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  1. 1. FSIS Directive 6410.1 Verifying Sanitary Dressing and Process Control Procedures in Slaughter Operations of Cattle of Any Age February 18 and March 23, 2010 Office of Policy and Program Development Policy Development Division
  2. 2. Purpose of Correlation <ul><li>To address new emphasis’ in the directive </li></ul><ul><li>To provide additional information regarding verification </li></ul><ul><li>To provide thought processes to assist IPP when making determinations of noncompliance </li></ul><ul><li>To address the role of sanitary dressing and process control within the food safety system </li></ul>
  3. 3. New Emphasis <ul><li>Verification of sanitary dressing and process control begins at receiving of cattle, not at the final rail (i.e., a system approach) </li></ul><ul><li>The Agency’s expectation is that the sanitary dressing and process control procedures being implemented be in a written document </li></ul>
  4. 4. New Emphasis (Continued) <ul><li>Noncompliance is not typically based on any single observation. It will involve consideration of a variety of factors </li></ul><ul><li>FSIS has identified typical locations in the slaughter process where carcass contamination is most likely to occur </li></ul>
  5. 5. New Emphasis - 1 <ul><li>Verification of sanitary dressing and </li></ul><ul><li>process control begins at receiving </li></ul><ul><li>of cattle, not at the final rail </li></ul><ul><li>(i.e., a system approach) </li></ul>
  6. 6. System Approach <ul><li>It is the expectation that each time IPP evaluate the sanitary dressing & process control procedures, they look at the entire slaughter system , not just one point in the process </li></ul><ul><li>When determining compliance, IPP should consider what they are seeing at that time regarding the system, but are to also consider what has been occurring historically in the operation </li></ul>
  7. 7. Note <ul><li>Additional information* might also be provided to off-line IPP from on-line IPP, as well as from production areas beyond the final rail. That information can be considered by off-line IPP when determining the compliance of sanitary dressing and process control procedures </li></ul><ul><li>*e.g., Information received from IPP in further processing; repetitive on-line contamination incidents; E.coli testing results </li></ul><ul><li>(either establishment’s or FSIS) </li></ul>
  8. 8. System Approach <ul><li>Determining compliance involves deciding if, overall, sanitary dressing operation and process control procedures that are in place, are effective to prevent the creation of insanitary conditions and thereby prevent contamination of carcasses </li></ul>
  9. 9. New Emphasis - 2 <ul><li>It is the Agency’s expectation that the </li></ul><ul><li>sanitary dressing and process control </li></ul><ul><li>procedures being implemented be in a </li></ul><ul><li>written document and that records be </li></ul><ul><li>maintained </li></ul><ul><li>Note: it is not a regulatory requirement that the procedure be written or that daily records be maintained </li></ul>
  10. 10. Definitions <ul><li>Process Control Procedure: A defined procedure or set of procedures designed by an establishment to provide control of operating conditions that are necessary for the production of safe, wholesome food </li></ul>
  11. 11. Definitions <ul><li>Process Control Procedures put in place by establishments typically include: </li></ul><ul><ul><li>observing or measuring system performance </li></ul></ul><ul><ul><li>analyzing the results to develop measures to ensure the process remains under control </li></ul></ul><ul><ul><li>taking action when necessary to ensure that the system continues to perform within the control criteria </li></ul></ul><ul><ul><li>planned measures taken by the establishment in response to any loss of process control </li></ul></ul>
  12. 12. Definitions <ul><li>Sanitary Dressing: Practice of handling carcasses by establishment employees and machinery, throughout the slaughter process, in a manner that produces a clean, safe, wholesome meat food product in a sanitary environment </li></ul>
  13. 13. Written Document <ul><li>Establishments may employ practices such as: </li></ul><ul><ul><li>Adequate separation of carcasses, parts and viscera </li></ul></ul><ul><ul><li>Routinely cleaning/sanitizing equipment used to cut carcasses </li></ul></ul><ul><ul><li>Good employee hygiene practices </li></ul></ul><ul><ul><li>Implementing decontamination and antimicrobial intervention treatments </li></ul></ul><ul><li>Implementation of practices such as these would be beneficial when supporting decisions that the establishment is reducing contamination on carcasses and therefore reducing the likelihood that E.coli O157:H7 may be present </li></ul>
  14. 14. Written Document <ul><li>HACCP plan </li></ul><ul><li>Sanitation SOP </li></ul><ul><li>SOP </li></ul><ul><li>GMP </li></ul><ul><li>Other Pre-requisite program </li></ul>
  15. 15. Written Document <ul><li>Regulations require that the hazard analysis include all documentation (i.e., written procedures and associated records) that supports the food safety system </li></ul><ul><li>Written sanitary dressing and process control procedures can be used as support for decisions made in the hazard analysis </li></ul>
  16. 16. Written Document <ul><li>If the procedures are not in a written document and if records are not maintained, it may be difficult for the establishment to demonstrate that the slaughter operation, any procedures implemented, and any interventions used, are effective to reduce E.coli O157:H7 to below detectable levels </li></ul>
  17. 17. New Emphasis - 3 <ul><li>Determining noncompliance will involve consideration of a variety of factors and will not typically be based on a single observation </li></ul>
  18. 18. Regulatory Basis <ul><li>Establishments are expected to slaughter and process cattle in a manner designed to prevent contamination of carcasses </li></ul><ul><ul><li>9 CFR 310.18(a) requires prevention of carcass contamination </li></ul></ul><ul><ul><li>9 CFR 416.1 requires that establishments be operated such that they do not create insanitary conditions or contaminate product </li></ul></ul>
  19. 19. Determining Noncompliance <ul><li>FSRE training thought process: </li></ul><ul><ul><li>Has not changed for SPS or SSOP issues other than Sanitary Dressing & Process control </li></ul></ul><ul><ul><li>IPP will continue to use the same thought process presented in FSRE training for issues such as lighting, rodent & pest control, ventilation, etc. </li></ul></ul><ul><ul><li>Compliance for issues other than sanitary dressing and process control will be determined based on the individual incidents observed </li></ul></ul>
  20. 20. Determining Noncompliance <ul><li>The thought process for determining compliance of the sanitary dressing and process control procedures is different because it is about a system </li></ul><ul><li>A specific event of finding contamination on a carcass may not be significant as it relates to the system </li></ul><ul><li>Finding contamination on a carcass still may need to be addressed as a specific incident </li></ul>
  21. 21. Determining Noncompliance <ul><li>Off-line IPP are to determine </li></ul><ul><li>noncompliance based on their evaluation of the sanitary dressing and process control </li></ul><ul><li>procedures in relation to the </li></ul><ul><li>food safety system </li></ul><ul><li>and not simply in relation to </li></ul><ul><li>one contamination event </li></ul>
  22. 22. Determining Noncompliance <ul><li>Use the information gathered while performing verification procedures to determine compliance </li></ul><ul><li>Document noncompliance in accordance with FSIS Directive 5000.1 </li></ul><ul><li>Cite 9 CFR 310.18(a) on Noncompliance Record (NR) </li></ul>
  23. 23. Determining Noncompliance <ul><li>The slaughter system, including sanitary dressing and process control procedures, needs to be designed to prevent the creation of insanitary conditions </li></ul><ul><li>If the system is not accomplishing that, the Agency has determined that noncompliance is to be documented as 06D01 noncompliance </li></ul>
  24. 24. New Emphasis - 4 <ul><li>FSIS has identified typical locations </li></ul><ul><li>in the slaughter process where carcass contamination is most likely to occur </li></ul>
  25. 25. Potential Contamination Points <ul><li>The points are identified to help off-line IPP focus their verification in order to ensure that: </li></ul><ul><ul><li>Contamination events are effectively prevented </li></ul></ul><ul><ul><li>The slaughter process is completed in a timely manner prior to chilling the carcass </li></ul></ul>
  26. 26. Potential Contamination Points <ul><li>Live Receiving/holding </li></ul><ul><li>Sticking </li></ul><ul><li>Hide Removal </li></ul><ul><li>Bunging </li></ul><ul><li>Head Removal </li></ul><ul><li>Rodding the weasand </li></ul><ul><li>Evisceration </li></ul><ul><li>Carcass Splitting </li></ul><ul><li>Head and Cheek Meat Processing </li></ul>
  27. 27. Potential Contamination Points <ul><li>Questions asked in the directive are: </li></ul><ul><ul><li>Intended to be thought provoking </li></ul></ul><ul><ul><li>Not intended to be prescriptive measures that establishments are required to implement </li></ul></ul><ul><ul><li>Not all inclusive </li></ul></ul>
  28. 28. NOTE <ul><li>The potential contamination points listed in the directive are not all-inclusive </li></ul><ul><li>IPP are not required to verify them in any specific order (e.g., sequential, start to finish) </li></ul>
  29. 29. <ul><li>There is an increased potential for contamination with pathogens such as E. coli O157:H7 & Salmonella due to their presence on the hide and feces of cattle </li></ul><ul><li>Transportation, unloading, & interaction with other cattle may cause stress and increased shedding of pathogens </li></ul>Live Receiving/Holding Why is this step vulnerable?
  30. 30. <ul><li>Cleaning unloading areas and pens </li></ul><ul><li>Cattle washing that is monitored to prevent contamination </li></ul><ul><li>Using a mud-scoring system to identify cattle that may present an increased likelihood of contamination during hide removal </li></ul>Measures the establishment can take to reduce the pathogen load
  31. 31. <ul><li>The animal is bled at this step </li></ul><ul><li>Regardless of the slaughter method, it’s important for the plant to minimize contamination of the carcass during any cut made at this step </li></ul>Sticking Why is this step vulnerable?
  32. 32. <ul><li>Use the smallest cut possible to accomplish bleeding </li></ul><ul><li>Use two knife system </li></ul><ul><li>(i.e., one knife is being used while one knife is being sanitized) </li></ul><ul><li>Clean hand between sticking each carcass </li></ul><ul><li>Use a validated decontamination or antimicrobial intervention treatment </li></ul>Measures the establishment can take to reduce the pathogen load
  33. 33. <ul><li>Hide is a significant source of contamination (e.g., dust, dirt, feces, mud) </li></ul><ul><li>It is important to maintain sanitary conditions when handling the hide </li></ul>Hide Removal Why is this step vulnerable?
  34. 34. <ul><li>Remove visible contamination at the cut line (e.g., with air knives or by steam vacuuming) </li></ul><ul><li>Remove the udder to prevent contamination with milk </li></ul><ul><li>Prevent contamination of the exposed carcass by the hide, a soiled knife, or employee </li></ul>Measures the establishment can take to reduce the pathogen load
  35. 35. <ul><li>Wash cabinets can be used at various points in the slaughter process </li></ul><ul><li>The establishment must ensure that the cabinets do not spread contamination to adjacent carcasses </li></ul>Wash Cabinets Why is this step vulnerable?
  36. 36. <ul><li>Controlling overspray </li></ul><ul><li>Removing abscesses, septic bruises, parasites or lesions before carcasses enter the cabinet </li></ul><ul><li>Ensuring carcasses with excessive contamination do not cross contaminate other carcasses </li></ul><ul><li>Ensuring carcasses with U.S. Suspect or Retained tags do not cross contaminate other carcasses </li></ul>Measures the establishment can take to reduce the pathogen load
  37. 37. <ul><li>This is the point where a cut is made around the rectum to free it from the carcass </li></ul><ul><li>It is tied off to prevent spillage of fecal material onto the carcass </li></ul>Bunging Why is this step vulnerable?
  38. 38. <ul><li>Tying off the bung in a sanitary manner </li></ul><ul><li>Maintaining employee hygiene to prevent cross contamination of carcasses </li></ul><ul><li>Using decontamination or antimicrobial intervention treatments </li></ul>Measures the establishment can take to reduce the pathogen load
  39. 39. <ul><li>This is the point where the brisket is split or cut along the centerline </li></ul><ul><li>If this is not done in a sanitary manner, contamination can be spread across the carcass </li></ul>Brisket Opening Why is step vulnerable?
  40. 40. <ul><li>Cleaning and sanitizing the brisket saw and knife between each carcass </li></ul><ul><li>Ensuring the gastrointestinal tract is not punctured </li></ul><ul><li>Maintaining employee hygiene to prevent cross contamination of carcasses </li></ul><ul><li>Using decontamination or antimicrobial intervention treatments </li></ul>Measures the establishment can take to reduce the pathogen load
  41. 41. <ul><li>It is important to maintain sanitary conditions because cross contamination can occur if the head comes into contact with insanitary heads, equipment, and employee handling </li></ul>Head removal Why is this step vulnerable?
  42. 42. <ul><li>Ensuring the head is not contaminated with digestive tract contents or SRMs </li></ul><ul><li>Thoroughly flushing the inside of the head before washing outside surfaces </li></ul><ul><li>Properly clean and maintain knives </li></ul><ul><li>Maintaining employee hygiene to prevent cross contamination of carcasses </li></ul><ul><li>Using decontamination or antimicrobial intervention treatments </li></ul>Measures the establishment can take to reduce the pathogen load
  43. 43. <ul><li>The weasand meat that is salvaged from the remainder of the gastrointestinal tract is used in raw ground beef production. </li></ul>Rodding the Weasand Why is this step vulnerable?
  44. 44. Rodding the Weasand Why is this step vulnerable? <ul><li>It is important to prevent contamination from being transferred from the exterior of the carcass to the interior, or onto the weasand </li></ul><ul><li>If the gastrointestinal tract is punctured, it can contaminate the exterior and interior of the carcass with ingesta </li></ul>
  45. 45. <ul><li>Closing the esophagus to prevent rumen contents from leaking </li></ul><ul><li>Maintaining proper employee hygiene </li></ul><ul><li>Changing or sanitizing the weasand rod between each carcass </li></ul><ul><li>Using decontamination or antimicrobial intervention treatments </li></ul>Measures the establishment can take to reduce the pathogen load
  46. 46. <ul><li>Contamination of the carcass and edible offal can occur if the viscera is not handled properly or if employee hygiene practices are not followed </li></ul>Evisceration Why is this step vulnerable?
  47. 47. <ul><li>Removing visible contamination from the area to be cut </li></ul><ul><li>Removing the uterus in a way that prevents cross contamination </li></ul><ul><li>Preventing footwear from contaminating other areas of the operation (e.g., on moving viscera tables) </li></ul>Measures the establishment can take to reduce the pathogen load on the viscera
  48. 48. <ul><li>Using knives to prevent puncturing the paunch & intestines </li></ul><ul><li>Removing contamination in a timely manner, & according to accepted reconditioning procedures </li></ul><ul><li>Using validated decontamination or antimicrobial intervention treatments </li></ul>Measures the establishment can take to reduce the pathogen load on the carcass
  49. 49. <ul><li>This is the point where carcasses are split vertically into two halves </li></ul><ul><li>Carcasses can be cross contaminated if sanitary dressing procedures or process control procedures are not followed </li></ul>Carcass splitting Why is this step vulnerable?
  50. 50. <ul><li>Cleaning and sanitizing saws and knives between each carcass </li></ul><ul><li>Allowing for adequate </li></ul><ul><li>distance between </li></ul><ul><li>carcasses to limit </li></ul><ul><li>carcass-to-carcass </li></ul><ul><li>contact </li></ul>Measures the establishment can take to reduce the pathogen load
  51. 51. <ul><li>Removing the spinal cord according to 9 CFR 310.22 </li></ul><ul><li>Using validated decontamination or antimicrobial intervention treatments </li></ul>Measures the establishment can take to prevent contamination of the carcass?
  52. 52. <ul><li>The head and cheek meat can be used in the production of raw beef products, including ground beef </li></ul><ul><li>It is important for the establishment to maintain sanitary conditions </li></ul>Head & Cheek Meat Processing Why is this step vulnerable?
  53. 53. <ul><li>Cleaning and sanitizing knives </li></ul><ul><li>Preventing cross contamination of heads </li></ul><ul><li>Maintaining proper employee hygiene </li></ul><ul><li>Quickly chilling the meat to prevent pathogen growth </li></ul><ul><li>Using validated decontamination or antimicrobial intervention treatments </li></ul>Measures the establishment can take to reduce the pathogen load
  54. 54. <ul><li>Delays in chilling, such as power outages, equipment failure, or holding carcasses for extended periods of time before reconditioning to remove visible contamination </li></ul><ul><li>When contamination occurs off-line, inspectors will verify that the plant takes steps to minimize the recurrence, and effectively addresses reconditioning of the contaminated carcasses. </li></ul>What are some other conditions that can cause pathogens to multiply?
  55. 55. Discussion
  56. 56. Sanitary Dressing & Process Control’s Role in the Food Safety System <ul><li>Effective Sanitary Dressing and Process control procedures are integral parts of the food safety system </li></ul><ul><li>Without effective sanitary dressing and process control procedures, carcasses could be overwhelmed with contamination </li></ul>
  57. 57. Sanitary Dressing & Process Control’s Role in the Food Safety System <ul><li>When contamination overwhelms the decontamination practices and antimicrobial interventions, the establishment may no longer be able to reduce E.coli O157:H7 to below detectable levels </li></ul><ul><li>It is essential that slaughter operations also have validated interventions that work in are integrated with sanitary dressing and process control procedures in order to reduce pathogens </li></ul>
  58. 58. Validated Interventions <ul><li>Until the CCP is demonstrated to achieve its anticipated effect under in-plant conditions, the CCP is theoretical and not adequately validated </li></ul><ul><ul><li>How establishments accomplish validation is up to each individual establishment </li></ul></ul><ul><ul><li>Testing before and after each intervention is one option but not currently a requirement </li></ul></ul>
  59. 59. Summary <ul><li>Sanitary dressing and process control procedures are key to preventing insanitary conditions and carcass contamination </li></ul><ul><li>Preventing carcass contamination is essential to ensuring that decontamination practices and validated antimicrobial measures are effective to reduce E.coli O157:H7 </li></ul>
  60. 60. Summary (Continued) <ul><li>Reducing E.coli O157:H7 is a regulatory requirement & is essential to ensuring food safety </li></ul><ul><li>Noncompliances are determined in relation to the food safety system </li></ul><ul><ul><li>Not in regard to one point in the process </li></ul></ul><ul><ul><li>Not in regard to one contamination incident </li></ul></ul><ul><li>Noncompliance will be documented as SPS/06D01 </li></ul>
  61. 61. Questions ?

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