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Hazard analysis critical control point approach to food safety: past, present, and future.

The Past

Certain technical information and thought processes existed before the hazard analysis critical control point (HACCP) concept evolved. These came from the fields of food technology, quality control, microbial ecology, epidemiology, military science, and space exploration.

In the field of food technology and quality control, certain processing and quality control developments were being used, including the Pareto principle, process technology, microbial preservation and control measures, and statistical-control charting. The Pareto principle states that for any situation, certain problems (hazards and risks in the HACCP concept) occur more frequently than others. These are known as the vital few, and the others are known as the trivial many. Prevention and control activities should be focused on the vital few - critical control points (CCPs) in the HACCP concept. Milk technology and associated testing and control measures were already well established. They included criteria for pasteurization with monitoring of each production lot or batch by time and temperature devices; rapid corrective actions (such as that provided by a flow-diversion valve); and verification by periodic visits, equipment testing by official agency personnel, and laboratory testing. Although these criteria were not HACCP systems per se, they included many of the elements basic to the HACCP approach.

In epidemiology, surveillance activities had to develop to an extent when it was realized that there were multiple foodborne diseases and that the incidence of some of these was high enough to warrant more effective preventive activities. The databases provided information about factors that contributed to foodborne outbreaks, which in turn identified CCPs. Additionally, information about the ecology of the significant etiologic agents had to be discovered so that their sources and modes of transmission, survival in foods and the environment, destruction, and propagation were known.

ln the area of military science, a "fail-safe" concept emerged to prevent nuclear holocaust. (The HACCP concepts of monitoring and preventive corrective actions are related.)

The Soviets put a satellite, known as "Sputnik," into space. The Americans, in competition during the cold war, decided to initiate a space program to beat the Soviets to the moon. An all-out program to this end was initiated. Particular efforts were made in all phases of this program to minimize the chances of failure. This included food for the astronauts. As a result, a high priority was placed on conducting hazard analyses of ingredients and processes. Critical operations were identified and monitored. Whenever control criteria were not met, prompt correction or product segregation and rejection occurred. These activities were verified to ensure that control was effective. This was the start of the HACCP approach to food safety.

Also, at this time, there was dissatisfaction with the status quo of food sanitation/hygiene/protection/safety programs. The first National Conference on Food Protection (CFP) was created to evaluate ongoing food protection activities, to brainstorm, and to make recommendations for new and, it was hoped, more effective approaches. The HACCP concept was introduced to the public health community and much of the food industry by the Food Processing Task Force at that conference in Denver in 1971. Rather general definitions and elements of the approach were given in the proceedings (1). This conference was in part sponsored by federal food-regulating agencies, and these agencies reviewed the recommendations to determine whether they could implement them. Following some outbreaks of botulism in commercially canned foods, modification of processes in that industry, and isolation of Clostridium botulinum from mushrooms, the U.S. Food and Drug Administration (FDA) initiated a mandatory HACCP program for low-acid canned foods. The HACCP concept, some applications, and background information were presented in a symposium on the subject at the meeting of the Institute of Food Technologists in New Orleans a few years later. The papers associated with that proceeding further defined and illustrated the concept (2-5).

ln concert with and in addition to what was discussed at the CFP, there was growing frustration about traditional approaches (which focused on inspections and end-product testing) to food safety, and there was no indication of any decline in the incidence of foodborne diseases. With the inspection approach, hazards are only identified when inspections are made, which may be hours, days, or months after the initial occurrence of the hazards. Interpretations of code requirements and compliance often differ by inspector and jurisdiction, as may the operations or facilities selected to receive attention. Hence, some or perhaps many hazardous situations may be missed. The greatest limitation of the inspection approach, however, is that the hazards, or even the operations at which the hazards are likely to occur (and which can be considered CCPs) may not occur at the time of the inspection; or the foods of concern may not be processed or prepared at that time and thus may not be evaluated. Yet an item that has not been checked off as deficient on an inspection form implies satisfactory compliance in that area. Corrective actions await identification of hazards during inspections and willingness of operators to make recommended changes or to otherwise correct the condition.

End-product testing has several limitations. One of the greatest is that the number of samples collected may not be sufficient to provide a high confidence that the product under investigation is not contaminated. For example, three samples with negative results give 95 percent confidence that the lot or batch is 75 percent or less contaminated. Even 60 samples with negative results still only give 95 percent confidence that the lot or batch is five percent or less contaminated. It would take 300 negative samples to provide this level of confidence that the lot or batch is one percent or less contaminated. If defective samples are found, it is not known which phase of the process or preparation was at fault, and hazard analyses have to be conducted to determine the likely source and mode of contamination or the process failure that resulted in survival or proliferation of the contaminant. Of further concern is that tests are not available or are not routinely conducted for all possible contaminants. Often, end-product testing uses indirect tests that look for indicator organisms rather than for pathogens; often these tests have no bearing on the presence of certain pathogens. Furthermore, the sample collected may not contain the pathogen even if the product is contaminated; or too small a quantity of sample may be taken to recover the pathogen. If the sample is improperly handled, the pathogen may decline, die off, or be outgrown by other micro-organisms. The media, incubation temperature and time, confirmatory tests, or other laboratory actions may be inappropriate for detection of the pathogen under consideration. Hence, negative results may give a false sense of security. Additionally, corrective actions cannot begin until the results of the tests are received - often a few days, a week, or even longer after the samples were collected. By contrast, CCP monitoring associated with the HACCP concept allows for immediate action.

Basic principles of the HACCP concept were defined in a document prepared for the World Health Organization (WHO) by the International Commission on Microbiological Specifications for Foods (ICMSF) (6). At that time, the HACCP system had three components: hazard analysis, determination of CCPs, and monitoring. A book by ICMSF further clarified the concept and gave examples for commodities commonly in international trade (7).

The National Research Council (NRC) initiated a study on microbiological criteria for foods in the early 1980s (8). The report pointed out some limitations of sampling and testing foods, but the most significant aspect of this report was that it embraced the HACCP approach. This study was sponsored by FDA, the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA), and the Marine Fisheries of the Department of Interior. No doubt the study stimulated thinking by federal food-regulatory administrators about the value of the HACCP approach to food safety. Another recommendation of the report was to create a National Advisory Committee on Microbiological Criteria for Foods, which was implemented. Following this study, NRC also issued reports on the scientific basis of meat and poultry inspection and seafoods (9, 10). The reports also endorsed the use of the HACCP concept for these commodities.

The International Association of Milk, Food and Environmental Sanitarians Committee on Communicable Diseases Affecting Man prepared a "how-to-do-it" manual, "Procedures to Implement the Hazard Analysis Critical Control Point (HACCP) System" (11). A year later, WHO published a manual titled "Hazard Analysis Critical Control Point Evaluations," geared toward guiding hazard analyses in homes and at small food shops and street vending operations in developing countries (12). The manual was based on the experience of doing hazard analyses of food preparation and storage activities in homes in which infants had diarrhea and at street vending operations, and it provided guidance for subsequent activities in these sorts of activities (13, 14). Additionally, WHO held several expert consultations/workshops relating to the HACCP concept and HACCP training approaches (15, 16).

Over time, hazard analyses made during outbreak investigations generate data on factors that contribute to outbreaks, and the data indicate likely CCPs (2, 17-24). Guidelines in the form of decision trees and tables have been developed to aid in selection of CCPs (25-28). CCPs are usually operations that have contributed to the origin and spread of contaminants, the survival of pathogens or toxins, and propagation - and for which effective control actions can be taken.

Seven principles of the HACCP concept were specified by the National Advisory Committee on Microbiological Criteria for Foods (29). These are

1. Conduct a hazard analysis.

2. Identify the CCPs in the process.

3. Establish critical limits for preventive measures associated with each identified CCP.

4. Establish CCP monitoring requirements.

5. Establish corrective actions to be taken when monitoring indicates that there is a deviation from an established critical limit.

6. Establish effective record-keeping procedures that document the HACCP system.

7. Establish procedures for verification that the HACCP system is working correctly.

In the following years, there was an explosion of articles, seminars, videos, training courses, guidelines, manuals, software, and other information on the HACCP approach. For example, the HACCP concept has been endorsed and/or promoted by organizations such as Alberta Food and Rural Development; the American Meat Institute Foundation; the Campden Food and Drink Research Association; the Codex Alimentarius Commission; the European Economic Communities; FDA; the Food Marketing Institute: the International Association of Milk, Food and Environmental Sanitarians; the International Life Science Institute-Europe; the International Meat and Poultry HACCP Alliance; the National Advisory Committee on Microbiological Criteria for Foods; the National Food Processors Association; the National Marine Fisheries Service; NRC; the National Restaurant Association; the National Sanitation Foundation (NSF); the New York State Department of Health; USDA; WHO; and several state, provincial, and local health departments in the United States and Canada (8, 9, 14-16, 24, 29-55). This list is incomplete, but it illustrates the variety of agencies and associations that have published documents on the topic. As the HACCP concept evolved, it became very well defined. Although certain groups have reworked a few of the definitions (sometimes to the detriment of the concept), the HACCP method is probably the most clearly defined and focused of all food safety approaches.

Hazard modeling programs (e.g., for microbial hazards) have been developed by a few groups (56-58). These will be an aid in hazard analysis. Computer software for this purpose is available from USDA and the Institute of Food Research (United Kingdom).

The Present

The HACCP concept evolved to compensate for the shortcomings of traditional approaches to food protection. Some people who have been schooled in and are experienced with the traditional approaches act as if the HACCP approach is threatening; they resist it and the change necessary to its implementation. Yet they use other state-of-the-art devices, such as computers, software systems, and the internet. Despite barriers, acceptance of the HACCP concept is evolving because of its unique attributes.

The HACCP approach is continuing to gain recognition and acceptance by the food industry and food-regulatory agencies. Many of the present activities involving the HACCP approach relate to implementation of HACCP systems, verification, and validation. For example, USDA has mandated that HACCP systems be employed in all meat and poultry processing plants (51, 52). FDA has mandated HACCP systems for seafood and fresh fruits and vegetables, as well as for low-acid canned foods (59, 60). Additionally, FDA has endorsed the HACCP systems for food service establishments, and guidelines have been annexed to the Food Code (35). Many other nations have similar activities. As a consequence of these actions, trade associations and professional associations are sponsoring HACCP-oriented training courses and publishing guidelines. NSF is integrating ISO-9000 principles with HACCP and initiating a food safety (HACCP-9000) third-party auditor and registration program (47). Some HACCP applications are attempting to come in line with the HACCP guidelines that are annexed to the Codex general principles of food hygiene (61, 62).

The Codex and some other groups and agencies have advocated so-called prerequisites for HACCP systems (42, 63). These are essentially good manufacturing or preparation practices or good sanitation and hygiene practices or facilities. HACCP systems, however, should be targeted to safety and should exclude quality control processes to maintain focus on control measures that are truly critical to food safety. It would be better to describe the so-called prerequisites as adjuncts to the HACCP system; most of them are basic to good production, manufacturing, and preparation practices. Major reasons for the emergence of the HACCP concept were that emphasis on sanitary inspections and final product testing was ineffective in reducing the incidence of foodborne disease and that these traditional activities had a high cost-to-benefit ratio. If there are any prerequisites to HACCP systems, they should be (a) management understanding of and commitment to the HACCP systems and (b) training and discipline of workers who are responsible for operations and monitoring at CCPs. Assuming that all hazards are recognized and that appropriate CCPs are identified, monitoring and prompt corrective actions at CCPs enable the HACCP system to give high assurance of food safety. This is so regardless of whether all sanitary and aesthetic measures are in place. (This does not mean, however, that there are any particular objections to the guidelines in the codex general principles document.)

Presently, there are software programs, as well as manuals, that can be used to assist in the development of HACCP systems. Whatever is used to aid in the development of generic HACCP systems, the systems must be tailored to meet the unique aspects of the production, processing, and preparation operations; the equipment being employed; the foods being processed or prepared; and the personnel.

The Future

The HACCP concept has come out of its lag phase and is in a phase of rapid deployment. The future probably will record that this concept replaced traditional approaches such as inspections, health examinations, and end-product testing. To predict the future, however, is speculative. Many seemingly unrelated and sometimes unpredictable events influence outcomes, particularly of actions taken by persons or companies. Furthermore, it will take time for some of the following predictions to become reality.

The number of HACCP principles will increase from seven to 10 or more. This will be done to further clarify this dynamic approach to food safety. Three principles that will emerge or are now being incorporated into existing principles or other related guidelines are

1. summary and interpretation of each HACCP system,

2. training, and

3. validation.

The eighth HACCP principle will be summary and interpretation of HACCP systems. This principle, unfortunately, has not been stressed in previous literature on the subject, but it is crucial to understanding the effectiveness of the system and its limitations. Such a review, which ordinarily fits on a single page, briefly summarizes the system, points out any remaining hazards, and assesses the risks of occurrence. Implemented HACCP systems, such as those for raw meat and poultry processes, may only minimize or, at best, reduce contamination and prevent bacterial multiplication. Remaining hazards and the risks of occurrence need to be stressed in the summary, so that those responsible for food processing or preparation fully understand the limitations, if any, of their operations. With this information, the processor or caterer can decide whether to (a) take the risk of starting or continuing the processing, (b) modify the process to make it safer, or (c) advise customers of appropriate actions to take to decrease any remaining hazards. Also, with this information, the purchaser can be aware of (a) subsequent preparation steps that must be taken to render the product safe and (b) precautions to take to avoid spreading the contaminants. Food regulatory officials can become aware of where to focus their verification activities and inspections and what needs to be stressed in training and health education.

The ninth HACCP principle will be education and training. Successful implementation of a HACCP system requires that several groups of persons be trained and/or educated. These include

* persons who conduct and design HACCP systems;

* persons responsible for operations that are designated as CCPs;

* persons who monitor CCPs;

* persons who verify or validate HACCP systems;

* executive staff of processing and food service establishments, companies and chains;

* administrators of public health and food regulatory agencies; and

* legislators and policy makers who promulgate laws or formulate regulations related to food safety and special-interest lobbyists who influence the passage of the laws or regulations.

Suggestions for approaches for these groups are given by Bryan, Moy et al., and Mayes (39, 53, 64). Without an understanding of hazards associated with food safety, food production, food processing and preparation, rational approaches for prevention and control will not be realized. Hence, HACCP-focused training of those involved in food safety, production, processing, and preparation is essential and must be considered an integral part of the HACCP concept. Presently, training for food handlers and managers is being conducted to various degrees on general principles of food hygiene and safety. What is needed for HACCP systems, however, is training related directly to formulation and process hazards, CCPs and their monitoring, rapid corrective actions, and other aspects of the HACCP system.

Validation will be the 10th HACCP principle. It consists of an initial review of the HACCP system to determine

1. whether it has considered all actual and likely hazards,

2. that it includes all applicable CCPs,

3. that it requires monitoring to be done precisely with calibrated instruments that can evaluate the process effectively, and

4. that it requires health risks to be reduced to acceptable levels.

Further validation includes a check that the HACCP system has, indeed, been implemented. Periodic audits are necessary to evaluate

1. whether the HACCP system is maintained,

2. whether monitoring is being done effectively, and

3. whether additional hazards have been introduced as a result of modification of formulations or processes.

If such modifications have been made, the system should be evaluated to determine the need

1. to select additional CCPs,

2. to modify critical limits and corrective actions, and

3. to revise monitoring and verification procedures.

Validation includes

1. reviewing specified hazards and CCPs;

2. reviewing process flow diagrams that indicated hazards and CCPs;

3. reviewing the detailed HACCP system and plan; and

4. observing on-site operations, measuring time-temperature exposures and characteristics of foods, and testing foods.

Presently, validation is incorporated into the verification principle, but the uniqueness of each activity is muddied and will need to be clarified by separation. Validation ought to be conducted by official agency personnel or third-party teams, not by establishment or corporate personnel - except to review and test their HACCP systems and plans.

Monitoring will become more technically sophisticated, even at the retail level. For temperature monitoring, for example, thermocouple probes will be inserted into foods, and information such as doneness or lack of compliance with the critical limit will be signaled and/or recorded. In some cases, the measurements will be recorded, saved, and printed out on request at the site or at corporate headquarters. The data will become part of CCP records available for verification. The technology is available and will become cheaper as demand for it increases. Each establishment or chain will have verification forms for use at various work stations by managers and quality control staff. As time goes by these forms will become automated and will be saved on computer disks for verification purposes.

HACCP systems will be verified and validated either by official agencies or by third-party auditors. This will provide confidence or certification that those producing, processing, or preparing food have designed and implemented the HACCP system to ensure that the risk of food-associated hazards is low Such approval will become an element of purchase specifications. HACCP systems that are validated by official agencies with professionally competent and HACCP-trained staff or certified as valid by accredited third parties should be granted universal acceptance until proven not to be adequate.

Surveillance of foodborne disease will intensify, and, upon detection of outbreaks at an implicated establishment, HACCP systems will be established or modified. Other entities processing or preparing the same foods or having similar operations will be alerted, and actions will be taken to ensure implementation or readjustment of HACCP systems. Summary data will include incidence of foodborne disease cases and outbreaks, prevalence of vehicles, and relative risks posed by factors that contributed to the outbreaks. These data can be used to indicate emerging hazards and CCPs. Regulatory, training, and education activities will focus on epidemiological data and be revised according to identification of contributory factors during outbreak investigations.

Conclusions

The HACCP concept is rational because it is based on historical data about causes of illness. It focuses attention on critical operations where control is essential. It is comprehensive because it relates to ingredients, processes, and subsequent use of products. It is continuous because problems are detected when they occur and corrective action is taken at that time. lt is systematic because it covers step-by-step operations. These attributes give a high degree of assurance that products processed and prepared under a properly designed and maintained HACCP system pose a low risk of foodborne illness.

HACCP is the art and science of food safety and is the leading activity for the future of this endeavor. The sooner food-regulatory officials and all involved with food production, processing, distribution, storage, marketing, and preparation learn this, the sooner foodborne diseases will disappear - and become an interesting note in history books or a reminder that a HACCP system was improperly designed, implemented, or maintained.

REFERENCES

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2. Bauman, H.E. (1974), "The HACCP Concept and Microbiological Hazard Categories," Food Technology, 28:30,32,34,78.

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63. Sperber, W.H., D.T. Bernard, K.E. Diebel, L.J. Moberg, L.R. Hontz, V.N. Scott, and K.E. Stevenson (1998), "The Role of Prerequisite Programs in Managing a HACCP System," Dairy Food Environ. Sanitat., 18:418-423.

64. Mayes, T. (1994), "HACCP Training," Food Control, 5:190-195.

Corresponding Author: Frank L. Bryan, Ph.D., M.P.H., Food Safety Consultation and Training, 8233 Pleasant Hill Rd., Lithonia, GA 30058.

(Adapted with permission from Proceedings of the First NSF International Conference on Food Safety, Albuquerque, New Mexico, November 16-18, 1998.)
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Grading Systems for Retail Food Facilities: A Risk-Based Analysis.
What we know and what we do: the gap in food safety. (Learning from Experience).
Where we are in retail food safety, how we got to where we are, and how do we get there? (Guest Commentary).
Special session added to NEHA's 2005 AEC & Exhibition: "What Health Inspectors Need to Know About Additional USDA Food Safety Requirements Effective...

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