ARCHIVED - Enhancing Risk Analysis: A More Systematic and Consistent Approach

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CFIA Transformation

  • Why are we doing this?
    • Globalization and industry consolidation
    • Shifting consumer landscape – aging population and increasing expectations
    • Evolving production and processing technologies
    • Emerging pathogens and diseases
    • Increased knowledge of risk and systems-based approaches
    • Advances in science and technology
    • Modernization initiatives of trading partners

What is CFIA Transformation?

  • A comprehensive agenda to strengthen our legislative foundation, regulatory programs and inspection delivery
  • CFIA's transformation agenda is focussed on the four inter-connected pillars of the Safe Food for Canadians Action Plan:
    • stronger safety rules;
    • more effective inspection;
    • commitment to service; and
    • more information for consumers.
  • Transformation efforts started with food, with plant and animal following

Oversight

  • Oversight is the collective activities that the CFIA undertakes as part of its regulatory responsibilities
  • Oversight activities include:
    • Inspections
    • Audits
    • Surveillance
    • Product sampling and testing
  • These activities take place along the production chain. For example:
    • before, during, and after the product is at market;
    • before and at place of import; and
    • prior to export

What is Changing in CFIA's Approach to Oversight?

  • The CFIA has a history of applying a risk-based approach to oversight in some sectors
  • Building on experience by formally embedding risk into decision-making process for oversight
  • The CFIA will continue to verify compliance of regulated parties; however, type, frequency and intensity of oversight activities will be proportional to risks
    • Enhanced approach would allow for the identification of those parties that warrant oversight over and above base levels

Expected Benefits

  • Consumers
    • Concentrating oversight efforts on areas of highest risk would result in great confidence that the safety outcomes are being met
    • Efficient use of resources provides value for Canadians
  • Regulated Parties
    • Consistently applied approach to oversight promotes compliance by providing greater predictability and transparency
    • Offers increased flexibility to allow regulated parties to adapt to changing trends in the marketplace and operating environment
  • CFIA
    • More efficiently and effectively fulfill its mandate
  • Aligns Canada with other leading countries that are using risk-informed systems
    • Increasing confidence among trading partners in CFIA's regulatory system and support for foreign market access

Strengthening Oversight Through Risk-Informed Decision Making

  • Foundation of CFIA's modernized approach is risk analysis
  • Described by international standard setting bodies as a process consisting of three separate, but integrated, components:
    • Risk Assessment – determines the degree of risk involved
    • Risk Management – establishes if and what measures are required to mitigate the risk
    • Risk Communications – ensures the appropriate involvement of stakeholders at various steps in the process
  • Risk analysis is an ongoing process. Risks in the operating environment constantly evolve, requiring the adaptability of the three components of the risk analysis framework

Risk Assessment – Building on the Past…

  • Risk assessment identifies and characterizes hazards to determine the probability of an event and severity of its impacts
    • involves taking into account information from various sources to determine the specific risks posed to health of humans, plants and animals
  • Risk assessments provide a characterization of risk, but do not provide any decisions on acceptability, or activities or actions intended to mitigate risks
    • Health Canada conducts health risk assessments on food for substances or microorganisms in food that pose a health risk to consumers (includes potential allergens)
    • The CFIA conducts risk assessments on establishments producing food, as well as for the purpose of protecting plant and animal health

Risk Assessment – …to Enhance Future Approaches

  • The CFIA is developing a Risk Assessment (RA) model for food establishments:
    • Would provide a standard and consistent tool to inform CFIA oversight decisions
    • Multi-year initiative beginning with certain establishments with intent to expand to all food license holders as well as non-food license holders
  • Worked in partnership with experts from academia, Health Canada and the Public Health Agency of Canada to
    • Identify criteria and their relative weights
    • Examine best practices and approaches taken in other countries

Risk Assessment – A Look at the RA Model for Food Establishments

Image - Risk Assessment – A look at the Risk Assessment Model for Food Establishments Description follows.
Description of Image – Risk Assessment – A look at the RA Model for Food Establishments

The image illustrates the Risk Assessment Model. The image is composed of a large arrow pointing to the right with 3 boxes within the arrow and a fourth box at the end, which the arrow points towards.

The 3 boxes represent the 3 factors to be included in the Risk Assessment Model. The information within these boxes is as follows from left to right:

  • Box 1. Initial Risk. E.g. type of hazard, type of product, production volume, target population, risk intelligence, etc.
  • Box 2. Mitigation Factors. E.g. Preventive Control Plan, process interventions, control of incoming ingredients etc.
  • Box 3. Establishment track record. E.g. compliance history, findings from inspections, etc.
  • The final fourth box that is at the tip of the arrow says Assessment Result.

Risk Assessment

  • To assess effectiveness of model, validation projects are being undertaken in some meat, poultry and dairy establishments in Quebec and Ontario
  • Validation projects will help inform the broader application of the RA model across commodity sectors
  • Risk assessment is a scientific process that should not be influenced by social, economic or political considerations; these are considered during the risk management process

Risk Management – An Overview

  • Risk management refers to coordinated activities put in place to direct and control identified risks
    • Regulated parties are responsible for managing risks related to their regulated activities
    • The CFIA provides oversight to help ensure that systems that are put in place are effectively managing those risks
  • Results from risk assessments are layered with other factors when making regulatory decisions determining type, frequency and intensity of oversight activities required
  • The CFIA currently uses many factors in its risk-informed decision making

Risk Management – Examples of Factors Used to Inform Oversight

Click on image for larger view
Image - Risk Management. Description follows.

Description of Image – Risk Management

The image is a funnel containing 7 circles representing different factors that affect regulatory decisions. The funnel points down to a rectangle representing Program Design which subsequently points to another rectangle representing Operational Delivery.

The circles represent factors from left to right and top to bottom as follows:

  • Trading Partner Requirements
  • Risk Assessment Result
  • Consumer Protection Against False Claims
  • Private Certification Schemes
  • Government of Canada Priorities
  • Global intelligence
  • Complaints

The first rectangle at the base of the funnel reads as follows:

  • Program Design
  • Frequency and;
  • Oversight approach (based on surveillance, audit, sampling and inspection)

The second rectangle following the first reads as follows:

  • Operational Delivery, staff would be dispatched to sectors/regulated parties of greatest risk to carry out oversight activities.

Risk Management – What's Changing

  • Modernized approach will use results from RA model to improve consistency when directing resources to those areas that warrant attention over and above base levels
  • Some components of the risk management approach may include oversight activities; compliance promotion products; industry surveillance; compliance verification; development of standards and guidelines, etc.
  • The CFIA is developing a risk management strategy that will articulate the principles and process the CFIA is proposing to use to manage risk to food safety, plant and animal health
    • Will continue to engage with stakeholders as this work progresses as part of CFIA's commitment to transparency

Risk Communications

  • Risk communications refers to the mutually beneficial exchange of information about risk between assessors, managers and stakeholders
  • Canadians expect open, timely access to information and opportunities to provide input into decisions that affect them
  • Risk is an inherent part of food production, preparation and consumption – the CFIA and industry share responsibility in helping consumers understand potential risks
  • Federal Government is pursing Canada's Action Plan on Open Government
    • Aims to foster greater openness and accountability, provide Canadians with opportunities to participate in government and drive innovation
  • There are three themes – Open Information, Open Data and Open Dialogue
  • CFIA's Transparency Policy is one way in which the CFIA is supporting Canada's commitment to Open Government
    • commits to enhancing exchange of information between all stakeholders through increased transparency, including communications about risk
  • Guiding principles used in CFIA's approach to transparency:
    • Usefulness
    • Clarity
    • Timeliness
    • Accessibility
    • Accountability

Risk Communications – CFIA's Transparency Agenda

  • The CFIA has a Transparency Agenda and is taking a phased approach to increasing its capacity on the risk communications front
  • Key accomplishments to date include:
    • Establishment of the Integrity and Redress Secretariat
    • Communicating through social media and user-friendly mobile communications
    • Healthy Canadians Website
    • Food recalls and allergy alerts online
    • Easy-to-understand food recall warnings
    • Email notification service
  • The next phase of the transparency agenda is strongly tied to the CFIA's modernization agenda and will be further consulted upon

Next Steps

  • Gather feedback from stakeholders on the proposed risk-based approach
  • Validate the RA model and adapt for other commodity types
  • Finalize the model, and continue work on development of program management and implementation of new approach:
    • Includes the development of the Risk Management Strategy
  • The CFIA will keep stakeholders informed on the progress and outcomes as the process moves forward

Questions

  1. What do you like about the proposed risk-based approach?
  2. What are your concerns, and how might they be addressed?

Feedback

  • By email: CFIA-Modernisation-ACIA@inspection.gc.ca
  • By mail:

    Strategic Partnerships Division
    1400 Merivale Road, Tower 1
    Floor 6, Suite 218
    Ottawa, ON K1A 0Y9
    Canada
    Attn: Linda Webster

  • By fax: 613-773-5606
  • To stay connected with the CFIA, sign up to our Listserv
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