4 Food Safety Management

and principles for decision-making, changes in systems and requirements for food production and processing, and for the
Chapter 2 strengthening of the infrastructure for food safety management (Table 2.1).
Hence, the 21st century sets the beginning of a new era in food safety. Reviewing the history of food safety from pre-
historic times, we can divide it in three major eras:
l A time where consumers were directly managing the safety of products by consuming a food and judging its safety by its
Fundamentals in Management of Food l
impact on their health.
A period where governments were managing food safety by testing products and removing contaminated or non-
Safety in the Industrial Setting: Challenges compliant products from the market; in general, food was considered safe unless people became ill or tests would
indicate otherwise.

and Outlook of the 21st Century l The present era where food businesses have become responsible for providing evidence that they have taken necessary
measures to prevent contamination of foods. This means that foods are considered safe when there are proofs that the
safeguard measures have been taken and the hygienic conditions of production, processing, transport and distribution or
preparation have been observed.
Yasmine Motarjemi , Veslemøy Andersen , and Huub Lelieveld
Food Safety Management Consultant, Nyon, Switzerland Global Harmonization Initiative (GHI), Vienna, Austria From the above, it follows that food safety management in the industry is not first a question of addressing food safety
problems, but essentially one of taking the necessary measures to prevent them, including the necessary research and tests
to confirm that the control measures are effective (validation) and properly implemented (verification). Since the intro-
duction of the HACCP (hazard analysis and critical control point) system, the role of governments has shifted from iden-
Chapter Outline
tifying potentially unsafe food or unsafe practices to supervising and verifying the implementation of food safety
Consumer Trust: The Corner Stone of a Food Business 3 Complexity of the Subject 11
The 21st Century: A New Era in Food Safety 3 Complexity of Food Operations 12
management systems by industry.
The Concept of Food Safety and Its Definition 5 Complexity of the Food Supply and External Environment 13
Elements of Food Safety Management 5 Human Factor 13
Government 5 Outlook: Whistleblowing 15
Industry 7 Conclusions 16
Consumers and Customers and the Informal Sector 9 References 16
TABLE 2.1 Key Guiding Principles that Gained Prominence in the 1990s for the Management of Food Safety (Motarjemi,
Academia 9 Further Reading 16 2014a)
Challenges in Management of Food Safety and Outlook 10 1. Integrated approach, i.e., consideration of the risks and control measures along the entire food chain, from primary production up to
the point of consumption
2. Shared responsibility, which is the recognition that all sectors, including consumers, have a responsibility in ensuring food safety
Consumer Trust: The Corner Stone of a Food Business 3. Multi-disciplinary approach, which comes from the understanding that ensuring food safety requires different types of scientific and
operational expertise
Successful and sustainable businesses are those that give priority to consumers and are able to meet their expectations.
Three fundamental expectations of consumers are to be able to trust the food businesses from which they buy their food 4. Evidence-based and risk-based decision-making to ensure objectivity and the most efficient use of resources in food safety
products, to be able to rely on their ability to ensure the safety of their products, and to have confidence that, in the event of a management. This principle is important to assure stakeholders or trading partners that measures are based on scientific and technical
evidence, and are effective and commensurate to the degree of risk. The principle also facilitates the implementation of the WTO/SPS
mishap, they will take the necessary measures to protect them and will act in a truthful and transparent manner. Therefore, it article on equivalence as it allows countries to deviate from the requirements of importing countries, if they can demonstrate the
cannot be stressed enough that the trust of consumers (and customers) is one of the most important assets of a food business equivalence of measures on a scientific basis
and that food safety is the foundation of this trust.
5. Transparency, uncertainty, and precautionary principles. Transparency is an obvious consequence of the above-mentioned
principles on the evidence-based decision-making process. However, it gains particular importance when there is uncertainty in data
or when data are lacking. The value of transparency is that, in absence of full scientific information or variation in the degree of risk,
the uncertainty and variability are declared, and evidence of the adequacy of protective measures is provided. Transparency also
The 21st Century: A New Era in Food Safety increases trust in stakeholders and trading partners. The precautionary principle states that if a product, an action or a policy has a
The end of the 20th century was marked by a drastic increase in the incidence of foodborne illnesses, large-scale outbreaks, suspected risk of causing harm to the public or to the environment, protective action should be supported before there is complete
scientific proof of a risk
and the emergence of new foodborne pathogens and chemical hazards. An alarming number of food safety incidents and
crises, widely reported by the media, also fueled the feeling of insecurity among consumers. A combination of different 6. Structured approach: i.e., while risk managers and risk assessors should maintain an active interaction, there should be a functional
factors is believed to have contributed to this trend, among which: separation between risk assessment and risk management to ensure objective and unbiased decision-making, balancing scientific
consideration with societal values and economic interests, as well as considering the risk perception of consumers
l The industrialization of agricultural production, mass production and increase in the number of food service
7. Harmonization of food standards which is a goal as well as a consequence of the WTO/SPS Agreement
establishments.
l The liberalization of trade and the growing number of imported foodstuffs. 8. Continuous improvement. As in any quality management system, a Plan, Check, Act, and Do/Review process should be applied to
food safety management. Such activities will continuously improve the safety of foods by reducing risks to a level that is as low as
l Tourism, urbanization with subsequent changes in lifestyle, food consumption pattern and food preparation practices.
technically/reasonably achievable
Additionally, the increased availability of and accessibility to information and its rapid communication through mass and
This principle does not apply to foods which present an immediate and/or an unacceptable risk to consumers’ health and where a crisis management procedure
social media further amplified the feeling of insecurity. The consumer perception and the trend of requiring better quality, should be implemented. The principle applies both in governmental functions, which should progressively drive the contamination of food supply and incidence
fresher food and more ethical food production practices has also weighed in the decision-making process. These develop- of illnesses to as low a level as technically and reasonably achievable (ALARA principle), and to industry where it is expected to have a yearly objective for
improving the food safety assurance system.
ments have been the impetus for major changes in the management of food safety and the development of new procedures

Food Safety Management. [Link]

Copyright © 2023 Elsevier Inc. All rights reserved. 3
 Fundamentals in Management of Food Safety in the Industrial Setting Chapter 2 5 6 Food Safety Management

The Concept of Food Safety and Its Definition

Today, the subject of food safety has become a discipline in its own right and a formal definition was elaborated by the
Codex Alimentarius Commission (Codex Alimentarius Commission (CAC), 2020) in 1969.
According to the CAC, “food safety is the assurance that food will not cause adverse health effects to the consumer when
it is prepared and/or eaten according to its intended use.”
This definition embodies several important notions:
1. The notion of adverse health effects, which separates safety aspects of food from other quality aspects that make food
unfit for human consumption without necessarily presenting a danger to health. The aspects of food that make it unfit for
human consumption, even though it is safe, are referred to by the CAC as food suitability.
2. The concept of assurance, i.e., food safety and its management should be based on measures that are in place to provide
assurance that food is safe. In other words, food safety depends on the conditions in which food is produced and pre-
pared, and not on the results of the end-product testing, which for many contaminants cannot be a reliable method for
food safety assurance. The conditions for ensuring both safety and suitability are referred by the CAC as “food
hygiene.”
3. Preparation and/or use of a food product should be considered in product design. A food product is considered safe if it
is prepared and/or used according to its intended use. Subsequently, the intended use should be considered by the man-
ufacturer in the design of the product as well as in their information conveyed to consumers. The consumer must also
follow on-pack instructions as provided by the manufacturer.

Elements of Food Safety Management

The modern approach to food safety management recognizes the need for cooperation of different sectors and a role and a
responsibility for each sector. Figure 2.1 illustrates the functions of the different sectors as described below.

Government
Public health and food control authorities have the leading role in managing food safety and must have the capability of
overseeing the safety of the food supply, from primary production up to the point of consumption. With this responsibility,
FIGURE 2.1 General overview of the organization of food safety management in society.
they have to do the following:
l Foresee all infrastructures and public health services that are necessary for a good food safety management, such as
public health laboratories, water supply and sanitation, etc.
FIGURE 2.2 Risk analysis process.
l Promulgate laws and regulations, which give priority to public health but which can also meet other societal and
environmental needs.
l Enforce legislation through the provision of advice to trade and the commercial sector, inspection and monitoring of
food supply, and, where necessary, prosecuting offenders. Risk Management
Risk Assessment Defining and
Examining
l Provide education to caregivers, consumers, travelers, health professionals and the public at large. science
implementing the
policies

Today, decisions on measures required to manage risks are taken in the context of the risk analysis process. There are
various types of models for describing the risk analysis process. Figure 2.2 depicts the process according to the CAC.
The process includes risk assessment, risk management, and risk communication. Risk Communication
As risk managers, regulatory authorities are, among others, responsible for (1) driving the risk analysis process, The exchange
of information
(2) setting public health goals, and (3) deciding on risk management priorities.
The risk management process itself comprises a number of steps that are briefly discussed here.
The first step is referred to as preliminary activities. As part of this, governmental risk managers will commission a
assessment policy in consultation with risk assessors and other interested parties. A risk assessment policy is a guidance to
preliminary risk profile for a given hazard or hazard/food. Based on the outcome of this and in the light of existing data,
risk assessors, outlining information such as:
they will decide if a risk assessment is required, or if it is possible to evaluate the various control options. Should risk
managers find that a risk assessment is justified, bearing in mind the resource and time investment, they may decide to l The purpose and scope of the risk assessment, e.g., sector of the food chain, types of food and products to consider.
commission a qualitative or a quantitative risk assessment. In this case, they are responsible for elaborating a risk l Target populations or subpopulations.
l Key scientific judgments, particularly when there is a high degree of uncertainty in existing data or in data gaps.
Codex Alimentarius Commission is an intergovernmental body, operating under the auspices of the World Health Organization and the Food and Agri- l The type and sources of data to be considered.
culture Organization of the United Nations. l How the data should be presented, in particular the types of assumptions and uncertainties.
 Fundamentals in Management of Food Safety in the Industrial Setting Chapter 2 7 8 Food Safety Management

The process of risk assessment and risk management follows an iterative interaction between risk assessors and risk man- Alimentarius Commission has developed a large number of codes of practice. The recommended International Code of
agers, during which these need to foster mutual understanding and refine the risk assessment so that it responds as closely as Practice – General Principles of Food Hygiene is one of the “horizontal” codes that has wide application in the food
possible to the questions posed by risk managers. When deciding on the appropriate control measures, risk managers need industry. For given categories of products, there are also product-specific codes where guidance is provided for the handling
to take into consideration a number of other factors, sometimes also referred to as “other legitimate factors.” These factors of that particular group of products.
vary according to the nature of the hazard under consideration and can include costs, feasibility, benefits, other risks (e.g., The second line of defense is the application of the HACCP system. During this process, hazards specific to a food and/
environmental or nutritional), consumer preferences and societal values such as animal welfare. At times, a risk assessment or process are proactively identified and control measures specific to the hazards in question are determined. Concerning
may be required to advise on the efficiency of the control measures, to develop an understanding of the public health steps that are considered critical for ensuring the safety of the food product, monitoring parameters characterizing the
outcome according to different levels of contamination, to have an estimation of the risk of various foods/hazards control measures and critical limits for the monitoring parameters are established and the steps are monitored to ensure
combination, etc. that the critical limits are respected at all times. Additionally, any regulatory requirements (such as codes of practices
In managing a risk, depending on its nature and degree and on other factors mentioned above, risk managers have dif- or national standards, food safety objectives, sampling plans, etc.) or customer requirements, e.g., specifications, perfor-
ferent options at hand. These range from taking a regulatory action, such as those listed below, to taking no action. mance criteria for intermediary processes, need to be considered during product/process design and respected during oper-
ations. Needless to say that during the development of an HACCP plan, measures identified for controlling the hazards and
l Compliance with certain standards (e.g., setting norms for a chemical hazards or food safety objectives, or microbio-
the parameters as well as limits to be respected need to be validated, short of which the HACCP study will become a simple
logical criteria for microbiological hazards).
paper exercise. HACCP also has other elements such as corrective actions in case the process is going out of control, and, as
l Labeling.
explained below, verification and documentation.
l Testing and/or certification of foods.
A strategy that has been used by some governments to assist small or less developed businesses in applying the HACCP
l A specific processing of foods to inactivate pathogens.
system is to develop HACCP-based codes of practice for specific categories of food products. Such an approach is
l Application of a code.
important for small or less developed businesses as these often lack expertise in food safety, and unless they are assisted
l Recalling a product in case of an incident.
by a trade organization, they may not be in a position to do an HACCP study by themselves. An HACCP-based code of
Alternatively, they may decide to manage the risk by providing education to consumers or requiring the training of food practice for a specific sector combines both the general principles of food hygiene and the considerations and requirements
handlers in food service establishments. It can also happen that they decide not to take any action (e.g., if the risk is low or specific to a given food sector.
negligible). In any event, the food safety authorities have the responsibility to communicate and explain their decisions to Frequently, the question is raised about the difference between the code approach to food safety assurance vs the HACCP
the stakeholders. system, and their respective benefits. Originally, a code approach was viewed as a general and prescriptive system of man-
To identify possible food safety problems and/or to review the implementation of the risk management decisions and to agement of food safety in a business. Subsequently, HACCP was recommended by public health authorities to promote a
evaluate the need for any revision in decisions or implementation, the collection of various types of data need be considered. preventive approach based on the analysis of hazards in foods or processes, before these lead to an incident. When applying
Examples are: the HACCP system, hazards specific to a particular food product, process and to the conditions in which the food is prepared
are identified and control measures specific to the hazard in question are devised. In this way, as opposed to codes that are
l Inspection reports and evaluation of implementation of risk management decisions by the food industry.
general guidance, through the HACCP system control measures are targeted to hazards specific to the product (raw material
l Monitoring of chemical contaminants.
or conditions of production). However, with experience, it became evident that both approaches have their respective values,
l Surveillance of foodborne diseases (data from different types of surveillance methods need to be considered).
and that HACCP would be more efficient if some basic hygienic conditions and preventive measures were in place. Today,
l Consumer complaints.
these are referred to as prerequisites in food safety assurance systems of the food industry, and it is recognized that it is by
l Trade rejections.
combining both approaches that the optimum conditions of food safety management are attained.
l Public recalls, withdrawals and/or incidents.
Very often, the documentation required as part of HACCP has given the HACCP system the negative image of being
l Applied research based on defined indicators (knowledge, gaps).
burdened by paperwork. However, records and documentation are essential as support material for communication between
Other types of information may also be required for planning improvement or preventive actions. Examples are trends in members of the HACCP team and/or with time, for the maintenance of the plan, i.e., for the HACCP team to be able to
incidents and alerts, be they occurring in a country or outside the national boundaries, adequacy of resources, as well as consider the need for any change in the plan and thus ensure that the system remains valid and up to date. Also, records are
various changes in society such as changes in climate, demography, international trade and travel, or emergence of new required to provide evidence to customers and/or inspectors of the adequacy of measures.
pathogenic agents. The third and last line of defense is verification activities. These are also part of the HACCP application, but to delineate
between measures implemented for prevention and those required for verifying that preventive measures are effective and
performing correctly, here these are presented separately.
Industry
As for the governmental evaluation process, verification activities include all tests and other data collected to verify that
The food industry is responsible for ensuring that the food that it puts on the marketplace or that is served in food service preventive measures achieve the objectives set. Verification should not be mistaken for validation, which is a process to
establishments is safe, fit for human consumption and meets regulatory requirements of the country where it is marketed. ensure that control measures are effective to achieve the objectives desired. The validation process is usually implemented
They have to consider the regulatory norms for hazards as food safety standards and ensure that their products are not during the product and process design stages, or when a change has been made in product design or during its
violating these limits. To meet these responsibilities, the food industry is required to have an integrated food safety manufacturing. If verification data indicate that a product is not meeting a set standard, even though the plan has been
assurance system. implemented, the validation of control measures may need to be questioned.
A model for this system consists in combining three sets of measures according to the three lines of defense (Figure 2.1). In principle, where codes of good practice and the HACCP system are optimally implemented, a high degree of safety
The first line of defense is the implementation of codes of good practices. These are a set of general principles and can be assured. Nevertheless, verification measures are important to detect any dysfunction in the system. They also
measures which have been identified through past experience as necessary to ensure the safety and wholesomeness of foods provide evidence of compliance with the food safety standard and should not be stopped on the grounds that data on con-
produced; with some adaptation, they are generally applicable to all categories of foods and products and/or establishments tamination are negative, as data are needed for proving compliance and the performance of the food safety assurance system
regardless of location, specific conditions, and types of business. Depending on the sector, they are referred to as Codes of at all times. Examples of verification measures are:
Good Agriculture Practice, Codes of Animal Husbandry, Codes of Good Manufacturing Practice, Codes of Good Transport
l Raw material and end-product testing.
or Storage Practice, etc. Very often, such codes are voluntary, but at times they are legally established by regulatory author-
l Environmental monitoring.
ities. However, where they do not exist or are not stringent enough, the industry may also develop such codes. The Codex
 Fundamentals in Management of Food Safety in the Industrial Setting Chapter 2 9 10 Food Safety Management

l Calibration and other maintenance checks. (e.g., interviews in the mass/social media). As such, they play an important role in both the management of food safety (in
l Release of products. particular risk assessment and risk communication) as well as the management of a crisis.
l Audits. On the technical aspects, scientists contribute to food safety management by providing different types of scientific data
l Consumer complaints handling. and their assessment, which is necessary for making decisions. Examples are:
Should verification data indicate non-compliance, the adequacy of the implementation of the HACCP system and the pre- l Toxicological information, mechanisms of contamination of foods with chemicals, or their formation.
requisites must be examined in the first place. In absence of any failure in implementation, the validation of the elements of l Ecology of microorganisms and epidemiology of foodborne diseases.
the HACCP study can then be questioned. l Validated analytical methods.
At times, in spite of all measures, it can happen that a raw material used in a product is contaminated or a product that is l Process and technologies to control hazards.
contaminated is marketed. Through a traceability system, i.e., information on the source of raw materials or on the cus- l Consumer perception, beliefs, and practices.
tomers who have received the product, a contaminated product can be traced and recalled. Regulatory authorities in some
In industry, scientists can minimize risks associated with products and processes by designing out risks during product
countries require that the traceability system of an establishment ensure that information on the source of a raw material or
development and defining necessary control measures for managing the operational risks during the production or
destination of a final product be available for one step up or one step down. With the globalization of the food supply and the
manufacturing of foods.
passing of food ingredients through various traders, it is sometimes difficult to ensure precise or valid information on the
Additionally, scientists can further contribute to the management of food by creating tools to make information on food
condition of the production of raw materials. Where information on traceability is lacking, the investigation of outbreaks
safety easily accessible to all stakeholders in society.
and the identification of the implicated food become more difficult as observed in an outbreak of Salmonella Saintpaul in
the United States in 2008 (CDC, 2008). Originally, the outbreak was attributed to tomatoes until it was discovered that the
main vehicle was jalapeño and serrano peppers. The outbreak lasted from April to August and some reported 1,442 persons Challenges in Management of Food Safety and Outlook
fell ill. The weaker the traceability, the larger the scale of the outbreak or product loss. This was demonstrated in the dioxin
incident in Ireland where a full product recall was conducted for pork meat, whereas for beef meat it was possible to limit In spite of measures implemented during the last decades and advances in science and technology (Table 2.2), managing
the recall to the contaminated product because after the BSE crisis, a traceability system was established for beef products food safety remains today a daunting task. Many factors contribute to this, understanding and recognizing these factors is
(Casey et al., 2010). Similarly, in the food manufacturing industry, the finer the traceability, e.g., indicating the date and important for managing food safety better and foreseeing the infrastructure, procedures, systems, and resources that are
time the product was produced, the smaller the quantity of product wasted in case of recall. required to this end.
Finally, the entire food safety assurance system should be supported by a well-performing crisis management system to For the food industry, a first challenge is to be able to ensure the safety of its products, and at the same time meet con-
protect consumers from exposure to contaminated products. sumers’ expectations in terms of quality. As will be seen later, managing food safety is by itself very complex; to achieve
Fundamental to all these systems are the training and education of the staff as well as the management’s commitment. this as well as to provide high quality products is very challenging and at times quite difficult as some requirements for food
Therefore, fostering a culture of food safety, from training of the staff to motivating them and appreciating their constraints, safety are not always consistent with the perceived quality.
constitutes one of the most important pillars of food safety management in industry and in governmental functions. The With the progress in the industrialization process and advances in science and technology, consumers’ expectations
importance of organization culture cannot be emphasized enough. Reporting any non-compliance or a risk-prone situation have also increased. Today, for most consumers, food is not only a source of nutrition, but it is also a source of pleasure
at an early stage can contribute to preventing outbreaks before they occur. and an “emotional experience.” Moreover, in recent years, with the fortification of food and the development of functional
foods, some consumers see foods as a means to alleviate their health risks. In modern societies, where the lifestyle and the

Consumers and Customers and the Informal Sector

Consumers at large and domestic and professional food handlers in particular also have an equally important role in food TABLE 2.2 Some Major Developments in Food Safety Management in the Last Two to Three Decades
safety. These include, but are not limited to: 1. Increased general awareness about food safety

l Observation of good hygienic practice in the preparation of food. 2. Research on pathogens, chemical contaminants, and technologies and increased scientific and technical know-how
l Reading information (e.g., “use by date” of products, product storage, possible presence of allergens, target consumer) 3. Development and emergence of high-performing food technologies and analytical methods
on the labels of products and observing the instruction for the preparation and storage of products.
4. Increased availability of epidemiological and scientific data on foodborne pathogens and chemical contaminants
l Reporting defective (unsafe) products to the public health/food safety authorities and/or manufacturer.
l Being discriminatory in the selection of products, brands and establishments (incl. restaurants, caterers) to exclude those 5. Improvement in the procedures for risk assessment and risk management
that may present a risk for health, do not respect food hygiene, do not meet regulatory requirements or have unethical 6. Strengthening of national legislation (standards, codes of practices) and its enforcement (inspection, monitoring)
practices.
7. Strengthening of the international requirements (Codex Alimentarius, Agreement of the Sanitary and Phytosanitary Measures of the
To enable consumers to assume their responsibility in the hygienic handling of food as well as to judge potential risks with World Trade Organization, ISO 22000 refers)
certain products, practices or establishments, consumer information, and education are key. This is best carried out by pro- 8. Increased preventive measures at the primary industry
fessionals who are both trusted by the general public and who also are in dialogue with the public in their everyday work.
9. Improvements in quality assurance, including application of the HACCP system
Examples are representative of consumer organizations, health professionals and school teachers.
10. Strengthening the foodborne disease and food contamination surveillance systems, alerts, traceability, and incident management

11. Increased training of professionals involved in food safety (governments, food industry, and food service sector)
Academia 12. Recognition of the importance of risk perception and good risk communication
Scientists in general, whether they work in academic institutions, in government or in industry, also have an important 13. Educational campaigns for consumers and the general public
function. With the trend in evidence-based decision-making and taking science into consideration, be it life or social sci-
14. Improved waste management, protection of the environment and of water and sanitation facilities.
ences, the role of this sector in the risk analysis process has increased during recent years. Their integrity, excellence and
relevance make them ideal communicators for managers (e.g., report of their results, articles) or for the general public
 Fundamentals in Management of Food Safety in the Industrial Setting Chapter 2 11 12 Food Safety Management

structure of family have changed, consumers also need food products to be more convenient in terms of accessibility, trans- is found in an outbreak of Staphylococcus aureus where it was believed that by reheating milk that was subject to
portation, storage, preparation, and use (e.g., easy opening). Many consumers also attach importance to the attractiveness of time–temperature, the milk could be rendered safe, while toxins of S. aureus are heat stable. In the area of chemicals,
products, e.g., color of the product or its packaging. Worldwide, price is also an important determining factor and many the contamination of soft drinks with benzene shows the global difficulty in keeping track of the scientific and technical
consumers seek foods that offer the best value for price. Food businesses also have to respect the cultural and traditional know-how and transferring it to a new generation of professionals. In 2006, it was found that some soft drinks, where a
values of the societies in which they operate, for instance they must observe the kosher and halal rules. Other factors that combination of sodium benzoate and citric or ascorbic acid was used, contained unacceptable levels of benzene due to the
may also impact consumers’ decisions with regard to their preference for one brand rather than another are issues related to interaction between these ingredients. This interaction and potential formation of benzene was known already in the 1990s,
the environment, animal welfare, ethical practices, and in general their perception of the responsible behavior of a but presumably, with time, this knowledge had faded away from the institutional memory of the scientific and technical
company. Thus, over and above safety, a successful business needs to meet a broad range of criteria that varies with life- organizations. A rigorous implementation of HACCP can prevent many such technical errors; however, it requires that
style, values, culture, the level of education, and the perception of consumers. HACCP studies be carried out by a team of competent experts and be duly validated. This is still not the case in many
It should be mentioned that food is also a means of subsistence for many people. The food industry, from the primary, businesses.
manufacturing, retail to the service industry is by far the biggest industry in the world; thus it provides job opportunities to a Thus, communicating the science of food safety to all stakeholders of the food chain, commensurate to their role and in a
considerable proportion of the world population. According to the International Labor Organization, in countries that have responsible manner, will be an important task in the 21st century. This is a huge but important challenge, as this means
official statistics, the food manufacturing industry alone employs some 22 million people. Besides providing job oppor- basically educating the entire world population in food safety since everyone is a potential food handler and some may have
tunities, the food industry is an engine for economic development as it provides food for the world population and supports a professional role in the food sector. This can be achieved only if food safety is taught systematically in schools, starting
international trade and food export, which is a source of foreign exchange. from primary schools to academia, be it food science and technology or public health and medicine. Making this science
Thus, as part of their social responsibility, food industries also have obligations toward their employees, their job accessible to every individual will promote common understanding. For the food industry personnel, training of the pro-
security and the economic role that they have in the community where they are established. Overcoming certain food safety fessionals is fundamental; while human error can be forgiven by consumers, ignorance, or negligence cannot.
issues, in particular where food safety standards are too stringent compared to what is possible, or where legislation is not
feasible, can be at the cost of compromising the livelihood of many people and crippling the frail economies of certain
Complexity of Food Operations
countries. On the other hand, in businesses that fail to ensure the safety of their products and are forced to close a factory
or go out of business, employees may also run the risk of losing their jobs. A second factor that undermines the efficiency of control measures is the complexity and variability of food operations, a
With regard to the management of food safety, there are many factors that contribute to this complexity and present situation that makes employees of food businesses more prone to error. In the food industry, food operations can be very
challenges. complicated by the number and variety of ingredients, recipes, processes, and standards to meet, in particular if products are
to be marketed to countries with different regulatory requirements. Changes in the various aspects of operations add to this
complexity: product formulation, raw materials, packaging, production and processing scheme, construction and mainte-
Complexity of the Subject
nance work, shift of personnel (including temporary personnel) and markets where the product is sold. Export of food to
In food safety, we are facing a mind-boggling number of hazards of biological, chemical, physical and other nature, not to different markets with different regulations, consumer practices or climatic conditions requires that these factors are con-
mention the unexpected chemicals that may find their way into the product due to accidental contamination, tampering or sidered in the design of the products.
sabotage. With developments in science and technologies, increases in our knowledge and analytical capabilities, the list of Such a complexity necessitates a very well organized and managed logistic infrastructure, planning, and discipline in
hazards is becoming longer. Chemical hazards alone group countless chemical agents, e.g., hundreds of different types of execution. Short of this, the situation becomes conducive to human error. The example of allergen management illustrates
pesticides, antibiotics, food additives, environmental contaminants from heavy metals to PCBs and radionuclides, naturally this point. Where processing or manufacturing of various products is shared on the same line of production, the man-
occurring toxins, including a number of mycotoxins, as well as processing and packaging contaminants. Microbial hazards agement of allergens may present a greater risk vs the use of dedicated lines. However, the latter is not always possible
are also numerous, but their greatest challenge lies in their multifaceted nature. For instance, they vary in their: particularly when small quantities of products are manufactured. Sharing the production lines would require a careful
scheduling of operations, dismantling and effective cleaning of equipment and careful labeling of allergens, sometimes
l Conditions for growth (pH, water activity, aerobic vs anaerobic conditions).
in several languages and according to the legislation of the different countries where products are marketed. A slight change
l Mechanism of pathogenicity and ability to produce toxins with different sensitivity to heat.
in any of the above parameters, if not managed, can lead to an error in labeling.
l Virulence and in their opportunistic nature, i.e., some pathogens target mainly vulnerable population groups.
At the agricultural level, the trend to use food for purposes other than consumption, e.g., fuel, will add a new dimension
l Dose–response relationship, which also depends on the food matrix and the target person.
to the complexity of the food chain and to the management of food safety, as this type of food may contain substances that
l Resistance to various control measures, e.g., heat, acidity, chlorination, etc.
are not appropriate for human consumption. Segregation of these foods from crops destined for human consumption will
l Ecology and vehicle of transmission.
require additional logistic infrastructure and thus again become a potential for human error.
l Health consequences.
Thus, a slight change in any of the production parameters requires a thorough examination of the consequences of these
Managing this technical and scientific complexity and communicating sophisticated set of information to decision-makers for the management of food safety and, if necessary, changes in the control measures. One should also bear in mind that
or other actors in the food chain are not always easy. A particular difficulty lies in communicating with food handlers/ these changes may impact on other hazards or quality parameters. Such situations often necessitate a re-examination of the
caterers in the food service industry, who have a generally low level of academic background, or with the general public HACCP study, and, if necessary, a change in the plan and its communication to operators and other relevant persons in the
in a convincing manner; yet this knowledge is fundamental to the decision-making process and a prerequisite to good prac- business.
tices. This communication becomes an intricate task when food safety measures are intertwined with economic factors, A case in point shows that a change of supplier has been the source of many incidents: in Germany, from April to Sep-
ingrained cultural habits and beliefs, or simply food preferences. An example is the consumption of raw milk or cheese tember 1993, a nationwide outbreak of salmonellosis associated with paprika potato chips affected an estimated 1000
made with raw milk vs the pasteurization of milk for health protection. children below the age of 14. In this outbreak, the trader changed the supplier of paprika for a totally unknown supplier
In the food industry, even in the most resourceful companies where there is access to technical expertise, the complexity without informing the customer (Lehmacher et al., 1995). An accidental breakdown in infrastructure, resulting in temporary
of food safety is an issue in designing food safety control systems, particularly when other conflicting quality criteria have change in conditions of processing and manufacturing foods, has also been the cause of food safety problems and foodborne
to be met. An example where this technical complexity has led to a mistake in decision-making can be seen in an outbreak of disease outbreaks; in an extensive outbreak of staphylococcal foodborne intoxication associated with low-fat milk in Osaka,
salmonellosis in the United Kingdom in 2006 (Carroll, 2009). In this incident, the company in question undermined the Japan, as many as 13,420 persons became ill. The incident was due to a power cut and storage of the milk in
consequences of low level of salmonella in chocolate. It assumed that at the level salmonellae were present, it did not time–temperature conditions allowing growth of S. aureus and formation of toxins (Asao et al., 2003). Reconstruction
present a concern for public health while a number of previous outbreaks provided evidence of the risks. Another example and maintenance work is a frequent cause of post-process contamination of products. From August 1998 to February
 Fundamentals in Management of Food Safety in the Industrial Setting Chapter 2 13 14 Food Safety Management

1999, a large multi-state outbreak of listeriosis occurred in the United States (CAC, 2020). Investigators documented more companies or governmental organizations have policies that pledge for food safety. However, many fail to implement their
than 100 illnesses in 22 states. A total of 21 deaths including 15 adults and 6 stillbirths/miscarriages were reported. CDC policies and to provide optimum infrastructure, processes, organizational culture, and required resources.
(Centers for Disease Control) and state and local health departments identified the vehicle for transmission as hot dogs and One reason is that leaders do not always appreciate the magnitude of the effort that is needed to ensure food safety in a
possibly deli meats produced under many brand names by one manufacturer. It is believed that dust kicked up during sustainable manner. Some consider safety as a granted attribute of a food product. While they are aware of the complexity of
summer maintenance of the air-conditioning system at the plant. their operations (as described above), however, they do not realize how this complexity impacts on food safety and its
In the food service industry or at the household level, preparation of food requires a multitude of tasks; a minor change in management. Food safety needs to be considered in the implication of any business decision at the outset, such as the
the ingredient, quantity, conditions, or procedure can make a difference in the safety of products. Without a specific decision to make a new acquisition, or develop or change a product or a process, implications for using contract-
knowledge of the consequences of the change, there is a risk for an incident. For instance, one of the frequent occasions manufacturer or subcontractors for specific services, or any other cost-cutting decision. Table 2.3 describes some frequently
for foodborne illness is festivity and/or other occasions where food is prepared in large quantities. In such occasions, the observed misperceptions. The financial competitiveness and the drive to increase profits are another reason for the gap
normal procedure may not be appropriate as the refrigerator may not have the capacity for rapid cooling of the food; con- between policies and actual practices. A possible consequence of this attitude is an approach to risk management and orga-
ditions of storage of food become then favorable for pathogen growth and/or production of toxins. nizational culture that oscillates between a protective approach with a reasonable safety margin and a more productive
A key measure for overcoming this factor is to carefully map the requirements for managing food safety, define the roles approach with a high level of risk taking. As Figure 2.3 shows, following each incident there is a shift toward a more
and responsibilities, the processes and principles for the management, in particular the change management, and, last but
not least, provide training and education commensurate to the role and responsibilities.
Protection Bankruptcy

Complexity of the Food Supply and External Environment

While in the past foods were produced locally, today many ingredients are imported from distant countries, and produced
under different legislative and social conditions. The liberalization of trade and also the tendency to provide consumers with
a varied and sometimes exotic food supply has of course encouraged this change. Food businesses often have difficulty in
foreseeing the hazards that may be associated with a raw material produced elsewhere. Testing the raw material is not
always an option or effective as it is difficult to test for all types of potential hazards and view the large number of agents
that may be present, considering that some of these may be unpredictable.
The incapacity to foresee hazards, particularly when there are fraudulent practices, has been the cause of numerous
small- and large-scale incidents. Examples are the import of honey contaminated with the prohibited antibiotic chloram- Catastrophe
phenicol in Europe in 2001, import of wheat gluten adulterated with melamine from China to the United States in 2007,
import of guar gum contaminated with pentachlorophenol (PCP) and dioxins from India to Europe in 2007, sunflower oil
contaminated with mineral oil imported from Ukraine to Europe in 2007, or more recently in 2017, application of fipronil in Production
egg production, etc. Emergence of foodborne hazards is also another factor that aggravates this unpredictability. Import of FIGURE 2.3 Changes in organizational culture leading to incidents. Adapted from Reason (1997).
raspberries with Cyclospora cayetanensis in the United States and fenugreek seeds contaminated with Shiga-producing
Escherichia coli O104:H4 (Germany and France 2011) are some examples of outbreaks of microbiological origin
(Herwaldt et al., 1997; EFSA (European Food Safety Authority), 2011; Motarjemi, 2011).
TABLE 2.3 Some Common Misperceptions Observed in Management of Food Businesses
Urbanization and industrialization have caused large-scale incidents of foodborne disease and, consequently, they make
negative publicity in the media. Perhaps the largest crisis in the history of food safety was the BSE epidemic, which affected Misperceptions Correction
many countries worldwide and led to a total reconsideration of the system of food safety management. For regulatory Food safety management is in conflict 1. There is no business without food safety
authorities, additional complexity comes from the fact that the size of food businesses varies from a few persons to a with economic interests 2. A good management of food safety can promote the business
few hundreds or thousands of persons; thus the resources and conditions for processing and handling foods are not equiv-
Food safety management is addressing Food safety management is taking necessary measures to prevent food safety problems,
alent. Therefore, devising regulations that are applicable to all the sizes and types of business, and yet are specific enough to food safety problems including confirmation that the measures are effective (validation) and implemented
be effective, is often difficult. At the international level, this becomes even more complex as the resources, infrastructure, (verification)
environmental and climatic conditions, lifestyle and sociocultural values differ among nations. Therefore, at times, har-
Our products are safe, as we have never A past record of safety is no guarantee for the future
monizing food safety legislation, although a necessity in the light of the international trade in food and feed, becomes par- had any incident
ticularly cumbersome.
With today’s globalized food supply, there is a need for worldwide strengthening of regulatory control, including pro- Our products are safe because the tests End-product testing is not an evidence of microbial safety, but a confirmation of the efficiency
were negative of the food safety management system
mulgating the necessary legislation and supervision of their implementation. Considering the limited resources for control,
it is important to reinforce the accountability and responsibility of food businesses. A continued effort for harmonizing food Regulatory requirements are 1. Regulatory requirements and their enforcement will:
safety regulations, and a reinforcement of international collaboration for sharing best practices, will remain essential for a impediments to the business a. Facilitate fair trade and a healthy competitive environment
b. Ensure that all stakeholders in the food chain fulfill their role; this decreases potential
more efficient management of food safety in the global food market. risks with suppliers and their raw material
c. Provide guidance to businesses, in particular small and less developed businesses, on
matters related to food safety, such as norms needed in designing and validating food
Human Factor safety assurance systems
People, be they managers of food businesses, farmers, workers on the production line, professionals working in the reg- d. Increase the confidence of consumers in the food supply and reassure consumers that
commercial products are safe and meet the nationally and/or internationally agreed
ulatory agencies or consumers, all play an important role in the management of food safety. Their knowledge, perception, safety and quality standards
and attitude as well as their motivation and commitment, and most importantly their capabilities to meet their responsi-
bilities, all impact on the safety of the food supply. Therefore, a first challenge is to ensure management commitment. Most
 Fundamentals in Management of Food Safety in the Industrial Setting Chapter 2 15 16 Food Safety Management

conservative approach to decision-making; later, the drive for increased profit swings the organizational culture and Conclusions
decision-making principles in the other direction, until another accident of greater magnitude occurs. Eventually, a cata-
strophic situation ensues. Often when the food manager does a good job, there are no incidents and hence the management Incidents in food safety in the past few decades have eroded the trust of consumers and have created misperception on the
wonders why they should spend funds on safety. A past record of safety is no guarantee for the future. subject, although among experts there is a general consensus that the food supply has never been safer. The new technol-
As to the technical staff or workers in food production, their role in food safety management is key. None of the food ogies that could contribute to the enhancement of food safety, such as food irradiation and biotechnology, carry the burden
safety systems and control measures can be effective without the intervention or supervision of qualified, skillful, and moti- of this mistrust.
vated staff. This is true in any organization, be it private or public. Yet, very often the importance of a professional human Regaining the trust of consumers and developing an international consensus among stakeholders on the acceptable level
resource management for food safety is overlooked. of risks and the safety measures for effectively addressing these risks remain an important challenge for the 21st century.
Over and above providing necessary training and education, a proficient human resource management should consider Finally, for an effective management of food safety over and above science, systems, equipment and procedures, con-
the needs of the employees to meet their responsibilities. These needs may be (1) material, such as equipment, tools, sideration of the human factor is essential. This ranges from factors underlying consumer choice and practices, to com-
optimum physical conditions or (2) managerial support, such as time for performing their tasks, clarification of authority mitment and motivation of managers in the food industry in providing adequate infrastructure and organizational
or other prerogatives, supporting policies, etc. – in other words, all that is needed to make the implementation of measures culture conducive to professional food safety management.
humanly feasible and enable employees to meet their responsibilities. Short of this, the situation can lead to human error, or Today, there is a wealth of scientific and technical know-how and an array of technologies and systems available to
the employees are forced to take shortcuts or violate the rules to perform their task. ensure a safe food supply. The challenge is to facilitate the access of food safety professionals and the general population
Finally, as alluded to above, the organizational culture will set the environment and the context in which employees to this know-how. The present book Food Safety Management: A Practical Guide for the Food Industry is developed with
work. This will have a major influence on the attitude and motivation of employees. An organizational culture may seem to this perspective.
be a vague concept, but it basically boils down to the set of values, written and unwritten rules that leaders “practice” and
reward or penalize their staff for. References
The role of leaders is essential for organizational culture. Leaders must have an exemplary behavior. Where there are
Asao, T., Kumado, Y., Kawai, T., Oda, H., Haruki, K., Nakazawa, H., et al., 2003. An extensive outbreak of staphylococcal food poisoning due to low-fat
discrepancies between the written and unwritten rules, or where managers preach values that they do not follow themselves,
milk in Japan: estimation of enterotoxin A in the incriminated milk and powdered skim milk. Epidemiol. Infect. 130 (1), 33–40.
the staff will suffer from stress and they are more likely to be complacent or non-compliant. The most detrimental factor in Carroll, C., 2009. Defying a reputational crisis—Cadbury’s salmonella scare: why are customers willing to forgive and forget? Corp. Reput. Rev. 12,
food safety management is an organizational culture that breeds fear. In a fear culture, employees are discouraged from 64–82.
reporting potential problems; they may cover up gaps and increase opportunities for incidents. Casey, D.K., James, S.L., Wall, P.G., 2010. A tale of two crises: the Belgian and Irish dioxin contamination incidents. Br. Food J. 112 (10), 1077–1091.
CDC, 2008. Outbreak of salmonella serotype Saintpaul infections associated with multiple raw produce items—United States. MMWR Morb. Mortal.
Wkly Rep. 57 (34), 929–934.
Codex Alimentarius Commission (CAC), 2020. Basic Text: General Principles of Food Hygiene CXC 1–1969, Revised in 2020. Food and Agriculture
Outlook: Whistleblowing Organization, Rome, Italy. [Link]
Although whistleblowing as such is not a new topic, in recent years its importance as a mechanism to combat corruption %252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf. (Accessed 25 October 2022).
and fraud, and as an additional element of risk management, has been increasingly recognized. Curiously, although fraud EFSA (European Food Safety Authority), 2011. Technical report of EFSA. In: Tracing Seeds, in Particular Fenugreek (Trigonella foenum-graecum) Seeds,
and mismanagement in food safety has been the cause of many scandals and crises, in this sector the subject has not received in Relation to the Shiga Toxin-Producing E. coli (STEC) O104:H4 2011. Outbreaks in Germany and France. European Food Safety Authority,
European Food Safety Authority (EFSA), Parma, Italy.
the same degree of recognition as in the financial sector (Motarjemi, 2014b; Soon and Manning, 2017; Visciano and
Herwaldt, B.L., Ackers, M.-L., The Cyclospora Working Group, 1997. An outbreak in 1996 of cyclosporiasis associated with imported raspberries.
Schirone, 2021). See also the Chapters 43 and 55 on crisis management and whistleblowing in this book.
N. Engl. J. Med. 336, 1548–1556.
The situation is evolving rapidly and today several countries have whistleblower legislation in place and offer protection Lehmacher, A., Bockem€ uhl, J., Aleksic, S., 1995. Nationwide outbreak of human salmonellosis in Germany due to contaminated paprika and paprika-
to employees who report wrongdoings. Some, such as the European Union directive, require medium and large companies powdered potato chips. Epidemiol. Infect. 115 (3), 501–511.
(companies with more than 50 employees) to set up an internal whistleblowing system. Motarjemi, Y., 2011. Food safety: what is the role for gastroenterologists? World Gastroenterol. News 16 (3), 3–4 (1).
In addition to regulatory requirements, since the mid-2000s the New York Stock Exchange (NYSE) has also required Motarjemi, Y., 2014a. Modern approach to food safety management. In: Encyclopedia of Food Safety. Elsevier.
multi-national companies listed on the NYSE to meet certain governance standards, including the establishment of a code Motarjemi, Y., 2014b. Whistleblowing: Food Safety and Fraud. [Link]
of business conduct and ethics. These standards require companies to establish an internal whistleblowing system and to food-safety-and-fraud/.
encourage their employees to report any non-compliance or problems of any other kind, in violation of laws, regulations or Reason, J.T., 1997. Managing the Risks of Organizational Accidents. Ashgate, Aldershot, UK.
the provisions of the code itself, and to protect them from retaliation. Several countries have now established fairly com- Soon, J.M., Manning, L., 2017. Whistleblowing as a countermeasure strategy against food crime. Br. Food J. 119 (12), 2630–2652.
prehensive legislation in this area; some, such as the United States, China, and Taiwan, have incorporated the subject into Visciano, P., Schirone, M., 2021. Food frauds: global incidents and misleading situations. Trends Food Sci. Technol. 114, 424–442.
their food legislation and provide a financial reward for whistleblowers.
For fear of reprisals, food professionals are still reluctant to report wrongdoings. Employee protection remains a chal- Further Reading
lenge for the future. To overcome this, employee bullying and harassment and negative corporate culture should be for-
Motarjemi, Y., 2010. Food regulations: global harmonization. In: Encyclopedia Biotechnol. Agric. Food. vol. 1. Francis and Taylor, pp. 262–268 (1).
mally recognized as a failure in food safety management and incorporated into inspection, auditing, certification, and
Motarjemi, Y., 2016. The starting point: what is food hygiene? In: Lelieveld, H., Holah, J., Gabric, D. (Eds.), Handbook of Hygiene Control in the Food
investigation of food safety incidents and considered as criminal offense. For more information see Chapter 55 on whis- Industry. Woodhead Publishing, pp. 1–11.
tleblowing in this book. Motarjemi, Y., 2016. Food safety management: state of the art. In: Lelieveld, H., Holah, J., Gabric, D. (Eds.), Handbook of Hygiene Control in the Food
Industry. Woodhead Publishing, pp. 101–121.

The definition of “whistleblower” varies according to the legislation of countries. For the purpose of this survey, the working definition used for the term
“whistleblower” is the one given by the Council of Europe. That is “any person who reports or discloses information on a threat or harm to the public
interest in the context of their work-based relationship, whether public or private.” The term “report” refers to internal reporting within an organization or
enterprise, while the term discloses refers to reporting to an outside authority or to the public.