Inspector General report: Review of plant-based manufactured food establishments

On this page

Executive summary

On November 1, 2024, the Canadian Food Inspection Agency's (CFIA) President directed the Agency's Inspector General to undertake a review of manufactured food establishments producing plant-based beverages to verify compliance with the Safe Food for Canadians Regulations (SFCR) and Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods. The scope of the review also included how the CFIA uses food-related consumer complaints to inform risk modelling and inspection frequencies. The CFIA Inspector General's Office (IGO) provides independent assurance to the CFIA's President on the effectiveness and efficiency of inspection delivery and supports continuous improvement through its findings and recommendations. Through this work, the Inspector General promotes accountability and high standards of performance.

The CFIA is responsible for the administration and enforcement of various federal acts and regulations, including the Safe Food for Canadians Act (SFCA), and the Food and Drugs Act. While industry is responsible for making sure the food they produce is safe, the CFIA verifies that industry is operating in compliance with regulatory requirements and takes action to mitigate risk and respond to non-compliance when there is a suspected food safety risk or regulatory violation. With the implementation of the SFCR in 2019, many food businesses now require a licence to carry out activities with respect to food. There are approximately 20,000 active Safe Food for Canadians licences across all food commodity sectors. Prior to the SFCR, the manufactured foods sector was not licensed under regulations enforced by the CFIA, but the new legislation brought thousands of new establishments into the CFIA's registry of federally licensed parties. Through phased implementation of the new Act, the CFIA prioritized enforcement of the SFCR in waves based on commodity sector, concluding in November 2022 when inspectors began verifying compliance with these new requirements at licensed manufactured food establishments in Canada.

Generally, the manufactured food sector includes products that fall outside the scope of the other eight specific food commodity categories in the SFCR (dairy, egg, fish and seafood, fresh fruits and vegetables, honey, maple, meat and poultry products, and processed fruits and vegetables). This sector includes a variety of products and food establishments presenting varied levels of food safety risk (for example infant foods, spices, baked goods, plant-based products and beverages). Canadian food businesses that manufacture or import these food products require a written preventive control plan (PCP) if their gross annual food sales are greater than $100,000. A PCP is a written document that demonstrates how hazards are identified and controlled.

Due to the volume of federally licensed food establishments, the CFIA delivers a risk-based food program that applies a model to determine, among other factors, the risk of all licensed food establishments. However, because the majority of the CFIA's inspection resources (70%) are fixed and assigned to the meat sector, the Agency continues to be challenged to meet inspection frequencies of all non-meat food commodities (including the manufactured food sector), as well as supporting unplanned, on-demand tasks such as food safety investigations and certifying Canadian food exports for compliance with foreign requirements.

Because food-related consumer complaints are an essential input to determining the Agency's oversight activities, the IGO included in the scope of this review an analysis of how complaint data is used. Complaints can indicate emerging food issues (such as a new or recurring hazard) or the loss of control over hazards at an establishment. Consumer complaints are used, along with other risk information, to identify areas of higher risk and how inspectors are assigned for inspection activities.

The CFIA receives a variety of food-related complaints that range from quality issues to food safety concerns. In responding to consumer complaints, inspectors follow operational procedures to prioritize them based on risk and respond accordingly.

Complaints received by the CFIA, and any resulting investigations are documented in two internal CFIA systems: the Issues Management System (IMS) and the Digital Service Delivery Platform (DSDP). The Agency relies on the ability to link data within these systems to accurately extract complaints to the Establishment-based Risk Assessment Model (ERAM), which is used to help inform the frequency of inspections at an establishment.

The ERAM was developed by the CFIA to evaluate domestic food establishments based on the risk they represent to Canadian consumers. The model considers the inherent risks of an establishment based on the type and volume of the products manufactured, the preventive controls in place, and historic compliance with the regulations. Confirmed food safety complaints are 1 of the additional sources of compliance information that is factored into the model.

This review conducted by the IGO included the on-site verification of a sample of plant-based manufacturing food establishments, the operating environment for licensing and oversight, and an analysis of consumer complaints received by the Agency between April 2021 and September 2024.

Summary of findings

  • Some licence holders are operating without appropriately identified potential hazards in their food safety written program (PCPs).
  • Adequate controls for hazards are not always in place in the production environment of the facilities visited.
  • Some licence holders do not appropriately identify the category for their ready-to-eat products per Health Canada's policy on Listeria monocytogenes.
  • Issues were observed related to building conditions and equipment which could potentially introduce food safety risks.
  • Controls regarding how Safe Food for Canadians licences are issued and follow-up inspections undertaken should be strengthened.
  • There are data integrity challenges and system limitations within the DSDP and IMS systems that are preventing the ERAM from incorporating consumer complaints as intended.
  • The IMS and related guidance do not support the consistent entry of complaint data into key fields resulting in data limitations for trending purposes.
  • Some consumer complaint data extracted to ERAM does not meet the ERAM's original objectives.
  • There is a lack of clarity in the expectations for an inspector on how to identify and respond to more than 1 complaint at an establishment.

Recommendations

  • Recommendation 1: The approval policy for licences in the manufactured food sector should be strengthened to ensure that it aligns with the risk posed by license holders operating without CFIA review of its PCP at the time of licensing.
  • Recommendation 2: Consider making the voluntary Additional Establishment Information Questionnaire mandatory, as it provides key information which informs the risk categorization of a licensed establishment.
  • Recommendation 3: Work planning processes should be enhanced to ensure that required inspection frequencies are aligned with operational capacity and focus on establishments presenting the highest risk. Delivery data on inspections should be reviewed, and action taken when frequencies are not being met at establishments of higher risk.
  • Recommendation 4: Review the current compliance promotion tools for manufactured foods establishments and identify ways to support regulated parties' awareness of their responsibilities under SFCA/R.
  • Recommendation 5: Review the food commodity classifications used by the DSDP system to ensure reporting at the appropriate level of detail is possible. Develop and implement a quality assurance strategy to increase the accuracy of information on license holders entered into My CFIA.
  • Recommendation 6: Improve the data system fields and/or guidance used for documenting complaints and establishment information so that all confirmed food safety complaints and related inspection information can be readily extracted to the ERAM.
  • Recommendation 7: Improve the guidance and/or data fields for recording food complaint information to support more consistent data entry to better allow for trending and to properly support the ERAM.
  • Recommendation 8: Validate the data types extracted to the ERAM to ensure that the intentions of the model are met, and establishments are assigned the appropriate and reliable level of risk.
  • Recommendation 9: Improve operational guidance to better support the inspector's ability to search and identify multiple similar complaints by establishment and to clarify the expectation for inspection activity (including on-site presence) in response to multiple complaints.

1. Introduction

On November 1, 2024, the Canadian Food Inspection Agency's (CFIA) President directed the Inspector General to undertake a review of manufactured food establishments producing plant-based beverages to verify compliance with the Safe Food for Canadians Act (SFCA), Safe Food for Canadians Regulations (SFCR) and Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods, as well as an analysis of consumer complaint trends as part of risk modelling and determining inspection frequency.

The CFIA's Inspector General's Office (IGO) provides independent assurance on the effectiveness and efficiency of inspection delivery and supports continuous improvement through its findings and recommendations. Through this work, the Inspector General promotes accountability and high standards of performance at the operational and national levels.

2. Objectives

The IGO's objectives for this project include:

  1. Gather and analyze information supporting regulatory compliance of Safe Food for Canadians (SFC) licence holders within the manufactured food sector producing plant-based products, including whether:
    • food safety hazards are properly identified and controlled
    • all mandatory preventive controls are implemented, as per the SFCR
    • Health Canada's Listeria Policy, where appropriate, is followed
    • there are other factors that may impact regulatory compliance of the licence holder and CFIA oversight.
  2. Analyze food-related consumer complaints received, report on any trends, and make recommendations on how the CFIA can use this information to better inform risk modelling and inspection frequency

3. Scope

The IGO conducted on-site verifications at 54 manufactured food establishments across Canada, with a focus on:

  • plant-based products
  • licences granted for activities where Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods would apply
  • establishments with licensed activities where no associated preventative control inspection (PCI) has been conducted.

In collaboration with the Policy and Programs Branch (PPB), the IGO identified specific types of foods to include in the scope of this project:

  • plant-based beverages
  • plant-based cheeses
  • plant-based yogurts
  • plant-based frozen desserts
  • Ready-to-Eat (RTE) simulated meat, poultry and plant-based protein products.

Due to the manufacturing process and their ready-to-eat nature, these products were deemed to have the potential to support pathogen growth if contaminated.

The analysis of consumer complaints included all consumer complaints related to domestic establishments manufacturing food received by the CFIA from the introduction of the complaint pathway procedure on April 1, 2021, to September 30, 2024.

4. Approach and methodology

A sample of SFC plant-based food licence holders was extracted from the Digital Service Delivery Platform (DSDP), the case management tool used by the CFIA to capture inspection findings, process industry service requests and assess/manage risk. Further in-person visits to retail outlets were conducted to identify products and manufacturers to be included in the review's scope.

The verifications were comprised of two components:

  • analysis of the written preventative control plan (PCP) during which 20 criteria were rated individually
  • on-site compliance verification during which 18 criteria were rated individually.

The IGO collaborated with Operations and Policy and Programs branches on prioritization of specific types of foods to include in scope, as well as development of the on-site verification worksheet to assess the written PCPs and on-site conditions of establishments.

The IGO verification officers who are designated as CFIA inspectors, contacted licence holders in advance and were accompanied on-site by regionally assigned inspectors. The role of the inspector was to:

  • support the IGO verification officers during the verifications
  • document as an inspection activity within the DSDP
  • ensure appropriate follow-up is conducted per the Standard Inspection Process (SIP), including taking appropriate compliance and enforcement actions, when required.

Results of the verifications were immediately shared with regional operations and compliance actions were taken to address verification findings that posed a risk to food safety.

To assess consumer complaint trends and their impact on risk modelling, the IGO began by identifying how consumer complaint data is currently analyzed by the CFIA. It then analyzed complaint data stored in the Issues Management System (IMS) database to identify potential limitations that could impede data from feeding into the Establishment-based Risk Assessment model (ERAM) as intended, as well as opportunities to improve and expand the ability to identify trends within complaint data. Further analysis was conducted on data for the 20 establishments with the most consumer complaints to better understand how complaints impact inspector presence at an establishment.

5. Regulatory overview

SFC licence holders are responsible for ensuring the food they prepare is safe and complies with the SFCR. CFIA inspectors verify that SFC licence holders are operating in compliance with these regulations. As it is not possible to inspect every food product regulated in Canada, the CFIA uses a risk-informed inspection approach to identify products and manufacturing establishments that present a higher level of food safety risk and to determine appropriate inspection frequencies.

5.1 Manufactured foods

There is a wide variety of foods and associated risks within the manufactured food sector. Prior to the SFCR, the sector was referred to as the 'non-federally registered sector' and was solely regulated under the Food and Drug Act and Regulations which did not require federal registration. This sector includes 12 sub-commodities for SFC licensing purposes:

  • alcoholic beverages
  • confectionary, sweeteners, snack foods and non-bakery desserts
  • fats and oils
  • food chemicals
  • foods not otherwise listed (such as cricket flour, plant-based protein foods)
  • grain derived foods
  • infant foods
  • multiple foods (prepared vegetarian meals/pizza, formulated liquid diets, meal replacements)
  • non-alcoholic beverages
  • nuts, grains, seeds
  • spices, herbs, flavours, condiments, and dressings
  • vegan dairy substitutes.

5.2 Safe Food for Canadians licence requirements for manufactured foods

The SFCR came into force on January 15, 2019, and key requirements were phased-in based on food commodity, type of activity and business size. Licensing requirements for manufactured foods came into force on July 15, 2020, and as of March 2025 there were 3,117 active SFC licences exclusively for manufactured food. Manufactured foods, in general, are comparatively lower risk based on how they are manufactured, and as such, most manufactured foods licences are approved without a pre-licence verification (PLV). The CFIA does not review the PCPs before issuing a licence.

5.3 Requirements for a written preventive control plan

The SFCR requires that food manufacturing establishments prepare, keep, maintain and implement a written PCP that demonstrates how risks to food are identified and controlled. A written program is essential to consistently identify potential hazards and implement food safety controls, identify deviation procedures, and document results.

For manufactured foods, if an SFC licence holder's gross annual food sales are greater than $100K, they must prepare, keep and maintain a written PCP for each activity identified in their licence. If a licence holder's gross annual food sales are $100K or less, they are exempt from having a written PCP; however, they are still required to meet all requirements within the SFCR Part 4: Preventive Controls, including hazard identification, mitigating controls as well as the maintenance and sanitation of the establishment. For instance, while a formal PCP is not required for these smaller establishments, the licence holder must still demonstrate through some reasonable form of documentation and practice that food safety risks are being controlled, such as cooking temperature records and the duration for cooked products.

5.4 Preventive control inspections

The PCI is an inspection task to evaluate a licence holder's food safety controls as mandated by regulatory requirements and their licence conditions. As per the 2024-2025 CFIA program direction on PCI frequencies for food, a PCI should be undertaken by the CFIA annually. However, the manufactured food sector has the greatest number of establishments with outstanding PCIs among all the licensed food commodities due to high numbers, limited inspector capacity and being in a lower ERAM risk category.

5.5 Establishment-based Risk Assessment model and prioritization of inspection activities

The ERAM for food establishments assesses food safety risks, taking into consideration:

  • risks associated with a specific food commodity, operation, or manufacturing process
  • mitigation strategies implemented by the industry to control their food safety risks
  • establishment compliance information.

According to operational guidance, inspectors should review the ERAM-FOOD risk profile of the licence holder's establishment prior to the first planned PCI to confirm the accuracy of the identified inherent risk factors and mitigation factors.

The ERAM is 1 source of data to inform program priorities and consequently where the CFIA inspectors should be assigned to focus on the areas of highest risk. Specifically:

  • The ERAM determines a risk category for each establishment (1 highest to 7 lowest).
  • The Work Tasking Logic Model (WTLM) uses ERAM risk results along with program priorities and operational guidance to prioritize planned inspection activities. As part of this prioritization process, the WTLM takes into consideration the level of food safety control within the establishments (for example, an establishment with weak food safety controls is prioritized for inspection over other establishments with strong food safety controls when all are within the same risk category).
  • The Preventive Control Inspection Frequencies for Food 2024-2025 Program Direction document provides direction to Operations staff and enables risk-informed decisions about the frequency of PCI for food businesses.

It is important to note that CFIA inspectors rely on their training and experience within a given food commodity, and consider compliance history, outstanding corrective measures at a facility, as well as their familiarity with a specific food establishment when prioritizing their inspection activities.

6. Detailed verification findings

The IGO conducted 54 on-site verifications between December 2, 2024, and February 12, 2025, across the four CFIA operational areas including Atlantic (4); Quebec (19); Ontario (16); and West (15). The establishments visited varied in size and complexity. The range of plant-based manufactured products included cheese, meat and milk beverage alternatives, tofu and other various ready-to-eat items. Twenty-six (26) of the 54 establishments had never been visited by the CFIA.

Specific assessment criteria included whether the establishments:

  1. had properly identified and controlled food safety hazards
  2. had implemented all mandatory preventive controls per their PCP and the SFCR
  3. were following the Health Canada Listeria Policy where appropriate.

Each verification was comprised of two components; a review of the establishment's PCP (when required) and an on-site verification to assess the conditions of the establishment and compliance with the regulations. The PCP was evaluated using 20 assessment criteria, and the on-site visit was comprised of 18 criteria, with the purpose of corroborating the information from the PCP, and to assess the on-site conditions in which the licence holder was processing.

6.1 Summary of on-site verifications

Of the 54 establishments visited, observations were categorized as follows:

  • 18% had no observations noted during the verification. They were able to demonstrate that appropriate food safety control measures were in place and operating in compliance with the regulations.
  • 37% had observations that presented little-to-no immediate food safety risk. For example:
    • improvements to their written PCP were required to ensure the establishment's food safety control measures were adequately documented
    • some written programs lacked an identified control for a hazard, but the operator was in fact actively monitoring in its production steps
  • 40% of establishments visited had non-compliances presenting a moderate food safety risk for incomplete hazard analysis documentation in the PCP. Specific examples include:
    • products were not properly categorized per Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat-Foods resulting in failure to identify Listeria as a potential hazard and therefore a lack of documented control measures such as sampling.
    • a lack of written controls for allergens, including missing ingredient lists and/or undeclared allergens on labels
    • a failure to demonstrate recall procedures in place
  • 5% of establishments were found to have critical food safety issues that required an immediate response by CFIA inspection staff to protect public health. In these cases, critical observations were found in the production process that did not adequately control for microbiological hazards including Listeria monocytogenes.

6.2 Compliance and enforcement action taken in response to critical issues

During verifications of the three establishments (5%) where critical food safety risks were observed, immediate action was taken by regional inspectors. These actions included notices to detain product, immediate more detailed follow-up inspections, and food safety assessments.

As a result of follow-up inspection activities:

  • 1 licence was suspended as the licence holder did not have a PCP nor control over Listeria or allergens. Regional staff conducted several follow-up inspections which led to additional non-compliances. Ultimately, the operator was not able to implement appropriate corrective actions and therefore the CFIA suspended their licence in February 2025.
  • Two licence holders voluntarily surrendered their licence. In both situations, the operator failed to meet their SFCR requirements and chose to relinquish their licence.

7. The CFIA operating environment and recommendations

7.1 Approval of Safe Food for Canadians licences for manufactured food

Since coming into force of the SFCR in 2019, SFC licences for manufactured food have been granted without PLVs, apart from infant formulas which do require a PLV due to the vulnerability of the population that consume these products. The current licence application for a manufactured food facility contains basic information on the products being produced. Most manufactured foods are considered lower risk due to their manufacturing practices (cooking) meaning they are provided a licence without verifying the licence holder has:

  • an effective PCP and controls in place to prevent or eliminate food safety hazards
  • accurately assessed their RTE product category
  • accurately assessed whether they meet PCP exemption requirements.

The licence holder's food safety controls are verified by the inspector when they are selected for an inspection later.

Recommendation 1: The approval policy for licences in the manufactured food sector should be strengthened to ensure that it aligns with the risk posed by licence holders operating without CFIA review of its PCP at the time of licensing.

7.2 Establishment risk assessments rely on voluntary information

The ERAM is currently used to assess the risks associated with federally regulated domestic food establishments. The ERAM categorizations are partly based on voluntary information – the Additional Establishment Information Questionnaire – provided by licence applicants who detail their products and food safety control measures. Because this questionnaire is currently optional, there is a risk that missing or incomplete information detailing food safety controls could impact the ERAM categorization and resulting assigned inspection frequency.

Presently, if the questionnaire is not provided, a risk category based on the average risk level for their commodity is assigned to the establishment. For manufactured foods, the average risk category level is 6 (1 highest and 7 lowest). While many products in the manufactured food sector are considered low risk, higher risk products (including plant-based foods) could be classified at the default level 6 in the absence of the voluntary information from the manufacturer. In addition to the inspector's knowledge of the facility or production processes of the food products, this ERAM risk categorization is used to support the prioritization of inspection visits.

Recommendation 2: Consider making the voluntary Additional Establishment Information Questionnaire mandatory, as it provides key information which informs the risk categorization of a licensed establishment.

7.3 Work planning to operational capacity

With the onboarding of thousands of new licences when SFC licensing was extended to the manufactured food sector, the Agency relies on risk assessment and risk categorization to inform its inspection frequencies. The Agency's program direction requires that all domestic establishments be subject to an annual inspection. What is variable is the number of specific inspection tasks (PCI sub-elements) that inspection staff undertake at that establishment, which is partially dependent on the ERAM risk category assigned to the establishment.

Due to inspection resource capacity challenges allocated to the manufactured foods sector, for fiscal year 2024-25 the CFIA delivered fewer than half of the planned inspections for manufactured foods, averaging 40% for ERAM categories 2-4; 20% for category 5; and averaging less than 10% for the lowest risk categories 6-7. Inspections are essential for both verifying the information that contributes to the ERAM categorizations as well as verifying the licensee's compliance with regulations.

Recommendation 3: Work planning processes should be enhanced to ensure that required inspection frequencies are aligned with operational capacity and focus on establishments presenting the highest risk. Delivery data on inspections should be reviewed, and action taken when frequencies are not being met at establishments of higher risk.

7.4 Lack of awareness of Safe Food for Canadians Regulations requirements by licence holders

During the on-site verifications, the IGO observed instances where the licence holder did not fully understand the SFCR requirements. The licence holder is responsible for complying with the regulations and ensuring their food products are safe irrespective of whether they have had previous in-person interactions with a CFIA inspector. Specifically:

  • Some licence holders were not aware of risks posed by Listeria monocytogenes and did not follow the recommendations of Health Canada's Listeria policy for controlling the associated risks.
  • Some licence holders with under $100,000 in revenue and therefore exempt from having a written PCP, did not understand that they were still required to be able to identify all hazards and demonstrate the controls in place for each hazard (cooking temperatures, charts, duration)
  • Overall, 45% of licence holders visited did not identify all hazards in their establishment and/or have effective controls in place.

Recommendation 4: Review the current compliance promotion tools for manufactured foods establishments and identify ways to support regulated parties' awareness of their responsibilities under the SFCA/R.

7.5 Data quality and extraction from the Agency's client management system

When the IGO sought to identify the population of SFC licensed plant-based food manufacturers in Canada, it consulted the Agency's client management system, the DSDP. However, it was determined that it was not possible to efficiently identify these specific manufacturers due to limitations with the information captured in the DSDP. Specifically, the IGO found that there is insufficient information on specific products being manufactured beyond the sub-commodity level. For example, when searching for licence holders producing plant-based beverages under the sub-commodity category of non-alcoholic beverages (Commodity Level 2), the results would also include other unrelated food items such as carbonated drinks, flavored water, coffee, tea, and soft drinks.

These data challenges are compounded with licence holders entering incorrect information in the external facing client management system, My CFIA.

The ability to quickly and efficiently report at an appropriate level of detail from the client management systems by commodity and by manufacturer, supports rapid and thorough food safety investigations, as well as work planning activities that rely on detailed knowledge of our regulated parties.

Recommendation 5: Review the food commodity classifications used by the DSDP to ensure reporting at the appropriate level of detail is possible. Develop and implement a quality assurance strategy to increase the accuracy of information on licence holders entered into My CFIA.

8. Consumer complaints and their impact on risk modelling

8.1 Data Integrity and extraction to support the Establishment-based Risk Assessment model

When the IGO assessed the food-related consumer complaints being extracted to the ERAM, it found that there are data integrity challenges and system limitations within the DSDP and IMS systems that are preventing the ERAM from fully incorporating consumer complaints as intended.

For example, it was found that consumer complaints in the IMS for a manufactured foods establishment or fresh fruit and vegetables (FFV) establishment are unable to be extracted to the ERAM. For a complaint to be extracted into the ERAM, the registration number and food program need to match in both systems (IMS and DSDP). Prior to the implementation of the SFCR, registration numbers were issued by the CFIA for only establishments under certain food programs, including dairy, fish and meat. Establishments under the FFV and manufactured foods programs were never assigned registration numbers as they were not required for these programs; however, without the registration numbers they are currently excluded from ERAM extraction.

Further, in the DSDP, establishment profiles are created by the regulated parties themselves through their My CFIA  portal/account. It was found that some of the regulated parties have inadvertently, or otherwise, created multiple party/establishment profiles for the same physical location. Some inspection cases were entered in a draft or duplicate profile that is not linked to an SFC licence, thus excluding them from the ERAM. 

Recommendation 6: Improve the data system fields and/or guidance used for documenting complaints and establishment information so that all confirmed food safety complaints and related inspection information can be more efficiently extracted to the ERAM.

8.2 Reliability of data within systems used for consumer complaints

In assessing the complaint data, it was noted that the IMS and the related inspector guidance do not consistently support efficient and reliable data input resulting in inconsistencies to support trend analysis. For example, commodity taxonomy and classification options within the IMS are overly complex, do not align with the DSDP or industry guidance and are not being selected consistently at the time the data is entered. It was noted that plant-based beverages (almond and soy 'milks') varied in their commodity classification at the time of data entry, with 'Dairy', 'Non-Alcoholic Beverage' or 'Nut, Grains and Seeds' being selected when the information was inputted. Further variation was observed at the subclass level, with entries where 'Dairy' was selected, ranging in subclass between 'by-products', 'cultured dairy products', 'milk/cream' and 'substitutes'. The Agency uses this commodity information, along with other relevant data from the IMS to identify trends and to inform on emerging food risks. The reliability of this trend data depends on accurate and consistent taxonomy and data entry.

Recommendation 7: Improve the guidance and/or data fields for recording food complaint information to support more consistent data entry to better allow for trending and to properly support the ERAM.

8.3 Establishment-based Risk Assessment model design considerations

The ERAM uses food safety complaints as a source of compliance information in its risk modelling. When assessing complaint data currently being extracted to the ERAM, the IGO determined that there may be additional information that should be incorporated. Specifically, the ERAM is currently designed to only extract food safety complaints that have been confirmed by an inspector through follow-up. A portion of complaints, however, are never confirmed because a root cause can not be determined with certainty due to a lack of evidence identifying a cause. These unresolved complaints are currently classified as "unconfirmed" and therefore excluded from the ERAM; however, for risk modelling purposes these complaints serve as valuable intelligence that may indicate an underlying manufacturing problem or broader systemic risk.

Though the ERAM is intended to extract only food safety complaints, it does receive some non-food safety complaints based on the current extraction parameters. Food safety complaints are identified based on broad hazard categories (microbiological, chemical, allergen). However, within the broader hazard categories used, the system provides several sub-categories which include non-food safety complaints such as non-harmful extraneous material (hair, insects) and microbiological quality concerns (non-pathogenic mould). As such, both food safety complaints and non-food safety quality related complaints are being extracted to the ERAM which may incorrectly impact the risk rating.

Recommendation 8: Validate the data types extracted to the ERAM to ensure that the intentions of the model are met and establishments are assigned the appropriate and reliable level of risk.

8.4 Inspector follow-up to multiple complaints at an establishment

The IGO found that inspectors following up on a complaint will search the IMS for similar incidents but may use inconsistent search parameters, which may reduce the ability to readily identify similar incidents. For example, it was observed that some IMS searches were limited to a specific product code (UPC), while others more broadly relied on search queries for all complaints for the same brand, establishment or for a food safety hazard. This inconsistent approach will yield different search results and could impact follow-up decisions. Additionally, when the IGO looked at the 20 food establishments with the most consumer complaints, it was found that on-site inspector presence increased in response to complaints, though some variation in number of on-sites was observed. The supporting operational guidance for responding to food complaints does not clearly define multiple similar complaints at an establishment and when they should trigger on-site inspection.

Recommendation 9: Improve operational guidance to better support the inspector's ability to search and identify multiple similar complaints by establishment and to clarify the expectation for inspection activity (including on-site presence) in response to multiple complaints.

9. Conclusion

The on-site verifications conducted by the IGO at the 54 plant-based food establishments and the findings referred to in section 6 of this report have been adequately addressed through follow-up actions by regional CFIA staff. For the observations and recommendations in Section 7 regarding the operating environment which supports how the CFIA manages licensing, allocates inspection resources and interacts with regulated parties, and Section 8 which reviewed how the CFIA incorporates food safety complaints into its risk analysis, the implicated CFIA branches have prepared an appropriate management response which has been reviewed by the Inspector General. Detailed action plans will be monitored by the Inspector General through CFIA governance committees to ensure implementation.

Date modified: