Food Investigation Response Manual
Appendix 3B - Health Risk Assessment Process
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A Health Risk Assessment (HRA) is one of the three components of a Health Risk Analysis, with the other two components being Risk Management and Risk Communication. The HRA is essential in assuring that sound science is used to establish standards and guidelines to facilitate food safety. The CODEX standard (CAC/GL-30) is used as a guideline for microbiological risk assessments.
Basic Steps of a Health Risk Analysis
- Identify issue and context (Health Risk Assessment)
- Assess risks and benefits (Health Risk Assessment)
- Identify and analyze options (Health Risk Management)
- Select strategy (Health Risk Management)
- Implement strategy (Health Risk Management & Communication)
- Evaluate (Health Risk Communication)
An HRA addresses the questions: What is the likelihood of harm? What is the potential degree of harm? The HRA process should utilize as much quantitative information as possible in order to estimate risk. To promote an unbiased process, it should be functionally distinct from Risk Management, operational and resource issues.
The HRA process involves (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization.
All stakeholders should contribute to this process, in order to facilitate transparency, utilize available expertise, ensure the inclusion of relevant information, enhance communication, and ensure a credible/accepted outcome.
During the HRA process it is important to use credible information to reduce uncertainty and increase reliability of the assessment. In the presence of incomplete or conflicting information, well-informed decisions may be needed to complete the assessment. In such cases these decisions need to be well researched, supported and documented.
The HRA process which currently exists between the Office of Food Safety and Recall (OFSR), Canadian Food Inspection Agency (CFIA) and Health Canada (HC) is as follows:
- A formal, written request for an HRA is submitted by a Technical Risk Assessor (CFIA), and may be referred to a Scientific Evaluator (Health Canada), if no guidelines exist.
- Completion of part A of HRA Request form.
- Inclusion of all available relevant information.
- All information is reviewed by the assessor.
- Assessor may request additional information.
- Assessor will search for similar issues in departmental database or literature.
- The HRA is performed by the assessor.
- The Completed HRA is returned to the requester.
Basic Steps of a Health Risk Assessment
- Clearly define purpose:
- What is the trigger?
- What is the scope of product(s) to be covered by the HRA?
- Preliminary investigation (usually completed before the HRA request):
- Collect pertinent information to assist in completion of the HRA.
- Summarize details surrounding the product of concern.
- Analysis of information, if available.
- Reported illnesses/reactions?
- Hazard Identification – Predominantly a qualitative process to determine which potential hazard(s) identified present a significant health risk to consumers:
- Identify biological, chemical or physical agent which may be present and capable of causing adverse health effects.
- Determine whether a health hazard exists or has the potential to exist.
- Hazard Characterization:
- What is the potential severity of adverse health effects?
- What is the potential duration of adverse health effects?
- Evidence – Scientific evidence which contributes to exposure assessment:
- Positive lab results.
- Strong epidemiological link between product and human illness.
- Product attributes which may be amenable to pathogen proliferation.
- Other supportive information.
- Exposure Assessment:
- Dose-Response Assessment.
- Level of contamination.
- Likelihood of Occurrence.
- Hazard Exposure Characterization: Quantitative/qualitative evaluation of potential exposure (dietary information, level of contamination).
- Information on product distribution, intended use, consumer habits, target populations, high-risk populations, etc.
- Risk Characterization:
- Determine likelihood of occurrence of illness as a result of consumption of the product.
- Based on steps 2 to 5, classify the level of risk as Health 1, Health 2, Health 3, or Other (no risk).
- Complete documentation:
- If applicable, support the HRA by indicating the Act, Regulation, Policy or Guideline that was used.
- Identify which section of the Act or Regulation that was violated.
- Identify any unknowns.
- Potential re-assessment of issue, if new relevant information becomes available.
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