What we heard: Consultations on the policy on Listeria monocytogenes in ready-to-eat foods

On this page

• Executive summary
• Introduction
• Overview of engagement process
• Summary of what we heard
• Conclusion

Executive summary

Protecting the health of the Canadian population and food supply is a top priority for Health Canada.

Health Canada has high standards for food safety and continuously reviews existing policies to protect the health and safety of the public. The review of our 2011 "Policy on Listeria monocytogenes in Ready-to-Eat Foods" (Listeria policy) was started under this premise.

As part of the review process, we looked at the latest science and the regulatory landscape in Canada and explored ways to provide clearer guidance. During the process of developing the Listeria policy, we conducted 2 public consultations:

• First consultation (November 6 to December 18, 2020)
  • invited interested parties to comment on the policy's clarity, effectiveness and challenges for implementation
• Revised draft consultation (February 11 to April 12, 2022)
  • invited comments on the revised policy

In total, Health Canada received over 480 comments from interested parties. The comments reflected a wide range of perspectives.

We carefully reviewed and considered all comments. We then revised the Listeria policy with input from the Canadian Food Inspection Agency and Public Health Agency of Canada. Where appropriate, we used all of the input we received to inform the policy review leading to the current publication of the Policy on Listeria monocytogenes in ready-to-eat foods .

This report summarizes the feedback we received. Seven key themes emerged from the revised draft consultation:

1. overall clarity and predictability
2. roles and responsibilities
3. control measures
4. validation
5. methodology
6. ready-to-eat foods specifically produced for vulnerable populations
7. other topics

Introduction

Health Canada's Listeria policy is an important tool used to help prevent the introduction of the illness-causing bacteria, L. monocytogenes, into ready-to-eat foods that are sold in Canada. This policy sets out the department's recommendations for applying, implementing and verifying control measures for L. monocytogenes in ready-to-eat foods to protect public health and safety. By following the Listeria policy, food businesses are more likely to discover potentially contaminated products before these products are sold.

In 2019, the Safe Food for Canadians Act and its regulations, the Safe Food for Canadians Regulations, came into force. That same year, Health Canada also saw a need to clarify the coverage of foods under the Listeria policy, which was last updated in 2011.

We are committed to providing clear, effective and predictable guidance that is science- and risk-based and reflects the Canadian food environment. As the Listeria policy applies to a wide range of ready-to-eat foods, it was important to consult various groups interested in this subject.

In order for the Listeria policy to be useful and tailored to its users, we held 2 phases of consultations. We collected information, suggestions and diverse perspectives from these users as well as those interested in our approach to controlling L. monocytogenes in ready-to-eat foods.

This "What we heard" report summarizes the feedback we received from the consultations. It reflects the views of individuals and groups who participated, not of the general Canadian population or the food industry. Please note that this report does not:

• include every comment
• proportionally reflect the comments that we received
• imply consensus on the part of all the people who participated

The views expressed are those of the people who participated in the consultations. They do not represent the views of Health Canada or the Government of Canada.

Overview of engagement process

Health Canada welcomed input from all interested parties, including members of the public.

The engagement process for reviewing the Listeria policy was done in 2 phases.

The first phase (November 6 to December 18, 2020) involved a web-based questionnaire. During a 6-week consultation period, a wide range of groups provided feedback on the clarity, effectiveness and challenges related to the policy since its implementation in 2011. We also looked at the latest science.

We then revised the Listeria policy with input from the Canadian Food Inspection Agency (CFIA) and Public Health Agency of Canada (PHAC).

The second phase (February 11 to April 12, 2022) was used to gather comments on the revised draft during a 60-day consultation period.

Table 1 shows the breakdown of all comments received during 2 phases of the engagement process. The comments are reported by groups and activities.

Table 1: Number of completed questionnaires, respondents and comments received, by groups and activities in the food sector

Groups and activities	Phase 1: Number of completed questionnaires	Phase 2: Number of respondents (and comments) from the draft consultation
Manufacturing and industry/trade associations	96	21 (195)
Importation	2	0 (0)
Government/regulatory agencies	14	9 (74)
Research centres	1	1 (2)
Consultation	5	2 (12)
Total count	118	33 (362)

Summary of what we heard

Participants appreciated the opportunity to provide feedback. A summary of their feedback follows.

Phase 1: Web-based questionnaire 2020

During the first consultation phase in 2020, Health Canada received feedback on how to make the 2011 Listeria policy clearer and more effective. Comments included clarifying:

• recommendations and requirements
• how data shared with regulatory authorities is being used
• which foods are covered under the policy, as well as a more precise definition of ready-to-eat foods
• the roles of Health Canada, CFIA, PHAC, and provinces and territories when it comes to applying the policy and conducting investigations
• the guidance related to sampling and testing food contact surfaces, end-product testing, follow-up actions for positive test results and trend analysis

Other comments from respondents to the questionnaire included:

• consider aligning for international trade
• seek consensus among inspectors on how the policy should be interpreted
• specify the testing methods to be used for environmental and end-product monitoring
• have the policy reflect an outcome-based approach similar to that of the Safe Food for Canadians Regulations
• consider adding a non-negotiable hold-release policy and performing enumeration for all ready-to-eat foods
• consider adding routine end-product testing

The following feedback that we considered outside of the scope of this review was shared with the appropriate groups for their consideration:

• add figures from CFIA's archived commodity-specific guidance
• specify the frequency for sampling of food contact surfaces, recognizing that factors such as production volume may affect this frequency

Phase 2: Draft policy consultation 2022

During the second phase of the engagement process (2022), respondents welcomed the opportunity to provide feedback on the draft revised Listeria policy. They welcomed Health Canada's efforts to clarify the existing recommendations in the Listeria policy and expressed interest in continued engagement.

The combined feedback from this 60-day public consultation was grouped under 7 key themes.

Theme 1: Overall clarity and predictability

In general, there was overall support for a risk-based and more outcome-based approach to L. monocytogenes in ready-to-eat foods.

Other general comments:

• The document is more comprehensive and easier to understand, which should result in enhanced predictability.
• The document is long, repetitive and difficult to understand for non-technical users.
• The hyperlinks, footnotes and in-text citations make it difficult to read.
• There is some confusion over whether the Listeria policy describes regulatory requirements or recommendations, as well as its link to federal food legislation.
• The legislative context, scope and categorization of ready-to-eat foods are useful.
• Specific terminologies need to be clearer (for example, listericidal, the relevant regulatory authority and unsatisfactory test results).
• The link between shelf-life and best-before dates is confusing.
• There is support for the risk-based approach to L. monocytogenes in ready-to-eat foods (for example, categorization, emphasis on foods specifically produced for vulnerable populations).
• The expansion of supply-chain controls on raw ingredients is a welcome addition.
• The definition of ready-to-eat foods is much clearer.

Recommendations were to:

• have a comprehensive, scientific version of the policy and a shorter version for industry that focuses on control measures
• add resources such as info sheets for small businesses who may not have scientific or technical expertise
• clarify when to use Health Canada's Listeria policy and CFIA's Control measures for Listeria monocytogenes in ready-to-eat foods
  • refer to CFIA's document as a complementary resource when appropriate
• adapt the approach in the draft revised Listeria policy to reflect the legislative environment
• give more examples of ready-to-eat foods that are excluded from the policy
  • there were some misunderstandings about what is and is not subject to the policy, such as certain food that should be cooked before it is consumed
• include more recent statistics on the prevalence of L. monocytogenes in the intestines of healthy humans and Canadian listeriosis rates in the background section
• incorporate an outcome-based approach for hot-filled/packed foods and the use of post-packaging treatments

Theme 2: Roles and responsibilities

Many participants said that the roles and responsibilities of industry, government, consumers, caterers and care providers should be clearer. Others felt that it was not relevant given that the policy is aimed at industry.

Suggestions included:

• add more information about the responsibilities of businesses that import or export ready-to-eat foods
• clarify the responsibility of food businesses and regulatory authorities in a more outcome-based legislative environment
• make it clear that provincial/territorial food regulatory authorities may apply the principles of the policy in relation to their laws
• add more information on the responsibilities of businesses that manufacture frozen ready-to-eat foods
  • thawing by other food businesses or by end-users is outside of the control of the businesses manufacturing frozen ready-to-eat foods
• include contact information of resources for businesses that need technical advice

Theme 3: Control measures

Participants liked the improved figures that describe guidelines for environmental sampling and end-product testing. These figures and Table 1 include all the pertinent information.

Participants also supported:

• providing examples of follow-up actions to positive ready-to-eat food test results
  • asked for more clarity on the link to recall
• the emphasis on trend analysis as an important part of the food safety system
  • asked for more detailed guidelines on data use and retention

Participants asked for more precise information on the activities that can be used to prevent or eliminate L. monocytogenes, to avoid misinterpretation. Suggestions included:

• take into consideration online marketing strategies that deviate from cooking instructions on the food label when determining if a food is subject to the Listeria policy
• understand that information on frozen food labels related to thawing times and temperatures may not be available
• consider 'high-risk' processing steps and food processing aids in the categorization of ready-to-eat foods
• mention high-pressure processing as a non-novel process
• consider adopting an environmental sampling approach based on the zone concept (that is, zones 1 to 4), rather than the broader approach which differentiates food contact from non-food contact surfaces
• mention the relevance of biofilms
• provide more specific guidelines for environmental sampling and end-product testing, especially for:
  • duration
  • sampling sites to be included during routine and investigative sampling
  • follow-up actions to positive test results
• consider the relevance of dividing Category 2 into 2A and 2B when they are associated with the same sampling guidelines and action level for L. monocytogenes
• consider that end-product samples taken shortly after start-up can help identify residual contamination more effectively than routine environmental monitoring
• consider that holding food pending test results may not be realistic for ready-to-eat foods with a particularly short shelf-life
• include guidance for food businesses that test ready-to-eat foods for Listeria spp.
• provide more detail on the following concepts:
  • differences between and expectations for routine and investigative sampling
  • assessment to be performed when test results from lots on hold indicate L. monocytogenes at levels that do not exceed those specified in Table 1
  • detectable limits in the context of an enumeration method

Theme 4: Validation

We received comments about validation studies used to:

• change the category of a ready-to-eat food
• demonstrate that the cooking instructions on the package label achieve a minimum 5-log reduction in numbers of L. monocytogenes

Overall, participants would like to see:

• the classification of a Category 1 ready-to-eat food changed to a Category 2 ready-to-eat food based on validation
• more clarity or detail on the validation procedure for changing the classification of a Category 1 ready-to-eat food to a Category 2 ready-to-eat food
• similar products or different sizes of the same products being acceptable for grouping in the context of validation studies for cooking instructions specified on the package label

Theme 5: Methodology

Some participants would like more information on how to demonstrate the effectiveness of the control measures put in place to address L. monocytogenes in ready-to-eat foods.

Overall, participants supported the methodology for environmental sampling and testing, including when and how to take samples, basing it on risk analysis and specifying corrective actions.

Suggestions included:

• clarify that testing for adenosine triphosphate (ATP), while helpful, is not a substitute for an environmental monitoring program
• provide more specific guidelines for environmental sampling and end-product testing, particularly in relation to tools and materials (for example, swabs, plates), methods to be used for testing and laboratory accreditation
• provide supplementary videos for sampling
• recommend compositing of Category 2 ready-to-eat food samples for end-product testing
• replace 'presence/absence' with 'detected/not detected' to more accurately reflect the methods used for environmental and end-product testing, as applicable

Theme 6: Ready-to-eat foods specifically produced for vulnerable populations

Some participants said that ready-to-eat foods specifically produced for vulnerable populations should be well defined to avoid inconsistencies in policy application and enforcement.

Suggestions included:

• add infants and newborns to the list of vulnerable populations
• better define what ready-to-eat foods specifically produced for vulnerable populations are, as food businesses may not know if their foods are going to vulnerable populations
  • for example, foods indirectly sold through distribution
• include the requirements and best practices for the manufacturing of foods that are excluded from the Listeria policy, particularly if these foods are specifically produced for vulnerable populations

Some participants pointed out that vulnerable populations shop for products within the general population. Those who are at higher risk for foodborne illness have been advised by health care providers to not consume certain products. Individuals who are in hospitals and long-term care homes do not have such a choice.

Theme 7: Other topics

We received some comments that are outside the scope of the Listeria policy, such as the following:

• share whole-genome sequencing data on publicly available databases to help identify clusters of listeriosis more rapidly
• provide information on the development of educational materials

We also received a significant number of recommendations that are within the mandate of CFIA and not Health Canada. We forwarded those recommendations as well as the following comments concerning the implementation of the Listeria policy to CFIA:

• regulatory authorities should work together when updating other Listeria-related resources
• additional guidance and training may be needed to support enforcement activities, particularly for ready-to-eat foods specifically produced for vulnerable populations
• regulatory authorities that are involved with implementing the Listeria policy and related investigations should receive training that is consistent across food commodities and regions
• industry will need a transition period to update their food safety programs

Participants also asked for more detail on the following concepts:

• notifying the relevant regulatory authority
• issuing a corrective action request
• undertaking the complaints and appeals process
• sampling frequency for environmental monitoring and end-product testing
• determining the number of sampling sites for routine monitoring
• determining an operation-specific timeframe in the context of persistence
• taking historical test results into consideration
• reconditioning or reprocessing
• reworking

Conclusion

Health Canada thanks everyone who participated in the consultations. We used this feedback to review, revise and finalize the Listeria policy.

• Policy on Listeria monocytogenes in ready-to-eat foods (2023)