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Executive Summary In September 1980 four federal agencies) requested that the National Research Council convene a panel of experts to formulate general prin- ciples for the application of microbiological criteria to food and food ingredients and to provide recommendations for a unified, coordinated appproach to the subject by policy-setting agencies. This report has been prepared by the Food and Nutrition Board Subcommittee on Microbio- logical Criteria in response to that request. The summary presented here follows the structure of the report: I. Introduction (Chapter 1) II. Basic Considerations A. Definitions, Purposes, and Needs for Microbiological Cri- teria (Chapter 2) B. Selection of Foods for Criteria Related to Safety (Chapter 3) C. Selection of Pathogens as Components of Microbiological Criteria (Chapter 4) D. Selection of Indicator Organisms and Agents as Components of Microbiological Criteria (Chapter 5) E. Consideration of Sampling Associated with a Criterion (Chapter 6) F. Consideration of Decision (Action) to be taken when a Cri- terion (Limit) is Exceeded (Chapter 7) The National Marine Fisheries Service (NMFS), the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the U.S. Army Natick Research and Development Center.

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2 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA G. Current Status of Microbiological Criteria and Legislative Bases (Chapter 8) III. Application of Microbiological Criteria to Foods and Food In- gredients (Chapter 9) IV. Expansion of the HACCP System in Food Protection Programs (Chapter 10) V. Plans of Action for Implementation of the HACCP System and of Microbiological Criteria for Foods and Food Ingredients (Chapter 11) Summary responses to 13 specific contract items related to certain aspects of microbiological criteria are given in Appendix A. INTRODUCTION Microorganisms are always associated with harvested plants and slaugh- tered animals, the raw materials of the food industry. Except for foods that are heat processed to the degree that they are sterilized, microorgan- isms are usually associated with food products. Some of these microor- ganisms may cause spoilage, others may cause foodborne disease, and still others may bring -about desirable changes as a result of growth in foods with which they are associated. There are two broad categories of foods, i.e., those that are shelf-stable and those that are perishable. The factors responsible for the stability of shelf-stable products must be properly controlled. With perishable foods, processing and storage conditions must be controlled to achieve maximum shelf-life consistent with product safety. Approaches to assurance of con- trol have varied. Among these have been (1) education and training, (2) inspection of facilities and operations, and (3) microbiological testing. The limitations of each are discussed in this report. The subcommittee concluded that the Hazard Analysis Critical Control Point system (HACCP), first presented at the 1971 National Conference on Food Protection, provides a more specific and critical approach to the control of microbiological hazards in foods than that provided by tradi- tional inspection and quality control approaches (see Chapters 1 and 10~. The system consists of (1) identification and assessment of hazards as- sociated with growing, harvesting, processing, marketing, preparation, and use of a given raw material or food product; (2) determination of critical control points to control any identifiable hazard; and (3) establishment of systems to monitor critical control points. Properly applied, the HACCP system separates the essential from the superfluous aspects of microbio- logical control by focusing attention on those points that directly affect

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EXECUTIVE SUMMARY - safety and quality and by monitoring to determine whether or not these points are under control. Monitoring may involve the application of microbiological testing, but more often physical and chemical tests as well as visual observations are used (see Chapter 101. The HACCP system has been successfully applied to microbiological control of low-acid canned foods, in which case it is mandated by federal law. It is likewise employed by some food processors in the control of products other than low-acid canned foods. But the use of the HACCP system by the food industry is far from universal, despite its merits. The HACCP system offers the food processor a rational approach to microbiological control. Of equal importance, the application of the HACCP system can lead to more effective and economical utilization of regulatory personnel as the inspector can focus attention on review of monitoring results. If these indicate satisfactory control over critical control points, the inspector has a high degree of assurance that the control of micro- biological hazards has been effective and can expend his efforts elsewhere. Chapter 10 presents the details of the HACCP system and the problems that must be solved if this system is to be embraced by the food industry and regulatory authorities. BASIC CONSIDERATIONS Standards, guidelines, and specifications are the terms used to identify the microbiological criteria that are discussed in this report (Chapter 21. A standard is part of a law or ordinance and is a mandatory criterion. A guideline is a criterion used to assess microbiological conditions during the processing, distribution, and marketing of foods. Guidelines are man- datory in that they signal when there are microbiological problems that require attention. A specification is used in purchase agreements between buyers and vendors of a food or ingredient. They may be mandatory or advisory. The components of a microbiological criterion are described and some of the potential contributions of criteria to food safety and quality are discussed (Chapter 21. The report emphasizes that microbiological criteria should be established and implemented only when there is a need and when the criterion can be shown to be effective and practical. It was concluded that microbiological quality standards such as those recently proposed for seafoods by FDA should be reviewed and evaluated according to the plan proposed in Chapter 11. There are a number of factors that will determine the foods for which criteria related to safety might be applied (Chapter 31. Of special impor

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4 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA lance is epidemiological evidence that the food in question is a significant vehicle of disease. Also important are various hazard considerations which include (1) susceptibility of the food to contamination by pathogens, (2) the opportunity for the survival of pathogens, (3) the likelihood of microbial growth during manufacture, storage, distribution, and preparation for serv- ing, (4) whether or not the food is to be cooked prior to serving, and (5) the susceptibility of Probable consumers to infectious agents or toxins. Microorganisms suitable as components of microbiological criteria (standards, guidelines, specifications) have been placed in two catego- r~es-pathogens and indicator organisms. Pathogens (Chapter 4) suitable for this purpose are those likely to be found in a food or ingredient that thereby becomes a potential vehicle for transmission of the organism or its toxin to consumers. Indicator organisms (Chapter 5) are those whose presence in a food indicates (1) that a pathogen or its toxin of concern may be present, (2) that faulty practices occurred that may adversely affect safety or shelf-life of the product, or (3) that the food or ingredient is unsuited for an intended use. Although the list of foodborne diseases and the microbial agents that cause them is long, only about 20 are known to be transmitted by foods with a consequence and/or frequency serious enough to cause concern. The discussion of each of these organisms2 includes its relative importance, the status of the methodist available for its detection and/or enumeration, and conclusions on the suitability of each to be a component of a micro- biological criterion; with respect to the latter, specific recommendations have been made. Indicator organisms and agents were evaluated relative to their use for the assessment of (1) numbers of microorganisms and/or microbial activ- ity,3 (2) potential human or fecal contamination or potential presence of ~- ~ ~ ~ ~ 2For emphasis the pathogens have been grouped in three categories according to the severity of the hazard they present: Severe hazards: Clostridium botulinum, Shigella, Vibrio cholerae, Salmonella typhi, Sal- monella paratyphi A, Salmonella paratyphi B. Salmonella paratyphi C, Salmonella sendai, Sal- monella cholerae-suis, Brucella abortus, Brucella melitensis, Brucella suds, Mycobacterium bovis, hepatitis A virus, fish and shellfish toxins, and certain mycotoxins. Moderate hazards, potentially extensive spread: Salmonella (species other than those given above), pathogenic Escherichia colt, and Streptococcus pyogenes. Moderate hazards, limited spread: Staphylococcus aureus, Clostridium perfringens, Bacillus cereus, Vibrio parahaemolyticus, Coxiella burnetii, Yersinia enterocolitica, Campylobacterfetus subsp. jejuni, Trichinella spiralis, and histamine. 3Aerobic plate count, thermoduric, psychrotrophic, thermophilic, proteolytic and lipolytic counts, the direct microscopic count, Howard mold count, rot fragment count, "machinery

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EXECUTIVE SUMMARY s pathogens,4 and (3) post-heat processing contamination.5 Each of these organisms, in addition to agents, 3 6 was discussed relative to its impor- tance, its status and limitation of method of detection or enumeration, and its suitability as a part of a microbiological criterion. It is recognized that the sampling plan and decision criteria are essential components of a microbiological criterion (Chapter 6~. They should be based on sound statistical concepts. The International Commission on Microbiological Specifications for Foods (ICMSF) concept of relating the stringency of the sampling plan to the degree of hazard of the food was endorsed by the subcommittee as an effective means in the selection process. Whenever applicable, attributes sampling plans such as the-ICMSF 2- and 3-class plans are recommended for microbiological criteria of foods and food ingredients in the United States. The action taken when the limit of a criterion is exceeded relates to the purpose for which the criterion was established (Chapter 71. Actions that may be taken under the following circumstances are discussed: (1) evidence of existence of a direct health hazard, (2) evidence that a direct health hazard could develop, (3) indications that a product was not produced under conditions assuring safety, (4) indications that a raw material may adversely affect shelf-life, and (5) evidence that a critical control point is not under control. Microbiological criteria are applied at the international, federal, and state or local levels (Chapter 81. The programs of the Joint FAD/WHO Codex Alimentarius Commission, the European Economic Community (EEC) and the ICMSF are described. The Canadian food standards also are discussed. The role and activities of the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the U.S. Army Natick Re- search and Development Center of the Department of Defense, and the National Marine Fisheries Service (NMFS) of the Department of Com- merce relative to microbiological criteria for foods are outlined. mold," yeast and mold count, heat-resistant molds, and thermophilic spore count. Examination for metabolic products such as by organoleptic examination, dye or indicator reduction time, pH, trimethylamine, total volatile nitrogen, indole, ethanol, diacetyl, histamine, endotoxins (Limulus amoebocyte lysate test), extract release volume, and adenosine triphosphate. 4Staphylococci, Escherichia colt, fecal coliforms, enterococci, and Pseudomonas aeruginosa. sColiform bacteria and Enterobacteriaceae. 6Thermonuclease and the use of U.V. light are discussed in a section on metabolic products of pathogens that indicate a potential health hazard. Included also is the application of the phosphatase test for milk and milk products.

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6 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA APPLICATION OF MICROBIOLOGICAL CRITERIA TO FOODS AND FOOD INGREDIENTS Detailed information on the application of microbiological criteria to 22 groups of foods and food ingredients is given in Chapter 9. Dairy Products Microbiological criteria play an important role as part of overall quality assurance programs applied by both industry and regulatory authorities. Microbiological safety of dairy products can be assured only through (1) pasteurization or more severe heat treatments, (2) prevention of post- heat treatment contamination and, for certain products, (3) end-product testing for appropriate pathogens or toxins. Microbiological criteria for most dairy products are included as an integral part of documents that present in detail the FDA and USDA dairy products control programs. The subcommittee concluded that, with few exceptions, there appears to be no need for imposing more severe or additional criteria. The Salmonella testing of dried milk as provided for in the USDA Salmonella Surveillance Program is a case in point. This Program has been reviewed in this report, and deilclencles primarily in sampling plans (which directly affect the severity of criteria imposed) have been pointed out. Recommendations for correction of these deficiencies as well as strengthening of the program have been made. Cheese is the other product for which greater attention to finished- product testing for a pathogen or its toxin is indicated. Of primary concern is S. aureus, especially its enterotoxins. The hazard is limited primarily to hard varieties, e.g., Cheddar and similar types and Swiss or Emmen- thaler. This hazard has been discussed and suggestions have been made for more rigorous application of microbiological criteria in programs to control this hazard. The continuous problem of the hazard of consuming raw milk and fresh cheese made from raw milk have been given particular attention. Outbreaks of milkborne disease caused by drinking raw milk purchased legally con- tinue to occur in the United States with regularity. Brucellosis due to consumption of fresh cheese made from raw milk and enterocolitis caused by certain pathogenic strains of E. cold are of recent occurrence. A strong position has been taken pointing out that health professionals have a responsibility to encourage efforts to see that the public and policymakers are kept adequately informed so that public policy on raw milk and dairy products made from raw milk is compatible with scientific knowledge and protection of the public's health.

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EXECUTIVE SUMMARY 7 Raw Meats and Poultry The causes and contributing factors of foodborne illness from meats and poultry have been thoroughly examined. The subcommittee could not establish a need for microbiological standards for pathogens in raw meat and poultry. Efforts to reduce foodborne illness caused by cooked meat and poultry should be directed to improved education, e.g., recognition of the potential presence of pathogens in raw animal foods and proper handling of raw and processed animal foods. In view of this need, renewed efforts to educate all persons that handle raw and processed animal foods of potential risks and proper food-handling practices are of the highest priority. Factors relating to achieving optimum shelf-life of raw meat and poultry are discussed. These include processing and storage conditions. The ap- plication of microbiological guidelines to monitor these operations is in- dicated. Present inspection practices of food-processing facilities by regulatory agencies need a more cost-effective approach by application of the HACCP system. Because the vast majority of foodborne disease is the direct result of mishandling of foods in food service operations and homes, the extent of regulatory inspection of food service operations is disproportionate compared with that of food-processing facilities. Therefore, emphasis of inspection should be directed more to those areas where mishandling of animal foods occurs more frequently, namely food service operations. Fish, Molluscs, and Crustaceans Measures to promote the safety and shelf-life of fish and shellfish are treated in this report. Although strict adherence to the recommendations of the National Shellfish Sanitation Program (NSSP) generally has resulted in the production of safe shellfish, there is need for more effective measures for monitoring the safety of these products, particularly with reference to the presence of viruses that may cause illness in humans. Intoxication (ciguatera and scombroid and paralytic shellfish poisoning EPSPl) resulting from consumption of fish and shellfish is a major concern. The regulatory limits for histamine in tuna and PSP toxin in raw shellfish are recognized as useful in the control of these foodborne diseases. Relative to ciguatera there is a need for a simple reliable test to detect toxic fish. The quality of raw fish can best be assured through application of the HACCP approach by sensory inspection of raw materials, proper tem- perature control, sanitation of equipment, and proper handling of product by employees.

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8 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA There are conflicting reports about the botulism hazard of raw fish stored under refrigeration in vacuum packages or in modified atmospheres. Thus, this packaging-storage method is not recommended for raw fish at the present time-there is need for research to examine the safety of this practice. Except for the NSSP criteria for shellfish, many of the microbiological criteria for fish and seafoods at the state or local level are not based on sound data or experience and are impractical from the standpoint of com- pliance or enforcement. These criteria need to be reexamined relative to the plans of action proposed in this report. It is recommended that the recently proposed FDA criteria for frozen crab cakes, frozen fish cakes, frozen fish sticks, and raw breaded shrimp be reviewed and evaluated according to the plan proposed in Chapter 11. Processed Animal Products Though such products as ground meat, poultry parts, and fish fillets are classified as processed, the safety and spoilage problems involved are the same as discussed above relative to raw animal products. In the present context, processed animal products are foods that are produced through the application of various physical and/or chemical treatments to raw animal products. Such treatments as pasteurization, curing, salting, and acidulation (including fermentation) tend to destroy or otherwise control the development of the microorganisms that normally spoil the raw products. Likewise, to a greater or lesser extent, these treatments destroy or prevent the growth of foodborne disease agents. These products vary considerably in their stability. Country cured hams and dry sausages may be stored for long periods at ambient temperatures without spoilage, whereas luncheon meats, cooked poultry, and smoked fish are highly perishable. Similarly, some of these products, if contam- inated and subject to temperature abuse, readily support the growth of toxigenic organisms. Ham, for example, has historically been the most important cause of staphylococcal foodborne illness. Others such as dried meats, poultry, and fish will not support the growth of pathogens but may create hazards if abused after reconstitution with water. The application of the HACCP system to the control of the safety and quality of these products is discussed. In many cases microbiological criteria play a role and where they apply they have been identified; but more often, physical and chemical measurements are the most effective means of monitoring critical control points. Three products in this category have in recent years caused multiple outbreaks of foodborne illness, namely smoked fish (botulism), dry sau

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- EXECUTIVE SUMMARY sage (staphylococcal intoxication), and cooked roast beef (salmonellosis). Effective control measures are discussed. 9 Eggs and Egg Products The regulation of eggs and egg products by the USDA in accordance with the Egg Products Inspection Act of 1970 is probably largely respon- sible for the dramatic decrease in egg-associated salmonellosis in recent years. Microbiological criteria play no role in the control of shell egg quality. Defective shell eggs are essentially eliminated from commerce by sorting and candling. Microbiological guidelines are useful in the monitoring of critical con- trol points in the production of egg products, e.g., equipment sanitation and environmental monitoring. The pasteurizing step is more effectively monitored by observing time/temperature relationships. A microbiological standard is applied to finished egg products and is enforced by the USDA. Deficiencies in the sampling plans embodied in this criterion are discussed and appropriate changes are recommended. Fruits and Vegetables Raw fruits and vegetables as marketed may harbor large populations of viable microorganisms, but they have not presented a serious public health problem in the United States and consequently the application of micro- biological criteria to these foods is not recommended. In the processing of fruits and vegetables for canning, drying, and freezing, there are opportunities for microbial buildup on equipment and growth in the food. Guidelines that limit counts of microorganisms or utilize microscopic counts for molds are recommended as a means of monitoring critical control points and promoting good processing condi- tions. Fruit Beverages Because of their high acidity, fruit juice beverages have rarely been vehicles for foodborne pathogens. Guidelines that limit numbers of viable organisms or levels of metabolic products can be useful to monitor critical control points in the processing line. Specifications that restrict spore counts of heat-resistant molds are recommended as a means to minimize spoilage outbreaks of pasteurized fruit beverages.

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10 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA Canned Foods The production of low-acid, acid, and water activity-controlled canned foods is regulated by the FDA. Regulations governing this program are contained in the Code of Federal Regulations. These regulations embody the HACCP approach to the control of safety and quality. Canned products were the first foods to which the application of HACCP was mandated by regulation. The success of this program should serve as a model to other segments of the food industry. Though finished-product microbiological criteria play no role in assur- ing the acceptability of finished products, guidelines are used in monitoring critical control points including equipment cleaning and sanitizing, mi- crobial buildup during operations, and the microbiological quality of chill water. Further, specifications are applied to critical raw materials to assure that the level of heat-resistant sporeformers does not exceed acceptable limits. Cereals and Cereal Products The usefulness of criteria for grains, pasta products, and pastries was considered, as were public health problems associated with these foods. The presence of mycotoxins on grains, contamination of soy and pasta products with salmonellae, and the growth of Staphylococcus aureus in certain cream-filled pastries were identified as the major problems. The use of microbiological criteria in support of HACCP programs is rec- ommended for these products. Fats and Oils Fats and oils in the presence of moisture and other essential nutrients are subject to degradation by a variety of microorganisms. Such a condition is provided by several processed foods in which fats and oils are major ingredients. Mayonnaise, salad dressings, peanut butter, margarine, and butter are of concern. For each of these products, the application of each or all of the three types of microbiological criteria is useful and in some instances essential to safety. For example, with respect to peanut butter routine testing of raw peanuts for aflatoxin and of the finished product for Salmonella is essential. The characteristics of these products that relate to either microbial growth or inhibition of growth in them are discussed, as are significant sources of contamination with either spoilage organisms or pathogens. Applica- tions of microbiological guidelines for monitoring critical control points

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EXECUTIVE SUMMARY 11 of manufacture are described. The need for routine testing of peanut butter for Salmonella has been emphasized. The subcommittee recommends amending the standards of identity for mayonnaise and salad dressings to include a specific requirement for a pH of 4.1 or below in the aqueous phase of these products. Sugar, Cocoa, Chocolate, and Confectioneries The major microbiological concerns for these foods are the presence of bacterial spores and yeasts in sugar and of salmonellae in cocoa and chocolate. Specifications that limit thermophilic spores in sugar for can- ning; yeasts, molds, and mesophilic bacteria in sugar for bottled beverages; and osmophilic yeasts for confectionery products are appropriate. The ingredients of confectionery and similar ready-to-eat foods should be free of enteric pathogens, in particular salmonellae. Spices Microbiological concerns are governed by end use. Spices to be used as table condiments should be free of salmonellae. Spices containing high numbers of sporeforming bacteria may cause spoilage during the heat processing of certain luncheon meats; those containing thermophilic spore- formers may cause spoilage of canned foods. In these instances, spices as ingredients constitute a critical control point and are generally monitored via specifications. Ethylene oxide and irradiation treatments are appro- priate control procedures when necessary. Yeasts Salmonellae in yeasts, especially in nutritional yeast that will be eaten without further heating, are a major concern. HACCP programs in the yeast industry must include routine testing for this pathogen. Microbio- logical guidelines are useful in the yeast industry for monitoring good manufacturing practices. Microbiological testing is also useful for the detection of contaminants that may cause spoilage of products containing yeasts, e.g., rope spores. Formulated Foods This broad category of products includes commercially prepared ready- to-cook or ready-to-eat foods containing ingredients from two or more food commodity categories. Beef and chicken potpies, the various pack

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12 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA aged meals or "dinners," meat and seafood salads, pizzas, dried infant formulae, dry soup mixes, and cake mixes are only a few examples of the host of such products that are available to the public. It has been emphasized that no useful single microbiological criterion can be devel- oped. Rather, the potential hazards of each product or group of products must be identified. Appropriate programs that embody the HACCP system including microbiological criteria (particularly guidelines as applied at critical control points in manufacture) must be individually designed if microbial growth and resulting hazard to health or of spoilage are to be prevented. Attention has been drawn to regulations of several states that specify a single criterion for all products within diverse groups such as salads. The deficiency of such criteria is presented. Nuts With the exception of coconut, the water activity of most nuts is suf- ficiently low to preclude bacterial growth. Because the growth of molds with the production of mycotoxins is a problem with peanuts and certain tree nuts, testing for these toxins should be part of a HACCP program. Nonsterile coconut should be free of salmonellae. A standard for E. cold on tree nuts has been imposed by the FDA. The presence of this organism is interpreted as an indication of the presence of filth. The subcommittee is not aware of epidemiological evidence that suggests a relationship between the presence of E. cold and enteric path- ogens in nuts. Miscellaneous Additives Gums, enzymes, and food colors are included in this category. There is little published information on their microbiology. Processors using these additives should apply various microbiological criteria, depending on end use, to assure the safety and quality of their products. Bottled Water, Processing Water, and Ice Bottled drinking water must be prepared from a safe source and must be processed, bottled, held, and transported under sanitary conditions. There is no epidemiological evidence to indicate that bottled drinking water sold in the United States offers a health hazard to the public. There- fore, there appears to be no need for additions to or modification of current standards. A periodic reassessment of practices in this rapidly expanding industry relative to the microbiological safety of bottled drinking water should be made.

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EXECUTIVE SUMMARY 13 Water and ice come in contact with or become a part of many foods during processing and storage and in food preparation. They have the potential of contributing spoilage bacteria and on occasion pathogens. The microbiological safety and quality of water and ice that come in contact with foods must be ensured. Pet Foods A major concern is that intermediate moisture and dry pet foods may harbor viable salmonellae and thus can be a vehicle for infection in the household of the pet owner. Microbiological control procedures by the processor should include (1) specifications that limit salmonellae in in- gredients, e.g., rendered products, and (2) guidelines for monitoring crit- ical control points in processing and in the plant environment. EXPANSION OF THE HACCP SYSTEM IN FOOD PROTECTION PROGRAMS Despite the successful application of HACCP in the control of the safety and quality of low-acid canned foods, this approach has not been uni- versally adopted by either industry or regulatory agencies in the control of other foods (see Chapter 101. The successful application of HACCP to low-acid canned foods can be attributed to several important factors: (1) industry and government, work- ing cooperatively, identified critical control points and developed appro- priate monitoring systems; (2) FDA required the training of key people involved in processing; (3) FDA inspectors were trained in the elements of HACCP, and plant inspections placed major emphasis upon review of monitoring results; and (4) the use of HACCP was mandated by federal regulation. If the HACCP system is to be more broadly applied in the food industry, certain requirements must be met, including: 1. Technical expertise must be employed in applying the system to each food. This involves a careful analysis of hazards, the identification of critical control points and the establishment of effective monitoring systems. 2. Those responsible for regulation must be trained in the elements of HACCP and in this approach to inspectional activity. 3. Those responsible for food processing must be trained in the HACCP approach, as was done with key personnel in low-acid canned food plants. 4. The use of the HACCP system by all segments of the food industry relative to microbiological hazards should be mandatory.

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14 EVALUATION OF THE ROLE OF MICROBlOLOGlCAL CRlTERlA Adversary attitudes and lack of cooperation between regulatory agencies and the food industry have presented a serious hindrance to the achieve- ment of common goals of food safety and quality. These problems were largely overcome with the application of HACCP to low-acid canned foods. They continue to be a problem in other segments of the food industry. A particularly sensitive issue relates to access to industry records. In- dustry recognizes that records of observations are needed for meaningful food protection, e.g., monitoring results from critical control points. But identification of which records are relevant for regulatory purposes is an issue of major disagreement. Much of the information in question may relate to manufacturing practices that may be proprietary. The regulator should have access to monitoring results at critical control points and the actions taken by the processor when limits are exceeded. The issue of access of records should be reviewed and resolved, as it is a serious impediment to expansion of the HACCP concept. Relative to HACCP, the subcommittee concluded that there should be no need for regulatory access to proprietary information having no relevance to food quality or safety. PLANS OF ACTION The subcommittee has proposed two plans of action that should be taken (Chapter 111. The first is a plan of action through which the use of the HACCP system could be applied universally in food protection programs of industry. The second is a plan for the implementation of microbiological criteria.