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