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    HACCP DECISION-MAKING DOCUMENTATION

    For

    BEEF SLAUGHTER

    Rosenthal Meat Science and Technology CenterEstablishment Number 1

    April 7, 2003

    The following definitions from USDAs Pathogen Reduction/HACCP regulation were reviewed

    before the team started reviewing the hazard analysis and documenting the thought process for each

    response.

    Food safety hazard: Any biological, chemical, or physical property that may cause a food to

    be unsafe for human consumption (USDA, 417.1).

    Hazard analysis Reasonably likely to occur A food safety hazard that is reasonablylikely to occur is one for which a prudent establishment would establish controls because it

    historically has occurred, or because there is a reasonable possibility that it will occur in the

    particular type of product being processed, in the absence of those controls (USDA, 417.2(a)(1)).

    HAZARD ANALYSIS:The following summarizes the discussions and thought process that impacted the decisions for eachstep of the flow chart for the three food safety hazard categories biological, chemical, and

    physical.

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    Cattle Receiving and Holding:

    Process Step Overview:

    We obtain cattle from various sources to use at our university. For most teaching and extensionactivities, cattle sources include those raised and fed at Texas A&M University, purchased from

    commercial feedyards, and obtained from various livestock shows across the state. For research

    animals, the source will vary depending on the project and may include animals that are prohibited

    from entering the food chain and processed only for data collection. On occasion, we may receiveanimals for custom slaughter.

    We transport some of the livestock to our facility and we receive some of the livestock from

    commercial transporters. Although it is not directly related to food safety, procedures are in placeto ensure humane handling of livestock during unloading and during holding as required by 9 CFR

    313. [Livestock Handling Standard Operating Procedures (SOPs), AUP 2002-227: Animal

    Science 307 (Meat Science), and other AUPs, as required]

    Hazard Analysis Logic:

    Chemical: Antibiotic Residue Cattle that are identified by the inspector as high risk are tested

    for antibiotic residue using a STOP test. To the best of the teams knowledge, there havebeen no positive antibiotic residues from Jan. 1, 1998 to December 15, 2002, as a result of

    high risk testing. High risk cattle, such as show steers, are identified in the pens, and the

    inspector samples liver and kidney for analysis. Any violation will be noted on an NR so

    the team will reassess this issue if future violations are noted. Based on this information theteam does not think that antibiotic residue is a food safety hazard that is reasonably likely to

    occur in this slaughter process.

    Illegal Drug Residue On Feb. 4, 2002, a steer from the Southwestern Livestock Show inFort Worth, Texas, was slaughtered, passed postmortem inspection and a STOP test, and the

    carcass was subsequently released for commerce. We were contacted by the livestock show

    to inform us that a urine sample from the steer tested positive for Phenylbutazone, a

    compound not approved for use in cattle. At the time of slaughter, show officials had notinformed us of the pending drug tests. Corrective actions for the unforeseen hazard were

    conducted on Feb. 15, 2002. Animal and product release forms have been developed and all

    animals from livestock shows must be released prior to the carcass and variety meats being

    used. At this time, we conclude that illegal drug residue is not a reasonably likely to occur

    food safety hazard for our establishment.

    Animals used for research involving non-approved chemical substances will be identified

    and segregated to ensure that products from them do not enter the food chain.

    We considered lead contamination as a potential chemical food safety hazard. According to

    Dr. James W. Barnett, Jr., Ph.D., Diplomate, American Board of Toxicology, If there wasingestion of one or a few lead shot or as subdivided by grinding, the estimated increase in

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    blood lead levels (approximately 0.12 0.36 g/dl/pellet) are well below levels that pose

    health hazards to children or adults. [See supporting documentation.]

    Physical: We acknowledge that some cattle may occasionally have buckshot, bullets, needles,

    etc. However, these cannot be identified at the time of receiving and may not be found as

    the product moves throughout the process. There have been no reported incidences of these

    physical hazards from Jan. 1, 1998 to Oct. 15, 2002. We also considered that size and shapeof metal will impact whether or not an object is a food safety hazard according to Olsen

    (1998), classifies hard or sharp objects over 7mm in length as potentially hazardous

    while objects that measure between 2 and 7 mm are normally considered a nonhazardous

    defect. [See supporting documentation.] Therefore, physical hazards are not identified as areasonably likely to occur food safety hazards for this process step.

    We are addressing lead shot as a potential chemical hazard.

    Biological: Pathogens. It is an accepted fact that raw meat is a potential source of pathogens

    (i.e., SalmonellaandE. coli O157:H7). The USDA/FSIS Nationwide Beef Microbiological

    Baseline Data Collection Program: Steers and Heifers October 1992 September 1993documents previous incidence levels. Also, based on the Smith and Elder data provided by

    USDAs FSIS these microorganisms are reasonably likely to occur. [See supporting

    documentation.] Therefore, we acknowledge that steps must be taken to try to prevent,eliminate or reduce to an acceptable level any pathogen contamination. At this step, there

    are no known interventions that can be used to eliminate these pathogens. We have

    identified subsequent steps of organic acid spraying to reduce pathogen contamination and

    chilling to reduce pathogen growth.

    The following discussion outlines the use of the CCP Decision Tree for this identified

    hazard:

    1. Do control measure(s) exist for the identified hazard (pathogens)? YES2. Does this step (receiving and holding) eliminate or reduce the likely occurrence of a

    hazard (pathogens) to an acceptable level? NO

    3. Could contamination with the identified hazard(s) (pathogens) occur in excess ofacceptable level(s) or could it increase to an unacceptable level? YES

    4. Will a subsequent step eliminate the identified hazard(s) or reduce its likely occurrenceto an acceptable level? YES, organic acid has been scientifically shown to reduce the

    likely occurrence of pathogens, and proper chilling will reduce the potential for pathogen

    growth.This step is not a CCP in our process.

    ###

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    Stunning:

    Process Step Overview:

    Proper stunning is used to comply with 9 CFR 313. Animals are driven into a knocking box, onehead at a time, to be stunned. Stunning is accomplished using a non-penetrating mechanical stunner

    (Cash Knocker). After stunning, the animal is released from the knocking box into the dry landing

    area for shackling and hoisting before the bleeding process.

    Hazard Analysis Logic:

    Physical: Stunning is accomplished using a non-penetrating mechanical stunner; however, there

    are some bone fragments that may enter the brain cavity. Brains are not kept for

    consumption. The brain cavity is flushed with water to remove the brains and any bonefragments that may occur due to fracturing the skull during stunning. We determined there

    are no physical food safety hazards associated with stunning cattle.

    Chemical and Biological: The team could not think of any chemical or biological hazards thatwould be associated with this step of the process.

    ###

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    Bleeding:

    Process Step Overview:

    We bleed the animal by first making a longitudinal opening through the hide in the center of theunderside of the neck from the sternum to the throatlatch, and after knife sanitizing, insert the knife

    immediately below the point of the sternum and sever the carotid artery and jugular vein. No edible

    blood is collected.

    Hazard Analysis Logic:

    Chemical and Physical: None identified at this time. The act of sticking an animal for bleeding

    does not introduce chemical or physical food safety hazards into the system. The fact that

    the knife has been sanitized is addressed in the Sanitation Standard Operating Procedures.Therefore, no chemical or physical food safety hazards were identified for this step.

    Biological: Pathogens. We know that the hide is a potential reservoir for pathogens. The act of

    sticking is the first step that involves opening the hide, so pathogens from the outside of thehide may contaminate the carcass. Therefore, the team acknowledges that subsequent steps

    must be taken to try to prevent, eliminate or reduce pathogens to an acceptable level. We

    have identified subsequent steps of organic acid spraying to reduce pathogen contaminationand chilling to reduce pathogen growth.

    The following discussion outlines the use of the CCP Decision Tree for this identified

    hazard:1. Do control measure(s) exist for the identified hazard (pathogens)? YES2.

    Does this step (bleeding) eliminate or reduce the likely occurrence of a hazard(pathogens) to an acceptable level? NO

    3. Could contamination with the identified hazard(s) (pathogens) occur in excess ofacceptable level(s) or could it increase to an unacceptable level? YES

    4. Will a subsequent step eliminate the identified hazard(s) or reduce its likely occurrenceto an acceptable level? YES, organic acid has been scientifically shown to reduce the

    likely occurrence of pathogens, and proper chilling will reduce the potential for pathogengrowth.

    This is not a CCP in our process.

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    Foreshanking and Heading:

    Process Step Overview:

    Steps in this process include removing the forefeet between the metacarpals and carpals (must beaccomplished before head removal), remove horns (if present) and ears across the top of the poll,

    splitting the hide down the middle of the face, and continuing to completely skin the head.

    The weasand (esophagus) is separated from the trachea and lungs by finding it near the knifeopening in the throat area and by using the weasand rod to detach it from a point on the throat to the

    base of the reticulum. This frees the esophagus from its attachments to the trachea and lungs so that

    during evisceration it may be pulled through the chest without tearing. We tie the weasand with

    string to prevent spillage of rumen contents. The esophagus is cut between the tied area and thehead before head removal.

    The head is removed by cutting through the muscles behind the poll and through the muscles at the

    underside of the throatlatch before making the final cut through the occipito-atlantal space. Thehead is carried to the head wash cabinet and further activities will be addressed during head

    processing.

    Hazard Analysis Logic:

    Chemical: The act of head removal and foreshanking is not conducive to introducing chemical

    hazards.

    Physical: The weasand is tied with string to prevent spillage during evisceration. The tying

    device is removed with the viscera, so it is not likely to contaminate the product. We couldnot identify any physical food safety hazards that would be introduced during the

    foreshanking and heading process.

    Biological: Pathogens. We acknowledge that the head removal process and foreshanking may

    introduce pathogens to the exposed areas of the head and carcass, which is virtually sterile

    before the hide is opened during this process step. As above, the team acknowledges thatsubsequent steps must be taken to try to prevent, eliminate or reduce pathogens to an

    acceptable level. We have identified subsequent steps of organic acid spraying to reduce

    pathogen contamination and chilling to reduce pathogen growth.

    The following discussion outlines the use of the CCP Decision Tree for this identifiedhazard:

    1. Do control measure(s) exist for the identified hazard (pathogens)? YES2. Does this step (foreshanking and heading) eliminate or reduce the likely occurrence of a

    hazard (pathogens) to an acceptable level? NO

    3. Could contamination with the identified hazard(s) (pathogens) occur in excess ofacceptable level(s) or could it increase to an unacceptable level? YES

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    4. Will a subsequent step eliminate the identified hazard(s) or reduce its likely occurrenceto an acceptable level? YES, organic acid has been scientifically shown to reduce the

    likely occurrence of pathogens, and proper chilling will reduce the potential for pathogengrowth.

    This step is not a CCP in our process.

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    Hindshanking and Rimming:

    Process Step Overview:

    We loosen the bung by making a circular cut around the anus (including vulva in females) andpulling outward cutting its attachments to the pelvic cavity. A plastic bag is placed around the bung

    and is secured with a tying device. The bagged bung is pushed back into the body cavity.

    We perform initial hide opening by making a cut immediately above the dew claws on the free hindleg up to the Achilles tendon and continuing to the bung area. We sanitize the knife after initial

    hide opening and before proceeding with hide removal. Additional hide removal steps include

    initial opening of the midline and skinning to remove the hide in the belly area, loosening of hide

    from foreshanks and brisket area, and skinning to remove the hide over the shoulders in preparationfor the hide puller. Wet udders are removed before proceeding to the hide puller.

    We remove hindshanks between the tarsals and metatarsals using a mechanical device that is

    sanitized after each use.

    Hazard Analysis Logic:

    Chemical: The act of hindshanking and rimming does not introduce chemical hazards.

    Physical: Bung is covered with a plastic bag to prevent leakage during evisceration. The bag

    and tying device are removed with the viscera, so it is not likely to contaminate the product.

    Biological: Pathogens. We acknowledge that the hindshanking and rimming may introducepathogens to the carcass, which is virtually sterile before the hide is opened. The team

    acknowledges that subsequent steps must be taken to try to prevent, eliminate or reducepathogens to an acceptable level. We have identified subsequent steps of organic acid

    spraying to reduce pathogen contamination and chilling to reduce pathogen growth.

    The following discussion outlines the use of the CCP Decision Tree for this identified

    hazard:

    1. Do control measure(s) exist for the identified hazard (pathogens)? YES2. Does this step (hindshanking and rimming) eliminate or reduce the likely occurrence of a

    hazard (pathogens) to an acceptable level? NO

    3. Could contamination with the identified hazard(s) (pathogens) occur in excess ofacceptable level(s) or could it increase to an unacceptable level? YES

    4.

    Will a subsequent step eliminate the identified hazard(s) or reduce its likely occurrenceto an acceptable level? YES, organic acid has been scientifically shown to reduce the

    likely occurrence of pathogens, and proper chilling will reduce the potential for pathogen

    growth.This step is not a CCP in our process.

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    Dehiding with Hide Puller:

    Process Step Overview:

    We use a hide puller that pulls the hide upward and away at a 45 angle. Workers assist in the hidepulling process by using air dehiders, especially in the side, shoulder, and back regions. The

    foreshanks are secured with chains that are sanitized between animals to prevent pulling the animal

    off of the rail during hide pulling. The hide is removed from the slaughter floor and placed in a

    refrigerated hide storage room adjacent to the slaughter floor.

    Hazard Analysis Logic:

    Chemical and Physical: The act of hide removal is not conducive to introducing chemical or

    physical hazards.

    Biological: Pathogens. We acknowledge that the hide removal process may introducepathogens to the carcass that is virtually sterile before the hide is removed. The carcass is

    now exposed and may become contaminated with pathogens. As above, the teamacknowledges that subsequent steps must be taken to try to prevent, eliminate or reduce

    pathogens to an acceptable level. We have identified subsequent steps of organic acid

    spraying to reduce pathogen contamination and chilling to reduce pathogen growth. Wenote that air-dehiders are used as processing tools during the hide removal step. These aid

    with the hide removal and the proper sanitation of these tools are addressed in the Sanitation

    Standard Operating Procedure.

    The following discussion outlines the use of the CCP Decision Tree for this identified

    hazard:1. Do control measure(s) exist for the identified hazard (pathogens)? YES2. Does this step (dehiding and hide puller) eliminate or reduce the likely occurrence of a

    hazard (pathogens) to an acceptable level? NO

    3. Could contamination with the identified hazard(s) (pathogens) occur in excess ofacceptable level(s) or could it increase to an unacceptable level? YES

    4. Will a subsequent step eliminate the identified hazard(s) or reduce its likely occurrenceto an acceptable level? YES, organic acid has been scientifically shown to reduce the

    likely occurrence of pathogens, and proper chilling will reduce the potential for pathogen

    growth.

    This step is not a CCP in our process.

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    Evisceration:

    Process Step Overview:

    We remove the oxtail, open the sternum with a brisket saw (sanitized between animals), make aknife cut from a point in the abdominal region, near the aitch bone, down to the point of the

    sternum, and remove the viscera and pluck. The inedible viscera and pluck are placed in a paunch

    truck and the edible items are placed on a stainless steel table for preparation for inspection.

    The inedible viscera is removed from the slaughter floor and placed in plastic barrels in a

    refrigerated storage room adjacent to the slaughter floor. Edible products are either boxed or hung

    on trees before being chilled.

    Hazard Analysis Logic:

    Chemical: The written Sanitation Standard Operating Procedures address the proper proceduresfor cleaning and sanitizing equipment used during evisceration. We could not identify any

    chemical food safety hazards for this step in the process.

    Physical: The plastic bag and tying devices used to prevent spillage from the weasand and

    leaking from the bung are removed with the viscera. The viscera are not kept for furtherprocessing at this facility and are rendered inedible. Therefore, we could not identify any

    physical food safety hazards as reasonably likely to occur for this step of the process.

    Biological: Pathogens. We acknowledge that the evisceration process may introduce pathogensto the carcass, which is virtually sterile. The exposed carcass may become contaminated

    with pathogens from the gastrointestinal tract during evisceration. As above, weacknowledge that subsequent steps must be taken to try to prevent, eliminate or reduce

    pathogens to an acceptable level. We have identified subsequent steps of organic acidspraying to reduce pathogen contamination and chilling to reduce pathogen growth.

    The following discussion outlines the use of the CCP Decision Tree for this identified

    hazard:1. Do control measure(s) exist for the identified hazard (pathogens)? YES2. Does this step (evisceration) eliminate or reduce the likely occurrence of a hazard

    (pathogens) to an acceptable level? NO

    3. Could contamination with the identified hazard(s) (pathogens) occur in excess ofacceptable level(s) or could it increase to an unacceptable level? YES4. Will a subsequent step eliminate the identified hazard(s) or reduce its likely occurrenceto an acceptable level? YES, organic acid has been scientifically shown to reduce the

    likely occurrence of pathogens, and proper chilling will reduce the potential for pathogengrowth.

    This step is not a CCP in our process.

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    Electrical Stimulation:

    Process Step Overview:

    We use a portable electrical stimulation unit that operates by placing a stainless steel probe

    (sanitized between carcasses) into the crest area of the carcass to administer the electrical current.

    The stimulator uses electrical currents to enhance the conversion of muscle to meat.

    The stimulator is operated by authorized personnel only, a safety horn alerts workers that the unit is

    about to be operated and has finished its cycle, and the controls must be in the operators hand to

    apply current.

    Hazard Analysis Logic:

    Chemical, Physical and Biological: None identified at this time. Electrical stimulation is usedto enhance the quality of the carcass and does not have an impact on food safety hazards.

    The voltage is not high enough to cause breakage of bones. Therefore, it was determinedthat electrically stimulating the carcass does not enhance or introduce chemical, physical or

    biological hazards to the carcass.

    ###

    Splitting:

    Process Step Overview:

    Splitting is accomplished using a band saw splitter (sanitized between carcasses) operated from anelevating platform. The carcass is split into two halves by sawing through the center of the chine

    bones and their dorsal spinous processes. Visual contamination, when found, along with blood

    clots, fatty or glandular tissue from the throat region, are removed from the carcass. Spinal cord isremoved from each side using a handheld scraper.

    Hazard Analysis Logic:

    Chemical, Physical and Biological: None identified at this time. Splitting is accomplished byusing a split saw. If a blade breaks on a split saw, it is not likely that contamination of

    edible tissue would occur because the blade is usually lodged in the vertebral column.

    Therefore, it was determined that splitting does not enhance or introduce any chemical,physical or biological hazards to the carcass.

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    Trim Zero Tolerance:

    Process Step Overview:

    We roll the carcass into the wash bay and all visible feces, milk, and ingesta is trimmed startingwith the foreshank, working up to the round, and then working back down to the foreshank. Once

    trimming is complete, the carcass is inspected for effectiveness of trimming.

    Hazard Analysis Logic:

    Chemical and Physical: None identified at this time. The process of visually inspecting the

    carcass for visible feces, milk, and ingesta does not impact chemical or physical food safety

    hazards. Therefore, none was identified for this step.

    Biological: Visible feces, milk and ingesta. USDAs Food Safety and Inspection Service

    requires the trimming of all visible feces, milk and ingesta from the carcass prior to washingas part of zero tolerance control. According to 62 Federal Register (FR) 63254, November

    28, 1997; the plant must address zero tolerance in the HACCP plan. Therefore, this step isidentified as a CCP to control visible feces, milk, and ingesta by knife trimming any visible

    contamination. [See supporting documentation.]

    ###

    Final Wash:

    Process Step Overview:

    We wash the carcass with warm water under high pressure beginning at the hind shank and workingdownward, paying special attention to the regions of the hock, crotch, throat, and beneath the

    foreshank to remove bone dust and other foreign materials.

    Hazard Analysis Logic:

    Chemical, Physical, and Biological. None identified at this time. Since the water is potable, we

    could not identify any chemical, physical, or biological food safety hazards that would be

    associated with this step. Final wash is used to remove bone dust, hair, and other foreignmaterials that are not food safety hazards.

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    Organic Acid Spray:

    Process Step Overview:

    After the final wash, a lactic acid solution is applied to all exposed areas of the carcass from thehind shank working downward using a hand-held spraying wand that mixes the lactic acid with

    water to achieve the appropriate concentration. Special care is given to ensure that both external

    and internal surfaces receive the spray.

    Hazard Analysis Logic:

    Chemical: The lactic acid used is a food grade substance that was approved by USDAs FSIS

    for use on carcasses at a 2.5% maximum level. We have letters of guarantee on file from

    our suppliers stating that food grade lactic acid is considered Generally Recognized asSafe under 21 CFR 184.1061. Therefore, no chemical food safety hazards were identified

    as reasonably likely to occur by the act of spraying the carcass with lactic acid.

    Physical: The step of mixing and applying lactic acid does not impact physical hazards;therefore, the team could not think of any physical hazard that were associated with this step

    of the process.

    Biological: Pathogens. Lactic acid has been shown to be an effective organic acid at reducing

    pathogen loads. FSIS Notice 49-94 (12-21-94) states that up to 2.5% of a food grade acid

    can be used. Therefore, we consider the use of lactic acid as a CCP for reducing pathogens,

    includingE. coliO157:H7, on the slaughter floor. Scientific literature is also available tosupport the use of lactic acid as a microbial intervention that will reduceE. coliO157:H7

    and Salmonella. This intervention has been scientifically validated to reduce levels ofE.coliO157:H7 (inoculated samples were reduced by at least 3 logs) that are higher than

    would be anticipated on carcasses during normal processing. [See supportingdocumentation.]

    The following discussion outlines the use of the CCP Decision Tree for this identified

    hazard:1. Do control measure(s) exist for the identified hazard (pathogens)? YES2. Does this step (spraying with organic acid) eliminate or reduce the likely occurrence of a

    hazard (pathogens) to an acceptable level? YES, spraying the carcass with organic acid

    will reduce pathogens.

    This step is a CCP in this process to reduce pathogens (i.e.,E. coli

    O157:H7 andSalmonella).

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    Chilling:

    Process Step Overview:

    The carcasses are placed into the hot box to initiate the chilling process. The hot box is designed to

    optimize the initial chill because it has high air movement at refrigeration temperatures to help

    reduce the surface and internal temperatures of the carcasses. The refrigeration system is a closed

    ammonia system and the cooling capacity is capable of chilling the number of carcasses that weproduce on a routine basis.

    Hazard Analysis Logic:

    Chemical. The refrigeration system operates with ammonia in a closed system; therefore, it wasnot considered as a reasonably likely to occur food safety hazard. We know that ammonia

    leaks could be a worker safety issue, but any contamination onto the product may causesome quality defects but would not be a food safety hazard because it will dissipate. In

    addition, ammonia is present in raw meat as a byproduct of the conversion of muscle tomeat. We could not think of any other potential chemical hazards that should be considered

    as part of the chilling process.

    Physical: None identified at this time. The team could not think of any physical food safety

    hazards that were associated with the chilling process.

    Biological: The process of chilling does not introduce biological hazards. Pathogens that arepresent when entering the chilling step cannot be eliminated either. Although microbial

    interventions are in place to reduce pathogens on the slaughter floor, the team recognizesthat pathogens may be present on the carcass as it passes from the slaughter floor to the

    cooler. Proper chilling of the carcass can help reduce the potential for pathogen growth.Therefore, the team considers chilling to be a CCP.

    The following discussion outlines the use of the CCP Decision Tree for this identified

    hazard:1. Do control measure(s) exist for the identified hazard (pathogens)? YES2. Does this step (chilling) eliminate or reduce the likely occurrence of a hazard (pathogen

    growth) to an acceptable level? YES, proper chilling of the carcass will reduce the

    potential for pathogen growth.

    This step is a CCP in our process.

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    Trim Zero Tolerance -- Heads:

    Process Step Overview:

    We place the head in the head cabinet and all visible feces, milk, and ingesta are trimmed. Oncetrimming is complete, the head is inspected for effectiveness of trimming.

    Hazard Analysis Logic:

    Chemical and Physical: None identified at this time. The process of visually inspecting thehead for visible feces, milk, and ingesta does not impact chemical or physical food safety

    hazards. Therefore, none were identified for this step.

    Biological: Visible feces, milk, and ingesta. USDAs Food Safety and Inspection Servicerequires the trimming of all visible feces, milk, and ingesta from the carcass prior to washing

    as part of zero tolerance control. According to 62 Federal Register (FR) 63254, November28, 1997, the plant must address zero tolerance in the HACCP plan. Therefore, this step is

    identified as a CCP to control visible feces, milk, and ingesta by knife trimming any visiblecontamination. [See supporting documentation.]

    ###

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    Organic Acid Spray -- Heads:

    Process Step Overview:

    A lactic acid solution is mixed and applied to all exposed areas of the head using a hand-heldspraying wand that mixes the lactic acid with water to achieve the appropriate concentration.

    Special care is given to ensure that both external and internal surfaces receive the spray.

    Hazard Analysis Logic:

    Chemical: The lactic acid used is a food grade substance that is approved for use on heads at a

    2.5 % maximum level. Therefore, no chemical food safety hazards were identified as

    reasonably likely to occur by the act of spraying the carcass with the lactic acid.

    Physical: The step of applying lactic acid does not impact physical hazards; therefore, the team

    could not think of any physical hazard that was associated with this step of the process.

    Biological: Pathogens. Lactic acid has been shown to be an effective organic acid at reducingpathogen loads. FSIS Notice 49-94 (12-21-94) states that up to 2.5% of a food grade acid

    can be used. Therefore, we consider the use of lactic acid as a CCP for reducing pathogens,

    includingE. coliO157:H7, on the slaughter floor. Scientific literature is also available tosupport the use of lactic acid as a microbial intervention that will reduceE. coliO157:H7

    and Salmonella. This intervention has been scientifically validated to reduce levels ofE.

    coliO157:H7 (inoculated samples were reduced by at least 3 logs) that are higher than

    would be anticipated on heads during normal processing. [See supporting documentation.]

    The following discussion outlines the use of the CCP Decision Tree for this identifiedhazard:

    1. Do control measure(s) exist for the identified hazard (pathogens)? YES2. Does this step (spraying with organic acid) eliminate or reduce the likely occurrence of a

    hazard (pathogens) to an acceptable level? YES, spraying heads with organic acid will

    reduce pathogens.

    This step is a CCP in this process to reduce pathogens (i.e., E. coliO157:H7 and

    Salmonella).

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    Chilling -- Heads:

    Process Step Overview:

    The heads are placed on a tree and put in the hot box to initiate the chilling process. The hot box isdesigned to optimize the initial chill because it has high air movement at refrigeration temperatures

    to help reduce the surface and internal temperatures of the heads. The refrigeration system is a

    closed ammonia system and the cooling capacity is capable of chilling the number of heads that we

    produce on a routine basis.

    Hazard Analysis Logic:

    Chemical. The refrigeration system operates with ammonia in a closed system; therefore, it was

    not considered as a reasonably likely to occur food safety hazard. The team could not thinkof any other potential chemical hazards that should be considered as part of the chilling

    process.

    Physical: None identified at this time. The team could not think of any physical food safetyhazards that were associated with the chilling process.

    Biological: The process of chilling does not introduce biological hazards. Pathogens that arepresent when entering the chilling step cannot be eliminated either. Although microbial

    interventions are in place to reduce pathogens on the slaughter floor, the team recognizes

    that pathogens may be present on the head as it passes from the slaughter floor to the cooler.

    Proper chilling of heads can help reduce the potential for pathogen growth. Therefore, theteam considers chilling to be a CCP.

    The following discussion outlines the use of the CCP Decision Tree for this identified

    hazard:1. Do control measure(s) exist for the identified hazard (pathogens)? YES2. Does this step (chilling) eliminate or reduce the likely occurrence of a hazard (pathogen

    growth) to an acceptable level? YES, proper chilling of heads will reduce the potential

    for pathogen growth.This step is a CCP in our process.

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    Variety Meat Processing:

    Process Step Overview:

    After removal during evisceration, the variety meats are prepared for chilling by trimming or otherprocedures.

    Hazard Analysis Logic:

    Physical: The team could not identify any physical hazards associated with the processing ofvariety meats. The meats are processed whole and are not altered in any way.

    Chemical: None identified at this time. Variety meat processing does not introduce any

    chemical hazards.

    Biological: Pathogens. It is an accepted fact that raw meat is a potential source of pathogens(i.e., SalmonellaandE. coli O157:H7). The USDA baseline studies document previous

    incidence levels. Therefore, we acknowledge that steps must be taken to try to eliminate,prevent or reduce to an acceptable level any pathogen contamination. The steps that are

    identified for this process will be discussed later in the subsequent steps organic acid

    spraying and chilling.

    The following discussion outlines the use of the CCP Decision Tree for this identified

    hazard:

    1. Do control measure(s) exist for the identified hazard (pathogens)? YES2. Does this step (variety meat processing) eliminate or reduce the likely occurrence of a

    hazard (pathogens) to an acceptable level? NO3. Could contamination with the identified hazard(s) (pathogens) occur in excess ofacceptable level(s) or could it increase to an unacceptable level? YES

    4. Will a subsequent step eliminate the identified hazard(s) or reduce its likely occurrenceto an acceptable level? YES, organic acid has been scientifically shown to reduce the

    likely occurrence of pathogens, and proper chilling will reduce the potential for pathogen

    growth.This is not a CCP in our process.

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    Trim Zero Tolerance Variety Meats:

    Process Step Overview:

    The variety meats are inspected for compliance with zero tolerance requirements.

    Hazard Analysis Logic:

    Chemical and Physical: None identified at this time. The process of visually inspecting the

    variety meats for visible feces, milk and ingesta does not impact chemical or physical foodsafety hazards. Therefore, none were identified for this step.

    Biological: Visible feces, milk, and ingesta. USDAs Food Safety and Inspection Service

    requires the trimming of all visible feces, milk, and ingesta from the variety meats prior towashing as part of zero tolerance control. According to 62 Federal Register (FR) 63254,

    November 28, 1997, the plant must address zero tolerance in the HACCP plan. Therefore,this step is identified as a CCP to control visible feces, milk, and ingesta by knife trimming

    any visible contamination.

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    Organic Acid Spray Variety Meats:

    Process Step Overview:

    A lactic acid solution is mixed and applied to all exposed areas of the variety meats using a hand-held spraying wand that mixes the lactic acid with water to achieve the appropriate concentration.

    Special care is given to ensure that both external and internal surfaces receive the spray.

    Hazard Analysis Logic:

    Chemical: The lactic acid used is a food grade substance that is approved for use on variety

    meats at a 2.5 % maximum level. Therefore, no chemical food safety hazards were

    identified as reasonably likely to occur by the act of spraying variety meats with the lactic

    acid.

    Physical: The step of applying lactic acid does not impact physical hazards; therefore, the teamcould not think of any physical hazard that was associated with this step of the process.

    Biological: Pathogens. Lactic acid has been shown to be an effective organic acid at reducing

    pathogen loads. Therefore, the team considers the use of lactic acid as a CCP for reducing

    pathogens on the slaughter floor. Scientific literature is available to support the use of lacticacid as a microbial intervention.

    The following discussion outlines the use of the CCP Decision Tree for this identified

    hazard:1. Do control measure(s) exist for the identified hazard (pathogens)? YES2.

    Does this step (spraying with organic acid) eliminate or reduce the likely occurrence of ahazard (pathogens) to an acceptable level? YES, spraying variety meats with organic

    acid will reduce pathogens.This step is a CCP in this process to reduce pathogens (i.e., E. coliO157:H7 and

    Salmonella).

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    Receiving Organic Acid:

    Process Step Overview:

    This is where the lactic acid we use in our organic acid rinses is received.

    Hazard Analysis Logic:

    Chemical: The lactic acid used is a food grade substance that is approved. We have letters of

    guarantee on file from our supplier stating that food grade lactic acid is consideredGenerally Recognized as Safe under 21 CFR 184.1061.

    Physical: The step of receiving the lactic acid does not impact physical hazards; therefore, the

    team could not think of any physical hazard that was associated with this step of the process.

    Biological: The team could not identify any biological food safety hazards that can be identifiedwith receiving the lactic acid.

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    Dry Storage:

    Process Step Overview:

    This is where the lactic acid we use in our organic acid spray is stored.

    Hazard Analysis Logic:Chemical: The team could not identify any chemical hazards associated with storing of the

    lactic acid.

    Physical: The step of storing the lactic acid does not impact physical hazards; therefore, theteam could not think of any physical hazard that was associated with this step of the process.

    Biological: The team could not identify any biological food safety hazards that can be identified

    with storing the lactic acid.

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