Guidebook When you are certain that you have an accurate flow diagram and your team has verified it, it is time to move to the final preliminary step Decide whether products can be grouped using the process categories in 417 2(b(1) This part of the regulations lists nine process categories into which meat and poultry production can be grouped; they and some examples are (i Slaughter--all species: beef, swine, and poultry (ii) Raw product-ground: ground beef, ground pork, ground turkey (ii) Ra product--not ground: boneless cuts, steak. (iv) Thermally processed--commercially sterile: canned beef stew, Pasta with meat (v)Not heat treated--shelf stable: summer sausage, dry salami (vi) Heat treated--shelf stable: meat and poultry jerky, snack sticks (vii) Fully cooked--not shelf stable: hot dogs, wieners, roast beef, ham (viii Heat treated but not fully cooked--not shelf stable: partially cooked patties, bacon (ix) Product with secondary inhibitors--not shelf stable: corned beef, cured beef One way to cut down on the paperwork that is a part of HACCP system is to control all products in the same process category using a single HACCP plan. This is especially advantageous for very small establishments which may produce many different products. If those products differ only in characteristics that would not affect safety, e. g. the amount or kind of seasoning used(hot vS.mild), they are clearly in the same process category and may be covered by the same HACCP fSiS has developed eleven generic HACCP models for the processes listed above and two more specific processes, Mechanically Separated(Species)/Mechanically Deboned Poultry and Irradiation(including all forms of approved irradiation procedures) Now you have completed the preliminary steps that will prepare you for HACCP system development. It is time for your team to apply the seven principles of HACCP and develop yo HACCP plan. The next seven sections(principles)of this Guidebook will take you through this process
Guidebook When you are certain that you have an accurate flow diagram and your team has verified it, it is time to move to the final preliminary step. 4. Decide whether products can be grouped using the process categories in 417.2(b)(1). This part of the regulations lists nine process categories into which meat and poultry production can be grouped; they and some examples are: (i) Slaughter--all species: beef, swine, and poultry (ii) Raw product—ground: ground beef, ground pork, ground turkey (iii) Raw product--not ground: boneless cuts, steaks (iv) Thermally processed--commercially sterile: canned beef stew, Pasta with meat (v) Not heat treated--shelf stable: summer sausage, dry salami (vi) Heat treated--shelf stable: meat and poultry jerky, snack sticks (vii) Fully cooked--not shelf stable: hot dogs, wieners, roast beef, ham (viii) Heat treated but not fully cooked--not shelf stable: partially cooked patties, bacon (ix) Product with secondary inhibitors--not shelf stable: corned beef, cured beef tongue One way to cut down on the paperwork that is a part of HACCP system is to control all products in the same process category using a single HACCP plan. This is especially advantageous for very small establishments which may produce many different products. If those products differ only in characteristics that would not affect safety, e.g. the amount or kind of seasoning used (hot vs. mild), they are clearly in the same process category and may be covered by the same HACCP plan. FSIS has developed eleven generic HACCP models for the processes listed above and two more specific processes, Mechanically Separated (Species)/ Mechanically Deboned Poultry and Irradiation (including all forms of approved irradiation procedures). Now you have completed the preliminary steps that will prepare you for HACCP system development. It is time for your team to apply the seven principles of HACCP and develop your HACCP plan. The next seven sections (principles) of this Guidebook will take you through this process. 7
Guidebook PRINCIPLE I: CONDUCT A HAZARD ANALYSIS The first principle of HACCP is to conduct a hazard analysis. Part 417 contains definitions as well as specific provisions which affect how your HACCP team must go about conducting its hazard analysis. Before beginning the process, your team should review the definitions of food safety hazard and preventive measure and look specifically at the requirements of 417 2(a) A. Conducting a hazard analysis is generally considered to be a two-step process. The first step is to identify the threats to human health, which might be introduced into meat and poultry products as those products are produced. These hazards are usually grouped into three categories: Biological (including microbiological), Chemical, and Physical 1. Biological hazards Biological hazards are living organisms that can make food unsafe to eat. Biological hazards may be bacterial, parasitical, or viral. Biological hazards are frequently associated with the raw materials from which meat and poultry products are made, including the animals and birds, which are primary components. However, biological hazards may be introduced during the processing of meat and poultry products: from the people who are involved in the processing from the environment in which the foods are processed; from other ingredients in the products or from the processes themselves Identifying the biological hazards to which your production processes might be subjected is clearly a difficult and important task--one that requires all the expertise that your HACCP team can bring to it. Currently, there is a great deal of emphasis on microbial hazards associated with meat and poultry products. Some of the major pathogens that may be associated with meat and poultry products are: Salmonella, Campylobacter jejuni, Escherichia coli 0157 H7, Listeria monocytogenes, Clostridium botulinum, Staphylococcus aureus, and Yersinia enterocolitica For details, refer to NACMCF document reference 14 listed in Appendix B 2. Chemical hazards Chemical hazards may be the result of something naturally occurring in foods or added during the processing of foods. Harmful chemicals have been associated with both acute cases of foodborne illness and chronic illness Naturally occurring chemical hazards are those that are natural constituents of foods and not the result of environmental, industrial, or other contamination. They include aflatoxins, mycotoxins and shellfish toxins Added chemical hazards are those which are intentionally or sometimes unintentionally added to food during the growing, harvesting, storage, processing, packaging, or distribution phases of production. This group of chemical hazards is very broad and might include components of animal feed or drinking water, animal drugs, pesticides, food ingredients themselves, or chemicals used in the processing establishment such as lubricants, cleaners, paints, and coatings
Guidebook PRINCIPLE I: CONDUCT A HAZARD ANALYSIS The first principle of HACCP is to conduct a hazard analysis. Part 417 contains definitions as well as specific provisions which affect how your HACCP team must go about conducting its hazard analysis. Before beginning the process, your team should review the definitions of food safety hazard and preventive measure, and look specifically at the requirements of 417.2(a). A. Conducting a hazard analysis is generally considered to be a two-step process. The first step is to identify the threats to human health, which might be introduced into meat and poultry products as those products are produced. These hazards are usually grouped into three categories: Biological (including microbiological), Chemical, and Physical. 1. Biological Hazards Biological hazards are living organisms that can make food unsafe to eat. Biological hazards may be bacterial, parasitical, or viral. Biological hazards are frequently associated with the raw materials from which meat and poultry products are made, including the animals and birds, which are primary components. However, biological hazards may be introduced during the processing of meat and poultry products: from the people who are involved in the processing; from the environment in which the foods are processed; from other ingredients in the products; or from the processes themselves. Identifying the biological hazards to which your production processes might be subjected is clearly a difficult and important task—one that requires all the expertise that your HACCP team can bring to it. Currently, there is a great deal of emphasis on microbial hazards associated with meat and poultry products. Some of the major pathogens that may be associated with meat and poultry products are: Salmonella, Campylobacter jejuni, Escherichia coli 0157:H7, Listeria monocytogenes, Clostridium botulinum, Staphylococcus aureus, and Yersinia enterocolitica. For details, refer to NACMCF document reference 14 listed in Appendix B. 2. Chemical Hazards Chemical hazards may be the result of something naturally occurring in foods or added during the processing of foods. Harmful chemicals have been associated with both acute cases of foodborne illness and chronic illness. Naturally occurring chemical hazards are those that are natural constituents of foods and not the result of environmental, industrial, or other contamination. They include aflatoxins, mycotoxins and shellfish toxins. Added chemical hazards are those which are intentionally or sometimes unintentionally added to food during the growing, harvesting, storage, processing, packaging, or distribution phases of production. This group of chemical hazards is very broad and might include components of animal feed or drinking water, animal drugs, pesticides, food ingredients themselves, or chemicals used in the processing establishment such as lubricants, cleaners, paints, and coatings. 8
Guidebook 3. Physical Hazards a physical hazard is a physical component of a food that is unexpected and may cause illness injury to the person consuming the food. Foreign materials such as glass, metal, or plastic are piece of equipment has not been properly controlled while the food was being proaulceo or a familiar physical hazards in meat and poultry products, usually found because a process There are a number of situations that can contribute to physical hazards in foods; they include - Contaminated raw materials --Poorly designed or poorly maintained facilities and equipment --Contaminated packaging materials; and Inattention to details by employees with key responsibilities B. This first step in identifying hazards which might be associated with your production process might be considered like a "brainstorming "session. Your hACCP team should use the flow diagram and product description, which you created in your preliminary steps, and systematically think about what could occur at each step in the process. Attachment 4 is a checklist of questions which might help your team to be as thorough as possible in considering the hazards which might be associated with your process C. The second step in performing a hazard analysis is to identify preventive measures that could be used to control each hazard. Preventive measures are the physical, chemical, or other means that can be used to control a food safety hazard. Attachment 5 is a form which you can use to go through your process systematically, identify the hazards which might occur at each step in the process and the preventive measures which might be used to prevent eliminate, or reduce each hazard to an acceptable level which you can use in conjunction with the checklist. More than one preventive measure may be needed to control a food safety hazard and more than one food safety hazard may be controlled by a specific preventiv measure D. Attachment 6 is a hazard analysis, which has been completed for a simple raw, ground process. When developing your hazard analysis, be sure to remember that supporting documentation for the decisions reached by the team is very important and a regulatory requirement [ 417 5(a)(1)). The supporting documentation can consist of the regulatory citation if the critical limit is based on a regulation, a scientific paper, study, or in-plant study. Historical information about the process can also be used. This information should be determinations about whether a hazard is reasonably likely to occur, it is helpful to list the o summarized as part of the supporting documentation for the team's decisions. When maki actual hazard or organism of concern. For example, metal contamination from equipment, Salmonella, Escherichia coli 0157: H7, Campylobacter jejuni, Listeria monocytogenes or other specific pathogenic hazards, or a specific residue that is known to occur in a like product. You will find this information very helpful when yearly reassessment, a deviation, or an unforeseen hazard occurs
Guidebook 3. Physical Hazards A physical hazard is a physical component of a food that is unexpected and may cause illness or injury to the person consuming the food. Foreign materials such as glass, metal, or plastic are familiar physical hazards in meat and poultry products, usually found because a process or a piece of equipment has not been properly controlled while the food was being produced. There are a number of situations that can contribute to physical hazards in foods; they include: --Contaminated raw materials; --Poorly designed or poorly maintained facilities and equipment; --Contaminated packaging materials; and, --Inattention to details by employees with key responsibilities. B. This first step in identifying hazards which might be associated with your production process might be considered like a “brainstorming” session. Your HACCP team should use the flow diagram and product description, which you created in your preliminary steps, and systematically think about what could occur at each step in the process. Attachment 4 is a checklist of questions which might help your team to be as thorough as possible in considering the hazards which might be associated with your process. C. The second step in performing a hazard analysis is to identify preventive measures that could be used to control each hazard. Preventive measures are the physical, chemical, or other means that can be used to control a food safety hazard. Attachment 5 is a form which you can use to go through your process systematically, identify the hazards which might occur at each step in the process and the preventive measures which might be used to prevent, eliminate, or reduce each hazard to an acceptable level which you can use in conjunction with the checklist. More than one preventive measure may be needed to control a food safety hazard and more than one food safety hazard may be controlled by a specific preventive measure. D. Attachment 6 is a hazard analysis, which has been completed for a simple raw, ground process. When developing your hazard analysis, be sure to remember that supporting documentation for the decisions reached by the team is very important and a regulatory requirement [§ 417.5(a)(1)]. The supporting documentation can consist of the regulatory citation if the critical limit is based on a regulation, a scientific paper, study, or in-plant study. Historical information about the process can also be used. This information should be summarized as part of the supporting documentation for the team’s decisions. When making determinations about whether a hazard is reasonably likely to occur, it is helpful to list the actual hazard or organism of concern. For example, metal contamination from equipment, Salmonella, Escherichia coli O157:H7, Campylobacter jejuni, Listeria monocytogenes or other specific pathogenic hazards, or a specific residue that is known to occur in a like product. You will find this information very helpful when yearly reassessment, a deviation, or an unforeseen hazard occurs. 9
Guidebook We cannot overemphasize how important it is to do a good job on your hazard analysis. This is often a difficult and time-consuming step and one that requires all the various technical and scientific resources you can obtain. You can refer to the nacmcf draft document-FSIS Microbiological Hazard Identification Guide for Meat and Poultry Components of products Produced by Very Small Plants", August 1999(Appendix B, Reference 14). We know that good HACCP system if you have not been careful and thorough in your hazard analysisop a doing a good job and taking your time here is worth the effort. You cannot expect to develop a PRINCIPLE II: IDENTIFY THE CRITICAL CONTROL POINTS The second HACCP principle is to identify the critical control points(CCPs)in the proces CCP is a point, step, or procedure in a food process at which control can be applied and, as result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels So far, in developing the HACCP plan, your HACCP team has identified biological, chemical and physical hazards in the raw materials and the ingredients you use as well as in the steps of your process. For each food safety hazard reasonably likely to occur, you have identified a preventive measure. Your next step is to find the point or points in the process where these preventive measures should be applied Fortunately, a great deal of work has already been done in identifying points where control can be applied in a process. Many points are commonly recognized in various food processing and production systems. Some common points where control can be applied in your process include Chilling to temperatures that minimize microbial growth --Cooking to specific temperatures for exact times in order to destroy microbial pathogens, Product formulations, such as the addition of cultures or adjustment of ph or water activity --Processing procedures such as filling and sealing cans; and, Slaughter procedures such as evisceration or antimicrobial interventions These are just a few examples of measures that may be CCPs. There are many more possibilities. Different facilities preparing the same food can differ in the number and types of CCPs they choose to use. This is to be expected The FSIS generic models, as well as other generic models, give you some ideas about what CCPs might work in the various process categories which are discussed. Your team needs to remember that these are just ideas designed to help get your team thinking creatively and carefully about your own processes and how you want to control them with your HACCP system Note: Identifying CCPs is one area in which there are differences between the regulatory requirements of Part 4 17 and the nacmcf guidance materials(reference 13). The latter include the use of a Decision Tree; the Decision Tree approach is not necessary for you to meet egulatory requirements; however, the thought process may be helpful. You must make sure that your HACCP system meets regulatory requirements
Guidebook We cannot overemphasize how important it is to do a good job on your hazard analysis. This is often a difficult and time-consuming step, and one that requires all the various technical and scientific resources you can obtain. You can refer to the NACMCF DRAFT document - “FSIS Microbiological Hazard Identification Guide for Meat and Poultry Components of Products Produced by Very Small Plants”, August 1999 (Appendix B, Reference 14)”. We know that doing a good job and taking your time here is worth the effort. You cannot expect to develop a good HACCP system if you have not been careful and thorough in your hazard analysis. PRINCIPLE II: IDENTIFY THE CRITICAL CONTROL POINTS The second HACCP principle is to identify the critical control points (CCPs) in the process. A CCP is a point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels. So far, in developing the HACCP plan, your HACCP team has identified biological, chemical, and physical hazards in the raw materials and the ingredients you use as well as in the steps of your process. For each food safety hazard reasonably likely to occur, you have identified a preventive measure. Your next step is to find the point or points in the process where these preventive measures should be applied. Fortunately, a great deal of work has already been done in identifying points where control can be applied in a process . Many points are commonly recognized in various food processing and production systems. Some common points where control can be applied in your process include: --Chilling to temperatures that minimize microbial growth; --Cooking to specific temperatures for exact times in order to destroy microbial pathogens; --Product formulations, such as the addition of cultures or adjustment of pH or water activity; --Processing procedures such as filling and sealing cans; and, --Slaughter procedures such as evisceration or antimicrobial interventions. These are just a few examples of measures that may be CCPs. There are many more possibilities. Different facilities preparing the same food can differ in the number and types of CCPs they choose to use. This is to be expected. The FSIS generic models, as well as other generic models, give you some ideas about what CCPs might work in the various process categories which are discussed. Your team needs to remember that these are just ideas designed to help get your team thinking creatively and carefully about your own processes and how you want to control them with your HACCP system. Note: Identifying CCPs is one area in which there are differences between the regulatory requirements of Part 417 and the NACMCF guidance materials (reference 13). The latter include the use of a Decision Tree; the Decision Tree approach is not necessary for you to meet regulatory requirements; however, the thought process may be helpful. You must make sure that your HACCP system meets regulatory requirements. 10
Guidebook PRINCIPLE IIE ESTABLISH CRITICAL LIMITS FOR EACH CRITICAL CONTROL POINT HACCP principle three instructs your team to establish critical limits for each preventive measure you will carry out at each CCP. This step involves establishing a criterion that must be met for each preventive measure associated with a CCP. Part 4 17 defines a critical limit as: the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard Critical limits are the boundaries of safety for preventive measures put in place at CCPs. A critical limit will usually be a reading or observation such as a temperature, a time, a product property such as water activity, or a chemical property such as available chlorine, salt concentration,or pH. Critical limits need to be exact and specific; HACCP plans should not nclude ranges as critical limits Many critical limits for identified CCPs have been established, either through regulatory requirements or through the technical and scientific literature, which are the bases of production processes. Your HACCP team will probably be familiar with many of these established critical limits such as: the minimum internal temperature to which products must be cooked the time which may elapse while product is being cooled to a specific temperature; the maximum dimensions of any metal fragments which could be found in products. These critical limits must be met if product safety is to be maintained When deciding what your critical limits should be, there are several sources to consider. First are the regulatory requirements, which apply to your processes. These must be met. For example, if you produce cooked beef products, you must have critical limits that meet the current FSIS regulatory requirements for those products. There may be other sources of critical limits such as the times and temperatures that you use in making the products you produce. These may be based on scientific and technical information from studies or food processing textbooks or they may be based on family recipes that have been passed down from one generation to the next critical limit for each preventive measure you intend to apply at your CCr to establish g om and have scientifically been shown to produce safe product. Critical limits may be drawn from specific challenge studies or from recognized experts. In any case, you need to establish a There are two types of critical limits. a critical limit can be an upper limit where a set amount o level cannot be exceeded. A critical limit can also be a lower limit where a minimum amount is required to produce the safe effect. To address the hazard in ground product of metal fragment from the grinding equipment, the upper critical limit for the preventive measure could be no sharp metal fragments more than 1/32 inch. A grinding room temperature of 50% F to help control pathogen growth is another kind of upper critical limit. An example of a lower critical limit would be the addition of an acidifier to inhibit bacterial growth
Guidebook PRINCIPLE III: ESTABLISH CRITICAL LIMITS FOR EACH CRITICAL CONTROL POINT HACCP principle three instructs your team to establish critical limits for each preventive measure you will carry out at each CCP. This step involves establishing a criterion that must be met for each preventive measure associated with a CCP. Part 417 defines a critical limit as: the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard. Critical limits are the boundaries of safety for preventive measures put in place at CCPs. A critical limit will usually be a reading or observation such as a temperature, a time, a product property such as water activity, or a chemical property such as available chlorine, salt concentration, or pH. Critical limits need to be exact and specific; HACCP plans should not include ranges as critical limits. Many critical limits for identified CCPs have been established, either through regulatory requirements or through the technical and scientific literature, which are the bases of production processes. Your HACCP team will probably be familiar with many of these established critical limits such as: the minimum internal temperature to which products must be cooked; the time which may elapse while product is being cooled to a specific temperature; the maximum dimensions of any metal fragments which could be found in products. These critical limits must be met if product safety is to be maintained. When deciding what your critical limits should be, there are several sources to consider. First are the regulatory requirements, which apply to your processes. These must be met. For example, if you produce cooked beef products, you must have critical limits that meet the current FSIS regulatory requirements for those products. There may be other sources of critical limits, such as the times and temperatures that you use in making the products you produce. These may be based on scientific and technical information from studies or food processing textbooks or they may be based on family recipes that have been passed down from one generation to the next and have scientifically been shown to produce safe product. Critical limits may be drawn from specific challenge studies or from recognized experts. In any case, you need to establish a critical limit for each preventive measure you intend to apply at your CCPs. There are two types of critical limits. A critical limit can be an upper limit where a set amount or level cannot be exceeded. A critical limit can also be a lower limit where a minimum amount is required to produce the safe effect. To address the hazard in ground product of metal fragments from the grinding equipment, the upper critical limit for the preventive measure could be no sharp metal fragments more than 1/32 inch. A grinding room temperature of 50° F to help control pathogen growth is another kind of upper critical limit. An example of a lower critical limit would be the addition of an acidifier to inhibit bacterial growth. 11