ISO 22000: Validation of Food Safety Management System

Validation 

ISO 22000 applies to all enterprises and organizations that directly has impact on the food chain, including feed producers, primary product producers (farms, fisheries, livestock producers), food manufacturers, retailers, restaurateurs and caterers, cleaning / washing / sterilization / disinfection service providers, transport and storage, as well as delivery services. In addition, the standard also applies to enterprises and organizations that are indirectly involved in the food chain, including equipment suppliers, cleaning agent and sterilization and disinfectant suppliers, packaging material suppliers, and suppliers of materials that come into contact with food products.

The food safety management system needs to include the capacity to plan and implement processes to verify the effectiveness of control measures, to validate them and to improve itself.

The concepts of monitoring, verification and validation can be confusing. ISO 22000 defines them as follows.

Validation (food safety) – “obtaining evidence that the control measures managed by the HACCP plan and by the operational PRPs are capable of being effective” – it is an assessment prior to starting operations.

Verification – “confirmation, through the provision of objective evidence, that specified requirements have been fulfilled” – it is an assessment carried out during and after operations.

Monitoring – “conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended” – it is an activity undertaken during operations.

The organization must validate the effectiveness of its operational PRPs and CCPs prior to finalizing the food safety management system, or whenever these control measures are changed.

Validation consists of a combination of tools used to ensure the total food safety management system is working to evaluate food safety data prior to release of the product through either internal or external audits. The validation can be defined as “obtaining evidence that a control measures or combination of control measures managed by the HACCP plan and by the operational PRPs are capable of being effective, if properly implemented is capable of controlling the hazard to specified outcome”.

Validation asks whether the hazard analysis was complete and if the control measures are effective “Are you doing the right thing”. The organization will validate that the selected control measures to verify whether they are capable of controlling the food safety hazards and control measures are effective and capable of ensuring control of the food safety hazards. If this cannot be confirmed, modify and reassess.

Prior to the implementation of your organization’s food safety management system, each operational PRP and CCP must be validated to determine if it is capable of achieving the intended control of the identified hazards. The control measures or combinations of control measures must demonstrate that they are capable of ensuring that the end products of the processes meet the defined acceptable levels.

The organization has a responsibility to make certain that their food safety management system is designed to produce the desired controls, is operated as designed, and is updated as new information is provided. This can become a complicated process.

The food safety management system should be developed using sound scientific principles. The necessary information for the system design can usually be obtained from colleges and universities, government agencies or research branches, trade or industry associations, consultants, or other parties that have expertise in the food process and product.

Once you have designed your control measures on paper, they must be validated. The validation process provides assurance that the control measure or the combination of control measures will deliver end products that are safe (i.e. within the acceptable levels required for each identified hazard).

Validation usually includes activities such as:

1. Reference to validations carried out by others or historical knowledge;
2. Experimental trials to mimic process conditions;
3. Collection of biological, chemical and physical hazard data during normal operating conditions;
4. Statistically designed surveys;
5. Generally accepted industrial practices;
6. Mathematical modeling;

If you are relying upon validations carried out by others, then you should ensure that the conditions of your application are consistent with those identified in the referenced validations.

Scaling up laboratory based experimental trials in a pilot plant may be required to ensure that the trials properly reflect actual processing variables and conditions. Intermediate and/or finished product sampling and testing based on the use of statistical sampling plans and validated testing methodology may be used.

Validations may be conducted by external parties. Microbiological or analytical testing can be used effectively to validate that a process is in control and that acceptable product is being produced.

If additional control measures, new technology or equipment, changes in the control measures, identification of new or emerging hazards or their frequency of occurrence, or unexplained failures of the system occur, re-validation of the system may be necessary.

Reassessment or Revalidation

The ISO 22000 food safety system literature uses the term “revalidation” or “reassessment” in regard to operational oversight. Most of the time, reassessment or revalidation refers to annual review activities that must be conducted to ensure that the ISO 22000 food safety system is operating as intended. In reality, a complete revalidation similar to the design qualification, installation qualification and operational qualification used in thermal processing protocols is rarely done. A complete validation or revalidation study needs to be conducted only if there are significant changes in processes, ingredients, products or equipment that can affect the food safety of the product.

If a complete revalidation is not needed, the plant should conduct either an annual or a continual reassessment of its ISO 22000 food safety system. The objective of reassessment is to determine whether the ISO 22000 food safety system (basically the HACCP plan and the PRPs) is operating as intended.

The reassessment should help answer the following question: Is the ISO 22000 food safety system (HACCP plan and PRPs) adequate to control the identified food safety hazards? The reassessment should lead to identification of activities to improve the ISO 22000 food safety system. It can be used as input for other verification activities, including the internal audit and management review.

Validation of Metal Detectors (an example)

Most metal detectors can be described as a tunnel with a conveyor. Validation data should ensure that the equipment can detect metal of the appropriate size at different locations on the belt, and at different locations in or around the package. For example, if a 50-lb. sack of flour is to be tested, the system could be validated by testing the standards at the leading edge, the tailing edge, on top of and under the bag.

This needs to be done for each product type. The validation protocol might even require that the standards be inserted into the bag at different locations. Multiple tests—a minimum of 10—should be done at each location. The people doing the validation study must also confirm that the settings remain the same throughout the test. The result should be the determination of where to place the test wands during calibration checks in the course of normal production. The location needs to be the spot where the magnetometer receives the weakest signal. Isn’t that a lot of work? Yes, but a rigorous test protocol such as this will provide confidence that the system works properly.

Validation of Control Measures to Inactivate Salmonella

When a lethality step is needed to inactivate Salmonella in a low-moisture product or ingredient, the processing parameters used should be adequate to inactivate the level of the organism likely to be present. According to the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), validation encompasses collecting and evaluating scientific data and technical information to demonstrate that the control measures and associated critical limits at the lethality step, when followed, will result in a safe product (NACMCF, 1998). In addition, it is necessary to demonstrate that the chosen control measure and critical limits can be applied in production at a critical control point. Validation of lethality steps for low-moisture foods involves determining an appropriate log reduction for Salmonella, determining the critical limits in the process required to achieve the reduction, and confirming the process equipment consistently delivers the critical limit parameters in the operation (NACMCF, 1998; Scott et al., 2006).

In general, NACMCF’s definition for pasteurization (NACMCF, 2006) can be used to guide the determination of an appropriate level of log reduction. With respect to a low-moisture product, NACMCF’s definition translates into applying any process, treatment, or combination thereof, to reduce the most resistant Salmonella serotype “to a level that is not likely to present a public health risk under normal conditions of distribution and storage.” NACMCF also indicated that a control measure aimed at inactivating the target pathogen does not protect the consumer if the product is subsequently recontaminated during manufacturing. The effective approach to prevent recontamination is through good hygiene practices verified by environmental monitoring to ensure that recontamination is not likely to occur.

The level of reduction required will depend on the potential levels of Salmonella, if present, in the raw ingredients. Efforts have been made to set an appropriate level of log reduction for a specific low-moisture product based on a risk assessment. For example, a risk assessment (Danyluk et al., 2006) conducted to assess the risk of salmonellosis from almond consumption was used to determine that a 4-log reduction of Salmonella in raw almonds is adequate to ensure safety of the finished product (AMS, 2007). In some instances, historical knowledge is used as the basis for validation (Scott, 2005).

For example, pasteurization at 72 °C for 15 sec is considered adequate to inactivate expected levels of vegetative pathogens of concern in raw milk. These parameters may be used as the critical limits or the basis to establish other process parameters as critical limits at the lethality step to inactivate Salmonella in the fluid milk ingredient for a dried milk product; preventing recontamination after pasteurization during drying and subsequent handling would be essential to protect the finished dried product from recontamination. Both industry guidelines (Froning et al., 2002) and FSIS regulations in 9 CFR 590.575 (CFR, 2008a) set parameters for the pasteurization of dried egg white, which include heating the product in a closed container to at least 130 °F (54.4 °C) for 7 days or longer until Salmonella is no longer detected (As a practical matter, the egg industry routinely uses a more severe heat treatment in order to eliminate the avian influenza virus as well as Salmonella). However, after pasteurization during drying and subsequent handling would be essential to protect the finished dried product from recontamination.

Both thermal and non-thermal control measures can be used for Salmonella inactivation to achieve the target log reduction. Various processing steps (e.g., cooking, frying, roasting, baking, heat extruding, fumigation) may be used to inactivate Salmonella in a low-moisture product. Thermal processing is the most commonly used control measure to inactivate Salmonella.

For example, the Almond Board of California’s Technical Expert Review Panel (ABC TERP) determined that oil roasting at or above 260 °F (126.7 °C) for 2 min will result in a 5-log reduction of Salmonella on the surface of whole almonds (ABC, 2007). The ABC TERP also provided minimum time and temperature combinations required for blanching processes to deliver a 4 or 5-log reduction of Salmonella on almonds (ABC, 2007). These parameters were determined based on heat resistance data for Salmonella Enteritidis PT 30 as the target organism.

It is useful to review available scientific data for the processing method of interest, including high temperature short time or low temperature long time when desirable for maintaining product quality. In order to assure appropriate validation, it is also necessary to evaluate scientific and processing equipment data and information specific to the processing technology under consideration. A process authority should be consulted where necessary.

For example, the ABC TERP, which consists of experienced microbiologists and processing experts, evaluates the adequacy of various treatments to inactivate Salmonella in raw almonds and develops guidelines for validating individual processes, including propylene oxide (PPO) treatment for raw almond kernels, PPO treatment for in-shell almonds, blanching, oil roasting, dry roasting and other processes that may be proprietary (ABC, 2007).

Validation testing can be carried out using Salmonella (appropriate strains), using a surrogate organism that has been validated for the product and process under consideration, or using a non-microbial method such as an enzyme that has been validated for use in such applications. When the time and temperature profiles of a process can be mimicked in the laboratory (e.g., oil roasting); a challenge study with appropriate Salmonella strains can be conducted in the laboratory to validate the process (Larkin, 2008). This approach has been used to validate a dry-air roasting process for peanuts, where a lab-scale roaster was used to mimic the actual processing times and temperatures and the process was found adequate to deliver a 4-log reduction of several Salmonella strains (Tuncan, 2008).

Reference:

http://graphics8.nytimes.com/packages/pdf/business/20090515_moss_ingredients/SalmonellaControlGuidance.pdf

http://fskntraining.org/sites/default/files/coca-colaFS09/ISO_08_English.pdf

http://www2.shimadzu.com/applications/lcms/Shimadzu_TechReport_Vol13_LCMS.pdf

http://www.foodsafetymagazine.com/magazine-archive1/augustseptember-2014/a-new-paradigm-for-validation-verification-and-monitoring/

http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/5100.2/Meat_and_Poultry_Hazards_Controls_Guide_10042005.pdf

ISO 22000: Management Review

Management Review

The management review is the review of food safety management system to ensure its continuing suitability, adequacy and effectiveness. The review also facilitates the assessment of opportunities for improvement and the need for change to the system, including the food safety policy. This review should take place at planned intervals. In the early stages of implementation, these intervals may be shorter than when the system is mature. Top management must review the performance of the food safety management system at planned intervals. The purpose of these reviews is to improve the effectiveness, suitability and adequacy of the system.

All companies have management meetings, but the management review is more than that. The function of management review is a high-level review to determine whether the FSMS is effective and efficient. How a management review is conducted varies with the size of the company. Small companies are now being required to implement management review in response to the requirements of GFSI-recognized audit schemes. In small companies, one person typically wears many hats. In a large company, the workload will be divided. One hint to better understand the management system and to create the foundation for the management review is to define who is responsible for managing each of the areas that comprise the FSMS. The job descriptions for each of these individuals must define their responsibilities within the FSMS. In addition, it is a good idea to create a single document that lists all the food safety areas and have each responsible person sign that list. This allows top management to better understand who is doing what, but will also help an auditor better understand who manages what. All of these persons will have a role in the management review.

The first review should precede the implementation of the food safety management system and focus on the approval of the food safety team’s proposals. Management should then adopt a programme of planned reviews. The frequency of these is likely to depend upon the nature of the organization and the scope and complexity of the system. This programme would probably commence with a review of the effectiveness of the new system, after the first round of internal audits. In addition, your organization may consider management reviews during the implementation of the system, to ensure its effectiveness.

When preparing for a management review, each person will be responsible for collating and analyzing the information related to food safety prior to the meeting. This information should include information from third-party audits, internal audit issues, quality issues, deviations from the HACCP plan, assessments of the results of verification activities, assessment of continual improvement activities that affect food safety, customer/consumer complaints, regulatory concerns, new technical data that affect their areas, emergency issues, “near misses” or other findings. Each manager, whether he/she is responsible for one area or many, will then bring this analysis to the review. In addition, the managers should bring ideas for further improving the FSMS to the meeting. Ideally, they should also conduct a preliminary evaluation of the potential benefits of the proposed change (i.e., a risk assessment of the proposed change).

The review will be convened and led by top management. Records or minutes of the meeting will be maintained. The presentations will focus on providing management with an overview of how the FSMS is being maintained, problems that have occurred and how the FSMS can be improved. The improvement plans will be evaluated by the management team. They should be prioritized based on potential risk to the business and those proposals that have the greatest potential benefits for the business should be targeted for implementation. One of the outputs of the meeting should be not only the selection of possible improvements, but establishing timelines for completion, assignment of resources to do the work and establishing responsibility for managing the program. The management review, therefore, becomes a tool for continual improvement.

The input to a management review must be sufficient to enable top management to assess whether or not the food safety management system meets its stated objectives. The results of the review must be recorded

ISO 22000 specifies that the management review should include:

1. Follow-up actions from previous management reviews;
2. Analysis of results of verification activities;
3. Changes in circumstances that can affect food safety;
4. Emergency situations, accidents and withdrawals;
5. Review of results of system-updating activities;
6. Review of communication activities, including customer feed-back;
7. Review of external audits or inspections.
8. The effectiveness of these reviews can be demonstrated by the minutes of the meetings.

The output of the management review must demonstrate that top management has taken decisions or other actions related to the assurance of food safety.

The management review minutes should include decisions or other actions on:

1. The assurance of food safety;
2. Improvement of the effectiveness of the food safety management system;
3. Resource needs;
4. Revisions of the organization’s food safety policy and related objectives.

ISO 22000: Top Management

Top Management

Food safety is the prime responsibility of everyone involved in food business and can most effectively be established, operated and updated within the framework of a properly structured food safety management system. Successful development and implementation of a food safety management system requires top management to make a significant commitment. It should be clearly supported by the business objectives of the organization. Top management is defined in ISO 9001 as the “person or group of people who directs and controls an organization at the highest level”. In a small or medium sized business, this may be the owner or owners (partners), a senior manager or perhaps the board of directors. It is essential that this group fully understand what is involved in developing and implementing a food safety management system and make a commitment to the process.

Top management support has generally been considered the most critical factor for the success of ISO 22000 projects. Typically, there have developed implicit or explicit assumptions that top management support has to be constant and consistent during the entire life of an ISO 22000 implementation project. Top management support has been widely identified and highly ranked as a critical success factor in most ISO 22000 implementations. Typical findings indicate that this level of support is critical for the success of ISO 22000 planning and system implementation. However, many aspects of top management support are not yet fully understood (Jarvenpaa & Ives, 1991; Sharma & Yetton, 2003).

An assumption of the ‘absolute’ criticality of top management support has been questioned, albeit reluctantly by a few recent studies. For example, Somers & Nelson (2004) observe that the perception of the importance of top management support among project members continues to decline over the course of the project. This observation contradicted their own expectation and hence led them to state that: ‘such behaviour is not fully understood’ (Somers & Nelson, 2004). Other studies found top management support not critical to the outcomes of a project and that efficiency and flexibility of the development process was significant in its own right, even without any effect of top management support (Marble, 2003; Nah et al, 2007).

Top management’s commitment is critical to the successful implementation of the food safety management system. The system costs time and money to develop, implement and maintain. It will directly involve top management itself in allocating resources and in decision making at key steps in the process, its maintenance and updating. As a rule of thumb, Top management has the responsibility to define, document and communicate its food safety policy and its objectives. This policy should be appropriate to the role of the organization in the food chain, conform to statutory, regulatory and agreed customer requirements, be communicated, implemented and maintained within the organization, reviewed regularly and supported by measurable objectives.

The development of a food safety management system takes planning. The top management of the organization, or you yourself as the small business owner, or those who have this responsibility, should be working from a plan when they commit to developing the system. The plan should identify the business objectives to be met by the system, set out the resources required and identify measurable objectives. As the organization moves from the development phase into implementation, top management will need to ensure that this too is planned, resource allocated and achievements are measured. Once implemented, top management’s responsibility for planning continues – it must now ensure that its management reviews are planned and that any changes to the system are also planned.

Most organizations use organizational charts and position descriptions to show the various functional responsibilities and authorities. In addition, the charts show how each function relates to other functions. Employees within each organizational unit or function can see where they fit within the organization, and also see the limits of authority that are delegated to each manager and function. Any organization’s food safety management system will involve all employees whose activities impact on food safety. However, it is necessary for one employee to be appointed and assigned responsibility for the development and implementation of the system.

ISO 22000 states that the responsibility and authority for the food safety management system must be assigned to one person. ISO 22000 identifies that person as the food safety team leader, appointed by top management. The team leader should be a member of the organization and have a basic knowledge of hygiene management, the application of HACCP principles and the requirements of ISO 22000. In a small or medium-sized organization, it is likely that this person will have other tasks and duties. These duties should not conflict with their food safety responsibilities.

Management Commitment

When an organization undertakes the development of a food safety management system, the first and most important task of top management is to define the purpose of the system. The purpose and commitment must be stated in the organization’s food safety policy. The primary driver for this decision should be to ensure that your organization is doing everything it can to ensure the production of safe food products. Simply seeking to have the certificate or meet the minimum regulatory requirement will result in less than optimum outcomes and do a disservice to the organization and its stakeholders. Thus top management’s commitment is critical to the successful implementation of the food safety management system. The system costs time and money to develop, implement and maintain, which will directly involve top management itself in allocating resources and in decision making at key steps in the process, its maintenance and updating.

Responsibility & Authority

Effective implementation of a food safety management system in large-scale retail begins with a commitment from senior management. Here, the quality manager plays a major role since he must convince top management of the merits of the approach and demonstrate the added value of the system. Aligning the project with the company’s strategy is fundamental to obtaining success. In order to gain management’s trust and support, the system implementation project must be seen as a translation of the company’s overall strategy. For example, a company focused strategy based on efficiency is not really compatible with the implementation of an ISO 22000 system, which is, by nature, focused on customer satisfaction. Conversely, a strategy based on satisfying the needs of existing and future customers, enabling the company to gain an edge over the competition, might find in the food safety management system the perfect operational and continual-improvement tool. Having committed itself to implementing the system, senior management must then ensure the information is disseminated throughout the company. This is critical for preparing staff to get involved in the process.

As a rule of thumb, it is essential to understand the role of each corporate department and its link with food safety, when designing and implementing a food safety management system. As an example, it is the purchasing department’s responsibility among other things, to look after the business relationship with suppliers and introduce new product references. This implies working in collaboration with the quality department, which, in turn, must implement a process for selecting, evaluating and monitoring its suppliers to ensure full control of the safety of food products delivered by suppliers and displayed on store shelves. This is unfortunately not always the case and in the absence of proper supplier control, products unknown to the quality department are sometimes sold in stores.

The technical department on the other hand, is responsible for purchasing the refrigerating equipment and deciding where it will be installed in the stores while ensuring its maintenance. To this end and in order to comply with good hygiene practice for store facilities and equipment, the technical manager must work hand in hand with the quality manager, especially regarding the intended use of the refrigeration equipment and the planning and execution of technical maintenance activities. For instance, refrigerated shelves with a 0 – 4 °C temperature range cannot be used for meat products, in particular mince meat (0 – 2 °C). Yet it is not unusual to find refrigerating systems that are unfit for their intended use in the store.

Communication

Horizontal and vertical integration, backed by top management, is facilitated by effective internal communication. The relevant parties dealing with food safety control within the company must be identified and communication flows established. i.e., effective communication between the marketing department and the quality department would help avoid plant schematics that are likely to affect food safety (for example cross-contamination by allergens from shelves reserved for non-food products). Vertical communication, in particular between the quality department and the store, is crucial in that it helps the system design process and enables the quality department to establish the procedures and tools that are best suited to the actual store, without losing sight of the commercial purpose.

Coordination

Food safety is an implicit requirement for the sale of foodstuffs. In the food industry, food safety management is the province of the quality management department, which has the necessary competencies in the field. Converting such management activities into a proper management system requires perfect coordination throughout the food company of the activities impacting on food safety. This type of coordination is referred to above as “horizontal and vertical integration” and, as such, requires an extra set of skills, in addition to the technical competencies, in order to implement a food safety management system. Leadership skills, for instance, are essential as the ability to convince and influence internal stakeholders, in particular top management, is a condition for the system’s efficiency.

Marketing and communication skills are also important as they help the people involved engage in the process. Thus top management plays a critical role in assigning right people for relevant job and authorizing them for the real world requirements. Besides, an in-depth knowledge and understanding of the company’s strategy helps to achieve company-wide integration of the food safety policy. Other competencies in human resources, operational management and finance can also be added. All these disciplines give food safety control a true management dimension, which is particularly emphasized in ISO 22000. As a result, this standard provides the food industry with a real opportunity to make food safety control more professional and expand it to other disciplines that are vital in order to succeed in today’s business world.

Reference

1. http://www.iso.org/iso/news.htm?refid=Ref1701
2. ISO 22000 Food safety management systems. An easy-to-use checklist for small business. Are you ready ?
3. https://www.academia.edu/1231505/Top_management_support_in_multiple-project_environment_an_in-practice_view

Food Microorganisms & Food Poisoning - I

Microbes in Foods

Nature uses microorganisms to carry out fermentation processes, and for thousands of years mankind has used yeasts, moulds and bacteria to make food products such as bread, beer, wine, vinegar, yoghurt and cheese, as well as fermented fish, meat and vegetables. Currently, more than 3500 traditionally fermented foods exist in the world. They are of animal or vegetable origin and are part of our daily life. Alcoholic drinks are not the only fermented drinks; cocoa beans and coffee grains are fermented after harvest in order to develop their typical flavour profiles. Moreover, fermented products have geographical specificities: in Europe, cheese and bread are widely consumed. In Africa, products manufactured from fermented manioc play a key role in the diet and in Asia, products derived from soy or fish are consumed on a daily basis. Fermentation is one of the oldest transformation and preservation techniques for food. This biological process allows not only the preservation of food but also improves its nutritional and organoleptic qualities (relating to the senses; taste, sight, smell, touch). A well conducted fermentation will favour useful flora, to the detriment of undesirable flora in order to prevent spoilage and promote taste and texture.

The first realization that microorganisms were involved in food production processes was in 1837, when scientists discovered the role of yeast in an alcoholic fermentation. Later, when the world renowned French chemist and biologist Louis Pasteur was trying to explain what happened during the production of beer and vinegar in the 1860es, he found that microorganisms were responsible. However, it wasn’t until after the Second World War that the food industry began to develop the biotechnological techniques we rely on today to produce a wide variety of better, safer foods under controlled conditions.

Food safety is a major focus of food microbiology. Pathogenic bacteria, viruses and toxins produced by microorganisms are all possible contaminants of food. However, microorganisms and their products can also be used to combat these pathogenic microbes. Probiotic bacteria, including those that produce bacteriocins, can kill and inhibit pathogens. Alternatively, purified bacteriocins such as nisin can be added directly to food products. Finally, bacteriophages, viruses that only infect bacteria, can be used to kill bacterial pathogens. Thorough preparation of food, including proper cooking, eliminates most bacteria and viruses. However, toxins produced by contaminants may not be liable to change to non-toxic forms by heating or cooking the contaminated food.

Food Poisoning

Foods contaminated with pathogenic microorganisms usually do not look bad, taste bad, or smell bad.  It is impossible to determine whether a food is contaminated with pathogenic microorganisms without microbiological testing. To avoid potential problems in foods, it is very important to control or eliminate these microorganisms in food products. Pathogenic microorganisms can be transmitted to humans by a number of routes. Diseases which result from pathogenic microorganisms are of two types: infection and intoxication.

Foodborne infection is caused by the ingestion of food containing live bacteria which grow and establish themselves in the human intestinal tract.

Foodborne intoxication is caused by ingesting food containing toxins formed by bacteria which resulted from the bacterial growth in the food item. The live microorganism does not have to be consumed.

For a foodborne illness (poisoning) to occur, the following conditions must be present:

1. The microorganism or its toxin must be present in food,
2. The food must be suitable for the microorganism to grow,
3. The temperature must be suitable for the microorganism to grow,
4. Enough time must be given for the microorganism to grow (and to produce a toxin).
5. The food must be eaten.

Symptoms of Foodborne Illness

The most common symptom associated with foodborne illnesses is diarrhea. Each pathogenic microorganism has its set of characteristic symptoms. The severity of the foodborne illness depends on the pathogenic microorganism or toxin ingested, the amount of food consumed (dose), and the health status of the individual. For individuals who have immune-compromised health conditions, or for the aged, children, or pregnant women, any foodborne illness may be life-threatening.

Food Microbiology and Foodborne Illness

Bacteria, yeasts, and mold are microorganisms associated with foods. The individual microorganism cannot be seen without the aid of a microscope. The size of these microorganisms is measured in microns (1 micron is 1/1000 of a millimeter). More than a thousand microorganisms in a cluster are barely visible to the eye.

Microorganisms may be classified into three groups according to their activity:

Beneficial microorganisms may be used in the process of making new foods. Cheese is made with microorganisms which convert the milk sugar to an acid.

Spoilage microorganisms cause food to spoil and are not harmful to humans. A spoilage microorganism is responsible for souring milk.

Pathogenic microorganisms are disease-causing microorganisms. The living microorganism or a toxin (microbial waste product) must be consumed to cause symptoms associated with specific pathogenic microorganisms.

Microorganisms can be found virtually everywhere. Bacteria and molds are found in the soil and water. Yeasts are found mainly in the soil. Plant and animal food products support the growth of microorganisms. Bacteria have been detected on plants and animals; molds are usually found on fruits and vegetables; yeasts are generally found on fruits. Many bacteria are part of the normal microflora of the intestinal tracts of man and animals. Microorganisms may be transferred from soil and water to plants and animals. Raw food stuffs contain microorganisms which may be transferred to processed foods by careless handling. Food handlers with poor hygiene practices may transfer microorganisms to food. If suitable conditions exist, some of these microorganisms may grow to create a public health concern. Specific bacterial species (pathogenic microorganisms) are the main causes of foodborne illnesses in humans. 

Growth Factors of Microorganisms

All microorganisms require moisture, a food source, enough time, and suitable temperatures to grow and multiply.

Moisture

Microorganisms are composed of about 80% water which is an essential requirement for microorganisms to grow. Moisture requirements vary for each species of microorganism. In general bacteria need more water than yeasts. Yeasts require more water than molds to grow. If water is not available for microorganisms in a food product, the microorganisms may remain but will not grow and multiply. Certain components in foods will make water unavailable for microorganisms(and thus can inhibit growth).

Salt & Sugar

Salt and sugar added to foods "tie" up water and lower the water activity. When enough salt or sugar is added to a food, the water activity will be lowered to a level that will prevent microorganisms from growing. In general, bacterial growth is inhibited by the addition of 5-15% salt. Yeasts and molds can tolerate up to 15% salt. To inhibit mold growth, 65-70% sugar must be added. The addition of up to 50% sugar will inhibit bacteria and yeast growth.

Some microorganisms are tolerant of certain conditions:

Halophilic (salt-liking) microorganisms require salt to be present for the organism to grow.

Osmiophilic (sugar-liking) microorganisms, usually yeasts, grow best at high concentrations of sugar.

Xerophilic (dry-liking) microorganisms can grow with limited moisture.

Food

Microorganisms need a source of nutrients to grow and multiply.

Time

Microorganisms need time to grow and multiply. Under favorable conditions (enough moisture and food available with the desired temperature), cell division (reproductive growth) may occur every 20 to 30 minutes. The time for a microbial cell to double is called the generation time.

Temperature

Microorganisms grow best within certain temperature ranges. Bacteria are classified into three groups, depending on the temperature at which the bacteria grow best.

Psychrophilic (cold-liking) bacteria (responsible for food spoilage in refrigerators, grow rapidly at room temp.)

- Growth range 32-77°F

- Optimum temperature 68-77°F

Mesophilic (middle-liking) bacteria 

- Growth range 68-110°F

- Optimum temperature 68-113°F

Thermophilic (heat-liking) bacteria

- Growth range 113-158°F

- Optimum temperature 122-131°F

Other factors affecting growth

Varying requirements for Oxygen (aerobic vs. anaerobic bacteria, e.g.)

pH - acidity or alkalinity  (most microorganisms prefer a pH near neutral [pH = 7.0])

Darkness vs. Light (Ultraviolet light is lethal to microorganisms)

The bacteria which cause foodborne illness in humans grow best at body temperature (98.6°F - mesophilic bacteria). 

References
Frazier, W.C. and Westhoff, D.C. 1988. Food
Microbiology 4^th Edition. McGraw-Hill Inc., New York, N.Y.

http://food.unl.edu/safety/poisoning

http://en.wikipedia.org/wiki/Food_microbiology

http://www.effca.org/content/microorganisms-food-production

Food Composition Data & Food Safety

Food Composition Data

Foods are chemically analyzed for a variety of purposes. Food composition databases rely on nutritional and toxicological analyses conducted by government, academia and industry to determine the potential contributions of foods to the diet, and to determine compliance with regulations concerning composition, quality, safety and labeling. Foods may also be analyzed for the purpose of ongoing monitoring of the food supply. The estimation of nutrient intake from food consumption requires reliable data on food composition. These data are also the fundamentals of food-based dietary guidelines for healthy nutrition, containing the necessary information on food sources for different nutrients. Furthermore, food composition tables can provide information on chemical forms of nutrients and the presence and amounts of interacting components, and thus provide information on their bioavailability. For some nutrients such as vitamin A, vitamin E and niacin, the concept of equivalence has been introduced to account for differences in the availability and biological activity of different chemical forms.

Impact of Food Composition Data for Food Safety

Levels of certain nutrients, additives and contaminants in foods are monitored for several reasons. Some nutrients, for example, may react adversely under particular processing conditions, producing poor sensory quality or affecting the safety of the food (e.g. trans fatty acids). Labeling regulations also require prescribed levels of nutrients in specific foods (e.g. vitamins and minerals in fortified foods, polyunsaturated fat levels in margarine). Certain toxic substances are limited to prescribed levels and are monitored by government, industry and other laboratories. The nutrient content of manufactured foods is rarely made available in electronic format to compilers, and care must be exercised when compiling databases using information provided on food labels.

Although most food composition tables focus on energy, macro and micronutrients, interest in non-nutritive components is increasing. Considering the beneficial effects of biologically active secondary plant cell compounds such as polyphenols and carotenoids, more data on these areas are needed. On the other hand, there are a number of naturally occurring or 'man-made' non-nutritive substances with negative effects, and to control exposure, the main dietary sources must be known. Another aspect is contaminants, which could have detrimental effects on consumers' health. Among these are agrochemicals, industrial pollutants reaching the food chain and substances formed during food preparation. A valid risk assessment requires data on exposure, and thus on the contents of contaminants in foods. However, these data are highly variable and may significantly differ even within narrowly confined regions.

Contaminants

Contaminants include mycotoxins, heavy metals and residues of pesticides, herbicides and animal growth promoters. The distribution of contaminants in foods is such that the concept of representative values for contaminants differs from that for nutrients. It may be misleading to list contaminant values in the same record as nutrients.

Bioactive substances

There has been a growing interest in the range of dietary phytochemicals in recent years, particularly in view of their possible protective action against cardiovascular diseases and certain cancers. These include isothiocyanates, polyphenols, flavonoids, isoflavones, lignans, saponins and coumestrol (AICR, 1996; Pennington, 2002). Consequently, there is a parallel interest in the inclusion of phytochemicals in food composition databases (Ziegler, 2001).

Anti-nutrients and toxicants

Some constituents have undesirable physiological effects, for example, goitrogens, haemagglutinins, antivitamin factors, trypsin inhibitors, oxalic acid and phytic acid. Data for these components should be included for the relevant foods. Other important natural toxicants include solanine, cyanides, glucosinolates, lathyrogens, mimosine and nitrosamines.

Additives

 Many additives are measured, in whole or in part, during the course of nutrient analyses. Salts, for example, are included in analyses for various cations and anions; protein additives are determined in nitrogen analysis; and some emulsifiers and thickeners are included in analyses for nitrogen, starch and unavailable carbohydrates. Clearly, specific analyses are preferable. However, the need for data on additives and other non-nutrient components of foods may relate to priorities regarding food safety and not necessarily to nutritional priorities.

Miscellaneous

The data exist for other compounds of interest, such as caffeine, theophylline, theobromine, tannins and other bioactive compounds (carnosine, carnitine and creatinine), they should be listed in the database at least up to the reference level.

  

Benefits of Food Composition Data

In agriculture, factors such as disease resistance and yield, rather than nutritional value, have tended to dominate decision-making regarding policies and programmes. Similarly, in food technology economic considerations such as consumer appeal and profitability have been the major influences on product development. Attitudes are changing, however, and nutritional quality is now one of the factors considered in cultivar selection and the development of processed foods.  The production, handling, processing and preparation of foods profoundly affect their nutritional quality. Extensive literature covers agricultural practices (climate, geochemistry, husbandry, post-harvest treatments); processing methods (freezing, canning, drying, extrusion); and stages in food preparation (holding, cutting, cooking). Most nutritional studies in these areas, however, cover a limited range of nutrients (notably labile vitamins); very little information is provided on the broad range of nutrients (Henry and Chapman, 2002; Harris and Karmas, 1988; Bender, 1978; Rechigl, 1982).

In many countries, government agencies often assess diets at the population level, through national food consumption surveys, in order to monitor trends in nutritional status and to evaluate the impact of nutrition policy. FCD are also widely used in the development of recipes, meals and menus for therapeutic diets, institutional catering and the commercial foodservice industry. Dietitians and clinicians need to design therapeutic diets for patients with specific nutritional requirements associated with their condition (e.g. metabolic disorders, diabetes). FCD are also an important tool in planning menus in care homes, hospitals and prisons to ensure adequate nutrient content. There is also a move towards the provision of point-of-sale nutritional information in foodservice outlets, which has increased the application of food composition data in the foodservice industry. The demand for point-of-purchase information on nutrient content has also been a driving force behind the inclusion of nutritional information on food labels. This is in the form of nutrition panels and, increasingly, front-of-pack or ‘signpost’ labeling, which provides information for consumers in a simplified format. Nutrient profiling, a tool for categorizing foods on the basis of their nutrient content, is a relatively new application of FCD. It will help assess the eligibility of foods to bear nutrition and health claims under new EU regulations. Other uses of food composition data in relation to food manufacturing include optimization of product composition when developing new products.

FCD are also used to help identify the needs of nutrition education and health promotion and to implement appropriate strategies, such as targeted interventions. They form an integral part of, and an educational resource for, food and nutrition training in schools, tertiary education and, increasingly, in workplace settings. They also have more general applications in agriculture and trade. For example, FCD can be used to monitor the nutrient content, safety and authenticity of foods. Improvements to the food supply, such as plant breeding, and new methods of cultivation, harvesting and preservation can be assessed using FCD. Finally, they form part of the evidence base in support of initiatives on nutrition and biodiversity.

Reference

http://www.fao.org/fileadmin/templates/food_composition/images/FCD.pdf

http://www.eurofir.org/?page_id=17

http://www.ncbi.nlm.nih.gov/pubmed/21045848