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Archived - 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

Why was a revision needed?

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):

Now (2011 version):

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:

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:

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

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:

Government

Health Canada

Canadian Food Inspection Agency

Provincial/Territorial Governments

CFIA's Responsibilities

Consumers

Canadian consumers are responsible for learning and adopting the following 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

Products not subject to the HC Listeria policy

Health Canada RTE Food Categories

RTE Food Categories Defined in the HC Listeria Policy

RTE Foods

HC RTE Food Category 1

Category 1 (High priority for oversight)

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

HC RTE Food Category 2

Category 2A

Example - sushi

Action Level > 100 CFU/g

Category 2B

Action Level > 100 CFU/g

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

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)

Product-related Control Measures

Process-related Control Measures

Establishment-related Control Measures (pre-requisites)

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:

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

The guidelines document includes:

Factors to Consider:

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

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

Guide to Process Control Technical Information

Important changes:

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

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

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:

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?

If Yes:

If No:

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

If Yes:

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):

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

If Yes:

If No

Next Steps

Next Steps for the CFIA

Next Steps for Importers

Next Steps for Domestic Processors

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