RIsk Analysis

Question 1

Traditional Food Safety System

Answer 1

• Reactive approach.
• Main responsibility with government.
• No structured risk analysis.
• Relies on end product inspection and testing

Level of risk reduction: Not always satisfactory

Question 2

Modern Food Safety System

Answer 2

• Preventive approach.
• Shared responsibility.
• Addresses farm-to-table continuum.
• Science based.
• Use of structured risk analysis.
• Establishes priorities.
• Integrated food control.
• Relies on process control.

Level of risk reduction: Improved

Question 3

Risk

Answer 3

A function of the probability of an adverse health
effect and the severity of that effect, consequential to a hazard(s) in food.

Question 4

Risk analysis is the ‘3rd wave’ of food safety:

Answer 4

1. Good Hygienic Practices in production and preparation to reduce the prevalence and concentration of the microbial hazard.
2. HACCP and HACCP-like approach, which proactively identifies and controls the hazard.
3. Risk analysis which, focuses on the consequences to humans of ingesting the microbial hazard and the occurrence of the hazard in the whole food chain (from farm to fork).

Question 5

FAO / WHO Expert Consultation 1995 defines RA as a process consisting of 3 components:

Answer 5

1. Risk Assessment
2. Risk Management
3. Risk Communication

Question 6

Risk assessment:

Answer 6

 Identifies the risk and factors that influence it.

 It requires scientifically derived information and the application of established scientific procedures carried out in a transparent manner.

 However, sufficient scientific information is not always available and so an element of uncertainty must be associated with any decision.

Question 7

Risk management:

Answer 7

The process, distinct from risk assessment,
of weighing policy alternatives in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.

Question 8

Risk communication:

Answer 8

The interactive exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors, and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic, community and other interested parties, including the explanation of risk assessment findings and the basis of risk
management decisions.

Question 9

Why do risk assessment?

Answer 9

1. To carry out basic research to expand the knowledge base and increase understanding about a particular risk.
2. To produce a baseline risk estimation that describes the risk in quantitative or qualitative terms.
3. To attribute risk (i.e. to assign a portion of a known risk among competing causes such as pathogens or foods).
4. To facilitate comprehensive risk management in response to an identified food safety risk.
5. To produce information that can be used to support the establishment of international food safety standards.

Question 10

TYPE OF RISK ASSESSMENT

Answer 10

1. Hazard identification
2. Exposure assessment
3. Hazard characterization
4. Risk characterization

Question 11

1. Hazard identification (RA)

Answer 11

 A qualitative description of hazard (agent), the
food and association of illness

 What agents of concern in the food? Evidence?

 Focus depends on purpose:
- Specific pathogen
- Specific food
- Broad community group
- Specific process
- Food handling process

Sources of information
 Epidemiological studies, surveillance data
 Clinical trials
 Lab. Animal studies
 Ecological studies through food chain
 Expert opinion (regulators, scientists, industry experts, etc.)
 Data collected used in exposure assessment

Question 12

EXPOSURE ASSESSMENT (RA)

Answer 12

 Evaluate the likely intake of hazard via food/other sources if relevant

 Scope & level of detail of EA defined by purpose and reason for doing assessment

 For most bacterial hazards, require consideration of:
- Survivor
- Growth
- Inactivation

Question 13

Factors influencing exposure assessment

Answer 13

1. Characteristics of the pathogenic agent
2. Microbiological ecology of the food
3. Initial contamination of the raw material
4. Amount of hand contact with product
5. Level of sanitation and process controls
6. Methods of processing, packaging, distribution, and storage of foods
7. Preparation steps such as cooking and holding

Question 14

Exposure assessment: data sources

Answer 14

 Published survey & experimental data
 Unpublished (government, industry surveys)
 Industry commodity associations
 Nutrition consumption studies

Question 15

HAZARD CHARACTERIZATION

Answer 15

 Qualitative &/or quantitative evaluation of nature of adverse effects associated with hazards that may be present in food

 If available, a dose response assessment should be carried out

 HC provides an estimate of the nature, severity, and duration of the adverse effects following ingestion of food containing hazards

Question 16

Dose response assessment of hazard characterization

Answer 16

 To determine the relationship between magnitude of exposure (dose) to the pathogen and the severity &/ or frequency of health effects (response)

 Sources of information:
- Human volunteer studies
- Population health statistics
- Outbreak data
- Animal trials

Question 17

4 possible responses to a dose pathogen (HC):

Answer 17

1. Probability of infection following ingestion
2. Probability of illness following infection
3. Probability of chronic sequel following illness
4. Probability of death (mortality)

Question 18

Dose-response relationship factors to be considered (HC):

Answer 18

1. Organism type and strain
2. Route of exposure
3. Level of exposure (the dose)
4. Adverse effect considered (the response)
5. Characteristics of the exposed population.

Question 19

RISK CHARACTERIZATION

Answer 19

 The integration of the three previous steps (hazard identification, exposure assessment, hazard characterization)

 To obtain a risk estimate of the likelihood and the severity of the adverse effect in a given population with attended uncertainties

 The final stage of risk assessment

 This can be:
- Qualitative (low, medium, high) or
- Quantitative (human infections, illnesses, or death per year or per 100,000 pop.)

Question 20

Production of a formal report

Answer 20

 Risk assessment should be fully and systematically documented

 To ensure transparency, report should indicate any constraints and assumptions

 Report should be made available to independent parties on request

Question 21

RISK MANAGEMENT

Answer 21

1. Risk Assessment:
   
   • Assess the risk of a food component using toxicological and epidemiological data.
   • Prefer an objective and quantitative approach.
2. Risk Evaluation:
   
   • Weigh the risk assessment results against socio-economic, political, and public perception factors.
   • This leads to setting a standard.
3. Standard Setting:
   
   • The standard is a key tool for risk management.
   • It helps evaluate toxicological risks from food components.
4. Action on Exceeding Standards:
   
   • If standards are exceeded, the situation may become hazardous.
   • Appropriate measures, such as risk prevention and mitigation, should be taken.
5. Monitoring and Control:
   
   • Authorities may regularly monitor and control potential risks.

Question 22

RISK COMMUNICATION

Answer 22

 The interactive exchange of information and options concerning risks and risk management among risk assessors, risk managers, consumers, and other interested parties

 This process informs others of the risk and the basis of risk management decisions.

Question 23

Effective risk communication

Answer 23

 Is on-going throughout the risk management process, including between managers & assessors

 Is proactive

 Include all legitimate stakeholders

 Takes into account the different priorities and
perspectives of stakeholders

 Requires the commitment & support of all stakeholders