PORK SLAUGHTER

GENERIC HACCP MODELFOR

PORK SLAUGHTER

Developed:June 18-20, 1996

Kansas City, Missouri

Submitted to

USDA, Food Safety and Inspection Service

by the

International Meat and Poultry HACCP Alliance

on

September 9, 1996

Pork Slaughter Model

TABLE OF CONTENTS

SECTION PAGE

Introduction ............................................................................. 2

Seven Principles of HACCP.......................................................... 3

Specifics About this Generic Model ................................................. 4

Using this Generic Model to Develop and Implement a HACCP Program ..... 6

Process Category Description......................................................... 9

Product Categories and Ingredients..................................................10

Flow Chart .............................................................................11

Hazard Analysis Worksheet ..........................................................14

HACCP Worksheet ....................................................................24

Examples of Record-Keeping Forms ................................................29

Appendix 1 (21 CFR Part 110).......................................................34

Appendix 2 (Process Categories).....................................................44

Appendix 3 (Overview of Hazards) ..................................................46

Appendix 4 (NACMCF Decision Tree) ..............................................48

Appendix 5 (References) ...............................................................50


GENERIC HACCP MODELFOR

PORK SLAUGHTER

Introduction:

Hazard Analysis Critical Control Point (HACCP) is a systematic, scientific approach to processcontrol. It is designed to prevent the occurrence of problems by ensuring that controls are applied atany point in a food production system where hazardous or critical situations could occur. Hazards caninclude biological (pathological and microbiological for beef slaughter), chemical or physicalcontamination of food products.

The United States Department of Agriculture (USDA) published a final rule in July 1996 mandatingthat HACCP be implemented as the system of process control in all USDA inspected meat and poultryplants. 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 the regulation will be made availablefor use by the industry.

In May 1996, the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS)awarded Contract Number 53-3A94-6-04 to the International Meat and Poultry HACCP Alliance forthe development of ten generic HACCP models. The ten models developed were:

1. Not Heat Treated, Shelf-Stable (dried products, those controlled by water activity, pH, freezedried, dehydrated, etc.)

2. Heat Treated, Shelf-Stable (rendered products, lard, etc.)3. Heat Treated Not Fully Cooked, Not Shelf-Stable (ready to cook poultry, cold smoked and

products smoked for trichinae, partially cooked battered, breaded, char-marked, batter set, andlow temperature rendered products, etc.)

4. Products with Secondary Inhibitors, Not Shelf-Stable (products that are fermented, dried,salted, brine treated, etc., but are not shelf-stable)

5. Irradiation (includes all forms of approved irradiation procedures for poultry and pork)6. Fully Cooked, Not Shelf Stable (products which have received a lethal kill step through a

heating process, but must be kept refrigerated. This includes products such as fully cookedhams, cooked beef, roast beef, etc.).

7. Beef Slaughter8. Pork Slaughter9. Poultry Slaughter10. Raw Products - not ground (all raw products which are not ground in their final form. This

includes beef trimmings, tenderized cuts, steaks, roasts, chops, poultry parts, etc.)

USDA developed three additional models:

1. Raw, Ground2. Thermally Processed/Commercially Sterile3. Mechanically Separated Species/Deboned Poultry

This document contains the generic HACCP model for the process category titled: Pork Slaughter

In order to develop this model, a literature review and an epidemiological assessment of the productsselected were performed to present an overview of the microbiological characteristics and profile of theproduct. This information then was reviewed by a team of industry, academic, public health officials,


and consumer representatives. The team met in a workshop in Kansas City, Missouri on June 18-20,1996. Subsequent to the workshop, this generic HACCP model was reviewed by small businessestablishments for clarity and usability, and it was submitted to an expert peer review panel fortechnical review.

Generic HACCP plans serve as useful guidelines; however, it is impossible for a generic model for tobe developed without it being too general. Therefore, it is incumbent on each plant’s HACCP Team totailor this model to fit products in each plant, based on the knowledge about the process. Severalpoints should be considered when using this model to develop specific HACCP plans.

All plants shall have Sanitation Standard Operating Procedures (SSOPs). Good ManufacturingPractices (GMPs) (FDA, 21 CFR 110; Appendix 1) and Standard Operating Procedures (SOPs) maybe in place as the foundation of the HACCP program. Good Manufacturing Practices are minimumsanitary and processing requirements applicable to all companies processing food. Standard OperatingProcedures (SOPs) are step-by-step directions for completing important plant procedures. SOPsshould specifically describe the method for conducting and controlling the procedure. SOPs should beevaluated regularly (i.e., daily) to confirm proper and consistent application, and modified asnecessary to ensure control.

Each generic model can be used as a starting point for the development of your plant-specific planreflecting your plant environment and the specific processes conducted. The generic model is notintended to be used “as is” for your plant-specific HACCP plans.

The generic models designed for use in developing a plant-specific HACCP plan are defined accordingto process category. In order to select the model or models that will be most useful for the activitiesperformed in your plant, the following steps should be taken.

If a model for a slaughter operation is required, select the model for the appropriate species. If a modelfor a processed product or products is required, make a list of all products produced in the plant.Examine the list and group all like products according to common processing steps and equipmentused. Compare these to the list of Process Models in Appendix 2. After reviewing and grouping theproducts produced, you will know the number of models that are needed to assist in developing yourplant-specific plans.

If an establishment is a combination plant, i.e. conducting both slaughter and processing activities, thetwo models can be merged into a plant-specific plan. In this case, over-lapping critical control points(CCPs) can be combined as long as all significant hazards are addressed.

Seven Principles of HACCP:

The following seven principles of HACCP were adopted by the National Advisory Committee onMicrobiological Criteria of Foods (NACMCF, 1992):

1. Conduct a hazard analysis. Prepare a list of steps in the process where significant hazardsoccur and describe the preventive measures.

Three types of hazards: Biological (B)— primarily concerned with pathogenic bacteria, such as Salmonella,

Staphylococcus aureus, Campylobacter jejuni, Clostridium perfringens,Clostridium botulinum, Listeria monocytogenes, and Escherichia coli O157:H7;also should consider Trichinella sprialis, and other parasites, as well as potentialpathological concerns.

Chemical (C)— toxic substances or compounds that may be unsafe for consumption;i.e., cleaners, sanitizers, pesticides, insecticides, rodenticides, paint, lubricants,etc.


Physical (P)— foreign objects which may injure the consumer; i.e., rocks, stones,wood, metal, glass, nuts, bolts, screws, plastic, knife blades, etc.

2. Identify the critical control points (CCPs) in the process. A critical control point is definedas a point, step or procedure at which control can be applied and a food safety hazard canbe prevented, eliminated or reduced to an acceptable level.

3. Establish critical limits for preventive measures associated with each identified CCP. Acritical limit is defined as a criterion that must be met for each preventive measureassociated with a CCP. Each CCP will have one or more preventive measures that must beproperly controlled to assure prevention, elimination, or reduction of hazards to acceptablelevels. Each preventive measure has associated with it critical limits that serve asboundaries of safety for each CCP.

4. Establish CCP monitoring requirements. Establish procedures for using the results ofmonitoring to adjust the process and maintain control.

5. Establish corrective action(s) to be taken when monitoring indicates that there is a deviationfrom an established critical limit.

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

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

Specifics about this Generic Model:

1. Products Included In This Model. This model deals only with pork slaughter . The productsamples include skin-on carcasses and skinned hot boned pork, and the following related products:Pork Heads (snout, tongue, cheek meat, ears, pate, brains, and lips); Pluck (heart, liver, and kidney);and Viscera (stomach, large intestines, small intestines, uteri and rectum).

2. Items Addressed. This model does not address certain aspects of product safety, such as SanitationStandard Operating Procedures (SSOPs). Good Manufacturing Practices (GMPs) and StandardOperating Procedures (SOPs) may be in place as the foundation of HACCP. The following is a list ofrecommended pre-requisite programs prior to the implementation of HACCP:

a. Sanitation Standard Operating Procedures (required by FSIS)b. Good Manufacturing Practicesc. Pest Controld. Preventive maintenance and calibration of equipmente. Potable water supply (including ice used in or on the product)f. Purchasing specifications for raw materials and related letters of guaranteeg. Temperature control programs for refrigerated rooms and vehiclesh. Training/education of employees regarding employee hygiene, HACCP policy and

responsibility.i. Recall procedures, including tracking ability of raw materials (including animals) and

finished product through distribution (labeling and coding).

3. Critical Control Points. The Critical Control Points in this model were established by the teammembers of the workshop. Some products or processes may require fewer or more CCPs dependingon the individual operation.

4. Product Flow. In the product flow, the general processes were included; however, order of flowvaries. The product flow of every HACCP plan should be specific and accurately reflect the processesinvolved at each plant.


5. Safety vs. Quality. Several parameters have been discussed to ensure a safe product. Onlyparameters relating to product safety were discussed. Quality issues were not addressed in this model.

6. Critical Limits. Critical limits selected must be based on the best information available to provide asafe product and yet be realistic and attainable. Processors must keep in mind that any product whichdoes not meet a critical limit must have a Corrective Action taken on the product before being releasedfrom the plant.

7. Process Authority. Reference may have been made about a “Process Authority” in this model. AProcess Authority may be an in-plant employee who has had specialized training, an outsideconsultant, or other professional.

8. Record-keeping. Record-keeping is an important part of the HACCP plan. Lack of accurate,current records may be cause for withholding or suspending inspection from a plant.

9. Chain of Custody. Chain of custody refers to the point at which a plant gains control of the meat.This is particularly important to know the history of incoming meat products. Requiring a HACCPplan from the supplier will in effect, extend the chain of custody to the supplier.

10. Sampling Procedures. Each plant must establish a sampling plan to verify critical control points(biological, chemical and physical) in the operation. The procedures will be based on prior knowledgeabout the problem areas and not necessarily on random testing. A Process Authority may helpestablish these sampling procedures which are most likely to identify a problem if it exists.


USING THIS GENERIC MODEL TO DEVELOP AND IMPLEMENT A HACCP PROGRAM

Getting Started: The plant should establish a HACCP team which includes at least one HACCP trainedindividual, and then develop a flow chart for each product (or process category). In addition, atraining program should be completed for all employees. It is important for all employees to haveownership in the HACCP plan and to participate in its development as appropriate. It also is importantthat the employees be given the authority to stop production if the process becomes out of control.This empowerment is critical to make the HACCP program a successful one. Once HACCP isestablished, it must be continually evaluated, upgraded, and modified. Experience in working aHACCP plan will be helpful in continual improvement in the plan. In effect, the HACCP program is along-term commitment to improving the safety of the product by controlling the process.

The NACMCF has 12 steps (five preliminary steps listed below and the seven principles previouslylisted) in developing a HACCP 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 beginning with conducting a hazard analysis.

The following steps should be considered when developing an effective HACCP system.

Before developing the HACCP system it is important to ensure that an adequate sanitation system(sanitation standard operating procedures - SSOPs) is in place for compliance with FSIS regulation.GMPs and SOPs are also important because they establish basic operational parameters for theproduction of safe food.

Assembling the HACCP Team: An important step in developing a plan is to gain managementcommitment and assemble a HACCP team. Top management must be fully committed to productsafety through HACCP to make the program effective. After commitment is obtained, the HACCPteam should be assembled. The team should consist of individual(s) from all aspects of productionand should include at least one HACCP trained individual.

Product Description. The description should include the products within the process, theirdistribution, intended use, and potential consumers. This step will help ensure that all areas of concernare addressed. If a particular area on the example form is not applicable to your process, then eliminateit from your description. The description for the Pork Slaughter is included in this model.

Flow Diagram. The HACCP team should develop and verify a flow diagram for production of theproduct(s). A simple flow diagram which includes every step of production is necessary. The flowdiagram should be verified for accuracy and completeness by physically walking through each step inthe diagram on the plant floor. The purpose of the flow diagram is to provide a clear, simpledescription of the steps in the process which are directly under the control of the facility. This modelcontains a generic flow diagram for Pork Slaughter .

Hazard Analysis. A hazard has been defined as any biological (B), chemical (C) or physical (P)property that may cause a food to be unsafe for human consumption. The hazard analysis is one of themost critical steps in the development of a HACCP plan. The HACCP team must conduct a hazard


analysis and identify steps in the process where significant hazards can occur. The significant hazardsmust be “of such a nature that their prevention, elimination, reduction or control to acceptable levels isessential to the production of safe food.” (NACMCF, 1992) The team should focus on risk andseverity as criteria for determining whether a hazard is significant or not. Risk, as defined by theNational Advisory Committee, is “likelihood of occurrence.” “The estimate of risk is usually based ona combination of experience, epidemiological data, and information in the technical literature.”(NACMCF, 1992). Severity is the potential magnitude of the consequences to the consumer if thehazard is not adequately controlled. Hazards that are not significant or not likely to occur will notrequire further consideration in the HACCP plan.

Appendix 3 provides a list of example food safety hazards as identified in the Pathogen Reduction;Hazard Analysis Critical Control Point (HACCP) Systems regulation (USDA, 1996).

The hazard analysis and identification of associated preventive measures accomplishes the following:Identifies hazards of significance and associated preventive measures.The analysis can be used to modify a process or product to further assure or improve food safety.The analysis provides a basis for determining CCPs, principle 2.

Critical Control Point (CCP): A CCP is any point, step, or procedure at which control can be appliedso that a food safety hazard can be prevented, eliminated, reduced, or controlled to acceptable levels.Information developed during the hazard analysis should enable the HACCP team to identify whichsteps in the process are CCPs. A decision tree, such as the NACMCF Decision Tree (Appendix 4)may be useful in determining if a particular step is a CCP for an identified hazard.

The CCPs discussed in this generic model should be considered as examples. Different facilitiespreparing the same product can differ in the risk of hazards and the points, steps, or procedures whichare considered CCPs. This can be due to differences in each facility layout, equipment, selection ofingredients, or the production process that is being used. Plant-specific HACCP plans may includeadditional or fewer CCPs than this model based on their individual process.

Critical Limit: A critical limit is a criterion that must be met for each preventive measure associatedwith a CCP. Therefore, there is a direct relationship between the CCP and its critical limits that serveas boundaries of safety. Critical limits may be derived from sources such as regulatory standards andguidelines, scientific literature, experimental studies, and advice from experts. The HACCPworksheet provided in this model summarizes the critical limits for each CCP. Critical limits must bebased on the best information available at the time to provide a safe product and yet must be realisticand attainable. Establishments must keep in mind that any product which does not meet the criticallimit must have a Corrective Action taken. Corrective actions may be as simple as re-processing or re-packaging or may require destroying the product.

Monitoring: Monitoring is a planned sequence of observations or measurements to assess whether aCCP is under control and produces an accurate record for future use in verification. Monitoring servesthree purposes:

1) Monitoring is essential to food safety management in that it tracks the systems operation.2) Monitoring is used to determine when there is a loss of control and a deviation occurs at a

CCP, exceeding the critical limit. Corrective action must then be taken.3) Monitoring provides written documentation for use in verifying the HACCP plan.

Because of the potential serious consequences of a critical defect, monitoring procedures must beeffective. Continuous monitoring is possible with many types of equipment, and it should be usedwhen possible.


Individuals monitoring CCPs must:1) Be trained in the technique used to monitor each preventive measure;2) Fully understand the purpose and importance of monitoring;3) Have ready access to the monitoring activity;4) Be unbiased in monitoring and reporting; and5) Accurately report the monitoring activity.

All records associated with monitoring must be signed or initialed, dated, and the time recorded by theperson conducting the monitoring activity.

Corrective Actions: Corrective actions are procedures to be followed when a deviation occurs.Because of variations in CCPs for different products and the diversity of possible deviations, specificcorrective action plans must be developed for each CCP. The actions must demonstrate that the CCPhas been brought under control and that the product is handled appropriately.

Record-Keeping: Record keeping is a critical aspect of the HACCP system. Records must be accurateand reflect the process, the deviations, the corrective actions, etc. Lack of accurate, current recordsmay be cause for withholding or suspension of inspection from the plant.

It is also important that all HACCP records dealing with CCPs and corrective actions taken, bereviewed on a daily basis by an individual who did not produce the records and who has completed acourse in HACCP, or the responsible establishment official who must sign or initial, date and recordthe time all records are reviewed. The HACCP plan and associated records must be on file at the meatand/or poultry establishment.

Example forms have been included in this model. It may be beneficial to combine forms as possible toreduce the amount of paperwork.

Verification: Verification consists of the use of methods, procedures or tests in addition to those usedin monitoring to determine that the HACCP system is in compliance with the HACCP plan andwhether the HACCP plan needs modification. There are three processes involved.

1) The scientific or technical process to verify that critical limits at CCPs are satisfactory —review of critical limits to verify that the limits are adequate to control hazards that are likelyto occur.2) Process verification to ensure that the facility’s HACCP plan is functioning effectively.3) Documented periodic reassessment, independent of quality audits or other verificationprocedures, that must be performed to ensure the accuracy of the HACCP plan.

Sanitation SOPs: According to USDA’s Pathogen Reduction/HACCP regulation (USDA, 1996),effective establishment sanitation is essential for food safety and to successfully implement HACCP.There are direct and substantial links between inadequate sanitation and the contamination of meat andpoultry products by pathogenic bacteria. Sanitation SOPs are necessary because they clearly defineeach establishment’s responsibility to consistently follow effective sanitation procedures andsubstantially minimize the risk of direct product contamination and adulteration.

Microbial testing for indicator organisms can be used to validate CCP effectiveness, and to establishin-plant trend analysis. Microbial testing should be part of a sanitation program in order to validateeffectiveness. Microbial testing does not indicate that the product is safe, but it is used to verify thatthe process was in control.

Pork Slaughter

PROCESS CATEGORY DESCRIPTION

PORK SLAUGHTER

WORKSHOP LOCATION: Kansas City, MO

COMMON NAME: (1) Pork Carcass (Skin-on)(2) Pork (Skinned) Hot Boned Meat(3) Heads (snout, tongue, cheek meat, ears,

pate/forehead, brains, and lips)(4) Pluck (heart, liver, and kidneys)(5) Viscera (stomach, large intestine, small

intestine, uteri, and rectum)

HOW IS IT TO BE USED: Whole carcass for fabrication (including hotboned meat)

TYPE OF PACKAGE:Pork carcass and Pork Hot Boned Meat — No packageHead, Pluck, and Viscera — Boxed

LENGTH OF SHELF-LIFE, AT WHATTEMPERATURE? The shelf-life should be 14-21 days

depending on the temperature (<40°F) andstorage conditions. The head, pluck andviscera should be frozen at -20° as soon aspossible. Products should be distributedwithin 90 days of slaughter.

LABELING INSTRUCTIONS:Not applicable for carcass or hot boned meat; mark of inspection.“Keep Frozen” on frozen head, pluck and viscera.

IS SPECIAL DISTRIBUTION CONTROL NEEDED?Maintain refrigerated or frozen storage conditions.

Pork Slaughter

PRODUCT CATEGORIES AND INGREDIENTS

PRODUCT CATEGORY: Pork Slaughter

WORKSHOP LOCATION: Kansas City, MO

MEAT AND MEATBYPRODUCTS

NON-MEATINGREDIENTS

BINDERS/EXTENDERS

Live Hogs N/A N/A

SPICES/FLAVORINGS RESTRICTEDINGREDIENTS

PRESERVATIVES/ACIDIFIERS

N/A N/A N/A

OTHERPackaging material for boxedproducts.

Pork Slaughter Flow Chart(Skin on Carcass)

Animal Receiving

Animal I.D.

Holding (Including suspect holding pens, ante mortem inspection, etc.)

Stunning/Shackling

Sticking/Bleeding

Scalding

Dehairing

Gambrelling

Singeing/Polishing/Shaving

(Including toenail removal)

Pre-eviscerationWash

Bunging

Head Dropping

Head Removal*

Midline & BrisketOpening

Pull Leaf Fat/Expose Kidney

Final Trim

Grade Stand

Final wash

Chilling

*The majority of industry operations remove the head following evisceration or splitting. In thesesituations the head removal step should be followed by an antibacterial intervention and the step bedesignated as a CCP.


Pork Slaughter Flow Chart(Skinned Hot Boned Pork)

Animal Receiving

Animal I.D.

Holding (Including suspect holding pens, ante mortem inspection, etc.)

Stunning/Shackling

Sticking/Bleeding

SkinningPreparation

Hide Pulling

Trimming

Bunging

Midline & BrisketOpening

Head Removal*

Final Trim

Final wash

Grading

Head Dropping

Evisceration (Include bladder &reproductive organremoval.)

Splitting

Pull Leaf Fat/Kidney Exposure

(Approved AntibacterialIntervention)

Hot Boning

Head Removal*

*The majority of industry operations remove the head following evisceration or splitting. In thesesituations the head removal step should be followed by an antibacterial intervention and the step bedesignated as a CCP.


Flow Chart for Heads

Remove

Wash/AntibacterialIntervention Rinse

Processing

Chill

Box

(Disassembly)

Remove

Wash

Chill

Box

Flow Chart for Pluck

Disassemble

Flow Chart for Viscera

Remove

Process

Disassembly

Wash

Box

Chill



Hazard Analysis Worksheet:

The Hazard Analysis Worksheet format used in this model is an example format. Alternative formscan be used for the hazard analysis.

This worksheet should be used in two steps.

The first step, is to review each process step listed in the Process Flow Diagram and identify allpotential hazards that can be introduced or enhanced at this step. Chemical, physical, and biologicalhazards should all be addressed. It is recommended that you list all potential hazards for each processstep before moving to column two.

The second step, is to determine if the potential hazard is significant . The significant hazards must be“of such a nature that their prevention, elimination, reduction, or control to acceptable levels isessential to the production of safe food.” (NACMCF, 1992) The team should focus on risk andseverity as criteria for determining whether a hazard is significant or not. Risk, as defined by theNational Advisory Committee, is “likelihood of occurrence.” “The estimate of risk is usually based ona combination of experience, epidemiological data, and information in the technical literature.”(NACMCF, 1992). Severity is the potential magnitude of the consequences to the consumer if thehazard is not adequately controlled. Hazards that are not significant or not likely to occur will notrequire further consideration in the HACCP plan.

It is important that you justify your decision for determining if a hazard is or is not significant. Thiswill help you document your rationale for making decisions and is a useful tool when you re-validateor revise your HACCP plan.

The fifth column, addresses preventive measures. For each significant hazard, identify preventivemeasures, if they exist. A preventive measure is a physical, chemical, or other means which can beused to control an identified food safety hazard.

It is recommended that you complete columns 1 through 5, before starting on column 6. Column sixasks, “Is this step a critical control point (CCP)?” A CCP is any point, step, or procedure at whichcontrol can be applied so that a food safety hazard can be prevented, eliminated, reduced, or controlledto acceptable levels. Information developed during the hazard analysis should enable the HACCP teamto identify which steps in the process are CCPs. A decision tree, such as the NACMCF Decision Tree(Appendix 4) may be useful in determining if a particular step is a CCP for an identified hazard. Thehazards identified during the development of this model were subjected to a decision tree by the teammembers. CCPs must be carefully developed and documented and must be for product safety only.Different facilities preparing the same product can differ in the risk of hazards and the points, steps, orprocedures which are CCPs.

The CCPs identified in this model are for illustrative purposes only. Individual plant process willdetermine the CCPs identified for plant-specific plans. Remember that Sanitation Standard OperatingProcedures are essential prerequisites to HACCP.


Ingredient/Process Step

Potential hazardintroduced,

controlled orenhanced at this

step

Is thepotential foodsafety hazardsignificant?

Justification for decision What controlmeasures can be

applied to preventthe significant

hazards?

Is this stepa criticalcontrolpoint

(CCP)?

AnimalReceiving

C: Antibiotics,residues

P: Foreignmaterials (needles,buckshot, etc.)

B: Pathogens,parasites(Salmonella, etc.)

C: No

P: No

B: Yes

C: The potential food safety hazard from chemicalresidues (antimicrobial, pesticides, herbicides, andheavy metals) is not considered to be significant asthere have been “no reports of residue-related humanillness in the United States associated withconsumption of commercially available meat orpoultry” (Kindred and Hubbert, 1993).

Monitoring for the presence of violative chemicalresidues is done by USDA and the slaughterestablishments. Industry educational programs such asthe Pork Quality Assurance (PQA) Program (NationalPork Producers Council, 1994) have promoted residueprevention on the farm. In addition to the and producerefforts to address residues, slaughter establishments canrequest letters of guarantee and copies of relevantanimal treatment records.

The above listed combination of no identified foodsafety illnesses from pork residues, industry andgovernment preventive and monitoring programs, andthe extremely low level of residues provides thejustification for chemical residues to not be considered asignificant food safety hazard for this product.

No controls at thispoint. Programs beingdeveloped by animalproducer groups mayaddress some of theseissues in the future.

No





step




hazards?


(CCP)?

Animal receivingcontinued...

P: Physical hazards that may be of concern are relatedto foreign materials such as broken hypodermic needlesthat could be present in muscle tissue. Industry qualityassurance programs include educational materials onproper injection techniques to minimize the potentialfor this to happen and how to address them if they dooccur. At the present time, there are not devicesavailable that are capable of detecting needles or otherobjects in the live animal. Detection devices may beused later in the processing stage to address thispotential hazard.

B: Hogs are potential carries of humanpathogens/parasites. Most animals are asymptomaticso there is no practical detection method in liveanimals. Control is better accomplished throughoutthe process through sanitation, trimming whennecessary and implementation and monitoring ofdesignated CCPs.

Animal I.D. N/A N o

Holding C: ResiduesP: None identifiedB: Pathogens

C: NoB: Yes

C: Monitored by plant prerequisite program. Use onlypreapproved cleaning chemicals, etc. for holding pens.Low risk/exposure.

B: Concern over animal shedding (salmonellae) whichmay occur within 3 hours of co-mingling (Cray, 1995).The holding period of animals prior to slaughter allowsfor rest and feed which have been shown to reduce theincidence of broken viscera and cross-contamination(Miller, et. al, 1996).

No specific controlsexist at this step;however, holding shouldbe geared to obtainoptimal benefits atslaughter (i.e., cleanpens, etc.)

No

Stunning/Shackling

N/A No





step




hazards?


(CCP)?

Sticking/Bleeding

C: None identifiedP: None identifiedB: Pathogens

No B: Low risk. Potential for cross contamination ofstick wound from animals that might be condemned orthat have abscesses. All stick wounds are trimmed outand condemned during the processing operation.

Recommend sanitizingknife (180°F water)between animals as partof the Sanitation SOPs.

No

Scalding C: Scalding agentsP: None identifiedB: Pathogens

C: NoB: No

C: Limited potential for contamination fromimproperly used chemicals in the scald water.

B: Low risk. There is some indication that there is apotential for an increase in internal contamination viathe stick wound during scalding (Woltersdorf, 1996).However, the risk to consumers is very low. All stickwounds are trimmed out and condemned in a subsequentprocess.

Recommend plantoperational procedures toassure proper chemicaland concentrations asapproved.

No

Dehairing C: None identifiedP: None identifiedB: Pathogens

Yes There is significant cross contamination duringconventional dehairing operations (Gill & Bryant,1993; and Knudtson, 1995). Note: There is a need for improved equipment designand investigation of alternative dehairing methods.

Controlled at a later stepin the process (i.e.,trimming, washing,etc.)

No

Gambrelling N/A No

Singeing/Polishing/Shaving(scraping)


Yes There is a lack of scientific evidence to show thatsingeing is a control for pathogens. Singing mayreduce but not eliminate contaminants (Gill, 1994).Significant increases in cross contamination may occurduring polishing (Knudtson & Hartman, and Gill et.al). Polishing will evenly distribute and may even addto the microbial burden (Merbrink & Borch, 1989; Gilland Bryant, 1992).Therefore, the singing, polishing and shaving processhas not been sufficiently studied to justify it as a CCP.There are other interventions further in the process thatbetter control contamination. However, the processneeds to be explored to see if the technology can beimproved to do the job without increasing thecontamination.

Controlled at a later stepin the process.

No





step

Is thepotential

food safetyhazard

significant?

Justification for decision What control measures canbe applied to prevent the

significant hazards?

Is thisstep a

criticalcontrolpoint

(CCP)?

Pre-eviscerationWash andantibacterialintervention


Yes High bacterial loads on the surface due to dehairing &polishing.

Note: Washing at this time is important as itremoves organisms prior to attachment.

Hot water &/or organic acid rinse,steam or other USDA approvedantibacterial intervention.(Organic rinse is recommended.)

YesCCP 1-B

Bunging C: None identifiedP: None identifiedB: Pathogens

Yes Possible fecal contamination from procedure. Eventhough rupture may occur on some animals it isimpossible to take corrective action at this step. It isrecommended that improved dressing procedures(bags, tying, plug, etc.) be investigated.

Operational procedures - sanitizeimplements in 180°F water.Ruptured bungs should be taggedfor railout. Trimming workershould identify carcasses needingtrimming or cleaning. Do this assoon as possible after notingcontamination as part of theplant’s Sanitation SOP.

No

Head dropping C: None identifiedP: None identifiedB: Pathogens

No Cervical abscesses are more of an aesthetic problemthan a human health threat. The major bacterialspecies associated with macroscopic lesions in pigsare considered non-pathogenic to humans orconstitute no risk for foodborne illness (Berends etal., 1993).

Operational procedures - sanitizeimplements in 180°F waterbetween carcasses as part of theplant’s Sanitation SOP.

No

Head removal(see analysis forHead)


No Same as above. Same as above. No

Open Midline &Brisket


No Potential for contamination of internal cavities byaccidentally cutting into the viscera, particularly thegastro-intestinal tract. Low incidence of occurrence;properly trained employees will reduce the incidence.

Operational procedures for workeridentification of carcasses needingtrimming or cleaning. Do this assoon as possible as part of theplant’s Sanitation SOP. Alsosubsequent wash/anti-microbialtreatment to reduce risk.

No





step




hazards?


(CCP)?

Evisceration C: None identifiedP: None identifiedB: Pathogens

Yes Same as above. Same as above. No

Splitting C: None identifiedP: BoneB: Pathogens

P: No

B: No

P: Small bone fragments are deposited on the outersurfaces; however, these are easily removed at the finalwash. Low risks.

B: On contaminated carcasses there is some potentialfor spreading the contamination via the splitting saw.This is controlled via the operational procedures andSanitation SOPs designed to prevent contamination.

Sanitize saw betweencarcasses; knowncontaminated carcassessplit on throw-out rail.

No

Head Removal(alternate site forHeads givenbelow)

Pull Leaf Fat &Expose Kidney

N/A No

Final Trim C: None identifiedP: DeadlocksB: Pathogens

P: NoB: Yes

P: Removed prior to fabrication. Metal detectors maybe used on trimmings. Low risk to cause healthproblems.

B: As contamination occurs during processing, itshould be removed as soon as possible by usingphysical trimming. The final trim rail is the finalpoint in the slaughter process to remove visiblecontamination prior to the antimicrobial intervention.

Trim and visualevaluation.

YesCCP 2

Grading N/A No

Final Wash &AntibacterialRinse

C: None identifiedP: Bone dust,chipsB: Pathogens

P: NoB: Yes

P: Small particles will wash off easily. Low risk

B: Appropriate step to reduce bacterial load fromprevious slaughter steps. (Alsmeyer, RH, Dickson, etal, 1991 & 1992; van Netten et al, 1994; USDA, FSISBackgrounder, 1992)

Hot water, organic acids,steam or other USDAapproved intervention.

YesCCP 3





step




hazards?


(CCP)?

Chill C: LubricantsP: Rail DustB: Pathogens

C: NoP: NoB: Yes

C & P: Preventive maintenance and Sanitation SOPsto prevent contamination.

B: Minimize growth of carcass bacteria throughtemperature control. Chilling must be consistent andmaintained to take into account high variable factorssuch as carcass size, air flow, temperature, fat cover oncarcasses, spacing, chilling method (i.e., spray chill,etc.). There is insufficient scientific data currentlyavailable to set specific time/temperature limits as itrelates to food safety (Gill, 1995). Factors such asinitial microbial load; cooler temperature; chillingmethod (blast chill, spray chill); air flow; heat transferfrom other carcasses; carcass spacing; carcass size; fatcover; and water temperature if spray chilled; allcontribute to highly variable rates of chilling. Thisvariation severely limits the ability of onerecommendation to apply time/temperature limits tothe whole industry for carcass chilling. The limitsshould be plant specific.

Rapid temperaturereduction (surface andmuscle)

YesCCP - 4 B





step

Is thepotential

food safetyhazard

significant?



hazards?


(CCP)?

SKINNED HOTBONED PORK

Hide RemovalPreparation


No B: Potential for cross contamination between carcassesand/or equipment. Contact with the skin, and possiblefecal contamination. Incidence of contamination very low;low risk. (If an antimicrobial treatment is not used later inthe process then you may want to consider making this orother steps CCPs.)

Sanitation SOPs shouldaddress wash/sanitizeknife between cuts,worker training, etc.Additional informationis needed relating to howskin preparation stepsfor the removal affectthe incidence of torn andbroken skins. Taggingfor trimming orimmediate rail-out ofimproperly dehidedcarcasses should occurand should be includedin written plantprocedures.

No

Final Trim C: None identifiedP: None identifiedB: Pathogens

Yes B: Since the product goes directly to boning and finishedproduct, it is important to remove all visible foreignmaterial from carcass at this step. The antibacterial rinsefollowing the final wash is a more effective step forcontrolling this hazard and is therefore the preferred CCP.

Trim all visiblecontaminants andforeign material.

No

Hot Boning C: None identifiedP: Bone fragmentsB: Pathogens

P: NoB: Yes

P: Risk/severity of bones will vary with individualsystems. Bone chips are usually not of sufficient size tobe of public health concern to the consumer, especiallywhen a bone collector is used. Bones may removed viagrinders equipped with bone collector. (If not used, youmay want to consider this site as a CCP.)

B: Potential for cross contamination which should beaddressed in the Sanitation SOPs.

Sanitation SOPs andemployee education willhelp control potentialcross contamination.

No





step




hazards?


(CCP)?

Hide Pulling C: None identifiedP: None identifiedB: Pathogens

Yes B: Contamination, carcass to carcass, equipment,airborne pathogens, hide left on carcass. Most of thecontaminating organisms originate from the hide. Apreviously ‘sterile’ surface is now exposed and may becontaminated either through direct or indirect contactwith hide, hair, fecal matter equipment and workerhandling. Any visible contamination will also betrimmed further during the processing where it may bemore effective in pathogen removal. (Johanson, 1983;Roberts, 1984)

Subsequent wash/antibacterial interventionstep applied. Properlytrain workers, properequipment adjustment.

Contamination shouldbe identified andremoved as soon aspossible.

*recommend hide pullerbe sanitized — shouldbe continuous forproduct contact surfaces.Any foreign materialwill be identified andremoved as soon aspossible.

No





step




hazards?


(CCP)?

HEADS

Removal N/A

Wash/Antibacterialintervention


Yes Potential for cross contamination from dressingoperation.

Wash followed byantibacterialintervention.

YesCCP #3

Disassembly N/A No

Chill N/A No

Box N/A No

PLUCK

Receive pluckfrom evisceration

N/A No

Disassembly N/A No

Wash N/A No

Chill N/A No

Box N/A No

VISCERA

Receive fromevisceration

N/A No

Disassembly C: None identifiedP: None identifiedB: Pathogens

Yes Cross contamination from broken guts. Broken guts are removedand condemned.Sanitation SOPs shouldprevent additionalproduct contamination.

No

Processing N/A No

Wash N/A No

Chill N/A No

Box N/A No


HACCP Worksheet:

The HACCP Worksheet format used in this model is an example format. Alternative forms can be usedfor the HACCP plan.

The first three columns of the form, identify the process step associated with the CCP, allows for CCPidentification (number and type of hazard), and provides a description of the CCP. Columns fourthrough eight are used to indicate the establishment’s critical limits, monitoring procedures, correctiveactions, recordkeeping methods, and verification procedures for each CCP.

A critical limit is a criterion that must be met for each preventive measure associated with a CCP.Critical limits may be derived from sources such as regulatory standards and guidelines, scientificliterature, experimental studies, and advice from experts. Critical limits must be based on the bestinformation available at the time to provide a safe product and yet must be realistic and attainable.Establishments must keep in mind that any product which does not meet the critical limit must have aCorrective Action taken. Corrective actions may be as simple as re-processing or re-packaging or mayrequire destroying the product.

Monitoring procedures should include a planned sequence of observations or measurements to assesswhether a CCP is under control and produce an accurate record for future use in verification.Monitoring serves three purposes:

1) Monitoring is essential to food safety management by tracking the systems operation.2) Monitoring is used to determine when there is a loss of control and a deviation occurs at a

CCP, exceeding the critical limit. Corrective action must then be taken.3) Monitoring provides written documentation for use in verifying the HACCP plan.

All records associated with monitoring must be signed or initialed, dated, and the time recorded by theperson conducting the monitoring activity.

Corrective actions are procedures to be followed when a deviation occurs. Because of variations inCCPs for different products and the diversity of possible deviations, specific corrective action plansmust be developed for each CCP. The actions must demonstrate that the CCP has been brought undercontrol and that the product is handled appropriately. Corrective action records must be signed, dated,and the time of action recorded by the individual responsible for taking the action.

Record keeping is a critical aspect of the HACCP system. Records must be accurate and reflect theprocess, the deviations, the corrective actions, etc. Lack of accurate, current records may be cause forwithholding or suspension of inspection from the plant. It is also important that all HACCP recordsdealing with CCPs and corrective actions taken, be reviewed on a daily basis by an individual, whodid not produce the records and who has completed a course in HACCP, or the responsibleestablishment official who must sign or initial, date, and record the time all records are reviewed. TheHACCP plan and associated records must be on file at the meat and/or poultry establishment.

Example recordkeeping forms have been included in this model. It may be beneficial to combineforms as practical to reduce the amount of paperwork.

Verification consists of the use of methods, procedures, or tests in addition to those used in monitoringto determine that the HACCP system is in compliance with the HACCP plan and whether the HACCPplan needs modification. Verification involves:

1) The scientific or technical process to verify that critical limits at CCPs are satisfactory —review of critical limits to verify that the limits are adequate to control the hazards and thatare likely to occur.2) Process verification to ensure that the facility’s HACCP plan is functioning effectively.3) Documented periodic revalidation, independent of quality audits or other verificationprocedures, that must be performed to ensure the accuracy of the HACCP plan.

HACCP WORKSHEET — GENERIC HACCP MODEL — PORK SLAUGHTER

PROCESSSTEP

CCPNUMBER

CCPDESCRIPTION

CRITICALLIMITS

ESTABLISHMENTMONITORING

CORRECTIVEACTION

HACCPRECORDS

HACCPVERIFICATION

Pre-eviscerationWash

CCP 1-B Wash completecarcass with water atsufficient force(water as it contactscarcass), volume andpressure (psisupplied to thehose) to removevisiblecontamination.

Force, volume andhose psi areintimatelyinterrelated and varyfrom plant to plantand factors can beadjusted formaximumeffectiveness.

Force of the watercontacting thecarcass is also afunction of distancefrom the nozzle.

Psi of water > 35and < 500 ml foreach carcass

Continuos monitoringby responsible plantemployee (recordedevery 30 minutes) bydesignated plantemployee that washer(individual or cabinet)is operating properly.

Carcass evaluation bytrained designatedindividual to assureremoval of visiblecontaminants (1-2% ofcarcasses, selectedrandomly). Equipmentchecked for psi, at leastonce per shift; assureapplication is nothindered by equipmentmalfunction.

Stop production,first/and/or adjustwash unit.Monitoringindividualempowered to stopproduction as soonas cabinet fails tooperate.

Unwashed productwill be reconditionedby hand washing,skinning orrecycling throughwash cabinet.

Continuousmonitoringresults arerecorded onappropriateform.

Record resultsof eachevaluation ofcarcasses onproductionform, recordedat least onceper shift.

Hold summary

Deviation/CorrectiveAction log

Verificationlog

All recordsshould besigned, datedand thespecific resultsrecorded.

Equipment(thermometer,pressure gage, etc.)calibration at thebeginning of everyshift and at lunchbreak (two checks pershift).

Random microbialtesting to comparewith baseline andmeasure progress.

Daily review ofrecords for this CCPprior to shippingproduct.

Check randomsampling of carcassesevery 1/2 hour todetermine visualcontaminants havebeen removed. (Sizeof sample will varydepending on the sizeof the operation andeach days’ totalsampling should bebetween 1-2% of thedaily kill.)

PROCESSSTEP

CCPNUMBER

CCPDESCRIPTION

CRITICALLIMITS


CORRECTIVEACTION

HACCPRECORDS

HACCPVERIFICATION

Final trim CCP 2-B Removal of allvisualcontamination bytrimming.

No visual fecal oringestacontamination oncarcass. Greaterthan 20% of thecarcasses (3 of 10sequential carcasses)having visiblecontaminants.(Horne, 1993)

Visual inspection in 2steps.

1. Continuous monitor100% or carcasses.

2. Designated monitorexamines X number ofcarcasses every X timeperiod. (1-2% ofproduction).

Reduce line speed by10% for eachcarcass that deviateson designatedmonitor’sexamination andincrease frequency ofmonitorexaminations.

Increase speed - (upto the originalspeed) in the same10% increments onthe basis of “cleantests.”

Rail out forindividual attentionand evaluation thosecarcasses that haveexcesscontamination.Should be identifiedby operator at thestation where thecontaminationoccurs.

Stop line.

Use carcassmapping toindicatelocation ofdefects.


Random microtesting to comparewith baseline andmeasure progress.



PROCESSSTEP

CCPNUMBER

CCPDESCRIPTION

CRITICALLIMITS


CORRECTIVEACTION

HACCPRECORDS

HACCPVERIFICATION

Final Wash &AntibacterialIntervention

CCP 3-B Wash completecarcass with water atsufficient force(water as it contactscarcass), volume andpressure (psisupplied to thehose) to removevisiblecontamination.

Use a pathogenintervention processapproved by USDAand/or scientificallyvalidated such as useof organic acids(acetic or lactic acid)or hot water. SeeFSIS Directive6340.1; December1993.

Psi of water > 35and < 500 ml foreach carcass

(Not enough datafor pork carcassesso the standard forbeef carcasses isused as anexample.) Lacticacid applied at 500ml per carcass and250 ml for each sideof a 2% solution at130°F. Acid andwater must remainon the carcass for30 seconds.

Continuous monitoringby designated plantemployee (record every30 minutes that wash(individual or cabinet)is operating properly.

Carcass evaluation bydesignated plantemployee to assureremoval of visiblecontaminants.Equipment checked forpsi, at least once pershift; assure applicationis not hindered byequipment malfunction.

Stop production,first/and/or adjustwas unit.Monitoringindividualempowered to stopproduction as soonas cabinet fails tooperate.

Unwashed productwill be reconditionedby hand washing,skinning orrecycling throughwash cabinet.

Continuousmonitoringresults arerecorded onappropriateform.

Record resultsof eachevaluation ofcarcasses onproductionform, recordedat least onceper shift.


Random microtesting to comparewith baseline andmeasure progress.



PROCESSSTEP

CCPNUMBER

CCPDESCRIPTION

CRITICALLIMITS


CORRECTIVEACTION

HACCPRECORDS

HACCPVERIFICATION

Chilling CCP 4-B Reduction of carcass(surface and internal)temperature within areasonable time inorder to minimizethe multiplicationof microorganisms.

< 40°F internal(ham) temperaturewithin 24 hours.

< 40°F within 12hours on carcasssurface

< 36°F in 24 hours

Note: Thesetemperatures arebased on bestestimates due toinsufficient data.More scientificresearch is needed inthis area (Gill,1994).

Monitor surfacetemperature & internaltemperature of productof 5 randomly selectedcarcasses/day/hot boxwith hand heldthermometer calibrateddaily and sanitizedbetween each use.

Continuous monitoringof room temperature ofcooler with diskrecording thermometer.

Air flow rate, velocityand carcass spacing mayalso be monitored toensure maximumcooling efficiency.

Contact maintenanceto repair coolerproblem; stopproduct flow untilproduct temperatureis reached. Transferproduct to a moreefficient cooler.

Temporarily utilizeCO2 for fastercooling of product.

Hold and evaluateproduct fordisposition (cooling,cooked product,condemn, etc.)

Checktemperature(product androom) every 1hour and makewritten record.

Maintainwritten recordson monitoringand correctiveactions for apre-determinedperiod of time.

Recordingthermometerrecords.


Random microtesting before andafter CCP to matchwith the baselinemicrobial data toestablish the processis workingeffectively.


Periodic (i.e., daily)observation and checkof temperatures andprocedure being usedto obtain temperature.


Example Records

YOUR COMPANY — FINAL WASH & ANTIBACTERIAL INTERVENTION

Date: ______________________ Critical Limits: 180°F water at carcass surface for 10 seconds

Monitor: ___________________ Corrective Action: Stop production, notify supervisor, hold and rework

HACCP Team Member: ______________ “at risk” product.

HACCP Coordinator: ________________

TIME TEMPERA-TURE

EXPOSURETIME

NOZZELSFUNCTIONING?

CORRECTIVEACTION

MONITOR’SINITIALS

VERIFICATIONINITIALS

YES NO

YOUR COMPANY — PORK CARCASS CHILL

Date: ______________________ Critical Limits: <40°F internal (ham) within 24 hours; surface 40°F within

Monitor: ___________________ 12 hours, 36°F within 24 hours.

HACCP Team Member: ______________ Corrective Action: Fix cooler problem; Stop product flow until temperature is reached; or transfer

HACCP Coordinator: ________________ product to more efficient on-site cooler or temporary use of CO2. Hold and evaluate product for disposition.

Time Temperature Lapsed Time(hrs)

CorrectiveAction

Monitor’sInitials

VerificationInitials

Internal Surface

YOUR COMPANY — PRE-EVISCERATION WASH

Date:___________________ All nozzles functioning and total coverage of all carcasses.

Monitor: ____________________

HACCP Team Member: ________________ Action: Stop Production, notify supervisor, rework carcasses not washed.


Time WashingAcceptable

Description & Corrective Action Monitor’sInitials

VerificationInitials

Yes No

YOUR COMPANY — HEAD WASH & ANTIBACTERIAL INTERVENTION

Date:___________________ Critical Limits: 180°F Water at carcass surface for 10 seconds.

Monitor: ____________________

HACCP Team Member: ________________ Corrective Action: Stop production, notify supervisor, rework at risk product.


Time Temperature ExposureTime

NozzlesWorking

Corrective Actions MonitorInitials

VerficationInitials

Yes No


APPENDIX 1

Pork Slaughter

This is not an FSIS requirement. The following Good Manufacturing Practices (21 CFRPart 110) codified by the Food and Drug Administration are being provided for referencematerial to help assist you in developing your plant’s manufacturing procedures. Thedocument provides information which may also be useful as part of your SanitationStandard Operating Procedures.

Pork SlaughterFOOD AND DRUGADMINISTRATION,DEPARTMENT OF HEALTHAND HUMAN SERVICES

21 CFR PART 110 - CURRENTGOOD MANUFACTURINGPRACTICE INMANUFACTURING,PACKING, OR HOLDINGHUMAN FOOD

Subpart A - General ProvisionsSec. 110.3 Definitions.Sec. 110.5 Current good manufacturing

practice.Sec. 110.10 Personnel.Sec. 110.19 Exclusions.

Subpart B - Buildings andFacil i t iesSec. 110.20 Plant and grounds.Sec. 110.35 Sanitary operations.Sec. 110.37 Sanitary facilities and

controls.

Subpart C - EquipmentSec. 110.40 Equipment and utensils.

Subpart D - [Reserved]

Subpart E - Production andProcess ControlsSec. 110.80 Processes and controls.Sec. 110.93 Warehousing and

distribution.

Subpart F - [Reserved]

Subpart G - Defect ActionLevelsSec. 110.110 Natural or unavoidable

defects in food for human use that present no health hazard.

SUBPART A - GENERALPROVISIONS

110.3 Definitions.

The definitions and interpretationsof terms in section 201 of theFederal Food, Drug, and CosmeticAct (the act) are applicable to suchterms when used in this part. Thefollowing definitions shall alsoapply:

(a) “Acid foods or acidifiedfoods” means foods that have anequilibrium pH of 4.6 or below. (b) “Adequate” means thatwhich is needed to accomplish theintended purpose in keeping withgood public health practice. (c) “Batter” means a semifluidsubstance, usually composed offlour and other ingredients, intowhich principal components offood are dipped or with which theyare coated, or which may be useddirectly to form bakery foods. (d) “Blanching,” except for treenuts and peanuts, means aprepackaging heat treatment offoodstuffs for a sufficient time andat a sufficient temperature topartially or completely inactivatethe naturally occurring enzymesand to effect other physical orbiochemical changes in the food. (e) “Critical control point”means a point in a food processwhere there is a high probabilitythat improper control may cause,allow, or contribute to a hazard orto filth in the final food ordecomposition of the final food. (f) “Food” means food asdefined in section 201(f) of the actand includes raw materials andingredients. (g) “Food-contact surfaces” arethose surfaces that contact humanfood and those surfaces fromwhich drainage onto the food oronto surfaces that contact the foodordinarily occurs during thenormal course of operations.'Food-contact surfaces' includesutensils and food-contact surfacesof equipment. (h) “Lot” means the foodproduced during a period of timeindicated by a specific code. (i) “Microorganisms” meansyeasts, molds, bacteria, and virusesand includes, but is not limited to,species having public healthsignificance. The term'undesirable microorganisms'includes those microorganisms thatare of public health significance,that subject food to decomposition,that indicate that food iscontaminated with filth, or thatotherwise may cause food to beadulterated within the meaning ofthe act. Occasionally in theseregulations, FDA used the adjective

'microbial' instead of using anadjectival phrase containing theword microorganism. (j) “Pest” refers to anyobjectionable animals or insectsincluding, but not limited to, birds,rodents, flies, and larvae. (k) “Plant” means the buildingor facility or parts thereof, used foror in connection with themanufacturing, packaging,labeling, or holding of humanfood. (l) “Quality control operation”means a planned and systematicprocedure for taking all actionsnecessary to prevent food frombeing adulterated within themeaning of the act. (m) “Rework” means clean,unadulterated food that has beenremoved from processing forreasons other than insanitaryconditions or that has beensuccessfully reconditioned byreprocessing and that is suitablefor use as food. (n) “Safe-moisture level” is alevel of moisture low enough toprevent the growth of undesirablemicroorganisms in the finishedproduct under the intendedconditions of manufacturing,storage, and distribution. Themaximum safe moisture level for afood is based on its water activity(a (INFERIOR w)). An a(INFERIOR w) will be consideredsafe for a food if adequate data areavailable that demonstrate that thefood at or below the given a(INFERIOR w) will not support thegrowth of undesirablemicroorganisms. (o) “Sanitize” means toadequately treat food-contactsurfaces by a process that iseffective in destroying vegetativecells of microorganisms of publichealth significance, and insubstantially reducing numbers ofother undesirable microorganisms,but without adversely affecting theproduct or its safety for theconsumer. (p) “Shall” is used to statemandatory requirements. (q) “Should” is used to staterecommended or advisoryprocedures or identifyrecommended equipment.

Pork Slaughter (r) “Water activity” (a(INFERIOR w)) is a measure of thefree moisture in a food and is thequotient of the water vaporpressure of the substance dividedby the vapor pressure of purewater at the same temperature.

110.5 Current goodmanufacturing practice.

(a) The criteria and definitions inthis part shall apply in determiningwhether a food is adulterated (1)within the meaning of section402(a)(3) of the act in that thefood has been manufactured undersuch conditions that it is unfit forfood; or (2) within the meaning ofsection 402(a)(4) of the act in thatthe food has been prepared,packed, or held under insanitaryconditions whereby it may havebecome contaminated with filth, orwhereby it may have beenrendered injurious to health. Thecriteria and definitions in this partalso apply in determining whethera food is in violation of section361 of the Public Health ServiceAct (42 U.S.C. 264). (b) Food covered by specificcurrent good manufacturingpractice regulations also is subjectto the requirements of thoseregulations.

110.10 Personnel.

The plant management shall takeall reasonable measures andprecautions to ensure thefollowing: (a) Disease control. Any personwho, by medical examination or supervisory observation, is shownto have, or appears to have, anillness, open lesion, including boils,sores, or infected wounds, or anyother abnormal source ofmicrobial contamination by whichthere is a reasonable possibility offood, food-contact surfaces, orfood-packaging materialsbecoming contaminated, shall be excluded from any operationswhich may be expected to result insuch contamination until thecondition is corrected. Personnelshall be instructed to report suchhealth conditions to theirsupervisors.

(b) Cleanliness. All personsworking in direct contact withfood, food-contact surfaces, andfood-packaging materials shallconform to hygienic practiceswhile on duty to the extentnecessary to protect againstcontamination of food. Themethods for maintainingcleanliness include, but are notlimited to: (1) Wearing outer garmentssuitable to the operation in amanner that protects against thecontamination of food, food-contact surfaces, or food-packaging materials. (2) Maintaining adequatepersonal cleanliness. (3) Washing hands thoroughly(and sanitizing if necessary toprotect against contamination withundesirable microorganisms) in anadequate hand-washing facilitybefore starting work, after eachabsence from the work station, andat any other time when the handsmay have become soiled orcontaminated. (4) Removing all unsecuredjewelry and other objects thatmight fall into food, equipment, orcontainers, and removing handjewelry that cannot be adequatelysanitized during periods in whichfood is manipulated by hand. Ifsuch hand jewelry cannot beremoved, it may be covered bymaterial which can be maintainedin an intact, clean, and sanitarycondition and which effectivelyprotects against the contaminationby these objects of the food, food-contact surfaces, or food-packaging materials. (5) Maintaining gloves, if theyare used in food handling, in anintact, clean, and sanitarycondition. The gloves should beof an impermeable material. (6) Wearing, where appropriate,in an effective manner, hair nets,headbands, caps, beard covers, orother effective hair restraints. (7) Storing clothing or otherpersonal belongings in areas otherthan where food is exposed orwhere equipment or utensils arewashed. (8) Confining the following toareas other than where food maybe exposed or where equipment or

utensils are washed: eating food,chewing gum, drinking beverages,or using tobacco. (9) Taking any other necessaryprecautions to protect againstcontamination of food, food-contact surfaces, or food-packaging materials withmicroorganisms or foreignsubstances including, but notlimited to, perspiration, hair,cosmetics, tobacco, chemicals, andmedicines applied to the skin. (c) Education and training.Personnel responsible foridentifying sanitation failures orfood contamination should have abackground of education orexperience, or a combinationthereof, to provide a level ofcompetency necessary forproduction of clean and safe food.Food handlers and supervisorsshould receive appropriate trainingin proper food handlingtechniques and food-protectionprinciples and should be informedof the danger of poor personalhygiene and insanitary practices. (d) Supervision. Responsibilityfor assuring compliance by allpersonnel with all requirements ofthis part shall be clearly assignedto competent supervisorypersonnel.

110.19 Exclusions.

(a) The following operations arenot subject to this part:Establishments engaged solely inthe harvesting, storage, ordistribution of one or more 'rawagricultural commodities,' asdefined in section 201(r) of theact, which are ordinarily cleaned,prepared, treated, or otherwiseprocessed before being marketedto the consuming public. (b) FDA, however, will issuespecial regulations if it is necessaryto cover these excluded operations.

SUBPART B - BUILDING ANDFACILITIES

110.20 Plant and grounds.

(a) Grounds. The grounds abouta food plant under the control ofthe operator shall be kept in a

Pork Slaughtercondition that will protect againstthe contamination of food. Themethods for adequate maintenanceof grounds include, but are notlimited to: (1) Properly storing equipment,removing litter and waste, andcutting weeds or grass within theimmediate vicinity of the plantbuildings or structures that mayconstitute an attractant, breedingplace, or harborage for pests. (2) Maintaining roads, yards, andparking lots so that they do notconstitute a source ofcontamination in areas where foodis exposed. (3) Adequately draining areasthat may contribute contaminationto food by seepage, foot-bornefilth, or providing a breeding placefor pests. (4) Operating systems for wastetreatment and disposal in anadequate manner so that they donot constitute a source ofcontamination in areas where foodis exposed. If the plant grounds arebordered by grounds not underthe operator's control and notmaintained in the mannerdescribed in paragraph (a) (1)through (3) of this section, careshall be exercised in the plant byinspection, extermination, or othermeans to exclude pests, dirt, andfilth that may be a source of foodcontamination. (b) Plant construction anddesign. Plant buildings andstructures shall be suitable in size,construction, and design tofacilitate maintenance and sanitaryoperations for food-manufacturing purposes.The plant and facilities shall: (1) Provide sufficient space forsuch placement of equipment andstorage of materials as is necessaryfor the maintenance of sanitaryoperations and the production ofsafe food. (2) Permit the taking of properprecautions to reduce the potentialfor contamination of food, food-contact surfaces, or food-packaging materials withmicroorganisms, chemicals, filth,or other extraneous material. Thepotential for contamination maybe reduced by adequate food

safety controls and operatingpractices or effective design,including the separation ofoperations in which contaminationis likely to occur, by one or moreof the following means: location,time, partition, air flow, enclosedsystems, or other effective means. (3) Permit the taking of properprecautions to protect food inoutdoor bulk fermentation vesselsby any effective means, including: (i) Using protective coverings. (ii) Controlling areas over andaround the vessels to eliminateharborages for pests. (iii) Checking on a regular basisfor pests and pest infestation. (iv) Skimming the fermentationvessels, as necessary. (4) Be constructed in such amanner that floors, walls, andceilings may be adequatelycleaned and kept clean and kept ingood repair; that drip orcondensate from fixtures, ductsand pipes does not contaminatefood, food-contact surfaces, orfood-packaging materials; and thataisles or working spaces areprovided between equipment andwalls and are adequatelyunobstructed and of adequatewidth to permit employees toperform their duties and to protectagainst contaminating food orfood-contact surfaces with clothingor personal contact. (5) Provide adequate lighting inhand-washing areas, dressing andlocker rooms, and toilet rooms andin all areas where food isexamined, processed, or stored andwhere equipment or utensils arecleaned; and provide safety-typelight bulbs, fixtures, skylights, orother glass suspended overexposed food in any step ofpreparation or otherwise protectagainst food contamination in caseof glass breakage. (6) Provide adequate ventilationor control equipment to minimizeodors and vapors (including steamand noxious fumes) in areas wherethey may contaminate food; andlocate and operate fans and otherair-blowing equipment in amanner that minimizes thepotential for contaminating food,food-packaging materials, andfood-contact surfaces.

(7) Provide, where necessary,adequate screening or otherprotection against pests.

110.35 Sanitary operations.

(a) General maintenance.Buildings, fixtures, and otherphysical facilities of the plant shallbe maintained in a sanitarycondition and shall be kept inrepair sufficient to prevent foodfrom becoming adulterated withinthe meaning of the act. Cleaningand sanitizing of utensils andequipment shall be conducted in amanner that protects againstcontamination of food, food-contact surfaces, or food-packaging materials. (b) Substances used in cleaningand sanitizing; storage of toxicmaterials. (1) Cleaningcompounds and sanitizing agentsused in cleaning and sanitizingprocedures shall be free fromundesirable microorganisms andshall be safe and adequate underthe conditions of use. Compliancewith this requirement may beverified by any effective meansincluding purchase of thesesubstances under a supplier'sguarantee or certification, orexamination of these substancesfor contamination. Only thefollowing toxic materials may beused or stored in a plant wherefood is processed or exposed: (i) Those required to maintainclean and sanitary conditions; (ii) Those necessary for use inlaboratory testing procedures; (iii) Those necessary for plantand equipment maintenance andoperation; and (iv) Those necessary for use inthe plant's operations. (2) Toxic cleaning compounds,sanitizing agents, and pesticidechemicals shall be identified, held,and stored in a manner thatprotects against contamination offood, food-contact surfaces, orfood-packaging materials. Allrelevant regulations promulgatedby other Federal, State, and localgovernment agencies for theapplication, use, or holding ofthese products should be followed. (c) Pest control. No pests shallbe allowed in any area of a food

Pork Slaughterplant. Guard or guide dogs maybe allowed in some areas of a plantif the presence of the dogs isunlikely to result in contaminationof food, food-contact surfaces, orfood-packaging materials.Effective measures shall be takento exclude pests from theprocessing areas and to protectagainst the contamination of foodon the premises by pests. The useof insecticides or rodenticides ispermitted only under precautionsand restrictions that will protectagainst the contamination of food,food-contact surfaces, and food-packaging materials. (d) Sanitation of food-contactsurfaces. All food-contactsurfaces, including utensils andfood-contact surfaces ofequipment, shall be cleaned asfrequently as necessary to protectagainst contamination of food. (1) Food-contact surfaces usedfor manufacturing or holding low-moisture food shall be in a dry,sanitary condition at the time ofuse. When the surfaces are wet-cleaned, they shall, when necessary,be sanitized and thoroughly driedbefore subsequent use. (2) In wet processing, whencleaning is necessary to protectagainst the introduction ofmicroorganisms into food, allfood-contact surfaces shall becleaned and sanitized before useand after any interruption duringwhich the food-contact surfacesmay have become contaminated.Where equipment and utensils areused in a continuous productionoperation, the utensils and food-contact surfaces of the equipmentshall be cleaned and sanitized asnecessary. (3) Non-food-contact surfaces ofequipment used in the operation offood plants should be cleaned asfrequently as necessary to protectagainst contamination of food. (4) Single-service articles (suchas utensils intended for one-timeuse, paper cups, and paper towels)should be stored in appropriatecontainers and shall be handled,dispensed, used, and disposed of ina manner that protects againstcontamination of food or food-contact surfaces.

(5) Sanitizing agents shall beadequate and safe underconditions of use. Any facility,procedure, or machine isacceptable for cleaning andsanitizing equipment and utensilsif it is established that the facility,procedure, or machine willroutinely render equipment andutensils clean and provideadequate cleaning and sanitizingtreatment. (e) Storage and handling ofcleaned portable equipment andutensils. Cleaned and sanitizedportable equipment with food-contact surfaces and utensilsshould be stored in a location andmanner that protects food-contactsurfaces from contamination.

110.37 Sanitary facilities andcontrols.

Each plant shall be equipped withadequate sanitary facilities andaccommodations including, butnot limited to: (a) Water supply. The watersupply shall be sufficient for theoperations intended and shall bederived from an adequate source.Any water that contacts food orfood-contact surfaces shall be safeand of adequate sanitary quality.Running water at a suitabletemperature, and under pressure asneeded, shall be provided in allareas where required for theprocessing of food, for thecleaning of equipment, utensils,and food-packaging materials, orfor employee sanitary facilities. (b) Plumbing. Plumbing shall beof adequate size and design andadequately installed andmaintained to: (1) Carry sufficient quantities ofwater to required locationsthroughout the plant. (2) Properly convey sewage andliquid disposable waste from theplant. (3) Avoid constituting a sourceof contamination to food, watersupplies, equipment, or utensils orcreating an unsanitary condition. (4) Provide adequate floordrainage in all areas where floorsare subject to flooding-typecleaning or where normaloperations release or discharge

water or other liquid waste on thefloor. (5) Provide that there is notbackflow from, or cross-connection between, pipingsystems that discharge waste wateror sewage and piping systems thatcarry water for food or foodmanufacturing. (c) Sewage disposal. Sewagedisposal shall be made into anadequate sewerage system ordisposed of through otheradequate means. (d) Toilet facilities. Each plantshall provide its employees withadequate, readily accessible toiletfacilities. Compliance with thisrequirement may be accomplishedby: (1) Maintaining the facilities in asanitary condition. (2) Keeping the facilities in goodrepair at all times. (3) Providing self-closing doors. (4) Providing doors that do notopen into areas where food isexposed to airbornecontamination, except wherealternate means have been taken toprotect against such contamination(such as double doors or positiveair-flow systems). (e) Hand-washing facilities.Hand-washing facilities shall beadequate and convenient and befurnished with running water at asuitable temperature. Compliancewith this requirement may beaccomplished by providing: (1) Hand-washing and, whereappropriate, hand-sanitizingfacilities at each location in theplant where good sanitary practicesrequire employees to wash and/orsanitize their hands. (2) Effective hand-cleaning andsanitizing preparations. (3) Sanitary towel service orsuitable drying devices. (4) Devices or fixtures, such aswater control valves, so designedand constructed to protect againstrecontamination of clean, sanitizedhands. (5) Readily understandable signsdirecting employees handlingunprotected food, unprotectedfood-packaging materials, of food-contact surfaces to wash and, whereappropriate, sanitize their handsbefore they start work, after each

Pork Slaughterabsence from post of duty, andwhen their hands may havebecome soiled or contaminated.These signs may be posted in theprocessing room(s) and in all otherareas where employees may handlesuch food, materials, or surfaces. (6) Refuse receptacles that areconstructed and maintained in amanner that protects againstcontamination of food. (f) Rubbish and offal disposal.Rubbish and any offal shall be soconveyed, stored, and disposed ofas to minimize the development ofodor, minimize the potential forthe waste becoming an attractantand harborage or breeding placefor pests, and protect againstcontamination of food, food-contact surfaces, water supplies,and ground surfaces.

SUBPART C - EQUIPMENT

110.40 Equipment and utensils.

(a) All plant equipment andutensils shall be so designed and ofsuch material and workmanship asto be adequately cleanable, andshall be properly maintained. Thedesign, construction, and use ofequipment and utensils shallpreclude the adulteration of foodwith lubricants, fuel, metalfragments, contaminated water, orany other contaminants. Allequipment should be so installedand maintained as to facilitate thecleaning of the equipment and ofall adjacent spaces. Food-contactsurfaces shall be corrosion-resistant when in contact with food.They shall be made of nontoxicmaterials and designed towithstand the environment of theirintended use and the action offood, and, if applicable, cleaningcompounds and sanitizing agents.Food-contact surfaces shall bemaintained to protect food frombeing contaminated by any source,including unlawful indirect foodadditives. (b) Seams on food-contactsurfaces shall be smoothly bondedor maintained so as to minimizeaccumulation of food particles,dirt, and organic matter and thus

minimize the opportunity forgrowth of microorganisms. (c) Equipment that is in themanufacturing or food-handlingarea and that does not come intocontact with food shall be soconstructed that it can be kept in aclean condition. (d) Holding, conveying, andmanufacturing systems, includinggravimetric, pneumatic, closed, andautomated systems, shall be of adesign and construction thatenables them to be maintained inan appropriate sanitary condition. (e) Each freezer and cold storagecompartment used to store andhold food capable of supportinggrowth of microorganisms shall befitted with an indicatingthermometer, temperature-measuring device, or temperature-recording device so installed as toshow the temperature accuratelywithin the compartment, andshould be fitted with an automaticcontrol for regulating temperatureor with an automatic alarm systemto indicate a significanttemperature change in a manualoperation. (f) Instruments and controls usedfor measuring, regulating, orrecording temperatures, pH,acidity, water activity, or otherconditions that control or preventthe growth of undesirablemicroorganisms in food shall beaccurate and adequatelymaintained, and adequate innumber for their designated uses. (g) Compressed air or othergases mechanically introduced intofood or used to clean food-contactsurfaces or equipment shall betreated in such a way that food isnot contaminated with unlawfulindirect food additives.

SUBPART D - [RESERVED]

SUBPART E - PRODUCTIONAND PROCESS CONTROLS

110.80 Processes and controls.

All operations in the receiving,inspecting, transporting,segregating, preparing,manufacturing, packaging, and

storing of food shall be conductedin accordance with adequatesanitation principles. Appropriatequality control operations shall beemployed to ensure that food issuitable for human consumptionand that food-packaging materialsare safe and suitable. Overallsanitation of the plant shall beunder the supervision of one ormore competent individualsassigned responsibility for thisfunction. All reasonableprecautions shall be taken toensure that production proceduresdo not contribute contaminationfrom any source. Chemical,microbial, or extraneous-materialtesting procedures shall be usedwhere necessary to identifysanitation failures or possible foodcontamination. All food that hasbecome contaminated to the extentthat it is adulterated within themeaning of the act shall berejected, or if permissible, treatedor processed to eliminate thecontamination. (a) Raw materials and otheringredients. (1) Raw materials andother ingredients shall be inspectedand segregated or otherwisehandled as necessary to ascertainthat they are clean and suitable forprocessing into food and shall bestored under conditions that willprotect against contamination andminimize deterioration. Rawmaterials shall be washed orcleaned as necessary to remove soilor other contamination. Waterused for washing, rinsing, orconveying food shall be safe andof adequate sanitary quality.Water may be reused for washing,rinsing, or conveying food if itdoes not increase the level ofcontamination of the food.Containers and carriers of rawmaterials should be inspected onreceipt to ensure that theircondition has not contributed tothe contamination or deteriorationof food. (2) Raw materials and otheringredients shall either not containlevels of microorganisms that mayproduce food poisoning or otherdisease in humans, or they shall bepasteurized or otherwise treatedduring manufacturing operationsso that they no longer contain

Pork Slaughterlevels that would cause the productto be adulterated within themeaning of the act. Compliancewith this requirement may beverified by any effective means,including purchasing raw materialsand other ingredients under asupplier's guarantee orcertification. (3) Raw materials and otheringredients susceptible tocontamination with aflatoxin orother natural toxins shall complywith current Food and DrugAdministration regulations,guidelines, and action levels forpoisonous or deleterioussubstances before these materialsor ingredients are incorporatedinto finished food. Compliancewith this requirement may beaccomplished by purchasing rawmaterials and other ingredientsunder a supplier's guarantee orcertification, or may be verified byanalyzing these materials andingredients for aflatoxins andother natural toxins. (4) Raw materials, otheringredients, and rework susceptibleto contamination with pests,undesirable microorganisms, orextraneous material shall complywith applicable Food and DrugAdministration regulations,guidelines, and defect action levelsfor natural or unavoidable defectsif a manufacturer wishes to use thematerials in manufacturing food.Compliance with this requirementmay be verified by any effectivemeans, including purchasing thematerials under a supplier'sguarantee or certification, orexamination of these materials forcontamination. (5) Raw materials, otheringredients, and rework shall beheld in bulk, or in containersdesigned and constructed so as toprotect against contamination andshall be held at such temperatureand relative humidity and in such amanner as to prevent the foodfrom becoming adulterated withinthe meaning of the act. Materialscheduled for rework shall beidentified as such. (6) Frozen raw materials andother ingredients shall be keptfrozen. If thawing is requiredprior to use, it shall be done in a

manner that prevents the rawmaterials and other ingredientsfrom becoming adulterated withinthe meaning of the act. (7) Liquid or dry raw materialsand other ingredients received andstored in bulk form shall be heldin a manner that protects againstcontamination. (b) Manufacturing operations.(1) Equipment and utensils andfinished food containers shall bemaintained in an acceptablecondition through appropriatecleaning and sanitizing, asnecessary. Insofar as necessary,equipment shall be taken apart forthorough cleaning. (2) All food manufacturing,including packaging and storage,shall be conducted under suchconditions and controls as arenecessary to minimize the potentialfor the growth of microorganisms,or for the contamination of food.One way to comply with thisrequirement is careful monitoringof physical factors such as time,temperature, humidity, a(INFERIOR w), pH, pressure, flowrate, and manufacturing operationssuch as freezing,dehydration, heat processing,acidification, and refrigeration toensure that mechanicalbreakdowns, time delays,temperature fluctuations, and otherfactors do not contribute to thedecomposition or contaminationof food. (3) Food that can support therapid growth of undesirablemicroorganisms, particularly thoseof public health significance, shallbe held in a manner that preventsthe food from becomingadulterated within the meaning ofthe act. Compliance with thisrequirement may be accomplishedby any effective means, including: (i) Maintaining refrigeratedfoods at 45 (degree)F (7.2(degree)C) or below as appropriatefor the particular food involved. (ii) Maintaining frozen foods ina frozen state. (iii) Maintaining hot foods at140 (degree)F (60 (degree)C) orabove. (iv) Heat treating acid oracidified foods to destroymesophilic microorganisms when

those foods are to be held inhermetically sealed containers atambient temperatures. (4) Measures such as sterilizing,irradiating, pasteurizing, freezing,refrigerating, controlling pH orcontrolling a (INFERIOR w) thatare taken to destroy or prevent thegrowth of undesirablemicroorganisms, particularly thoseof public health significance, shallbe adequate under the conditionsof manufacture, handling, anddistribution to prevent food frombeing adulterated within themeaning of the act. (5) Work-in-process shall behandled in a manner that protectsagainst contamination. (6) Effective measures shall betaken to protect finished foodfrom contamination by rawmaterials, other ingredients, orrefuse. When raw materials, otheringredients, or refuse areunprotected, they shall not behandled simultaneously in areceiving, loading, or shipping areaif that handling could result incontaminated food. Foodtransported by conveyor shall beprotected against contamination asnecessary. (7) Equipment, containers, andutensils used to convey, hold, orstore raw materials, work-in-process, rework, or food shall beconstructed, handled, andmaintained during manufacturingor storage in a manner thatprotects against contamination. (8) Effective measures shall betaken to protect against theinclusion of metal or otherextraneous material in food.Compliance with this requirementmay be accomplished by usingsieves, traps, magnets, electronicmetal detectors, or other suitableeffective means. (9) Food, raw materials, andother ingredients that areadulterated within the meaning ofthe act shall be disposed of in amanner that protects against thecontamination of other food. Ifthe adulterated food is capable ofbeing reconditioned, it shall bereconditioned using a method thathas been proven to be effective orit shall be reexamined and foundnot to be adulterated within the

Pork Slaughtermeaning of the act before beingincorporated into other food. (10) Mechanical manufacturingsteps such as washing, peeling,trimming, cutting, sorting andinspecting, mashing, dewatering,cooling, shredding, extruding,drying, whipping, defatting, andforming shall be performed so asto protect food againstcontamination. Compliance withthis requirement may beaccomplished by providingadequate physical protection offood from contaminants that maydrip, drain, or be drawn into thefood. Protection may be providedby adequate cleaning andsanitizing of all food-contactsurfaces, and by using time andtemperature controls at andbetween each manufacturing step. (11) Heat blanching, whenrequired in the preparation offood, should be effected byheating the food to the requiredtemperature, holding it at thistemperature for the required time,and then either rapidly cooling thefood or passing it to subsequentmanufacturing without delay.Thermophilic growth andcontamination in blanchers shouldbe minimized by the use ofadequate operating temperaturesand by periodic cleaning. Wherethe blanched food is washed priorto filling, water used shall be safeand of adequatesanitary quality. (12) Batters, breading, sauces,gravies, dressings, and other similarpreparations shall be treated ormaintained in such a manner thatthey are protected againstcontamination. Compliance withthis requirement may beaccomplished by any effectivemeans, including one or more ofthe following: (i) Using ingredients free ofcontamination. (ii) Employing adequate heatprocesses where applicable. (iii) Using adequate time andtemperature controls. (iv) Providing adequate physicalprotection of components fromcontaminants that may drip, drain,or be drawn into them.

(v) Cooling to an adequatetemperature duringmanufacturing. (vi) Disposing of batters atappropriate intervals to protectagainst the growth ofmicroorganisms. (13) Filling, assembling,packaging, and other operationsshall be performed in such a waythat the food is protected againstcontamination. Compliance withthis requirement may beaccomplished by any effectivemeans, including: (i) Use of a quality controloperation in which the criticalcontrol points are identified andcontrolled during manufacturing. (ii) Adequate cleaning andsanitizing of all food-contactsurfaces and food containers. (iii) Using materials for foodcontainers and food- packagingmaterials that are safe and suitable,as defined in Sec. 130.3(d) of thischapter. (iv) Providing physicalprotection from contamination,particularly airbornecontamination. (v) Using sanitary handlingprocedures. (14) Food such as, but notlimited to, dry mixes, nuts,intermediate moisture food, anddehydrated food, that relies on thecontrol of a (INFERIOR w) forpreventing the growth ofundesirable microorganisms shallbe processed to and maintained ata safe moisture level. Compliancewith this requirement may beaccomplished by any effectivemeans, including employment ofone or more of the followingpractices: (i) Monitoring the a (INFERIORw) of food. (ii) Controlling the solublesolids-water ratio in finished food. (iii) Protecting finished foodfrom moisture pickup, by use of amoisture barrier or by othermeans, so that the a (INFERIOR w)of the food does not increase to anunsafe level. (15) Food such as, but notlimited to, acid and acidified food,that relies principally on thecontrol of pH for preventing thegrowth of undesirable

microorganisms shall bemonitored and maintained at a pHof 4.6 or below. Compliance withthis requirement may beaccomplished by any effectivemeans, including employment ofone or more of the followingpractices: (i) Monitoring the pH of rawmaterials, food in process, andfinished food. (ii) Controlling the amount ofacid or acidified food added tolow-acid food. (16) When ice is used in contactwith food, it shall be made fromwater that is safe and of adequatesanitary quality, and shall be usedonly if it has been manufactured inaccordance with current goodmanufacturing practice as outlinedin this part. (17) Food-manufacturing areasand equipment used formanufacturing human food shouldnot be used to manufacturenonhuman food-grade animal feedor inedible products, unless there isno reasonable possibility for thecontamination of the human food.

110.93 Warehousing anddistribution.

Storage and transportation offinished food shall be underconditions that will protect foodagainst physical, chemical, andmicrobial contamination as well asagainst deterioration of the foodand the container.

SUBPART F - [RESERVED]

SUBPART G - DEFECTACTION LEVELS

110.110 Natural or unavoidabledefects in food for human use thatpresent no health hazard.

(a) Some foods, even whenproduced under current goodmanufacturing practice, containnatural or unavoidable defects thatat low levels are not hazardous tohealth. The Food and DrugAdministration establishesmaximum levels for these defectsin foods produced under current

Pork Slaughtergood manufacturing practice anduses these levels in decidingwhether to recommend regulatoryaction. (b) Defect action levels areestablished for foods whenever it isnecessary and feasible to do so.These levels are subject to changeupon the development of newtechnology or the availability ofnew information. (c) Compliance with defectaction levels does not excuseviolation of the requirement insection 402(a)(4) of the act thatfood not be prepared, packed, orheld under unsanitary conditionsor the requirements in this part thatfood manufacturers, distributors,and holders shall observe currentgood manufacturing practice.Evidence indicating that such aviolation exists causes the food tobe adulterated within the meaningof the act, even though theamounts of natural or unavoidabledefects are lower than the currentlyestablished defect action levels.The manufacturer, distributor, andholder of food shall at all timesutilize quality control operationsthat reduce natural or unavoidabledefects to the lowest level currentlyfeasible. (d) The mixing of a foodcontaining defects above thecurrent defect action level withanother lot of food is notpermitted and renders the finalfood adulterated within themeaning of the act, regardless ofthe defect level of the final food. (e) A compilation of the currentdefect action levels for natural orunavoidable defects in food forhuman use that present no healthhazard may be obtained uponrequest from the IndustryPrograms Branch (HFF-326),Center for Food Safety andApplied Nutrition, Food and DrugAdministration, 200 C St. SW.,Washington, DC 20204.


APPENDIX 2

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PROCESS CATEGORIES(Pathogen Reduction/HACCP Regulation, 1996)

1. Not Heat Treated, Shelf-Stable (dried products, those controlled by water activity,pH, freeze dried, dehydrated, etc.)

2. Heat Treated, Shelf-Stable (rendered products, lard, etc.)

3. Heat Treated Not Fully Cooked, Not Shelf-Stable (ready to cook poultry, coldsmoked and products smoked for trichinae, partially cooked battered, breaded,char-marked, batter set, and low temperature rendered products, etc.)

4. Products with Secondary Inhibitors, Not Shelf-Stable (products that are fermented,dried, salted, brine treated, etc., but are not shelf-stable)

5. Irradiation (includes all forms of approved irradiation procedures for poultry andpork)

6. Fully Cooked, Not Shelf Stable (products which have received a lethal kill stepthrough a heating process, but must be kept refrigerated. This includes productssuch as fully cooked hams, cooked beef, roast beef, etc.).

7. Beef Slaughter

8. Pork Slaughter

9. Poultry Slaughter

10. Raw Products - not ground (all raw products which are not ground in their finalform. This includes beef trimmings, tenderized cuts, steaks, roasts, chops, poultryparts, etc.)

11. Raw, Ground

12. Thermally Processed/Commercially Sterile

13. Mechanically Separated Species


APPENDIX 3

Pork Slaughter

Overview of Biological,Chemical and Physical Hazards(Pathogen Reduction/HACCP Regulation, USDA, 1996)

(Hazards are not limited to the following information.)

Biological Hazards : The following biological hazards should be considered:

Pathogenic microorganisms:Bacillus cereusCampylobacter jejuniClostridium botulinumClostridum perfringensEscherichia coli O157:H7Listeria monocytogenesSalmonella sppStaphylococcus aureusYersinia enterocolitica

Zoonotic agents:Trichinella spiralisTaenia saginataTaenia soliumToxoplasma gondiiBalantidium coliCryptosporidium spp.

Chemical Hazards : The following sources were identified.1) Agriculture chemicals: pesticides, herbicides, animal drugs, fertilizers, etc.2) Plant chemicals: cleaners, sanitizers, oils, lubricants, paints, pesticides, etc.3) Naturally-occurring toxicants: products of plant, animal or microbial metabolismsuch as aflatoxins, etc.4) Food chemcals: preservatives, acids, food additives, sulfiting agents, processingaids, etc.5) Environmental contaminants: lead, cadmium, mercury, arsenic, PCBs.

Physical Hazards :Glass, metal, stones, plastics, bone, bullet/BB shots/needles, jewelry, etc.


APPENDIX 4

The NACMCF (1992) CCP Decision Tree(Apply at each point where an identified hazard can be controlled.)

Q1. Do preventive measure(s)exist for the identified hazard?

Q2. Does this step eliminate orreduce the likely occurrence ofa hazard to an acceptable level?

Q3. Could contamination withidentified hazard(s) occur inexcess of acceptable level(s) orcould these increase tounacceptable level(s)?

Q4. Will a subsequent step, prior toconsuming the food, eliminatethe identified hazard(s) orreduce the likely occurrence toan acceptable level?

Modify step, process or product

YES NO

Is control at this stepnecessary for safety?

NO Not a CCP

YES

STOP*

NO

YES

YES NO Not a CCP STOP*

YES

NO

Not a CCP STOP*

This is a CRITICALCONTROL POINT

*Proceed to the next step in the selected process

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APPENDIX 5

References

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2. Alsmeyer RH. How Lactic Acid Restricts Growth of Microorganisms. 3. Baker DA. Application Of Modeling In HACCP Plan Development, 1995,

International Journal of Food Microbiology 25:251-261. 4. Berends JM, Snijders MA, van Logtestijn JG. Efficacy Of Current EC Meat Inspection

Procedures And Some Proposed Revisions With Respect To Microbiological Safety: ACritical Review. Veterinary Record, 1993, 133:411-415.

5. Cacciarelli MA, Stringer WC, Anderson ME, Naumann HD. Effects Of Washing And

Sanitizing On The Bacterial Flora Of Vacuum-Packaged Pork Loins, 1983, Journal ofFood Protection 46:231-234.

6. Coates KJ, Beattie JC, Morgan IR, Widders PR. The Contribution Of Carcass

Contamination And The Boning Process To Microbial Spoilage Of Aerobically StoredPork, 1995, Food Microbiology 12:49-54.

7. Currier M, Singleton M, Lee J Lee DR. Salmonella In Swine At Slaughter: Incidence

And Serovar Distribution At Different Seasons, 1986, Journal of Food Protection49:366-368.

8. Fedorka-Cray PJ, Whipp SC, Isaacson RE, Nord N, Lager K. Transmission Of

Salmonella typhimurium To Swine, 1994, J Veterinary Microbiology, Article 822:1-12.

9. Fraser AM, Sawyer SA, Andrews SA, et al. A Food Classification Scheme To

Summarize Epidemiological Patterns Of Food-Borne Illness. Dairy, Food andEnvironmental Sanitation, 1995, 15-5:292-300.

10. Gill CO. Current And Emerging Approaches To Assuring The Hygienic Condition Of

Red Meats, 1994, Canadian Journal of Animal Science, Contribution No. 762. 11. Gill CO, Jones T. The Presence Of Aeromonas, Listeria And Yersinia In Carcass

Processing Equipment At Two Pig Slaughtering Plants, 1995, Food Microbiology12:135-141.

12. Gill CO, McGinnis DS, Bryant J, Chabot B. Decontamination Of Commercial,

Polished Pig Carcasses With Hot Water, 1995, Food Microbiology 9:335-343. 13. Gill CO, Bryant J. The Presence Of Escherichia coli, Salmonella And Campylobacter

In Pig Carcass Dehairing Equipment, 1993, Food Microbiology 10:337-344. 14. Ghosh AC. An Epidemiological Study Of The Incidence Of Salmonella In Pigs, 1972,

J. Hyg. Camb. 70:151-160.

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Salmonella choleraesuis In Swine, 1996, Applied and Environmental Microbiology 62-1:141-146.

17. Gray, JT, Fedorka-Cray PJ, Stabel TJ, Ackermann MR. Veterinary Microbiology,

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And Cold Tolerant Pathogens On Pork, International Journal of Food Microbiology,1995, 25:141-151.

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Salmonella In Slaughterhouses And In Normal Slaughter Pigs, 1963, Zentbl Vet Med.10:1-27.

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Amer. Vet. Med. Assoc, 1993, 202-1:46-49. 22. Kindred T, Patel B, Walcott J. The FSIS National Residue Program, 1996, review

paper being published in Euro Residue III. 23. Kotula AW, Emswiler-Rose BS. Airborne Microorganisms In A Pork Processing

Establishment, 1988, Journal of Food Protection 51:935-937. 24. Knudtson LM, Hartman PA. Enterococci in Pork Processing, 1993, Journal of Food

Protection 56-1:6-8 &17. 25. Linton AH, Heard TW, et al. Computer-Based Analysis Of Epidemiological Data

Arising From Salmonellosis In Pigs, 1970, Res. Vet. Sci. II: 523-532. 26. Miller MF, Carr MA, Bawconry DW, Ramsey CB, and Thompson LD. Microbiology

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Pork Producers Level III, 1994. 28. Newell KW, Williams LP. The Control Of Salmonella Affecting Swine And Man,

1971, J.A.V.M.A. 158(January 1):89-97. 29. Notermans S, Gallhoff G, Zwietering MH and Mead GC. Identification Of Critical

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Potentially Hazardous Microorganisms, 1994, Food Microbiology 11:203-214.

31. Riette LJ, Van Laack M, Johnson JL, et al. Survival Of Pathogenic Bacteria On PorkLoins As Influenced By Hot Processing And Packaging, 1993, Journal of FoodProtection 56:847-851.

32. Tompkin RB. The Hazard Analysis Critical Control Point (HACCP) System.

Presented at the Texas A&M University’s Center for Food Safety and the InternationalMeat & Poultry HACCP Alliance Symposium, College Station, Texas, December 2,1994.

33. USDA, FSIS, Dec. 1992. Backgrounder: Anti-Microbial Sprays For Livestock

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Infection In Internal Organs Of Swine, 1989, Am J Vet Res 50-7: 1015-1021.

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