Chapter 1 Risk Analysis Framework

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• Chapter 1Risk Analysis Framework

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Concept of Risk
General Risk Probability of an undesirable
outcome from a particular event Food Risk
Probability of an adverse health outcome, either
immediate or in the long-term
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FOOD RISK

• Definition
• Probability of an adverse health outcome -
• Immediate
• eg, food poisoning, allergy, intolerance,
  headache, nausea
• Longer-term
• eg, organ damage, birth defects, cancer, chronic
  illness

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What is Risk Analysis?

• Structured framework to address two questions
• What is the nature and magnitude of the health
  risk associated with a particular chemical?
• How should the risk be managed and communicated
  to those affected?

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Elements of Risk Analysis

• Risk Assessment
• Risk Management
• Risk Communication

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How do these elements work together?
Risk Assessment
Risk Management
Risk Communication
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Risk Analysis Framework International/Codex

• Joint FAO/WHO Consultations (1995-99)
• Agreed that risk analysis consists of 3 stages
• risk assessment
• risk management
• risk communication
• Developed definitions for the three stages
• Developed principles for risk assessment

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Risk Analysis Framework
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Objective of Risk Analysis

• Risk analysis is a scientifically based, open and
  transparent process that follows a structured
  approach comprising three components risk
  assessment, risk management, and risk
  communication
• Permits determination of risk levels for
  foodborne hazards
• Facilitates the development of risk management
  policies and risk communication strategies

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Risk Analysis Definitions

• Risk Assessment
• The scientific evaluation of known or potential
  adverse effects resulting from human exposure to
  food-borne hazards.
• Risk Management
• The process of weighing policy alternatives to
  accept, minimise or reduce assessed risks and to
  select and implement appropriate options
• Risk Communication
• An interactive process of exchange of information
  and opinion on risk among risk assessors, risk
  managers and other interested parties

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DEFINITIONS

• Hazard is the intrinsic property of a biological,
  chemical or physical agent to cause harm.
• Risk is the probability that a biological,
  chemical or physical agent will cause harm.

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DEFINITIONS

• Risk assessment is the process of using available
  information to identify, characterize and
  quantify the adverse health effects of exposure
  to a biological, chemical or physical agent.
• Risk management is the process of integrating
  risk assessment results with social and economic
  goals and, after considering policy options, of
  identifying a strategy to control the risk.

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Risk Assessment
Risk Management
Risk Communication

• Risk assessment is a scientifically based process
  consisting of 4 steps
• Hazard identification
• Hazard characterization
• Exposure assessment
• Risk characterization

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Risk Assessment Elements

• Hazard identification
• Identification of biological, chemical, or
  physical agent

3. Dietary exposure Estimate of intake
2. Hazard characterisation Evaluation of adverse
health effect
4. Risk characterisation Probability of
occurrence and severity of potential adverse
health effect
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Chemical Risk Factors in Food

• Agricultural chemical residues
• Veterinary chemical residues
• Cooking and process related agents
• Environmental contaminants
• Food additives
• Food processing aids

• Packaging migrants
• Plant toxins
• Marine toxins
• Mycotoxins
• Radionuclides
• Nutrients
• Novel food ingredients

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Risk Assessment
Risk Management
Risk Communication

• The process of weighing alternative approaches
  and, if needed
• Selecting and implementing appropriate control
  measures
• Control measures will depend on how acceptable
  the risk is to the public

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Elements of Risk Management

• Identification of the food safety problem and
  commissioning the risk assessment
• 2. Evaluation of risk management options
• 3. Implementing the decision
• 4. Monitoring and review of effectiveness of the
  risk management decision

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Risk Management Goal

• To reduce food risks to acceptable levels
• Determine the relative importance of the
  foodborne hazard
• 2. Establishing measures to meet the level of
  acceptable risk
• 3. Evaluating the effectiveness of the risk
  management decision

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Factors Influencing Acceptable Risk

• Unacceptable risk
• Negligible risk

Potential for harm
Social, Psychological, Ethical Factors
Acceptable Risk
Perceived benefits
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Risk Management Measures

• Standards
• restrict the levels of chemicals in food (eg
  MRLs, MLs, prohibitions)
• microbiological limits
• Ingredient labeling (eg allergens)
• Guideline levels
• contaminants, microbiological contamination

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Risk Management Measures

• Codes of Practice
• good hygienic practice, nutrient claims
• Education programs/material
• advice on Listeria and mercury for pregnant women)

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Risk Management
Risk Assessment
Risk Communication

• The interactive exchange of information and
  opinions throughout the risk analysis process,
  concerning risks, risk-related factors and risk
  perception, among all interested parties,
  including explanation of the risk assessment
  findings and the basis of risk management
  decisions

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Risk Communication Elements

• Nature of risk
• Associated uncertainties and constraints
• Risk management options
• How the risk management measure addresses the
  risk

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Risk Communication Goals

• To ensure that all information and opinion
  required for effective risk management is
  incorporated into the decision making process
• Promote engagement of all interested parties in
  the risk analysis process
• Facilitate consistent, transparent and effective
  decision making
• Promote understanding of the decision and
  decision making process

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Risk Communication Examples

• Engaging consumers and industry in particular
  projects
• Holding workshops
• Encouraging consultation with the public
• Public release of assessment reports
• Use of web page, fact sheets, explanatory
  publications
• Presentations at conferences and community based
  events
• Engagement with the media

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Where is Risk Analysis Used?

• Establishing food standards and other regulation
• Is regulation needed?
• If so, what type of regulation?
• Addressing food emergencies
• What is the public health risk?
• What action should be taken,eg advice to public,
  recalls, no action, amend regulatory requirements?

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Use of Risk Analysis

• Challenges
• Availability of nationally relevant data
• Availability of adequately trained staff
• Communicating complex concepts

• Benefits
• Identification of public health problems
• Targeting resources to highest risk areas
• Faciliating trade negotiations
• Better informed community

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Summary - Risk Analysis

• Risk Analysis provides
• Framework for organizing data and information in
  a rational and consistent way
• Guidelines and rules for different parts of the
  food chain
• Facility to make of rational and transparent
  decisions to protect health