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Appendix G Report Of The WHOIICMSF1 Meeting On Hazard Analysis: Critical Con';ro! Point System In Food Hygiene Geneva, 9-10 June 1980 CONTENTS Preface .................... I. Introduction II. Control options ................. A. Education and training ................. B. Inspection of facilities and operations C. Microbiological testing or examination D. A modified approach ................. III. Hazard Analysis Critical Control Point (HACCP) system A. Hazard analysis ..................................... 1. In food processing plants ................ 2. In food service establishments ......... 3. In the home .............. Page 400 400 401 402 402 402 ...... 403 . · ~ 403 404 404 406 407 407 407 B. Critical control points 1. Determination at food processing plants 2. Determination in food service establishments and homes 408 International Commission on Microbiological Specifications for Foods. 399

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400 APPENDIX G C. Monitoring 1. At food processing plants 2. In food service establishments 408 409 410 411 411 411 3. In homes IV. Application of HACCP system A. Approaches to hazard analysis B. Approaches to critical control point determination 413 C. Approaches to the establishment of monitoring system V. Conclusions and proposed strategy VI. Recommendations References Annex-List of Participants PREFACE 413 414 416 417 420 In view of the emphasis given to the application of Hazard Analysis Critical Control Point (HACCP) by the WHO Expert Committee on Mi- crobiological Aspects of Food Hygiene (1976),~ the World Health Or- ganization proposed that this be further studied and practical guidelines elaborated for its use in both developed and developing countries. The purposes of this meeting were: (1) to review the literature relating to HACCP; (2) to collect information on the practical use of the system; (3) to assess its practical use in developing as well as in developed coun- tries; and (4) to prepare a guide for this system, particularly for its potential use in developing countries. I. INTRODUCTION Microbiological hazards in food, which may result in either human illness or food spoilage, are well documented. In terms of human morbidity alone, the importance of microbiological hazards exceeds that of the other health hazards associated with foods, such as pesticide residues, food additives, chemical toxicants, and natural poisons or toxic substances. WHO Technical Report Series, No. 598, 1976.

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APPENDIX G 401 While incidence data are incomplete, available information provides con- siderable cause for concern (Todd, 1978; Vernon, 19771. Numerous microbiological agents of food-borne disease have been iden- tified (WHO, 1976; Speck, 1976; ICMSF, 1978), and factors that influence the occurrence, development and control of hazardous numbers or con- centrations of these agents in foods have been described (ICMSF, 1980a, b). Although the epidemiology and control of many food-borne disease-caus- ing agents have been described in considerable detail, the role of other agents is yet to be determined (Riemann & Bryan, 19794. With regard to food spoilage, the literature is replete with studies dealing with the nature, causes and control of microbiological spoilage or dete- rioration of many food commodities (ICMSF, 1980b). As a consequence, specific spoilage problems have been identified, and the principles on which control programmes can be based have been established. Never- theless, the economic losses continue to be enormous. New and modified technologies may introduce additional opportunities for the entry of microbiological contaminants and for their survival or proliferation along the food chain, which may require new approaches to hazard control. The places in the food chain where foods may be mishandled are nu- merous. Three such places are food processing or manufacturing plants, food service establishments (e.g., restaurants, cafeterias, and institutional kitchens), and homes. Available surveillance data indicate that the inci- dence of food-borne disease outbreaks caused by mishandling foods in food processing plants is very much lower than mishandling foods in food service establishments or in the home (Health and Welfare Canada, 1976- 1979; United States Department of Health, Education, and Welfare, 1975- 19791. However, whilst the number of outbreaks attributed to faulty pro- cessing is relatively few, the potential for involving large numbers of persons is high, particularly for foods distributed regionally, nationally or internationally. Therefore, rigorous and continuing applicator of control measures to prevent food-borne illness and food spoilage arising as a result of poor processing or manufacturing practice is necessary. II. CONTROL OPTIONS Traditionally, three principal means have been used by governmental agencies and commercial organizations to control microbiological hazards of foods. These are education and training (A), inspection of facilities and operations (B), and microbiological testing (C). Sophisticated programmes utilize combinations of all three approaches.

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402 APPENDIX G A. Education and training Education and training programmes for the control of microbial hazards of foods are directed primarily towards developing an understanding of the causes of microbial contamination, including the survival and/or growth of the contaminants. An appreciation of personal hygiene, community sanitation and food hygiene should be acquired during primary and sec- ondary education. The extent of training required depends upon the tech- nical complexity of the food operations and the level of responsibility of the individuals involved. Broad in-depth training may be necessary for some, e.g., supervisory personnel; for others, training may relate only to some specific aspects of a food operation. Trained personnel should be able to select and apply control measures that are essential for providing safe products of acceptable quality. B. Inspection of facilities and operations Inspection of facilities and equipment and observations of hygienic practices of personnel which are often required by regulatory authorities are commonly used to check adherence to good food handling practices. Such practices may be those considered essential by the inspector, or they may be specified in various advisory or mandatory documents, such as Good Manufacturing Practice (GMP) guidelines, Codes of Hygienic Prac- tice (such as those developed by the Codex Alimentarius Food Hygiene Committee), or food control laws, ordinances or regulations. Unfortu- nately, such documents often contain vague terms, such as "satisfactory," "adequate," "acceptable," "if necessary," "suitable," relative to some stated requirement, without specifying what is considered to be in com- pliance with the requirement. This lack of specificity, or some indication of the relative importance of the requirement, leaves the interpretation of compliance solely to the discretion of the inspector. Lack of discrimination between important and relatively unimportant requirements may result in overemphasis upon unnecessary or relatively minor requirements and thus increase costs without significantly reducing hazards. Also, requirements that are critical to the safety of the product may be overlooked or under- estimated. C. Microbiological testing or examination Samples of ingredients, materials obtained from selected points during the course of processing or handling, and the final product are sometimes examined for microorganisms. Such sampling and testing assist in deter

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APPENDIX G 403 mining adherence to good manufacturing, handling and distribution prac- tices. In some instances, foods are examined for specific pathogens or their toxins (e.g., salmonellae or staphylococcal enterotoxins). More of- ten, however, examinations are made to detect either organisms that are indicative of the possible presence of pathogens or spoilage or for specific spoilage organisms. Microbiological criteria (i.e., standards, spec~ca- tions, and guidelines) that state acceptable numerical limits for microor- ganisms in foods are useful to government and industry. Principles of sampling and the establishment and application of microbiological criteria have been proposed (FAD/WHO, 1979), and sampling plans, test pro- cedures, and decision criteria (limits) for many foods have been suggested (ICMSF, 1974~. D. A modified approach Whilst the above control options are widely applied, singly or in com- bination, there is little epidemiological evidence of their effectiveness, as the incidence of food-borne disease remains high even in the developed countries that apply these measures. Concern over apparent lack of success in this respect, as well as the need to reduce costs associated with assuring the safety and quality of foods, has led to the development of a more rational approach based on the Hazard Analysis Critical Control Point (HACCP) system. This HACCP concept, first presented at the 1971 Na- tional Conference on Food Protection (United States Department of Health, Education, and Welfare, 1972), was originally developed for use in food processing establishments (Kaufmann & Schaffner, 1974), but it has been extended more recently to food service establishments (Bobeng & David, 1977; Bryan & McKinley, 1979; Bryan, 1980), and to the home (Zottola & Wolf, 19801. III. HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP) SYSTEM The Hazard Analysis Critical Control Point (HACCP) system consists of: (1) an assessment of hazards associated with growing, harvesting, processing/manufacturing, distribution, marketing, preparation and/or use of a given raw material or food products; (2) determination of critical ~"Hazards" include contamination of food with unacceptable levels of food-borne disease- causing microorganisms and/or contamination with spoilage organisms to the extent that hazards occur within the expected shelf life or use of the product.

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404 APPENDIX G control points required to control any identified hazards; and (3) establishment of procedures to monitor critical control points.3 Basi- cally, the HACCP system provides a more specific and critical approach to the control of microbiological hazards than that achievable by traditional inspection and quality control procedures. A. Hazard analysis A hazard analysis consists of an evaluation of all procedures concerned with the production, distribution, and use of raw materials and food prod- ucts: (1) to identify potentially hazardous raw materials and foods that may contain poisonous substances, pathogens, or large numbers of food spoilage microorganisms, and/or that can support microbial growth; (2) to find sources and specific points of contamination by observing each step in the food chain; and (3) to determine the potential for microorganisms to survive or multiply during production, processing, distribution, storage, and preparation for consumption. The participants did not deal with HACCP in growing and harvesting areas but thoroughly discussed the application of this system in processing plants, food service establishments and the home. 1. In food processing plants A hazard analysis should be carried out on all existing products and on any new products that a processor intends to manufacture. Changes in raw materials used, product formulation, processing, packaging, distri- bution, or intended use of the product should indicate the need for re- analysis of hazards, because such changes could adversely affect safety or shelf life. Microbiological hazards will vary from one product to an- other, depending upon the raw materials, the processing procedures, the manner in which the finished product is marketed, and its ultimate use. They may vary from one food processing plant to another producing the same product and therefore must be determined by observations and in- vestigations of the particular processing plant. Hazards caused by microbiological contamination of raw materials must be evaluated. In some cases, microbiological safety and shelf life depend 2"Critical control point" is a location or a process which, if not correctly controlled, could lead to contamination with foodborne pathogens or spoilage microorganisms or their survival or unacceptable growth. 3"Monitoring" is the checking or verifying that the processing or handling procedure at the critical control point is properly carried out.

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APPENDIX G 405 almost entirely on the selection of microbiologically suitable raw materials. For example, in the manufacture of dry blended products which are re- constituted without further heating, processing cannot be relied upon to eliminate contamination present in raw materials. Also, the stability of low-acid canned foods is dependent upon control of the level of ther- mophilic spore-forming bacteria in the ingredients. Food products manufactured from raw materials of animal origin should receive special attention because they are the main source of different food-borne diseases in man (salmonellosis, campylobacteriosis, yersi- niosis). Other food products that can be assumed to be contaminated with pathogenic microorganisms are of vegetable origin. Such ingredients must be carefully considered in a hazard assessment of processes that utilize them. Many of the processes used in food manufacture, such as heat treatment, acidulation, fermentation, and salting, will destroy or inhibit the growth of harmful microorganisms. However, other procedures, such as cooling of cooked products, boning of cooked meats, chilling of cans after ster- ilization in retorts, and slicing of processed meats, may add harmful microorganisms. Hazards associated with these procedures must be eval- uated, and the consequences of failure of processing steps designed to destroy or inhibit harmful microorganisms must be understood. For ex- ample, the failure of a starter culture to initiate acid production promptly may permit the growth of staphylococci and enterotoxin production during the manufacture of cheese or fermented meats. Failure to allow for the equilibration of pH in an acidified canned food during pasteurization could result in growth of Clostridium botulinum spores. Similarly, failure to "vent" a retort properly prior to heat processing could result in cold spots, thus leading to under-processing and failure to destroy C. botulinum. The physicochemical characteristics of a finished product that influence growth, death, or survival of microorganisms should be identified. These include such factors as water activity, pH, the presence of preservatives, the packaging system, and the gaseous environment within it. If inter- actions between various physical and chemical agents are relied on for safety, e.g., aw and pH, pH and preservatives, packaging and gas at- mosphere, fermentation and pH reduction, then these factors must be defined in terms of their influence on the microbial flora during processing, distribution, storage, and use by the consumer. Hazard analysis should include an evaluation of the potential of the food processing plant environment as a source of contamination to the finished product. For example: · To what extent is there opportunity for cross-contamination between contaminated raw materials and finished goods?

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406 APPENDIX G · Is air movement away from finished goods and toward raw materials? · Are there steps, such as the manual handling of products that are eaten without further cooking, where employees could contaminate the finished product with pathogenic microorganisms? · Is the cooling water of satisfactory microbiological quality? 2. In food service establishments Each phase of food preparation operations-from taking delivery of foods to serving-should be examined step by step for sources or means of contamination, possibilities of the contaminants surviving heating pro- cesses, and likelihood of microbial growth. Particular attention should be given to foods and food preparation procedures that are known from epidemiological studies to be a hazard (Bryan, 1978; ICMSF, 1980b). A few examples are as follows: Raw meat, poultry, eggs, fish and rice are frequently contaminated with food-borne pathogens when they reach food service establishments. For example, poultry frequently harbours salmonellae which may be spread to surfaces of equipment, to the hands of workers and to other materials. The possibility of cross-contamination to cooked foods must be checked during hazard analyses. For products eaten raw, such as certain fish (com- mon in Japan), oysters, clams, etc., hazard analyses must concentrate on chilling practices before and after these products arrive at the establish ment. If frozen turkeys are not completely thawed before cooking, salmonellae may survive the cooking process. Also, the interiors of rolled roasts, meat loaves and various ground meat products may contain food-borne path- ogens. The significance of such contamination must be considered in any hazard analysis of a food service operation which offers these products. Therefore the thoroughness of cooking these products must be evaluated. Food handlers constitute a hazard. Cooked ingredients in potato salad, for instance, can be contaminated by persons during peeling, slicing, chopping or mixing operations in its preparation. Hazard analysis should therefore include observations of food handling and hand-washing prac- tices of the kitchen staff. Epidemiological information indicates that the most important factors contributing to the occurrence of food-borne disease outbreaks are related to operations that follow cooking. For instance, rice becomes hazardous after cooking when it is left unrefrigerated for several hours or stored in large masses in large pots overnight. These conditions may permit growth of Bacillus cereus and formation of heat-stable toxin. Hazards intensify as the time between preparation and serving of food lengthens. Hazards

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APPENDIX G 407 analyses must assess conditions after cooking, while keeping food hot cooling and cold storage, and reheating practices. 3. In the home Homemakers can examine their kitchen environments for hazards only if they are aware of these hazards. Such awareness can result only from education, i.e., at home during childhood, in school, in special courses on homemaking, from publications from various sources and through experience. B. Critical control points A critical control point is a location or a process which, if not correctly controlled, could lead to unacceptable contamination, survival, or growth of food-borne pathogens or spoilage microorganisms. 1. Determination at food processing plants Incoming raw materials may constitute critical control points, depending upon their origin and use. If one or more steps in a process can be depended upon to eliminate harmful microorganisms in a particular raw material, that raw material does not constitute a critical control point. For example, the testing, for Salmonella, of eggs used in the manufacture of mayonnaise is not usually a critical control point because most countries require may- onnaise to be so formulated that its content of acetic acid and pH will kill these organisms. Also, if the consumers' use of the product destroys contamination, for example, as in the cooking of raw pork sausage, then inspection of the incoming raw pork does not constitute a critical control point. Microbiological examination of such raw materials only provides an indirect means of evaluating general microbial quality. Organoleptic evaluation will often provide more useful information. If, on the other hand, neither processing techniques nor consumer use can be depended upon to eliminate harmful microorganisms from raw materials, then these constitute critical control points. Particularly im- portant in this respect are sensitive raw materials, e.g., dried eggs and milk which may contain salmonellae, and nut meats which may be con- taminated with mycotoxins. If raw materials are not controlled at this point, the harmful microorganisms or toxins they may contain are likely to contaminate finished products, such as chocolate confectionery and beverages that are not heated before consumption. Raw spices may be heavily contaminated with spore-forming organisms

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408 APPENDIX G which may lead to a significant loss of expected shelf life of cooked sausages. Thus, the examination of such spices for spore-forming micro- organisms constitutes a critical control point. However, spore-forming microorganisms in spices used, for instance, in small amounts at meal time to flavour food are not a critical control point, because they have no relevance to quality or safety. Processing time-temperature combinations are frequently the most crit- ical control points. For example, if a heat process is depended upon to destroy microorganisms, then the required combinations of processing time and temperature must be carefully established and followed. Simi- larly, the temperatures at which products are held prior to and during cooling and freezing and the length of time they are held are frequently critical control points. Amongst other factors that can adversely affect safety and quality is improper sanitation in the plant, and packaging materials. If poor sanitation in a particular process step is likely to affect adversely safety of the finished product this would constitute a critical control point. Products may be subjected to environmental contamination from such sources as air, water, insects, rodents and personnel. Incoming packaging materials do not usu- ally constitute a critical control point, except in the case of containers used for canned foods, where lack of integrity of the finished package may affect the safety or quality of the end product. The critical control points in the manufacture of a number of different types of food products have been described (Corlett, 1973, 1978, 1979; Peterson & Gunnerson, 1974; Ito, 19741. 2. Determination in food service establishments and homes Much of the discussion in the previous section is applicable in principle to food service operations and to homes. Places or points in food service operations or in homes where foods are handled or stored after cooking are particularly important critical control points. These points include the handling of cooked foods, keeping hot, cooling, cold storage and reheating (Bryan, 1978, 1979, 1980~. C. Monitoring After analysing the hazards presented by a particular product and iden- tifying critical control points, it is necessary to establish monitoring sys- tems to ensure that these points are under control. Such monitoring may involve only visual inspection for example, the pre-operational inspec- tion of a temperature recorder to determine that the chart has been properly

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APPENDIX G 409 installed. Similarly, since the safety of boned cooked chicken may be affected by handling by employees, hand-washing procedures should be observed. Although such observations do not involve measurements, they should be recorded on suitable check lists. More commonly, chemical, physical or microbiological tests are used for monitoring. For each critical control point the appropriate monitoring test must be determined, the procedures documented and the frequency of testing spec- ified. Applicable statistically sound sampling plans must be employed. For example, for critical control points involved in canning operations, evaluation and sampling procedures are available (FDA, 1973a; FPI, 19751. Similar sampling plans have been recommended for the microbiological examination of other foods (National Research Council, 1969; ICMSF, 19741. 1. At food processing plants In no phase of food processing is monitoring of critical control points so essential to the safety of the finished products as in the manufacture of low-acid canned foods. Indeed, in the United States, such monitoring is subject to federal regulations (FDA, 1973a, b; FPI, 19751. The extent of such monitoring has been reviewed by Ito (19741. Safety of low-acid canned foods is based upon the establishment of heat processes capable of destroying microorganisms of public health significance and of spoilage types likely to grow at normal ambient temperatures. Physical and chem- ical tests are performed during production to ensure that all factors nec- essary to the application of the established safe processes have been adequately controlled. Numerous checks and tests are made at various critical control points, including the adequacy of ingredient blending, determination of consistency, ratio between solids and liquids, weight of product placed in the container, amount of head space, adequacy of the double-seam, time and temperature during sterilization in retorts, quality of cooling water, and post-processing handling of cooled cans. There is no intent, here, to indicate all of the points that are monitored. Rather, the object is to emphasize the importance of checking each critical control point to ensure that the established procedures have been properly carried out. This necessitates specifying the method for measuring each parameter, the determination of satisfactory limits for each test and the determination of the frequency with which the tests and checks will be employed. The results of these tests must be recorded. If a defect is observed, remedial action should be taken and documented. Monitoring systems for nonsterilized foods are also often complex and detailed and may involve microbiological examinations, for example, the

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4lO; APPENDIX G production of non-fat dried milk or dried egg solids. The prime hazard presented by both products is the danger of post-proce~sing contamination with Salmonella. Such products should therefore meet microbiological criteria recommended by the National Research Council (1969) and ICMSF (1974), and those often required by regulatory agencies. Assuming mon- itoring of the pasteurization process indicates proper time and temperature relationships., the most likely source of contamination of the finished product would be the environment. It has been repeatedly shown that when potential far such environmental contamination exists, a continuing environmental sampling programme is more likely to detect a problem than is finished product analysis. Accordingly, in such operations well- selected points in the environment that constitute critical control points should be constantly monitored. If Salmonellae are detected in samples from such points, negative results of tests on finished products should be interpreted with extreme care. An analogous situation would be presented by a dry-blended product composed of multiple ingredients, each of which had been pre-tested and found negative for Salmonella. Here, raw ma- terials, the environment and the finished product are critical control points which must be subject to constant monitoring. 2. In food service establishments Many of the measures for monitoring critical control points described in the previous section are applicable to food service establishments. Visual inspection, however, is the usual approach. Inspection forms developed for thp purpose of hazard analysis, which are useful to record information obse!ryed during monitoring, include those related to the inspection of incoming foods, storage conditions and each step of preparation of po- tentially hazardous foods. Certain foods-milk and milk products, canned foods, meat, poultry, shellfish should come from known safe sources thee have been subjected to previous monitoring. These and other foods s should be checked when received for integrity of can or other packaging, signs of spoilage, and perhaps temperature. Thermometers in cold storage rooms should be checked. Particular attention during inspection should be given to: temperatures of food, hygienic practices and techniques of handling foods by workers, whether employees are ill or have infections likely to be transmitted by food, and opportunities for cross-contamination from raw foods to cooked foods. If the cleanliness of equipment is a critical control point, managers should establish a hygiene maintenance schedule that specifies what should be cleaned, how it should be cleaned, when it should be cleaned, and

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APPENDIX G 411 who should clean it. Daily checks should be made to determine whether the schedule is being followed. The capability of cleaning equipment and the effectiveness of the procedures can be evaluated by checking tem- peratures, length of washing and rinsing cycles, water pressures, and concentrations of detergents or disinfectants. Furthermore, microbiolog- io.~1 monitoring can be done on surfaces of equipment to evaluate the ~ O efficiency of cleaning. Physical and chemical evaluations or cleaning and disinfection processes, however, are usually of more value. Measuring the temperatures of foods during preparation and storage is probably the most useful monitoring technique for critical control points in food service operations. Temperatures of certain potentially hazardous foods, such as poultry and pork products, should be measured at the completion of cooking and reheating, or a short time thereafter (during the period of post-heating temperature rise) to determine whether the interior has reached a temperature at which vegetative cells of food-borne pathogens would be killed. Particular attention should be given to the monitoring of temperatures of cooked foods while kept hot or cooling. Several temperature measurements taken at intervals are necessary to evaluate time-temperature conditions (Bryan & McKinley, 19791. Microbiological sampling and testing of foods at various steps of pro- cessing or of finished products provide additional means of monitoring critical control points. Interpretation of these, however, must be based upon ingredients and all of the previous steps of preparation, heating and storage. 3. In homes Monitoring in homes includes: observing that certain foods in their preparation actually come to a boil, checking pressures (temperatures) and times during heating of low-acid canned foods, inserting a thermometer into meat and poultry during cooking, checking that shallow containers are used to store cooked foods in refrigerators, that foods are not left at room temperature for several hours, and that in the case of heat-and-serve items the manufacturer's instructions with regard to storage and prepa- ration of the food are followed. IV. APPLICATION OF HACCP SYSTEM A. Approaches to Hazard Analysis When considering hazard analysis both food poisoning and spoilage microorganisms are of concern. Knowledge that a food is hazardous may

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412 APPENDIX G derive from one of two sources: (1) Epidemiological information indi- cating that a product is potentially a health hazard or is microbiologically unstable may derive from effective surveillance programmer that collect data on the incidence of food-borne disease and assess significance. Feed- back from marketing sources of a particular product may indicate hazards relating to stability or, on occasion, food poisoning hazards. From the viewpoint of hazard analysis, epidemiological marketing information is most desirable, as the assessment is based on factual information. (2) Technical information may indicate that the product poses a health hazard or is subject to spoilage. Here, reaching a decision with respect to hazard is far more difficult than in the first situation. While accurate data concerning product composition and the influence of processing can be obtained at the processing level, it is often difficult to relate this information to the subsequent effects of storage, distribution and actual use of the product. This lack of information necessitates additional safe- guards in analyses, which frequently lead to overcontrol. If an existing product or a new product concept is to be subjected to hazard analysis, a food microbiologist) with extensive knowledge of the requirements for the type of product under evaluation should be consulted. For example, the following questions should be considered: 1. What are the conditions of intended distribution and use? Is the product to be distributed under ambient or cold storage tem- peratures? What is the expected shelf life both during distribution and storage and in the hands of the person who will ultimately use the product? How will the product be prepared for consumption? Is it likely to be cooked and then held for a period of time before consumption? What mishandling of the product is likely to occur in the hands of the consume, or during marketing? 2. What is the product formulation? What is the pH? What is the water activity? Are preservatives used? What packaging is used, and is this integral to product stability, e.g., the vacuum packaging of fresh meats? 3. What is the intended process? Consideration should be given to those steps that lead to the de ~The participants particularly dealt with microbiological aspects of the subject matter. Other specialists should be consulted when pathogenic agents, e.g., chemicals, are involved.

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APPENDIX G 413 struction, inhibition, or growth of food-borne disease or spoilage . . microorganisms . Based on answers to the above, and other available information, the expert food microbiologist is able to give a preliminary assessment of the potential hazards involved in the manufacture, distribution and use of the product. However, it is desirable and in many cases necessary to check the assessment by inoculation of the product with appropriate food-borne pathogens and potential spoilage organisms. The inoculated food must be packaged under intended marketing conditions and then be subjected to tests under expected storage, distribution and consumer use conditions. Such tests should include evaluation of the effects of mishandling on product safety and stability. The test protocols, including the nature and size of the inoculum as well as other details, should be under the direction of an expert food microbiologist. B. Approaches to Critical Control Point Determination Sometimes critical control points are obvious from the hazard analysis. Epidemiological data collected during investigations of outbreaks that occurred in similar places can also be used as a guide. At other times, more extensive research on the food or the process, including microbiol- ogical investigations, may be necessary to establish appropriate control points. Of particular value is a determination of temperatures and times at which the product is held during processing or preparation for con- sumption at an establishment. Microbiological investigations usually form a vital part of the procedure of selecting critical control points, and should include in-depth investi- gations of raw materials to establish types and numbers that may be a hazard in a final product, as well as collection of samples of products and/or materials from the surfaces of equipment coming in contact with the food at various stages during the manufacture or preparation for con- sumption. Statistically valid sampling procedures should be used and re- peated on a number of occasions to obtain a realistic picture of the status at different operations, in order to identify stages in processing and the environment where unrestricted microbial growth may occur. Generally, these can be detected by simple aerobic plate count determinations. C. Approaches to the Establishment of Monitoring System The type of monitoring system depends upon the nature of the critical control point under consideration.

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414 APPENDIX G 1. If a raw material is a critical control point, a specification should be set for that raw material detailing the microbiological tests, sampling plans and limits to be employed. Ideally, the supplier will perform the required tests and ensure that the materials comply with the specifications before the product is delivered to the user. However, it may be advisable for the user to check the consignment upon receipt, particularly if it is from a new supplier. Raw material storage conditions should be monitored to ensure that the satisfactory quality of the material is maintained until . . it Is user a. 2. Monitoring of process critical control points may involve micro- biological tests but may be best achieved by physical and chemical tests, because the results of these are more rapidly available. There are, however, situations where in-process microbiological monitoring is necessary as, for example, in the production of highly sensitive foods for infants, chil- dren or malnourished persons. It may also be necessary to monitor the effectiveness of sanitation measures by the use of microbiological tests. In situations where a heat-stable toxin is a potential hazard, the product should be examined prior to a heat process for numbers of the toxicogenic organisms to assess the likelihood of the hazard. 3. Visual observation, although it may appear to be a mundane activity, is often the key means of monitoring critical control points. Personnel responsible for such monitoring require considerable training and exper- tise. 4. End product monitoring by microbiological testing is generally very limited. More often, determination of product attributes, such as pH, water activity, preservative level and salt content will give far more information about safety and stability. There are situations where microbiological examination of the finished product is mandatory, e.g., the examination of certain high-risk foods for Salmonella. For this purpose, the sampling plans and analytical procedure recommended by ICMSF should be fol- lowed (ICMSF, 1974, 19781. 5. Check lists should be employed for monitoring critical control points. These should show details of the location of the points, the monitoring procedures, the frequency of monitoring and satisfactory compliance cri- teria. V. CONCLUSIONS AND PROPOSED STRATEGY The above considerations have been mainly concerned with the appli- cation of the HAC,CP system by food manufacturers and food service establishments in developed countries. The participants of the meeting concluded that:

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APPENDIX G 415 · The HACCP concept is a desirable alternative to more traditional control options. It can be applied at a better cost/benefit ratio in comparison with other approaches, as it is based upon a more systematic and logical approach to the avoidance of food hazards. · Application of the HACCP concept would likewise be very useful to food industries in developing countries. They recognized, however, that introduction of this approach to control would require the same degree of scientific sophistication as is necessary to its successful use in developed countries, since conducting hazard analyses and determining critical con- trol points require the input of trained specialists who are supported by adequate laboratory services. · Outside experts, supported by adequate laboratory facilities, could conduct hazard analyses and determine critical control points in specific food processing operations in developing countries, leading to the estab- lishment of appropriate monitoring systems that could be administered by personnel in these countries. This would require the establishment of adequate laboratory facilities and the training of personnel. · Were such programmer undertaken, it would be necessary for outside experts periodically to carry out on-the-spot reviews of results and prog ress. It was therefore proposed that WHO consider implementing the appli- cation of the HACCP system to food production in developing countries. The proposed strategy to achieve this would be: A. WHO should select a food produced in a developing country or countries. The food selected should be one which has been identified as a health hazard or has been frequently rejected by importing countries. B. WHO should convene an expert consultation to consider the ap- plication of the HACCP system to the selected food. This consultation should be composed of experts in the technology and microbiology of that particular food, including some with an extensive knowledge of the tech- nologies used in different developing countries for the production of that particular food. Prior to convening the consultation, data such as those outlined in the previous section on application of the HACCP system should be available for review. If the application of the HACCP system is considered appropriate, the consultation should identify the probable hazards associated with the food, consider the likely critical control points and suggest potentially applicable monitoring procedures. C. WHO should select a country and food processing plants within that country in which the system could be tested. D. Outside experts designated by WHO should, with the appropriate national authorities of that particular country, conduct a thorough hazard

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416 APPENDIX G analysis of the country's manufacturing plants for the selected food, and by means of the system indicated in this report identify the critical control points. E. Procedures necessary to monitor the critical control points should then be established. In cases where the necessary monitoring capabilities are not available at the outset of the programme, it is proposed that WHO offer the necessary assistance to provide these. This may require the establishment and operation of laboratories, and the training of personnel. F. Experience has shown that the HACCP system will be effective only if it is regularly reviewed. In order to ensure an optimal system it is suggested that the manufacturers and the national authorities in the de- veloping countries regularly evaluate the progress of the programme, and if necessary make improvements. To assist in this WHO should supply the participating country or countries with outside experts. G. If the programme is successful in one developing country, it should be extended to other countries. H. WHO should convene other consultations to consider the extension of the HACCP system to other foods, if the results of the initial programme are sufficiently encouraging. VI. RECOMMENDATIONS The participants concluded that the Hazard Analysis Critical Control Point (HACCP) system is an effective and economical approach to en- suring the safety and quality of foods produced in developed countries and can be similarly applied in developing countries. In order to implement the HACCP system in developing countries, they recommended that WHO, in cooperation with other appropriate bodies, pursue the following activ- ities: 1. That a food be selected which, on the basis of firm epidemiological evidence, is a hazard in national or international trade and for which a developing country can be identified in which a pilot programme can be established. 2. That a pilot programme for application of the HACCP system to the selected product be initiated and a protocol developed for application of the system in the pilot programme. The protocol should be based on the best information available concerning the most likely hazards, critical control points and applicable monitoring procedures. 3. That appropriate experts be recruited to work directly with relevant industry and government personnel in the selected country, in whatever manner Is necessary, to:

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APPENDIX G 417 (a) conduct hazard analysis of the operation; (b) identify the critical control points pertinent to the hazards iden- tified; (c) specify systems to monitor the critical control points and to assist in the application of the monitoring procedures; (d) conduct periodical reviews of the processing plants' use of the established HACCP system, including records of the results of monitoring checks of critical control points. 4. That any necessary assistance be given to provide adequate mon- itorin~ facilities. . ~ c, 5. That9 if the pilot programme is successful9 WE10 extend this activity to other countries that produce the same product. 6. That when review of the pilot programme or other considerations justify it9 appropriate consultationfs) be held to consider implementation of additional programmer for application of the HACCP system. 7. That encouragement be given to the incorporation into Codex A1- .: ~entarius Codes of Hygienic Practice of the identification of critical control points appropriate to the commodity concerned and9 as far as possible the respective monitoring techniques required be specified. 8. That encouragement be given to the establishment of food-borne disease surveillance programmer to collect epidemiological data on foods ~w ~ r ~ ~ ~. ~ . 1 produced in developing countries and to identify the hazards and faulty processing operations that contribute to food-borne disease outbreaks. 9. ~ net encouragement be given to research on quantitative ap- proaches to risk analysis and on the development of rapid and practical microbiological test procedures for monitoring critical control points. 10. That discussion of the HACCP system be incorporated into appro- priate WHO training programmer. REFERENCES Bobeng, B. J. & David, B. D. 1977 HACCP models for quality control of entree production in foodservice systems, J. Food Prot., 40, 632-638 Bryan, F. L. 1978 Factors that contribute to outbreaks of foodborne disease, J. Food Prot., 41, 816- 827 Bryan, F. L. 1979 Prevention of foodborne diseases in food-service establishments, J. Environ. Health, 41, 198-206 Bryan, F. L. 1980 Foodborne disease in the United States associated with meat and poultry, J. Food Prot., 43, 140-150

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418 APPENDIX G Bryan, F. L. & McKinley, T. W. 1979 Hazard analysis and control of roast beef preparation in food service establishments, J. Food Prot., 42, 4-18 Corlett, D. A., Jr. 1973 Freeze processing: prepared foods, seafood, onion and potato products. Presented at the "HACCP Inspector Training Course," given to United States Food and Drug Administration Inspectors, Chicago, Illinois Corlett, D. A., Jr. 1978 Critical factors in thermal processing. IFT Short Course, Fundamentals of Thermal Processing Corlett, D. A., Jr. 1979 Industry's approach to proper can handling. Presented on the programme "Can Handling" sponsored by the Food Processors Institute, in cooperation with the Na- tional Food Processors Association, San Francisco, California FAD/WHO 1979 Report of an FAD/WHO Working Group on Microbiological Criteria for Foods, Geneva, 20-26 February (Unpublished document WG/Microbiol/79/1) Food and Drug Administration (FDA) 1973a Thermally processed low-acid foods packaged in hermetically sealed containers. Part 128B (recodified as Part 113), Fed. Register, 38, No. 16, 24 January, pp. 2398- 2410 Food and Drug Administration (FDA) 1973b Emergency permit control. Part 90 (recodified as Part 109), Fed. Register, 38, No. 92, 14 May, pp. 12716- 12721 Food Processors Institute (FPI) 1975 Cannedfoods-Principles of thermal process control in container closure evaluation, 2nd ed. Edited and illustrated by the National Canners Association, Berkeley, Cali- fornia Health and Welfare Canada (1976, 1978, 1979) Food-borne disease in Canada, Annual Summaries, 1973, 1974, 1975. Health Pro- tection Branch, Ottawa, Ontario International Commission on Microbiological Specifications for Foods (ICMSF) 1974 Microorganisms in foods. II. Sampling for microbiological analysis: Principles and specific applications. Toronto, Canada, University of Toronto Press International Commission on Microbiological Specifications for Foods (ICMSF) 1978 Microorganisms in foods. I. Their significance and methods of enumeration, 2nd ed. Toronto, Canada, University of Toronto Press International Commission on Microbiological Specifications for Foods (ICMSF) 1980a Microbial ecology offoods. Vol. 1. Factors affecting life and death of microorgan- isms. New York, Academic Press International Commission on Microbiological Specifications for Foods (ICMSF) 1980b Microbial ecology offoods. Vol. 2. Food commodities. New York, Academic Press Ito, K. 1974 Microbiological critical control points in canned foods, Food Technol., 28, 16, 48 Kaufmann, F. L. & Schaffner, R. M. 1974 Hazard analysis, critical control points and good manufacturing practices regulations (sanitation) in food plant inspections, Proc. IV ant. Congress Food Science and Technol., pp. 402-407 National Research Council 1969 An evaluation of the Salmonella problem. Washington, D.C., National Academy of Sciences

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APPENDIX G 419 Peterson, A. C. & Gunnerson, R. E. 1974 Microbiological critical control points in frozen foods, Food Technol., 28, 37-44 Riemann, H. & Bryan, F. L., eds. 1919 Food-borne infections and intoxications. New York, Academic Press Speck, M., ed. 1976 Compendium of methods for the microbiological examination of foods. Washington, D.C., American Public Health Association Todd, E.C.D. 1978 Food-borne diseases in six countries A comparison, J. Food Prot., 41, 559-565 United States Department of Health, Education and Welfare 1972 Proceedings of the 1971 National Conference on Food Protection. Washington, D.C., United States Government Printing Office United States Department of Health, Education and Welfare 1975- Food-borne disease annual summaries, i974, 1975, 1976, 1977, 1978. Atlanta, 1979 Georgia, Center for Disease Control Vernon, E. 1977 Food poisoning and Salmonella infection in England and Wales, 1973-75. An analysis of reports to the public health laboratory services, Publ. Health (Lond.), 1, 225-235 World Health Organization (WHO) 1976 Microb~olo~eal aspects of food hygiene, Technical Report Series, No. 598, Geneva Zottola, E. A. & WoH, I. D. 1980 Recipe Hazard Analysis RHAS ~ systematic approach to analysing potential haz- ards in a recipe for home food preparation (Unpublished)

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420 APPENDIX G List of Participants World Health Organization Dr. A. Koulikovskii, Food Hygienist, Veterinary Public Health, Division of Communicable Diseases, WHO, Geneva, Switzerland Dr. Z. Matyas, Chief, Veterinary Public Health, Division of Communicable Diseases, WHO, Geneva, Switzerland (Secretary) International Commission on Microbiological Specifications for Foods Dr. A. C. Baird-Parker, Unilever Research, Colworth Laboratory, Unilever Limited, Colworth House, Sharnbrook, Bedford MK44 ILQ, United King- dom Dr. F. L. Bryan, Chief, Foodborne Disease Training, Instructional Services Division, Bureau of Training, Centers for Disease Control, Atlanta, Georgia 30333 Dr. J. C. Olson, Jr., Consulting Food Microbiologist, 4982 Sentinel Drive 204, Bethesda, Maryland 20016 Dr. M. van Schothorst, Nestle Products Technical Assistance Co., B.P. 88, 1814 La Tour de Peilz, Switzerland Dr. J. H. Silliker, President, Silliker Laboratories, Inc., 1139 East Domin- guez, Suite 1, Carson, California 90746 Mr. B. Simonsen, Danish Meat Products Laboratory, Ministry of Agriculture, Howitzve; 13, DK-2000 Copenhagen F