Veterinary Research Communications, 29(Suppl.

2) (2005) 117–121
DOI: 10.1007/s11259-005-0023-3

C Springer 2005

The Food Safety Management System

M.L. Stecchini∗ and M. Del Torre
Department of Food Science, University of Udine, Udine, Italy
∗
Correspondence: E-mail: mara.stecchini@uniud.it

Stecchini, M.L. and Del Torre, M., 2005. The food safety management system. Veterinary Research Communica-
tions, 29(Suppl. 2), 117–121

ABSTRACT
A comprehensive food safety strategy involves establishing risk management goals, food safety objectives and,
for production systems, performance objectives and performance criteria. The working instructions for each
step of the process should be validated for their effect before integration within a specific HACCP plan. The
importance of realistic inactivation models to predict the hygienic equivalence of food processing operations
is discussed.

Keywords: food safety objective, performance criterion, performance objective, risk management

INTRODUCTION

Risk analysis (RA), and its component parts (risk assessment, risk management and risk
communication) should be used as a tool in evaluating and controlling microbiological
hazards (CCFH, 2004b). A risk-management based approach is required to develop rec-
ommendations to ensure consumer protection and facilitate fair practices in the food trade.
This structured approach may employ microbiological risk assessment and may utilize a
spectrum of risk communication products including guidance documents, codes of hygiene
practice, food safety objectives (FSO) and microbiological criteria (CCFH, 2004a).
Some general guidelines used to manage pathogens in foods have been described by
ICMSF (2002), indicating the respective roles of industry and government. A series of steps
is described, including: a) analysis of epidemiological data which may give rise to concern
for public health or a need for improved controls; b) risk evaluation by an expert panel or
through quantitative risk assessment; c) establishment of a FSO when necessary; d) assessing
whether the FSO is technologically achievable through preliminary process and/or product
formulation criteria; and e) if the FSO is achievable, establishment of process/product
requirements.
The four components of generic frameworks for managing food-borne risks, previously
described by FAO/WHO (1997, 2000, 2002), have been used as “building blocks” for the
development of guidelines, included in a recent CCFH report (CCFH, 2004b). These four
components can be summarized as follows: a) preliminary risk management activities; b)
identification and evaluation of risk management options; c) selection of MRM options and
implementation of the risk management decision; d) monitoring and review.
Possible risk management options include: avoiding risk, reducing exposure, enhancing
consumer awareness, controlling initial hazard levels, preventing an increase in the hazard

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levels, reducing hazard levels, removing pathogens, etc. (FAO/WHO, 2002). An appropriate
level of protection (ALOP), expressed in terms of a desired reduction in the current level
of risk, could be defined as the food safety goal. An ALOP is currently defined as “a
statement of the degree of public health protection that is to be achieved by the food safety
system”. An explicit description of an ALOP may be in terms of the probability of an
adverse public health consequence or the incidence of disease (e.g. the number of cases per
100,000 population per year). Translation of an ALOP into a Food Safety Objective (FSO),
expressed in terms of the required level of hazard control in food, provides a measurable
target for producers, manufacturers and control authorities. An FSO is defined as “the
maximum frequency and/or concentration of a microbiological hazard in a food at the
time of consumption that provides an appropriate level of protection” (ICMSF, 2002).
An alternative definition of an FSO might be a limit to the prevalence and the average
concentration of a microbial hazard in food, at an appropriate step in the food chain at or near
the point of consumption, that provides the appropriate level of protection (Havelaar et al.,
2004).
FSOs will usually need to be used in conjunction with performance objectives (PO) that
establish the required level of control of the hazard at specified stages along the food chain
(CCFH, 2004b). Furthermore, performance criteria (PC) can be expressed by the food busi-
ness in terms of a desired reduction in the concentration of a hazard in the course of a
particular control measure, e.g. the result of a particular treatment (CCFH, 2004b). As a
direct consequence of the introduction of the concepts of FSO/PO, the role of microbiolog-
ical criteria (MC) will expand, providing objective means of verifying at a specified level
of confidence that a PO or PC (or a FSO) is being met (CCFH, 2004b).

PUBLIC HEALTH GOALS FOR L. monocytogenes

The United States of America has initiated an ALOP approach with the recommendations
included in the “Healthy People 2010” report (Office of Disease Prevention and Health Pro-
motion, 2000), with the aim of reducing foodborne listeriosis by 50% by the end of the year
2005. To set FSOs would require risk assessment of this disease with dose response curves.
The risk management goal of decreased incidence of food-borne listeriosis to 0.25 cases per
100,000 population could be linked to FSOs, since dose-response data are available through
the FDA/FSIS/CDC (2003) and FAO/WHO (2001) risk assessment for L. monocytogenes
in ready-to-eat (RTE) foods.
The FAO/WHO Listeria risk assessment data in RTE foods (FAO/WHO, 2001) indicates
that
• nearly all cases of listeriosis result from the consumption of high numbers of L. mono-
cytogenes;
• preventing high levels of contamination at the time of consumption has the greatest impact
on reducing listeriosis;
• most cases of listeriosis are associated with the consumption of foods that do not meet
current standards;
• the potential for growth strongly influences risk.
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Guidelines for the control of L. monocytogenes in foods were presented based on FAO/
WHO risk assessment principles. The guidelines (CCFH, 2001) suggested a microbiological
criteria at 100 cfu/g at the point of consumption (FSO). However, a revised document
(CCFH, 2003) modified the guidelines, splitting them into two separate documents: one
that contained general guidance for managing L. monocytogenes in foods and the other on
the specific microbiological criteria on L. monocytogenes for foods in international trade.
At present CCFH has proposed draft guidelines on the application of general principles of
food hygiene to the management of L. monocytogenes in foods (CCFH, 2004c), but has not
yet made use of the results of the WHO/FAO risk assessment in the formulation of specific
limits.
The EU position concerning the concentration of L. monocytogenes in ready-to-eat (RTE)
foods was expressed in a conclusion written by the Scientific Committee on Food (SCF)
(European Commission, 2000), based on the recommendations made by the Scientific Com-
mittee on Veterinary Measures relating to Public Health (SCVPH) (European Commission,
1999) which stated that “a level of <100 cfu/g L. monocytogenes at the point of consumption
poses a low risk”. Furthermore, the SCF supports the SCVPH recommendation that manu-
facturers’ efforts should be focused on the food commodity types where L. monocytogenes
can multiply.
POs, unlike FSOs, are intended to be measurable and verifiable. This would typically
be done by the establishment of a MC that would provide a statistically based means of
verifying within a stated degree of confidence that the PO is not being exceeded (CCFH,
2004b).

PERFORMANCE CRITERIA (PC) SET TO MEET ESTABLISHED FSO

(EVEN IF HYPOTHETICAL FOR L. monocytogenes)

Given an FSO or PO, the food business would design its operational MRM systems, i.e.
through selecting appropriate PC and control measures. In practice, to achieve the defined
FSO, it is necessary to implement one or more control measures at one or more steps in the
food chain. The outcomes of these control measures are defined as performance criteria. The
PC for a microbiocidal control measure (e.g. heat treatment) expresses the desired reduction
of the microbial population that occurs during application of the control measure, whereas
a PC for a microbiostatic control measure (e.g. chilling) expresses the maximum increase
in the microbial population that is acceptable under the various conditions pertaining to the
applied measure (CCFH, 2004b). An example of a published performance criterion for L.
monocytogenes includes a 6D reduction of the pathogen in ready to eat chilled foods (Lund
et al., 1989).
When establishing performance criteria, consideration should be given to the initial level
of a hazard and changes occurring during production, distribution, storage, preparation and
use of the food. The availability of an MRA that includes modelling the hazard exposure
pathway will be of particular assistance here (FAO/WHO, 2002).
An equation to establish performance criteria and examples of performance criteria de-
veloped to achieve a defined L. monocytogenes FSO, are reported by ICMSF (2002). A
revised formula has been published by Todd (2003).
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IMPLEMENTATION OF PERFORMANCE CRITERIA FOR L. monocytogenes

Performance criteria, alone or in combination, may be implemented as food safety mea-

sures in GHP and/or HACCP-based food control systems (FAO/WHO, 2002). According to
ICMSF (2002), the food safety measures applied to achieve control over a specific hazard
are classified as process criteria, such as the time and temperature of heat treatment, and
product criteria, such as the water activity of the product.
Performance criteria at each step of the food chain are predetermined and validated at spe-
cific points (i.e. validating that POs are met by the respective PCs) as well as regarding the
overall food chain (i.e. validating that the FSO is met) (CCFH, 2004b). In the “Proposed draft
guidelines for the validation of food hygiene control measures” (CCFH, 2004d) suggestions
were made to further clarify the link between HACCP principles and validation of the man-
agement measures and to stress that the pertinence and efficacy of the HACCP plans in terms
of food safety should be validated by the industry, on a scientific basis, without prejudice
to any individual management measures or any combination of management measures.
With regard to the potentially different stress tolerance imposed by mild technologies on
L. monocytogenes cells, additional studies are required to validate the food safety measures
required to achieve the established level of protection. Furthermore, traditional thermal
process models do not take into account stress response. Accurate and robust inactivation
models are necessary to overcome this problem. The shape of the L. monocytogenes inacti-
vation curves was found to be influenced by heat or osmotic stress and a distribution model
(Weibull) performed much better than the classic first order approach (unpublished data).

CONCLUSION

The continued safe expansion in sales and consumption of fresh and mild-treated foods
without associated L. monocytogenes illness will be achieved by developing and imple-
menting the scientific basis for performance criteria needed to prevent an increase and to
reduce the level of the hazard. Moreover, risk assessment will be used for the evaluation of
the best alternatives in determining food safety, thus making a contribution to the process
of evaluating management options.

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