Summary of Comments Received on Health Canada's proposed policy on Listeria monocytogenes in ready-to-eat (RTE) foods - March to May, 2010

Background

After the 2008 deli-meat listeriosis outbreak, Health Canada started a review of its policy on Listeria monocytogenes in ready-to-eat foods to update the policy with the latest science available. The revised policy incorporates the recommendations in the Report of the Independent Investigator into the 2008 Listeriosis Outbreak. The Department^{Footnote 1} has currently completed its update of the 2004 policy on Listeria monocytogenes in RTE foods, in view of enhancing the control of Listeria in high-risk foods.

The purpose of this policy is to provide guidance regarding industry verification and control, as well as regulatory oversight and compliance activities of RTE foods with respect to their potential to support the growth of Listeria monocytogenes. More specifically, the revised policy differs from the 2004 version in that:

1. New end-product compliance criteria have been developed. These are similar to the International Codex Alimentarius Commission standards.
2. The definitions of RTE foods in which growth of L. monocytogenes can or cannot occur have been modified and/or developed. Validation data to support the categorization of RTE foods (i.e., Category 2A or 2B) are to be reviewed by regulatory authorities. The list of food products implicated in listeriosis outbreaks has been updated.
3. The compliance action decision tree, including environmental testing for Listeria spp. and end-product testing for L. monocytogenes, has been modified, to include more details related to sampling.
4. It is now stated that an environmental monitoring program should be included in all plants used in the production of RTE foods, as defined in the policy.
5. Recommendations which encourage the use of post-process lethality treatments and/or L. monocytogenes growth inhibitors are provided to industry.
6. There is an increased focus on outreach with the federal/provincial/territorial community to increase awareness of the potential risks of foodborne listeriosis and to provide guidance on how to reduce the risks of acquiring listeriosis to personnel in institutions where high-risk people may be exposed.

On March 22, 2010, the proposed "Policy on Listeria monocytogenes in ready-to-eat (RTE) foods" was posted on the Health Canada website in order to obtain comments from the large stakeholder community. At the same time, Health Canada's Bureau of Microbial Hazards (BMH), Food Directorate sent e-mails to targeted stakeholder groups requesting their input on the proposed policy document. Comments were accepted until 12:00 a.m. EDT on May 3, 2010.

On March 29, 2010 the Bureau of Microbial Hazards, Food Directorate, Health Canada, participated in a question-and-answer session on the Health Canada's proposed revised policy on Listeria monocytogenes in RTE foods. This session was to notify consumer's associations of the public consultation and to answer any questions they may have had concerning this subject.

Summary of Comments:

Health Canada received input from various stakeholders representing governments, industry, academia and professional organizations, including:

Governments:

• Alberta Agriculture and Rural Development
• Alberta Health Services
• British Columbia Centre for Disease Control
• Canadian Food Inspection Agency
• Health Canada (other sections)
• Ministère de l'Agriculture, des Pêcheries et de l'Alimentation du Québec
• Nova Scotia Department of Agriculture - Food Safety
• Ontario Ministry of Agriculture, Food and Rural Affairs

Industry:

• Aliments Médaillon Foods Inc.
• Aquastar Canada
• Bonduelle North America
• Central-Epicure Food Products Ltd.
• DuPont Canada - Qualicon
• Fleishman
• Fumoir La Fée des Grèves
• Grimm's Fine Foods
• Maple Leaf Foods Inc.
• Nolisea Consultants Inc.
• Orca Specialty Foods Ltd.
• Premium Brands
• Santa Maria Foods ULC

Academia:

• University of Manitoba

Professional organizations:

• American Meat Institute
• Canadian Cattlemen's Association
• Canadian Council of Grocery Distributors
• Canadian Meat Council
• Canadian Nurses Association
• Canadian Produce Marketing Association
• Canadian Spice Association
• Dairy Processors Association of Canada
• Food Processors of Canada
• Food and Consumer Products of Canada
• International Cheese Council of Canada

Stakeholders generally supported the proposed policy on Listeria monocytogenes in RTE foods and noted that the draft is aligned with the International Codex Alimentarius Commission standards.

Key issues that were identified by stakeholders during the comment period are highlighted below.

1) Applicability of the policy to the retail food sector

Questions/Comments

How does this policy apply to the retail food sector (e.g., retail establishments that slice ready-to-eat meats for consumers, etc.)?

Health Canada's Response

This policy does not address the foodservice or retail establishments. It is the intention of the Listeria policy to provide guidance to RTE food processors on how to address L. monocytogenes in the environment of processing establishments. Specific guidance for foodservice and retail establishments is not provided in this policy, but will be addressed in separate documents being drafted jointly with industry.

2) Targeted high risk population

Questions/Comments

How does one define RTE foods that are "targeted to high risk populations"?

Health Canada's Response

RTE foods that are intended to be produced for consumption by individuals who are known to be in the high-risk category (i.e., final distribution of such ready-to-eat products is known to be targeted specifically to pregnant women, elderly and/or immunocompromised individuals) should receive the highest priority for industry verification and control, as well as regulatory oversight and compliance activities.

Questions/Comments

If you know that a RTE product which initially falls within Category 2 is intended to be produced for a high-risk population, would it be tested as per Category 1 (i.e., presence/absence)? If not, what levels would make it a Health Risk 1, i.e., > 100 CFU/g or ≤ 100 CFU/g?

Health Canada's Response

If counts are > 100 CFU/g, the product(s) would be considered a Health Risk 1 situation automatically. If counts ≤ 100 CFU/g are detected, a Health Risk Assessment may be requested which may lead to a Health Risk 1 concern.

3) HRA request

Questions/Comments

Under which circumstances would a Health Risk Assessment be requested/performed, and how does one ensure consistency?

Health Canada's Response

The goal of this policy is to provide general guidance regarding industry verification and control, as well as regulatory oversight and compliance activities of RTE foods with respect to their potential to support the growth of L. monocytogenes. Specifics will be left to the discretion of the regulatory authority.

4) Sampling guidelines and Methods

Questions/Comments

Could any Listeria spp. or L. monocytogenes specific method be used for analysis?

Health Canada's Response

Analysis of "food contact surfaces/non-food contact surfaces/end-products" for the presence of "Listeria spp./L. monocytogenes" should be conducted using any method published in the Health Canada's Compendium of Analytical Methods for "Listeria spp./L. monocytogenes" in which the "application" section is appropriate for the intended purpose (e.g., MFHPB methods and MFLP methods).

Questions/Comments

What is the recommended testing frequency for RTE products based on their categories?

Health Canada's Response

The purpose of this policy is to provide general guidance. Specifics will be left to the discretion of the regulatory program (to be determined by each program).

Questions/Comments

How many food contact surface and non-food contact surface sites should be analyzed to be in line with the Listeria policy?

Health Canada's Response

The number of meaningful food contact surface and non-food contact surface sampling sites (preferably 10) selected on each processing line/in the plant should depend on the complexity of the line(s)/plant, respectively. If more than 10 food contact surface/non-food contact surface sites are selected, a compositing protocol should be developed and validated. The number of swabs and enrichment protocol may vary according to the processing conditions. Figures 1, 2 and 3 should be followed accordingly.

Questions/Comments

What actions should be taken when a food contact surface is positive for L. monocytogenes versus Listeria spp.?

Health Canada's Response

If a food contact surface is found positive for Listeria spp., Figures 1 and 2 (depending on the type of ready-to-eat food being produced) should be followed. If any food contact surface is found positive for L. monocytogenes, end-product testing for L. monocytogenes should be performed.

Questions/Comments

It may appear that no action is required after the first Listeria spp. positive result in the environment, meaning that no follow-up in the end-product is required, and hence, allowing a contaminated product to be in the Canadian food supply. How is this protecting the health of Canadians?

Health Canada's Response

In Step A of Figures 1 and 2, the recommendation is to test for Listeria spp. on food contact surfaces. Results from this test would not definitely indicate if L. monocytogenes is present or not in the food, but provide an indication that further testing and corrective actions are required, as per Figure 1 or 2. Guidance in Figures 1 and 2 is reflective of the risk the RTE food may pose to consumers if contaminated with Listeria. Our goal is to encourage companies to perform aggressive environmental sampling on a regular basis and perform trend analysis on their results to detect problems that need corrective action.

5) Categorisation of RTE food products and the requirement for validation data

Questions/Comments

Can high-pressure processed food be considered under Category 2B?

Health Canada's Response

No, high pressure processed food will not automatically be considered to fall under Category 2B. However, other criteria (e.g., process, packaging, outbreak data) could have an impact on the level of priority for oversight assigned to the RTE food products.

Questions/Comments

The policy outlines the categorization of RTE products based on scientific information. What might constitute acceptable validation data? Could the use of growth models be acceptable in some circumstances as supportive data? Could literature reviews be utilized, etc?

Health Canada's Response

RTE foods in which the growth of L. monocytogenes will not occur or in which limited growth of L. monocytogenes to levels not greater than 100 CFU/g can occur, should be determined based on scientific data. This can be demonstrated, for example, by challenge tests, information from the scientific literature, validated predictive microbiological modeling complemented with other data sources, Health Risk Assessments, or a combination of these. The measurement error of the validation method should also be taken into consideration.

6) Definitions

Questions/Comments

How is a "lot" being defined in this policy document?

Health Canada's Response

"A lot consists of all of the same product type processed on a given line, between two complete sanitation cycles, but not exceeding one day's production. When testing this lot, the 5 sample units submitted for analysis must be representative of these products and production conditions".

Implicated RTE products:
"As a minimum, all the products processed on the same line (i.e., using the same equipment) as the tested products are considered implicated when a tested lot has an unsatisfactory result. It should be noted that results from root cause analysis may also trigger the need to include additional products as part of the implicated products".

Line:
"A number of pieces of equipment (e.g., slicers, tables, conveyors, packaging or filling machines) used in series in the post-lethality environment, as applicable, to prepare RTE foods for final packaging".

Questions/Comments

Are there any food exemptions to this policy?

Health Canada's Response

Yes, for example, the following foods would be exempt from the provisions of the Listeria policy:

• Dry goods (e.g., cereals, dried herbs, dried spice mixtures, dry pasta, bread, etc.).
• Raw fruits and raw vegetables, i.e., fresh fruit and vegetables that have been either washed or peeled, sliced, chopped or shredded prior to being packaged for sale with cooking instructions on the package (e.g., mixed fresh-cut vegetables intended as pizza dressing or intended for use in preparing soup), as well as raw whole fresh fruits and vegetables, i.e., whole fresh fruit and vegetables that have only been trimmed, cleaned, brushed, washed, graded, packaged or otherwise prepared for human consumption (e.g., fresh herbs, whole or trimmed fruit or vegetables, whole leaf vegetables and berries).
• Any raw meat or raw fish or seafood (with the exception of sushi, which may or may not contain raw fish as well as steak tartar and Carpaccio where the meat component is raw, are considered RTE and hence are subject to the provisions of this policy).
• Products that are fully cooked in a hermetically-sealed container and are not exposed to the environment after a validated heat treatment (e.g., canned foods, aseptic processing and packaging as well as cook-in-bag products which achieve a minimum 5-log reduction in numbers of L. monocytogenes).
• Processed products which require cooking and which are clearly labelled with adequate cooking instructions. Processed products which have a cooked appearance (but are not fully cooked) may be considered RTE, and thus may be subjected to the provisions of this policy, if they only have microwave cooking instructions, or if the instructions are only to warm and serve.