Implementation of the 2011 Health Canada Policy on Listeria monocytogenes in Ready-to-Eat Foods

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The following information in the implementation of the 2011 Health Canada Policy on Listeria monocytogenes in ready-to-eat foods was shared with industry in a presentation at meetings held during March and April 2012.

Fish, Seafood and Production Division
March 2012

Objectives

  1. To introduce the Health Canada (HC) 2011 Policy on Listeria monocytogenes in Ready-to-Eat Foods (hereafter referred to as the Listeria policy) to registered establishments and importers
  2. To explain the impact of the policy on fish and fish products
  3. To provide information on the CFIA's role in the implementation, oversight and enforcement of the 2011 HC Listeria policy
  4. To provide information on industry's roles and responsibilities in relation to the 2011 policy.

Overview of the presentation

  1. Reason for the HC Listeria Policy Revision
  2. General characteristics of Listeria monocytogenes
  3. Roles and responsibilities
  4. Foods that are subject to the HC Listeria policy
  5. HC RTE food categories
  6. Fish Inspection Program guidance documents
  7. Validation process
  8. Next steps

Key reference documents

  1. Fish Products Standards and Methods Manual, Appendix 2: Bacteriological Guidelines for Fish and Fish Products
  2. Fish Products Standards and Methods Manual, Appendix 2, Classification of Ready-to-Eat (RTE) Foods
  3. Guidelines on the Control Measures for Preventing the Contamination and Growth of Listeria monocytogenes (Appendix I)
  4. Guidelines for the Development of an Environmental Sampling Program (Appendix J)

Reason for the HC Listeria Policy Revision

Effective Date
April 1, 2011

  • Health Canada is responsible for setting food safety standards
  • CFIA is responsible for enforcing these standards

Why was a revision needed?

  • Listeriosis outbreak in 2008 resulting in 23 deaths
  • Findings of an independent investigator - Weatherill Report, 2009
  • Changes in international food safety guidance on Listeria monocytogenes (Codex Alimentarius - 2007 and 2009)

Key Revisions

1. Amendment of RTE product categories

Note that now, fewer products fall under the lower risk category

Lower risk products characteristics:

Before (under 2004 policy):

  • pH < 5, or
  • Aw ≤ 0.92, or
  • pH < 5.5 and Aw <0.95, or
  • refrigerated for ≤10 days

Now (2011 version):

  • pH < 4.4, or
  • Aw < 0.92, or
  • pH < 5 and Aw < 0.94, or
  • refrigerated for ≤ 5 days

Unchanged: frozen until consumption RTE products

2. New end product action levels:

Category 1: Detected in 125 g (2004 ~ Detected in 25 or 50 g)
Category 2 (2A and 2B): >100 CFU/g

3. Environmental monitoring program (i.e., swabbing)

Should be included in all plants producing RTE foods

4. "Notify regulator"

Included in follow up for industry when industry finds Listeria monocytogenes in products or Listeria spp. on Food Contact Surfaces (FCS)

5. Post-lethality treatments

and/or the use of Listeria growth inhibitors (e.g., sodium diacetate) is encouraged

General Characteristics of Listeria monocytogenes

Facts about Listeria monocytogenes

General characteristics:

  1. Pathogenic to humans
  2. Found in soil, water, drains, ventilation systems, cracks, etc.
  3. Grows between -0.4 and 45°C
  4. Can live with or without oxygen
  5. Wide pH range (4.4 or greater)
  6. Water activity (Aw) ≥ 0.92

Unique Characteristics:

  • Listeria monocytogenes is widely present in the natural environment
  • Listeria monocytogenes can grow in foods stored under refrigerated temperatures

Roles and Responsibilities

RTE food processors, RTE food importers

Processors and Importers must ensure that the foods they sell comply with all applicable legislative and regulatory requirements including Sections 4 and 7 of the Food and Drugs Act (FDA) and relevant sections of the Fish Inspection Act and Regulations

The 2011 HC Listeria Policy provides recommendations regarding the verification, monitoring and control of Listeria and can be of assistance to industry in complying with the FDA

In order to demonstrate due diligence, the recommendations outlined in the HC Listeria Policy should be applied by industry

The HC Listeria Policy outlines the minimum actions that should be taken to prevent the presence of harmful levels of L. monocytogenes in finished RTE foods

Industry can always go above and beyond these recommendations

RTE food processors

The HC Listeria Policy advises that RTE food processors minimize the potential for Listeria spp. contamination by:

  • Implementing effective QMP controls to minimize all potential sources of food contamination
  • Implementing other controls when possible (e.g., Listeria monocytogenes inhibitors and post-lethality treatments)

The HC Listeria Policy advises that RTE food processors should monitor and verify the effectiveness of their Listeria controls by:

  • Implementing an environmental sampling program
  • Conducting end-product testing when appropriate

RTE food importers

The HC Listeria Policy advises that RTE food processors minimize the potential for Listeria spp. contamination by:

Obtaining information on the products they sell:

  • Product parameters (e.g., pH and Aw)
  • Product shelf life
  • Whether or not the product was manufactured using effective GMPs and/or HACCP system for control of Listeria monocytogenes

Government

Health Canada

  • Develops food safety standards and policies to help minimize the risk of foodborne illnesses
  • Consults with CFIA and the provincial/territorial governments on these standards and policies
  • Helps Canadians maintain and improve their health

Canadian Food Inspection Agency

  • Protects Canadians from preventable health risks
  • Protects consumers through a fair and effective food, animal and plant regulatory regime that supports competitive domestic and international markets
  • Contributes to the security of Canada's food supply and agricultural resource base

Provincial/Territorial Governments

  • Work together with CFIA to conduct oversight activities of the food industry, such as: providing information to industry, assessing establishment's Listeria controls, taking compliance action, conducting food safety investigations.

CFIA's Responsibilities

  • Works with provincial and territorial governments to ensure food safety requirements are met in the food industry.
  • Inspects establishments and audit their Quality Management Programs (QMPs)
  • Samples and tests product, water, ice and the processing environment
  • Assesses validation data, process controls and verification procedures

Consumers

Canadian consumers are responsible for learning and adopting the following practices:

  • Responsible food selection
  • Safe food handling and storage
  • Safe food preparation practices

Foods that are subject to the HC Listeria Policy

The Listeria Policy applies to Ready-To-Eat (RTE) foods sold in Canada, whether domestically produced or imported

The ListeriaPolicy does not apply to RTE foods prepared in retail establishments and food service establishments

See the definition of "RTE food" in the 2011 HC Listeria policy for more details regarding products covered/not covered.

RTE Foods

  • Foods that: do not require further preparation prior to consumption, other than washing/rinsing, thawing or warming.

Products not subject to the HC Listeria policy

  • Products that are fully cooked in a hermetically sealed container and are not exposed to the environment after a validated heat treatment.
  • Processed products which require cooking and which are clearly labelled with adequate cooking instructions
  • Raw fish or seafood, which includes live molluscan shellfish, are not covered by the policy. Exception: sushi, which is subject to the provisions of the HC Listeria policy.

Health Canada RTE Food Categories

RTE Food Categories Defined in the HC Listeria Policy

RTE Foods

  • Category 1 (High priority for oversight)
  • Category 2 (Med - Low Priority for oversight)
    • Category 2A (Med to Low Priority for oversight)
    • Category 2B (Low Priority for oversight)
HC RTE Food Category 1

Category 1 (High priority for oversight)

  • RTE foods in which the growth of L. monocytogenes can occur.
  • RTE products with a shelf life >5 days with no validated control measures

Examples - Refrigerated seafood pâtés or mousses may be classified as Category 1 RTE foods because their pH and water activity generally supports the growth of L. monocytogenes.

Action Level - Detected

  • These foods should receive the highest priority for industry verification and control, as well as regulatory oversight and compliance activities.
  • The presence of Listeria monocytogenes in these products would lead to follow-up actions.
  • A Health Risk 1 concern would likely be triggered and a public alert and recall may be issued if the food has left the control of the processor.
HC RTE Food Category 2

Category 2A

  • RTE products, which are known to occasionally contain low levels of L. monocytogenes and do not have a kill step
  • Refrigerated RTE products with a shelf life of 5 days or less.
  • RTE products with shelf life > 5 days and reviewed and confirmed validation studies by regulatory authorities

Example - sushi

Action Level > 100 CFU/g

  • These foods should receive a medium to low priority with regards to industry verification and control, as well as regulatory oversight and compliance activities
  • The presence of L. monocytogenes at levels > 100 CFU/g in a Category 2A food will lead to follow-up actions and will likely trigger a Health Risk 2 level of concern
  • However, the food becomes a Health Risk 1 concern if it is intended to be produced for a high-risk population group (e.g., a hospital or a retirement home) or intended for use in a Category 1 food

Category 2B

Action Level > 100 CFU/g

RTE products in which the growth of L. monocytogenes cannot occur throughout the stated shelf life:

  • stored under "frozen" conditions until consumption; or
  • have a pH < 4.4; or
  • have an Aw < 0.92; or
  • have a pH < 5.0 and the Aw < 0.94;
  • or products not meeting the physico-chemical parameters above, with a refrigerated shelf life > 5 days, and validated control measures
Food Categories Defined in the Listeria Policy
Category 1Category 2ACategory 2B
Definition Includes RTE foods in which Lm can grow Includes RTE foods in which Lm can grow to levels of 100 CFU/g or less Includes RTE foods in which Lm cannot grow
Nature of Concern Health Risk 1 Health Risk 2
(Health Risk 1 if Lm levels are >100 CFU and food is intended for high risk groups or intended for use in Cat 1 food)
Health Risk 2
(Health Risk 1 if Lm levels are >100 CFU and food is intended for high risk groups or intended for use in Cat 1 food)
Level of Priority
(control, monitoring, verification, oversight)
High Medium
(unless the food is intended for high risk groups or intended for use in a Cat. 1 food)
Low
(unless the food is intended for high risk groups or intended for use in a Cat. 1 food)
Examples Mousse smoked salmon and sushi frozen shrimp, pickled herring

CFIA Decision Tree

CFIA Listeria Decision Tree - Figure 1 of Appendix 2 of the Fish Products Standards and Methods Manual

Listeria monocytogenes Guidelines
Product Type / CategoryLaboratory methodAction Level
  • Category 1 RTE Fish products
    (The growth of L. monocytogenes can occur and could exceed 100 CFU/g before the end of the stated shelf-life.)
  • RTE products with a shelf life > 5 days.
Presence/absence in 125 g
(MFHPB-30 or equivalent) on 5 sample units of 25 g each
Detected
  • Category 2A RTE Fish products
    (The growth of L. monocytogenes can occur but would not exceed levels greater than 100 CFU/g before the end of the stated shelf-life)
  • Refrigerated RTE products with a shelf-life of ≤ 5 days
  • Refrigerated RTE products with a shelf-life of > 5 days validated to not support, to the end of shelf life, the growth of Lm to levels exceeding 100 CFU/g
Enumeration in 50 g
(MFLP-74 or equivalent) on 5 sample units of 10 g each
> 100 CFU/g
  • Category 2B RTE Fish products
    (The growth of L. monocytogenes cannot occur throughout the shelf life.)
  • Frozen until consumption RTE products
  • RTE products with a pH <4.4
  • RTE products with an Aw <0.92
  • RTE products with a pH <5.0 and an Aw <0.94
  • RTE product validated to have Lm growth of < 0.5 log CFU/g
Enumeration in 50 g
(MFLP-74 or equivalent) on 5 sample units of 10 g each
> 100 CFU/g
Approved Additives:
AdditivesPermitted in or uponMaximum level of useReferences
Sodium diacetate Prepared and preserved fish products, such as smoked fish Up to 0.25% of final product weight Interim Market Authorization published in Canada Gazette Part I: February 14, 2009

Processing Aids:

Health Canada has issued a "Letter of No Objection" for the use of Listex P100 (bacteriophage) in cold-smoked fish and other food products.

Fish Inspection Program Guidance Documents

New

Updated

New Document - Guidelines on the Control Measures for Preventing the Contamination and Growth of Listeria monocytogenes (Appendix I of the QMP Reference Standard)

  • Provide guidance on the development and implementation of control measures for Listeria monocytogenes by establishments.
  • The control measures are meant to prevent, eliminate or reduce L. monocytogenes to an acceptable level as well as control and prevent conditions that will enable growth and/or contamination.
  • The control of L. monocytogenes depends on:
    • product characteristics;
    • processing methods;
    • equipment and establishment design.
  • Under the Quality Management Program (QMP), the control measures must be identified as part of either the:
    • HACCP plan as a Critical Control Point (CCP);
    • Prerequisite Program; or
    • Regulatory Action Plan (RAP)

Product-related Control Measures

  • Incoming materials (ingredients)
  • Product formulation (Aw, pH)
  • Food additives and/or processing aids (inhibitors)
  • Storage conditions (inhibits growth) (frozen)
  • Shelf life (restricting the shelf life of refrigerated products to 5 days or less)

Process-related Control Measures

  • Temperature/time controls
  • Lethality treatment ("kill step")
  • Packaging and filling
  • Post-lethality treatments

Establishment-related Control Measures (pre-requisites)

  • Prevention of cross-contamination (sanitary zones);
  • Enhanced sanitation controls;
  • Equipment design and maintenance;
  • Personnel hygiene and training programs;
  • Instructions for visitors, maintenance and cleaning staff.

Verification of Control Measures

The effectiveness and implementation of the control measures used to eliminate, inhibit and prevent the growth of L. monocytogenes can be verified through:

  • Environmental testing; and
  • Product testing.

New Document - Guidelines for the Development of an Environmental Sampling Program (Appendix J of the QMP Reference Standard)

  • Developed as a tool to assist processors in establishing an Environmental Sampling Program for Listeria spp., including Listeria monocytogenes, in the processing environment.
  • The 2011 HC Listeria Policy states that establishments producing RTE foods should implement an Environmental Sampling Program, which would be integrated to their Quality Management Program (QMP).
  • Environmental sampling assesses the effectiveness of QMP controls in RTE processing environments and the potential for product contamination
  • If industry tests for the presence of L. spp. in the environment and responds to any positive results in a responsible manner, the risk of producing foods contaminated with potentially harmful levels of Listeria monocytogenes can be minimized.

The guidelines document includes:

  • factors to consider when developing the program;
  • elements to include in the program;
  • the response to follow when Listeria spp. is present in the processing environment and;
  • the response to follow when there's evidence of persistent contamination in an establishment.

Factors to Consider:

  • The Type of RTE Product
  • Type of Process/Operation
  • Consumer/Target groups
  • Historical Information

Elements

  1. Sampling Procedures
  2. Testing Method
  3. Target Organism
  4. Sampling Sites
  5. Sampling Frequency
  6. Review
  7. Response when Listeria spp. is detected in the processing environment

Figures 1 and 2 from the 2011 HC Listeria Policy will now be discussed.

Trend Analysis and Review

  • Should be part of an establishment's verification process
  • Can be used to detect trends which may indicate the presence of bacterial niches or biofilms
  • Allows the establishment to be more proactive in investigating and mitigating possible sources of Listeria spp.
  • The results of trend analysis should be used to achieve improved control of Listeria over time

Updated Document - Process Control Document Requirements

The document on Process Control Requirements for imported products has been revised and separated into 2 documents:

  1. Regulatory Standard on Process Control Document Requirements; and
  2. Guide to Process Control Technical Information

Regulatory Standard

  • Regulatory requirements for process control documents
  • Internationally recognized control measures
  • Type of processing information required

Guide to Process Control Technical Information

  • Technical information, on the control measures, critical limits and critical factors
  • Product examples

Important changes:

  • New: The guide identifies the HC category which applies to each type of RTE product based on the storage conditions, shelf life, use of inhibitors and use of safety parameters (pH, Aw).
  • New: Information on the sanitation program and other GMPs is now included as a means to demonstrate, in the absence of other processing controls, that a RTE product was processed under sanitary conditions.

Validation Process

Validation

"Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome."

(Codex Alimentarius Commission)
www.codexalimentarius.net/download/standards/11022/cxg_069e.pdf

Validation - Who conducts Validation?

Industry

  • It is the responsibility of the processor/importer to demonstrate which category the RTE food belongs to.
  • If insufficient, inadequate or no information exists regarding the 2A or 2B categorization of the RTE food product, or if the categorization has not been confirmed by regulatory authorities, it will by default be considered as a Category 1. Hence the method of analysis for Category 1 foods will be applied.

Health Canada "Policy on Listeria monocytogenes in RTE Foods", April 2011

Validation - How this fits with QMP?

The QMP (and Hazard Analysis and HACCP Plan) are the tools to manage the implementation of the 2011 HC Listeria Policy and control Listeria in the product and establishment environment

Compliance to Pre-requisites, RAPs, and associated SOPs is crucial

  • control hazards, prevent or eliminate a hazard or reduce the likelihood of occurrence of a hazard to an acceptable level, provide the basic operating conditions and processing environment required to producing safe food

These programs must function as intended, especially at CCPs.

Requirements for validation studies:

Health Canada Requirements

Refer to the Health Canada document "Validation of food safety measures to limit or prevent the growth of Listeria monocytogenes in Ready-to-Eat foods" (under review).

Pre-validation tasks:
  • Hazard identification
    - Biological hazard: Listeria monocytogenes
  • Food safety outcome
    - Goal or product criteria to meet: e.g., the growth of L. monocytogenes will be less than a 0.5 log CFU/g increase throughout the stated shelf life of the RTE product.
  • Identification of the measure(s) that require validation
    - Control measures: product, process, establishment

1) Literature review (relevant and complete)
- Review information published in last 10 years

2) Challenge Studies (performed by a qualified laboratory):
- Involves the product being deliberately inoculated with a microorganism of concern (i.e., Listeria monocytogenes) to determine the ability of the product to support or inhibit the survival and growth of the microorganism for the duration of the shelf life (under defined storage temperatures).

Note: Challenge studies must meet the requirements of the Health Canada document " Listeria monocytogenes Challenge Testing of Refrigerated Ready-to-Eat Foods"

3) Identification and control of key process parameters, meaning:
- Identification of the process parameters applied to reduce, eliminate or inhibit the hazard being addressed.
- Ensuring the controls are in place to ensure these process parameters are respected and the desired safety outcome is obtained (critical control point under the Hazard Analysis Critical Control Plan of the Quality Management Program).

4) Modelling (optional)

When validation studies are/are not required:

1. Do the physio-chemical parameters of the RTE product fall into the following range throughout its stated shelf life?

  • pH < 4.4, regardless of Aw
  • Aw < 0.92, regardless of pH
  • Combination of pH < 5.0 and Aw < 0.94
  • Frozen until consumption

If Yes:

  • Category 2B - No validation studies required
  • Action Level > 100 CFU/g

If No:

  • What is the refrigerated shelf life?

2. Is the refrigerated shelf life of the RTE food ≤ 5 days?

If Yes:

  • Category 2A - No validation studies required
  • Action level > 100 CFU/g

The refrigerated shelf life of ≤ 5 days is a time period that would not allow sufficient time, under reasonably foreseeable conditions of distribution, storage and use, for L. monocytogenes to grow to levels > 100 CFU/g throughout the stated shelf life.

If No (i.e., the shelf life is > 5 days):

  • The shelf life is >5 days. There could be a time period that could allow sufficient time for L. monocytogenes to grow to levels > 100 CFU/g throughout the stated shelf life.
  • There are no recognized physico-chemical properties to prevent growth.
  • Are there additional control measures?

3. Is the RTE food subject to other control measures?

If Yes:

  • The control measures must be validated and confirmed to substantiate the product category:
    • For Category 2A - The RTE food will only support limited growth of L. monocytogenes to ≤ 100 CFU/g throughout its stated shelf life.
    • For Category 2B - L. monocytogenes will not increase in numbers by 0.5 log CFU/g throughout its stated shelf life, under reasonable foreseeable conditions of distribution, storage and use (i.e., L. monocytogenes cannot grow throughout its stated shelf life).

If No

  • There are no recognized physico-chemical properties to prevent growth
  • The shelf life is > 5 days
  • There are no control measures - L. monocytogenes could potentially grow to levels > 100 CFU/g throughout its stated shelf life.
  • Category 1
  • Action Level: Detected in 125 g

Next Steps

Next Steps for the CFIA

  • Product testing will continue as per the Fish Inspection Program Sampling plan for 2011/12
  • Inspectors will commence Environmental Sampling in March, 2012
    • Food Contact Surfaces will be tested for all Listeria species, including L. monocytogenes
  • Environmental Sampling will be done as part of a Compliance Verification
  • Environmental Sampling will be prioritized based on risk

Next Steps for Importers

  • Importers are to determine the product categories for all RTE products they import
  • Importers are to provide this information to inspectors for review and confirmation of the product categories
  • Importers are to inform suppliers of the recommendations in the 2011 HC Listeria Policy, and the implications when a product obtains unsatisfactory test results for L. monocytogenes in Canada
  • Importers are to verify supplier's process control documentation to ensure Listeria controls are in place

Next Steps for Domestic Processors

  • Processors are to determine the categories of all RTE products they produce that are subject to the 2011 HC Listeria Policy
  • This information is to be made available to inspectors for review and confirmation of product categories
  • An Environmental Sampling Program should be implemented in their processing facilities.
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