Record of Decision: Sampling and Testing Fresh Fruits and Vegetables for the Presence of Listeria monocytogenes

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April 17, 2013

Originator

Fresh Fruit and Vegetables Program

Subject

Sampling and Testing Fresh Fruits and Vegetables by the CFIA for the Presence of Listeria monocytogenes, Based on Health Canada 2011 Policy on Listeria monocytogenes in Ready-to-Eat (RTE) Foods

Question or Description of Problem

  1. Which Fresh Fruit and Vegetables are in the scope of the Health Canada 2011 Policy on Listeria monocytogenes in Ready-to-Eat (RTE) Foods (hereafter referred to as the Listeria policy)?
  2. What specific information is needed on the sample submission form?
  3. How will the laboratory analyse samples?
  4. Who should be notified when Listeria monocytogenes is detected in a Fresh Fruit or Vegetable?
  5. What are the follow up activities when Listeria monocytogenes or Listeria spp. is detected?

Decision

A. Which Fresh Fruit and Vegetables are in the Scope of the Health Canada Listeria Policy?.

1. Ready-to-Eat (RTE) Fresh-Cut Fruits and Vegetables
RTE fresh-cut fruits and vegetables are covered by the Listeria policy and therefore should be tested for the presence of Listeria monocytogenes. These RTE foods could have the potential to support growth of the organism and as such they are further categorized as:

Category 1:
RTE Fresh-Cut fruits and vegetables:

  • Known to support the growth of Listeria monocytogenes.

    or

  • Have a stated shelf life longer than 5 days and:
    • Insufficient, inadequate or no information, as determined by validated data, is provided to consider it as either Category 2A or Category 2B RTE product

      or

    • Its categorisation, as either Category 2A or 2B, has not been assessed and confirmed by the regulatory authority.

Category 2A:

  • Refrigerated RTE fresh-cut fruits and vegetables with a shelf-life of ≤ 5 days (no validation required)

    or

  • RTE fresh-cut fruits and vegetables known to occasionally contain low levels of Listeria monocytogenes and do not have a kill step and for which scientific evidence (i.e., validation required) is provided to demonstrate that growth of Listeria monocytogenes is limited to ≤ 100 cfu/g throughout the stated shelf-life.

Category 2B:

  • RTE fresh-cut fruits and vegetables in which the growth of Listeria monocytogenes cannot occur throughout the stated shelf life (i.e., a RTE food in which Listeria monocytogenes does not increase in numbers by 0.5 log cfu/g or greater throughout the stated shelf-life) and for which validation studies are needed. No validation is needed if the RTE fresh-cut fruits and vegetables have a pH < 4.4, regardless of aw; aw < 0.92, regardless of pH; or a pH < 5.0 and aw < 0.94.

* Stated shelf life, also referred to as durable life date in the Listeria policy, and can be calculated using the packing date (obtained from the company) and the best before date stated on a package of a food.

2. Non-RTE Fresh-Cut Fruits and Vegetables
Non-RTE fresh-cut fruits and vegetables are not covered by the Listeria policy. Non-RTE fresh-cut produce with cooking instructions (e.g. soup mixes, stew mixes) are products which are further processed to eliminate Listeria monocytogenes in the final product. However, certain fresh-cut products which bear cooking instructions are still covered by the Listeria policy. For instance, fresh-cut products which have not received a lethal process and which can be eaten raw, e.g., sliced mushrooms and certain cut vegetables for barbecuing commonly found in RTE trays are still included in the scope of the Listeria policy because the cooking instructions are simply options for consumers. Product labelling, therefore, cannot be used as the sole criterion to determine inclusion or exclusion from the Listeria policy.

3. Raw Whole Fresh Fruits or Vegetables
Raw whole fresh fruits and vegetables (including fresh herbs, leafy vegetables, spinach, and sprouts) are not covered by the Listeria policy.

B. What Specific Information is needed on the Sample Submission Form?

  • If known, indicate on the sample submission form the sample category (i.e., Category 1, 2A or 2B), based on physico-chemical parameters (pH, aw), stated shelf-life and/or CFIA evaluation and confirmation of validated data.

C. How will the Laboratory Analyse Samples?

Laboratory analysis

 

Monitoring and directed end product samples

  • A composite of the 5 sample units is analysed for the presence of Listeria monocytogenes using an acceptable screening method or the cultural method (i.e., MFHPB-30); acceptable methods can be found in the Health Canada Compendium of Analytical Methods. The most recent published version of the method will be used and the Application section of the method chosen must be appropriate for the intended purpose; see Table 1 of the Listeria policy for more details.
  • For any samples that are presumptive positive, the following analyses will be performed concurrently:
    • Confirmation of Listeria monocytogenes detection
    • pH and aw individually on 3 of the 5 sample units
    • enumeration individually on each of the 5 sample units

Category 1 presumptive positive samples will be enumerated individually for the purpose of data collection.

Monitoring and directed environmental samples:

  • All monitoring environmental swab samples may be composited. All directed environmental swab samples will be analysed individually.

D. Who should be notified when Listeria monocytogenes is detected in a Fresh Fruit or Vegetable?

  • When Listeria monocytogenes is detected in any fresh fruit or vegetable product, the Food Safety Science Directorate - Food Laboratory Program will notify the Fresh Fruit and Vegetables Program at National Headquarters and the Office of Food Safety and Recall. Subsequently, the Area Recall Coordinator and Area Specialist should be notified, who in turn will contact the Fresh Fruit and Vegetables Program Specialist.
  • If the implicated product is confirmed not to be in distribution, the Fresh Fruit and Vegetables Program Specialist may contact the Food Safety Division for technical assessment on a case by case basis.

E. What are the Follow-up Activities when Listeria monocytogenes or Listeria spp. is Detected?

Consult the Follow up Guidelines for Fresh Fruits and Vegetables when Listeria is detected in end product and/or in environment.

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