Generic HACCP Model for Raw, Ground Meat, and Poultry Products

100

Transcript of Generic HACCP Model for Raw, Ground Meat, and Poultry Products

Page 1: Generic HACCP Model for Raw, Ground Meat, and Poultry Products
Page 2: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

i

Table of Contents

Introduction................................................................................1

Principles of HACCP

Principle No. 1....................................................................1Principle No. 2....................................................................1Principle No. 3....................................................................1Principle No. 4....................................................................1Principle No. 5....................................................................1Principle No. 6....................................................................1Principle No. 7....................................................................1

Definitions.................................................................................2Corrective action..................................................................2Criterion...........................................................................2Critical Control Point (CCP).....................................................2Critical limit.......................................................................2Deviation..........................................................................2HACCP............................................................................2HACCP Plan......................................................................2HACCP System...................................................................2Hazard Analysis...................................................................2Monitor............................................................................2Preventive measure...............................................................2Process............................................................................2

Development of the Plant Specific HACCP Plan.......................................3Description of the Product.......................................................3Process Flow Diagram...........................................................3Hazard Analysis Form...........................................................3Critical Control Point (CCP) Determination...................................4HACCP Plan.....................................................................4

Page 3: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

ii

Steps for Selecting a Generic Process Model..............................................5Process Platform for Use of Generic Models......................................5

CCP Decision Tree .......................................................................... 8Model Plan for Raw Ground Process......................................................9Hazard Analysis............................................................................9

Preparing Your HACCP Plan ......................................................................................11

Process Description Form................................................................12

Product and Ingredients Form............................................................14

Process Flow Diagram ................................................................................................16

Hazard Analysis/Preventive Measures Form...........................................18

CCP Determination Form................................................................21

HACCP Plan Form.......................................................................24

Process Category Description Form............................................................................34

Product and Ingredients Form............................................................36

Process Flow Diagram - Pork Sausage...................................................37

Hazard Analysis/Preventive Measures Form............................................40

CCP Determination Form.................................................................45

HACCP Plan Form........................................................................48

Appendix 1 - List of Process Models....................................................58

Appendix 2 - Process Flow Chart for Models..........................................59

Appendix 3 - Examples of Food Safety Hazards.......................................60

Page 4: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

iii

Appendix 4 - Literature Review for Hazard Identification.............................61

Part I - Factors Affecting the Epidemiology of Foodborne Illness.................................63

General.................................................................................................63

Part II - Prevalence of Pathogens Found in Ground Beef and Fresh Pork Sausage................67

Part III - Effects of Processing Procedures on the Growth of pathogens

...........................75

Sources for Epidemiology of Foodborne Illness

.....................................................83

General ................................................................................83

Microorganisms..................................................................... 84

Factors Influencing/Controlling Microbial Growth.................................85

Technique Description ...............................................................87

Composition, Nutrition ..............................................................88

Hard Particles ........................................................................89

Attachment 1 - Examples of Questions to be Considered in a Hazard Analysis...................90

Page 5: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

i

INTRODUCTION

The Hazard Analysis Critical Control Points (HACCP) concept is a systematic, scientificapproach to process control. The Food Safety Inspection Service (FSIS) views HACCP as ameans of preventing the occurrence of health and safety hazards in plants producing meat andpoultry products. It does this by ensuring that controls are applied at any point in a foodproduction system where hazardous situations could occur. These hazards may includebiological, chemical, or physical adulteration of food products.

The United States Department of Agriculture (USDA) published a final rule in July 1996mandating that HACCP be implemented as the system of process control in all USDA inspectedmeat and poultry plants. As part of its effort to assist establishments in the preparation of plant-specific HACCP plans, FSIS determined that a generic model for each process defined in theregulation will be made available for use by the regulated industry.

In addition to the generic model, background information on HACCP is included to assistan establishment in conducting a hazard analysis and developing a plant-specific plan.

The regulation includes specific references to the development and maintenance ofstandard operating procedures for sanitation, and these standard operating procedures should bein place before a HACCP system is implemented. For this reason, principles of good sanitationare not included as part of the HACCP plan.

Principles of HACCP

The foundation of HACCP can be found in the seven principles that describe its functions. These seven principles are:

Principle No. 1: Conduct a Hazard Analysis. Prepare a list of steps in the process where significant hazards occur, and describe the preventive measures.

Principle No. 2: Identify the Critical Control Points (CCP’s) in the process.

Principle No. 3: Establish critical limits for preventive measures associated with each identified CCP.

Principle No. 4: Establish CCP monitoring requirements. Establish procedures for using the results of monitoring to adjust the process and maintain control.

Principle No. 5: Establish corrective action to be taken when monitoring indicates that there is a deviation from an established critical limit.

Principle No. 6: Establish effective recordkeeping procedures that document the HACCP system.

Principle No. 7: Establish procedures to verify that the HACCP system is working correctly.

Page 6: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

ii

Definitions

Some definitions of commonly used HACCP terms are included below to clarify some ofthe terms used in reference to HACCP, hazard analysis, model development, and the developmentof the plant-specific plan.

Corrective action. Procedures to be followed when a deviation occurs.

Criterion. A standard on which a judgement or decision can be based.

Critical Control Point (CCP). A point, step, or procedure in a food process at whichcontrol can be applied and as a result a food safety hazard can be prevented, eliminated, orreduced to acceptable levels.

Critical limit. The maximum or minimum value to which a physical, biological, or chemicalhazard must be controlled at a critical control point to prevent, eliminate, or reduce to anacceptable level the occurrence of the identified food safety hazard.

Deviation. Failure to meet a critical limit.

HACCP. Hazard Analysis and Critical Control Points. A process that identifies specifichazards and preventive and control measures to ensure the safety of food.

HACCP Plan. The written document that is based upon the principles of HACCP and thatdelineates the procedures to be followed to ensure the control of a specific process orprocedure.

HACCP System. The HACCP plan in operation, including the HACCP Plan itself.

Hazard (Food Safety). Any biological, chemical, or physical property that may cause afood to be unsafe for human consumption.

Hazard Analysis. The identification of any hazardous biological, chemical, or physicalproperties in raw materials and processing steps, and an assessment of their likelyoccurrence and potential to cause food to be unsafe for consumption.

Monitor. To conduct a planned sequence of observations or measurements to assesswhether a CCP is under control and to produce an accurate record for future use inverification.

Preventive measure. Physical, chemical, or other means that can be used to control an identified food health hazard.

Process. A procedure consisting of any number of separate, distinct, and orderedoperations that are directly under the control of the establishment employed in themanufacture of a specific product, or a group of two or more products wherein all CCP’s,

Page 7: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

NACMCF, HACCP, 1992

iii

such as packaging, may be applied to one or more of those products within the group.

Development of the Plant Specific HACCP Plan

The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) hasdefined 12 steps (five preliminary steps listed below and the seven principles frompage 1) in developing a HACCP plant-specific plan.

PRELIMINARY STEPS

1) Assemble the HACCP team.2) Describe the food and its method of distribution.3) Identify the intended use and consumers of the food.4) Develop a flow diagram which describes the process.5) Verify the flow diagram.

Then apply the seven principles from page 1 beginning with conducting a hazard analysis.

There are certain elements required of a HACCP plan developed for a specific inspectedestablishment. Keep these in mind when proceeding with the steps in plan development. Thefollowing steps are all a part of developing your plant-specific plan:

Description of the Product: This is the first step in the development of the model for yourprocess. It will aid you in describing your product(s) so that you may progress throughthe remainder of model development. The section listing special handling considerationsmay not be applicable to your particular process and thus may not need to be completed.

Process Flow Diagram: This form should be completed for your process following thecompletion of the product(s) description. This step includes the course of the process asthe product(s) moves from receiving to finished product shipping. It is helpful tocomplete this portion of your plan while actually walking through your plant and followingthe production steps involved in the particular product or process.

Hazard Analysis: The Hazard Analysis is a critical step in the development of a plant-specific HACCP plan. This portion of plan development must take into consideration therisk or likelihood of occurrence, and the severity of each hazard. In order to beconsidered, an identified hazard must be "of such a nature that its prevention, elimination,or reduction to an acceptable level is essential to the production of a safe food." Hazardsthat are not significant or not likely to occur will not require further consideration. Thepotential significance of each hazard should be assessed according to its frequency, risk,and severity. "Risk is an estimate of the likely occurrence of a hazard. The estimate ofrisk is usually based on a combination of experience, epidemiological data, andinformation in the technical literature." For example, it is well documented that during1

the process of poultry slaughter, Salmonella is an organism of public health significance

Page 8: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

iv

that constitutes a risk of sufficient severity for inclusion into a HACCP plan foridentification and description of preventive measures. If the plan does not take intoconsideration the points at which the growth and proliferation of this organism can occur,and identify appropriate preventive measures, a safe food will not be produced. Pathogenic microorganisms of public health significance should be identified in the HazardAnalysis under the appropriate process step as a biological hazard with preventivemeasures to preclude their growth and proliferation.

Remember that in your hazard analysis there are three categories of hazards to consider:chemical, biological, and physical. Appendix 3 includes a table of hazards that arecontrolled in a HACCP system. Each process step will be evaluated to determine ifsignificant hazards from one or more of these categories are present. The hazards will belisted at each process step along with the specific preventive measures that can control thehazard. For example, if your plant-specific HACCP plan identifies foreign material as aphysical hazard for receiving non-meat ingredients, a preventive measure must be includedensuring that the materials are handled and stored in a manner so as not to contaminate theproduct.

If conclusive epidemiological data are available, this information should be used todetermine significance of identified hazards and determine the appropriate preventivemeasure: cooking or cooling temperatures, use of antimicrobial rinses, etc.

Identify the processing steps that present significant hazards and any preventive measureson the Hazard Analysis/Preventive Measures Form. These will be derived from theprocess steps on your flow diagram. This activity is one of the major portions of theHazard Analysis. The use of technical literature, epidemiological data, and assistancefrom an individual with HACCP training at least described in 9CFR 417 is crucial at thispoint to ensure that adequate preventive measures have been identified and significanthazards have been addressed.

Critical Control Point (CCP) Determination: Identification and description of the CCP foreach identified hazard is the next step in plan development. The CCP determination andthe information and data you recorded on the Hazard Analysis/Preventive Measures formwill be required for completion of this portion of the plan.

HACCP Plan Development: This portion of the plan development will be used todesignate the specific activities, frequencies, critical limits, and corrective actions thatensure that your process is under control and adequate to produce a safe product. Thispart will include all the information gathered to this point in your plan developmentprocess steps. In addition, the HACCP plan will include specification of critical limits.These limits will be specified after the identification of the CCP’s for the process and willbe listed in the HACCP Plan. The critical limit must include at a minimum the regulatoryrequirement for that specific process step or an equivalent process proven to render theproduct unadulterated.

The following will be identified or described in the HACCP plan: the establishment

Page 9: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

v

monitoring procedure or device to be used; the corrective action to be taken if the limit isexceeded; the individual responsible for taking corrective action; the records that will begenerated and maintained for each CCP; and the establishment verification activities and thefrequency at which they will be conducted.

A copy of the Decision Tree developed by the NACMCF is included at the end of thissection. The use of the Decision Tree is optional. The questions in the Decision Tree are listed atthe top of each page of the CCP Determination form of the generic model. These questionsshould be answered when identifying critical control points for your HACCP plan. Rememberthat the HACCP plan should cover health and safety CCP’s, not economic and quality concerns. A CCP should be identified when it presents a significant hazard and has a significant likelihood ofoccurrence. Hazards that are unlikely to occur or do not present significant hazards will not beconsidered during Hazard Analysis and, therefore, will not be identified as a CCP.

Remember that HACCP is a system of process control for the plant and not an inspectionsystem. The creation of the plant-specific plan and its successful operation is the responsibility ofeach establishment. The plant-specific plan that you have developed will be used to help youmonitor your process. The plan should be reassessed routinely by the plant to determine ifupdates are needed. Such cases may include, but are not limited to: new products are added; aprocess undergoes substantial changes, such changes in raw materials or their source; productformulation processing or slaughter methods or systems; production volume; packaging finishedproduct distribution systems; the intended use or consumers of the finished product; or it isdetermined that the plan does not adequately ensure process control, defined as when criticallimits are not being met. Revision of the HACCP plan should be conducted with the advice andassistance of an individual trained to meet the requirements in 9CFR 417.7.

The generic models use examples of products within the specific process category. Theinformation for your plant-specific plan, and the products covered by the process, may differ andtherefore will require different CCP’s. There are two HACCP Plans included in the Handbook tohelp illustrate how two products can fit into the same generic process model.

Specific information related to regulatory requirements for HACCP can be found in Part417 of the regulations. The 1992 paper on HACCP by the NACMCF contains importantinformation on HACCP plan development, and is a recommended reference tool for use whencreating your-plant specific plan.

Steps for Selecting a Generic Process Model

Process Platform for Use of Generic Models

Each generic model was developed by a committee of experts to serve as a guide forcreating HACCP plans for various processes. Each generic model can be used as a starting pointfor the development of your plant-specific plan reflecting your plant environment and the specificprocesses conducted. The generic model is not intended to be used "as is" for your plant-specificHACCP plans.

The generic models designed by FSIS for use in developing a plant-specific HACCP plan

Page 10: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

vi

are defined according to process. In order to select the model or models that will be most usefulfor the activities performed in your plant, the following steps should be taken.

If a model for a slaughter operation is required, select the model for the appropriatespecies. If a model for a processed product or products is required, proceed as directed in thesteps below. If an establishment is a combination plant, i.e. conducting both slaughter andprocessing activities, the two models can be merged into a plant-specific plan. In this case,overlapping critical control points (CCP’s) can be combined as long as all significant hazards areaddressed.

1) Make a list of all products produced in the plant. Examine the list and group alllike products according to common processing steps and equipment used. Compare these to the list of Process Models in Appendix 1. After reviewing andgrouping the products produced, you will know the number of models that areneeded to develop your plant-specific plans.

2) Refer to the process control flow chart (Appendix 2). This will show whichprocess models will fit your product(s) groups most closely. To use the flow charteffectively, move in a step-by-step fashion by asking yourself these questions:

Is the product(s) shelf stable? Some questions that will determine if a process fits one ofthe shelf stable categories are:

Does the process result in a product sterilized in a sealed package?

Does the process dry the product(s) to an acceptable water activity?

Does the process result in a product(s) that need not be refrigerated?

Does the process acidify the products(s) to an acceptable pH, or is there acombination of the activities listed above resulting in a shelf stable product(s)?

If so, proceed to the categories listed for shelf stable processes.

Is the product(s) not shelf stable? Some questions that will help with this determinationare:

Does the process result in a product(s) that must be kept refrigerated, frozen, or atan acceptable holding (heat) temperature?

If so, proceed through the remaining steps, for example:

If a product is not shelf stable but fully cooked, then the "Fully Cooked, Not Shelf-Stable Meat and Poultry Products" model will be most useful. "Fully cooked"

Page 11: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

vii

implies that the process includes an acceptable heat treatment that renders a finalproduct ready to eat without further cooking, although the product may bewarmed or reheated by the consumer.

If a product is not shelf stable and not fully cooked, but receives other processingthat does not involve a heat treatment, the model "Generic HACCP Model forMeat and Poultry Procucts with Secondary Inhibitors, Not Shelf- Stable" will bemost useful. If some heat treatment is involved in the process that does not resultin a fully cooked product - for example, a cold smoke - the Generic HACCPModel Heat Treated Not Fully Cooked, Not Shelf Stable Meat and PoultryProducts" will be most useful.

If a product is not shelf stable and is raw, the "Generic HACCP Model for Raw,Ground Meat and Poultry Products" or "Generic HACCP Model for Raw, NotGround Meat and Poultry Products" models will be most useful. Products in the"Generic HACCP Model for Raw, Not Ground Meat and Poultry Products"category may contain process steps in addition to cutting, boning, or breaking, butshould not contain a process step that significantly alters the raw nature of theproduct. Products in the "Generic HACCP Model for Raw, Ground Meat andPoultry Products" process category are subjected to the grinding process and mayinclude products such as fresh sausage.

After the correct generic model has been selected, you should proceed through the stepsoutlined in the model. The same generic process model may include diverse products, so it isimportant that you identify and group all products covered by the process model in order tocorrectly identify the hazards, create a representative flow diagram, identify all critical controlpoints and critical limits, etc. The similarities within groupings will be confirmed as you workthrough the hazard analysis flow diagram and process flow. Not all steps will be common to allproducts grouped in the process model, but if you have grouped correctly you will see that thesteps involved are very similar. If you find that a product has been mis-grouped, repeat the stepsoutlined above to determine if another generic process model is more appropriate.

Now you are ready to develop your plant-specific HACCP plan(s) according to theprocedures shown in the generic process model(s).

Page 12: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

Appendix 1 CCP DECISION TREE

(Apply at each step of the process with an identified hazard.)

Q1. DO PREVENTIVE MEASURE(S) EXIST FOR THE IDENTIFIED HAZARD? 9 9 8YES NO MODIFY STEP, PROCESS OR PRODUCT 9 9 8

9 IS CONTROL AT THIS STEP NECESSARY FOR SAFETY?6 YES 9 9 9 NO6 NOT A CCP 6 STOP*

Q2. DOES THIS STEP ELIMINATE OR REDUCETHE LIKELY OCCURRENCE OF A HAZARDTO AN ACCEPTABLE LEVEL? 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 9 9NO YES 9 9

9Q3. COULD CONTAMINATION WITH IDENTIFIED 9

HAZARD (S) OCCUR IN EXCESS OF ACCEPTABLE 9LEVEL(S) OR COULD THESE INCREASE TO 9UNACCEPTABLE LEVEL(S)? 9 9 9 9YES NO 6 NOT A CCP 6 STOP* 9 9 9

9Q4. WILL A SUBSEQUENT STEP ELIMINATE 9

IDENTIFIED HAZARD(S) OR REDUCE THE 9LIKELY OCCURENCE TO AN ACCEPTABLE 9LEVEL? 9 9 9 9 9YES 6 NOT A CCP 6 STOP* NO 6 6 6 6 6 6 6 6 6 CCP

* Proceed to the next step in the described process

Page 13: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

ix

Model Plan for Process: Raw Ground

Hazard Analysis

Conducting an analysis of the physical, chemical, and biological hazards associated with aprocess is a critical first step in the effective development and implementation of the plant-specificHACCP plan. The information gathered should focus on addressing points of public healthsignificance associated with the manufacture of those products by a particular process used inyour plant. The hazard analysis must be conducted as a starting point in the developmentof the plant-specific plan. Information for a hazard analysis can be obtained from a localpublic library, community college or university library, the extension service, scientificpublications, FDA guidelines, USDA Guidebook for the Preparation of HACCP Plans andMeat and Poultry Products Hazards and Control Guide, or other sources that are availableto the general public. It is important to include as much information as possible relevant tothe public health hazards associated with your process, including information on suppliersperformance at meeting public health related specifications, in-plant incidents ofcontamination or adulteration, and product recalls. This will ensure that process hazards arerecognizable as you proceed through the remaining steps of creating the plant-specific HACCPplan. An example of information needed for an analysis of the hazards associated with a specificprocess follows on the next few pages. Included along with this information should be yourexperience with, and knowledge of the process, and how it occurs in your plant.

There are a few important aspects to note when reviewing the information over the nextfew pages. Every establishment should validate the HACCP plans adequacy in controlling thefood safety hazards identified during the hazard analysis and should verify that the plan is beingeffectively inplemented. Each establishment should maintain records documenting theestablishments HACCP plan, including references to all supporting documentation.

Epidemiological information is used to assess the public health significance of the knownhazards associated with the specific process. These include the types and severity of diseases andinjury caused by the occurrence of biological, physical, and chemical contamination. It also willassist you when you are ready to use the decision tree to determine the validity, existence, andappropriateness of a critical control point. This information can aid in determining a significanthazard from an insignificant one based on the frequency, severity, and other aspects of the risk.

The biological, chemical, or physical hazard information gathered will aid in determiningwhere a hazard may occur in the process, what could cause the hazard, how it can be prevented,and actions to be taken if conditions which could result in a hazard occur. Information onphysical hazards may be more general and may consist simply of items found in foods that areinjurious to human health such as glass, metal, broken needles, etc. The evaluation of physicalhazards should include the suppliers utilized and their ability to provide products, ingredients, ormaterials that meet the food safety requirements of the plant. Past incidents of physicalcontamination occuring in the plant should also be a consideration when determining thesignificance of a hazard and the likely occurrence of a similar or related

deviation. If specific chemical hazards exist that are associated with the process, these shouldalso be considered as part of the hazard analysis. Examples may be residues from veterinary

Page 14: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

x

drugs or zoonotic diseases present in animals at the time of slaughter, natural toxins, or pesticidespresent in non-meat ingredients.

Creating a bibliography of the sources used will help document and provide thescientific basis for considering a hazard and determining its significance. It will also beuseful when a plan is validated, reassessed, or when the hazard analysis is reassessed. Although a bibliography is a useful tool it is not a regulatory requirement.

Page 15: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xi

Preparing Your HACCP Plan

Assemble the HACCP team.

Your HACCP team should be composed of a HACCP trained individual and othermember(s) who are familiar with the product and the process as it is conducted in your plant. There is no set number of participants. This will be determined by each individual establishment.

All team members should receive at least a basic introduction to HACCP. Training can beformal classroom training, on-the-job training, information from college courses, and/or HACCPbooks or manuals.

Some textbooks and journal articles that are recommended for all HACCP model teamsare:

1. HACCP in Meat, Poultry and Fish Processing. 1995.eds. Pearson and Dutson. Blackie Academic and Professional, Glasgow.

2. HACCP in Microbiological Safety and Quality. 1988. eds. ICMFS. Blackwell Scientific Publications, Oxford.

3. An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients. 1985. National Research Council, National Academy Press, Washington, DC .

4. Microorganisms in Foods. Vol 5. ICMSF. Blackwell Scientific Publications, Oxford.

All the forms used in the model are examples for guidance only. Other forms a plant may wish touse are also appropriate, if the information required in 9 CFR part 417 is included.

Page 16: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xii

Process Description Form

The Process Description Form is used to describe each food product included in eachprocess category that is manufactured in the establishment. The description(s) answers thefollowing questions: 1) Common name of product; 2) How is it to be used (the intended use ofthe food by end users or consumers) (Note: the intended consumers may be the general public ora particular segment of the population such as infants, the elderly, immune compromisedindividuals) or another inspected establishment for further processing; 3) Type of packaging used(plastic bag/vacuum packed); 4) Length of shelf life, and appropriate storage temperature; 5)Where it will be sold (retail/wholesale); 6) Labeling instructions (keep frozen/keep refrigerated,thawing and cooking instructions, safe food handling); and 7) Special distribution controls (keepfrozen/keep refrigerated).

Questions 6 and 7 are optional if there are no specific labeling or special instructions.

This form describes the food and its method of distribution. This information is importantwhen determining whether a significant hazard exists and how/where it can be controlled.

Page 17: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xiii

PROCESS DESCRIPTION

PROCESS CATEGORY : RAW, GROUND

PRODUCT EXAMPLE : GROUND BEEF

THE FOLLOWING QUESTIONS NEED TO BE ANSWERED WHEN DEVELOPING THEPRODUCT CATEGORY DESCRIPTION:

1. COMMON NAME? GROUND BEEF

2. HOW IS IT TO BE USED? COOKED AND CONSUMED

3. TYPE OF PACKAGE? BULK-PACKED (E.G., PLASTIC BAG, VACUUMPACKED); LAYER OR STACK PACKED, PATTIEPACKED

4. LENGTH OF SHELF LIFE, 3 - 6 MONTHS AT 0EF OR BELOWAT WHAT TEMPERATURE? 7 DAYS AT 40EF

5. WHERE WILL IT BE SOLD? RETAIL AND HRI, WHOLESALE CONSUMERS? GENERAL PUBLIC; MAY INCLUDE INTENDED USE? HOSPITALS

6. LABELING INSTRUCTIONS? KEEP FROZEN; COOKING INSTRUCTIONS(MINIMUM INTERNAL TEMPERATURE FORCOOKING); THAWING INSTRUCTIONS; KEEPREFRIGERATED; SAFE FOOD HANDLING LABEL

7. IS SPECIAL DISTRIBUTION KEEP FROZEN, KEEP REFRIGERATEDCONTROL NEEDED?

Page 18: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xiv

Product and Ingredients Form

The Product and Ingredients Form consists of a full description of the food including therecipe or formulation used. This should include the meat and any edible casings and all addedingredients such as water, spices, restricted ingredients, etc. The formulation may be included andshould indicate the amount or percentage of each ingredient in the formulation.

This form is only needed if there is more than one ingredient.

Page 19: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xv

LIST PRODUCT(S) AND INGREDIENTS

PROCESS CATEGORY: RAW, GROUND

PRODUCT EXAMPLE : GROUND BEEF

MEAT

BEEF

Page 20: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xvi

Process Flow Diagram

The Process Flow Diagram is used to provide a simple description of the steps involved inthe process. The diagram will be helpful to the HACCP Team in the preparation of their HACCPplan and will also serve as a future guide for regulatory officials who must understand the processfor their verification activities.

The flow diagram must cover all the steps in the process which are directly under thecontrol of the establishment. It can also include steps in the food chain which are before and afterthe processing that occurs. For the sake of simplicity, the flow diagram should consist solely ofwords, not engineering drawings.

Member(s) of the HACCP Team should use the drafted flow diagram and walk throughthe plant to follow the actual process flow as it occurs and make any adjustments, as necessary.

Page 21: Generic HACCP Model for Raw, Ground Meat, and Poultry Products
Page 22: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xviii

Hazard Analysis/Preventive Measures Form

The Hazard Analysis/Preventive Measures Form is used to review the steps listed in theProcess Flow Diagram and identify where significant hazards could occur and describe thepreventive measures, if they exist. A hazard is defined as a biological, chemical, or physicalproperty that may cause a food to be unsafe for consumption. The hazard must be of such anature that its prevention, elimination, or reduction to acceptable levels is essential to theproduction of a safe food. Hazards of low risk and/or not likely to occur would not requirefurther consideration.

The Hazard Analysis consists of asking a series of questions which are appropriate to thespecific food process and establishment. The analysis should question the effect of a variety offactors upon the safety of the food. Factors must be considered that may be beyond the control ofthe processor. During the Hazard Analysis, safety concerns must be differentiated from qualityconcerns. Each step in the process flow will be evaluated to determine if any significant hazardsshould be considered at that step. Examples of questions to be considered during hazard analysishave been included as Attachment 1.

The potential significance of each hazard should be assessed by considering its risk andseverity. Risk is an estimate of the likely occurrence of a hazard. Risk is usually based upon acombination of experience, epidemiological data, and information in the technical literature. Severity is the seriousness of the hazard. This should be a consideration since it affects publichealth.

Preventive Measures, if they exist, must also be identified. A preventive measure is aphysical, chemical, or other means which can be used to control an identified food safety hazard.

The fourth column on the Hazard Analysis/Preventive Measures form is for illustrativepurposes only and need not be included in a plant-specific HACCP plan.

Page 23: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xix

HAZARD ANALYSIS/PREVENTIVE MEASURES

PROCESS CATEGORY : RAW, GROUNDPRODUCT EXAMPLE : GROUND BEEF

Process Step Chemical (C)

HAZARDSBiological (B) Including Examples of How Hazard IsMicrobiological Preventive Measures Introduced *

Physical (P) * Not to be included in a plant specificHACCP plan.

RECEIVING - B (Microbial Growth) - Insufficient temperature Maintain product temperature B-Transport refrigeration unit is notMEAT control will result in unacceptable microbial at a level sufficient to preclude functioning properly (out of freon). growth. Ayers, J.C. 1979 bacterial growth.

Microbial contamination of beef from E. coli due B-The shipping container (theto lack of supplier process control. Accept only meat from plants cardboard combo bin) was crushed by

B (Mishandling) - The integrity of the immediate place. (the film wrapped around thecontainer is compromised such that microbial individual trays) was torn andcontamination could occur. Visual inspection of containers punctured introducing harmful

P (Foreign Material) - Visible foreign material container is not compromised.that could compromise product safety. P-Pieces of glass found in product fromMeat and Poultry Products Hazards and Control Visual inspection of a sufficient a broken light bulb, metal clips, knives,Guide. representative sample to ensure plastic, etc.

with a viable HACCP system in a forklift and the immediate container

to ensure that immediate microbes into the product.

no foreign material is present.

RECEIVING - C (Deleterious Chemicals) - Chemicals/non-meat Verify that the letter of C-The new tray pack "diapers"NON-MEAT ingredients/packaging materials, are not guarantee is on file and ordered came in and the letter of

acceptable for intended use. Should be food appropriate for product use. guarantee is present with the shipment,grade material approved for intended use. however the letter states that theBean, N.H. and P.M. Griffin 1990. Third party audit of suppliers. diapers are acceptable for industrial

P (Foreign Material) - Visible foreign material Visual inspection of a sufficientthat could compromise product safety; rodent representative sample to ensure P-Black material that resembles rodentdroppings, insects, etc. no foreign material is present. droppings are found on the surface of

use and not food grade.

the styrofoam trays.

STORAGE - MEAT B (Microbial Growth) - Insufficient temperature Monitor the internal product B-Cooler generator breaks down andcontrol could result in unacceptable microbial temperature and environmental the ambient room temperature in thegrowth. Internal product temperature and temperature (ex. cooler or cooler increases above 50EF for 10environmental temperature must be monitored. freezer) to ensure that the meat hours increasing product temperatureAyers, J.C. 1979, Bryan, F.L., 1988, does not exceed a level sufficient above compliance permitting excessivePalumbo, S.A., et.al. 1994 to preclude bacterial growth for bacterial growth.

more than 1 hour, and thetemperature of the cooler orfreezer does not exceed 50 EFfor more than 2 hours.

STORAGE - P (Foreign Material/Adulteration) - All non-meat Visual inspection of storage area P-The product is stored directly againstNON-MEAT ingredients, packaging materials, etc. not stored to ensure that materials are the walls which have visible debris on

to prevent contamination due to foreign material. stored in a clean area, are them. The debris falls into theMeat and Poultry Products Hazards and Control covered, and not resting directly packaging materials that contactGuide. on the floor. product.

ASSEMBLE/ B (Microbial Growth) - Inadequate temperature Monitor ambient room B-As a result of a mechanicalPRE-WEIGH/ control could result in unacceptable microbial temperature and product breakdown, the product movement intoPRE-GRIND/ growth. Internal product temperature and temperature to ensure that the cooling cycle was delayed 6 hoursRE-WORK environmental temperature must be monitored. product temperature does not and the product temperature increasesFINAL GRIND Ayers, J.C. 1979 exceed a level sufficient to above 55EF due to exposure to ambientMEAT preclude bacterial growth for room temperature.

P (Foreign Materials) - Visible foreign material more than 2 hours and thatthat could compromise product safety; metal and room temperature does not P-Moving parts of the grinder are notplastic shavings, rubber gloves, bone, etc. exceed 50 EF for more than 4 set properly or are worn and grindUSDA Guidebook. Meat and Poultry Products hours. together leaving pieces of ground metalHazards and Control Guide. in the product.

Visual inspection of all productas it is processed to ensure noforeign material is present.

Page 24: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HAZARD ANALYSIS/PREVENTIVE MEASURES

PROCESS CATEGORY : RAW, GROUNDPRODUCT EXAMPLE : GROUND BEEF

Process Step Chemical (C)

HAZARDSBiological (B) Including Examples of How Hazard IsMicrobiological Preventive Measures Introduced *

Physical (P) * Not to be included in a plant specificHACCP plan.

xx

PACKAGING/ B- Survival of microorganisms of public health B-Use of safe food handling labelLABELING significance after cooking by the consumer. P-Use of metal detectors on all

P (Foreign Material) product.packaged product. P-Broken metal clips from chub pack in

COOLING AND B- (Microbial Growth) - The potential for an Monitor the product B-Continuous recording device has notSTORAGE OF increase in microbial growth if the product temperature to assure that been calibrated for weeks and is notPRODUCT temperature is not maintained at temperature or stored product is maintained at a recording actual ambient room

below the level where pathogens survive and level sufficient to preclude temperatures. The actual ambientgrow rapidly. Ayres, J.C. 1979, microbial growth. room temperature is 27 degrees higherJohnston, R.W. et. al. 1982., than it should be, increasing productPalumbo,S.A. et.al. 1994 Monitoring the ambient room temperature to the point where

temperature to assure that it bacteria can proliferate and/or spoilagedoes not exceed 50 EF for more can occur.than 1 hour.

SHIPPING B (Microbial Growth) - Potential for an increase Product must be 40 EF or less Product was not #40EF before it leftin bacterial flora and other enteric pathogens prior to leaving the the dock and microbial proliferationthat will proliferate to unsafe levels on the establishment. resulted during transport.product if the temperature increases duringtransport. Ayres, J.C. 1979, Refrigerated transport.Abdel-Rahman, H.T. El-Khaleib, and A.K.Timmawy. 1988.

Page 25: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xxi

CCP Determination Form

The Critical Control Point (CCP) Determination form is used to identify the criticalcontrol points in the process. A critical control point is defined as a point, step, or procedureat which control can be applied and a food safety hazard can be prevented, eliminated, orreduced to an acceptable level. All significant hazards identified in the hazard analysis must beaddressed. Identification of each CCP can be facilitated by the use of a CCP Decision Tree(See Decision Tree). The Decision Tree asks a series of four, yes or no, questions to assist indetermining if a particular step is a CCP for a previously identified hazard. These fourquestions are listed at the top of the CCP Determination form. Use this as a guide whendetermining if an identified significant hazard is a critical control point. CCP’s must becarefully developed and documented and must be for product safety only. Differentfacilities preparing the same food can differ in the risk of hazards and the points, steps,or procedures which are CCP’s. This can be due to differences in each facility such aslayout, equipment, selection of ingredients, or the process that is employed.

In this document the CCP’s that are identified are for illustrative purposes only. Yourindividual process will determine the CCP’s identified. Remember that proper SanitationStandard Operating Procedures and maintenance programs are essential prerequisites toHACCP.

Page 26: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

CC

P D

ET

ER

MIN

AT

ION

(A C

RIT

ICA

L C

ON

TR

OL

PO

INT

IS

DE

FIN

ED

AS

A P

OIN

T, S

TE

P O

R P

RO

CE

DU

RE

AT

WH

ICH

CO

NT

RO

L C

AN

BE

AP

PL

IED

AN

D A

FO

OD

SA

FE

TY

HA

ZA

RD

CA

N B

E P

RE

VE

NT

ED

, EL

IMIN

AT

ED

, OR

RE

DU

CE

D T

O A

CC

EP

TA

BL

E L

EV

EL

S)

PR

OC

ESS

STE

PH

AZ

AR

D(S

)

Q1.

DO

PR

EV

EN

TIV

EQ

2. D

OE

S T

HIS

ST

EP

Q3.

CO

UL

DQ

4. W

ILL

AM

EA

SUR

ES

EX

IST

FO

RE

LIM

INA

TE

OR

CO

NT

AM

INA

TIO

N W

ITH

SUB

SEQ

UE

NT

ST

EP

#C

CP

T

HE

ID

EN

TIF

IED

RE

DU

CE

TH

E L

IKE

LY

IDE

NT

IFIE

D H

AZ

AR

D(S

)E

LIM

INA

TE

HA

ZA

RD

(S)

HA

ZA

RD

(S)?

OC

CU

RR

EN

CE

OF

AO

CC

UR

IN

EX

CE

SS O

FO

R R

ED

UC

E T

HE

LIK

EL

Y

*If n

o=no

t a C

CP

-Ide

ntif

y ho

w a

ndw

here

this

haz

ard

will

be

cont

rolle

d.

* I

f yes

= m

ove

to n

ext q

uest

ion.

HA

ZA

RD

(S) T

O A

NA

CC

EP

TA

BL

E L

EV

EL

S O

RO

CC

UR

RE

NC

E T

O A

NA

CC

EP

TA

BL

E L

EV

EL

?C

OU

LD

TH

ESE

IN

CR

EA

SEA

CC

EP

TA

BL

E L

EV

EL

?

TO

UN

AC

CE

PT

AB

LE

*If n

o=m

ove

to th

e ne

xt q

uest

ion.

*If y

es=C

CP

LE

VE

LS?

*If n

o=no

t a C

CP

.

*If y

es=m

ove

to th

e ne

xt q

uest

ion.

*If n

o=C

CP

.

*If y

es=n

ot a

CC

P.

Rec

eivi

ng-M

eat

B -

Mic

robi

al G

row

th.

YE

SY

ES

CC

P 1B

C -

N/A

(N

ot A

pplic

able

)

P - F

orei

gn M

ater

ial

YE

SY

ES

CC

P 1P

Rec

eivi

ng-N

on-M

eat

B -

N/A

low

ris

k

C -

Del

eter

ious

Che

mic

als.

Y

ES

YE

SC

CP

1C

P - F

orei

gn M

ater

ial.

YE

SY

ES

CC

P 2P

Stor

age-

Mea

tB

- M

icro

bial

Gro

wth

.Y

ES

YE

SC

CP

2B

C -

N/A

P - N

/A

low

ris

k

Stor

age-

Non

-Mea

tB

- N

/A

C -

N/A

P - F

orei

gnY

ES

YE

ST

his

may

be

cont

rolle

d us

ing

CC

P 3P

Mat

eria

l/Adu

ltera

tion.

GM

P’s

if a

pla

nt in

corp

ora

tes

CC

P 4

P in

to th

eir

HA

CC

Ppl

an.

Ass

embl

e:W

eigh

/B

- M

icro

bia

l Gro

wth

.Y

ES

YE

SC

CP

3B

Pre

-Gri

nd/R

e-W

ork/

Fin

al G

rind

-Mea

tC

- N

/A

P -

For

eign

Ma

teria

l.Y

ES

NO

YE

SN

OC

CP

4P

Page 27: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

CC

P D

ET

ER

MIN

AT

ION

(A C

RIT

ICA

L C

ON

TR

OL

PO

INT

IS

DE

FIN

ED

AS

A P

OIN

T, S

TE

P O

R P

RO

CE

DU

RE

AT

WH

ICH

CO

NT

RO

L C

AN

BE

AP

PL

IED

AN

D A

FO

OD

SA

FE

TY

HA

ZA

RD

CA

N B

E P

RE

VE

NT

ED

, EL

IMIN

AT

ED

, OR

RE

DU

CE

D T

O A

CC

EP

TA

BL

E L

EV

EL

S)

PR

OC

ESS

STE

PH

AZ

AR

D(S

)

Q1.

DO

PR

EV

EN

TIV

EQ

2. D

OE

S T

HIS

ST

EP

Q3.

CO

UL

DQ

4. W

ILL

AM

EA

SUR

ES

EX

IST

FO

RE

LIM

INA

TE

OR

CO

NT

AM

INA

TIO

N W

ITH

SUB

SEQ

UE

NT

ST

EP

#C

CP

T

HE

ID

EN

TIF

IED

RE

DU

CE

TH

E L

IKE

LY

IDE

NT

IFIE

D H

AZ

AR

D(S

)E

LIM

INA

TE

HA

ZA

RD

(S)

HA

ZA

RD

(S)?

OC

CU

RR

EN

CE

OF

AO

CC

UR

IN

EX

CE

SS O

FO

R R

ED

UC

E T

HE

LIK

EL

Y

*If n

o=no

t a C

CP

-Ide

ntif

y ho

w a

ndw

here

this

haz

ard

will

be

cont

rolle

d.

* I

f yes

= m

ove

to n

ext q

uest

ion.

HA

ZA

RD

(S) T

O A

NA

CC

EP

TA

BL

E L

EV

EL

S O

RO

CC

UR

RE

NC

E T

O A

NA

CC

EP

TA

BL

E L

EV

EL

?C

OU

LD

TH

ESE

IN

CR

EA

SEA

CC

EP

TA

BL

E L

EV

EL

?

TO

UN

AC

CE

PT

AB

LE

*If n

o=m

ove

to th

e ne

xt q

uest

ion.

*If y

es=C

CP

LE

VE

LS?

*If n

o=no

t a C

CP

.

*If y

es=m

ove

to th

e ne

xt q

uest

ion.

*If n

o=C

CP

.

*If y

es=n

ot a

CC

P.

Pac

kagi

ngB

- N

/A

Low

Ris

kC

ontr

olle

d at

ass

embl

y &

stor

age

& b

y us

e of

saf

e fo

od

hand

ling

labe

l

C -

N/A

(N

ot A

pplic

able

)

P - F

orei

gn M

ater

ial

YE

SN

OY

ES

NO

CC

P 5P

Coo

ling

and

Stor

age

B -

Mic

robi

al G

row

th.

YE

SY

ES

CC

P 4B

of P

rodu

ctC

- N

/A

P - N

/A

Ship

ping

B -

Mic

robi

al G

row

th.

YE

SY

ES

CC

P 5B

C -

N/A

P - N

/A

Page 28: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xxiv

HACCP Plan Form

The HACCP Plan Form is used to develop a Plant-Specific HACCP Plan. This plancan serve as a useful guide, however, it is essential that the unique conditions within eachfacility be considered during the development of the plant-specific plan. The first threecolumns on the form are transferred from the CCP Determination Form. The fourth column isused to establish critical limits for preventive measures associated with each identified CCP.

A Critical Limit is defined as the maximum or minimum value to which a physical,biological, or chemical hazard must be controlled at a CCP to prevent, eliminate, or reduce toan acceptable level the occurrence of the identified food safety hazard. Each CCP will haveone or more preventive measures that must be properly controlled to assure prevention,elimination, or reduction of hazards to acceptable levels. Critical Limits may be derived fromsources such as regulatory standards and guidelines, literature surveys, experimental studiesand subject matter or technical experts. The fifth column is used to establish monitoringrequirements.

Monitoring is a planned sequence of observations or measurements to assess whethera CCP is under control and to produce an accurate record for future use in verification. Monitoring is essential to food safety management by tracking the HACCP system’soperation. If monitoring indicates that there is a trend towards loss of control, then action canbe taken to bring the process back into control before a deviation occurs. Monitoringprovides written documentation for use in verification of the HACCP plan. All records anddocuments associated with CCP monitoring must be signed or initialled, dated, and the timerecorded by the person doing the monitoring.

Column six is used to establish corrective actions to be taken when monitoringindicates that there is a deviation from an established critical limit. Where there is a deviationfrom established critical limits, corrective action plans must be in place to: 1) determine thedisposition of non-compliant product; 2) fix or correct the cause of non-compliant product toassure that the CCP is under control; and 3) maintain records of the corrective actions thathave been taken where there has been a deviation from critical limits; and 4) assure that noproduct that is injurious to health or otherwise adulterated as a result of the deviation enterscommerce. Because of the variations in CCP’s for different processes and the diversity ofpossible deviations, plant specific corrective actions must be developed for each CCP. Theactions must demonstrate that the CCP has been brought under control. Documentation ofthe corrective actions taken must be signed, dated, and the time of action recorded by theindividual responsible for taking corrective actions.

Column seven is used to establish effective recordkeeping procedures that documentthe HACCP system. The maintenance of proper HACCP records is an essential part of theHACCP system to document that each CCP is under control and to verify the adequacy of theHACCP plan. Records serve as: 1) a written documentation of the establishment’s compliancewith their HACCP plan; 2) the only reference available to trace the history of an ingredient ina processing operation, or a finished product should problems arise; 3) a ready source ofinformation to identify trends in a particular operation that may result in a deviation if not

Page 29: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xxv

properly corrected; and, 4) good evidence in potential legal actions. In accordance with theHACCP principles, HACCP records must include; records associated with establishing andmonitoring CCP’s and critical limits, records for the handling of deviations, and recordsassociated with verification of the HACCP plan. It is also very important that all HACCPrecords dealing with plant operations at CCP’s and corrective actions taken, be reviewed on adaily basis by a designated individual who must sign or initial, date and record the time allrecords are reviewed. The approved HACCP plan and associated records must be on file atthe meat and/or poultry establishment.

Column eight of the HACCP plan establishes procedures for verification that theHACCP system is working correctly. The verification process is designed to review theHACCP plan; to establish whether the CCP’s and critical limits have been properly establishedand are being adequately controlled and monitored; and to determine if the procedures forhandling process deviations and recordkeeping practices are being followed. The effectivecompletion of this step is crucial.

Page 30: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HA

CC

P P

LA

N

PR

OC

ESS

CA

TE

GO

RY

:R

AW

, GR

OU

ND

PR

OD

UC

T E

XA

MP

LE

:G

RO

UN

D B

EE

F

PR

OC

ESS

ST

EP

DE

SCR

IPT

ION

CC

PC

RIT

ICA

L L

IMIT

SP

ER

SON

RE

SPO

NSI

BL

ER

ESP

ON

SIB

LE

RE

CO

RD

SR

ESP

ON

SIB

LE

BIO

LO

GIC

AL

C

HE

MIC

AL

PH

YSI

CA

L

MO

NIT

OR

ING

CO

RR

EC

TIV

E/P

RE

VE

NT

IVE

VE

RIF

ICA

TIO

NH

AZ

AR

DP

RO

CE

DU

RE

S/F

RE

QU

EN

CY

/A

CT

ION

/PE

RSO

NH

AC

CP

PR

OC

ED

UR

E/P

ER

SON

RE

CE

IVIN

G -

B -

Mic

robi

al1

BT

empe

ratu

re w

ithi

nIn

tern

al te

mpe

ratu

re m

onit

ored

If p

rodu

ct te

mpe

ratu

re is

out

of

Rec

ord

all r

esul

tsT

wic

e W

eekl

y vi

sual

ME

AT

Gro

wth

.pl

ant s

peci

fica

tion

s.*

whe

n a

ship

men

t is

rece

ived

by

com

plia

nce,

imm

edia

tean

d co

rrec

tive

obse

rvat

ion

of p

rodu

ct

B -C

onta

iner

1 B

Imm

edia

te c

onta

iner

isV

isua

l ins

pect

ion

of im

med

iate

the

mea

t pro

duct

, ide

ntif

y an

dSi

gns

reco

rd a

nddi

d no

t pro

duce

the

Inte

grit

yin

tact

.co

ntai

ner

at th

e ti

me

a sh

ipm

ent

cont

rol a

ffec

ted

prod

uct f

orre

cord

s ti

me

and

reco

rds

and

who

has

P -

For

eign

Mat

eria

l.no

n-fo

od m

ater

ial.

pers

onne

l.N

otif

y pl

ant d

esig

nee.

HA

CC

P, o

r th

e1

PN

o vi

sibl

e ha

zard

ous

proc

essi

ng b

y th

e re

ceiv

ing

acti

on to

pre

vent

reo

ccur

renc

e.

cour

se o

f ins

truc

tion

on

* C

arca

sses

or

red

mea

tre

ceiv

ing

log.

Inc

lude

lot #

,ac

tion

s ta

ken

in H

AC

CP

Log

mus

t be

rece

ived

at 4

0Eda

te, c

ondi

tion

, tim

e of

rece

ivin

g lo

g. S

igns

rec

ord

and

Aud

it to

ver

ify

sam

plin

gF

or

belo

w.

insp

ecti

on a

nd s

ign

the

reco

rd.

reco

rds

tim

e of

obs

erva

tion

.te

chni

ques

and

acc

urac

y

*Not

e: I

nsuf

fici

ent

accu

racy

of t

empe

ratu

resc

ient

ific

dat

a ex

ist

devi

ces;

det

erm

ine

if th

ere

gard

ing

the

grow

th o

fC

riti

cal L

imit

cor

resp

onds

path

ogen

s du

ring

to th

e pl

ant r

ecor

ds; c

heck

chill

ing.

How

ever

the

to s

ee if

Cri

tica

l Lim

it is

chill

ing

para

met

ers

adeq

uate

for

haza

rd;

prov

ided

abo

ve w

illas

sure

cor

rect

ive

acti

ons

cont

rol q

ualit

y an

d lim

tar

e ad

equa

te; d

ocum

ent

the

grow

th r

ates

of e

ven

find

ings

.ps

ychr

otro

phic

spo

ilage

orga

nism

s, T

here

fore

,W

eekl

y ca

libra

tion

of

thes

e pa

ram

eter

s ar

e th

erm

omet

ers.

mor

e th

an s

uffi

cien

t to

prev

ent g

row

th o

fm

esop

hilli

c en

teri

cba

cter

ial p

atho

gens

.

the

rece

ivin

g pe

rson

nel.

cont

aine

r is

com

prom

ised

or

acti

on(s

) in

a pl

ant

and

rece

ivin

g pr

oced

ures

,

is r

ecei

ved

and

befo

redi

spos

itio

n; ta

ke c

orre

ctiv

eda

te o

f obs

erva

tion

.su

cces

sful

ly c

ompl

eted

a

Rec

ord

all f

indi

ngs

in H

AC

CP

Rec

eivi

ng p

erso

nnel

doc

umen

tsC

orre

ctiv

e A

ctio

nof

fici

al.

fore

ign

mat

eria

l is

note

d in

/on

spec

ific

log/

reco

rd.

done

by

an in

divi

dual

who

resp

onsi

ble

esta

blis

hmen

t

of r

ecor

ds; v

erif

y

Page 31: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HA

CC

P P

LA

N

PR

OC

ESS

CA

TE

GO

RY

:R

AW

, GR

OU

ND

PR

OD

UC

T E

XA

MP

LE

:G

RO

UN

D B

EE

F

PR

OC

ESS

ST

EP

DE

SCR

IPT

ION

CC

PC

RIT

ICA

L L

IMIT

SP

ER

SON

RE

SPO

NSI

BL

ER

ESP

ON

SIB

LE

RE

CO

RD

SR

ESP

ON

SIB

LE

BIO

LO

GIC

AL

C

HE

MIC

AL

PH

YSI

CA

L

MO

NIT

OR

ING

CO

RR

EC

TIV

E/P

RE

VE

NT

IVE

VE

RIF

ICA

TIO

NH

AZ

AR

DP

RO

CE

DU

RE

S/F

RE

QU

EN

CY

/A

CT

ION

/PE

RSO

NH

AC

CP

PR

OC

ED

UR

E/P

ER

SON

RE

CE

IVIN

G-

C -

Del

eter

ious

1 C

Let

ters

of g

uara

ntee

Supe

rvis

ory

revi

ew o

f let

ters

of

Est

ablis

h pr

ogra

m th

roug

hR

ecor

d al

l res

ults

Tw

ice

Wee

kly

visu

alN

ON

-ME

AT

Che

mic

als.

are

on fi

le fo

r al

lgu

aran

tee

for

each

new

purc

hasi

ng d

ept.

to a

ssur

e th

atan

d co

rrec

tive

insp

ecti

on o

f pro

duct

and

P -

For

eign

Mat

eria

l.2

PN

o vi

sibl

e or

det

ecta

ble

gu

aran

tee

for

each

shi

pmen

t.gu

aran

tee

is n

ot p

rese

nt o

r is

esta

blis

hmen

t off

icia

l.

pack

agin

g m

ater

ials

/pa

ckag

ing

mat

eria

l/non

-mea

tle

tter

s of

gua

rant

ee a

re o

n fi

leac

tion

(s) i

n a

plan

tob

serv

atio

n of

rec

eivi

ngno

n-m

eat s

uppl

ies

used

supp

ly b

roug

ht o

nto

prio

r to

del

iver

y.sp

ecif

ic lo

g/re

cord

. pr

oced

ures

, don

e by

an

by th

e es

tabl

ishm

ent.

esta

blis

hmen

t pre

mis

es.

Sign

s re

cord

, dat

ein

divi

dual

who

did

not

Spec

ific

food

con

tact

Not

ify

plan

t des

igne

e.an

d re

cord

s ti

me

ofpr

oduc

e th

e re

cord

s an

dac

cept

abili

ty m

ust

Che

ck in

com

ing

mat

eria

l/ob

serv

atio

n.w

ho h

as s

ucce

ssfu

llym

atch

that

of t

hesu

pplie

s to

see

if m

ater

ial

If p

roce

ss d

oes

not d

emon

stra

teco

mpl

eted

a c

ours

e of

inco

min

g sh

ipm

ent.

iden

tifi

cati

on m

atch

es th

eco

ntro

l wit

hin

wri

tten

HA

CC

PC

orre

ctiv

e A

ctio

nin

stru

ctio

n on

HA

CC

P, o

r

fore

ign

mat

eria

l or

unac

cept

able

, do

not a

llow

mat

ter.

Che

ck le

tter

s of

gua

rant

ee fo

rpa

ckag

ing

mat

eria

ls/n

on-m

eat

Thi

rd p

arty

aud

it o

f

acco

mpa

nyin

g le

tter

of

Pla

n pr

oced

ures

and

lett

er o

fL

og.

the

resp

onsi

ble

mat

eria

ls, s

uppl

ies

used

at t

hesu

pplie

s to

ent

er e

stab

lishm

ent;

supp

lier

on a

yea

rly

basi

s.ti

me

each

shi

pmen

t is

rece

ived

take

cor

rect

ive

acti

on to

pre

vent

and

prio

r to

rel

ease

from

the

reoc

curr

ence

; des

igna

ted

Aud

it b

y re

ceiv

ing

rece

ivin

g ar

ea to

ass

ure

that

rece

ivin

g pe

rson

nel d

ocum

ents

man

ager

to v

erif

yth

ey a

re to

be

used

as

inte

nded

.ac

tion

s ta

ken

in H

AC

CP

sam

plin

g te

chni

ques

and

Vis

ual i

nspe

ctio

n of

pro

duct

date

s an

d re

cord

s ti

me

ofve

rify

acc

urac

y of

whe

n it

is r

ecei

ved

and

prio

r to

obse

rvat

ion.

tem

pera

ture

dev

ices

;us

e in

or

on p

rodu

ct.

dete

rmin

e if

the

crit

ical

Rec

ord

all f

indi

ngs

in H

AC

CP

plan

t rec

ords

; che

ck to

see

rece

ivin

g lo

g. S

igns

rec

ord,

if c

riti

cal l

imit

is a

dequ

ate

date

s an

d re

cord

s ti

me

offo

r ha

zard

; ass

ure

obse

rvat

ion.

corr

ecti

ve a

ctio

ns a

re

rece

ivin

g lo

g. S

igns

rec

ord,

accu

racy

of r

ecor

ds;

limit

cor

resp

onds

to th

e

adeq

uate

; doc

umen

tfi

ndin

gs.

Page 32: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HA

CC

P P

LA

N

PR

OC

ESS

CA

TE

GO

RY

:R

AW

, GR

OU

ND

PR

OD

UC

T E

XA

MP

LE

:G

RO

UN

D B

EE

F

PR

OC

ESS

ST

EP

DE

SCR

IPT

ION

CC

PC

RIT

ICA

L L

IMIT

SP

ER

SON

RE

SPO

NSI

BL

ER

ESP

ON

SIB

LE

RE

CO

RD

SR

ESP

ON

SIB

LE

BIO

LO

GIC

AL

C

HE

MIC

AL

PH

YSI

CA

L

MO

NIT

OR

ING

CO

RR

EC

TIV

E/P

RE

VE

NT

IVE

VE

RIF

ICA

TIO

NH

AZ

AR

DP

RO

CE

DU

RE

S/F

RE

QU

EN

CY

/A

CT

ION

/PE

RSO

NH

AC

CP

PR

OC

ED

UR

E/P

ER

SON

STO

RA

GE

-B

- M

icro

bial

2 B

*Pro

duct

in s

tora

ge n

otE

nvir

onm

enta

l and

inte

rnal

If p

roce

ss m

onit

orin

g do

es n

otR

ecor

d al

l res

ults

Tw

ice

Wee

kly

visu

alM

EA

TG

row

th.

to e

xcee

d 40

EF

.te

mpe

ratu

re m

onit

ored

tw

ice

dem

onst

rate

con

trol

wit

hin

and

corr

ecti

vein

spec

tion

of

Env

iron

men

tal

for

the

func

tion

thro

ugh

defi

ned

proc

edur

es, c

ontr

ol a

ffec

ted

stor

age

orte

mpe

ratu

re r

ecor

ds b

y te

mpe

ratu

re w

ithi

nac

tivi

ties

.pr

oduc

t, ev

alua

te o

pera

tion

for

mai

nten

ance

an in

divi

dual

who

did

not

plan

t spe

cifi

cati

ons.

caus

e of

def

icie

ncy;

rep

air

log/

reco

rd, S

ign

prod

uce

the

reco

rds

and

Car

cass

es o

r m

eat m

ust

stor

age

log,

sig

n, d

ate,

and

devi

ce, c

oole

r; r

echi

ll or

reco

rd ti

me

ofco

mpl

eted

a c

ours

e of

be s

tore

d at

40E

F o

rre

cord

tim

e of

obs

erva

tion

.co

ndem

n pr

oduc

t; c

orre

ct o

rob

serv

atio

nin

stru

ctio

n on

HA

CC

P, o

rbe

low

. A

max

imum

of

adju

st p

roce

dure

s; t

ake

the

resp

onsi

ble

50E

F m

aint

aine

d in

Ref

rige

rati

on o

pera

tion

and

corr

ecti

ve a

ctio

n to

pre

vent

Cor

rect

ive

Act

ion

esta

blis

hmen

t off

icia

l.pr

oduc

t han

dlin

g ar

eas.

cont

rols

rou

tine

ly m

onit

ored

by

reoc

curr

ence

; pla

nt d

esig

nee

Log

.T

herm

omet

ers

mus

t be

pers

onne

l res

pons

ible

for

the

docu

men

ts a

ctio

ns ta

ken

inA

udit

to v

erif

y sa

mpl

ing

calib

rate

d an

d ac

cura

tefu

ncti

on.

HA

CC

P s

tora

ge lo

g.te

chni

ques

and

acc

urac

yto

wit

hin

+/- 1

EF

.of

rec

ords

; ver

ify

*Not

e: I

nsuf

fici

ent

once

a m

onth

and

the

resu

lts

devi

ces;

det

erm

ine

if th

esc

ient

ific

dat

a ex

ist

ente

red

in a

mai

nten

ance

log,

crit

ical

lim

it c

orre

spon

dsre

gard

ing

the

grow

th o

fsi

gned

, tim

e of

cal

ibra

tion

to th

e pl

ant r

ecor

ds; c

heck

path

ogen

s du

ring

reco

rded

and

dat

ed.

to s

ee if

cri

tica

l lim

it is

chill

ing.

How

ever

the

adeq

uate

for

haza

rd;

chill

ing

para

met

ers

assu

re c

orre

ctiv

e ac

tion

spr

ovid

ed a

bove

will

are

adeq

uate

; doc

umen

tco

ntro

l qua

lity

and

limt

find

ings

.th

e gr

owth

rat

es o

f eve

nps

ychr

otro

phic

spo

ilage

Wee

kly

eval

uati

on o

for

gani

sms,

The

refo

re,

calib

rati

ons

log

and

thes

e pa

ram

eter

s ar

e ca

libra

tion

of

mor

e th

an s

uffi

cien

t to

ther

mom

eter

s.

prev

ent g

row

th o

fm

esop

hilic

ent

eric

bact

eria

l pat

hoge

ns.

daily

by

pers

onne

l res

pons

ible

wri

tten

HA

CC

P p

lan

acti

on(s

) in

a pl

ant

ther

mom

eter

s an

d

Rec

ord

all f

indi

ngs

in H

AC

CP

and/

or r

eadj

ust r

efri

gera

tion

reco

rd, d

ate

and

who

has

suc

cess

fully

The

rmom

eter

s ar

e ca

libra

ted

Not

ify

plan

t des

igne

e.ac

cura

cy o

f tem

pera

ture

Page 33: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HA

CC

P P

LA

N

PR

OC

ESS

CA

TE

GO

RY

:R

AW

, GR

OU

ND

PR

OD

UC

T E

XA

MP

LE

:G

RO

UN

D B

EE

F

PR

OC

ESS

ST

EP

DE

SCR

IPT

ION

CC

PC

RIT

ICA

L L

IMIT

SP

ER

SON

RE

SPO

NSI

BL

ER

ESP

ON

SIB

LE

RE

CO

RD

SR

ESP

ON

SIB

LE

BIO

LO

GIC

AL

C

HE

MIC

AL

PH

YSI

CA

L

MO

NIT

OR

ING

CO

RR

EC

TIV

E/P

RE

VE

NT

IVE

VE

RIF

ICA

TIO

NH

AZ

AR

DP

RO

CE

DU

RE

S/F

RE

QU

EN

CY

/A

CT

ION

/PE

RSO

NH

AC

CP

PR

OC

ED

UR

E/P

ER

SON

STO

RA

GE

-P

- F

orei

gn M

ater

ial/

3 P

No

visi

ble

fore

ign

Vis

ual i

nspe

ctio

n of

sto

rage

If p

roce

ss m

onit

orin

g do

es n

otR

ecor

d al

l res

ults

Tw

ice

Wee

kly

visu

alN

ON

-ME

AT

Adu

lter

atio

nm

ater

ial.

room

and

non

-mea

t sup

plie

s/de

mon

stra

te c

ontr

ol w

ithi

nan

d co

rrec

tive

insp

ecti

on o

f pro

duct

don

epa

ckag

ing

mat

eria

ls p

rior

to u

sew

ritt

en H

AC

CP

pla

nac

tion

(s) i

n a

plan

tby

an

indi

vidu

al w

ho d

idin

pro

duct

by

the

indi

vidu

alpr

oced

ures

, con

trol

aff

ecte

dst

orag

e lo

g/re

cord

not p

rodu

ce th

e re

cord

sre

leas

ing

the

pack

agin

g m

ater

ial

mat

eria

l, in

gred

ient

, or

supp

ly;

and

sign

rec

ord.

and

who

has

suc

cess

fully

or n

on-m

eat i

ngre

dien

t.re

wor

k if

pos

sibl

e; c

orre

ct o

rco

mpl

eted

a c

ours

e of

Rec

ord

all f

indi

ngs

in H

AC

CP

oper

atio

n fo

r ca

use

ofL

og.

the

resp

onsi

ble

reco

rds

log,

sig

n re

cord

, dat

ede

fici

ency

; tak

e co

rrec

tive

esta

blis

hmen

t off

icia

l.an

d re

cord

tim

e of

obs

erva

tion

.ac

tion

to p

reve

nt r

eocc

urre

nce;

adju

st p

roce

dure

s; e

valu

ate

Cor

rect

ive

Act

ion

inst

ruct

ion

on H

AC

CP

, or

docu

men

t act

ions

take

n in

Aud

it r

ecor

ds to

ver

ify

HA

CC

P s

tora

ge o

r co

rrec

tive

sam

plin

g te

chni

ques

and

acti

on lo

g. S

ign

reco

rd, d

ate

accu

racy

of r

ecor

ds;

and

reco

rd ti

me

of o

bser

vati

on.

dete

rmin

e if

the

crit

ical

Not

ify

plan

t des

igne

e.pl

ant r

ecor

ds; c

heck

to s

eelim

it c

orre

spon

ds to

the

if c

riti

cal l

imit

is a

dequ

ate

for

haza

rd; a

ssur

eco

rrec

tive

act

ions

are

adeq

uate

; doc

umen

tfi

ndin

gs.

Page 34: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HA

CC

P P

LA

N

PR

OC

ESS

CA

TE

GO

RY

:R

AW

, GR

OU

ND

PR

OD

UC

T E

XA

MP

LE

:G

RO

UN

D B

EE

F

PR

OC

ESS

ST

EP

DE

SCR

IPT

ION

CC

PC

RIT

ICA

L L

IMIT

SP

ER

SON

RE

SPO

NSI

BL

ER

ESP

ON

SIB

LE

RE

CO

RD

SR

ESP

ON

SIB

LE

BIO

LO

GIC

AL

C

HE

MIC

AL

PH

YSI

CA

L

MO

NIT

OR

ING

CO

RR

EC

TIV

E/P

RE

VE

NT

IVE

VE

RIF

ICA

TIO

NH

AZ

AR

DP

RO

CE

DU

RE

S/F

RE

QU

EN

CY

/A

CT

ION

/PE

RSO

NH

AC

CP

PR

OC

ED

UR

E/P

ER

SON

ASS

EM

BL

E:

B -

Mic

robi

al3

B*P

rodu

ct te

mpe

ratu

reP

rodu

ct te

mpe

ratu

re m

onit

ored

If p

roce

ss d

oes

not d

emon

stra

teR

ecor

d al

l res

ults

Tw

ice

Wee

kly

WE

IGH

/G

row

th.

mai

ntai

ned

at o

r be

low

for

each

lot a

fter

fina

l gri

nd b

y co

ntro

l wit

hin

wri

tten

HA

CC

Pan

d co

rrec

tive

mea

sure

men

t of p

rodu

ctP

RE

-GR

IND

/40E

F d

urin

g ha

ndlin

gpe

rson

nel r

espo

nsib

le f

or th

eP

lan

proc

edur

es, i

dent

ify

and

acti

on(s

) in

a pl

ant

tem

pera

ture

s by

an

RE

-WO

RK

for

mor

e th

an 3

hou

rs.

func

tion

.co

ntro

l aff

ecte

d pr

oduc

t;pr

oces

sing

and

indi

vidu

al w

ho d

id n

otF

INA

L G

RIN

Dco

rrec

t or

adju

st p

roce

dure

s;m

icro

biol

ogic

alpr

oduc

e th

e re

cord

s an

dM

EA

TA

max

imum

of 5

0E F

Rec

ord

all f

indi

ngs

in H

AC

CP

reco

ndit

ion/

rew

ork

prod

uct;

test

ing

log

and/

orw

ho h

as s

ucce

ssfu

lly

P -

For

eign

Mat

eria

l4

Pto

wit

hin

+/- 1

EF

. m

etal

det

ecti

on d

evic

e pr

ior

toIf

fore

ign

mat

eria

l is

dete

cted

,an

d co

rrec

tive

/to

the

plan

t rec

ords

; che

ck

mai

ntai

ned

in p

rodu

ctpr

oces

sing

log,

sig

n re

cord

, dat

eev

alua

te o

pera

tion

for

caus

e of

corr

ecti

ve a

ctio

nco

mpl

eted

a c

ours

e of

hand

ling

area

s.

and

reco

rd ti

me

of o

bser

vati

on.

defi

cien

cy; t

ake

corr

ecti

velo

g. S

ign

reco

rd,

inst

ruct

ion

on H

AC

CP

, or

Gro

wth

of L

.ac

tion

to p

reve

nt r

eocc

urre

nce;

date

nd

reco

rd ti

me

the

resp

onsi

ble

mon

ocyt

ogen

es a

tpl

ant d

esig

nee

docu

men

tsof

obs

erva

tion

.es

tabl

ishm

ent o

ffic

ial.

veri

fica

tion

exc

eeds

1ac

tion

s ta

ken

in H

AC

CP

lo

g in

crea

se o

ver

init

ial

proc

essi

ng l

og, s

igns

rec

ord,

Aud

it to

ver

ify

sam

plin

gm

onit

orin

g sa

mpl

e at

date

s an

d re

cord

tim

e of

tech

niqu

es a

nd a

ccur

acy

rece

ivin

g.ob

serv

atio

n/co

rrec

tive

act

ion.

of r

ecor

ds; v

erif

y

The

rmom

eter

s m

ust b

eN

otif

y pl

ant d

esig

nee.

devi

ces;

det

erm

ine

if th

eca

libra

ted

and

accu

rate

All

prod

uct i

s ru

n th

roug

h a

Rec

ord

all r

esul

tscr

itic

al li

mit

cor

resp

onds

No

met

al p

arti

cles

toD

eter

min

e so

urce

of

log/

reco

rd a

nd/o

ras

sure

cor

rect

ive

acti

ons

exce

ed 1

/32

inch

es.

cont

amin

atio

n th

roug

hco

rrec

tive

act

ion

are

adeq

uate

; doc

umen

t

No

visi

ble

fore

ign

Per

sonn

el r

espo

nsib

le fo

r th

eda

te a

nd r

ecor

dm

ater

ial.

func

tion

doc

umen

ts a

ctio

nsti

me

ofW

eekl

y ca

libra

tion

of

than

suf

fici

ent t

osi

gns

reco

rd, d

ate,

and

rec

ord

dete

ctor

s.pr

even

t gro

wth

of

tim

e of

obs

erva

tion

/cor

rect

ive

mes

ophi

llic

ente

ric

acti

on.

bact

eria

l pat

hoge

ns.

pack

agin

g.re

tain

pro

duct

for

rew

ork

and

prev

enti

ve a

ctio

n(s)

to s

ee if

cri

tica

l lim

it is

rete

stin

g or

con

dem

n.

in a

form

ulat

ion

adeq

uate

for

haza

rd;

eval

uati

on o

f the

ope

rati

on.

log.

Sig

n re

cord

,fi

ndin

gs.

take

n in

HA

CC

P r

ecor

ds lo

g,ob

serv

atio

n.th

erm

omet

ers

and

met

al

accu

racy

of t

empe

ratu

re

Page 35: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HA

CC

P P

LA

N

PR

OC

ESS

CA

TE

GO

RY

:R

AW

, GR

OU

ND

PR

OD

UC

T E

XA

MP

LE

:G

RO

UN

D B

EE

F

PR

OC

ESS

ST

EP

DE

SCR

IPT

ION

CC

PC

RIT

ICA

L L

IMIT

SP

ER

SON

RE

SPO

NSI

BL

ER

ESP

ON

SIB

LE

RE

CO

RD

SR

ESP

ON

SIB

LE

BIO

LO

GIC

AL

C

HE

MIC

AL

PH

YSI

CA

L

MO

NIT

OR

ING

CO

RR

EC

TIV

E/P

RE

VE

NT

IVE

VE

RIF

ICA

TIO

NH

AZ

AR

DP

RO

CE

DU

RE

S/F

RE

QU

EN

CY

/A

CT

ION

/PE

RSO

NH

AC

CP

PR

OC

ED

UR

E/P

ER

SON

CO

OL

ING

AN

DB

- M

icro

bial

4 B

*Pro

duct

tem

pera

ture

Pro

duct

tem

pera

ture

s,If

pro

cess

mon

itor

ing

does

not

Rec

ord

all r

esul

tsT

wic

e W

eekl

yST

OR

AG

E O

FG

row

th.

mai

ntai

ned

at o

r be

low

mon

itor

ed p

rior

to r

elea

se fo

rde

mon

stra

te c

ontr

ol w

ithi

nan

d co

rrec

tive

mea

sure

men

t of p

rodu

ctP

RO

DU

CT

40E

F.

ship

ping

or

once

per

day

. w

ritt

en H

AC

CP

pla

nac

tion

(s) i

n a

plan

tte

mpe

ratu

res,

of

Env

iron

men

tal

mon

itor

ed e

very

4 h

ours

by

prod

uct,

adju

st, o

r re

pair

and/

or c

orre

ctiv

ete

mpe

ratu

res

done

by

ante

mpe

ratu

re d

oes

not

pers

onne

l res

pons

ible

for

the

refr

iger

atio

n un

it a

s re

quir

ed,

acti

on lo

g. S

ign

indi

vidu

al w

ho d

id n

otex

ceed

50 E

F fo

r m

ore

func

tion

.re

chill

or

cond

emn

or c

ook

reco

rd, d

ate

and

prod

uce

the

reco

rds

and

than

2 h

ours

.pr

oduc

t; c

orre

ct o

r ad

just

reco

rd ti

me

ofw

ho h

as s

ucce

ssfu

lly

The

rmom

eter

s m

ust b

eR

outi

ne m

onit

orin

g of

for

caus

e of

def

icie

ncy;

take

inst

ruct

ion

on H

AC

CP

, or

calib

rate

d an

d ac

cura

tere

frig

erat

ion

cont

ols

and

corr

ecti

ve a

ctio

n to

pre

vent

the

resp

onsi

ble

to w

ithi

n +/

- 1 E

F.

oper

atio

ns b

y pe

rson

nel

reoc

curr

ence

; pla

nt d

esig

nee

esta

blis

hmen

t off

icia

l.

*Not

e: I

nsuf

fici

ent

HA

CC

P r

ecor

ds lo

g. S

ign

Aud

it to

ver

ify

sam

plin

gsc

ient

ific

dat

a ex

ist

Rec

ord

all f

indi

ngs

in H

AC

CP

reco

rd, d

ate

and

reco

rd t

ime

ofte

chni

ques

and

acc

urac

yre

gard

ing

the

grow

th o

fst

orag

e lo

g. S

ign

reco

rd, d

ate

obse

rvat

ion/

cor

rect

ive

acti

on.

of r

ecor

ds; v

erif

ypa

thog

ens

duri

ngan

d an

d re

cord

tim

e of

accu

racy

of t

empe

ratu

rech

illin

g. H

owev

er th

eob

serv

atio

n.de

vice

s; d

eter

min

e if

the

chill

ing

para

met

ers

Not

ify

plan

t des

igne

e.cr

itic

al li

mit

cor

resp

onds

prov

ided

abo

ve w

illto

the

plan

t rec

ords

; che

ckco

ntro

l qua

lity

and

limt

to s

ee if

cri

tica

l lim

it is

the

grow

th r

ates

of e

ven

adeq

uate

for

haza

rd;

psyc

hrot

roph

ic s

poila

geas

sure

cor

rect

ive

acti

ons

orga

nism

s, T

here

fore

,ar

e ad

equa

te; d

ocum

ent

thes

e pa

ram

eter

s ar

e fi

ndin

gs.

mor

e th

an s

uffi

cien

t to

prev

ent g

row

th o

fW

eekl

y ca

libra

tion

of

mes

ophi

llic

ente

ric

ther

mom

eter

s.ba

cter

ial p

atho

gens

.

Env

iron

men

tal t

empe

ratu

repr

oced

ures

, con

trol

aff

ecte

dst

orag

e lo

g/re

cord

envi

ronm

enta

l

resp

onsi

ble

for

the

func

tion

.do

cum

ents

act

ions

take

n in

proc

edur

es; e

valu

ate

oper

atio

nob

serv

atio

n.co

mpl

eted

a c

ours

e of

Page 36: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HA

CC

P P

LA

N

PR

OC

ESS

CA

TE

GO

RY

:R

AW

, GR

OU

ND

PR

OD

UC

T E

XA

MP

LE

:G

RO

UN

D B

EE

F

PR

OC

ESS

ST

EP

DE

SCR

IPT

ION

CC

PC

RIT

ICA

L L

IMIT

SP

ER

SON

RE

SPO

NSI

BL

ER

ESP

ON

SIB

LE

RE

CO

RD

SR

ESP

ON

SIB

LE

BIO

LO

GIC

AL

C

HE

MIC

AL

PH

YSI

CA

L

MO

NIT

OR

ING

CO

RR

EC

TIV

E/P

RE

VE

NT

IVE

VE

RIF

ICA

TIO

NH

AZ

AR

DP

RO

CE

DU

RE

S/F

RE

QU

EN

CY

/A

CT

ION

/PE

RSO

NH

AC

CP

PR

OC

ED

UR

E/P

ER

SON

PA

CK

AG

ING

P -

For

eign

Mat

eria

l5

PN

o vi

sibl

e fo

reig

nP

acka

ging

per

sonn

el w

illIf

pro

cess

is n

ot in

con

trol

Rec

ord

all r

esul

tsW

eekl

y ob

serv

atio

n of

mat

eria

l pre

sent

inm

onit

or th

e m

etal

det

ecto

rw

ithi

n w

ritt

en H

AC

CP

pla

nan

d co

rrec

tive

proc

edur

es a

nd/o

r vi

sual

prod

uct.

Con

dem

nop

erat

ion

to a

ssur

e th

at it

ispr

oced

ures

, con

trol

aff

ecte

dac

tion

(s) i

n a

plan

tin

spec

tion

of p

rodu

ct b

ypr

oduc

t or

rem

ove

func

tion

ing

as d

esig

ned.

Set

ting

prod

uct,c

onde

mn,

rec

alib

rate

pack

agin

gan

indi

vidu

al w

ho d

id n

otfo

reig

n pa

rtic

les

1/32

"w

ill b

e ch

ecke

d pr

ior

to s

hift

equi

pmen

t, re

insp

ect p

rodu

ct,

log/

reco

rd a

nd/o

rpr

oduc

e th

e re

cord

s an

dor

larg

erst

art u

p. R

ecor

d al

l fin

ding

s on

and

take

act

ion

to p

reve

ntco

rrec

tive

act

ion

who

has

suc

cess

fully

calib

rati

on c

hart

, sig

n re

cord

,re

curr

ence

. R

ecor

d ac

tion

slo

g. S

ign,

rec

ord

com

plet

ed a

cou

rse

ofda

te a

nd r

ecor

d ti

me

ofta

ken

in H

AC

CP

pac

kagi

ng lo

g.

tim

e of

res

ults

and

inst

ruct

ion

on H

AC

CP

, or

obse

rvat

ion.

A

utom

atic

Sign

rec

ord,

dat

e an

d re

cord

date

rec

ord.

the

resp

onsi

ble

dete

ctor

s ar

e ca

libra

ted

once

tim

e of

obs

erva

tion

/cor

rect

ive

esta

blis

hmen

t off

icia

l.pe

r m

onth

and

the

resu

lts

acti

on.

ente

red

in a

mai

nten

ance

log,

Aud

it to

ver

ify

sam

plin

gsi

gned

, dat

ed, a

nd ti

me

ofN

otif

y pl

ant d

esig

nee.

tech

niqu

es a

nd a

ccur

acy

calib

rati

on e

nter

ed.

of r

ecor

ds; d

eter

min

e if

the

crit

ical

lim

itco

rres

pond

s to

the

plan

tre

cord

s; c

heck

to s

ee if

crit

ical

lim

it is

ade

quat

efo

r ha

zard

s; a

ssur

eco

rrec

tive

act

ions

are

adeq

uate

; doc

umen

tfi

ndin

gs.

Wee

kly

calib

rati

on o

fm

etal

det

ecti

on d

evic

e.

Page 37: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HA

CC

P P

LA

N

PR

OC

ESS

CA

TE

GO

RY

:R

AW

, GR

OU

ND

PR

OD

UC

T E

XA

MP

LE

:G

RO

UN

D B

EE

F

PR

OC

ESS

ST

EP

DE

SCR

IPT

ION

CC

PC

RIT

ICA

L L

IMIT

SP

ER

SON

RE

SPO

NSI

BL

ER

ESP

ON

SIB

LE

RE

CO

RD

SR

ESP

ON

SIB

LE

BIO

LO

GIC

AL

C

HE

MIC

AL

PH

YSI

CA

L

MO

NIT

OR

ING

CO

RR

EC

TIV

E/P

RE

VE

NT

IVE

VE

RIF

ICA

TIO

NH

AZ

AR

DP

RO

CE

DU

RE

S/F

RE

QU

EN

CY

/A

CT

ION

/PE

RSO

NH

AC

CP

PR

OC

ED

UR

E/P

ER

SON

SHIP

PIN

GB

- M

icro

bial

5 B

*Pro

duct

mus

t rea

ch a

Pro

duct

will

be

mai

ntai

ned

at o

rIf

pro

cess

doe

s no

t dem

onst

rate

Rec

ord

all r

esul

tsT

wic

e W

eekl

yG

row

th.

tem

pera

ture

of <

40 E

Fbe

low

40 E

F a

t the

tim

e of

cont

rol w

ithi

n w

ritt

en H

AC

CP

and

corr

ecti

vem

easu

rem

ent o

f pro

duct

prio

r to

leav

ing

the

ship

ping

. T

ruck

tem

pera

ture

plan

pro

cedu

res,

con

trol

acti

on(s

) in

a pl

ant

tem

pera

ture

s, o

fes

tabl

ishm

ent.

will

not

exc

eed

50 E

F p

rior

toaf

fect

ed p

rodu

ct, e

valu

ate

spec

ific

shi

ppin

gen

viro

nmen

tal

*Not

e: I

nsuf

fici

ent

mai

nten

ance

and

mon

itor

ing

oftr

ansp

ort;

cor

rect

or

adju

stre

cord

tim

e of

not p

rodu

ce th

e re

cord

ssc

ient

ific

dat

a ex

ist

refr

iger

atio

n un

it o

pera

tion

and

proc

edur

es; t

ake

corr

ecti

veob

serv

atio

n.

and

who

has

suc

cess

fully

rega

rdin

g th

e gr

owth

of

cont

rols

.ac

tion

to p

reve

nt r

eocc

urre

nce;

com

plet

ed a

cou

rse

ofpa

thog

ens

duri

ngpl

ant d

esig

nee

docu

men

tsin

stru

ctio

n on

HA

CC

P, o

rch

illin

g. H

owev

er th

eSh

ippi

ng p

erso

nnel

will

rec

ord

acti

ons

take

n in

HA

CC

Pth

e re

spon

sibl

ech

illin

g pa

ram

eter

sal

l fin

ding

s in

HA

CC

P s

hipp

ing

reco

rds

log,

sig

ns r

ecor

d an

des

tabl

ishm

ent o

ffic

ial.

prov

ided

abo

ve w

illlo

g,si

gn r

ecor

d an

d re

cord

lot #

reco

rds

tim

e of

cont

rol q

ualit

y an

dan

d ti

me

of o

bser

vati

on.

obse

rvat

ion/

corr

ecti

ve a

ctio

n.A

udit

rec

ords

to v

erif

ylim

it th

e gr

owth

rat

es o

fsa

mpl

ing

tech

niqu

es a

ndev

en p

sych

rotr

ophi

cN

otif

y pl

ant d

esig

nee.

accu

racy

of r

ecor

ds;

spoi

lage

org

anis

ms,

veri

fy a

ccur

acy

ofT

here

fore

, the

sete

mpe

ratu

re d

evic

es;

para

met

ers

are

mor

ede

term

ine

if th

e cr

itic

alth

an s

uffi

cien

t to

limit

cor

resp

onds

to th

epr

even

t gro

wth

of

plan

t rec

ords

; che

ck to

see

mes

ophi

llic

ente

ric

if c

riti

cal l

imit

is a

dequ

ate

bact

eria

l pat

hoge

ns.

for

haza

rd; a

ssur

e

load

ing.

oper

atio

n fo

r ca

use

ofan

d/or

cor

rect

ive

tem

pera

ture

s, a

nd/o

r

If p

lant

ow

ned

truc

k, r

outi

neco

ndem

n pr

oduc

t, re

ject

Sign

rec

ord

and

by a

n in

divi

dual

who

did

defi

cien

cy; r

echi

ll, r

ewor

k or

acti

on lo

g/re

cord

. tr

uck

tem

pera

ture

s, d

one

corr

ecti

ve a

ctio

ns a

read

equa

te; d

ocum

ent

find

ings

.

Wee

kly

calib

rati

on o

fth

erm

omet

ers.

Page 38: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xxxiv

Process Category Description Form

The Process Category Description Form is used to describe each food product foreach process category that is manufactured in the establishment. The description(s) answersthe following questions: 1) Common name of product; 2) How is it to be used (the intendeduse of the food by end users or consumers (the intended consumers may be the general publicor a particular segment of the population such as infants, the elderly, immune compromisedindividuals)) or another inspected establishment for further processing; 3) Type of packagingused (plastic bag/vacuum packed)); 4) Length of shelf life, and appropriate storagetemperature; 5) Where it will be sold (retail/wholesale); 6) Labeling instructions (keepfrozen/keep refrigerated, thawing and cooking instructions, safe food handling); and 7)Special distribution controls (keep frozen/keep refrigerated).

Questions 6 and 7 are optional if there are no specific labeling or special instructions.

This form describes the food and its method of distribution. This information isimportant when determining whether a significant hazard exists and how/where it can becontrolled.

Page 39: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xxxv

PROCESS DESCRIPTION

PROCESS CATEGORY : RAW, GROUND

PRODUCT EXAMPLE : FRESH PORK SAUSAGE

THE FOLLOWING QUESTIONS NEED TO BE ANSWERED WHEN DEVELOPING THEPRODUCT CATEGORY DESCRIPTION:

1. COMMON NAME? FRESH PORK SAUSAGE

2. HOW IS IT TO BE USED? COOKED AND CONSUMED

3. TYPE OF PACKAGE? BULK-PACKED (E.G., PLASTIC BAG, VACUUMPACKED); LAYER OR STACK PACKED, LINKPACKED

4. LENGTH OF SHELF LIFE, 3 - 6 MONTHS AT 0EF OR BELOWAT WHAT TEMPERATURE? 7 DAYS AT 40EF

5. WHERE WILL IT BE SOLD? RETAIL AND HRI, WHOLESALE CONSUMERS? GENERAL PUBLIC, NO DISTRIBUTION INTENDED USE? TO SCHOOLS OR HOSPITALS

6. LABELING INSTRUCTIONS? KEEP FROZEN; COOKING INSTRUCTIONS(MINIMUM INTERNAL TEMPERATURE FORCOOKING); THAWING INSTRUCTIONS; KEEPREFRIGERATED; SAFE FOOD HANDLING

LABEL

7. IS SPECIAL DISTRIBUTION KEEP FROZEN, KEEP REFRIGERATEDCONTROL NEEDED?

Product and Ingredients Form

Page 40: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xxxvi

The Product and Ingredients Form consists of a full description of the food includingthe recipe or formulation used. This should include the meat and any edible casings and alladded ingredients such as water, spices, restricted ingredients, etc. The formulation may beincluded and should indicate the amount or percentage of each ingredient in the formulation.

This form is only needed if there is more than one ingredient.

Page 41: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xxxvii

LIST PRODUCT(S) AND INGREDIENTS

PROCESS CATEGORY: RAW, GROUND

PRODUCT EXAMPLE : FRESH PORK SAUSAGE

MEAT

PORKEDIBLE CASING

INGREDIENTS

WATERSPICE MIXSUGAR

Page 42: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xxxviii

Process Flow Diagram

The Process Flow Diagram is used to provide a simple description of the stepsinvolved in the process. The diagram will be helpful to the HACCP Team in the preparationof their HACCP plan and will also serve as a future guide for regulatory officials who mustunderstand the process for their verification activities.

The flow diagram must cover all the steps in the process which are directly under thecontrol of the establishment. It can also include steps in the food chain which are before andafter the processing that occurs. For the sake of simplicity, the flow diagram should consistsolely of words, not engineering drawings.

Member(s) of the HACCP Team should use the drafted flow diagram and walkthrough the plant to follow the actual process flow as it occurs and make any adjustments, asnecessary.

Page 43: Generic HACCP Model for Raw, Ground Meat, and Poultry Products
Page 44: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xl

Hazard Analysis/Preventive Measures Form

The Hazard Analysis/Preventive Measures Form is used to take the steps listed in theProcess Flow Diagram and identify where significant hazards could occur and describe thepreventive measures, if they exist. A hazard is defined as a biological, chemical, or physicalproperty that may cause a food to be unsafe for consumption. The hazard must be of such anature that its prevention, elimination or reduction to acceptable levels is essential to theproduction of a safe food. Hazards of low risk and not likely to occur would not requirefurther consideration.

The Hazard Analysis consists of asking a series of questions which are appropriate tothe specific food process and establishment. It should question the effect of a variety offactors upon the safety of the food. Factors must be considered that may be beyond thecontrol of the processor. During the Hazard Analysis, safety concerns must be differentiatedfrom quality concerns. Each step in the process flow will be evaluated to determine if anysignificant hazards should be considered at that step. Examples of questions to be consideredduring hazard analysis have been included as Attachment 1.

The potential significance of each hazard should be assessed by considering its risk andseverity. Risk is an estimate of the likely occurrence of a hazard. Risk is usually based upon acombination of experience, epidemiological data, and information in the technical literature. Severity is the seriousness of the hazard.

Preventive Measures, if they exist, must also be identified. A preventive measure is aphysical, chemical, or other means which can be used to control an identified food safetyhazard.

The fourth column on the Hazard Analysis/Preventive Measures form is for illustrativepurposes only and need not be included in a plant specific HACCP plan.

Page 45: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xli

HAZARD ANALYSIS/PREVENTIVE MEASURES

PROCESS CATEGORY: RAW, GROUNDPRODUCT EXAMPLE: FRESH PORK SAUSAGE

Process Step HAZARDS Preventive Measures Examples of How Hazard IsBiological (B) Including Introduced MicrobiologicalChemical ( C)Physical (P)

(This may be controlled using (This column is for illustrative purpose onlyGMP’s. Not to be included in a and not to be included in a plant specificplant specific HACCP plan) HACCP plan)

RECEIVING-MEAT

B (Microbial Growth) - Insufficient Maintain product B-Transport refrigeration unit istemperature control will result in temperature at or below a not functioning properly (out ofunacceptable microbial proliferation. level sufficient to preclude freon).Ayres, J.C. 1979, Duitschaver, C.L. microbial growth.and C.I. Buteau. 1979. B-The shipping container

B Trichinae cysts pierced by a bloody forklift and

B (Mishandling) - The integrity of the wrapped around the individualimmediate container is compromised Visual inspection to ensure trays) was torn and puncturedsuch that microbial contamination no foreign material.* introducing harmful microbescould occur. into the product.

P (Foreign Material) - Visible foreign not compromised.* product from a broken light bulb;material that could compromise metal clips, knives, etc.product safety. Meat and Poultry Analysis of supplierProducts Hazards and Control Guide. history to determine

Visual inspection to ensurethat immediate container is P-Pieces of glass found in

occurrence ofcontamination.

(cardboard combo bin) was

the immediate container (the film

RECEIVING - C (Deleterious Chemicals) - Verify that the letter of C-The new tray pack “diapers”NON-MEAT Chemicals/non-meat ingredients/ guarantee is on file and ordered came in and the letter of

packaging materials, are not acceptable appropriate for product guarantee is present with thefor intended use. Food grade material use. shipment, however the lettershould be approved for intended use. states that the diapers are Bean, N.H. and P.M. Griffin, 1990. Third party audit of acceptable for industrial use and

P (Foreign Material) - Visible foreignmaterial that could compromise Visual inspection to ensure P-Pieces of metal are found in theproduct safety; metal, plastic, wood, no visible foreign material spice mix.etc. Meat and Poulty Hazards and is present.*Control Guide

supplier* not food grade.

Analysis of past history ofincidence of contaminationfrom each supplier.

Page 46: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HAZARD ANALYSIS/PREVENTIVE MEASURES

PROCESS CATEGORY: RAW, GROUNDPRODUCT EXAMPLE: FRESH PORK SAUSAGE

Process Step HAZARDS Preventive Measures Examples of How Hazard IsBiological (B) Including Introduced MicrobiologicalChemical ( C)Physical (P)

(This may be controlled using (This column is for illustrative purpose onlyGMP’s. Not to be included in a and not to be included in a plant specificplant specific HACCP plan) HACCP plan)

xlii

STORAGE - B (Microbial Growth) - Insufficient Monitor the internal B-Cooler generator breaks downMEAT cooling could result in unacceptable product temperature to and the ambient room

microbial growth. Internal product ensure temperature is at or temperature in the coolertemperature and environmental below a level sufficient to increases above 50 EF for 10temperature must be monitored. preclude microbial growth hours increasing productAyres, J.C. 1979, Johnston, R.W. et.al. and environmental temperature above 40 EF1982. temperature does not permitting excessive bacterial

exceed 50 EF for more growth.than 2 hours (e.g. cooler orfreezer) to ensure productsafety.

STORAGE - P (Foreign Material/Adulteration) - All Visual inspection of P-The product is stored directlyNON-MEAT non-meat ingredients, packaging storage area to ensure that against the walls which have

materials, etc. must be stored to materials are maintained visible debris on them. Theprevent contamination due to foreign in a proper manner(off the debris falls onto the packagingmaterial. floor and away from materials that contact product.**

walls).

Page 47: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HAZARD ANALYSIS/PREVENTIVE MEASURES

PROCESS CATEGORY: RAW, GROUNDPRODUCT EXAMPLE: FRESH PORK SAUSAGE

Process Step HAZARDS Preventive Measures Examples of How Hazard IsBiological (B) Including Introduced MicrobiologicalChemical ( C)Physical (P)

(This may be controlled using (This column is for illustrative purpose onlyGMP’s. Not to be included in a and not to be included in a plant specificplant specific HACCP plan) HACCP plan)

xliii

ASSEMBLE/ B (Microbial Growth) - Insufficient Monitor ambient room B-As a result of a mechanicalPRE-WEIGH/ control of internal product temperature temperature and product breakdown, the productPRE-GRIND/ and environmental temperature could temperature to ensure movement into the cooling cycleRE-WORK result in unacceptable microbial temperature of product was delayed 6 hours and theFINAL GRIND growth. Ayres, J.C. 1979, Comi, G. et. does not exceed a level product temperature increasesMEAT al., 1992. sufficient to preclude above 55EF due to exposure to

P (Foreign Materials) - Visible foreign than 2 hours, and the roommaterial that could compromise temperature does not P-Moving parts of the grinder areproduct safety; metal and plastic exceed 50 EF for more not set properly or are worn andshavings, rubber gloves, bone, etc. than 4 hours. grind together leaving pieces ofMeat and Poultry Products Hazards metal in the product.and Control Guide.Surkiewics, B.F.,et al. 1972.

microbial growth for more ambient room temperature.

Visual or mechanicalinspection to ensure nohazardous foreign materialis present.Equipment maintenanceona routine basis.

**This may be controlledusing the SSOP.

ASSEMBLE/ NONEPRE-WEIGHNON-MEAT

FORMULATION P (Foreign Materials) - Visible foreign Visual or mechanical P-The product was not properlymaterial that could compromise inspection to ensure no ground and large sharp pieces ofproduct safety; metal and plastic foreign material is present. bone are still present in theshavings, bone, etc. product.

Each plant should reviewtheir history of physicalcontamination incidence todetermine the level of riskand the appropriate pointfor addressing the physicalhazard.

Page 48: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HAZARD ANALYSIS/PREVENTIVE MEASURES

PROCESS CATEGORY: RAW, GROUNDPRODUCT EXAMPLE: FRESH PORK SAUSAGE

Process Step HAZARDS Preventive Measures Examples of How Hazard IsBiological (B) Including Introduced MicrobiologicalChemical ( C)Physical (P)

(This may be controlled using (This column is for illustrative purpose onlyGMP’s. Not to be included in a and not to be included in a plant specificplant specific HACCP plan) HACCP plan)

xliv

SAUSAGE C: N/A Each plant should review P- The stuffer was not routinelySTUFFER their history of physical maintained and worn metal

P:(Foreign Materials) - Visible foreign contamination incidence to pieces from the stuffing hornmaterial that could compromise determine the level of risk contaminated the product.product safety; metal and plastic and the appropriate pointshavings, bone, etc. for addressing the physical

hazard.

PACKAGING/ B: Trichinosis due to undercooking by B-Apply safe foodLABELING consumer. handling label.

C: None identifiedP: None identified

COOLING AND B (Microbial Growth) - Product Maintain product at B-Continuous temperatureSTORAGE OF temperature if not maintained at an temperature adequate to recording device has not beenPRODUCT acceptable level would result in an limit microbial growth. calibrated for weeks and is not

increase in microbial growth. Cooling recording actual ambient roomrates must be sufficient to limit the Assure that the temperatures. The actual ambientgrowth of enteric pathogens and temperature and recording room temperature is 27 degreesbacteria of human health significance. device used are higher than it should be,Ayres, J.C. 1979 appropriately calibrated. increasing product temperature toBuchanan, R.L. and L.A. Klawilter. the point where bacteria can1992. Product is arranged to proliferate and/or spoilage can

assure adequate airflow to occur.maintain acceptable temperature (# 40 EF)throughout all parts ofproduct.

Monitoring the ambientcooler room temperature toassure product temperatureis adequate to limitmicrobial growth.

SHIPPING B (Microbial Growth) - Potential for an Product temperature must Product was not #40EF before itincrease in bacterial flora and other be #40EF prior to leaving left the dock and microbialenteric pathogens that will proliferate the establishment. proliferation resulted duringon the product if the temperature transport.significantly increases over time Refrigerated transport.during transport. Ayres, J.C. 1979

Page 49: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xlv

CCP Determination Form

The Critical Control Point (CCP) Determination form is used to identify the criticalcontrol points in the process. A critical control point is defined as a point, step, or procedureat which control can be applied and a food safety hazard can be prevented, eliminated, orreduced to an acceptable level. All significant hazards identified in the hazard analysis must beaddressed. Identification of each CCP can be facilitated by the use of a CCP Decision Tree(See Attachment 2). The Decision Tree asks a series of four, yes or no, questions to assist indetermining if a particular step is a CCP for a previously identified hazard. These fourquestions are listed at the top of the CCP Determination form. Use this as a guide whendetermining if an identified significant hazard is a critical control point. CCP’s must becarefully developed and documented and must be for product safety only. Different facilitiespreparing the same food can differ in the risk of hazards and the points, steps, or procedureswhich are CCP’s. This can be due to differences in each facility such as layout, equipment,selection of ingredients, or the process that is employed.

In this document the CCP’s that are identified are for illustrative purposes only. Yourindividual process will determine the CCP’s identified. Remember that Sanitation StandardOperating Procedures and maintenance programs are essential prerequisites to HACCP.

Page 50: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

CC

P D

ET

ER

MIN

AT

ION

(A C

RIT

ICA

L C

ON

TR

OL

PO

INT

IS

DE

FIN

ED

AS

A P

OIN

T, S

TE

P O

R P

RO

CE

DU

RE

AT

WH

ICH

CO

NT

RO

L C

AN

BE

AP

PL

IED

AN

D A

FO

OD

SA

FE

TY

HA

ZA

RD

CA

N B

E P

RE

VE

NT

ED

, EL

IMIN

AT

ED

, OR

RE

DU

CE

D T

O A

CC

EP

TA

BL

E L

EV

EL

S)

PR

OC

ESS

STE

PH

AZ

AR

D(S

)

Q1.

DO

PR

EV

EN

TIV

EQ

2. D

OE

S T

HIS

ST

EP

Q3.

CO

UL

DQ

4. W

ILL

AM

EA

SUR

ES

EX

IST

FO

RE

LIM

INA

TE

OR

CO

NT

AM

INA

TIO

N W

ITH

SUB

SEQ

UE

NT

ST

EP

#C

CP

T

HE

ID

EN

TIF

IED

RE

DU

CE

TH

E L

IKE

LY

IDE

NT

IFIE

D H

AZ

AR

D(S

)E

LIM

INA

TE

HA

ZA

RD

(S)

HA

ZA

RD

(S)?

OC

CU

RR

EN

CE

OF

AO

CC

UR

IN

EX

CE

SS O

FO

R R

ED

UC

E T

HE

LIK

EL

Y

*If n

o=no

t a C

CP

-Ide

ntif

y ho

w a

ndw

here

this

haz

ard

will

be

cont

rolle

d.

* I

f yes

= m

ove

to n

ext q

uest

ion.

HA

ZA

RD

(S) T

O A

NA

CC

EP

TA

BL

E L

EV

EL

S O

RO

CC

UR

RE

NC

E T

O A

NA

CC

EP

TA

BL

E L

EV

EL

?C

OU

LD

TH

ESE

IN

CR

EA

SEA

CC

EP

TA

BL

E L

EV

EL

?

TO

UN

AC

CE

PT

AB

LE

*If n

o=m

ove

to th

e ne

xt q

uest

ion.

*If y

es=C

CP

LE

VE

LS?

*If n

o=no

t a C

CP

.

*If y

es=m

ove

to th

e ne

xt q

uest

ion.

*If n

o=C

CP

.

*If y

es=n

ot a

CC

P.

Rec

eivi

ng-M

eat

B -

Mic

robi

al G

row

th.

NO

*E

sta

blis

hmen

t’s o

nly

supp

lier

has

an

oper

atin

g H

AC

CP

sys

tem

for

prod

uct

ion

and

tra

nspo

rta

tion

of m

eat p

rodu

cts.

P -

For

eign

Ma

teria

l. T

his

NO

is c

ontr

olle

d by

su

pplie

rsp

ecifi

catio

n pr

oced

ure

s

Rec

eivi

ng-N

on-M

eat

B -

N/A

C -

Del

eter

iou

s C

hem

ica

ls.

YE

SY

ES

CC

P 1

C

P -

For

eign

Ma

teria

l.Y

ES

YE

SC

CP

1P

Stor

age-

Mea

tB

- M

icro

bia

l Gro

wth

.Y

ES

YE

SC

CP

1B

C -

N/A

- in

-pla

nt c

hem

ica

l con

tam

ina

tion

- lo

w in

cide

nce

-

cont

rolle

d by

SS

OP

’s

P -

N/A

- n

o si

gnifi

cant

ha

zard

s id

entif

ied

Stor

age-

Non

-Mea

tB

- N

/A -

no

sign

ifica

nt h

aza

rds

iden

tifie

d

C -

N/A

-

low

like

hood

of o

ccu

rren

ce

P -

For

eign

YE

SY

ES

Thi

s m

ay

be c

ontr

olle

dC

CP

2P

*M

ate

rial/A

dulte

ratio

n.th

rou

gh p

lant

GM

Ps

if C

CP

3P

is p

art

of t

he H

AC

CP

pla

n.

Ass

embl

e/P

re-W

eigh

/B

- M

icro

bia

l Gro

wth

.Y

ES

YE

SC

CP

2B

Pre

-Gri

nd/R

e-w

ork/

Fin

al G

rind

- M

eat

C -

N/A

P -

For

eign

Ma

teria

l.Y

ES

NO

YE

SY

ES

Page 51: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

CC

P D

ET

ER

MIN

AT

ION

(A C

RIT

ICA

L C

ON

TR

OL

PO

INT

IS

DE

FIN

ED

AS

A P

OIN

T, S

TE

P O

R P

RO

CE

DU

RE

AT

WH

ICH

CO

NT

RO

L C

AN

BE

AP

PL

IED

AN

D A

FO

OD

SA

FE

TY

HA

ZA

RD

CA

N B

E P

RE

VE

NT

ED

, EL

IMIN

AT

ED

, OR

RE

DU

CE

D T

O A

CC

EP

TA

BL

E L

EV

EL

S)

PR

OC

ESS

STE

PH

AZ

AR

D(S

)

Q1.

DO

PR

EV

EN

TIV

EQ

2. D

OE

S T

HIS

ST

EP

Q3.

CO

UL

DQ

4. W

ILL

AM

EA

SUR

ES

EX

IST

FO

RE

LIM

INA

TE

OR

CO

NT

AM

INA

TIO

N W

ITH

SUB

SEQ

UE

NT

ST

EP

#C

CP

T

HE

ID

EN

TIF

IED

RE

DU

CE

TH

E L

IKE

LY

IDE

NT

IFIE

D H

AZ

AR

D(S

)E

LIM

INA

TE

HA

ZA

RD

(S)

HA

ZA

RD

(S)?

OC

CU

RR

EN

CE

OF

AO

CC

UR

IN

EX

CE

SS O

FO

R R

ED

UC

E T

HE

LIK

EL

Y

*If n

o=no

t a C

CP

-Ide

ntif

y ho

w a

ndw

here

this

haz

ard

will

be

cont

rolle

d.

* I

f yes

= m

ove

to n

ext q

uest

ion.

HA

ZA

RD

(S) T

O A

NA

CC

EP

TA

BL

E L

EV

EL

S O

RO

CC

UR

RE

NC

E T

O A

NA

CC

EP

TA

BL

E L

EV

EL

?C

OU

LD

TH

ESE

IN

CR

EA

SEA

CC

EP

TA

BL

E L

EV

EL

?

TO

UN

AC

CE

PT

AB

LE

*If n

o=m

ove

to th

e ne

xt q

uest

ion.

*If y

es=C

CP

LE

VE

LS?

*If n

o=no

t a C

CP

.

*If y

es=m

ove

to th

e ne

xt q

uest

ion.

*If n

o=C

CP

.

*If y

es=n

ot a

CC

P.

For

mul

atio

nB

- N

/AC

ontr

olle

d at

mea

t for

mul

atio

nan

d st

orag

e

C -

N/A

P - F

orei

gn M

ater

ial.

YE

SN

OY

ES

NO

CC

P 3P

Coo

ling

and

Stor

age

ofB

- M

icro

bial

Gro

wth

.Y

ES

YE

SC

CP

3BP

rodu

ctC

- N

/A

P - N

/A

Ship

ping

B -

Mic

robi

al G

row

th.

YE

SY

ES

CC

P 4B

C -

N/A

P - N

/A

Page 52: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xlviii

HACCP Plan Form

The HACCP Plan Form is used to develop a Plant Specific HACCP Plan. This plancan serve as a useful guide, however, it is essential that the unique conditions within eachfacility be considered during the development of the plant specific plan. The first threecolumns on the form are transferred from the CCP Determination Form. The fourth column isused to establish critical limits for preventive measures associated with each identified CCP.

A critical limit is defined as the maximum or minimum value to which a physical,biological, or chemical hazard must be controlled at a CCP to prevent, eliminate, or reduce toan acceptable level the occurrence of the identified food safety hazard. Each CCP will haveone or more preventive measures that must be properly controlled to assure prevention,elimination, or reduction of hazards to acceptable levels. Critical Limits may be derived fromsources such as regulatory standards and guidelines, literature surveys, experimental studiesand subject matter, or technical experts. The fifth column is used to establish monitoringrequirements.

Monitoring is a planned sequence of observations or measurements to assess whethera CCP is under control and to produce an accurate record for future use in verification. Monitoring is essential to food safety management by tracking the HACCP system’soperation. If monitoring indicates that there is a trend towards loss of control, then action canbe taken to bring the process back into control before a deviation occurs. Monitoringprovides written documentation for use in verification of the HACCP plan. All records anddocuments associated with CCP monitoring must be signed, dated, and the time recorded bythe person doing the monitoring.

Column six is used to establish corrective actions to be taken when monitoringindicates that there is a deviation from an established critical limit. Where there is a deviationfrom established critical limits, corrective action plans must be in place to: 1) determine thedisposition of non-compliant product; 2) fix or correct the cause of non-compliant product toassure that the CCP is under control; 3) maintain records of the corrective actions that havebeen taken where there has been a deviation from critical limits; and, 4) assure that no productthat is injurious to health or otherwise aduterated as a result of the deviation enters commerce. Because of the variations in CCP’s for different processes and the diversity of possibledeviations, specific corrective actions must be developed for each CCP. The actions mustdemonstrate that the CCP has been brought under control. Documentation of the correctiveactions taken must be signed by the individual responsible for taking corrective actions.

Column seven is used to establish effective recordkeeping procedures that documentthe HACCP system. The maintenance of proper HACCP records is an essential part of theHACCP system to document that each CCP is under control and to verify the adequacy of theHACCP plan. Records serve as: 1) a written documentation of the establishment’s compliance

Page 53: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xlix

with their HACCP plan; 2) the only reference available to trace the history of an ingredient,in-process operation, or a finished product, should problems arise; 3) a ready source of information to identify trends in a particular operation that may result in adeviation if not properly corrected; and, 4) good evidence in potential legal actions againstthe establishment. In accordance with the HACCP principles, HACCP records must include: records associated with establishing critical limits, records for the handling of deviations, andrecords associated with verification of the HACCP plan. It is also very important that allHACCP records dealing with plant operations at CCP’s and corrective actions taken bereviewed on a daily basis by a designated individual who must sign, date and record the timeall records are reviewed. The approved HACCP plan and associated records must be on fileat the meat or poultry establishment.

Column eight of the HACCP plan establishes procedures for verification that theHACCP system is working correctly. The verification process is designed to review theHACCP plan; to establish whether the CCP’s and critical limits have been properly establishedand are being adequately controlled and monitored; and, to determine if the procedures forhandling process deviations and recordkeeping practices are being followed.

The effective completion of this step is crucial since here is where you will define yourcritical limits that will be used to determine process control at each particular CCP.

Page 54: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HA

CC

P P

LA

N

PR

OC

ESS

CA

TE

GO

RY

:R

AW

, GR

OU

ND

PR

OD

UC

T E

XA

MP

LE

:F

RE

SH P

OR

K S

AU

SAG

E

PR

OC

ESS

ST

EP

DE

SCR

IPT

ION

CC

PC

RIT

ICA

L L

IMIT

SP

ER

SON

RE

SPO

NSI

BL

ER

ESP

ON

SIB

LE

RE

CO

RD

SSO

N

BIO

LO

GIC

AL

C

HE

MIC

AL

PH

YSI

CA

L

MO

NIT

OR

ING

CO

RR

EC

TIV

E/P

RE

VE

NT

IVE

VE

RIF

ICA

TIO

NH

AZ

AR

DP

RO

CE

DU

RE

S/F

RE

QU

EN

CY

/A

CT

ION

/PE

RSO

NH

AC

CP

PR

OC

ED

UR

E/P

ER

RE

SPO

NSI

BL

E

RE

CE

IVIN

G -

B -

Mic

robi

al1

BT

empe

ratu

re w

ithi

nIn

tern

al te

mpe

ratu

re m

onit

ored

If p

rodu

ct te

mpe

ratu

re e

xcee

dsR

ecor

d al

l res

ults

Bi-

wee

kly

visu

alM

EA

TG

row

th.

plan

t spe

cifi

cati

ons.

*as

pro

duct

is r

ecei

ved

by40

EF

, im

med

iate

con

tain

er is

and

corr

ecti

veob

serv

atio

n of

B -

Mis

hand

ling

Imm

edia

te c

onta

iner

isV

isua

l ins

pect

ion

of im

med

iate

prod

uct:

iden

tify

and

con

trol

and/

or c

orre

ctiv

epr

oced

ures

, don

e by

P -

For

eign

Mat

eria

l.1

PN

o vi

sibl

e ha

zard

ous

rece

ivin

g pe

rson

nel.

corr

ecti

ve a

ctio

n to

pre

vent

Aud

it to

ver

ify

clea

n an

d in

tact

.co

ntai

ner

at th

e ti

me

each

affe

cted

pro

duct

for

disp

osit

ion

acti

on lo

g an

d si

gnre

ceiv

ing

man

ager

.

fore

ign

mat

eria

l.**

reoc

curr

ence

. sa

mpl

ing

tech

niqu

es

* C

arca

sses

or

red

mea

tre

ceiv

ing

log,

sig

ns, a

nd d

ates

tem

pera

ture

mus

t be

rece

ived

at 4

0 Ere

cord

.de

vice

s; d

eter

min

e if

F o

r be

low

.th

e C

riti

cal L

imit

* N

ote:

Ins

uffi

cien

tpl

ant r

ecor

ds; c

heck

scie

ntif

ic d

ata

exis

tto

see

if C

riti

cal

rega

rdin

g th

e gr

owth

of

Lim

it is

ade

quat

epa

thog

ens

duri

ngfo

r ha

zard

; ass

ure

chill

ing

para

met

ers

corr

ecti

ve a

ctio

nspr

ovid

ed a

bove

will

are

adeq

uate

;co

ntro

l qua

lity

and

docu

men

t fin

ding

s.lim

it th

e gr

owth

rat

es o

fev

en p

sych

rotr

ophi

cW

eekl

y ca

libra

tion

spoi

lage

org

anis

ms.

of

ther

mom

eter

s.T

here

fore

, the

sepa

ram

eter

s ar

e m

ore

than

suf

fici

ent t

opr

even

t gro

wth

of

mes

ophi

lic e

nter

icba

cter

ial p

atho

gens

.

** C

onde

mn

prod

uct o

rre

mov

e pa

rtic

les

1/32

"or

larg

er.

qual

ifie

d pe

rson

nel.

com

prom

ised

or

fore

ign

acti

on(s

) in

a pl

ant

prod

uct a

nd

ship

men

t is

rece

ived

by

or r

etur

n to

sup

plie

r; ta

kere

cord

.

Rec

ord

all f

indi

ngs

in H

AC

CP

and

accu

racy

of

rece

ivin

g lo

g, s

ign,

and

dat

eP

lant

des

igne

e do

cum

ents

reco

rds;

ver

ify

reco

rd.

acti

ons

take

n in

HA

CC

Pac

cura

cy o

f

mat

eria

l is

note

d in

/on

the

mea

tsp

ecif

ic lo

g/re

cord

rece

ivin

g

corr

espo

nds

to th

e

Page 55: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HA

CC

P P

LA

N

PR

OC

ESS

CA

TE

GO

RY

:R

AW

, GR

OU

ND

PR

OD

UC

T E

XA

MP

LE

:F

RE

SH P

OR

K S

AU

SAG

E

PR

OC

ESS

ST

EP

DE

SCR

IPT

ION

CC

PC

RIT

ICA

L L

IMIT

SP

ER

SON

RE

SPO

NSI

BL

ER

ESP

ON

SIB

LE

RE

CO

RD

SSO

N

BIO

LO

GIC

AL

C

HE

MIC

AL

PH

YSI

CA

L

MO

NIT

OR

ING

CO

RR

EC

TIV

E/P

RE

VE

NT

IVE

VE

RIF

ICA

TIO

NH

AZ

AR

DP

RO

CE

DU

RE

S/F

RE

QU

EN

CY

/A

CT

ION

/PE

RSO

NH

AC

CP

PR

OC

ED

UR

E/P

ER

RE

SPO

NSI

BL

E

RE

CE

IVIN

G- N

ON

-C

- D

elet

erio

us1

CL

ette

rs o

f gua

rant

eeSu

perv

isor

y re

view

of l

ette

rs o

fE

stab

lish

prog

ram

thro

ugh

Rec

ord

all r

esul

tsT

wic

e w

eekl

yM

EA

TC

hem

ical

s.ar

e on

file

for

all

guar

ante

e fo

r ea

ch n

ewpu

rcha

sing

dep

t. to

ass

ure

that

and

corr

ecti

vein

spec

tion

of

P -

For

eign

Mat

eria

l.2

PN

o vi

sibl

e fo

reig

nid

enti

fica

tion

mat

ches

the

cont

rol w

ithi

n w

ritt

en H

AC

CP

Yea

rly

audi

t of

pack

agin

g m

ater

ials

/pa

ckag

ing

mat

eria

l/non

-mea

tle

tter

s of

gua

rant

ee fo

r ea

chac

tion

(s) i

n a

plan

tpr

oduc

t and

non-

mea

t sup

plie

s us

edsu

pply

bro

ught

ont

oin

gred

ient

and

pac

kagi

ngsp

ecif

ic lo

g/re

cord

obse

rvat

ion

ofby

the

esta

blis

hmen

tes

tabl

ishm

ent p

rem

ises

.m

ater

ial a

re o

n fi

le p

rior

toan

d/or

cor

rect

ive

rece

ivin

gth

at s

peci

fy fo

od g

rade

deliv

ery.

acti

on lo

g. S

ign

proc

edur

es, d

one

bym

ater

ial m

ust b

e us

ed.

Che

ck in

com

ing

mat

eria

l/re

cord

and

dat

e.qu

alif

ied

pers

onne

l

mat

eria

l.ac

com

pany

ing

lett

er o

fP

lan

proc

edur

es a

nd le

tter

of

supp

liers

by

thir

d

supp

lies

to s

ee if

mat

eria

lIf

pro

cess

doe

s no

t dem

onst

rate

guar

ante

e.gu

aran

tee

is n

ot p

rese

nt o

rpa

rty.

Che

ck le

tter

s of

gua

rant

ee a

tpa

ckag

ing

mat

eria

ls/n

on-m

eat

Aud

it to

ver

ify

appr

opri

ate

tim

es fo

rsu

pplie

s to

ent

er e

stab

lishm

ent;

sam

plin

g te

chni

ques

mat

eria

ls/s

uppl

ies

used

on

ata

ke c

orre

ctiv

e ac

tion

to p

reve

ntan

d ac

cura

cy o

fco

ntin

uous

bas

is to

ass

ure

reoc

curr

ence

; pla

nt d

esig

nee

reco

rds;

ver

ify

com

plia

nce.

docu

men

ts a

ctio

ns ta

ken

inac

cura

cy o

f

Vis

ual i

nspe

ctio

n of

pro

duct

at

reco

rd.

devi

ces;

det

erm

ine

ifap

prop

riat

e ti

mes

by

qual

ifie

dth

e cr

itic

al li

mit

pers

onne

l.co

rres

pond

s to

the

Rec

ord

all f

indi

ngs

in H

AC

CP

to s

ee if

cri

tica

l lim

itre

cord

s lo

g an

d si

gn r

ecor

d.N

otif

y pl

ant d

esig

nee.

is a

dequ

ate

for

acce

ptab

le, d

o no

t allo

w

HA

CC

P r

ecor

ds lo

g an

d si

gns

tem

pera

ture

plan

t rec

ords

; che

ck

haza

rd; a

ssur

eco

rrec

tive

act

ions

are

adeq

uate

;do

cum

ent f

indi

ngs.

Page 56: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HA

CC

P P

LA

N

PR

OC

ESS

CA

TE

GO

RY

:R

AW

, GR

OU

ND

PR

OD

UC

T E

XA

MP

LE

:F

RE

SH P

OR

K S

AU

SAG

E

PR

OC

ESS

ST

EP

DE

SCR

IPT

ION

CC

PC

RIT

ICA

L L

IMIT

SP

ER

SON

RE

SPO

NSI

BL

ER

ESP

ON

SIB

LE

RE

CO

RD

SSO

N

BIO

LO

GIC

AL

C

HE

MIC

AL

PH

YSI

CA

L

MO

NIT

OR

ING

CO

RR

EC

TIV

E/P

RE

VE

NT

IVE

VE

RIF

ICA

TIO

NH

AZ

AR

DP

RO

CE

DU

RE

S/F

RE

QU

EN

CY

/A

CT

ION

/PE

RSO

NH

AC

CP

PR

OC

ED

UR

E/P

ER

RE

SPO

NSI

BL

E

STO

RA

GE

- M

EA

TB

- M

icro

bial

1 B

Env

iron

men

tal a

ndE

nvir

onm

enta

l and

inte

rnal

If p

roce

ss d

oes

not d

emon

stra

teR

ecor

d al

l res

ults

Tw

ice

wee

kly

visu

alG

row

th.

inte

rnal

tem

pera

ture

tem

pera

ture

mon

itor

ed a

tco

ntro

l wit

hin

wri

tten

HA

CC

Pan

d co

rrec

tive

insp

ecti

on a

ndw

ithi

n pl

ant

appr

opri

ate

tim

es b

y qu

alif

ied

plan

pro

cedu

res,

con

trol

acti

on(s

) in

a pl

ant

tem

pera

ture

che

cksp

ecif

icat

ions

.pe

rson

nel.

affe

cted

pro

duct

, rec

hill

spec

ific

log/

reco

rdof

pro

duct

don

e by

a

Car

cass

es o

r m

eat m

ust

Mon

itor

ref

rige

rati

onre

frig

erat

ion

devi

ce, c

oole

r,ac

tion

log.

Sig

nno

t pro

duce

the

be s

tore

d at

40E

F o

rpa

ram

eter

s da

ily b

yco

rrec

t or

adju

st p

roce

dure

s;re

cord

and

rec

ord

reco

rds

and

who

belo

w.

A m

axim

um o

fm

aint

enen

ce p

erso

nnel

.ev

alua

te o

pera

tion

for

caus

e of

tim

e of

succ

essf

ully

50E

F m

aint

aine

d in

defi

cien

cy; t

ake

corr

ecti

veob

serv

atio

n.co

mpl

eted

a c

ours

epr

oduc

t han

dlin

gac

tion

to p

reve

nt r

eocc

urre

nce;

of in

stru

ctio

n in

area

s.*

plan

t des

igne

e do

cum

ents

HA

CC

P, o

r th

e

*Not

e: I

nsuf

fici

ent

reco

rds

log

and

sign

s re

cord

.es

tabl

ishm

ent

scie

ntif

ic d

ata

exis

tof

fici

al.

rega

rdin

g th

e gr

owth

of

Rec

ord

all f

indi

ngs

in H

AC

CP

Not

ify

plan

t des

igne

e.pa

thog

ens

duri

ngre

cord

s lo

g an

d si

gn r

ecor

d,A

udit

to v

erif

ych

illin

g pa

ram

eter

sda

te, a

nd r

ecor

d ti

me

ofsa

mpl

ing

tech

niqu

espr

ovid

ed a

bove

will

obse

rvat

ion.

and

accu

racy

of

cont

rol q

ualit

y an

dre

cord

s; v

erif

ylim

it th

e gr

owth

rat

es o

fac

cura

cy o

fev

en p

sych

rotr

ophi

cte

mpe

ratu

resp

oila

ge o

rgan

ism

s.

devi

ces;

det

erm

ine

ifT

here

fore

, the

seth

e cr

itic

al li

mit

para

met

ers

are

mor

eco

rres

pond

s to

the

than

suf

fici

ent t

opl

ant r

ecor

ds; c

heck

prev

ent g

row

th o

fto

see

if c

riti

cal l

imit

mes

ophi

lic e

nter

icis

ade

quat

e fo

rba

cter

ial p

atho

gens

.ha

zard

; ass

ure

prod

uct;

repa

ir a

nd/o

r re

adju

stan

d/or

cor

rect

ive

indi

vidu

al w

ho d

id

acti

ons

take

n in

HA

CC

Pre

spon

sibl

e

corr

ecti

ve a

ctio

nsar

e ad

equa

te;

docu

men

t fin

ding

s.

Wee

kly

calib

rati

ons

of th

erm

omet

ers.

Page 57: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HA

CC

P P

LA

N

PR

OC

ESS

CA

TE

GO

RY

:R

AW

, GR

OU

ND

PR

OD

UC

T E

XA

MP

LE

:F

RE

SH P

OR

K S

AU

SAG

E

PR

OC

ESS

ST

EP

DE

SCR

IPT

ION

CC

PC

RIT

ICA

L L

IMIT

SP

ER

SON

RE

SPO

NSI

BL

ER

ESP

ON

SIB

LE

RE

CO

RD

SSO

N

BIO

LO

GIC

AL

C

HE

MIC

AL

PH

YSI

CA

L

MO

NIT

OR

ING

CO

RR

EC

TIV

E/P

RE

VE

NT

IVE

VE

RIF

ICA

TIO

NH

AZ

AR

DP

RO

CE

DU

RE

S/F

RE

QU

EN

CY

/A

CT

ION

/PE

RSO

NH

AC

CP

PR

OC

ED

UR

E/P

ER

RE

SPO

NSI

BL

E

STO

RA

GE

-P

- F

orei

gn M

ater

ial/

2 P

No

visi

ble

fore

ign

Vis

ual i

nspe

ctio

n of

sto

rage

If p

roce

ss d

oes

not d

emon

stra

teR

ecor

d al

l res

ults

Wee

kly

visu

alN

ON

-ME

AT

Adu

lter

atio

nm

ater

ial.

room

and

rep

rese

ntat

ive

sam

ple

cont

rol w

ithi

n w

ritt

en H

AC

CP

and

corr

ecti

vein

spec

tion

of

insp

ecti

on fo

r fo

reig

n m

ater

ial

plan

pro

cedu

res,

con

trol

acti

on(s

) in

a pl

ant

prod

uct a

nd r

oom

of n

on-m

eat s

uppl

ies/

affe

cted

pro

duct

, rec

hill

spec

ific

log/

reco

rdby

an

indi

vidu

alpa

ckag

ing

mat

eria

ls a

tpr

oduc

t; c

orre

ct o

r ad

just

and/

or c

orre

ctiv

ew

ho d

id n

ot p

rodu

ceap

prop

riat

e ti

mes

by

qual

ifie

dpr

oced

ures

; eva

luat

e op

erat

ion

acti

on lo

g. S

ign

the

reco

rds

and

who

pers

onne

l.fo

r ca

use

of d

efic

ienc

y; ta

kere

cord

and

rec

ord

succ

essf

ully

Rec

ord

all f

indi

ngs

in H

AC

CP

reoc

curr

ence

; pla

nt d

esig

nee

obse

rvat

ion.

of in

stru

ctio

n in

reco

rds

log

and

sign

rec

ord.

docu

men

ts a

ctio

ns ta

ken

inH

AC

CP

, or

the

corr

ecti

ve a

ctio

n to

pre

vent

tim

e of

com

plet

ed a

cou

rse

HA

CC

P r

ecor

ds lo

g an

d si

gns

resp

onsi

ble

reco

rd.

esta

blis

hmen

tof

fici

al.

Aud

it to

ver

ify

sam

plin

g te

chni

ques

and

accu

racy

of

reco

rds;

ver

ify

accu

racy

of

tem

pera

ture

devi

ces;

det

erm

ine

ifth

e cr

itic

al li

mit

corr

espo

nds

to th

epl

ant r

ecor

ds; c

heck

to s

ee if

cri

tica

l lim

itis

ade

quat

e fo

rha

zard

; ass

ure

corr

ecti

ve a

ctio

nsar

e ad

equa

te;

docu

men

t fin

ding

s.

Page 58: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HA

CC

P P

LA

N

PR

OC

ESS

CA

TE

GO

RY

:R

AW

, GR

OU

ND

PR

OD

UC

T E

XA

MP

LE

:F

RE

SH P

OR

K S

AU

SAG

E

PR

OC

ESS

ST

EP

DE

SCR

IPT

ION

CC

PC

RIT

ICA

L L

IMIT

SP

ER

SON

RE

SPO

NSI

BL

ER

ESP

ON

SIB

LE

RE

CO

RD

SSO

N

BIO

LO

GIC

AL

C

HE

MIC

AL

PH

YSI

CA

L

MO

NIT

OR

ING

CO

RR

EC

TIV

E/P

RE

VE

NT

IVE

VE

RIF

ICA

TIO

NH

AZ

AR

DP

RO

CE

DU

RE

S/F

RE

QU

EN

CY

/A

CT

ION

/PE

RSO

NH

AC

CP

PR

OC

ED

UR

E/P

ER

RE

SPO

NSI

BL

E

ASS

EM

BL

E/

B -

Mic

robi

al2

BP

rodu

ct te

mpe

ratu

reP

rodu

ct te

mpe

ratu

re m

onit

ored

If p

roce

ss d

oes

not d

emon

stra

teR

ecor

d al

l res

ults

Per

iodi

cP

RE

-WE

IGH

/G

row

th.

mai

ntai

ned

at o

r be

low

at a

ppro

pria

te ti

mes

by

cont

rol w

ithi

n w

ritt

en H

AC

CP

and

corr

ecti

vem

easu

rem

ent o

fP

RE

-GR

IND

/40E

F d

urin

g ha

ndlin

g.*

qual

ifie

d pe

rson

nel.

Pla

n pr

oced

ures

, ide

ntif

y an

dac

tion

(s) i

n a

plan

tpr

oduc

tR

E-W

OR

Kco

ntro

l aff

ecte

d pr

oduc

t;sp

ecif

ic lo

g/re

cord

tem

pera

ture

s by

FIN

AL

GR

IND

A m

axim

um o

f 50E

Fco

rrec

t or

adju

st p

roce

dure

s;an

d/or

cor

rect

ive

desi

gnat

edM

EA

Tm

aint

aine

d in

pro

duct

Ref

rige

rati

on c

ontr

ols

and

reco

ndit

ion/

rew

ork

prod

uct;

acti

on lo

g, s

ign

pers

onne

l.ha

ndlin

g ar

eas.

oper

atio

ns r

outi

nely

mon

itor

edev

alua

te o

pera

tion

for

caus

e of

reco

rd, d

ate

and

*Not

e: I

nsuf

fici

ent

func

tion

.ac

tion

to p

reve

nt r

eocc

urre

nce;

obse

rvat

ion.

sam

plin

g te

chni

ques

scie

ntif

ic d

ata

exis

tpl

ant d

esig

nee

docu

men

tsan

d ac

cura

cy o

fre

gard

ing

the

grow

th o

fac

tion

s ta

ken

in H

AC

CP

reco

rds;

ver

ify

path

ogen

s du

ring

reco

rds

log

and

sign

s re

cord

.ac

cura

cy o

fch

illin

g pa

ram

eter

ste

mpe

ratu

repr

ovid

ed a

bove

will

Rec

ord

all f

indi

ngs

in H

AC

CP

Not

ify

plan

t des

igne

e.de

vice

s; d

eter

min

e if

cont

rol q

ualit

y an

dre

cord

s lo

g an

d si

gn r

ecor

d.th

e cr

itic

al li

mit

limit

the

grow

th r

ates

of

corr

espo

nds

to th

eev

en p

sych

rotr

ophi

cpl

ant r

ecor

ds; c

heck

spoi

lage

org

anis

ms.

to

see

if c

riti

cal l

imit

The

refo

re, t

hese

is a

dequ

ate

for

para

met

ers

are

mor

eha

zard

; ass

ure

than

suf

fici

ent t

oco

rrec

tive

act

ions

prev

ent g

row

th o

far

e ad

equa

te;

mes

ophi

lic e

nter

icdo

cum

ent f

indi

ngs.

bact

eria

l pat

hoge

ns.

by p

erso

nnel

res

pons

ible

for

the

defi

cien

cy; t

ake

corr

ecti

vere

cord

tim

e of

Aud

it to

ver

ify

Wee

kly

calib

rati

onof

ther

mom

eter

s.

Page 59: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HA

CC

P P

LA

N

PR

OC

ESS

CA

TE

GO

RY

:R

AW

, GR

OU

ND

PR

OD

UC

T E

XA

MP

LE

:F

RE

SH P

OR

K S

AU

SAG

E

PR

OC

ESS

ST

EP

DE

SCR

IPT

ION

CC

PC

RIT

ICA

L L

IMIT

SP

ER

SON

RE

SPO

NSI

BL

ER

ESP

ON

SIB

LE

RE

CO

RD

SSO

N

BIO

LO

GIC

AL

C

HE

MIC

AL

PH

YSI

CA

L

MO

NIT

OR

ING

CO

RR

EC

TIV

E/P

RE

VE

NT

IVE

VE

RIF

ICA

TIO

NH

AZ

AR

DP

RO

CE

DU

RE

S/F

RE

QU

EN

CY

/A

CT

ION

/PE

RSO

NH

AC

CP

PR

OC

ED

UR

E/P

ER

RE

SPO

NSI

BL

E

FO

RM

UL

AT

ION

P -

For

eign

mat

eria

l.3

PN

o vi

sibl

e fo

reig

nV

isua

l ins

pect

ion

of p

rodu

ct a

tIf

pro

cess

doe

s no

t dem

onst

rate

Rec

ord

all r

esul

tsD

aily

vis

ual

mat

eria

ls.

appr

opri

ate

tim

es b

y qu

alif

ied

cont

rol w

ithi

n w

ritt

en H

AC

CP

and

corr

ecti

veob

serv

atio

n of

Con

dem

n pr

oduc

t or

cont

rol a

ffec

ted

prod

uct;

spec

ific

log/

reco

rdvi

sual

insp

ecti

on o

fre

mov

e pa

rtic

les

1/32

"R

ecor

d al

l fin

ding

s in

HA

CC

Pco

rrec

t or

adju

st p

roce

dure

s;an

d/or

cor

rect

ive

prod

uct,

done

by

or la

rger

. N

o bo

nere

cord

s lo

g an

d si

gn r

ecor

d.re

cond

itio

n/re

wor

k pr

oduc

t;ac

tion

log,

sig

nde

sign

ated

part

icle

s >

0.8

inch

(20

eval

uate

ope

rati

on fo

r ca

use

ofre

cord

, dat

e an

dpe

rson

nel.

mm

).de

fici

ency

; tak

e co

rrec

tive

reco

rd ti

me

of

pers

onne

l.P

lan

proc

edur

es, i

dent

ify

and

acti

on(s

) in

a pl

ant

proc

edur

es a

nd/o

r

acti

on to

pre

vent

reo

ccur

renc

e;ob

serv

atio

n.A

udit

to v

erif

ypl

ant d

esig

nee

docu

men

tssa

mpl

ing

tech

niqu

esac

tion

s ta

ken

in H

AC

CP

and

accu

racy

of

reco

rds

log

and

sign

s re

cord

.re

cord

s; v

erif

y

Not

ify

plan

t des

igne

e.de

vice

s; d

eter

min

e if

accu

racy

of

tem

pera

ture

the

crit

ical

lim

itco

rres

pond

s to

the

plan

t rec

ords

; che

ckto

see

if c

riti

cal l

imit

is a

dequ

ate

for

haza

rd; a

ssur

eco

rrec

tive

act

ions

are

adeq

uate

;do

cum

ent f

indi

ngs.

Page 60: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HA

CC

P P

LA

N

PR

OC

ESS

CA

TE

GO

RY

:R

AW

, GR

OU

ND

PR

OD

UC

T E

XA

MP

LE

:F

RE

SH P

OR

K S

AU

SAG

E

PR

OC

ESS

ST

EP

DE

SCR

IPT

ION

CC

PC

RIT

ICA

L L

IMIT

SP

ER

SON

RE

SPO

NSI

BL

ER

ESP

ON

SIB

LE

RE

CO

RD

SSO

N

BIO

LO

GIC

AL

C

HE

MIC

AL

PH

YSI

CA

L

MO

NIT

OR

ING

CO

RR

EC

TIV

E/P

RE

VE

NT

IVE

VE

RIF

ICA

TIO

NH

AZ

AR

DP

RO

CE

DU

RE

S/F

RE

QU

EN

CY

/A

CT

ION

/PE

RSO

NH

AC

CP

PR

OC

ED

UR

E/P

ER

RE

SPO

NSI

BL

E

CO

OL

ING

AN

DB

- M

icro

bial

3 B

Pro

duct

tem

pera

ture

Pro

duct

tem

pera

ture

s,If

pro

cess

doe

s no

t dem

onst

rate

Rec

ord

all r

esul

tsD

aily

mea

sure

men

tST

OR

AG

E O

FG

row

th.

mai

ntai

ned

at o

r be

low

envi

ronm

enta

l tem

pera

ture

sco

ntro

l wit

hin

wri

tten

HA

CC

Pan

d co

rrec

tive

of p

rodu

ctP

RO

DU

CT

40E

F.*

mon

itor

ed e

very

four

hou

rs b

ypl

an p

roce

dure

s, c

ontr

olac

tion

(s) i

n a

plan

tte

mpe

ratu

res,

of

A m

axim

um o

f 50 E

Fpr

oced

ures

; eva

luat

e op

erat

ion

acti

on lo

g, a

nd s

ign

by d

esig

nate

dm

aint

aine

d in

pro

duct

Ref

rige

rati

on c

ontr

ols

and

for

caus

e of

def

icie

ncy;

take

reco

rd, d

ate

and

pers

onne

l.st

orag

e ar

ea.

oper

atio

n ro

utin

ely

mon

itor

edco

rrec

tive

act

ion

to p

reve

ntre

cord

tim

e of

*Not

e: I

nsuf

fici

ent

func

tion

.do

cum

ents

act

ions

take

n in

sam

plin

g te

chni

ques

scie

ntif

ic d

ata

exis

tH

AC

CP

rec

ords

log

and

sign

san

d ac

cura

cy o

fre

gard

ing

the

grow

th o

fR

ecor

d al

l fin

ding

s in

HA

CC

Pre

cord

.re

cord

s; v

erif

ypa

thog

ens

duri

ngre

cord

s lo

g an

d si

gn r

ecor

d.ac

cura

cy o

fch

illin

g pa

ram

eter

ste

mpe

ratu

repr

ovid

ed a

bove

will

Not

ify

plan

t des

igne

e.de

vice

s; d

eter

min

e if

cont

rol q

ualit

y an

dth

e cr

itic

al li

mit

limit

the

grow

th r

ates

of

corr

espo

nds

to th

eev

en p

sych

rotr

ophi

cpl

ant r

ecor

ds; c

heck

spoi

lage

org

anis

ms.

to

see

if c

riti

cal l

imit

The

refo

re, t

hese

is a

dequ

ate

for

para

met

ers

are

mor

eha

zard

; ass

ure

than

suf

fici

ent t

oco

rrec

tive

act

ions

prev

ent g

row

th o

far

e ad

equa

te;

mes

ophi

lic e

nter

icdo

cum

ent f

indi

ngs.

bact

eria

l pat

hoge

ns.

pers

onne

l res

pons

ible

for

the

affe

cted

pro

duct

, rec

hill

cool

er lo

g/re

cord

envi

ronm

enta

lfu

ncti

on.

prod

uct;

cor

rect

or

adju

stan

d/or

cor

rect

ive

tem

pera

ture

s do

ne

by p

erso

nnel

res

pons

ible

for

the

reoc

curr

ence

; pla

nt d

esig

nee

obse

rvat

ion.

Aud

it to

ver

ify

Wee

kly

calib

rati

onof

ther

mom

eter

s.

Page 61: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

HA

CC

P P

LA

N

PR

OC

ESS

CA

TE

GO

RY

:R

AW

, GR

OU

ND

PR

OD

UC

T E

XA

MP

LE

:F

RE

SH P

OR

K S

AU

SAG

E

PR

OC

ESS

ST

EP

DE

SCR

IPT

ION

CC

PC

RIT

ICA

L L

IMIT

SP

ER

SON

RE

SPO

NSI

BL

ER

ESP

ON

SIB

LE

RE

CO

RD

SSO

N

BIO

LO

GIC

AL

C

HE

MIC

AL

PH

YSI

CA

L

MO

NIT

OR

ING

CO

RR

EC

TIV

E/P

RE

VE

NT

IVE

VE

RIF

ICA

TIO

NH

AZ

AR

DP

RO

CE

DU

RE

S/F

RE

QU

EN

CY

/A

CT

ION

/PE

RSO

NH

AC

CP

PR

OC

ED

UR

E/P

ER

RE

SPO

NSI

BL

E

SHIP

PIN

GB

- M

icro

bial

4 B

Pro

duct

mus

t rea

ch a

Pro

duct

tem

pera

ture

s, tr

uck

If p

roce

ss d

oes

not d

emon

stra

teR

ecor

d al

l res

ults

Dai

ly m

easu

rem

ent

Gro

wth

.te

mpe

ratu

re o

f #

40E

Fte

mpe

ratu

res,

and

/or

cont

rol w

ithi

n w

ritt

en H

AC

CP

and

corr

ecti

veof

pro

duct

prio

r to

leav

ing

the

envi

ronm

enta

l tem

pera

ture

s,pl

an p

roce

dure

s, c

ontr

olac

tion

(s) i

n a

plan

tte

mpe

ratu

res,

of

esta

blis

hmen

t.*m

onit

ored

at a

ppro

pria

te ti

mes

affe

cted

pro

duct

, rec

hill

spec

ific

log/

reco

rden

viro

nmen

tal

Tru

ck te

mpe

ratu

re n

otIf

pla

nt o

wne

d tr

uck,

rou

tine

eval

uate

ope

rati

on fo

r ca

use

ofre

cord

, dat

e an

dte

mpe

ratu

res,

don

eto

exc

eed

50E

F p

rior

tom

aint

enan

ce a

nd m

onit

orin

g of

defi

cien

cy; t

ake

corr

ecti

vere

cord

tim

e of

by d

esig

nate

dsh

ippi

ng p

rodu

ct.

refr

iger

atio

n un

it o

pera

tion

and

acti

on to

pre

vent

reo

ccur

renc

e;ob

serv

atio

n.pe

rson

nel.

*Not

e: I

nsuf

fici

ent

acti

ons

take

n in

HA

CC

PA

udit

to v

erif

ysc

ient

ific

dat

a ex

ist

reco

rds

log

and

sign

s re

cord

.sa

mpl

ing

tech

niqu

esre

gard

ing

the

grow

th o

fan

d ac

cura

cy o

fpa

thog

ens

duri

ngre

cord

s; v

erif

ych

illin

g pa

ram

eter

sR

ecor

d al

l fin

ding

s in

HA

CC

PN

otif

y pl

ant d

esig

nee.

accu

racy

of

prov

ided

abo

ve w

illre

cord

s lo

g an

d si

gn r

ecor

d.te

mpe

ratu

reco

ntro

l qua

lity

and

devi

ces;

det

erm

ine

iflim

it th

e gr

owth

rat

es o

fth

e cr

itic

al li

mit

even

psy

chro

trop

hic

corr

espo

nds

to th

esp

oila

ge o

rgan

ism

s.

plan

t rec

ords

; che

ckT

here

fore

, the

seto

see

if c

riti

cal l

imit

para

met

ers

are

mor

eis

ade

quat

e fo

rth

an s

uffi

cien

t to

haza

rd; a

ssur

epr

even

t gro

wth

of

corr

ecti

ve a

ctio

nsm

esop

hilic

ent

eric

are

adeq

uate

;ba

cter

ial p

atho

gens

.do

cum

ent f

indi

ngs.

by q

ualif

ied

pers

onne

l.pr

oduc

t, re

ject

tran

spor

t;an

d/or

cor

rect

ive

tem

pera

ture

s,

cont

rols

.pl

ant d

esig

nee

docu

men

ts

corr

ect o

r ad

just

pro

cedu

res;

acti

on lo

g, s

ign

and/

or tr

uck

Wee

kly

calib

rati

onof

ther

mom

eter

s.

Page 62: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lviii

Appendix 1 - List of Process Models

Generic HACCP Model for Beef Slaughter

Generic HACCP Model for Poultry Slaughter

Generic HACCP Model for Pork Slaughter

Generic HACCP Model for Raw, Not Ground Meat and Poultry Products

Generic HACCP Model for Raw, Ground Meat and Poultry Products

Generic HACCP Model for Mechanically Separated (Species)/Mechanically Deboned

Generic HACCP Model for Heat Treated Not Fully Cooked, Not Shelf Stable Meat and Poultry Products

Generic HACCP Model for Meat and Poultry Products with Secondary Inhibitors, Not Shelf-Stable

Generic HACCP Model for Not Heat Treated, Shelf-Stable Meat and Poultry Products

Generic HACCP Model for Fully Cooked, Not Shelf-Stable Meat and Poultry Products

Generic HACCP Model for Heat Treated, Shelf-Stable Meat and Poultry Products

Generic HACCP Model for Thermally Processed Commercial Sterile Meat and Poultry Products

Generic HACCP Model for Irradiation

Page 63: Generic HACCP Model for Raw, Ground Meat, and Poultry Products
Page 64: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lx

Appendix 3

EXAMPLES OFFOOD SAFETY HAZARDS BEING CONTROLLED IN HACCP PROGRAMS

PHYSICAL CHEMICAL BIOLOGICAL

Glass Allergens Cross-ContaminationMetal Animal Drug Residues - Post CookedOther Foreign Materials Cleaning Compound Pathogens

Residues - Raw Ingredients - Raw Storage

Illegal Residues/Pesticides Zoonotic Disease - Packaging Materials Parasites

- Raw Ingredients Decomposition - Shipping Containers

Natural ToxinsUnapproved direct orindirect food or coloradditives

Page 65: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxi

Appendix 4

Literature Review for Hazard Identification - Ground Beef/Pork Sausage

Appendix 4, a source review of the literature was prepared for two product examplesof the Raw, Ground Meat and Poultry Products process. The literature search focused onground beef and fresh pork sausage products. The sources listed in this review were gatheredprimarily from a search of databases (e.g., Food Science and Technology Abstracts, Agricola,and Medline) on CD-ROM. Bound abstracts, such as the Food Safety and TechnologyAbstracts and the Bibliography of Agriculture, also could be used. References cited inscientific journal articles are another source of material.

The source review is divided into three parts: foodborne illnesses; the prevalence ofpathogens found in ground beef and fresh pork sausage; and the effect of processingprocedures, such as the application of heat, on the growth of pathogens in these products.

The first section lists articles on foodborne illnesses associated with meat products ingeneral, or ground beef and pork sausage in particular. The initial search used "foodborneillnesses" as a keyword. This search was narrowed to include only foodborne illnesses causedby meat products, ground beef, or pork sausage. Another search of the articles on foodborneillness was conducted to determine the pathogens involved in the various outbreaks orincidents of foodborne illness related to raw, ground meat. From this search, the pathogens ofinterest were found to include, but not be limited to, E. coli O157:H7, Shiga-like toxinproducers, Salmonella, Clostridium perfringens, Clostridium botulinum, Listeriamonocytogenes, Yersinia, and Trichinella spiralis. These sources listed in this section indicatewhether a problem exists; the extent of that problem (percentage of population affected andassociated costs); and the risk associated with eating undercooked meat products. Thissection underscores the importance of establishing a HACCP program for the products inquestion. These references may indicate the level of microorganisms that can cause illness in asusceptible individual. In addition, the pathogens to test for in a microbiological monitoringprogram would be indicated from these references.

While the first section identifies the various foodborne pathogens, the second sectionlists references for the prevalence of those pathogens in raw, ground meat products i.e., howoften the pathogens in question are found in raw, ground product. The number of organismsusually found in this type of product also may be reported in some of the references. Thereview was not limited to those products of U.S. origin since outbreaks could involveimported product. These references can assist in identifying the hazards associated with raw,ground meat products -the first HACCP principle. In addition, the microbiological testing ofthe raw, ground product for pathogens will be based on the information contained in thescientific literature. For example, since E. coli O157:H7 is a pathogen of concern in groundbeef, this product may be examined for this organism when an establishment submits samples

Page 66: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxii

for microbiological testing.

References to factors that control, limit, or influence the growth or survival of thepathogens cited above were the primary focus for Appendix 4. The various pathogens servedas the keywords in this search. This search was further defined by the factors that affectgrowth of any microorganism, such as a salt concentration or thermal process. Thisinformation will be used to determine the preventive measures when initially organizing theHACCP plan. It is also necessary for establishing the critical limits and monitoring proceduresof the HACCP plan.

Page 67: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxiii

Part I - Factors Affecting the Epidemiology of Foodborne Illness

General

Bean, N. H. and P. M. Griffin. 1990. Foodborne disease outbreaks in the United States, 1973-1987: Pathogens, vehicles, and trends. J. Food Prot. 53(9):804-817.

The etiologic agents and food vehicles associated with the 7458 outbreaks(involving 237,545 cases) of foodborne disease reported to the Centers forDisease Control between 1973 and 1987 were examined. Bacterial pathogensaccounted for 66% of outbreaks and 87% of cases, viruses 5 and 9%, parasites 5and <1%, and chemicals 25 and 4%, respectively. Salmonella accounted for42% of outbreaks and 51% of cases due to bacterial pathogens. When data from1973-75 were compared to 1985-87, a 75% increase in the proportion ofoutbreaks and 130% increase in the proportion of cases due to Salmonella wereobserved; in particular, outbreaks due to Salmonella enteritidis increasedmarkedly. The proportion of Salmonella outbreaks with a known vehicle thatwere associated with beef (the food most frequently associated with Salmonellaoutbreaks) peaked at 30% in 1981, dropped to 4% in 1982, and has since risengradually. The proportion of Salmonella outbreaks due to chicken and eggsincreased over the study period. Bacteria not previously recognized asimportant foodborne pathogens that emerged during the study period includeCampylobacter jejuni, Escherichia coli O157:H7, and Listeria monocytogenes.Bacterial pathogens accounted for 90% of deaths, with L. monocytogenes(317/1,000 cases) and Clostridium botulinum (192/1,000 cases) having the highestdeath-to-case ratios. The proportion of outbreaks in which the food wasprepared in a commercial or institutional establishment and the medianoutbreak size both increased. Investigation and analysis of foodborne diseaseoutbreaks continue to play a key role in understanding foodborne illness and indesigning and evaluating control measures.

Bryan, F. L. 1980. Foodborne diseases in the United States associated with meat andpoultry. J.Food Prot. 43(2):140-150.

Surveillance data from 1968 to 1977 indicate that meat and poultry andproducts made from them were vehicles in over 50% of reported outbreaks offoodborne disease. The 3 most commonly identified vehicles were ham, turkeyand roast beef. Ground (cooked) beef, pork, sausage and chicken were alsofrequently reported as vehicles. These foods were mishandled to the extent thatoutbreaks resulted in food service establishments (65%), in homes (31%) and inprocessing plants (4%). The most frequently identified factors that contributedto these outbreaks were improper cooling of cooked foods (48%), foods prepareda day or more before serving (34%), inadequate cooking or thermal processing

Page 68: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxiv

(27%), infected person touching cooked foods (23%), inadequate reheating ofcooked and chilled foods (20%), improper hot storage of cooked foods (19%)and cross-contamination of cooked foods from raw foods (15%). Commonlyreported foodborne diseases associated with these vehicles were staphylococcalintoxication, salmonellosis, Clostridium perfringens gastroenteritis, andtrichinosis.

Bryan, F. L. 1988. Risks of practices, procedures and processes that lead to outbreaks of foodborne diseases. J. Food Prot. 51(8):663-673.

Factors that contributed to 766 outbreaks of foodborne disease in the USAbetween 1977 and 1982 are reported and tabulated. The main contributoryfactors include: inadequate or improper cooling, a time lapse of greater than orequal 12 h between preparation and eating, and contaminated rawfood/ingredient; these factors were implicated in 40.9, 25.2 and 22.8% ofoutbreaks, resp. Additional contributory factors include inadequate heatprocessing, colonized persons handling implicated foods, improper cleaning ofequipment and improper fermentation. Data accumulated from 1961 to 1982(1918 outbreaks) are classified by disease (salmonellosis, staphylococcal foodpoisoning, botulism, Clostridium perfringens enteritis, shigellosis, typhoid fever,Vibrio parahaemolyticus gastroenteritis and Bacillus cereus gastroenteritis), andare grouped according to whether the factors affect contamination, survival or growth of the contaminant. The incidence of various contributory factors is also classified according to place where the implicated foods were mishandled (food service establishments, homes and food processing plants). The importance of distinguishing between frequently and rarely occurring contributory factors is emphasized so that priorities can be defined for preventative and control programs and critical control points indicated.

Doyle, M. P. 1992. A new generation of foodborne pathogens. Dairy, Food andEnvironmental Sanitation 12(8):490,492-493.

Pathogens that have been recognized in the last 10-15 yr as important causes offoodborne disease are discussed, including: Campylobacter jejuni; Yersiniaenterocolitica; Vibrio vulnificus; Listeria monocytogenes; enterohaemorrhagicEscherichia coli O157:H7; and Salmonella enteritidis (ovarian-infecting). C.jejuniis associated with foods of animal origin producing illness with ingestion of onlylow numbers of infective cells. Outbreaks in the USA of Y. enterocolitica are fewbut symptoms are severe and include diarrhoea, fever, headache and intenseabdominal pain. The organism grows at refrigeration temp. Raw oysters havebeen identified as the vehicle of infection for V. vulnificus causing severe illness.L. monocytogenes is of particular risk for immunocompromised individuals. Theorganism is present in low numbers in ready-to-eat meats, cooked poultry, milk

Page 69: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxv

and dairy products and vegetables. Low-acid soft cheeses are of particularconcern to high-risk individuals. The organism can be ingested by mostindividuals in the population with no ill-effects. Enterohaemorrhagic E. coliO157:H77 has been associated with undercooked ground beef, unpasteurizedmilk and person-to-person transmission. Illness from S. enteritidis has beenprincipally associated with the use of uncooked eggs. S. enteritidis has beenidentified in ovarian tissue of hens, thus eggs laid by these hens are infected bythe pathogen prior to purchase and consumption.

Gravani, R. B. 1987. The causes and costs of foodborne disease. Dairy Food Sanitation 7(1):20-25.

This article highlights the importance of food safety and discusses the prevalenceand economic impact of foodborne diseases in the USA. Foods incriminated infoodborne illnesses are listed. Red meats, poultry, fish and shellfish, ethnic foodsand salads account for the majority of cases of food poisoning, but dairyproducts have also been implicated. Factors contributing to outbreaks offoodborne illness are outlined.

McIntosh, W. A., et al. 1994. Perceptions of risks of eating undercooked meat andwillingness to change cooking practices. Appetite 22(1): 83-96.

Knowledge and awareness of food safety issues relating to improperly cookedhamburger and willingness to change hamburger cooking practices wereexamined from a representative sample of 1004 adult Texans. Awareness of thedanger of improperly cooked hamburger, knowledge of specific foodbornepathogens and knowledge of food safety practices had no effect on willingness tochange behavior, but respondents who were better-educated, female andHispanic and respondents who used newspapers/magazines or televisions wereall more likely to report willingness to change their cooking practices.

Notermans, S. 1992. Existing and emerging foodborne diseases. International J. FoodMicrobiology 15(3/4):197-205.

Data recorded in different countries show that the incidence of some foodbornediseases due to microbial contamination has increased in recent years. Results ofanalysis of available data from several countries are discussed in terms of thefrequency of foodborne diseases, causative agents and incriminated foods. Microorganisms responsible for existing foodborne diseases (Salmonella,Campylobacter and Staphylococcus aureus) and emerging foodborne diseases(C.jejuni/coli, S. enteritidis, pathogenic Escherichia coli, Listeria monocytogenes,Aeromonas spp., Yersinia enterocolitica and molds) are addressed.

Page 70: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxvi

Schothorst, M. van and L. J. Cox. 1989. “Newer” or emerging pathogenic microorganisms in meat and meat products. Proceedings, International Congress of Meat Science and Technology No. 35, Vol. I(35):55-67.

This paper discusses the reasons for emergence of ‘new’ pathogens, i.e. changesin eating habits, changes in perception, awareness and interest, improvement ofdetection methods, improved epidemiology, changes in food production (rawmaterials), changes in food processing technology, changes in handling andpreparation practices, demographic changes (the state of the population,mobility and social conditions) and changes in the behavior of microorganisms. 'Newer' foodborne pathogens are outlined (Escherichia coli 0157:H7, Listeriamonocytogenes, Campylobacter jejuni, Yersinia enterocolitica, Vibrio vulnificusand Aeromonas hydrophila) and future developments considered.

Steahr, T. 1994. Food-borne illness in the United States: geographic anddemographic patterns. International J. Environ. Health Research 4(4):183-195.

Foodborne illness in the USA has been defined on the basis of List A (a listing offoodborne disease as classified by the International Classification of Diseases, 4thEdition, Clinical Modification (ICD-9-CM)). Geographical and demographicpatterns are presented for foodborne illness in the USA based on national datafor patients discharged from hospital by List A categorization of foodbornedisease in 1990. Frequency of category types (e.g. cholera, shigellosis,staphylococcal food poisoning) is considered. Variations by age, sex, region andrace based on hospital discharge, physician visit and mortality data are alsopresented. Benefits and limitations of the current method of determining theprevalence of foodborne illness are discussed and the need to establish the actualfrequency of unreported cases of foodborne illness is stressed.

Todd, E.C.D. 1989. Costs of acute bacterial foodborne disease in Canada and the United States. International J. Food Microbiol 9(4):313-326.

Bacterial foodborne disease incidence is increasing in industrialized countries. InCanada and the USA many millions of cases are believed to occur each year. Economic impact of this is huge. Medical costs and lost income are easier todetermine than losses to food companies, legal awards and settlements, value oflost leisure time, pain, grief, suffering and death. Evaluation of costs at thenational level for Canada and the USA, based on all available costs for 61incidents, showed that costs of company losses and legal action were muchhigher than medical/hospitalization expenses, lost income or investigationalcosts. It was reckoned that, on an annual basis, 1 million cases of acute bacterialfoodborne illness in Canada cost nearly 1.1 billion and 5.5 million cases in theUSA cost nearly 7 billion. The value of deaths was a major contributor to

Page 71: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxvii

overall costs, especially for diseases like listeriosis, salmonellosis, Vibrio infectionsand hemorrhagic colitis. Salmonellosis was the most important disease ineconomic terms, because it affects all parts of the food system [and becauseproper control measures need to be implemented], unlike typhoid fever andbotulism which are largely controlled by public health authorities and the foodindustry.

Todd, E. 1990. Epidemiology of foodborne illness: North America. Lancet336(8718):788-790.

The epidemiology of foodborne diseases in Canada and the USA is discussedwith reference to: surveillance (including the completeness and quality of thereports); estimated incidence and costs of foodborne disease; and recentfoodborne disease concerns (salmonellosis, Escherichia coli O157:H7,campylobacteriosis, Listeria monocytogenes Vibrio spp., staphylococcal toxins,botulism, paralytic shellfish poisoning).

Part II - Prevalence of Pathogens Found in Ground Beef and Fresh Pork Sausage

Abdel-Rahman, H., T. El-Khateib, and A. K. El-Timmawy. 1988. Spoilage and foodpoisoning organisms in frozen ground beef. Fleischwirtschaft 68(7):881-882.

50 packs of frozen ground beef from supermarkets in Egypt were studied forspoilage and pathogenic bacteria. Of 518 isolates of spoilage bacteria, 43.8%were Enterobacteriaceae, 30.9% were pseudomonads and 25.3% werelactobacilli. The incidence of individual sp. within these groups was considered. Clostridium perfringens, Staphylococcus aureus and Shigella dysenteriae wereisolated from 34, 80 and 1.4% of samples, resp. Salmonellae were not detected inany sample.

Adesiyun, A. A. 1993. Prevalence of Listeria spp., Campylobacter spp., Salmonella spp., Yersinia spp. and toxigenic Escherichia coli on meat and seafoods in Trinidad. Food Microbiology 10(5):395-403.

Occurrences of species of Listeria, Campylobacter, Salmonella, Yersinia andEscherichia coli in raw meats (beef, ground beef, mutton, goat meat, pork andchicken) and seafoods (fish and shrimps) in Trinidad were studied. Toxigenicityand antibiograms of E. coli isolates were also established. 480 samples werestudied, of these: 28 (5.8%) were positive for Listeria spp. (of which 9 (1.9%) and14 (2.9%) were positive for L. monocytogenes and L. innocua, respectively); thehighest prevalence (14.8%) was in fish. L. monocytogenes serotypes 4b and 1/2cwere present in both locally produced and imported meats. 29 (6.0%) samples

Page 72: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxviii

were positive for Campylobacter; 28 (96.6%) of positive samples were chickensand 1 (3.4%) was shrimps. 43 (9.0%) samples were positive for E. coli. Allsamples were negative for Yersinia. Only 2 (4.7%) of the positive E. coli samplesproduced verocytotoxins while 1 (2.3%) isolate produced heat labile toxin. 33(76.7%) of the E. coli strains isolated were resistant to $1 antimicrobial agent(s). Frequency of contamination of meats and seafoods was low, as was the healthrisk to consumers. Based on the frequency of contamination and the largeamounts of fish eaten in Trinidad, it is possible that seafoods may pose thegreatest risk of listeriosis.

Chapman, P. A., et al. 1993. Cattle as a possible source of verocytotoxin-producingEscherichia coli O157 infections in man. Epidemiology and Infection111(3):439-447.

In May-June 1992 cases of infection with verocytotoxin-producing (VT-+)Escherichia coli O157 in South Yorkshire (UK) could have been associated withprior consumption of beef from a local abattoir. During investigation of theabattoir, bovine rectal swabs and samples of meat [meat trimmings from neckend of carcass] and surface swabs from beef carcasses were examined for E. coliO157, isolates of which were tested for toxigenicity, plasmid content and phagetype. E. coli O157 was isolated from 84 (4%) of 2103 bovine rectal swabs; ofthese 84, 78 (93%) were VT-+, the most common phage types being 2 and 8, thetypes implicated in the cluster of human cases. Positive cattle were from diversesources within England. E. coli O157 was isolated from 7 (30%) of 23 carcassesof rectal swab-positive cattle and from 2 (8%) of 25 carcasses of rectalswab-negative cattle. The study has shown that cattle may be a reservoir of VT-+E. coli 0157 and that contamination of carcasses during slaughter and processingmay be the mechanism by which beef and beef products become contaminatedand thereby transmit the organism to man.

Comi, G., et al. 1992. Listeria monocytogenes serotypes in Italian meat products. Letters-in-Applied-Microbiology 15(4): 168-171.

Listeria monocytogenes was isolated and enumerated in Italian fresh groundbeef, fresh pork meat and industrial sausages. All samples contained less than2000 L. monocytogenes/g of meat. The main serotyope isolated was 1/2c (56.9%). Other serotypes isolated included 1/2a, 1/2b, 3c, 4b and 4c. A prevalence of lessvirulent serotypes over more virulent was thus noted. It seems that the lowincidence of listeriosis from these products is related to the low concentrationand virulence of L. monocytogenes present.

Doyle, M. P. 1991. Escherichia coli O157:H7 and its significance in foods.

Page 73: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxix

International J. Food Microbiol 12(4):289-301.

Escherichia coli O157:H7 was conclusively identified as a pathogen in 1982following its association with 2 food-related outbreaks of an unusualgastrointestinal illness. The organism is now recognized as an important causeof foodborne disease, with outbreaks reported in the USA, Canada and the UK. Illness is generally quite severe, and can include 3 different syndromes, i.e.,hemorrhagic colitis, haemolytic uraemic syndrome and thromboticthrombocytopenic purpura. Most outbreaks have been associated with eatingundercooked ground beef or, less frequently, drinking raw milk. Surveys ofretail raw meats and poultry revealed E. coli O157:H7 in 1.5-3.5% of groundbeef, pork, poultry and lamb. Dairy cattle, especially young animals, have beenidentified as a reservoir. The organism is typical of most E. coli, but does possessdistinguishing characteristics. For example, E. coli O157:H7 does not fermentsorbitol within 24 h, does not possess beta-glucuronidase activity, and does notgrow well or at all at 44-45.5 degree C. The organism has no unusual heat resistance; heating ground beef sufficiently to kill typical strains of Salmonellaewill also kill E. coli O157:H7. The mechanism of pathogenicity has not beenfully elucidated, but clinical isolates produce ‘sw1 verotoxin which are believedto be important virulence factors. Little is known about the significance ofpre-formed verotoxins in foods. The use of proper hygienic practices in handlingfoods of animal origin and proper heating of such foods before consumption areimportant control measures for the prevention of E. coli O157:H7 infections.

Duitschaever, C. L. and C. I. Buteau. 1979. Incidence of Salmonella in pork and poultry products. J. Food Prot. 42(8):662-663.

223 retail samples of pork and poultry products were purchased in the Torontoarea and analyzed for Salmonella contamination. Procedure used was lactosepre-enrichment incubation at 41 degree C, enrichment incubation intetrathionate-novobiocin or selenite-cystine broth followed by plating ontoSalmonella-Shigella, bismuth/sulphite or xylose/lactose/deoxycholate agar. Suspect colonies were transferred to triple sugar/Fe or lysine/Fe/agar slants ormalonate broth and further identified using the API microscreening system.Confirmation was by serotyping. 36 of the 223 samples (16.14%) containedSalmonella sp.; for individual products results were: pork sausages 15 of 105contained Salmonella; turkey sausages 3 of 3; ground pork 5 of 25; pork chops 7of 50; chicken parts 5 of 7; and barbecued back pork 1 of 33. A total of 37isolates was obtained (1 pork sausage contained 2 spp.) which were classifiedinto 10 serotypes; Salmonella agona (11 of 37) and S. typhimurium (8 of 37)predominated. Occurrence of S. agona in ready-to-eat barbecued pork indicatesneed for legislation on retail storage temp. of this product.

Page 74: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxx

Johnston, R. W., et al. 1982. Incidence of Salmonella in fresh pork sausage in 1979compared with 1969. J. Food Science 47(4)1369-1371.

A survey was conducted to determine incidence of Salmonella in fresh porksausage. Retail size samples representing different days of production werecollected from 40 federally inspected plants and analyzed for the presence ofSalmonellae. The results obtained during the 1979 survey were compared toresults obtained in a similar 1969 survey. Salmonellae were isolated from 162 ofthe 566 (28.6%) samples analyzed in 1969. For the samples analyzed in 1979, 74of 603 samples (12.4%) were positive for Salmonellae. Ladiges, W. C., et al.1974. Incidence and viability of Clostridium perfringens in ground beef. J. MilkFood Technol. 37(12):622-623. The incidence of Clostridium perfringens in 95ground beef samples obtained from a retail store in Denver, Colorado was47.4%. Although viability was not reduced after 24 h at - 20C, greater than 90%of the organisms usually could not be detected after frozen storage over a4-month period.

Ladiges, W.C. and J. F. Foster. 1974. Incidence of Salmonella in beef and chicken. J. Milk Food Technol. 37(4): 213-214.

A survey was undertaken to determine the incidence of Salmonella in retailpurchases of beef, ground beef, and chicken fryers. Salmonella were isolatedfrom 3 of 36 (8.3%) fresh whole chicken fryers. No Salmonella were detected in129 quarter of carcass beef or in 100 samples of ground beef. The failure todetect Salmonella in beef products is discussed.

Lior, H. 1994. Escherichia coli O157:H7 and verotoxigenic Escherichia coli (VTEC). Dairy, Food and Environmental Sanitation 14(7):378-382.

Infections caused by Escherichia coli O157:H7 and by vertoxigenic (Shiga-liketoxin) producing E. coli are discussed. Aspects considered include: symptomsand pathogenesis of disease; foods associated with outbreaks (including beefmince [ground beef], turkey roll, and raw milk; identification of serotypes of E.coli responsible for the outbreaks; and methods of detection of E. coli verotoxins. Ways in which the risk of infection by these pathogens can be minimized arepresented.

McLauchlin, J., et al. 1988. Listeriosis and food-borne transmission. LancetI(8578):177-178.

Attention is drawn to increasing incidence of listeriosis in the UK (at least 1case/230 000 of the population in England and Wales) due to Listeria

Page 75: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxi

monocytogenes, to the fact that its ubiquity and growth characteristics(resistance to nitrites and salt, growth at 4 degree C) favor food-bornetransmission, and to the lack of knowledge on the scale of food-borne listeriosis.Epidemiological studies of outbreaks that may be food-borne are hindered asmany strains of L. monocytogenes are not phage-typable. A DNA probe method,using cloned biotin-labelled DNA sequences from L. monocytogenes and the‘Blu-gene’ biotin detection system (Gibco) was successfully used to type 24epidemiologically unrelated strains, and revealed 8 distinct patterns. Improvedtyping systems will increase the understanding of listeriosis epidemiology.

Mermelstein, N. H. 1993. Controlling E. coli 0157:H7 in meat. Food Technol. 47(4):90-91.

The improved inspection procedures and regulations imposed following a fatalfood poisoning outbreak in the US caused by ingestion of undercookedhamburgers contaminated with Escherichia coli 0157:H7 are described. Aspectsconsidered include: the food poisoning outbreak; details of E. coli 0157:H7;detection of the organism; recommendations to livestock operations, processors,ground beef producers and foods service and retail industries (to implement theHACCP system); recommendations for research into the ecology of E. coli;animal and carcass inspection; increased numbers of inspectors; and educationof the consumer and foods service handlers to prevent foodborne illness.

Read, S. C., et al. 1990. Prevalence of verocytotoxigenic Escherichia coli in ground beef, pork, and chicken in southwestern Ontario. Epidemiol. Infect. 105:11-20.

Samples of ground beef (225), pork (235) and chicken (200) were randomlyselected from meat processing plants in the Southwestern Ontario area. Supernants of broth cultures of the samples were tested for verocytotoxins usinga Vero cell assay. Neutralization of cytotoxic activity using antisera specific forthree types of verocytotoxin (Verotoxin 1, Verotoxin 2 and Shiga-like toxin II)was performed on positive samples. Isolation of verocytotoxigenic Escherichiacoli (VTEC) was attempted from positive samples. VTEC were confirmed as E.coli biochemically, test for drug resistance, and serotyped. Based onneutralization studies, the prevalence of VTEC in beef and pork was at least36.4% and 10.6%, respectively. This is much higher than has been reportedfrom a survey of retail meats in which a method designed to detect only E. coliO157:H7 was used. Isolations of VTEC were made from 10.4% of the beefsamples and 3.8% of the pork samples. No VTEC were recovered from thechicken samples. The majority of VTEC isolates were susceptible to commonlyused antimicrobial agents. A number of the serotypes of the VTEC isolatesrecovered have been associated with human disease; however, no VTEC ofserotype O157:H7 were isolated.

Page 76: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxii

Rindi, S., D. Cerri, and B. Gerardo. 1986. [Thermophilic Campylobacter in fresh porksausages.] Industrie-Alimentari 25(241):648-650.

2 spp. of Campylobacter were isolated from 200 samples of pork sausage: onebelonged to the NARTC group of Skirrow & Benjamin [Campylobacter;Epidemiology, Pathogenesis & Biochemistry (1982); Ed. Newell, Lancaster], theother was identified as C. jejuni (resistant to nalidixic acid.)

Riley, L. W. 1987. The epidemiologic, clinical, and microbiologic features of hemorrhagic colitis. Ann. Rev. Microbiol 41:383-407.

Aspects of hemorrhagic colitis are reviewed; the disease is primarily food-borne(although person-to-person transmission is possible) and is associated mostfrequently with Escherichia coli serotype O157:H7. Cattle may be a reservoir ofthis serotype for human infection; E. coli O157:H7 has been isolated from cattle,hamburger meat is the food most frequently implicated in the disease, andconsumption of raw milk has also been associated with hemorrhagic colitis. Other aspects of the epidemiology and clinical manifestations of the disease aredescribed. The disease can result in serious complications and death.Microbiology of E. coli O157:H7 is also described; this strain can survive up to 9months at -20 degree C in ground beef and grows poorly at 44-45.5 degree C, thetemp. generally used to isolate E. coli from foods. Pathogenesis of the disease ispresently unknown; studies to establish the virulence mechanism are suggested.

Samadpour, M., et al. 1994. Occurrence of Shiga-like toxin-producing Escherichia coliin retail fresh seafood, beef, lamb, pork, and poultry from grocery stores in Seattle,Washington. Appl. Environ. Microbiol. 60(3):1038-1040.

Fresh meat, poultry, and seafood purchased from Seattle area grocery stores were investigated for the presence of Shiga-like toxin-producing Escherichia coli byusing DNA probes for Shiga-like toxin (SLT) genes I and II. Of the 294 samples tested, 17% had colonies with sequence homology to SLT I and/or SLT IIgenes.

Schuchat, A., B. Swaminathan, and C. V. Broome. 1991. Epidemiology of humanlisteriosis. Clin. Micro. Rev. 4(2):169-183.

A review article discussing the current information on epidemic and sporadicdisease caused by Listeria monocytogenes is presented. Recent developments inthe microbiological detection and serotyping of L. monocytogenes are alsodiscussed. Aspects considered include: microbiology of L. monocytogenes; L.monocytogenes in the environment; L. monocytogenes in animals; L.monocytogenes in humans; epidemiological patterns of disease; diagnosis,

Page 77: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxiii

treatment, and prevention; and issues for the food industry.

Silas, J. C., et al. 1984. Update: prevalence of Salmonella in pork sausage. J. AnimalScience 59(1):122-124.

175 samples of fresh pork sausage representing 35 different commercial brandsfrom 6 different retail stores were examined for the presence of Salmonella bystandard enrichment, plating, biochemical and serological techniques. Contamination levels varied from 0 to 50% among stores and 0 to 28% amongbrands. Prior research implied reduced prevalence of Salmonella in fresh porksausage; however, these results indicate no variation in prevalence since 1969.

Surkiewicz, B. F., et al. 1972. Bacteriological survey of fresh pork sausage produced at establishments under federal inspection. Appl. Microbiol. 23(3):515-520.

At the time of manufacture, 75% of 67 sets of finished fresh pork sausagecollected at 44 plants had aerobic plate counts in the range of 500,000 or fewer/g;88% contained 100 or fewer E. coli/g; and 75% contained 100 or fewer S.aureus/g (geometric means of 10 samples). Salmonella were isolated from 28% of529 samples of pork trimmings used for sausage, and from 28% of 560 finishedsausage samples. Semiquantitative analysis revealed that Salmonella were at lowlevels; more than 80% of the Salmonella-positive samples were positive only in25-g portions (negative in 1.0- and 0.1-g portions).

Surkiewicz, B. F., et al. 1975. Bacteriological survey of raw beef patties produced atestablishments under federal inspection. Appl. Microbiol. 29(3):331-334.

At the time of manufacture, 76% of 74 sets of raw beef patties collected in 42federally inspected establishments had aerobic plate counts of 1,000,000 orfewer/g; 84% contained 100 or fewer coliforms/g; 92% contained 100 or fewerEscherichia coli/g; and 85% contained 100 or fewer Staphylococcus aureus/g(geometric means of 10 patties/set). Salmonella were isolated from only three(0.4%) of 735 beef patties.

Tarr, P. I. 1994. Review of 1993 Escherichia coli O157:H7 outbreak: Western UnitedStates. Dairy, Food and Environmental Sanitation 14(7):372-373.

A description of the 1993 Escherichia coli O157:H7 outbreak in Washington,USA, is given and the investigation that followed is discussed. Within 1 wk,hamburgers consumed at multiple outlets of the same fast food restaurant chainhad been implicated as the vehicle of infection, beef mince [(ground beef] fromwhich the hamburgers had been made) was microbiologically tested, andincriminated lots were recalled. It is concluded that this epidemic demonstrates

Page 78: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxiv

the value of baseline epidemiological surveillance data on this (and other)foodborne pathogens, combined with a rapid and thorough investigativeresponse to an outbreak.

Vorster, S. M., et al. 1994. Incidence of Staphylococcus aureus and Escherichia coli inground beef, broilers and processed meats in Pretoria, South Africa. J. FoodProt. 57(4):305-310.

Three types of processed meats (vienna sausages, shoulder ham, and cervelat),ground beef and broilers were purchased from 17 different supermarkets in thePretoria area (South Africa) during 1991. The 232 samples were analyzed for thepresence of Escherichia coli and Staphylococcus aureus, with the total aerobicplate counts (APCs) also being determined. Escherichia coli was found in 74.5%of the ground beef samples, in 79.1% of the broilers, and 27.7% of the processedmeats. Staphylococcus aureus was found in 23.4% ground beef, 39.5% broilerand 7.1% processed meat samples. The total APCs ranged from as low as log101 CFU/g of sample (shoulder ham) to as high as log10 12.1 CFU/g (ground beef). No identifiable relationship between the total APCs and the occurrence of E. coliand/or S. aureus was evident. This study confirms the view that E. coli and S.aureus are frequent contaminants of meat, with South Africa being no exception.

Warnken, M. B., et al. 1987. Incidence of Yersinia species in meat samples purchased in Rio de Janeiro, Brazil. J. Food Prot. 50(7):578-579.

Twenty-five samples of several types of meat purchased at supermarkets in Riode Janeiro were analyzed for presence of Yersinia. Species were isolated from80% of beef and chicken giblets, 60% of ground beef and beef liver and 20% ofpork. Fifteen strains were identified as Yersinia intermedia, 9 as Y. entercolitica,4 as Y. kristensenii and 1 as Y. frederiksenii. Two strains of Y. intermedia,serotype 0:13,7 were positive in both the autoagglutination andcalcium-dependency tests. Two strains of atypical Y. intermedia (serotype 0:29and one not typable) and one strain of atypical Y. entercolitica, serotype 0:16,were positive only in the autoagglutination test. Seventeen strains isolated frommeat produced heat stable toxin.

Weissman, M. A. and J. A. Carpenter. 1969. Incidence of Salmonella in meat and meat products. App. Micro. 17(6):899-902.

The incidence of Salmonella spp. in 50 pork carcasses from 5 abattoirs and 50beef carcasses from 4 abattoirs was 56% and 74% respectively. The value forbeef is higher than previously reported. Suggested areas for sampling are thecervical and anal areas of the carcass. Salmonella were detected in 38% of freshpork sausage samples, 9% smoked pork sausage and in one sample of

Page 79: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxv

miscellaneous sausage products.

Part III - Effects of Processing Procedures on the Growth of Pathogens

Ayres, J. C. 1979. Salmonella in meat products. Proceedings of the 31st Annual Reciprocal Meat Conference. pp. 148-155.

Occurrence of Salmonella in meat and meat products is discussed with referenceto literature data. Aspects considered include: sources of contamination;cross-contamination of pigs held for prolonged periods at the abattoir beforeslaughter; incidence of Salmonella in meat trimmings and comminuted meatproducts; vacuum packaging of meat, and its inhibitory effect on growth ofSalmonella; effects of temp. on growth or survival of Salmonella in packagedground beef; incidence of Salmonella in retail samples of meat and meatproducts; and need for hygienic handling and constant refrigeration of meat tominimize danger of growth of Salmonella or contamination of other foods.

Buchanan, R. L. and L. A. Klawitter. 1992. The effect of incubation temperature, initialpH, and sodium chloride on the growth kinetics of Escherichia coli O157:H7.Food Microbiol. 9:185-196.

The effects of initial pH, sodium chloride content, and incubation temperatureon the aerobic and anaerobic growth kinetics of a three strain mixture ofEscherichia coli O157:H7 were evaluated using brain heart infusion broth. Thethree variables interacted to affect growth, with the primary effects being notedin relation to generation times (GTs) and lag phase durations (LPDs). Themaximum population densities (MPDs) achieved by the cultures were largelyindependent of the three variables; however, there was a general depression ofMPDs by 0.5-1.0 log cycles when the cultures were incubated anaerobically.Under the otherwise optimal conditions, GTs and LPDs were largely unaffectedby initial pH at values $ 5.5. Initial pH had a greater effect when the NaClcontent was elevated. Increasing NaCl levels decreased the growth rate of theorganism, with the effect being greater if the other variables were also non-optimal. In general, the effect of temperature could be adequately described bythe Ratkowsky square root function; however, there was a general depression ofoptimal growth temperatures and an increase in the differential between Tmin

and actual temperature that did not support growth as other variables becamenon-optimal. Comparison of the current data with previous reports suggest thatthe growth kinetics of E. coli O157:H7 are similar to those for non-pathogenicstrains.

Conner, D. E., et al. 1993. Heat Resistance of Escherichia coli O157:H7 in low-fat meat

Page 80: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxvi

and poultry products. Highlights of Agricultural Research 40:11.

This research targeted the influence of fat-reduction formulations on the survival of the E. coli O157:H7 when heating ground beef, pork sausage, ground turkey, and ground chicken at various temperatures and fat concentrations.

Crespo, F. L. and H. W. Ockerman. 1977. Thermal destruction of microorganisms inmeat by microwave and conventional cooking. J. Food Prot. 40(7):442-444.

When heating ground beef to internal temp. of 34 degree , 61 degree , and 75degree C, high temp. (232 plus/minus 6 degree C) oven cooking was moreeffective for bacterial destruction than low temp. (149 plus/minus 6 degree C)oven cooking. Low temp. oven cooking was more effective than microwavecooking. These differences in microbial destruction rates became significant (Pless than 0.05) when the meat reached the 75 degree C internal temp. level.

Doyle, M. P. and J. L. Schoeni. 1987. Isolation of Escherichia coli O157:H7 from retailfresh meats and poultry. Appl. Environ. Microbiol. 53(10):2394-2396.

A total of 896 samples of retail fresh meats and poultry was assayed forEscherichia coli serogroup O157:H7 by a hydrophobic grid membrane filter-immunoblot procedure developed specifically to isolate the organism from foods.The procedure involves several steps, including selective enrichment, filtration ofenrichment culture through hydrophobic grid membrane filters, incubation ofeach filter on nitrocellulose paper on selective agar, preparation of animmunoblot (by using antiserum to E. coli O157:H7 culture filtrate) of eachnitrocellulose paper, selection from the filters of colonies which corresponded toimmunopositive sites on blots, screening of isolates by a Biken test for precipitinlines from metabolites and antiserum to E. coli O157:H7 culture filtrate, andconfirmation of isolates as Vero cell cytotoxic E. coli O157:H7 by biochemical,serological, and Vero cell cytotoxicity tests. E. coli O157:H7 was isolated from 6(3.7%) of 164 beef, 4 (1.5%) of 264 pork, 4 (1.5%) of 263 poultry, and 4 (2.0%)of 205 lamb samples. One of the 14 pork samples and 5 of 17 beef samplescontaminated with the organism were from Calgary, Alberta, Canada, grocerystores, whereas all other contaminated samples were from Madison, Wis., retailoutlets. This is the first report of the isolation of E. coli O157:H7 from food otherthan ground beef, and the results indicate that the organism is not a rarecontaminant of fresh meats and poultry.

Doyle, M. P. and J. L. Schoeni. 1984. Survival and growth characteristics of Escherichiacoli associated with hemorrhagic colitis. Appl. Environ. Microbiol. 48(4):855-856.

Page 81: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxvii

Escherichia coli O157:H7 in ground beef was more sensitive to heat thanSalmonella, but survived for 9 months at -20EC with little change in number.The organisms grew well in Trypticase soy broth (BBL Microbiology Systems)between 30 and 42EC, with 37EC being optimal for growth. E. coli O157:H7grew poorly in the temperature range (44 to 45.5EC) generally used for recoveryof E. coli from foods.

El-Kest, S., et al. 1991. Fate of Listeria monocytogenes during freezing and frozenstorage. J Food Science 56(4): 1068-1071

Lethal and sublethal effects on Listeria monocytogenes Scott A caused byfreezing and storage or a combination of both, single and multiple freeze-thawcycles, and presence or absence of nutrients in the medium in which thepathogen was suspended, were investigated.] A cell suspension of L.monocytogenes was frozen for 30 min at -18 degree C, or 10 min in liquidnitrogen (LN) at -198 degree C. Solidification required 15 min at -18 degree Cand approx. 1 min at -198 degree C. Freezing and storage for 1 month inphosphate buffer (PB) at -18 degree C caused 87% death and 79% injury. Thesewere 54 and 45%, resp., for cells in Tryptose Broth (TB) at -18 degree C.Freezing and storage 1 month in LN caused no death or injury of cells suspendedin PB, whereas some injury and death occurred in TB. Freezing at -198 degree Cfollowed by storage 1 month at -18 degree C resulted in 60% death and 36%injury in PB, and 61 and 44.2%, in TB. Repeated freezing and thawing causedmore death/injury than did a single freeze-thaw cycle.

Fain, A. R., et al. 1991. Lethality of heat to Listeria monocytogenes Scott A: D-value andz-value determinations in ground beef and turkey. J. Food Prot. 54(10)756-761.

D-Values and z-values for Listeria monocytogenes strain Scott A weredetermined in lean (2.0% fat) and fatty (30.5%) ground beef inoculated withapprox. 10-7 cells/g. Inoculated ground meat was sealed in glass thermal deathtime tubes which were completely immersed in a circulating water bath and heldat prescribed temp. for predetermined times. Survival was determined byenumeration on Columbia CNA agar base containing 1% sodium pyruvate witha CNA + 4% horse blood overlay (CBNA) and on Listeria Plating Medium(LPM). D-values for L. monocytogenes in lean and fatty ground beef at 125degree F were 81.3 and 71.1 min, resp., as enumerated on CBNA plus pyruvate.D-values at 135 degree F were 2.6 and 5.8 min in lean and fatty beef. At 145degree F, D-values were determined to be 0.6 and 1.2 min. D-values calculatedfrom LPM recovery data from fatty ground beef at 125 degree F were 56.1 and34.5 min, resp. D-values at 135 degree F were 2.4 and 4.6 min in lean and fattybeef. At 145 degree F a D-value of 0.5 min was calculated in lean beef and aD-value of 1.1 min was determined in fatty beef. The z-values determined in lean

Page 82: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxviii

beef and fatty beef using CBNA recovery data were 9.3 and 11.4 degree F, resp.The z-value in lean beef using LPM recovery data was 9.8 degree F. The z-valuein fatty beef using LPM recovery data was 13.2 degree F. A D-value for groundturkey meat at 160 degree F could not be determined under the conditions ofthis study. Problems encountered are discussed.

Goepfert, J. M. and H. U. Kim. 1975. Behavior of selected food-borne pathogens in rawground beef. J. Milk Food Technol. 38(8):449-452.

Raw ground beef was inoculated with five strains each of Escherichia coli,enterococci, Salmonellae, Staphylococci, Bacillus cereus, and Clostridiumperfringens. Changes in population levels of these organisms, psychrotrophs, andtotal aerobic flora as these were influenced by temperature and packaging filmwere recorded. Among the organisms inoculated, only E. coli, Salmonellae, andthe enterococci were able to grow and then only at the highest test temperature(12.5 C). As expected, the packaging film did not influence the behavior of any ofthe test organisms. These results and the fact that a cooking step is involveddemonstrate why ground beef is very rarely involved as a vehicle in bacterialfood poisoning. This study indicates that there is no reason to expect protectionof public health to evolve from bacteriologic standards which limit numbers ofnon-pathogenic organisms.

Harris, L. J. and M. E. Stiles. 1992. Reliability of Escherichia coli counts for vacuum-packaged ground beef. J. Food Prot. 55(4):266-270.

Test strains of Escherichia coli were inoculated into fresh ground beef that beenirradiated or carefully excised and aseptically ground. Samples were vacuum-packaged and stored at 4EC. Plate counts on selective media incubated at 35 or45EC were highly consistent during the 7- to 20-d storage periods. The standardmost probable number (MPN) technique (lauryl tryptose broth at 35EC,followed by EC broth at 45EC) was also reliable. In contrast, direct inoculationinto broths incubated at 45EC gave unreliable and highly variable results. Thecause of the variability of the MPN counts 45EC could not be determined. It wasnot due to lactic acid bacteria growing in the ground beef. E. coli in refrigerated,vacuum-packaged ground beef can be reliably detected by direct inoculation ofseveral plating media incubated at 45EC. Direct inoculation of selective brothmedia for the MPN technique at 45EC is not recommended.

Kotula, A. W., et al. 1983. Trichinella spiralis: Effect of high temperature on infectivityof pork. Experimental Parasitol. 56:15-19.

Twenty gram samples of homogenized Boston shoulder from swine

Page 83: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxix

experimentally infected with Trichinella spiralis were sealed in plastic pouches,pressed to a uniform thickness of 2mm, and subjected to water bathtemperatures of 49, 52, 55, 60, and 63±0.5C for intervals of 2 min to 6 hr,especially within the interval of 0 to 15 min. These times included a period ofabout 1 min at the start and a period of about 1 min at the end for temperatureequilibration. Treated samples were rapidly chilled to 25C and then digested in a1% pepsin-HCl solution at 37 C for 18 hr to recover T. spiralis larvae. Therecovered larvae were suspended in 2 ml saline; 1 ml of this suspension wasintroduced into the stomach of each of two rats. The linear equation,log(time)=17.3 -0.0302(temperature), was calculated from the time required ateach temperature for the inactivation of T. spiralis larvae. The correlationcoefficient for that relationship was r = -0.994. Larvae heated in the meat to 55Cfor 4 min retained their infectivity, but were rendered noninfective after 6 min at55C. At 60C, larvae were not infective after only 2 min (zero dwell time);whereas at 52C, 47 min were required to render the larvae noninfective. Larvaein meat heated to 49C were infective after 5 hr but not after 6 hr. These datademonstrate that the destruction of infectivity of T. spiralis is time-temperaturerelated.

Kotula, A. W., et al. 1983. Destruction of Trichinella spiralis during cooking. J. FoodScience 48:765-768.

Center cut chops (longissimus dorsi) 2.5 cm in thickness, from 31 pigsexperimentally infected with Trichinella spiralis larvae and containing 37±5larvae per gram were cooked to a final internal temperature of 66, 71, 77 or82EC by one of eight methods to determine their efficacy in killing encystedlarvae. The results indicate that with the time and temperatures used in thisstudy, some rapid methods of cooking pork chops that involved the use of amicrowave oven did not completely destroy T. spiralis larvae at 77 and 82EC.The data also showed that cooking pork chops to an internal temperature of77EC in the conventional oven, convection oven, flat grill, charbroiler or deep fatfryer did inactivate encysted T. spiralis larvae in pork chops.

Line, J. E., et al. 1991. Lethality of heat to Escherichia coli 0157:H7: D-value and z-value determinations in ground beef. J. Food Prot. 54(10):762-766.

D-values and z-values were determined for lean (2.0% fat) and fatty (30.5% fat)ground beef inoculated with approx. 10-7 Escherichia coli 0157:H7 cells per g.Inoculated ground meat was sealed in glass thermal death time tubes which werecompletely immersed in a circulating water bath and held at prescribed temp.for predetermined times. Survival was determined by enumeration on platecount agar (PCA) containing 1% sodium pyruvate and by the 2-h indole test.D-values for fatty ground beef exceeded those for lean ground beef at the temp.

Page 84: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxx

tested. D-values for lean and fatty ground beef at 125 degree F were 78.2 and115.5 min, resp., as enumerated on PCA plus pyruvate. D-values at 135 degree Fwere 4.1 and 5.3 min for lean and fatty beef. At 145 degree F D-values weredetermined to be 0.3 and 0.5 min. D-values calculated from 2-h indole test datafor lean and fatty ground beef at 125 degree F were 80.1 and 121.0 min, resp.D-values at 135 degree F were 4.0 and 7.4 min for lean and fatty beef and at 145degree F a D-value of 0.2 min was calculated for lean beef only, due toinsufficient survival of E. coli 0157:H7 in fatty beef at this temp. The z-valuesdetermined for lean beef and fatty beef using PCA were 8.3 and 8.4 degree F,resp. The z-value for lean beef using the 2-h indole data was 7.8 degree F. Noz-value for fatty beef using 2-h indole data could be determined.

Linton, R. H., M. D. Pierson, and J. R. Bishop. 1990. Increase in heat resistance of ListeriamonocytogenesScottAbysublethalheatshock.J.FoodProt. 53(11):924-927.

Log phase cells of Listeria monocytogenes Scott A were heat shocked in

Page 85: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxxi

trypticase soy + 0.6% yeast extract broth at 40, 44 and 48 degree C for 3, 10 and20 min, followed by heating at 55 degree C for 50 min in order to determine anoptimum heat shock response. Most heat shocking temp. significantly increasedthermal resistance (P less than 0.05). Increasing heat shock temp. and timeallowed the organism to survive much longer than nonheat shocked cells at 50-65degree C. Optimal heat shock condition was 48 degree C for 20 min whereD-values at 55 degree C increased 2.3-fold in nonselective agar and 1.6-fold inselective agar. Cells heat shocked at 48 degree C for 10 min gave more consistentresults; these cells were heat processed at 50, 55, 60 and 65 degree C todetermine a z-value. Although D-values notably increased due to heat shocking,z-values remained constant. Heat shocking at 48 degree C significantly increasedD-value ratios for cells enumerated on nonselective vs. selective media. Heatshocking conditions may be created in pasteurization or minimal thermalprocessing of food allowing increased heat resistance of pathogenic and spoilagemicroorganisms.

Palumbo, S. A., et al. 1994. Influence of temperature on hemorrhagic Escherichia coli:Verotoxin production and minimum temperature of growth. (81st AnnualMeeting of IAMFES) Dairy, Food Environ. Sanitation p.612.

Hemorrhagic Escherichia coli has emerged as a major foodborne pathogen. Ingeneral, its culture characteristics are similar to nonpathogenic strains.Refrigeration of fresh foods, particularly red meats, represents one means ofcontrolling the growth of pathogens in these foods. However, there are no dataon the effect of temperature on the growth of hemorrhagic E. coli and onvertoxin production. Using BHI broth in a temperature gradient incubator set at5 to 50EC, we determined time to visible turbidity for 15 O157:H7, O26:H11,and O111:NM strains. At this point, samples were removed for verotoxin assay.The minimum temperature of growth ranged from 6.9 to 13 EC, with 10 strainsgrowing at 9.0-9.5 EC. Except for the two O111:NM strains, verotoxin wasproduced at all temperatures. Production was a time-temperature relationship,with more verotoxin produced at higher temperatures. Holding foods at 5 ECshould prevent hazards from this organism.

On the basis of studies on meat deboning using various types of deboning machines, a proposal for guidelines for the production and processing of mechanically deboned meat were worked out. The draft proposal covers qualitative and hygienic characteristics, as well as methods for determination of the ratio of bone marrow and bone chips in the mechanically deboned meat; it is recommended that the proportion of marrow and bone chips should be less than 10% in selected meat products.

Schoeni, J. L., K. Brunner, and M. P. Doyle. 1991. Rates of thermal inactivation of

Page 86: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxxii

Listeria monocytogenes in beef and fermented beaker sausage. J. Food Prot.54(5):334-337.

Rates of thermal inactivation of a 5-strain mixture of Listeria monocytogenes[Scott A, V7, LM-101M, LM-102M, LM-103M] were determined in ground beefroast and fermented beaker sausage. Ground beef contaminated with L.monocytogenes Scott A from an experimentally infected cow was also examined.D-values for the 5-strain mixture at 54.4, 57.2, 60.0 and 62.8 degree C were 22.4,15.7, 4.47, and 2.56 min, resp., for ground beef roast. D-values for fermentedbeaker sausage at 48.9, 51.7, 54.4, and 60.0 degree C were 98.6, 44.4, 20.1, 11.2,and 9.13 min, resp. D-values for the single strain of L. monocytogenes mixture in ground beef from the infected cow were about 2-4xless at equivalent temp. than those of the 5-strain L. monocytogenes mixture inground beef roast. Results from the 5-strain mixture indicate that L.monocytogenes is about 4x more heat resistant that Salmonella in ground beefroast.

Todd, E., et al. 1991. "Thermal resistance of verotoxigenic Escherichia coli in groundbeef -Initial work" in Escherichia coli O157:H7 and other verotoxigenic E. coli infoods. E. C. C. Todd and J. M. MacKenzie (Ed.) pp. 93-109.

Because E. coli O157:H7 and possibly other verotoxigenic E. coli have beenresponsible for human infections arising from consumption of undercookedhamburger, it was important to establish the heat resistance of these organismsin ground beef, and ultimately to determine the minimum heat processes thatsubstantially reduce the risk of illness. Eighteen strains (10 E. coli O157:H7 ornon-motile and 8 other verotoxigenic E. coli representing 7 serotypes) werescreened for high, medium or low heat resistance in phosphate buffer. Stationaryphase (17 h) cells were used for the heat resistance studies, because they were attheir maximum resistance at this time. Washed cells were added to phosphatebuffer and heated at 52 EC for various times. Surviving cells were recovered ontryptic soy agar containing 0.25 g of fast green/L to enable automated counting.D-values ranged from 7.0 to 37.4 (mean 19 min) for O157 and 4.6 to 20.1 min(mean 13 min) for the other E. coli strains. The most resistant strains for bothgroups (one O157 and one O26) were then tested in irradiated regular groundbeef (24% fat) packed in flexible pouches. Heating times between 55 and 60 ECfor 0 to 90 min were used to calculate three D-values for each of the strains. ForO157 these ranged from 31.4 min (at 55 EC) to 1.7 min (at 60 EC) and for O26from 16.9 min (at 55 EC) to 1.2 min (at 60 EC). From these data z-values forO157 and O26 were calculated to be 3.5CE and 4.3 CE, respectively. These valuesare about the same as those reported by Doyle and Schoeni and by Line et al.More resistant clones were then selected for subsequent heat resistance studies;with these clones D-values were found to be higher in medium ground beef.

Page 87: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxxiii

Restaurant and home cooking methods will be evaluated later for their ability toeliminate these pathogens in rare, medium and well-done hamburger patties.

Page 88: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxxiv

Sources for Epidemiology of Foodborne Illness

General

Bean, N. H. and P. M. Griffin. 1990. Foodborne disease outbreaks in the United States, 1973-1987: Pathogens, vehicles, and trends. J. Food Prot. 53(9): 804-817.

Bryan, F. L. 1980. Foodborne diseases in the United States associated with meat and poultry. J.Food Prot. 43(2): 140-150.

Bryan, F. L. 1988. Risks of practices, procedures and processes that lead to outbreaks of foodborne diseases. J. Food Prot. 51(8): 663-673.

Doyle, M. P. 1992. A new generation of foodborne pathogens. Dairy, Food and Environmental Sanitation 12(8): 490, 492-493.

Gravani, R. B. 1987. The causes and costs of foodborne disease. Dairy Food Sanitation 7(1):20-25.

McIntosh, W. A., et al. 1994. Perceptions of risks of eating undercooked meat and willingnesstochangecookingpractices. Appetite22(1):83-96.

Notermans, S. 1992. Existing and emerging foodborne diseases. International J. Food Microbiology 15(3/4): 197-205.

Page 89: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxxv

Schothorst, M. van and L. J. Cox. 1989. ‘Newer’ or emerging pathogenic microorganisms in meat and meat products. Proceedings, International Congress of Meat Science and Technology No. 35, Vol. I(35): 55-67.

Steahr, T. 1994. Food-borne illness in the United States: geographic and demographic patterns. International J. Environ. Health Research 4(4): 183-195.

Todd, E. C.D. 1989. Costs of acute bacterial foodborne disease in Canada and the United States. International J. Food Microbiol 9(4): 313-326.

Todd, E. 1990. Epidemiology of foodborne illness: North America. Lancet 336(8718): 788-790.

Microorganisms

Abdel-Rahman, H., T. El-Khateib, and A. K. El-Timmawy. 1988. Spoilage and food poisoning organisms in frozen ground beef. Fleischwirtschaft 68(7): 881-882.

Adesiyun, A. A. 1993. Prevalence of Listeria spp., Campylobacter spp., Salmonella spp., Yersinia spp. and toxigenic Escherichia coli on meat and seafoods in Trinidad. Food Microbiology 10(5): 395-403.

Chapman, P. A., et al. 1993. Cattle as a possible source of verocytotoxin-producing Escherichia coli O157 infections in man. Epidemiology and Infection 111(3): 439-447.

Comi, G., et al. 1992. Listeria monocytogenes serotypes in Italian meat products. Letters-in-Applied-Microbiology 15(4): 168-171.

Doyle, M. P. 1991. Escherichia coli O157:H7 and its significance in foods. Intrnatl. J. Food Microbiol. 12(4): 289-301.

Duitschaever, C. L. and C. I. Buteau. 1979. Incidence of Salmonella in pork and poultry products. J. Food Prot. 42(8): 662-663.

Johnston, R. W., et al. 1982. Incidence of Salmonella in fresh pork sausage in 1979 compared with 1969. J. Food Science 47(4) 1369-1371.

Ladiges, W.C. and J. F. Foster. 1974. Incidence of Salmonella in beef and chicken. J.

Page 90: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxxvi

Milk Food Technol. 37(4): 213-214.

Lior, H. 1994. Escherichia coli O157:H7 and verotoxigenic Escherichia coli (VTEC). Dairy, Food and Environmental Sanitation 14(7): 378-382.

McLauchlin, J., et al. 1988. Listeriosis and food-borne transmission. Lancet I(8578): 177-178.

Mermelstein, N. H. 1993. Controlling E. coli 0157:H7 in meat. Food Technol. 47(4): 90-91.

Read, S. C., et al. 1990. Prevalence of verocytotoxigenic Escherichia coli in ground beef, pork, and chicken in southwestern Ontario. Epidemiol. Infect. 105: 11-20.

Riley, L. W. 1987. The epidemiologic, clinical, and microbiologic features of hemorrhagic colitis. Ann. Rev. Microbiol 41: 383-407.

Rindi, S., D. Cerri, and B. Gerardo. 1986. [Thermophilic Campylobacter in fresh pork sausages.] Industrie-Alimentari 25(241): 648-650.

Samadpour, M., et al. 1994. Occurrence of Shiga-like toxin-producing Escherichia coliin retail fresh seafood, beef, lamb, pork, and poultry from grocery stores in Seattle,Washington. Appl. Environ. Microbiol. 60(3):1038-1040.

Schuchat, A., B. Swaminathan, and C. V. Broome. 1991. Epidemiology of human listeriosis. Clin. Micro. Rev.4(2): 169-183.

Silas, J. C., et al. 1984. Update: prevalence of Salmonella in pork sausage. J. Animal Science 59(1): 122-124.

Surkiewicz, B. F., et al. 1972. Bacteriological survey of fresh pork sausage produced at establishments under federal inspection. Appl. Microbiol. 23(3): 515-520.

Surkiewicz, B. F., et al. 1975. Bacteriological survey of raw beef patties produced at establishments under federal inspection. Appl. Microbiol. 29(3): 331-334.

Tarr, P. I. 1994. Review of 1993 Escherichia coli O157:H7 outbreak: Western United States. Dairy, Food and Environmental Sanitation 14(7): 372-373.

Vorster, S. M., et al. 1994. Incidence of Staphylococcus aureus and Escherichia coli in ground beef, broilers and processed meats in Pretoria, South Africa. J. FoodProt. 57(4):305-310.

Page 91: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxxvii

Warnken, M. B., et al. 1987. Incidence of Yersinia species in meat samples purchased in Rio de Janeiro, Brazil. J. Food Prot. 50(7): 578-579.

Weissman, M.A. and J. A. Carpenter. 1969. Incidence of Salmonellae in meat and meat products. App. Micro. 17(6): 899-902.

Factors Influencing/Controlling Microbial Growth

Ayres, J.C. 1979. Salmonella in meat products. Proceedings of the 31st AnnualReciprocal Meat Conference. pp. 148-155.

Buchanan, R. L. and L. A. Klawitter. 1992. The effect of incubation temperature, initialPh, and sodium chloride on the growth kinetics of Escherichia coli O157:H7.Food Microbiol. 9: 185-196.

Conner, D. E., et al. 1993. Heat Resistance of Escherichia coli O157:H7 in low-fat meat and poultry products. Highlights of Agricultural Research 40:11.

Crespo, F.L. and H. W. Ockerman. 1977. Thermal destruction of microorganisms inmeat by microwave and conventional cooking. J. Food Prot. 40(7): 442-444.

Doyle, M. P. and J. L. Schoeni. 1984. Survival and growth characteristics of Escherichiacoli associated with hemorrhagic colitis. Appl. Environ. Microbiol. 48(4):855-856.

El-Kest, S., et al. 1991. Fate of Listeria monocytogenes during freezing and frozenstorage. J Food Science 56(4): 1068-1071

Fain, A. R., et al. 1991. Lethality of heat to Listeria monocytogenes Scott A: D-value andz-value determinations in ground beef and turkey. J. Food Prot. 54(10):756-761.

Goepfert, J. M. and H. U. Kim. 1975. Behavior of selected food-borne pathogens in rawground beef. J. Milk Food Technol. 38(8): 449-452.

Harris, L. J. and M. E. Stiles. 1992. Reliability of Escherichia coli counts for vacuum-packaged ground beef. J. Food Prot. 55(4): 266-270.

Kotula, A. W., et al. 1983. Trichinella spiralis: Effect of high temperature on infectivityof pork. Experimental Parasitol. 56: 15-19.

Kotula, A. W., et al. 1983. Destruction of Trichinella spiralis during cooking. J. Food

Page 92: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxxviii

Science 48: 765-768.

Line, J. E., et al. 1991. Lethality of heat to Escherichia coli 0157:H7: D-value andz-value determinations in ground beef. J. Food Prot. 54(10): 762-766.

Linton, R.H., M. D. Pierson, and J. R. Bishop. 1990. Increase in heat resistance ofListeria monocytogenes Scott A by sublethal heat shock. J. Food Prot. 53(11):924-927.

Palumbo, S. A., et al. 1994. Influence of temperature on hemorrhagic Escherichia coli:Verotoxin production and minimum temperature of growth. (81st AnnualMeeting of IAMFES) Dairy, Food Environ. Sanitation p. 612.

Schoeni, J.L., K. Brunner, and M. P. Doyle. 1991. Rates of thermal inactivation of

Listeria monocytogenes in beef and fermented beaker sausage. J. Food Prot.54(5): 334-337.

Todd, E., et al. 1991. "Thermal resistance of verotoxigenic Escherichia coli in groundbeef - Initial work" in Escherichia coli O157:H7 and other verotoxigenic E. coliin foods. E. C. C. Todd and J. M. MacKenzie (Ed.) pp. 93-109.

Technique Description

Anon. 1977. The nearer the bone...Brit. Food J. 79(878): 90-92

Anon. 1984. Mechanically recovered meat. Brit. Food J. 86(921): 102-103.

Doolan, M. 1993. The automation of meat deboning. Bull., Inst. of Meat 2(10): 8-9.

Expert Panel on Food Safety and Nutrition. 1979. Mechanically deboned red meat, poultry, and fish. Food Tech. 33(3):77-79.

Field, R.A. 1976. Increased animal protein production with mechanical deboners. World Rev. Animal Prod. 12(1): 61-73.

Fonkwe, L. G. and Singh, R. K. 1994. Protein recovery from mechanically deboned turkey residue. Transact. ASAE. 37(2): 527-534.

Longdell, G. R. 1994. Advanced technologies in the meat industry. Meat Sci. 36(1/2) 277-291.

Mawson, R. F. and Collinson, B. R. 1974. Evaluation of Beehive mechanical deboning

Page 93: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

lxxxix

process. Meat Indus. Res. New Zeal. 391, 71 pp.

McCurdy, S. M. et al. 1987. Protein recovery from mechanically separated pork residue. Can. Inst. Food Sci. Tech. J. 20: 53-55.

Paardekooper, E. J. C. et al. 1992. Pig (meat) processing: recent developments and perspectives. Fleisherei. 43(2): III-IV.

Taendler, K. 1978, ’Hard separator meat’ and ’soft separator meat’: regulations and recommendations for manufacture and processing. Fleishwirtschaft 58(4): 535-536.

Veerkamp, C. H. and Elsinga, W. 1981. Preparation of useful by-products from cooked fowl frames. World Py. Sci. Assn. Europ. Fed. Py. Meat Symp. Lecture

Composition, Nutrition

Allred, L. C. et al. 1990. Protein quality and iron bioavailability of mechanically and hand-deboned turkey meat fed to rats. Poult. Sci. 69(2): 341-347.

Angel, S. et al. 1987. Upgrading spent layer meat by mechanical deboning and further processing. Proc. Europ. Mtg. Meat Res. Workers. #33, V. II, 6(13): 288-289.

Chant, J. L. et al. 1977. Composition and palatability of mechanically deboned meat

and mechanically separated tissue. J. Food Sci. 42(2): 306-309.

Field, R. A. and Arasu, P. 1981. A simple method of estimating amount of red marrow present in mechanically deboned meat. J. Food Sci. 46(5): 1622-1623.

Field, R. A. and Riley, M. L. 1974. Characteristics of meat from mechanically deboned lamb breasts. J. Food Sci. 39(4): 851-852.

Masood, M. 1994. Effects of raw materials and acidulants on composition of chicken broth from a broiler. Dissert. Abs. Intrnatl. 54(12): 5999.

Mast, M. G., et al. 1982. Effect of auger-and press-type mechanical deboning machines on selected characteristics of mechanically deboned poultry. J. Food Sci. 47(6): 1757-1762, 1766.

McMillin, K. W. 1980. The nutritional and physical characteristics of mechanically processed beef and pork product. Dissert. Abs. Intrnatl. 40(12): 5598.

Page 94: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xc

McNeill, J., et al. 1988. Influence of carcass parts and food additives on the oxidative stability of frozen mechanically-separated and hand-deboned chicken meat. Py. Sci. 67(2): 270-274.

Murphy, E. W., et al. 1980. Health and Safety Aspects of the Use of Mechanically Deboned Poultry. Report, USDA, FSQS.

Padda, G. S. 1983. Mechanical deboning - a way to full utilization of poultry meat. Poultry Guide 20(7): 92-94.

Riihonen, L. M. 1991. Applications and stability of mechanically deboned meat. Dissert. Abstrs. Intern. 52(4): 523-524.

Tso, N. T., et al. 1984. Bioavailability to rats of calcium in meat products prepared from hand or mechanically deboned beef shank. J. Nutr. 114(5): 946-952.

Hard Particles

Anon. 1991. X-Ray meat inspection scans up to nine tons per hour. Prep. Foods. 160(3): 87.

Anon. 1994. Defect Detector. Food Tech N. Z. 29(2): 8

Fried, I. et al. 1976. Symposium: properties, problems, and utilization of mechanically-deboned muscle tissue. Food Tech. 30(9): 35-38, 40, 42, 44, 46, 48,

50-51, 54, 56,58,60, 62-64, 66, 68, 76, 114.

Hyman, F. N., et al. 1993. Eating as a hazard to health: preventing, treating dental injuriescausedbyforeignobjects infood.J.

Page 95: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xci

Amer.Dent.Assn.124(11):65-69.

Mast, M. G., et al. 1982. Effect of auger- and press-type mechanical deboning machines on selected characteristics of mechanically deboned poultry. J. Food Sci. 47(6): 1757-1762, 1766.

Noble, J. 1976. "No Bones About It"--the case for mechanical deboning. Quick Frozen Foods. 39(4): 185, 192, 196, 198, 200.

Swatland, H. J. 1994. Scientific aspects of bone. Bull., Inst. Meat 4(15): 14-17.

Vyzkumny, U. M. P. 1977. Hygienic aspects of the production and processing of mechanically deboned meat from meaty bones. Proc. Eur. Mtg. Meat Res.Workers. 23: N8:1-N8:44

Page 96: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xcii

Attachment 1

Examples of Questions to be Considered in a Hazard Analysis

The Hazard Analysis consists of asking a series of questions which areappropriate to each step in a HACCP plan. It is not possible in these recommendationsto provide a list of all the questions which may be pertinent to a specific food or process. The Hazard Analysis should question in the effect of a variety of factors upon the safetyof the food.

A. Ingredients

1. Does the food contain any sensitive ingredients that may presentbiological hazards (e.g., Salmonella, Staphylococcus aureus);chemical hazards (e.g., aflatoxin, antibiotic or pesticide residues);or physical hazards (stones, glass, metal)?

2. Is potable water used in formulating or in handling the food?

B. Intrinsic factors

Physical characteristics and composition (e.g., pH, type of acidulants,fermentable carbohydrate, water activity, preservatives) of the foodduring and after processing

1. Which intrinsic factors of the food must be controlled in order toassure food safety?

2. Does the food permit survival or multiplication of pathogensand/or toxin formation in the food during processing?

3. Will the food permit survival or multiplication of pathogens and/ortoxin formation during subsequent steps in the food chain?

4. Are there other similar products in the market place? What hasbeen the safety record for these products?

C. Procedures used for processing

1. Does the process include a controllable processing step that

Page 97: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xciii

destroys pathogens? Consider both vegetative cells and spores.

2. Is the product subject to recontamination between processing(e.g., cooking, pasteurizing) and packaging?

D. Microbial content of the food

1. Is the food commercially sterile (e.g., low acid canned food)?

2. Is it likely that the food will contain viable sporeforming ornonsporeforming pathogens?

3. What is the normal microbial content of the food?

4. Does the microbial population change during the normal time thefood is stored prior to consumption?

5. Does the subsequent change in microbial population alter thesafety of the food pro or con?

E. Facility design

1. Does the layout of the facility provide an adequate separation ofraw materials from ready-to-eat foods if this is important to foodsafety?

2. Is positive air pressure maintained in product packaging areas? Isthis essential for product safety?

3. Is the traffic pattern for people and moving equipment asignificant source of contamination?

F. Equipment design

1. Will the equipment provide the time-temperature control that isnecessary for safe food?

2. Is the equipment properly sized for the volume of food that will beprocessed?

3. Can the equipment be sufficiently controlled so that the variationin performance will be within the tolerances required to produce a

Page 98: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xciv

safe food?

4. Is the equipment reliable or is it prone to frequent breakdowns?

5. Is the equipment designed so that it can be cleaned and sanitized?

6. Is there a chance for product contamination with hazardoussubstances (e.g., glass)?

7. What product safety devices are used to enhance consumer safety?

" metal detectors" magnets" sifters" filters" screens" thermometers" deboners" dud detectors

G. Packaging

1. Does the method of packaging affect the multiplication ofmicrobial pathogens and/or the formation of toxins?

2. Is the package clearly labeled "keep refrigerated" if this isrequired for safety?

3. Does the package include instructions for the safe handling andpreparation of the food by the end user?

4. Is the packaging material resistant to damage thereby preventingthe entrance of microbial contamination?

5. Are tamper-evident packaging features used?

6. Is each package and case legibly and accurately coded?

7. Does each package contain the proper label?

H. Sanitation

Page 99: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xcv

1. Can sanitation impact upon the safety of the food that is beingprocessed?

2. Can the facility and equipment be cleaned and sanitized to permitthe safe handling of food?

3. Is it possible to provide sanitary conditions consistently andadequately to assure safe foods?

I. Employee health, hygiene, and education

1. Can employee health or personal hygiene practices impact uponthe safety of the food being processed?

2. Do the employees understand the process and the factors theymust control to assure the preparation of safe foods?

3. Will the employees inform management of a problem which couldimpact upon safety of the food?

J. Conditions of storage between packaging and the end user

1. What is the likelihood that the food will be improperly stored atthe wrong temperature?

2. Would an error in improper storage lead to a microbiologicallyunsafe food?

K. Intended use

1. Will the food be heated by the consumer?

2. Will there likely be leftovers?

L. Intended consumer

1. Is the food intended for the general public?

2. Is the food intended for consumption by a population withincreased susceptibility to illness (e.g., infants, the aged, theinfirmed, immunocompromised individuals)?

Page 100: Generic HACCP Model for Raw, Ground Meat, and Poultry Products

xcvi

********************************************************************