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Quality Assurance & Food Safety (/magazine/) / June 2014 (/magazine/issue/June 2014)

Microbiological Risk Assessment

Features - Food Safety

MRA provides a comprehensive scientific tool to address foodborne pathogens.

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June 3, 2014

Lakshmikantha Channaiah (/author/7569)

Reducing risks from foodborne pathogens is an essential part of

every food manufacturer’s responsibility to protect both its
customers and its business. It is most important to identify and
regulate foods that are likely to make someone sick. Microbiological
risk assessment (MRA) can be effectively used as a tool to manage
the risks posed by foodborne microbiological hazards. MRA acts as
a basic framework for a modern food safety system and helps in identifying potential microbial
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hazards and possible adverse consequences arising from consumption of foods containing
microbial pathogens and/or microbial toxins. MRA also helps in identifying control or management
strategies that help in reducing potential microbial
Subscribe risks
Now in food.

Risk assessment plays a pivotal role in the whole risk analysis process, which is composed of
three components: risk assessment, risk management, and risk communication (illustrated in
Figure 1 below), as advocated by the Codex Alimentarius Commission (CODEX) established by
the World Health Organization (WHO) and Food and Agricultural Organization (FAO) in the 1990s.

Risk assessment helps in establishing food safety standards, whereas risk management evaluates
the decision making of risk as it relates to human health. Risk communication, on the other hand,
ensures that the logic, outcomes, significance, and limitations of the risk assessment are clearly
understood by risk assessors, risk managers, and stakeholders. These three components are
interdependent and must work closely for better results.

Microbial Risk Assessment

Hazard identification. Hazard identification is the first step in risk assessment. It helps in
identifying potential microorganism(s) of concern capable of causing adverse health effects which
may be present in specific food and/or processes. In general, these microbial hazards are
identified from publicly available databases such as published literature, epidemiological studies,
foodborne disease reports, etc. It also provides information such as types of disease caused (e.g.,
acute or chronic), the modes in which the microorganism(s) affect the host (e.g., microorganism
vs. its toxin byproduct), and the target susceptible populations (children, pregnant women,
immunocompromised individuals, etc.). Both experience and analytical data are crucial for
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identifying realistic microbial hazards. For a realistic approach the hazards must be identified to
the source (e.g., waterborne or foodborne). Also, the hazard identification should include an
assessment of impact of the hazard on human healthNow
Subscribe such as when, where, how, etc.

Hazard characterization. In MRA, the hazard characterization step provides a qualitative or

quantitative description of the severity and duration of adverse health effects that may result from
the ingestion of a group of microorganism(s) or the toxin byproduct in food. In short, the step
determines the relationship between a pathogen and any related adverse effect. At this point, the
severity of the health effect also must be considered.

Exposure assessment. The goal of the exposure assessment is to evaluate the qualitative or
quantitative probability of microorganism(s) or the toxin byproduct in a food product at the time of
consumption. This also includes the probability of microorganism(s) or the toxin as exposures
from other sources including space. Additionally, the microbiological exposure assessment should
include the interactive characterization of the source(s), the route(s) of exposure, and the
pathogen prevalence/occurrence in the evaluation of the magnitude and frequency of exposure to
a microbial pathogen and/or the toxin.

Risk characterization. Risk characterization is the last step in MRA; its purpose is to determine the
quantitative and/or qualitative estimation of the probability of occurrence and severity of known
potential adverse health effects in a given population. Here, the exposure and dose-response
assessments are integrated to mathematically estimate the overall probability of the effect on
public health. This estimation is based on hazard identification, hazard characterization, and
exposure assessment.

Applications of MRA
As food safety management moves toward risk-based food management, food manufacturers will
need to provide evidence that their foods comply with current safety standards. MRA helps risk
managers to properly manage a food safety system, evaluate risk management options, implement
food safety programs, prevent a recall or outbreak, assure maximum food safety and advise on
issues of public health. It also aids in ensuring the transparency of decision making and
communication. Also, MRA helps industry to scientifically develop HACCP plans.

Qualitative vs. Quantitative

The estimation of the probable microbial risk can be qualitative or quantitative, based on the data
and methods used. A qualitative MRA might be established before a quantitative MRA in order to
give an idea of the potential magnitude of risk from foodborne pathogens, and to indicate whether
or not a more in-depth analysis is needed to better understand the situation.
A quantitative microbial risk assessment (QMRA) can use either deterministic or stochastic
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models for overall assessment. The deterministic models do not include randomness whereas
stochastic models include components of randomness. Also, deterministic models use single-
point estimate values, whereas stochasticSubscribe
models use statistical distributions of values as inputs.
Now

The QMRA is recognized as a resource-intensive task requiring a multidisciplinary approach. A

variety of software tools are available to support MRA.

The quality of the results of an MRA depends mainly on use of appropriate data. These include
pathogen data (e.g., strain, virulence factors, generation time, antibiotic resistance, dosage, etc.),
food product (e.g., low moisture, high moisture, shelf stable, etc.), process data (e.g., heat,
extrusion, low acid, etc.), and consumer data (e.g., handling practices, quantity of serving, human
susceptibility, etc.).

This information can be obtained from scientific publications (peer-reviewed journals), databases
from food industries, federal agencies (e.g., FDA, USDA, ComBase, etc.), international
organizations (WHO, FAO, etc.), and consultation with food experts.

Additionally, data from clinical, epidemiological studies, as well as surveillance and outbreak
investigations can be used in the MRA. In the absence of such suitable data, estimates of risks
can be obtained through attaining judgment from multiple experts.

There are, however, limitations. Depending on the complexity, the MRA may or may not determine
whether a microbial risk is acceptable or not. The acceptable limit is based not only on scientific
data, but also on social, ethical, economic considerations and it should be determined in
discussions with all stakeholders. Failure to do so may lead to improper estimates of risk. Also,
there are many scientific data gaps that limit the precision necessary for quantitative risk
assessment.

Summary
MRA helps managers better understand the interaction between microorganisms, processes,
foods, and human illness. MRA acts as a comprehensive scientific tool to identify and manage the
risks posed by foodborne microbiological hazards with the objectives of producing safer food,
reducing the numbers of foodborne illnesses, and facilitating domestic and international trade in
food. Despite the limitations of microbiological risk assessment, it is clear that MRA provides a
structured way of identifying and assessing microbiological risks in food, thus easing the
interactions between decision makers, stakeholders, and the general public.

The author is Global Manager, Food Safety Services Innovation.

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