Meeting FSO and PO Through Control Measures
3.2 Control Measures
While microbiological criteria have played an important role in defining what microbiological speci-fications of food have been considered acceptable, in isolation they cannot be considered genuinely effective for the control of microbial hazards. In ICMSF Book 4 (ICMSF 1988) it was recognized that more emphasis should be placed on the use of selected, targeted control measures and less on micro-biological testing of food. ICMSF Book 8 (ICMSF 2011) further stressed the role of testing to verify the effectiveness of a food safety management system, and the use of data for assessing process con-trol and product acceptance, providing practical examples of useful approaches applied to a range of product categories and for a variety of foods and processing environments. For each product category, the most effective control measures are being suggested that are based on the principles described in ICMSF (2002), of which this book is a revised version. Microbiological testing alone is not being recommended by ICMSF as an effective control measure and food manufacturers should rather con-trol their concon-trol measures, processes and the conditions of their operations to assure that their prod-ucts would meet the relevant microbiological criteria if sampled.
In the present day, many food manufacturers and other food business operators around the world have indeed adopted food safety assurance approaches to ensure the safety of finished products. These approaches rely on the selection of sound product designs and processes for producing the foods and on control of food operations by use of prerequisite and HACCP programs. In doing so, explicit safety expectations, e.g. FSOs/POs or microbiological criteria, are being met.
Historically, major advances in consumer protection have resulted from the development and implementation of selected, targeted control measures at one or more steps along the food chain, from the farm up to the consumer. These advances have followed periods of extensive investigation to gain the information necessary to understand the pathogens (e.g. sources, life cycle, parameters influenc-ing growth, survival, death, or metabolite production).
Control measures are the actions and activities used to prevent, eliminate or reduce a food safety hazard to a tolerable level. They generally fall into three categories:
Controlling initial levels
• Avoiding foods with a history of contamination or toxicity (e.g., raw milk, raw molluscan shellfish harvested under certain conditions).
• Selecting ingredients (e.g., pasteurized liquid eggs or milk).
• Using microbiological testing and criteria to reject unacceptable ingredients or products.
Preventing increase of levels
• Preventing contamination (e.g., adopting Good Agricultural Practices during primary production or implementing Good Hygiene Practices that minimize contamination during processing opera-tions, such as slaughter, separating raw from cooked ready-to-eat foods, implementing employee practices that minimize contamination, using aseptic filling techniques).
• Preventing growth of pathogens (e.g., chilling and holding temperatures, pH, aw, preservatives).
Reducing levels
• Destroying pathogens (e.g., freezing to kill certain parasites, sanitizers, pasteurization, irradiation).
• Removing pathogens (e.g., washing, ultra-filtration, centrifugation).
One or more of the above activities may be necessary to control a hazard at a particular step in a food supply chain. In addition, one or more control measures may be applied at different steps along the food supply chain, in order to eliminate, prevent or reduce a hazard to an acceptable level. Each participant along the food chain has a responsibility to apply those control measures that contribute to
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providing safe foods. Even at the final food preparation and consumption stage, measures can be taken to avoid recontamination or growth of micro-organisms. For instance, good hygiene is an important control measure at the stage of final food preparation in the home or in a food service operation as it is essential to control cross contamination. As such, the education of food handlers in the home or in food service in the necessary skills and knowledge about good hygiene in itself can be seen as an important control measure.
Regarding FBOs, the various control measures they apply generally fall into two sets of programs:
– good practices such as Good Agricultural Practices (GAP), Good Manufacturing Practices (GMP) and/or Good Hygiene Practices (GHP) and
– programs based on the principles of Hazard Analysis Critical Control Point (HACCP).
The good practices mentioned in the first program are part of a broader suite of systems collec-tively referred to as pre-requisite programs (Chap. 1). Good Hygiene Practices (GHP) can be viewed as the basic sanitary conditions and practices that must be maintained to produce safe foods. It also includes certain support activities such as raw material selection, product labeling and coding or recall procedures. Effective application of GHP provides the foundation upon which the second program, HACCP, is developed and implemented. The development of an effective HACCP system involves a systematic approach to the identification, evaluation, and control of all types of food safety hazards in a food operation.
It is important to note that HACCP is not implemented in lieu of prerequisite programs such as GHP. On the other hand, and failures to maintain and implement prerequisite programs can invalidate a HACCP system and result in production of unsafe food. It is necessary to consider the hazards that are most likely to occur in each particular food operation and pay particular attention to those ele-ments of the prerequisite programs, in particular GAP and GHP, and as well as HACCP that will contribute most in controlling the hazards.
3.2.1 Good Hygiene Practices (GHP)
The General Principles of Food Hygiene (CAC 1997a) focus on the hygiene related prerequisite pro-grams and describe the major components of GHP as:
• Design and facilities (location, premises and rooms, equipment facilities)
• Control of operation (control of food hazards, key aspects of food hygiene control, incoming mate-rial requirements, packaging, water, management and supervision, documentation and records)
• Maintenance and cleaning (maintenance and cleaning, cleaning programs, pest control systems, waste management, monitoring effectiveness)
• Personal hygiene (health status, illness and injuries, personal cleanliness and behavior, visitors)
• Transportation (general requirements, use and maintenance)
• Product information and consumer awareness (lot identification, product information, labeling, consumer education, handling/storage instructions)
• Training (awareness and responsibilities, training programs, instruction and supervision, refresher training)
As stated previously, effective application of GHP and other prerequisite programs provide for the foundation upon which HACCP systems are developed and implemented. Failure to maintain and implement GHP or other prerequisite systems programs can invalidate a HACCP system and result in production of unsafe food.
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Effective control of a hazard in a food necessitates consideration of the components that generally (i.e. the prerequisite programs) and/or specifically (i.e. HACCP) are likely to have significant impact in controlling the hazard. For example, the risk of certain chemical hazards (e.g., paralytic shellfish poisoning, ciguatera toxin, scombroid poisoning) and biological hazards (e.g., pathogenic Vibrio spp.) being used in a range of finished goods all produced without a heating step to reduce risks, may be controlled through general incoming material requirements). Incoming material requirements related to biological hazards may be of lesser importance for a food product that will be cooked sufficiently to eliminate enteric pathogens that may be present, provided that sufficient cooking as a step at food preparation can be relied on. Thus, the various components of a pre-requisite program such as GHP do not carry equal weight in all food operations. It is necessary to consider the generic hazards that are most likely to occur across the foods produced in a particular operation and then apply those GHPs that will be most effective for controlling these hazards. This does not mean that the other components of GHP are ignored. Some, for example, may be very important to ensure a food meets established quality requirements.
In certain situations, selected components of GHP may carry particular significance and should be incorporated into the HACCP plan. For example, equipment maintenance and calibration are impor-tant for large continuous ovens used in cooking meat products. In this example, the procedure and frequency (e.g., monthly, quarterly) for conducting checks on heat distribution during cooking could be incorporated into the HACCP plan as a verification procedure. In addition, it is normally necessary to verify the accuracy of the thermometers used for monitoring oven temperatures during cooking.
There are several examples of outbreaks related to the failure to apply effective GHP. Table 12.1 in Chap. 12 details a wide range of outbreaks related to environmental contamination caused by poor design of equipment, poor separation of raw and cooked product, poor maintenance or cleaning of equipment or poor management of controls during transportation. In addition to environmental con-tamination, a large number of outbreaks from food service establishments can be attributed to poor personal hygiene (NSW Food Authority 2014).
Information on hygienic design of facilities and equipment, cleaning and disinfection, health and hygiene of personnel, and education and training are discussed in ICMSF book 4 (ICMSF 1988).
3.2.2 Hazard Analysis and Critical Control Point (HACCP)
The Codex document on the Hazard Analysis and Critical Control Points (HACCP) System and Guidelines for its Application (CAC 1997b) lists seven principles:
1. Conduct a hazard analysis
2. Determine the critical control points 3. Establish critical limits
4. Establish monitoring procedures 5. Establish corrective actions 6. Establish verification procedures
7. Establish record keeping and documentation procedures
The development of an effective HACCP system involves a systematic approach to the identifica-tion, evaluaidentifica-tion, and control of food safety hazards in a food operation. HACCP plans specify the actions to be taken in a food operation to control food safety hazards. HACCP plans also specify records to be generated during the operation for use in verification that critical limits have been met at Critical Control Points (CCPs) in the operation. In the event a deviation occurs at a critical control point (CCP), the deviation should be detected in time to ensure that corrective actions will prevent
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unsafe food from reaching consumers. This may necessitate collecting and analyzing samples from across the questionable quantity of food. The principles described in this text for sampling food can be applied to help assess the safety of a suspect lot and lead to appropriate disposition of the food (see Chap. 11, Sect. 11.2).
Codex Alimentarius has defined a critical control point as “a step at which control can be applied and that is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level”
(CAC 1997b). The interpretation of what is considered an acceptable level has been left to the judg-ment of the HACCP team and respective competent authorities.
As discussed in the previous two Chapters, the concepts of FSO and PO can be used by competent authorities to communicate to food business operators the level of control necessary for a hazard to be reduced to “an acceptable level”. Food business operators can also use the PO concept for coordina-tion across a food supply chain between FBOs.
The production of safe food or food ingredients requires food business operators to selectively apply prerequisite programs such as GHP and the principles of HACCP to develop and implement a total food safety management system that will control the significant hazards in the food/ingredients being produced, handled or prepared.
Some risk management principles are best addressed through GHP measures (e.g., controlling the initial levels of a hazard through good hygiene), or control measures within other prerequisite pro-grams, and others are clearly part of a defined CCP within HACCP (e.g., reducing the level of a sig-nificant hazard through a decontamination step). As mentioned above, in certain situations selected components of GHP may carry particular significance and should be incorporated into the HACCP plan. This is particularly relevant where the safe production of food requires a number of risk manage-ment control measures to be applied in combination to ensure a safe product.
For example, in the manufacture of fresh-cut, leafy green salads it is not possible to apply a single CCP such as a thermal pasteurization step to ensure safety without compromising quality of the prod-uct. Instead, to ensure a safe product requires a number of different risk management control mea-sures, such as good agricultural practice, an effective washing step and control of the product distribution and retail conditions.
Over the last two decades, ICMSF and Codex Alimentarius have developed a risk-based frame-work for managing risks associated with foods, resulting in publication of new principles and guide-lines for microbiological risk management (CAC 2007a). The use of these risk management principles provides a hierarchy of risk management metrics to guide the application of control measures through-out the food chain (see also Chap. 1).
Where regulatory authorities have stipulated their food safety expectations in terms of FSO or PO values for a type of food product, they will be concerned with whether a typical food safety manage-ment system implemanage-mented at a relevant point in the food supply chain for that group of products can meet the FSO/PO. To that end, they may provide default or ‘safe haven’ guidance to the industry on control measures that would be able to ensure that the stipulated objective(s) is met consistently, when adequately implemented by Industry. As noted before, such measures may be single control measures or combinations of control measures. Guidance may also be provided on potential issues related to processes and handling that Industry needs to be aware of in establishing the required effective food safety management system.
Food manufacturers design processes at a particular step in a food supply chain to meet the PO established by a government or the food business operator, ensuring that they can deliver the Performance Criterion (PC) across the step that is required to covert the hazard level coming into the step to the PO (CAC 2007a). The PC is “the effect in frequency and/or concentration of a hazard in a food that must be achieved by the application of one or more control measures to provide or contribute to a PO or an FSO” (CAC 2015). To achieve the PC, an operator selects one or more suitable control measures that have been duly validated (CAC 2008a).
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The implementation of control measures will continue to be met through the use of pre-requisite programs and HACCP. However, it is expected that the use of the new risk management concepts will facilitate an understanding of different responsibilities for managing food safety through the food supply chain as well as better articulate in quantitative terms the stringency required of a given HACCP plan to achieve a defined outcome. It will facilitate the quantification of CCPs and critical limits within a HACCP plan with regards to the level or probability of a given hazard being properly controlled, which is a critical aspect of validation. As mentioned earlier, many outbreaks are related to failures in GHP and there are entire classes of foods for which current processing capabilities are limited to relatively small reductions (e.g. fresh produce). This has led to consideration of the use of the risk management framework in defining the performance of not only HACCP but also of GHP in managing risks (Buchanan and Williams 2013).
