for image: This flow chart explains the procedures when Food Contact Surfaces (FCS) are tested for Listeria spp. or L. monocytogenes on dedicated or non-dedicated production line(s) used for Category 1 products. This is Test 1.

There are three possible results and procedures for each:

  • Positive for L. monocytogenes,
  • Positive for Listeria spp.; and,
  • Negative for Listeria spp.

Positive for L. monocytogenes (Test 1)

  • The result is considered unsatisfactory and operator must take following actions:

Unsatisfactory Result:

  • Respond to Corrective Action Request (CAR)
  • Intensive sanitation and cleaning
  • Review of appropriate sections of HACCP system
  • Test product for L. monocytogenes from the lot produced when FCS was sampled according to Appendix 4. Product testing is not required if testing has been conducted under M200 and M200RB.
  • Start testing the same FCS for Listeria spp. on the first production day after corrective action(s)

Operator must follow the FCS testing procedure:

FCS Testing Procedure:

  • Continue testing the same FCS for three consecutive production days
  • Hold product pending test result
  • If any follow-up test is positive for any Listeria spp., test the product from the same lot for L. monocytogenes and restart the FCS test sequence from the beginning until three consecutive negative test results are obtained.

Note:

  1. If any FCS tests positive for L. monocytogenes, the product from the same lot must also be tested for L. monocytogenes.
  2. The IIC will collect verification sample from the same FCS within three production days after the completion of operator's three consecutive Listeria spp. negative test results.

Positive for Listeria spp. (Test 1)

  • The result is considered investigative and operator must take following actions:

Investigative result:

  • Corrective Action (Intensive sanitation & cleaning)
  • Review of appropriate sections of HACCP system
  • Follow-up test on the same FCS for Listeria spp. on the first production day after corrective action(s) (Test 2)
  • CFIA recommends holding product(s) from Test 2

In case the follow-up Test (Test 2) is positive for any Listeria spp. the result is considered unsatisfactory and operator must take following action:

Unsatisfactory result

  • Respond to Corrective Action Request (CAR)
  • Intensive sanitation and cleaning
  • Review of appropriate sections of HACCP system
  • Test product for L. monocytogenes from the lot produced when FCS was sampled according to Appendix 4. Product testing not required if testing has been conducted under M200 and M200RB.
  • Start testing the same FCS for Listeria spp. on the first production day after corrective action(s)

Operator must follow the FCS testing procedure:

FCS testing procedure

  • Continue testing the same FCS for three consecutive production days
  • Hold product pending test result
  • If any follow-up test is positive for any Listeria spp., test the product from the same lot for L. monocytogenes and restart the FCS test sequence from the beginning until three consecutive negative test results are obtained.

Note:

  1. If any FCS tests positive for L. monocytogenes, the product from the same lot must also be tested for L. monocytogenes .
  2. The IIC will collect verification sample from the same FCS within three production days after the completion of operator's three consecutive Listeria spp. negative test results.

Or

In case the follow-up Test (Test 2) is negative for all Listeria spp.. product can be released and operator will follow normal sampling schedule for FCS.

Negative for Listeria spp. (Test 1)

If the results are negative for Listeria spp. then operator will follow normal sampling schedule for FCS.

Appendix 3. Operator's procedure when Food Contact Surfaces are tested for Listeria spp. on production line(s) dedicated to Category 2A or 2B products.

Click on image for larger view
Operator's procedure when Food Contact Surfaces are tested for Listeria species on production line(s) dedicated to Category 2A or 2B products. Description follows.

Description for image: This flow chart shows the procedures when Food Contact Surfaces (FCS) are tested for Listeria spp. or L. monocytogenes, on production lines dedicated for Category 2A and 2B. This is Test 1.

There are three possible results and procedures for each:

  • Positive for L. monocytogenes,
  • Positive for Listeria spp.; and,
  • Negative for Listeria spp.

Positive for L. monocytogenes (Test 1)

  • The result is considered unsatisfactory and operator must take following actions:

Unsatisfactory Result:

  • Respond to Corrective Action Request (CAR)
  • Intensive sanitation and cleaning
  • Review of appropriate sections of HACCP system
  • Test product for L. monocytogenes from the lot produced when FCS was sampled according to Appendix 5. Product testing is not required if testing has been conducted under M200 and M200RB.
  • Start retesting the same FCS for Listeria spp. on the first production day after corrective action(s)

Operator must follow the FCS testing procedure:

FCS Testing Procedure:

  • Continue testing the same FCS for three consecutive production days
  • Hold product pending test result
  • If any follow-up test is positive for any Listeria spp., test the product from the same lot for L. monocytogenes and restart the FCS test sequence from the beginning until three consecutive negative test results are obtained.

Note:

  1. If any FCS tests positive for L. monocytogenes, the product from the same lot must also be tested for L. monocytogenes.
  2. The IIC will collect verification sample from the same FCS within three production days after the completion of operator's three consecutive Listeria spp. negative test results.

Positive for Listeria spp. (Test 1)

  • The result is considered investigative and operator must take following steps:

Investigative result:

  • Corrective Action (Intensive sanitation & cleaning)
  • Review of appropriate sections of HACCP system
  • Follow-up test on the same FCS for Listeria spp. on the first production day after corrective action(s) (Test 2)

In case the follow-up Test (Test 2) is positive for Listeria spp. the operator must take following action:

  • Corrective Action (Intensive sanitation & cleaning)
  • Review appropriate sections of HACCP system
  • Follow-up test on the same FCS for Listeria spp. on the first production day after corrective action(s) - (Test 3)
  • CFIA recommends holding product from Test 3 sampling day until results are known

In case the follow–up Test 3 is positive for any Listeria spp. then the result is considered unsatisfactory and operator must take following actions:

Unsatisfactory result

  • Respond to Corrective Action Request (CAR)
  • Intensive sanitation and cleaning
  • Review of appropriate sections of HACCP system
  • Test product for L. monocytogenes from the lot produced when FCS was sampled according to Appendix 5. Product testing not required if testing has been conducted under M200 and M200RB.
  • Start retesting the same FCS for Listeria spp. on the first production day after corrective action(s)

Operator must follow the FCS testing procedure below:

FCS testing procedure

  • Continue testing the same FCS for three consecutive production days
  • Hold product pending test result
  • If any follow-up test is positive for any Listeria spp., test the product from the same lot for L. monocytogenes and restart the FCS test sequence from the beginning until three consecutive negative test results are obtained.

Note:

  1. If any FCS tests positive for L. monocytogenes, the product from the same lot must also be tested for L. monocytogenes.
  2. The IIC will collect verification sample from the same FCS within three production days after the completion of operator's three consecutive Listeria spp. negative test results.

Or

In case the follow-up Test (Test 2) is negative for all Listeria spp. the product can be released and operator will follow normal sampling schedule for FCS.

Or

In case the follow-up Test (Test 3) is negative for all Listeria spp. the product can be released and operator will follow normal sampling schedule for FCS.

Negative for Listeria spp. (Test 1)

If the results are negative for Listeria spp. then operator will follow normal sampling schedule for FCS.

Appendix 4. Operator's and CFIA's procedures when Category 1 product(s) is tested for L. monocytogenes

Click on image for larger view
Operator's or Canadian Food Inspection Agency's procedure when Category 1 product(s) is tested for Listeria monocytogenes. Description follows.

Description for image: This flow chart explains the procedures when Category 1 product(s) are tested for L. monocytogenes

There are two possible results and procedures:

  • L. monocytogenes detected
  • L. monocytogenes not detected

L. monocytogenes detected

  • The result is considered unsatisfactory and operator must take following actions:

Unsatisfactory Result:

  • Corrective Action Request (CAR) issued by inspector.
  • Operator submits an acceptable action plan - Intensive sanitation and cleaning; review appropriate sections of HACCP system
  • Operator condemns or reworks the affected product(s)
  • Health Risk Assessment is conducted before the reworked product is released. For Health Risk Assessment contact the Area Operations Specialist.
  • Implement Hold-and-Test procedure on current production on the affected line for 5 consecutive production days according to section 4.3.4

In case the product is positive for L. monocytogenes during the Hold and Test procedure the operator must take following action:

  • Corrective action
  • Intensive sanitation and cleaning; review appropriate sections of HACCP system
  • Operator condemns or reworks the affected product(s)
  • Health Risk Assessment is conducted before the reworked product is released. For Health Risk Assessment contact the Area Operations Specialist.
  • Restart hold-and-test from the beginning

In case the product is negative for L. monocytogenes during the Hold and Test procedure the product can be released.

Note: The IIC will collect follow-up product verification sample within three production days after the satisfactory completion of operator's hold-and-test procedure.

L. monocytogenes not detected

  • The product can be released if L. monocytogenes not detected.

Appendix 5. Operator's and CFIA's procedures when Category 2 product(s) are tested for L. monocytogenes.

Note: Operators to follow MOP Chapter 11 for guidance on export to the US.

Click on image for larger view
Operator's or Canadian Food Inspection Agency's procedure when Category 2 product(s) are tested for Listeria monocytogenes. Description follows.

Description for image: This flow chart shows the procedures when Category 2 are tested for L. monocytogenes (Lm), It is recommended to hold the product of the sampling day until results are received.

Note: Operators must follow Manual of Procedures (MOP) Chapter 11 for guidance on export to the US.

The testing proceeds to Enrichment method (presence/absence testing) of Lm on composite of 125g (5 subunits of 25g each) and there are two possible results:

  • Presumptive positive
  • Lm not detected

Lm not detected

  • The product can be released if Lm is not detected

Presumptive positive

It is subject to confirmatory test for detection of Lm. If Lm is detected, there are two possibilities:

1. In case there is >100 CFU/g in any of the 5 subunits in Test 1 the result is considered Unsatisfactory and operator must take following action:

Unsatisfactory Result:

  • Corrective Action Request (CAR) issued by CFIA
  • Operator submits an acceptable action plan
  • Intensive sanitation and cleaning
  • Review appropriate sections of HACCP system
  • Verify processing parameters (pH, aw, freezing, antimicrobial) used for classification of product into Category 2 as per section 3.1
  • Operator condemns or reworks the affected product(s)
  • Health Risk Assessment (HRA) will be conducted before the reworked product is released. For Health Risk Assessment contact the Area Operations Specialist.
  • Implement Hold-and-Test procedure on current production on the affected line for five consecutive production days according to section 4.3.4.

During Hold-and–Test if there is any unsatisfactory result the operator must take following actions:

  • Corrective action
  • Intensive sanitation and cleaning
  • Review appropriate sections of HACCP system
  • Verification of processing parameters
  • Operator condemns or reworks the affected product(s)
  • Health Risk Assessment will be conducted before the reworked product is released. For Health Risk Assessment contact the Area Operations Specialist.
  • Restart Hold-and-Test from the beginning

If the results are satisfactory during the Hold-and-Test procedure the product can be released.

Note: The IIC will collect follow-up product verification sample within three production days after the satisfactory completion of operator's hold-and-test procedure.

2. In case all subunits are ≤100 CFU/g (i.e., no subunit is >100 CFU/g) - Test 1 the result is considered Investigative and operator must proceed to Step 1 which includes the following:

Step 1:

  • Appropriate corrective action(s) and verification of processing parameters (e.g., pH, aw, anti-microbial etc.) used for classification of product into Category 2
  • Product cannot be released for consumption by high–risk population groups, cannot be mixed into Category 1 products and cannot be exported if it does not meet importing country's requirements for L. monocytogenes tolerance limits
  • Appropriate corrective actions and follow-up testing of Category 2 product (n=5) from another lot immediately after the corrective actions.

During the follow-up testing (Test 2) there are three possible results:

1. Lm not detected (Test 2)

The result is satisfactory and product can be released if Lm is not detected

2. In case there is >100 CFU/g in any of the 5 subunits in Test 2, the result is considered Unsatisfactory and operator must take following action:

Unsatisfactory Result

  • Corrective Action Request (CAR) issued by CFIA
  • Operator submits an acceptable action plan - Intensive sanitation and cleaning
  • Review appropriate sections of HACCP system
  • Verify processing parameters (pH, aw, freezing, antimicrobial) used for classification of product into Category 2 as per section 3.1.
  • Operator condemns or reworks the affected product(s)
  • Health Risk Assessment (HRA) will be conducted before the reworked product is released. For Health Risk Assessment contact the Area Operations Specialist.
  • Implement Hold-and-Test procedure on current production on the affected line for five consecutive production days according to section 4.3.4.

During Hold-and–Test if there is any unsatisfactory result the operator must take following actions:

  • Corrective action
  • Intensive sanitation and cleaning
  • Review appropriate sections of HACCP system
  • Verification of processing parameters
  • Operator condemns or reworks the affected product(s)
  • Health Risk Assessment will be conducted before the reworked product is released. For Health Risk Assessment contact the Area Operations Specialist.
  • Restart Hold-and-Test from the beginning

If the results are satisfactory during the Hold-and-Test procedure the product can be released.

Note: The IIC will collect follow-up product verification sample within three production days after the satisfactory completion of operator's hold-and-test procedure.

3. In case there is Presumptive positive or Lm detected and all subunits are ≤100 CFU/g (Test 2) the result is considered investigative and operator must proceed to Step 1 which includes the following:

Step 1:

  • Appropriate corrective action(s) and verification of processing parameters (e.g., pH, aw, anti-microbial etc.) used for classification of product into Category 2
  • Product cannot be released for consumption by high–risk population groups, cannot be mixed into Category 1 products and cannot be exported if it does not meet importing country's requirements for L. monocytogenes tolerance limits
  • Appropriate corrective actions and follow-up testing of Category 2 product (n=5) i.e., Test 3 from another lot immediately after the corrective actions.

During the follow-up testing (Test 3) there are three possible results:

1. Lm not detected (Test 3)

The result is satisfactory and product can be released if Lm is not detected

2. In case there is >100 CFU/g in any of the 5 subunits in Test 3, the result is considered Unsatisfactory and operator must take following action:

Unsatisfactory Result

  • Corrective Action Request (CAR) issued by CFIA
  • Operator submits an acceptable action plan
  • Review appropriate sections of HACCP system
  • Verify processing parameters (pH, aw, freezing, antimicrobial) used for classification of product into Category 2 as per section 3.1 of the policy
  • Operator condemns or reworks the affected product(s)
  • Health Risk Assessment (HRA) will be conducted before the reworked product is released. For Health Risk Assessment contact the Area Operations Specialist.
  • Implement Hold-and-Test procedure on current production on the affected line for five consecutive production days according to section 4.3.4.

During Hold-and–Test if there is any unsatisfactory result the operator must take following actions:

  • Corrective action
  • Intensive sanitation and cleaning
  • Review appropriate sections of HACCP system
  • Verification of processing parameters
  • Operator condemns or reworks the affected product(s)
  • Health Risk Assessment will be conducted before the reworked product is released. For Health Risk Assessment contact the Area Operations Specialist.
  • Restart Hold-and-Test from the beginning

If the results are satisfactory during the Hold-and-Test procedure the product can be released.

Note: The IIC will collect follow-up product verification sample within three production days after the satisfactory completion of operator's hold-and-test procedure.

3. In case there is Presumptive positive or Lm detected in Test 3 and all subunits are ≤100 CFU/g, the result is considered unsatisfactory and operator must take following action:

Unsatisfactory Result

  • Corrective Action Request (CAR) issued by CFIA
  • Operator submits an acceptable action plan - Intensive sanitation and cleaning
  • Review appropriate sections of HACCP system
  • Verify processing parameters (pH, aw, freezing, antimicrobial) used for classification of product
  • into Category 2 as per section 3.1 of the policy
  • Operator condemns or reworks the affected product(s)
  • Health Risk Assessment (HRA) will be conducted before the reworked product is released. For Health Risk Assessment contact the Area Operations Specialist.
  • Implement Hold-and-Test procedure on current production on the affected line for five consecutive production days according to section 4.3.4 of the policy.

During Hold-and–Test if there is any unsatisfactory result the operator must take following actions:

  • Corrective action
  • Intensive sanitation and cleaning
  • Review appropriate sections of HACCP system
  • Verification of processing parameters
  • Operator condemns or reworks the affected product(s)
  • Health Risk Assessment will be conducted before the reworked product is released. For Health Risk Assessment contact the Area Operations Specialist.
  • Restart Hold-and-Test from the beginning

If the results are satisfactory during the Hold-and-Test procedure the product can be released.

Note: The IIC will collect follow-up product verification sample within three production days after the satisfactory completion of operator's hold-and-test procedure.

Appendix 6. Recommended procedure for testing Non-FCS (NFCS) for Listeria spp.

Click on image for larger view
Recommended procedure for testing Non-food contact surface for Listeria species. Description follows.

Description for image: This flow chart shows the recommended procedure for operator's when Non-Food Contact Surfaces (NFCS) are tested for Listeria spp.

There are two possible results and procedures for each:

Negative for Listeria spp. (Test 1)

In case the result is negative the operator can follow normal sampling schedule for NFCS.

Positive for Listeria spp. (Test 1)

  • The operator is recommended to do intensive sanitation and cleaning and take a follow-up test for Listeria spp. on the same NFCS as soon as possible after the notification of test result (Test 2)

During follow-up Test 2, there are two possibilities:

  • Negative for Listeria spp. (Test 2)
    In case there is a negative Listeria spp. test during follow-up Test 2, the operator can follow normal sampling schedule for NFCS
  • Positive for Listeria spp. (Test 2)
    In case there is a positive Listeria spp. test during follow-up Test 2, the operator is recommended to repeat intensive sanitation and cleaning and do a follow-up test for Listeria spp. on the same NFCS as soon as possible after the notification of test result (Test 3)

During follow-up Test 3, there are two possibilities:

  • Negative for Listeria spp.. on same and/or adjoning NFCS (Test 3)
    In case there is a negative Listeria spp. test during follow-up Test 3, the operator can follow normal sampling schedule for NFCS.
  • Positive for Listeria spp. on same and/or adjoning NFCS (Test 3)
    In case there is a positive Listeria spp. test during follow-up Test 3, the operator is recommended to repeat intensive sanitation and cleaning and test adjoining FCS for Listeria spp. according to Appendix 2 or 3, as applicable. The operator may continue follow-up testing for Listeria spp. on the same and adjoining NFCS until NFCS tests negative.

Glossary

Antimicrobial agent
A substance in or added to a RTE product that has the effect of reducing or eliminating a microorganism, including a pathogen such as L. monocytogenes, or that has the effect of suppressing or limiting growth of L. monocytogenes in the product throughout the stated shelf-life of the product. Examples of antimicrobial agents that can be added to RTE meat and poultry products: Carnobacterium maltaromaticum CB1, sodium diacetate, sodium lactate and potassium lactate either alone or in combination.
Antimicrobial process
An operation, such as freezing, applied to a RTE product that has the effect of suppressing or limiting the growth of a microorganism, such as L. monocytogenes, in the product throughout the stated shelf-life of the product.
Deli product
A ready-to-eat meat or poultry product that is typically sliced, either in an official establishment or after distribution from an official establishment, and is typically assembled in a sandwich for consumption. Deli products include sliced and un-sliced deli meats, deli-salads, pâtés, and meat spreads.
Food Contact Surface (FCS)
Any surface or object in the post-lethality processing environment that comes in contact with the RTE meat or poultry product.
Hotdog product
A ready-to-eat meat or poultry frank, frankfurter, or wiener.
Lethality treatment
A process, including the application of an antimicrobial agent, which eliminates or reduces the number of pathogenic microorganisms on or in a product to make the product safe for human consumption. Examples of lethality treatments are cooking or the application of an antimicrobial agent or process that eliminates or reduces pathogenic microorganisms.
Lot
For the sampling purpose, a lot is defined as all products produced under the same conditions using the same equipment, which are produced between two satisfactory complete sanitation operations. A sanitation operation is considered satisfactory if it cuts off the transfer of microbial contamination from one lot to another. The lot size should be the same as the one used by the operator in normal circumstances for commercial purposes. The operator cannot reduce the size of the lot in anticipation of testing requirements.
Post-lethality exposed product
A ready-to-eat product that comes into direct contact with a food contact surface after the lethality treatment in a post-lethality processing environment (This excludes cook-in-bag products).
Post-lethality processing environment
The area of an establishment into which product is routed after having been subjected to an initial lethality treatment. The product may be exposed to the environment in this area as a result of slicing, peeling, re-bagging, cooling semi-permeable encased product with a brine solution, or other procedures.
Post-lethality treatment
An intervention step that is applied or is effective after post-lethality exposure e.g. HPP. It is applied to the sealed package of RTE product in order to reduce or eliminate the level of pathogens resulting from contamination from post-lethality exposure.
Date modified: