Establishment Thought Process for Hazard Analysis 9/11/2012

ESTABLISHMENT THOUGHT PROCESS FOR HAZARD ANALYSIS

Objectives
To demonstrate mastery of this module, the inspection program personnel (IPP) will: 1. Utilize the guideline Meat and Poultry Hazards and Control Guide. a. Find common hazards for a process step. b. Find common controls for a hazard at a process step. Define prerequisite program. Understand the thought process that an establishment uses to determine what hazards exist at process steps.

2. 3.

Establishment Thought Process for Hazard Analysis

The hazard analysis is the foundation of the food safety system. A thorough hazard analysis is the key to preparing an effectively designed HACCP plan. Federally inspected establishments must conduct hazard analyses for each process. During the development and design of the hazard analysis, establishments must consider all three types of hazards biological, chemical, and physical at each step they identify in the production process. Once the establishment has identified potential hazards, these hazards are evaluated to determine if each one is not reasonably likely to occur or reasonably likely to occur. If the establishment determines that the hazard is reasonably likely to occur, a preventive measure must be identified and a critical control point must be developed to address the hazard at that step or a step later in the process. If the establishment determines the hazard is not reasonably likely to occur, they must provide the basis for this decision.

Meat and Poultry Hazards and Controls Guide

FSIS developed the Meat and Poultry Hazards and Controls Guide (HCG) to help FSIS personnel evaluate all aspects of an establishments HACCP system for producing meat and poultry products. It can also be used by establishments. The HCG identifies common process steps, hazards and controls an establishment might use for different types of products. It is a very helpful reference when considering whether an establishment has addressed typical hazard and controls for a particular product and process. All products and processes are not covered in the HCG. Nor is this guideline intended to be used as anything other than a resource (i.e., it is not a requirement). The Meat and Poultry HCG does not address the slaughter processing category, and as a result, it does not list the common hazards and frequently used controls for the steps in the slaughter process.

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Workshop: Orientation to The Meat and Poultry Hazards and Controls Guide (HCG)
Use the copy of the HCG provided in your notebook to answer the following questions. 1. The HCG is divided into 4 sections. The sections are: a. __________________________________________________ b. __________________________________________________ c. __________________________________________________

d. __________________________________________________

2. How many HACCP process categories are there? _____________ 3. Is any process category missing? If so, which? _______________ 4. On what page is the a. List of general verification questions? ___________________ b. Receiving and storage of raw materials step? _____________

5. What are some common biological hazards at the Drying process step? _____________________________________________________ 6. What are frequently used controls for biological hazards at the Drying process step? _____________________________________________________________ 7. What are some common physical hazards at the Mixing/grinding/boning/fabrication process step? _____________________________________________________ 8. What are frequently used controls for physical hazards at the Mixing/grinding/boning/fabrication process step? _____________________________________________________________

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Establishment Thought Process for Hazard Analysis 9/11/2012

9. Must the establishment consider all the questions in the HCG for its process? YES NO

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Establishment Thought Process for Hazard Analysis 9/11/2012

Prerequisite Program - GMP and SOP

A prerequisite program is a procedure or set of procedures that is designed to provide basic environmental or operating conditions necessary for the production of safe, wholesome food. The programs provide a foundation for the development and implementation of an effective HACCP system. They frequently function across product lines and are often managed as facility-wide programs rather than being process or product specific. Some establishments may use prerequisite programs, such as Good Manufacturing Practices (GMP) and/or Standard Operating Procedures (SOP) to reduce the likelihood of certain hazards. GMPs are minimum sanitary and processing requirements and SOP are step-by-step directions for completing important procedures. GMPs are fairly broad and general and can be used to help guide the development of Standard Operating Procedures (SOP), which are very specific. GMPs are not designed to control specific hazards, but are intended to provide guidelines to help establishments produce safe and wholesome products. SOP, on the other hand, are very specific instructions for performing a procedure and may address a specific hazard. Sanitation SOP (SSOP) may be considered by establishments to reduce the likelihood of occurrence of some food safety hazards. For example, the SSOP may address washing and sanitizing of knife and hands between carcasses to reduce potential contamination with pathogens. An establishment may determine that a hazard is not reasonably likely to occur, using the justification that a properly designed and implemented prerequisite program is preventing the hazard from occurring. Some examples of prerequisite programs include: Process Step Receiving Live cattle Cooler Receiving Raw Beef Post-lethality exposed contact surfaces Receiving Potential hazard SRM Common Prerequisite Program Age verification by a dentition program to ensure all cattle under 30 months of age, tonsils and distal ileum removed Temperature control program Supplier purchase specifications Annual audits of suppliers Finished product verification testing Sanitize equipment with ozone

Pathogen growth E. coli O157:H7 and other Shiga toxin producing pathogens Listeria monocytogenes Foreign objects

Incoming product inspection

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Establishment Thought Process for Hazard Analysis 9/11/2012

Example: Thought Process for Poultry Slaughter Hazard Analysis

This example addresses the production of safe raw product and the thought process an establishment follows in its hazard analysis. We will take a brief look at a simplified example using poultry slaughter as our model. This flow chart shows slaughter process steps and a summary of the food safety hazards that the establishment could judge reasonably likely to occur. Keep in mind that this flowchart is a simplified training example and that processes, hazards, and established CCPs will vary among establishments. Poultry Slaughter Flow Diagram
Receiving/Holding Live Poultry

Food Safety Hazards

Receiving/ Holding Live Poultry BiologicalPathogens; Salmonella, Campylobacter ChemicalAntibiotic residues PhysicalForeign material contamination

Unloading/Hanging/ Stunning /Bleeding

Scalding/ picking/ hock cutter/ transfer/ rehang

Evisceration/ Inspection

Evisceration BiologicalPathogens; Salmonella, Campylobacter ChemicalNone PhysicalMetal contamination

Antimicrobial Rinse/ Zero Tolerance/ Final Wash

Final Wash BiologicalPathogens; Salmonella, Campylobacter ChemicalNone PhysicalNone

Chilling

Packaging/ Labeling/ Storage/ Shipping

Example: for training use only

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Establishment Thought Process for Hazard Analysis 9/11/2012

Lets take a look at specific steps in the poultry slaughter process and the food safety considerations the establishment could use in performing a thorough hazard analysis. In this example, we will look only at 3 of the steps: receiving/holding live poultry, evisceration and final wash. We are considering each of these steps from the perspective of a highly mechanized, large poultry establishment that processes thousands of carcasses daily. We will look at each step and give a short discussion of the considerations the establishment might have. This discussion is followed by questions and answers that represent an example of the establishments possible thought process. Keep in mind that for every hazard identified in the previous flow chart, the establishment must determine if the hazard is reasonably likely to occur in its operation. If a hazard is identified as likely to occur in the operation, the establishment must determine where in the process to address the hazard. It must control the hazard or reduce it to an acceptable level. That point is the critical control point (CCP). The CCP does not have to be at the location at which the hazard is identified. While the establishment has great flexibility their decisions during the hazard analysis, there are some regulatory requirements that must still be met during slaughter. These requirements include prevention of fecal contamination, the temperature of birds exiting the chiller, and some sampling requirements. Supporting documentation also must be maintained and available upon request. We will discuss these in later sections of the training. Process Step - Receiving/Holding Live Poultry Biological Hazards Birds are transported to the establishment in cages or coops and are unloaded onto a conveyor belt. The poultry will arrive live and the establishments hazard analysis must consider the potential for food safety hazards at each step. At this step, the establishment considers the potential biological, chemical and physical food safety hazards. At the receiving step, the live birds will naturally arrive with bacteria. Bacteria is present on the feathers as well as naturally occurring in the gastrointestinal tract (GI) tract. In particular, Campylobactor jejuni and Salmonella are of concern in poultry. These pathogens come into the establishment with the live bird at receiving. The presence of these pathogens is a public health risk. Establishments must demonstrate that they are able to control the occurrence of Campylobactor jejuni and Salmonella in their product. FSIS conducts sampling to verify process control. We will talk more about sampling programs and the FSIS Salmonella Performance Standards in a subsequent section of this training. Raw carcasses, by their very nature, do not have a lethality step that kills pathogens. So, the establishment must determine how they will otherwise control or reduce the hazard to an acceptable level.

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Establishment Thought Process for Hazard Analysis 9/11/2012

Establishments should consider pathogens (Campylobactor, Salmonella) as a potential biological hazard when receiving the live bird. The establishment would ask: Is this biological hazard reasonably likely to occur? NoIf no, the establishment should have strong supporting documentation to support the decision. YesIf yes, the establishment must address this hazard with a CCP. In order to deal with the risk of pathogens entering the system with the receiving poultry, most establishments address this hazard later on in the process. The establishment may use some antimicrobial treatment or other chemical in the antimicrobial in addition to keeping the carcasses at a temperature that minimizes bacterial growth. Remember, the hazard must be controlled, eliminated or reduced to an acceptable level at or after the step where the hazard is introduced. Chemical Hazards Some establishments may determine that the potential for a chemical hazard is negligible and if so may not address it at all. Other establishments consider chemical hazards as potential to occur. For example, growers may have administered antibiotics to the birds as a result of infection or disease. Proper withdrawal from time of antibiotic administration to the time of slaughter is necessary to ensure the residues dont enter the food chain at unacceptable levels. Some establishments develop purchase specification programs that outline an agreement and commitment from the grower to adhere to good commercial practices regarding antibiotic residue. Purchase specifications or letters of guarantee may specify that poultry are purchased from growers that practice best commercial practices for animal husbandry. The establishment may consider antibiotic residue as a potential chemical hazard in their process. The establishment would ask: Is this chemical hazard reasonably likely to occur? NoIf no, the establishment should have supporting documentation to support the decision. They may use the purchase specification program or avoidance program to prevent the hazard from occurring. These programs could be part of their Sanitation Standard Operating Procedures (SOP) or stand alone prerequisite programs. YesIf yes, the establishment must address this hazard with a CCP. Perhaps the establishment would receive and document the receipt of letters of guarantee as a CCP or implement their own sampling program. Physical Hazards

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Establishment Thought Process for Hazard Analysis 9/11/2012

There is also a risk that some foreign material has contaminated the poultry that is being received, thus posing a physical hazard. However, many establishments determine this risk is negligible and choose not to address it as a potential hazard. Process Step - Evisceration Biological Hazards At this step, the birds internal organs are removed in a manner to present them for inspection. Fecal contamination is common at this step, and therefore poses an increased risk and potential for biological hazards at this point. The biological hazards would be Salmonella and Campylobacter jejuni. The establishment would ask: Is this biological hazard reasonably likely to occur? NoIf the establishment judges this hazard is not likely to occur in its process it should have supporting documentation to support this decision. YesIf the establishment judges this hazard is likely to occur, it must be addressed with a CCP somewhere in the process. Establishments commonly address the pathogens somewhere later in the process. The establishment may use some antimicrobial treatment or chemical intervention as a preventive measure. Chemical Hazards The establishment may determine that the potential for chemical hazards is negligible at the evisceration step. Physical Hazards The establishment may determine that the potential for physical hazards is negligible at the evisceration step. Process Step - Final Wash This step typically occurs after the Zero Tolerance step, where all visible fecal contamination has been removed. While the visible contaminants have been addressed, the potential for pathogen growth is usually addressed here with a CCP. There may be more than one CCP at which pathogens are controlled. In that case, this step would be one of them. This is one location where the establishment will typically apply antimicrobial interventions such as treatments, sprays, washes and/or chemicals such as chlorine. Biological Hazards

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Establishment Thought Process for Hazard Analysis 9/11/2012

The establishment should consider the growth of pathogens that have survived through the prior steps of the slaughter process. Pathogen growth would be a potential biological hazard at this step in the process. The establishment would ask: Is this biological hazard reasonably likely to occur? NoIf no, the establishment should have strong supporting documentation to support the decision. YesIf yes, the establishment must address this hazard with a CCP. A common antimicrobial treatment used at this step is Trisodium Phosphate (TSP). the establishment will ensure and support that it is being used at a concentration that will control or eliminate the growth of pathogens or reduce the pathogens to an acceptable level. If there is more than one CCP, perhaps the establishment may show that this concentration in combination with other interventions at other steps will control the pathogens. The establishment could choose to use temperature to control the pathogens, such as a rapid chill system or temperature control program. Chemical Hazards The establishment may recognize that the use of antimicrobial interventions, and other treatments could lead to a potential food safety hazard. Chlorine at elevated levels has been proven to be unsafe. The establishment could decide there is some potential for chemical hazards at the final wash process step. The establishment would ask: Is this chemical hazard reasonably likely to occur? NoIf no, the establishment would have supporting documentation to support the decision. They could use a prerequisite program here or some type of Sanitation SOP. YesIf yes, the establishment must address this hazard with a measureable CCP. The establishment might use the chemical concentration (Chlorine ppm (parts per million), etc.) as the measurement to determine this hazard is under control. Physical Hazards The establishment may determine that the potential for physical hazards is negligible at the final wash step.

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Example: Thought Process for Raw Intact Hazard Analysis

This example addresses the production of safe raw intact product, and the thought process an establishment follows in its hazard analysis. We will take a brief look at a simplified example using Beef Trimmings as our model. This flow chart shows the process steps and a summary of the food safety hazards that the establishment could judge reasonably likely to occur. Keep in mind that this flowchart is a simplified training example and that processes, hazards, and established CCPs will vary among establishments. Beef Trimmings Flow Diagram
Receiving Carcasses/ Packing Material

Food Safety Hazards

Receiving Raw Meat BiologicalPathogens; Salmonella, Campylobacter, STEC including E. coli O157:H7; SRMs Chemicalnone Physicalnone Receiving Packaging Material Biologicalnone Chemicalprocess contaminants, non-food grade material Physicalnone

Cold Carcass Storage

Thawing of Frozen Meat

Fabrication of Beef Trimmings Labeling

Fabrication Biological Pathogens; Salmonella, Campylobacter, STEC including E. coliO157:H7 ChemicalNone Physicalnone

Beef trimmings

Packaging/labeling

Finished Product Cold Storage

Example: for training use only

Shipping

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Establishment Thought Process for Hazard Analysis 9/11/2012

Lets take a look at specific steps in the raw intact beef trimmings process and the food safety considerations the establishment could use in performing a thorough hazard analysis. In this example, we will look only at 3 of the steps: receiving carcasses, receiving packaging material and fabrication. We will look at these steps and give a short discussion of the considerations the establishment might have. Like the last example, the discussion is followed by questions and answers that represent an example of the establishments possible thought process. Keep in mind that for every hazard identified in the previous flow chart, the establishment must determine if the hazard is reasonably likely to occur in its operation. If a hazard is identified as likely to occur in the operation, the establishment must determine where in the process to address the hazard. It must control the hazard or reduce it to an acceptable level. That point is the critical control point (CCP). The CCP does not have to be at the location at which the hazard is identified. Process Step Receiving carcasses Biological Hazards Raw beef carcasses are typically transported to the establishment in refrigerated trucks to maintain a safe temperature of the product. Some establishments further process animals slaughtered in their own facility. At this step, the establishment considers the potential biological, chemical and physical food safety hazards. Carcasses are being received as a result of the prior slaughter process. Bacteria that may have survived slaughter interventions is present on the raw meat. In particular, Campylobacter, Salmonella and pathogenic E. coli are of great concern in raw beef. The presence of these pathogens is a public health risk. The establishment must determine how they will otherwise control or reduce the hazard to an acceptable level. Establishments that receive raw beef must consider pathogenic E. coli somewhere in their Hazard Analysis. They should also consider pathogens - Campylobactor and Salmonella as potential biological hazards present on the raw meat. The establishment would ask: Is this biological hazard reasonably likely to occur? NoIf no, the establishment should have strong supporting documentation to support the decision. This documentation should include some form of robust product sampling, conducted either by the supplier of the raw meat, or the receiving establishment. Documentation could also include letters of guarantee or certificates ensuring the receiving establishment that the raw meat was properly treated with a validated antimicrobial intervention or process.

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Establishment Thought Process for Hazard Analysis 9/11/2012

YesIf yes, the establishment must address this hazard with a CCP. In order to deal with the risk of pathogens entering the system with the raw meat, the establishment may use some antimicrobial treatment in the product in addition to keeping the product at a temperature that minimizes bacterial growth. Remember, the hazard must be controlled, eliminated or reduced to an acceptable level at or after the step where the hazard is introduced. Additionally, according to 9 CFR 310.22, establishments that process the carcasses or parts of cattle must develop, implement and maintain written procedures for the removal, segregation and disposition of specified risk materials (SRM). So would consider SRM in the hazard analysis. The establishment would ask: Is this biological hazard reasonably likely to occur? NoIf no, the establishment should have supporting documentation. This documentation could be in the form of records from the supplier ensuring that the meat came only from cattle younger than 30 months of age and that SRMs have been removed from all cattle. The supplier could also have a dentition program where the cattles teeth are checked to determine age at time of slaughter. YesIf yes, the establishment must address this hazard with a CCP.

Chemical Hazards The establishment may determine that the potential for chemical hazards is negligible at this step. Physical Hazards The establishment may determine that the potential for physical hazards is negligible at this step. Process Step Receiving Packaging Material The establishment is receiving packaging material in order to protect and preserve the product during handling, transport, shipping and/or distribution. Biological Hazards The establishment may determine that the potential for biological hazards is negligible at this step.

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Establishment Thought Process for Hazard Analysis 9/11/2012

Chemical Hazards The establishment may determine that the potential for chemical hazards is present at this step. If packaging materials contain chemicals that are not acceptable for contact with food, or safe in processing environments, these items could result in a food safety hazard. The establishment would ask: Is this chemical hazard reasonably likely to occur? NoIf no, the establishment should have supporting documentation. They could have documentation from the packaging supplier ensuring that only food grade and/or FDA approved materials are being delivered. YesIf yes, the establishment must address this hazard with a CCP.

Physical Hazards The establishment may determine that the potential for physical hazards is negligible at this step. Process Step - Fabrication Carcasses are cut into smaller pieces at this step, which results in the beef trimmings. Biological pathogens which entered with the raw meat could grow or be crosscontaminated at this step. Biological Hazards The establishment should consider the growth of pathogens that have survived through the prior steps. Pathogen growth would be a potential biological hazard at this step in the process. Is this biological hazard reasonably likely to occur? NoIf no, the establishment should have supporting documentation to support the decision. They could implement a temperature control and sanitation program. Documentation of the program itself and records generated as a result of program implementation would be maintained. YesIf yes, the establishment must address this hazard with a CCP Chemical Hazards

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The establishment may determine that the potential for chemical hazards is negligible at this step. Physical Hazards The establishment may determine that the potential for physical hazards is negligible at this step.

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Example: Thought Process for Raw Non-Intact Hazard Analysis

This example addresses the production of safe raw non-intact product, and the thought process an establishment follows in its hazard analysis. This brief look is at a simplified example using Ground Beef as our model. This flow chart shows the process steps and a summary of the food safety hazards that the establishment could judge reasonably likely to occur. Keep in mind that this flowchart is a simplified training example and that processes, hazards, and established CCPs will vary among establishments. Ground Beef Flow Diagram
Receiving Meat, Nonmeat ingredients, Packaging Materials

Food Safety Hazards

Receiving Raw Meat, Trimmings BiologicalPathogens; Salmonella, Campylobacter, STEC including E. coliO157:H7, SRMs Chemicalnone Physicalnone

Cold Meat Storage

Weigh non-meat and meat ingredients, grind meat meat

Weighing and Grinding Biological Pathogens; Salmonella, Campylobacter, STEC including E. coliO157:H7 ChemicalAllergens PhysicalMetal

Mix, Final Grind Labeling

Patty Formation

Example: for training use only

Freezing

Packaging, Labeling

Storage, Shipping, Distribution

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Establishment Thought Process for Hazard Analysis 9/11/2012

Lets take a look at specific steps in the raw non-intact ground beef process. Well look only at 2 of the steps: receiving raw meat and weighing and grinding. Process Step Receiving raw meat, trimmings/ Receiving Non-meat ingredients Biological Hazards Raw beef trimmings may typically be transported to the establishment in refrigerated trucks to maintain a safe temperature of the product. At this step, the establishment considers the potential biological, chemical and physical food safety hazards. Bacteria that may have survived previous interventions is present on the raw meat. In particular, Campylobacter, Salmonella and pathogenic E. coli are of great concern in raw beef. The presence of these pathogens is a public health risk. The establishment must determine how they will otherwise control or reduce the hazard to an acceptable level. Establishments that receive raw beef must consider pathogenic E. coli somewhere in their Hazard Analysis. They should also consider pathogens - Campylobactor and Salmonella as potential biological hazards present on the raw meat. The establishment would ask: Is this biological hazard reasonably likely to occur? NoIf no, the establishment should have strong supporting documentation to support the decision. This documentation should include some form of robust product sampling, conducted either by the supplier of the raw meat, or the receiving establishment. Documentation could also include letters of guarantee or certificates ensuring the receiving establishment that the raw meat was properly treated with a validated antimicrobial intervention or process. YesIf yes, the establishment must address this hazard with a CCP. In order to deal with the risk of pathogens entering the system with the raw meat, the establishment may use some antimicrobial treatment in the product in addition to keeping the product at a temperature that minimizes bacterial growth. Remember, the hazard must be controlled, eliminated or reduced to an acceptable level at or after the step where the hazard is introduced. Additionally, according to 9 CFR 310.22, establishments that process the carcasses or parts of cattle must develop, implement and maintain written procedures for the removal, segregation and disposition of specified risk materials (SRM). So would consider SRM in the hazard analysis. The establishment would ask:

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Establishment Thought Process for Hazard Analysis 9/11/2012

Is this biological hazard reasonably likely to occur? NoIf no, the establishment should have supporting documentation. This documentation could be in the form of records from the supplier ensuring that the meat came only from cattle younger than 30 months of age and that SRMs have been removed from all cattle. The supplier could also have a dentition program where the cattles teeth are checked to determine age at time of slaughter. YesIf yes, the establishment must address this hazard with a CCP.

Chemical Hazards The establishment may determine that the potential for chemical hazards is negligible at this step. Physical Hazards The establishment may determine that the potential for physical hazards is negligible at this step. Process Step Weighing and Grinding Biological Hazards Pathogens of concern could grow at this step as a result of increased temperature at grinding. The establishment would ask: Is this biological hazard reasonably likely to occur? NoIf no, the establishment should have supporting documentation to support the decision. This documentation might include some type of temperature control program to keep the product cold enough to discourage pathogen growth. YesIf yes, the establishment must address this hazard with a CCP.

Chemical Hazards The establishment may determine that there is a potential for chemical hazards as a result of allergens in the non-meat ingredients.

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Establishment Thought Process for Hazard Analysis 9/11/2012

The establishment would ask: Is this chemical hazard reasonably likely to occur? NoIf no, the establishment should have supporting documentation. They could have documentation from the supplier stating ingredients with allergens are clearly and properly identified, the establishment could have their own allergen program that addresses the control, identification and separation of of these ingredients to ensure proper labeling and prevent cross-contamination. Such programs could also be addressed in the establishments SSOPs. YesIf yes, the establishment must address this hazard with a CCP.

Physical Hazards The establishment may determine that the potential for metal contamination is a physical hazard to be addressed at this step. The establishment would ask: Is this physical hazard reasonably likely to occur? NoIf no, the establishment should have supporting documentation. They could have an equipment maintenance or metal detection program, along with records documenting its proper and consistent implementation. YesIf yes, the establishment must address this hazard with a CCP.

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Example: Thought Process for Heat Treated Not Fully Cooked Not Shelf Stable Hazard Analysis
This is a brief look is at a simplified example using Bacon as our model. This flow chart shows the process steps and a summary of the food safety hazards that the establishment could judge reasonably likely to occur. Keep in mind that this flowchart is a simplified training example and that processes, hazards, and established CCPs will vary among establishments. Bacon Flow Diagram
Receiving/storing Meat, Non-meat ingredients, Packaging Materials

Food Safety Hazards

Weighing and Mixing

Weighing and Mixing Biological none ChemicalNitrite, Nitrates Physicalnone Injection Biological none Chemicalnone, Physicalneedles

Injection

Hang on trees

Cool in cooler (cure, drain, dry)

Example: for training use only

Smoking

Cooling

Shaping, Slicing, Packaging, Labeling

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Establishment Thought Process for Hazard Analysis 9/11/2012

Lets take a look at specific steps in the raw non-intact ground beef process. Well look only at 2 of the steps: receiving raw meat and weighing and grinding. Process Step Weighing and Mixing Biological Hazards The establishment may determine that the potential for biological hazards is negligible at this step. Chemical Hazards Non-meat ingredients are combined to form a curing or pickling solution. Sugar, salt and some form of nitrate or nitrite are used to create the cure. The amounts of nitrite and nitrate allowed are restricted by FSIS regulations. Additives that have regulatory limits are known as restricted ingredients. Because nitrates are reduced to nitrites and is further converted to nitric oxide which react with amines present in muscle fibers to form nitrosamines (are known to cause cancer), the nitrite and nitrates levels must be closely monitored. The establishment would ask: Is this chemical hazard reasonably likely to occur? NoIf no, the establishment should have supporting documentation. The establishment could choose to purchase nitrite products that come in premeasured packets, to maintain greater control of the amount added to product. The establishment could have specific procedures and protocols for handling nitrite products or controlled inventory to ensure they are clearly and properly identified and separated. YesIf yes, the establishment must address this hazard with a CCP. Physical Hazards The establishment may determine that the potential for physical hazards is negligible at this step. Process Step Injection Biological Hazards The establishment may determine that the potential for biological hazards is negligible at this step.

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Establishment Thought Process for Hazard Analysis 9/11/2012

Chemical Hazards The establishment may determine that the potential for chemical hazards is negligible at this step. Physical Hazards The establishment may determine that the potential for needle contamination is a physical hazard to be addressed at this step. The establishment would ask: Is this physical hazard reasonably likely to occur? NoIf no, the establishment should have supporting documentation. They could have an equipment maintenance or metal/needle detection program, along with records documenting its proper and consistent implementation. YesIf yes, the establishment must address this hazard with a CCP.

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Example: Thought Process for Product with Secondary Inhibitors Hazard Analysis
This brief look is at a simplified example using Sliced Country Style Ham as our model. Keep in mind that this flowchart is a simplified training example and that processes, hazards, and established CCPs will vary among establishments. Country Style Ham Flow Diagram
Receiving Meat, Nonmeat ingredients, Packaging Materials

Food Safety Hazards

Receiving Raw Pork BiologicalPathogens; Salmonella, Campylobacter, STEC including E. coliO157:H7, Trichinea Chemicalnone Physicalnone

Storage of Meat and non-meat items

Weigh non-meat and meat ingredients, mixing

Cure application/ Dry Cure

chemical hazard**************

Example: for training use only

Refrigeration/ equilibration

Maturation/ Drying

Packaging, Labeling

Storage, Shipping, Distribution

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Establishment Thought Process for Hazard Analysis 9/11/2012

Lets take a look at specific steps in the raw non-intact ground beef process. Well look only at receiving. Process Step Receiving raw pork/ Receiving Non-meat ingredients Biological Hazards Pork whole muscle meat may typically be transported to the establishment in refrigerated trucks to maintain a safe temperature of the product. At this step, the establishment considers the potential biological, chemical and physical food safety hazards. Bacteria that may have survived previous interventions is present on the raw pork. In particular, Campylobacter, Salmonella, and Trichinea are of concern in raw pork. The presence of these pathogens is a public health risk. The establishment must determine how they will otherwise control or reduce the hazard to an acceptable level.

The establishment would ask: Is this biological hazard reasonably likely to occur? NoIf no, the establishment should have strong supporting documentation to support the decision. This documentation could include some form of validated processes and procedures to support an appropriate kill of these pathogens as a result of the process. Establishments rely on the combination of a complex system of factor s to ensure product safety. There would be some clear and consistent documentation of critical factors and parameters and records proving they have been consistently achieved such as, time, temperature, acidity, and cure composition. YesIf yes, the establishment must address this hazard with a CCP.

Chemical Hazards The establishment may determine that the potential for chemical hazards is negligible at this step. Physical Hazards The establishment may determine that the potential for physical hazards is negligible at this step.

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Process Step Weighing and Mixing Biological Hazards The establishment may determine there are no potential biological hazards introduced or enhanced at this step. Chemical Hazards The establishment may determine that the potential for chemical hazards is present at this step due to the handling of chemical accelerants and accidulants, which must be used in the proper amounts, in addition to the use of nitrite products at this step. The establishment would ask: Is this chemical hazard reasonably likely to occur? NoIf no, the establishment should have supporting documentation. The establishment could choose to purchase these compounds premeasured packets, to maintain greater control of the amount mixed and added to product. The establishment could have specific procedures and protocols for handling nitrite products and other chemicals or maintain controlled inventory to ensure they are clearly and properly identified and separated. YesIf yes, the establishment must address this hazard with a CCP.

Physical Hazards The establishment could determine that the potential for physical hazards is negligible at this step.

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