The Establishment-based Risk Assessment (ERA) Food Model
Risk-informed and safety-focused: The ERA model for domestic food establishments

How CFIA targets inspection efforts to where they matter most.

Food safety is a shared responsibility and the CFIA plays a central role by focusing resources where they are needed most. We use a science-based, risk-informed approach to guide our decisions and inspection activities, helping to protect consumers while supporting industry competitiveness.

Risk-informed decision-making is at the heart of the CFIA's work. By embracing new technologies and tools, we continue to improve the efficiency and responsiveness of our services.

The Establishment-based Risk Assessment (ERA) Food Model is one of the tools used to help CFIA prioritize inspections by looking at the food safety risks of food businesses while considering:

  • the hazards linked to food products and how they are processed (for example, operational complexity)
  • what the business is doing to control these risks
  • the business's history of following safety rules

The ERA food model helps CFIA inspectors decide where to spend more time, so that they are looking at the highest-risk places to keep food safe, supporting a more strategic and effective approach to food safety oversight.

On this page

Why the CFIA uses the ERA-Food model

The CFIA implemented the ERA‑Food model to strengthen how it assesses food safety risk in food establishments.

The model is a tool the CFIA uses as part of its overall food safety risk analysis. It helps CFIA plan its programs, set priorities, use resources effectively, and create yearly work plans. As a result, regulated parties can expect a consistent, efficient, and transparent approach to oversight.

How does the ERA-Food model work

The ERA-Food model uses scientific data, and information from food businesses, including CFIA compliance information, to calculate the risk level of an establishment. Businesses share information through the Food Safety Supplemental Information questionnaire.

Each establishment's risk level along with other information (for example, intelligence gathered from inspectors), informs inspection priorities. The higher the risk level, the higher the inspection priority for an establishment.

Establishments can access their individual results and work with the CFIA on measures they can take to reduce their risk level.

Industry involvement in the ERA-Food model

Businesses provide information about their establishment's mitigation measures and operational activities when applying for a domestic Safe Food for Canadians licence and filling out the Food Safety Supplemental Information Questionnaire (FSSI) (previously the Additional Establishment Information Questionnaire) in My CFIA. An establishment is also prompted to provide this information when it renews or modifies its licence. Additionally, information can be updated anytime in My CFIA. This information along with the compliance assessment of an establishment is used to understand how risky the establishment might be when it comes to food safety.

More information on how to provide this information can be found on the My CFIA – User guidance page.

Information (risk factors) considered by the ERA-Food model

There are three kinds of risk factors that are included in the ERA-Food model: inherent, mitigation and compliance factors.

Inherent factors are the risks associated with a specific food commodity, operation or manufacturing process, such as:

  • type of activity
  • commodity
  • type of products
  • volume
  • processing steps
  • distribution to a vulnerable subpopulation

Mitigation factors are the measures or strategies that a food establishment has implemented to control the inherent risks and reduce the overall risk of a food safety issue, such as:

  • additional processes/treatments
  • international scheme certification
  • third party audit
  • control of incoming supplies
  • quality control/food safety assurance personnel
  • sampling plan

Compliance factors refer to a food establishment's track record on how well it has complied with regulatory requirements, such as:

  • inspection results and impact assessment
  • history of enforcement actions and control measures
  • recalls (class I, II, III)
  • food safety confirmed complaints

Data sources used by the ERA-Food model

Data for the inherent and mitigation factors are collected through the My CFIA portal, where food businesses fill out the Food Safety Supplemental Information (FSSI) questionnaire when they apply, renew or amend their licence.

Data on compliance factors are directly extracted from CFIA databases.

Development and scientific foundation of the ERA-Food model

The ERA-Food model is grounded in science and built with input from experts in academia, industry, and government. It also draws from similar international models, published research, and advanced modelling tools.

Also, the CFIA reviews and updates the ERA-Food model on an ongoing basis, using the most up-to-date science, technology, and risk assessment approaches. The model is designed to adapt quickly to emerging global and scientific trends, new risks and changes within establishments.

Since its implementation, the ERA-Food model has gained international attention. Scientific journals that focus on food safety, like Microbial Risk Analysis, Food Microbiology, Food Control and International Journal of Food Microbiology have published articles about how the model was developed.

Built with rigour

As part of the ERA-Food model development, since 2013 the tool has gone through:

Identification of risk factors associated with food safety risk

The objective of this step was to identify the most meaningful food safety risk factors to be used in a risk assessment model for food establishments by considering food hazards. An initial literature review, along with advice from an expert panel, was used to develop a comprehensive list of risk factors that could potentially contribute to the food safety risk attributed to domestic food establishments. In 2013, 75 Canadian experts completed an online questionnaire to assess the 155 identified risk factors according to their impact on food safety. Based on this study, 51 risk factors were excluded. The findings of this expert consultation are available in Microbial Risk Analysis Journal.

Further refinement of food safety risk factors

For a quantitative risk assessment model, a limited number of risk factors are needed. Thus, other criteria were considered to refine the list of risk factors such as:

  • the clarity of their definition
  • the merging of risk factors sharing similar concepts
  • the inclusion of only measurable risk factors (for example the probability that this factor can be objectively assessed during an inspection process)
  • the availability of data sources

The final list of risk factors is described below and the process followed for the refinement is available in Food Microbiology Journal. Briefly, risk factors are grouped into inherent risk factors, mitigation factors and compliance factors.

Inherent risk factors represent those associated with a specific food commodity, operation or manufacturing process. These factors include:

  • the type of commodity and product
  • the distribution volume
  • the type of activities conducted at the establishment (for example, whether it is processing or storage)
  • the direct distribution to a vulnerable population, such as residents of nursing homes, hospitals or daycares
  • whether the products are subjected to specific processing steps such as slicing or dicing.

Mitigation factors are the measures or strategies that a food establishment is using to reduce the inherent risk and therefore reduce the risk of a food safety issue. These strategies include:

  • the implementation of an internationally recognized private certification scheme (meaning recognized preventive control plan)
  • whether the establishment is subjected to third-party audits in addition to those conducted as part of the private certification scheme
  • the implementation of a sampling plan
  • having a full-time employee responsible for quality assurance and food safety on site
  • the application of specific risk-prevention processes (for example high pressure processing)
  • the application of control activities for incoming supplies such as reviewing certificate or analysis from suppliers

Compliance factors refer to a food establishment's track record with respect to how well it has complied with regulatory requirements. This is assessed using the food establishment's historical and current data such as information pertaining to recalls, complaints, inspection reports for the establishment's Preventive Control Plan Sub-elements and enforcement and control actions taken.

Impact of individual risk factors on the food safety risk of an establishment

The objective of this step was to quantify the relative importance of the criteria used to measure the risk factors included in the ERA-Food model based on their impact on food safety. Overall, 173 criteria were presented to 29 Canadian experts during a 2-round face-to-face expert consultation to estimate their relative risk to human health. There was a good consensus on the relative risk given to most criteria. Respondent profile did not have an influence on the results. Median values for each criterion are used in the ERA-Food model. The peer-reviewed scientific paper is available in Food Control Journal.

Expert analysis of foodborne illness sources

The objective of this step is to estimate the contribution of different food commodities and sub-products to foodborne illnesses in the Canadian population. To achieve this, a study was conducted in 2016 and published as a scientific paper in International Journal of Food Microbiology. Since then, sources attribution estimates have been updated through subsequent studies completed in recent years to ensure the model reflects current trends in food safety risk.

In the recent studies, 51 Canadian experts completed a questionnaire to identify the commodities and sub-products that are associated with the largest food safety health burden while considering the food availability, consumption patterns and serving sizes. Experts evaluated up to 31 selected pathogen-commodity combinations and they also provided their level of certainty. Respondent profiles did not have an influence on the results. Since experts provided different levels of certainty for each pathogen-commodity combination, a weighted average was used to calculate the source attribution. The methodology and results of these studies are currently being prepared for submission to a peer-reviewed journal.

Model design

The ERA-Food model concept is based on the allocation of risks to food establishments based on their impact on consumer health in Canada. The total impact (expressed as DALYs – Disability Adjusted Life Years units) is calculated considering the number of cases associated with each food safety hazard yearly, their attribution to specific food commodities and sub-products, and the health impact per case of illness for each hazard. The initial health impact is first allocated to individual establishments based on the type of activity and the volume of each product they manufacture. This value is then adjusted considering the presence or absence of specific food safety risk factors and their relative risk. A scientific paper on the ERA-Food model design is currently being prepared for submission to a peer-reviewed journal.

Testing of the model through pilot projects

Testing of the model was completed for each commodity (for example, a testing was done for meat establishments, dairy establishments, honey establishments, etc.) to obtain risk results and to validate the data collection tool. Participating food establishments were randomly selected to reflect the range of establishment sizes and types of food products across the industry.

As a result of the pilot projects and feedback from industry and senior inspectors, the model was improved, and an automated version of the data collection tool was developed.

Performance validation by senior inspectors

This step was designed to evaluate the model performance by estimating the agreement between the risk assessments done by the ERA-Food model and CFIA senior inspectors, and to refine the model if needed.

Risk factors information associated with each food establishment that participated in the pilot projects was summarized and shared with experts for their assessment. Each expert categorized 10 establishments according to their impact to consumers' health including two (2) controls (high and low risk). This assessment was compared to the calculation made by the model, resulting in the findings described in the table below.

Commodity Outcome
Dairy A good correlation was achieved between the ERA-Food model and the senior inspectors' assessment. Minor refinements were done in the model.
Meat/poultry
Fish/seafood Discrepancies were identified and triggered a reassessment of the categorization of fish sub-products which was completed promptly.
Maple Inspectors did not consider the production volume as significantly impacting the risk result of an establishment. When fixing this variable, the correlations were excellent. Since the volume is used as a measure of exposure assessment by the model, no adjustment was done to ERA-Food model.
Honey
Eggs and egg products A very good correlation was achieved between the ERA-Food model and inspector assessment. No refinements were applied.
Fruits and vegetables A moderate correlation was achieved between the ERA-Food model and inspector assessment. A more granular categorization of the fresh fruits and vegetables commodity was implemented and validated by the Scientific Advisory Committee.
Manufactured Foods A good correlation was achieved between the ERA-Food model and the senior inspector assessment. No further refinements were applied.

For more information, email cfia.eramodel-modeleere.acia@inspection.gc.ca.

ERA-Food Scientific Advisory Committee members

The ERA-Food Scientific Advisory Committee (SAC) is comprised of members from academia (for example, University of Guelph, Université de Montreal, Dalhousie University, University of Manitoba), industry and other government departments (Health Canada, Public Health Agency of Canada). For more information about the SAC, you can reach out to the ERA technical team at cfia.eramodel-modeleere.acia@inspection.gc.ca

Ongoing updates and governance

Since 2013, the CFIA has reviewed and updated the ERA-Food model on an ongoing basis, using the latest science, technology, and risk assessment approaches to adapt to emerging global and scientific trends, new risks, and changes within establishments

For questions or comments email: cfia.eramodel-modeleere.acia@inspection.gc.ca

Additional resources