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10 Expansion of the HACCP System in Food Protection Programs This subcommittee embraces the Hazard Analyses Critical Control Point (HACCP) concept as an effective and rational approach to the assurance of safety and to the prevention or delay of spoilage in foods (see Chapter 1 and Appendix G). In the application of HACCP the use of microbio- logical criteria is at times the most effective means of monitoring critical control points. In other instances, monitoring of critical control points can best be accomplished through the use of physical and chemical tests, visual observations, and sensory evaluations. Thus, microbiological criteria may play an important role or no role at all depending upon the nature of the food or the process. The applicability of microbiological criteria to the monitoring of critical control points in the production of various food commodities is discussed in detail in Chapter 9. FACTORS TO BE CONSIDERED FOR IMPLEMENTATION OF HACCP Initially, HACCP was established by the FDA as an approach to the control of microbiological hazards in the mushroom-canning industry. After considerable refinement, the FDA applied HACCP to all low-acid canned foods; this approach to the control of microbiological hazards in low-acid canned foods was then mandated by federal regulations (FDA, 1973a,b). The application of HACCP as a means of controlling microbiological hazards in low-acid canned foods has been successful for a number of reasons: 308

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EXPANSION OF THE HACCP SYSTEM 309 1. Industry and government, working cooperatively, identified and de- veloped monitoring procedures for critical control points in the production of this class of foods. The procedures included details with respect to the frequency with which the tests should be per- formed, the keeping of records, and the actions to be taken when monitoring results indicated lack of compliance, i.e., failure at a critical control point. 2. The FDA required that operators of retorts, aseptic processing pack- aging systems, product formulating systems, and container closure inspectors be under the supervision of a person who had satisfac- torily completed the prescribed course approved by the FDA Com ~ missioner. 3. FDA inspectors were trained in the elements of the HACCP system. As a result, FDA inspectors became knowledgeable of the critical control points in the production of these products. At the time of plant inspections, major emphasis was placed upon review of mon- itoring results. 4. The use Of the HACCP .;v.stem was mandated by federal regulation. The four points below are of considerable importance if the HACCP system is to be more broadly applied in the food industry: 1. The hazard analysis of a food process requires technical sophisti- cation as does the identification of critical control points and the establishment of effective monitoring programs. Assistance from experts from disciplines other than microbiology may be required. The large, technically sophisticated processor may have personnel capable of accomplishing these tasks, whereas smaller operators are less likely to have them. The HACCP system as it has been applied to low-acid canned foods evolved as a result of joint industry/gov- ernment cooperation. For it to be applied effectively in other areas, similar cooperative efforts will be required. This need not necessarily require industry/government collaboration, but the appropriate tech- nical manpower can be mobilized within segments of the industry. This could be done through various industry trade associations. For example, the American Meat Institute (AMI, 1982) published guide- lines for the production of dry and semidry sausages. Technical expertise for the establishment of these guidelines came from within the industry, and there seems little doubt that they will be acceptable to the USDA, the organization responsible for regulating these prod- ucts. If only the technically sophisticated companies within a given segment of the food industry apply the HACCP system, then the

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310 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA value of an industry-wide application to the production of a given product or products will be lost. For this reason organized technical input by industry is essential. From the pooling of industry and government manpower, specific codes of Good Manufacturing Practices should evolve. These are needed since, as indicated in Chapter 1, "umbrella" codes are non- specific and vague to the degree that the courts have held that they do not have the force of law (U.S. v. An Article of Food, 19721. If technical manpower is not utilized to establish HACCP systems within various segments of the food industry, then the weak links within a given segment will be the technically unsophisticated com- panies. The argument many be made that use of the HACCP system would place such companies at a competitive disadvantage. On the other hand, their failure; to utilize HACCP would tend to result in greater exposure of their products to microbiological hazards. The greatest cost/benefit advantage would accrue if all producers within a given industry were applying HACCP principles in the control of their products and if regulators were judging manufacturing practices according to the HACCP principles, i.e., review of the results of monitoring critical control points. 2. Those responsible for regulation must be trained in the concepts of the HACCP system. FDA inspectors were so trained in the HACCP approach as applied to low-acid canned foods. Furthermore, they received training in application of the HACCP approach to the reg- ulation of other types of foods. However, HACCP inspections with respect to other foods were optional. In fact, there have been no formal personnel training sessions by FDA since 1975. As a result of the optional status of HACCP inspections and the failure to train personnel, the HACCP approach to regulatory control has fallen into disuse in the United States (except for its application to low-acid canned foods, where it is mandated by law). 3. The successful use of the HACCP approach to the control of low- acid canned foods was due in part to the mandatory training of various categories of food processing technicians. Courses at se- lected universities were established by the FDA for this purpose. If HACCP is expanded, it will necessitate similar training of individ- uals in other segments of the industry. This training could be un- dertaken by industry, perhaps through trade associations or other appropriate organizations within various segments of the industry. Again, technical input could come from the technically sophisticated segments within a given industry.

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EXPANSION OF THE HACCP SYSTEM 311 4. An important factor contributing to the successful application of HACCP in the low-acid canned food industry was mandatory use of this system. For HACCP use to be broadly realized, it is likely that the utilization of this system will have to be required by reg- ulation. It would thus be mandated that food processors establish monitoring programs relating to critical control points affecting the microbiological safety or quality of their products, such points hav- ing been established by hazard analysis. Quality attributes other than those relating to microbiological hazards would not be subject to such regulation. The regulation would require only a statement to identify the basic elements of the HACCP system including a pro- vision requiring that the appropriate records be readily available to representatives of regulatory agencies. Details of the mechanism of applying the HACCP system should be the prerogative of the food establishment. PROBLEMS ASSOCIATED WITH IMPLEMENTATION OF THE HACCP APPROACH It was thought that the HACCP concept, so successfully applied to low- acid canned foods, would find its place in other segments of the industry, and that companies producing a given product or group of similar products would apply the system and identify critical control points and appropriate monitoring procedures. The regulatory inspectors would initially review the plant control protocols and satisfy themselves that the critical control points in a given program had been properly identified and that appropriate monitoring systems had been established. Regulatory emphasis would next be focused on a review of monitoring results that, if satisfactory, would correctly lead the inspector to conclude that the foods of concern were being produced under adequate microbiological control. This then would prevent the inspector from duplicating control efforts and would permit him to proceed elsewhere to make evaluations, thus providing more ef- ficient use of inspectional personnel. Herein resides the cost/benefit value of the HACCP approach in regulatory control. From a regulatory standpoint, a complete familiarity with and under- standing of processes and product flows would greatly aid agency as- sessment of the effectiveness of a food firm's programs designed to assure product safety and quality. However, it is nearly impossible for any one regulatory inspector to have an intimate knowledge of every type of food- processing system. Utilization of HACCP as an integral part of the reg- ulatory process would do much to obviate need for an investigator to know

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312 EVALUATION OF THE ROLE OF MlCROBlOLOGlCAL CRlTERlA everything about the intricacies of a firm's processing systems. The net result would be cost-effective and less time-consuming and more mean- ingful to the regulatory evaluation of a firm's ability to assure safe and wholesome products. In the past, adversary attitudes and lack of cooperation between regu- latory agencies and the food industry have presented a serious hindrance to achievement of common goals of food quality and safety assurance. Regulatory agencies and the food industry have failed to recognize their responsibilities in areas of mutual concern and failed to capitalize on the special abilities and expertise which each can provide. They have failed to work in concert in an atmosphere of mutual respect, understanding, and trust to achieve these common objectives. A particularly sensitive issue in this regard relates to access to industry records. Industry 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 purpose is an issue of major disagreement between regulatory agencies and the food industry. Much of the information in question may relate to manufacturing practices that may be proprietary in nature. The regulator should have access to monitoring results on critical control points and the action taken when limits are exceeded. The issue of access to records should be reviewed and resolved so that the food industry's apprehensions are allayed and regulatory agencies have the necessary assistance for effective execution of their responsibilities. The adversary atmosphere that has historically existed is counterproductive to both the processor and the regulator and is the most serious impediment to the expansion of the HACCP concept. There should be no need for regulatory access to proprietary information having no relevance to food safety or quality. There is no fundamental reason why the broad application of HACCP throughout the food industry should not occur. The costlbenefit ratio is highly advantageous. The technical expertise necessary to establish HACCP systems in var- ious phases of the food industry must come from various experts within the involved industries. Considerations by these experts would result in identification of appropriate critical control points, monitoring systems, and acceptable (and relevant) recordkeeping systems that should be ac- cessible to regulatory authorities. Regulatory officials should have the option to assess the appropriateness of the selected critical control points, the adequacy of the monitoring system, and the actions taken when limits are exceeded. Essential to the implementation of the HACCP system is the adequate training of inspectors.

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EXPANSION OF TlIE HACCP SYSTEM THE NEED FOR APPLICATION OF HACCP AT ALL POINTS IN THE FOOD CHAIN 313 The foregoing discussion has focused upon the application of HACCP in food-processing facilities; however, the concept is applicable at all points in the food chain. A few examples follow. 1. Diseased meat animals constitute a health hazard. The critical control point identified by the USDA is at the processing plant prior to slaughter, and it is monitored by ante mortem inspection by veter inary authorities. 2. Antibiotic residues in milk constitute a health hazard to sensitized individuals in the human population. Furthermore, such residues may prevent desired acid production in milk used to manufacture cheese. This may lead to spoilage or to health hazards such as the formation of Staphylococcus enterotoxin. These hazards may be monitored by analysis of milk samples at the farm level or in the processing plant. 3. Hazardous pesticide residues in fruits and vegetables can be moni- tored at appropriate points by chemical tests. 4. Storage of improperly dried grain at the farm or elevator level may cause spoilage and/or the hazard of mycotoxin formation. Critical control points can be monitored by appropriate tests to assure proper moisture control. 5. Microbiological hazards can arise during shipment of both perishable and shelf-stable foods from the processing plant to storage ware- houses (see Chapter 91. For example, critical control points in the shipment of carcass meat include the internal temperature of the carcasses at the time of loading, the temperature of the air circulating in the transportation vehicle, the spacing of the carcasses, the air movement within the transportation vehicle, and the temperature of that air throughout the shipment. These critical control points can be monitored by physical tests, e.g., recording thermometers and visual observations. In the shipment of shelf-stable products, the cleanliness of vehicles may affect the safety and quality of goods being shipped and thus is a critical control point. This should be monitored before loading by visual inspection. Such inspection should include determination of general cleanliness, the absence of insect and rodent problems, and the soundness of the transportation vehicle. 6. Improper warehousing frequently leads to product recalls due to storage of foods under insanitary conditions. These problems can

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314 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA be circumvented by appropriate monitoring of identified critical con- trol points in the storage facility, for example, the monitoring of insect and rodent control programs. 7. At the retail level abuse of perishable foods, such as meats, poultry, and fish may lead to health and spoilage hazards. Storage temperature is a critical control point, as is the method of loading retail cases, for these may greatly influence temperature distribution. Hazards are created by cross-contamination. Cleanliness of equipment is a critical control point. At no point in the food chain is there greater need for control over microbiological hazards than in food service establishments and in homes. Even if all those responsible for food production, from the farmer to the retailer, are successful in the control of microbiological hazards, the up timate user of food products is generally responsible for foodborne diseases as a result of improper handling and storage practices. Table 10-1 dra- matically illustrates this point. It will be noted that approximately 97% of foodborne disease outbreaks reported to the Centers for Disease Control over a 5-year period were traced to mishandling in food service estab- lishments and in homes. The relationships shown in Table 10-1 are un- doubtedly skewed. Foodborne disease outbreaks are poorly reported. Isolated incidents occurring in homes are far less likely to be noted than are large outbreaks traced to food service establishments. Furthermore, the figure for the proportion of outbreaks traced to food-processing plants is un- doubtedly in error "on the high side," since such outbreaks are more likely to come to the attention of regulatory authorities. The conclusion is clear: most foodborne illness is caused by those who prepare foods in homes and food service establishments. If foods are not properly handled at these two points, foodborne illness is inevitable; thus, this nullifies to a large extent preventive measures that may have been applied earlier in TABLE 10-! Foodborne Disease Outbreaks Classified by Place of Mishandling Foods, United States, 1974 to 1978 Number ofPercent of PlaceOutbreaksKnown Places Food service establishment1,28577 Homes32720 Food processing plants523 Other/unknown/unspecified6 15 TOTAL2,279100 SOURCE: Bryan, 1982, p. 67.

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EXPANSION OF THE HACCP SYSTEM 315 the food chain, e.g., at processing plants and in distribution channels. No dramatic decrease in the incidence of foodborne disease can be expected until those who prepare and handle foods in homes and food service establishments become knowledgeable in the principles of proper food handling and apply these principles. Factors contributing to foodborne disease outbreaks are summarized in Table 10-2. The ultimate consumer of food must, in most cases, "further process" the products of the food industry, such processing being done in a kitchen of a home or a food service establishment. The factors listed in Table 10-2 include processing errors most frequently made at these points. The HACCP approach is applicable to the control of microbiological hazards in food service establishments jut as it is at previous links in the food chain. The use of the HACCP system in food service establishments has been studied extensively by Bryan (1982) (Table 10-31. The hazards, critical control points, and monitoring procedures applicable to food ser- vice establishments have been set forth in considerable detail. An extensive bibliography relating to the use of HACCP in controlling microbiological hazards in a number of specific foods prepared in food service establish- ments is also given. No attempt will be made to summarize these studies. TABLE 10-2 Factors Contributing to Outbreaks of Foodborne Disease, United States, 1961 to 1976 Factors Percentagesa Improper cooling Lapse of a day or more between preparing and serving Colonized persons touching cooked foods Inadequate thermal processing, canning, or cooking Improper hot storage Inadequate reheating Contaminated raw food Cross-contamination Improper cleaning of equipment Obtaining foods from unsafe sources Use of leftovers 46 21 20 16 16 12 7 4 NOTE: Other factors were faulty fermentations, toxic species of plants or mushrooms mistaken for edible varieties, poor dry storage practices, storing high-acid foods in toxic containers, incidental additives, and in- tentional additives (for example, MSG). aPercentages exceed 100 because foodborne diseases have multiple caus- ation: foods must become contaminated, contaminants may survive pro- cesses, and frequently bacterial pathogens multiply to reach large numbers or to produce toxins. SOURCE: Bryan, 1978.

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326 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA The salient conclusion is that the HACCP system can be used in the facilities from which most reported outbreaks of foodborne disease arise. The situation in the food service industry is analogous to that existing in the food-processing segment. Various codes of practice exist, but these contain vague terms subject to interpretation by inspectors and food service managers. As with processing codes little distinction is made between the important and unimportant, this leading to emphasis on practices of little significance and underemphasis on those with direct bearing on foodborne illnesses. A case in point is the USDHEW Food Service Sanitation Manual (FDA, 1976), which contains a model food service sanitation ordinance that has been adopted by many states and municipalities by reference. Unfortunately, those responsible for making inspections at the state and local levels often are ill-prepared to uniformly interpret the ordinance in terms of separation of the essential from the extraneous. As with food-processing operations, the application of the HACCP concept in food service operations would identify the critical control points for appropriate monitoring and thereby place emphasis on factors most responsible for foodborne illness. The application of HACCP to food service operations would necessitate input from technical personnel within the industry as well as public health authorities. It would also require training of inspectors to this new approach. At the present time one of the greatest deficiencies in food service sanitation is the lack of adequate regulatory control. At the point from which most foodborne illness prob- lems emanate there is the least degree of regulation. The use of the HACCP system would not obviate this problem, but it would greatly increase the efficiency and effectiveness of existing manpower for inspection. The elements of HACCP that are applicable to food service establish- ments also apply to food handling in the home. As laws and regulations cannot be applied to practices within the home, the alternative is education in proper food-handling practices. Unfortunately, sporadic attempts to accomplish this have not been met with much success. For example, in April 1973 the Gallup Organization reported that, among women, 74% did not know what Salmonella is; 66% did not know how to minimize its spread; and 39% thought that raw meat and poultry are inspected for the presence of Salmonella by federal and state employees (GAO, 19741. Clearly, educational efforts have not been successful in reducing the in- cidence of foodborne illness, including salmonellosis, for its incidence has remained unchanged or perhaps increased somewhat (Silliker, 1980~. One reason for lack of success of educational programs directed at adults may be the sporadic nature of educational efforts. Education and training for prevention of foodborne illness must be continuing processes. New personnel continuously enter the food-processing and food service indus

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EXPANSION OF THE HACCP SYSTEM 327 tries and new homemakers continuously undertake food preparation in the home. These facts necessitate constant repetition of good food-handling educational programs. Perhaps positive effects, though long range, could be expected from educational programs directed toward tomorrow's home- makers, schoolchildren. Over a period of time they could become knowl- edgeable and perhaps even influence their elders in proper food-handling practices. Such programs are virtually nonexistent in the United States. In Denmark no formal education is directed toward the consumer, but there is an intensive program providing students in the seventh, eighth, ninth, and tenth grades with a course consisting of two hours per week covering food handling, food preparation, and cooking (Health/Agricul- ture/Industry Committee on Salmonella, 1979~. Such an approach is wor- thy of consideration in the United States. Adequate teacher training is essential for its success. COST/BENEFIT ASPECTS OF REGULATORY CONTROL THROUGH HACCP INSPECTIONS The proper implementation of HACCP by the food industry would lead to more cost-effective and efficient regulatory control. At the present time the size of the food industry is so great as to make it physically impossible for the FDA and other regulatory agencies to inspect establishments under their control with sufficient frequency. With respect to FDA, HACCP systems would involve, primarily, review of monitoring results. If these appeared satisfactory, the inspectors would be free to place emphasis on other facilities. On-the-line inspections by USDA resident inspectors in the meat and poultry industry is labor-intensive and expensive. The Booze- Allen report on the USDA Meat and Poultry Inspection Program (Anon- ymous, 1977) recommended less on-the-line inspection. Application of the HACCP concept to meat and poultry inspection (see Chapter 9) would no doubt greatly increase the efficiency and effectiveness of this regulatory activity without compromising consumer safety. Finally, emphasis on the principles of the HACCP system for application in food service establishments and in the home should measurably improve food sanitation practices at these two points in the food chain. REFERENCES AMI (American Meat Institute) 1982 Good Manufacturing Practices I: Voluntary Guidelines for the Production of Dry Fermented Sausage. II: Voluntary Guidelines for the Production of Semi-dry Fer- mented Sausage. Washington, D.C.: American Meat Institute.

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328 EVALUATION OF THE ROLE OF MICROBIOLOGICAL CRITERIA Anonymous 1977 Study of the federal meat and poultry inspection system. Vols. 1, 2, 3. Submitted to USDA by Booze, Allen and Hamilton, June 13, 1977. Washington, D.C. Bryan, F. L. 1978 1982 Factors that contribute to outbreaks of foodborne disease. J. Food Prot. 41:816-827. Microbiological hazards of feeding systems. Pp. 64-80 in Microbiological Safety of Foods in Feeding Systems. Committee on Microbiology of Food, Advisory Board on Military Personnel Supplies, Commission on Engineering and Technical Systems, National Research Council. Washington, D.C.: National Academy Press. FDA (Food and Drug Administration) 1973a Thermally processed low-acid foods packaged in hermetically sealed containers. Part 128B (recodified as Part 113), Federal Register 38(16) 2398-2410. Jan. 24. 1973b Emergency permit control. Part 90 (recodified as Part 109), Federal Register 38(92): 12716-12721. May 14. 1976 Food Service Sanitation Manual. Model food service sanitation ordinance. Washing ton, D.C.: USDHEW/PHS/FDA. GAO (U.S. General Accounting Office) 1974 Salmonella in raw meat and poultry: An assessment of the problem. Report to Congress (B- 164031 (2)), July 22. Washington, D. C. Health/Agriculture/Industry Committee on Salmonella 1979 Report on the Scandinavian Salmonella control program in poultry with added ob- servations from Finland, Germany and Switzerland. Ottawa, Canada. Silliker, J. H. 1980 Status of Salmonella 10 years later. J. Food Prot. 43:307-313. U.S. v. An Article of Food 1972 Pasteurized whole eggs, 339 F. Supp. 131 (N.D. Gal, 1972).