MICROBIOLOGICAL

RISK ASSESSMENT
(MRA)

MICROBIOLOGICAL RISK
ASSESSMENT
A structured and scientific approach to
evaluating microbiological risks
Approach is widely used to assess risks in
food products but is applicable to any
exposure to microorganisms i.e. from
home and personal care products
Recognised by WTO and captured in Codex
Alimentarius principles and guidelines
(Food)
Sits in a framework of Risk Analysis

SEAC

RISK ANALYSIS = THE COMMON

FRAMEWORK
Risk Analysis:
Risk Management
Risk Assessment
Risk
Communication
Triggered by World
Trade Organisation
(WTO)
Advocated by many
governments and
inter-governmental
SEAC
organisations (FAO,

?
RA

HACCP
GHPs/GMPs/GAPs

Principles of Risk Analysis

Common framework for decision making
Systematic (structured, phased)
Transparent (specifies knowledge, assumptions,
uncertainties)
Objective (sound science and peer review)
Open (improved internal / external stakeholder
involvement)
RM/RA responsibilities duly separated

Principles help decision-making in complex situations

SEAC

MICROBIOLOGICAL RISK
ASSESSMENT: COMPONENTS
Hazard Identification
- What is the problem
- What is the hazard (pathogen, toxin?)
- Which foods are associated

Hazard Characterisation

Exposure Assessment

- Which consumers are

vulnerable?
- At what level(s) does the hazard
cause illness?
- What are traits of the hazard
leading to illness?

- What is the level of the hazard in

the food eaten?
- How much of the food is eaten?
- How often is the food eaten?

Risk Characterisation
- What is the risk to consumers and to sup-groups of
consumers?
- What effect have different mitigation actions?
- What are key assumptions and uncertainties in the

Different shapes & sizes of Risk Assessment

Qualitative / Quantitative
Risk
Assessment

Risk
Management

Deterministic / Probabilistic
Risk Estimate / Risk Ranking
Reactive / Proactive

Risk
Communication

SEAC

Back of envelope / 20 man year

MICROBIOLOGICAL RISK
ASSESSMENT ESTIMATES

Population level:

Estimated number of cases of illness per

year per population (e.g. 100.000 persons)
caused by a micro-organism present in a
particular product group

Consumer level
Chance of illness due to consumption/use
of a specific product to which a particular
hazard can be associated (per serving /
SEAC

use)

Other outcomes of MRAs: relative benchmarks

A ranking of products according to risks they
individually pose to consumers
May categorise products according to risk
categories, to assign management priorities
May provide risk estimates for different
processing, distribution and consumer use
scenarios
Insight into critical processes, handling, use

SEAC

OUTLINE

What is MRA?
Who does it and why?
Case study herbal tea

SEAC

GOVERNMENTS

SEAC

MRA provides a harmonised approach to evaluate

risk and prioritise issues / solutions

Links control to public health protection via

concepts of Appropriate Level of Protection and
Food Safety Objectives

Supports the governmental / societal move away

from hazard-based to risk-based decision-making

Supports the notion that zero risk does not

exist

Gives industry the knowledge to meet

government standards and manage risks

INDUSTRY
Simulating consumer safety of complex or
radical product innovations
Simulating safe changes to processing
(e.g. reduction of heat for quality
improvement).
Simulating safe shelf-life to enter new
markets
Determining performance standards that
would meet quantitative government
criteria
Reactively in incident situations
SEAC

OUTLINE
What is MRA?
Who does it and why?

Case study herbal tea

SEAC

PROBLEM DEFINITION
Infused chamomile tea sampled with
>103 cfu/ml (total viable aerobic
count - TVC) post dispensing
Small sample size, but indicates
vending machine water temperature
not sufficient to inactivate
organisms
No standards for infused tea
Question What is the risk to the
consumer of drinking tea as
SEAC
dispensed?

HAZARD IDENTIFICATION
Bacillus spp. recovered, most probably
but not exclusively, other than B. cereus
Likely from spores in the tea sample (hot water
would eliminate vegetative cells present)
Bacillus spp. are common in a wide range of
environments and raw materials (also in
many processed foods).
Bacillus cereus is well established as a cause of
foodborne illness in humans. Other Bacillus
spp. less commonly so.

SEAC

HAZARD CHARACTERISATION
Large numbers of B. cereus are required to cause
food poisoning. Numbers found in foods
implicated in B. cereus food poisoning are
typically within the range of 105 to 109 cfu/g or ml.
The infective dose for non-cereus Bacillus spp. is
also considered to be very high. In outbreaks
associated with these organisms, levels were
always above 106/g
Limit of acceptability in RTE foods (SEAC conclusion,
UK HPA guidelines, EU industry guidelines) is less
than 105 cfu/g.

SEAC

EXPOSURE ASSESSMENT
The teas samples in consumer trial
contained maximum levels of 3 x103
cfu/ml.
Assumption this level is
representative of the maximum
across all dispensed product)
Tea will be consumed immediately level will not change.

SEAC

RISK CHARACTERISATION
The highest level measured in samples
(3 x103 cfu/ml) is below the limit that
has been identified as a public health
concern (105 cfu/ml).
The health risk to consumers is
considered negligible and acceptable.

SEAC