HACCP Principles & Application GuidelinesAdopted August 14, 1997NATIONAL ADVISORY COMMITTEE ON MICROBIOLOGICAL CRITERIA FOR FOODSThe National Advisory Committee on Microbiological Criteria for Foods (NACMCF) is an advisory committee chartered under the U.S. Department of Agriculture (USDA) and comprised of participants from the USDA (Food Safety and Inspection Service), Department of Health and Human Services (U.S. Food and Drug Administration and the Centers for Disease Control and Prevention) the Department of Commerce (National Marine Fisheries Service), the Department of Defense (Office of the Army Surgeon General), academia, industry and state employees.
NACMCF provides guidance and recommendations to the Secretary of Agriculture and the Secretary of Health and Human Services regarding the microbiological safety of foods.TABLE OF CONTENTS. StepPotential Hazard(s)JustificationHazard to be addressed in plan?Y/NControlMeasure(s)5. CookingEnteric pathogens:e.g., Salmonella,verotoxigenic- E. Colienteric pathogens have been associated with outbreaks of foodborne illness from undercooked ground beefYCookingThe hazard analysis summary could be presented in several different ways.
One format is a table such as the one given above. Another could be a narrative summary of the HACCP team's hazard analysis considerations and a summary table listing only the hazards and associated control measures.Determine critical control points (CCPs) (Principle 2)A critical control point is defined as a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. The potential hazards that are reasonably likely to cause illness or injury in the absence of their control must be addressed in determining CCPs.Complete and accurate identification of CCPs is fundamental to controlling food safety hazards. The information developed during the hazard analysis is essential for the HACCP team in identifying which steps in the process are CCPs. One strategy to facilitate the identification of each CCP is the use of a CCP decision tree (Examples of decision trees are given in and ). Although application of the CCP decision tree can be useful in determining if a particular step is a CCP for a previously identified hazard, it is merely a tool and not a mandatory element of HACCP.
A CCP decision tree is not a substitute for expert knowledge.Critical control points are located at any step where hazards can be either prevented, eliminated, or reduced to acceptable levels. Examples of CCPs may include: thermal processing, chilling, testing ingredients for chemical residues, product formulation control, and testing product for metal contaminants. CCPs must be carefully developed and documented. In addition, they must be used only for purposes of product safety.
For example, a specified heat process, at a given time and temperature designed to destroy a specific microbiological pathogen, could be a CCP. Likewise, refrigeration of a precooked food to prevent hazardous microorganisms from multiplying, or the adjustment of a food to a pH necessary to prevent toxin formation could also be CCPs. Different facilities preparing similar food items can differ in the hazards identified and the steps which are CCPs. This can be due to differences in each facility's layout, equipment, selection of ingredients, processes employed, etc.Establish critical limits (Principle 3)A critical limit is a maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard. A critical limit is used to distinguish between safe and unsafe operating conditions at a CCP. Critical limits should not be confused with operational limits which are established for reasons other than food safety.Each CCP will have one or more control measures to assure that the identified hazards are prevented, eliminated or reduced to acceptable levels. Each control measure has one or more associated critical limits.
Critical limits may be based upon factors such as: temperature, time, physical dimensions, humidity, moisture level, water activity (a w), pH, titratable acidity, salt concentration, available chlorine, viscosity, preservatives, or sensory information such as aroma and visual appearance. Critical limits must be scientifically based.
For each CCP, there is at least one criterion for food safety that is to be met. An example of a criterion is a specific lethality of a cooking process such as a 5D reduction in Salmonella. The critical limits and criteria for food safety may be derived from sources such as regulatory standards and guidelines, literature surveys, experimental results, and experts.An example is the cooking of beef patties.
The process should be designed to ensure the production of a safe product. The hazard analysis for cooked meat patties identified enteric pathogens (e.g., verotoxigenic E. Coli such as E. Coli O157:H7, and salmonellae) as significant biological hazards. Furthermore, cooking is the step in the process at which control can be applied to reduce the enteric pathogens to an acceptable level. To ensure that an acceptable level is consistently achieved, accurate information is needed on the probable number of the pathogens in the raw patties, their heat resistance, the factors that influence the heating of the patties, and the area of the patty which heats the slowest. Collectively, this information forms the scientific basis for the critical limits that are established.
Some of the factors that may affect the thermal destruction of enteric pathogens are listed in the following table. In this example, the HACCP team concluded that a thermal process equivalent to 155° F for 16 seconds would be necessary to assure the safety of this product. To ensure that this time and temperature are attained, the HACCP team for one facility determined that it would be necessary to establish critical limits for the oven temperature and humidity, belt speed (time in oven), patty thickness and composition (e.g., all beef, beef and other ingredients). Control of these factors enables the facility to produce a wide variety of cooked patties, all of which will be processed to a minimum internal temperature of 155° F for 16 seconds. In another facility, the HACCP team may conclude that the best approach is to use the internal patty temperature of 155° F and hold for 16 seconds as critical limits. In this second facility the internal temperature and hold time of the patties are monitored at a frequency to ensure that the critical limits are constantly met as they exit the oven.
The example given below applies to the first facility. Process StepCCPCritical Limits5. CookingYESOven temperature:° FTime; rate of heating and cooling (belt speed in ft/min): ft/minPatty thickness: in.Patty composition: e.g. All beefOven humidity: % RHEstablish monitoring procedures (Principle 4)Monitoring is a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification. Monitoring serves three main purposes.
First, monitoring is essential to food safety management in that it facilitates tracking of the operation. If monitoring indicates that there is a trend towards loss of control, then action can be taken to bring the process back into control before a deviation from a critical limit occurs. Second, monitoring is used to determine when there is loss of control and a deviation occurs at a CCP, i.e., exceeding or not meeting a critical limit.
When a deviation occurs, an appropriate corrective action must be taken. Third, it provides written documentation for use in verification.An unsafe food may result if a process is not properly controlled and a deviation occurs. Because of the potentially serious consequences of a critical limit deviation, monitoring procedures must be effective. Ideally, monitoring should be continuous, which is possible with many types of physical and chemical methods. For example, the temperature and time for the scheduled thermal process of low-acid canned foods is recorded continuously on temperature recording charts. If the temperature falls below the scheduled temperature or the time is insufficient, as recorded on the chart, the product from the retort is retained and the disposition determined as in Principle 5.
Likewise, pH measurement may be performed continually in fluids or by testing each batch before processing. There are many ways to monitor critical limits on a continuous or batch basis and record the data on charts. Continuous monitoring is always preferred when feasible. Monitoring equipment must be carefully calibrated for accuracy.Assignment of the responsibility for monitoring is an important consideration for each CCP.
Specific assignments will depend on the number of CCPs and control measures and the complexity of monitoring. Personnel who monitor CCPs are often associated with production (e.g., line supervisors, selected line workers and maintenance personnel) and, as required, quality control personnel. Those individuals must be trained in the monitoring technique for which they are responsible, fully understand the purpose and importance of monitoring, be unbiased in monitoring and reporting, and accurately report the results of monitoring. In addition, employees should be trained in procedures to follow when there is a trend towards loss of control so that adjustments can be made in a timely manner to assure that the process remains under control.
The person responsible for monitoring must also immediately report a process or product that does not meet critical limits.All records and documents associated with CCP monitoring should be dated and signed or initialed by the person doing the monitoring.When it is not possible to monitor a CCP on a continuous basis, it is necessary to establish a monitoring frequency and procedure that will be reliable enough to indicate that the CCP is under control. Statistically designed data collection or sampling systems lend themselves to this purpose.Most monitoring procedures need to be rapid because they relate to on-line, 'real-time' processes and there will not be time for lengthy analytical testing. Examples of monitoring activities include: visual observations and measurement of temperature, time, pH, and moisture level.Microbiological tests are seldom effective for monitoring due to their time-consuming nature and problems with assuring detection of contaminants. Physical and chemical measurements are often preferred because they are rapid and usually more effective for assuring control of microbiological hazards. For example, the safety of pasteurized milk is based upon measurements of time and temperature of heating rather than testing the heated milk to assure the absence of surviving pathogens.With certain foods, processes, ingredients, or imports, there may be no alternative to microbiological testing.
However, it is important to recognize that a sampling protocol that is adequate to reliably detect low levels of pathogens is seldom possible because of the large number of samples needed. This sampling limitation could result in a false sense of security by those who use an inadequate sampling protocol. In addition, there are technical limitations in many laboratory procedures for detecting and quantitating pathogens and/or their toxins.Establish corrective actions (Principle 5)The HACCP system for food safety management is designed to identify health hazards and to establish strategies to prevent, eliminate, or reduce their occurrence. However, ideal circumstances do not always prevail and deviations from established processes may occur. An important purpose of corrective actions is to prevent foods which may be hazardous from reaching consumers.
Where there is a deviation from established critical limits, corrective actions are necessary. Therefore, corrective actions should include the following elements: (a) determine and correct the cause of non-compliance; (b) determine the disposition of non-compliant product and (c) record the corrective actions that have been taken. Specific corrective actions should be developed in advance for each CCP and included in the HACCP plan. As a minimum, the HACCP plan should specify what is done when a deviation occurs, who is responsible for implementing the corrective actions, and that a record will be developed and maintained of the actions taken. Individuals who have a thorough understanding of the process, product and HACCP plan should be assigned the responsibility for oversight of corrective actions. As appropriate, experts may be consulted to review the information available and to assist in determining disposition of non-compliant product.Establish verification procedures (Principle 6)Verification is defined as those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan. The NAS (1985) pointed out that the major infusion of science in a HACCP system centers on proper identification of the hazards, critical control points, critical limits, and instituting proper verification procedures.
These processes should take place during the development and implementation of the HACCP plans and maintenance of the HACCP system. An example of a verification schedule is given in.One aspect of verification is evaluating whether the facility's HACCP system is functioning according to the HACCP plan. An effective HACCP system requires little end-product testing, since sufficient validated safeguards are built in early in the process. Therefore, rather than relying on end-product testing, firms should rely on frequent reviews of their HACCP plan, verification that the HACCP plan is being correctly followed, and review of CCP monitoring and corrective action records.Another important aspect of verification is the initial validation of the HACCP plan to determine that the plan is scientifically and technically sound, that all hazards have been identified and that if the HACCP plan is properly implemented these hazards will be effectively controlled. Information needed to validate the HACCP plan often include (1) expert advice and scientific studies and (2) in-plant observations, measurements, and evaluations. For example, validation of the cooking process for beef patties should include the scientific justification of the heating times and temperatures needed to obtain an appropriate destruction of pathogenic microorganisms (i.e., enteric pathogens) and studies to confirm that the conditions of cooking will deliver the required time and temperature to each beef patty.Subsequent validations are performed and documented by a HACCP team or an independent expert as needed. For example, validations are conducted when there is an unexplained system failure; a significant product, process or packaging change occurs; or new hazards are recognized.In addition, a periodic comprehensive verification of the HACCP system should be conducted by an unbiased, independent authority.
Such authorities can be internal or external to the food operation. This should include a technical evaluation of the hazard analysis and each element of the HACCP plan as well as on-site review of all flow diagrams and appropriate records from operation of the plan.
A comprehensive verification is independent of other verification procedures and must be performed to ensure that the HACCP plan is resulting in the control of the hazards. If the results of the comprehensive verification identifies deficiencies, the HACCP team modifies the HACCP plan as necessary.Verification activities are carried out by individuals within a company, third party experts, and regulatory agencies.
It is important that individuals doing verification have appropriate technical expertise to perform this function. The role of regulatory and industry in HACCP was further described by the NACMCF (1994).Examples of verification activities are included as.Example of a Company Established HACCP Verification Schedule. CCPHazardsCritical limit(s)MonitoringCorrective ActionsVerificationRecords.Support documentation such as validation records.Records that are generated during the operation of the plan.Examples of HACCP records are given in.The successful implementation of a HACCP plan is facilitated by commitment from top management. The next step is to establish a plan that describes the individuals responsible for developing, implementing and maintaining the HACCP system. Initially, the HACCP coordinator and team are selected and trained as necessary. The team is then responsible for developing the initial plan and coordinating its implementation. Product teams can be appointed to develop HACCP plans for specific products.
An important aspect in developing these teams is to assure that they have appropriate training. The workers who will be responsible for monitoring need to be adequately trained. Upon completion of the HACCP plan, operator procedures, forms and procedures for monitoring and corrective action are developed. Often it is a good idea to develop a timeline for the activities involved in the initial implementation of the HACCP plan. Implementation of the HACCP system involves the continual application of the monitoring, record-keeping, corrective action procedures and other activities as described in the HACCP plan.Maintaining an effective HACCP system depends largely on regularly scheduled verification activities. The HACCP plan should be updated and revised as needed.
An important aspect of maintaining the HACCP system is to assure that all individuals involved are properly trained so they understand their role and can effectively fulfill their responsibilities.National Advisory Committee on Microbiological Criteria for Foods. The principles of risk assessment for illness caused by foodborne biological agents. Adopted April 4, 1997.An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients. National Academy of Sciences, National Academy Press, Washington, DC.National Advisory Committee on Microbiological Criteria for Foods. The role of regulatory agencies and industry in HACCP. Food Microbiol. 21:187-195.Examples of Common Prerequisite ProgramsThe production of safe food products requires that the HACCP system be built upon a solid foundation of prerequisite programs.
Each segment of the food industry must provide the conditions necessary to protect food while it is under their control. This has traditionally been accomplished through the application of cGMPs.
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These conditions and practices are now considered to be prerequisite to the development and implementation of effective HACCP plans. Prerequisite programs provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome food. Common prerequisite programs may include, but are not limited to:Facilities: The establishment should be located, constructed and maintained according to sanitary design principles. There should be linear product flow and traffic control to minimize cross-contamination from raw to cooked materials.Supplier Control: Each facility should assure that its suppliers have in place effective GMP and food safety programs. These may be the subject of continuing supplier guarantee and supplier HACCP system verification.Specifications: There should be written specifications for all ingredients, products, and packaging materials.Production Equipment: All equipment should be constructed and installed according to sanitary design principles.
Preventive maintenance and calibration schedules should be established and documented.Cleaning and Sanitation: All procedures for cleaning and sanitation of the equipment and the facility should be written and followed. A master sanitation schedule should be in place.Personal Hygiene: All employees and other persons who enter the manufacturing plant should follow the requirements for personal hygiene.Training: All employees should receive documented training in personal hygiene, GMP, cleaning and sanitation procedures, personal safety, and their role in the HACCP program.Chemical Control: Documented procedures must be in place to assure the segregation and proper use of non-food chemicals in the plant. Examples of How the Stages of Hazard Analysis are used to Identify and Evaluate Hazards.Hazard Analysis StageFrozen cooked beef patties produced in a manufacturing plantProduct containing eggs prepared for foodserviceCommercial frozen pre-cooked, boned chicken for further processingStage 1 Determine potential Hazard hazards associatedIdentification with productEnteric pathogens (i.e., E.
Coli O157:H7 and Salmonella)Salmonella in finished product.Staphylococcus aureus in finished product.Stage 2 Hazard EvaluationAssess severity of health consequences if potential hazard is not properly controlled.Epidemiological evidence indicates that these pathogens cause severe health effects including death among children and elderly. Undercooked beef patties have been linked to disease from these pathogens.Salmonellosis is a food borne infection causing a moderate to severe illness that can be caused by ingestion of only a few cells of Salmonella.Certain strains of S. Aureus produce an enterotoxin which can cause a moderate foodborne illness.Determine likelihood of occurrence of potential hazard if not properly controlled.E.
Coli O157:H7 is of very low probability and salmonellae is of moderate probability in raw meat.Product is made with liquid eggs which have been associated with past outbreaks of salmonellosis. Recent problems with Salmonella serotype Enteritidis in eggs cause increased concern. Probability of Salmonella in raw eggs cannot be ruled out.If not effectively controlled, some consumers are likely to be exposed to Salmonella from this food.Product may be contaminated with S. Aureus due to human handling during boning of cooked chicken. Enterotoxin capable of causing illness will only occur as S. Aureus multiplies to about 1,000,000/g. Operating procedures during boning and subsequent freezing prevent growth of S.
Aureus, thus the potential for enterotoxin formation is very low.Using information above, determine if this potential hazard is to be addressed in the HACCP plan.The HACCP team decides that enteric pathogens are hazards for this product.Hazards must be addressed in the plan.HACCP team determines that if the potential hazard is not properly controlled, consumption of product is likely to result in an unacceptable health risk.Hazard must be addressed in the plan.The HACCP team determines that the potential for enterotoxin formation is very low. However, it is still desirable to keep the initial number of S. Aureus organisms low. Employee practices that minimize contamination, rapid carbon dioxide freezing and handling instructions have been adequate to control this potential hazard.Potential hazard does not need to be addressed in plan.
For illustrative purposes only. The potential hazards identified may not be the only hazards associated with the products listed. The responses may be different for different establishments.Example I of a CCP Decision TreeImportant considerations when using the decision tree:.The decision tree is used after the hazard analysis.The decision tree then is used at the steps where a hazard that must be addressed in the HACCP plan has been identified.A subsequent step in the process may be more effective for controlling a hazard and may be the preferred CCP.More than one step in a process may be involved in controlling a hazard.More than one hazard may be controlled by a specific control measure.