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OPPD Policy Development Division Omaha, Nebraska

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1 OPPD Policy Development Division Omaha, Nebraska
FSIS DIRECTIVE VERIFYING SANITARY DRESSING AND PROCESS CONTROL PROCEDURES BY OFF-LINE INSPECTION PROGRAM PERSONNEL (IPP) IN POULTRY SLAUGHTER OPERATIONS A Systems Approach OPPD Policy Development Division Omaha, Nebraska

2 OPPD Policy Development Division Omaha, Nebraska
OBJECTIVES Discuss a ‘system’ as it relates to sanitary dressing and process control Role of sanitary dressing and process control as a part of the establishment’s food safety system Directive Locations in the slaughter process where carcass contamination is most likely to occur Verification Establishment Interventions Determining compliance Read slide OPPD Policy Development Division Omaha, Nebraska

3 OPPD Policy Development Division Omaha, Nebraska
BACKGROUND Effective sanitary dressing and process control procedures are crucial to an establishment’s ability to produce a clean, safe, and wholesome product. Carcass contamination is a vehicle for the transfer of pathogens. As set out in 9 CFR (e), poultry carcasses contaminated with visible fecal material must be prevented from entering the chilling tank. FSIS Salmonella verification testing results have shown reduced Salmonella levels in poultry establishments since FSIS implemented Salmonella performance categories (Category 1, 2, and 3) and other policies designed to lower levels of Salmonella (71 FR 9772, February 27, 2006; 73 FR 4767, January 28, 2008; and 75 FR 27288, May 10, 2010). OPPD Policy Development Division Omaha, Nebraska

4 OPPD Policy Development Division Omaha, Nebraska
KEY POINT Sanitary dressing noncompliances are determined based on cumulative information reflecting the food safety system Sanitary Dressing noncompliance is not documented in regard to one point in the process. Sanitary Dressing noncompliance is not documented in regard to one contamination incident. Before we go any farther, we need to address one issue and keep this fact in mind…Sanitary dressing noncompliance is not based on one incident of insanitary conditions. Read slide We’ll talk more about this as we proceed but it is important the we start the presentation with this point in mind… OPPD Policy Development Division Omaha, Nebraska

5 Sanitary Dressing and Process Control Correlation Presentation
FOOD SAFETY SYSTEM A food safety system includes all aspects of the operation For example: Slaughter Fabrication and Grinding Product storage Product Testing Control Programs Customer feedback Lets talk a bit about systems…Read slide We can probably all think of any number of systems… (Read Slide) OPPD Policy Development Division Omaha, Nebraska

6 Sanitary Dressing and Process Control Correlation Presentation
What is the key to making the system work? What is an example of a system? Building a house Flying an airplane Making bread Sewing a dress Slaughtering cattle Follow the blueprints Complete a pre-flight check and follow the flight plan Follow the recipe Follow the pattern Follow Sanitary Dressing & Process Control Procedures (Click to add each heading and bullet) OPPD Policy Development Division Omaha, Nebraska

7 OPPD Policy Development Division Omaha, Nebraska
This is the “system” we are all familiar with…slaughtering poultry includes some specific steps For example, Hanging, bleeding, scalding, evisceration, etc. We all know that when something goes wrong at the beginning of the process, it affects everything else down stream That is because it is a system. In fact, it is a system within a system..it is the first step in the overall system of preparing product to be shipped to the consumer If one of the early steps of food production fails, it affects steps later on in the process and ultimately the entire system is out of control. OPPD Policy Development Division Omaha, Nebraska

8 Sanitary Dressing and Process Control Correlation Presentation
SYSTEM APPROACH It is the expectation that each time IPP evaluate the sanitary dressing & process control procedures, they look at the entire slaughter system, and beyond , not at just one point in the process NOTE: 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 (i.e., consider cumulative information) FSIS personnel need to think beyond the boundaries of the kill floor when evaluating whether or not the slaughter system’s sanitary dressing and process control procedures are working. Carcasses don’t just disappear into space when they leave the kill floor…they move on to fabrication and become things like whole birds, drums, thighs, wings and ground product OPPD Policy Development Division Omaha, Nebraska

9 Sanitary Dressing and Process Control Correlation Presentation
It’s a puzzle Process control programs Fabrication & grinding Zero Tolerance In the very simplest terms…the food safety system is a puzzle where, ideally, all the pieces fit together Each piece affects the others All steps in Slaughter operations including waivers Salmonella Category Product Testing OPPD Policy Development Division Omaha, Nebraska

10 Sanitary Dressing and Process Control Correlation Presentation
SYSTEM APPROACH FSIS’ role is to think about all the available information to see how the pieces interact with each other and ultimately fit together Our role is to observe what the establishment is doing, and think about how what is being done at each part of the process affects the other parts of the process If something does not work correctly at the beginning, it will probably have a negative result at the end OPPD Policy Development Division Omaha, Nebraska

11 Sanitary Dressing and Process Control Correlation Presentation
NOTE IPP have an opportunity to gather information about the system every time they walk out onto the slaughter floor regardless of whether or not they are conducting the PHIS Poultry Sanitary Dressing task Sanitary dressing/process control verification is about looking at, and thinking about, the “Big Picture” and not just a snapshot of what is happening in the operation. Each trip into the facility is an opportunity to observe the operation and to consider how what is occurring affects the system as a whole. OPPD Policy Development Division Omaha, Nebraska

12 Sanitary Dressing and Process Control Correlation Presentation
Role of sanitary dressing and process control as a part of the establishment’s food safety system OPPD Policy Development Division Omaha, Nebraska

13 OPPD Policy Development Division Omaha, Nebraska
SANITARY DRESSING Practice of handling carcasses and parts by establishment employees and machinery, throughout the slaughter process, in a manner that produces a clean, safe, wholesome poultry product in a sanitary environment. Let’s talk a bit about what sanitary dressing actually is… This is the definition that is included in the directive Read slide OPPD Policy Development Division Omaha, Nebraska

14 Process Control Procedures
Sanitary Dressing and Process Control Correlation Presentation Process Control Procedures A defined procedure or set of procedures designed by an establishment to provide control of those operating conditions that are necessary for the production of safe, wholesome food. 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 This is also one of the definitions in the directive and it addresses what IPP might see in the operation OPPD Policy Development Division Omaha, Nebraska

15 Sanitary Dressing and Process Control Correlation Presentation
NOTE The point of sanitary dressing and process control is to reduce contamination and to ensure that poultry carcasses are as clean as possible throughout the entire slaughter operation. The establishment should not be waiting until just before the birds falls into the chiller to take care of contamination Read slide OPPD Policy Development Division Omaha, Nebraska

16 NOTE Contamination events on carcasses should be prevented throughout the slaughter process to in order to prevent the creation of insanitary conditions OPPD Policy Development Division Omaha, Nebraska

17 Sanitary Dressing and Process Control Correlation Presentation
WHY IT’S IMPORTANT Preventing carcass contamination is essential to ensuring that decontamination practices and validated antimicrobial interventions are effective to reduce Salmonella and generic E.coli Being proactive is better for food safety than being reactive Keep in mind, Sanitary dressing and process control begins at receiving of birds, not at the final point before birds fall into the chiller. It is the responsibility of the establishment to reduce Salmonella and Campylobacter. Reducing the amount of contamination that is present on a carcass helps the establishment accomplish reduction of pathogens OPPD Policy Development Division Omaha, Nebraska

18 OPPD Policy Development Division Omaha, Nebraska
FSIS DIRECTIVE OPPD Policy Development Division Omaha, Nebraska

19 OPPD Policy Development Division Omaha, Nebraska
FSIS DIRECTIVE Provides definitions for such terms as Process Control, Sanitary Dressing, Contamination of Carcasses and Parts, and Food safety System. Describes points in the slaughter process where carcass contamination with foodborne pathogens, such as Salmonella and Campylobacter, is most likely to occur   The directive addresses several issues OPPD Policy Development Division Omaha, Nebraska

20 OPPD Policy Development Division Omaha, Nebraska
FSIS DIRECTIVE Explains how IPP are to gather and assess information about the slaughter operation when verifying that the establishment’s sanitary dressing and process control procedures are effectively ensuring sanitary conditions Addresses supervisory responsibilities associated with IPP verification activities OPPD Policy Development Division Omaha, Nebraska

21 OPPD Policy Development Division Omaha, Nebraska
DEFINITIONS Contamination of Carcasses and Parts: Carcasses and parts that, based on organoleptic inspection, have been prepared, packed, or held under insanitary conditions that may have caused them to come into contact with filth, or that may have caused them to be injurious to health, and are condemnable unless they can be effectively reprocessed. Lets discuss a couple of important definitions. We have already defined sanitary dressing and process control, now we will address contamination… Read slide OPPD Policy Development Division Omaha, Nebraska

22 NOTE Not all contamination is directly associated with food safety.
Sound judgment must be used when determining whether the conditions observed during the slaughter process are part of the slaughter process or are present as an unavoidable consequence of the slaughter process. It is important to remember that when considering observed contamination, evaluation on a case-by-case basis will be needed to determine whether the conditions observed have resulted in either the creation of an insanitary condition or the adulteration of product. OPPD Policy Development Division Omaha, Nebraska

23 OPPD Policy Development Division Omaha, Nebraska
DEFINITIONS Food Safety System: A systematic approach implemented to prevent foodborne illness. The food safety system includes the development and implementation of a Hazard Analysis and Critical Control Point (HACCP) Plan in accordance with 9 CFR 417 and a Sanitation Standard Operating Procedure (SOP) in accordance with 9 CFR 416. The food safety system also includes any programs or procedures an establishment uses (e.g., prerequisite programs and SSOP) to prevent food safety hazards from occurring and to support decisions in the hazard analysis OPPD Policy Development Division Omaha, Nebraska

24 ADDITIONAL DEFINITIONS
Poultry Chiller Makeup Water Free Available Chlorine Reuse Water There are several additional definitions in the directive that are important but they are not going to be discussed in the presentation. You have already read them and should be familiar with them. OPPD Policy Development Division Omaha, Nebraska

25 POTENTIAL CONTAMINATION POINTS
Live receiving and hanging Stunning and Bleeding Scalding Feather removal and Picking Evisceration On-line reprocessing Off-line reprocessing Product reconditioning Chilling The directive addresses each of these points in more detail but for the purposes of this presentation we are only going to mention them briefly OPPD Policy Development Division Omaha, Nebraska

26 LIVE RECEIVING & HANGING
Poultry arrive at the establishment in transport cages, are unloaded, and are hung on shackles before stunning and bleeding Potential for contamination with enteric pathogens because of the presence of these pathogens on the feathers, skin, crop, and cloaca & in the feces The first step we will address is Live receiving and hanging. Why is this step a concern related to contamination of carcasses? In addition, transportation and handling during transport and unloading, may cause stress and increased shedding of pathogens and cross-contamination of cages and birds. OPPD Policy Development Division Omaha, Nebraska

27 OPPD Policy Development Division Omaha, Nebraska
STUNNING & BLEEDING Point in the slaughter process where the bird is stunned, cut, & bled Stunning methods used typically used include electrical, mechanical, or chemical Bleeding ensures death by slaughter and ensures that poultry have stopped breathing before going into the scalder NOTE: Stunning is not required by regulation however…9 CFR (b) requires that poultry be slaughter using good commercial practices Carcasses can become contaminated during the initial cut due to improperly adjusted machinery OPPD Policy Development Division Omaha, Nebraska

28 OPPD Policy Development Division Omaha, Nebraska
SCALDING Point in the slaughter process where the birds are placed in hot water in order to facilitate feather removal  Salmonella and Campylobacter contamination consistently decrease when scalding is well controlled Scalding is an important step that can reduce levels of Salmonella and Campylobacter on the carcasses, since much of the dirt, litter, and feces on carcasses is removed at this step. Salmonella and Campylobacter contamination consistently decrease when scalding is well controlled. OPPD Policy Development Division Omaha, Nebraska

29 FEATHER REMOVAL & PICKING
Point in the slaughter process designed to remove feathers and, in most cases, the uppermost layer of skin before evisceration Feather removal (i.e., picking) frequently results in increased microbial contamination of poultry carcasses Cross-contamination of the carcasses occurs because of contact with contaminated rubber picking fingers and contaminated recycled water. OPPD Policy Development Division Omaha, Nebraska

30 OPPD Policy Development Division Omaha, Nebraska
EVISCERATION Point in the process where removal of the internal organs, and of any processing defects, from the poultry carcasses occurs Evisceration includes multiple processes. It begins at the transfer point (i.e., re-hang) and ends when the carcass enters the chiller.  It is the point in the slaughter process where the removal of the viscera (i.e., the edible offal that includes the heart, liver, and gizzard) occurs by automated or manual means. If viscera are not handled properly, or if employee hygiene practices are not followed, an increase in microbial contamination can occur OPPD Policy Development Division Omaha, Nebraska

31 OPPD Policy Development Division Omaha, Nebraska
ON-LINE REPROCESSING Point in the slaughter process where contaminated eviscerated carcasses are reprocessed on-line following the provisions of a waiver granted in accordance with 9 CFR 381.3(b) If the OLR is not operating adequately in accordance with the provisions allowed in the waiver, both microbial and visable contamination may continue down the line and not be removed prior to the carcasses falling into the chiller. OPPD Policy Development Division Omaha, Nebraska

32 OPPD Policy Development Division Omaha, Nebraska
NOTE Establishments need to have requested to participate in the Salmonella Initiative Program (SIP) or have a SIP letter (i.e. a No Objection letter) on file that addresses the alternative procedures or criteria that the establishment must adhere to in order to maintain its waiver. See FSIS Directive Read slide Also addresses the antimicrobial range of concentrations used in the approved OLR system See FSIS Directive Verification of SIP The most significant is that the latest Fed Register for SIP is no longer the 2008, it is 2011 (see slide 3) It is 76 FR 41186, July 13, 2011 OPPD Policy Development Division Omaha, Nebraska

33 OFF-LINE REPROCESSING
This is the point in the evisceration process where internally contaminated carcasses are reprocessed off-line according to 9 CFR (b)(1) and (b)(2) Proper handling of carcasses during off line reprocessing should result in preventing the spread of contamination from the inside of the carcasses to the exterior surfaces. NOTE: establishments may have a waiver for Off line reprocessing to use another approved OFLR system other than 20 ppm chlorine OPPD Policy Development Division Omaha, Nebraska

34 PRODUCT RECONDITIONING
Point in slaughter and further processing where contaminated eviscerated carcasses & parts that have fallen on the floor, or otherwise have become contaminated off-line, are reconditioned in order to restore sanitary conditions.   Proper handling of carcasses during off line reprocessing should result in preventing the spread of contamination on the carcass or between carcasses. Proper handling of carcasses during product reconditioning should result in preventing the spread of contamination on the carcass or between carcasses. OPPD Policy Development Division Omaha, Nebraska

35 OPPD Policy Development Division Omaha, Nebraska
CARCASS CHILLING Point when eviscerated carcasses are chilled in order to inhibit microbial growth and meet the regulatory requirements of 9 CFR (b)(1) There are two types of chilling systems: immersion and air Cross-contamination may occur when sanitary conditions are not maintained in the chiller, or when carcasses entering the chiller carry high levels of pathogens Immersion chilling can result in the spread of bacterial pathogens between carcasses in the chiller because of the dispersal of contamination by the chill media and by the unavoidable fact that the carcasses touch. OPPD Policy Development Division Omaha, Nebraska

36 OPPD Policy Development Division Omaha, Nebraska
GIBLET CHILLING Cross-contamination may occur when sanitary conditions are not maintained in the giblet chiller, or when parts entering the chiller carry high levels of contamination Note: there is not a specific standard for what constitutes excessive giblet contamination, however, improper adjustment, monitoring, and employee operation of the giblet harvesting machinery or manual harvesting is usually the source of these gut segments mixed with edible giblets. however, if there is evidence of a high incidence of contamination associated with a giblet sorting table or giblet chiller, then SPS noncompliance can be used to document either grossly visible fecal findings or non-leaking intestinal segments, citing 9 CFR (a) sanitary dressing procedures which may indicate a loss of process control. OPPD Policy Development Division Omaha, Nebraska

37 PHIS SANITARY DRESSING TASK
Sanitary Dressing and Process Control Correlation Presentation PHIS SANITARY DRESSING TASK PHIS requires that each task have a “start” and “end” date IPP are not limited to conducting the Poultry Sanitary Dressing task all in one day Can be spread out over a period of days, if necessary, in order to gather as much available information so that IPP can make a sound regulatory decision about the system The process of conducting Sanitary Dressing/Process Control verification is no different under PHIS with the exception that now there is a separate task just for sanitary Dressing IPP still need to gather as much available information as possible in order to a sound regulatory decision about the system, but now they have some latitude to spread it out over a period of days if necessary OPPD Policy Development Division Omaha, Nebraska

38 OPPD Policy Development Division Omaha, Nebraska
FSIS VERIFICATION The verification activities addressed in the directive are to be used in conjunction with, and can be conducted simultaneously with, those addressed in the following directives: FSIS PHIS Directive , Verifying and Establishment’s FSIS Directive Ante-mortem and Post-mortem Poultry Inspection FSIS , Verification of Procedures for Controlling Fecal Material, Ingesta and Milk in Slaughter Operations FSIS Directive , Verification of Non-food Safety Consumer Protection Regulatory Requirements, Part IV, G Read slide OPPD Policy Development Division Omaha, Nebraska

39 OPPD Policy Development Division Omaha, Nebraska
FSIS VERIFICATION IPP need to verify, in off-line activities, that preventive steps are taken to ensure carcasses and parts, including giblets, are not contaminated, and that contamination events are rare. In addition, before the carcasses enter the chiller, IPP conduct zero tolerance checks to verify that there is no visible fecal contamination on the carcasses.   OPPD Policy Development Division Omaha, Nebraska

40 OPPD Policy Development Division Omaha, Nebraska
FSIS VERIFICATION IPP verify compliance with 9 CFR (e) by determining whether the establishment's sanitary dressing and process control procedures are adequate to ensure that carcasses entering the chiller are not contaminated with fecal material. In an establishment that uses a process control system, such as Statistical Process Control (SPC), as part of its sanitary dressing and process control procedures, IPP are to verify that the establishment is implementing its SPC system according to its plan, including documenting any actions that it takes in response to any SPC observations and results. OPPD Policy Development Division Omaha, Nebraska

41 OPPD Policy Development Division Omaha, Nebraska
FSIS VERIFICATION IPP that perform off-line slaughter verification duties are to perform the PHIS Poultry Sanitary Dressing task to verify that insanitary conditions are not being created. Evaluate the sanitary dressing and process control procedures as they relate to the establishment’s food safety system; and not just as a single aspect of the slaughter process. Verify that the sanitary dressing, and process control procedures, are sufficient to prevent the contamination of carcasses during slaughter operations. OPPD Policy Development Division Omaha, Nebraska

42 OPPD Policy Development Division Omaha, Nebraska
FSIS VERIFICATION Conditions that could affect the sanitary dressing and process control system, include but are not limited to, the following: An increased number of positive establishment or FSIS Salmonella or Campylobacter test results; An increased number of establishment generic E.coli or indicator organism test results that exceed either the establishment’s or regulatory control limits; OPPD Policy Development Division Omaha, Nebraska

43 OPPD Policy Development Division Omaha, Nebraska
FSIS VERIFICATION An increase in fecal zero tolerance noncompliances; Documented evidence of carcass contamination that demonstrates a repeated or on-going loss of process control (e.g., incidental contamination documented under SPS, or zero tolerance noncompliances). OPPD Policy Development Division Omaha, Nebraska

44 OPPD Policy Development Division Omaha, Nebraska
FSIS VERIFICATION IPP are to gather information using the questions in the directive to determine whether an establishment’s slaughter operation meets the requirements of 9 CFR 416 or is creating insanitary conditions that may result in product contamination. The questions provided at each point in the directive may vary depending on the type of slaughter operation being conducted (e.g., a highly automated line vs. traditional hand operated line). OPPD Policy Development Division Omaha, Nebraska

45 OPPD Policy Development Division Omaha, Nebraska
NOTE The questions in the directive are not to be considered to be a checklist and are not all-inclusive but are to be considered when gathering information about the establishment’s food safety system. OPPD Policy Development Division Omaha, Nebraska

46 NOTE A negative response to one of the questions in
the directive is not an automatic indication of regulatory noncompliance or of a system failure. A negative response may simply mean that additional consideration is needed or other considerations apply. When making determinations of regulatory compliance, IPP performing off-line duties are to consider how all the information they have gathered relates to the food safety system. OPPD Policy Development Division Omaha, Nebraska

47 OPPD Policy Development Division Omaha, Nebraska
FSIS VERIFICATION This evaluation could include, but is not limited to, considering the following information: Information regarding sanitary dressing and process control procedures, and decontamination and antimicrobial intervention treatments; Feedback from further processing operations to the slaughter operation Observations of the plant employees performance of their assigned duties at particular points in the process. Feedback is important as it provides information that addresses the systems effectiveness relative to microbial testing on carcasses and parts; Observations of plant employees is important because appropriate performance by establishment personnel is necessary for adequate process control OPPD Policy Development Division Omaha, Nebraska

48 OPPD Policy Development Division Omaha, Nebraska
NOTE When the information gathered suggests that the establishment has lost control of its process, IPP are to consider whether they should increase the frequency of their verification of sanitary dressing and process control procedures. They are to consult their immediate supervisor if they need guidance. OPPD Policy Development Division Omaha, Nebraska

49 Sanitary Dressing and Process Control Correlation Presentation
Establishment Interventions OPPD Policy Development Division Omaha, Nebraska

50 ESTABLISHMENT INTERVENTIONS
Sanitary Dressing and Process Control Correlation Presentation ESTABLISHMENT INTERVENTIONS Interventions typically are able to reduce bacteria at a given rate (e.g., a 2 log reduction) If the bacteria is present at a 5 log level, the intervention won’t be able to address all the bacteria (i.e. the intervention is overwhelmed) (Read slide) OPPD Policy Development Division Omaha, Nebraska

51 ESTABLISHMENT INTERVENTIONS
Sanitary Dressing and Process Control Correlation Presentation ESTABLISHMENT INTERVENTIONS Measures need to be taken from the beginning of slaughter process, including at receiving, to minimize contamination so that the interventions will work appropriately Without effective sanitary dressing and process control procedures, carcasses could become excessively contaminated, and thereby overwhelming any interventions OPPD Policy Development Division Omaha, Nebraska

52 OVERWHELM AN INTERVENTION
Sanitary Dressing and Process Control Correlation Presentation OVERWHELM AN INTERVENTION There is so much contamination on the bird, or the carcass, that the establishment’s intervention(s) aren’t capable of working as designed and therefore not able to achieve a desired level of pathogen reduction So, when we say that an intervention could be “overwhelmed”, what do we mean? (Click for explanation) (Read slide) OPPD Policy Development Division Omaha, Nebraska

53 OVERWHELM AN INTERVENTION
Sanitary Dressing and Process Control Correlation Presentation OVERWHELM AN INTERVENTION When contamination overwhelms the decontamination practices and antimicrobial interventions, the establishment may no longer be able to reduce Salmonella and Campylobacter to the levels expected by the HACCP plan It is essential that slaughter operations also have interventions that are integrated with sanitary dressing and process control procedures in order to reduce pathogens (Read slide) OPPD Policy Development Division Omaha, Nebraska

54 Sanitary Dressing and Process Control Correlation Presentation
Determining Compliance OPPD Policy Development Division Omaha, Nebraska

55 OPPD Policy Development Division Omaha, Nebraska
BEFORE WE PROCEED…. An issue that needs to be addressed is how incidental contamination that is determined to create an insanitary condition is to be documented in PHIS OPPD Policy Development Division Omaha, Nebraska

56 INCIDENTAL CONTAMINATION
Incidental contamination (e.g., ingesta, feces, UFM, rail dust) does not automatically represent an insanitary condition. Even if there are observations of contamination on carcasses during the slaughter process, the establishment still has the opportunity to implement measures that will address the contamination before the carcasses enter the chiller. (Read slide) IPP must assess the available information and evaluate each occurrence of incidental contamination to determine whether the establishment has failed to prevent the creation of insanitary slaughter conditions prior to carcasses entering the chiller. For additional information there is a posted Q & A in askFSIS titled Visible Contamination. Note- This q & A was originally directed towards cattle but the thought processes are the same in poultry. OPPD Policy Development Division Omaha, Nebraska

57 9 CFR 416.1 START ALL THE SLAUGHTER STEPS & INTERVENTIONS ALONG THE WAY So…in the simplest terms and under typical conditions, incidental contaminations (found after the birds are unloaded and up to the point in the process where the establishment has had opportunity to apply their interventions and the carcasses falls into the chiller), would be documented as Sanitation Performance Standard (SPS) noncompliance, not as a Sanitation SOP noncompliance. Once the carcass has passed all the establishments interventions and the establishment has applied any measures to prevent contamination, if incidental contamination is observed, it would typically be documented as a Sanitation SOP noncompliance. NOTE: This does not include fecal contamination found during the performance of the Zero Tolerance Verification task END SPS NONCOMPLIANCE OPPD Policy Development Division Omaha, Nebraska

58 What do FSIS Personnel Need to Do to Determine Compliance ?
Sanitary Dressing and Process Control Correlation Presentation What do FSIS Personnel Need to Do to Determine Compliance ? GAD So…now that we know how we would document incidental contamination…how will IPP determine if there is noncompliance with the sanitary dressing verification task? They will gather information related to the slaughter operation and determine what that information indicates about the slaughter system Gather Information Assess the Information Determine Compliance or noncompliance OPPD Policy Development Division Omaha, Nebraska

59 Sanitary Dressing and Process Control Correlation Presentation
GATHER Gather as much information as possible In-plant Observations Your own On-line IPP PHV/SPHV Historical information NRs MOIs Test Results Establishment Results FSIS Results Communication with other inspectors There are a variety of ways in which IPP will gather information about the establishment’s sanitary dressing and process control system (Read Bullets) OPPD Policy Development Division Omaha, Nebraska

60 Sanitary Dressing and Process Control Correlation Presentation
COMMUNICATION EST A Slaughter Fabrication An important point about Communication… It is very important that IPP talk to each other…the inspectors in one side of an establishment need to share information with inspectors in the other side of the establishment Sometime things will happen in the kill floor that would be pertinent to the inspector in fabrication Sometimes things will happen in fabrication that need to be shared with the off-line inspector on the kill floor Change box to “ exceeded S std for ground” instead of trim There have been problems with sanitary dressing and several zero tolerance noncompliances Thanks…That might explain the recent positive test result of ground poultry OPPD Policy Development Division Omaha, Nebraska

61 Sanitary Dressing and Process Control Correlation Presentation
COMMUNICATION EST A Slaughter Fabrication Sometimes things will happen in fabrication that need to be shared with the off-line inspector on the kill floor There has been a positive test result in the trim Thanks…We will check the sanitary dressing and zero tolerance OPPD Policy Development Division Omaha, Nebraska

62 Sanitary Dressing and Process Control Correlation Presentation
COMMUNICATION EST B EST A And occasionally feedback will come from an inspector across the street or across the country. That feedback is important to the offline slaughter inspector when it comes to making decisions about sanitary dressing and process control. There was a positive test result in the ground poultry Thanks…We will check the sanitary dressing and zero tolerance OPPD Policy Development Division Omaha, Nebraska

63 Sanitary Dressing and Process Control Correlation Presentation
ASSESS Sanitation is the foundation of a food safety system Sanitary Dressing and Process control is a part of that sanitation foundation Decisions made by the establishment to control enteric pathogens such as Salmonella will be affected by what the establishment does in regard to sanitary dressing and process control The underlying foundation of food safety is sanitation… (Read Slide) (As prep for the next slide) What do IPP have to think about in relation to sanitation as it applies to sanitary dressing? They need to be aware of regulatory basis… So….What is the regulatory basis for why FSIS expects an establishment to have good sanitary dressing and process control? OPPD Policy Development Division Omaha, Nebraska

64 Sanitary Dressing and Process Control Correlation Presentation
REGULATORY BASIS Establishments are expected to slaughter and process poultry in a manner designed to prevent contamination of carcasses 9 CFR requires that establishments be operated such that they do not create insanitary conditions or contaminate product 9 CFR (e) requires prevention of carcass contamination (Read slide) Add (a)??? OPPD Policy Development Division Omaha, Nebraska

65 Sanitary Dressing and Process Control Correlation Presentation
REGULATORY BASIS Other regulations can be integral to sanitary dressing and process control if procedures related to those regulations have been included in the SSOP, HACCP plan or a prerequisite program 9 CFR 416 9 CFR 417 (Read slide) OPPD Policy Development Division Omaha, Nebraska

66 Sanitary Dressing and Process Control Correlation Presentation
DETERMINE Any determination of noncompliance must be based on all the pieces of information that has been gathered regarding the system OPPD Policy Development Division Omaha, Nebraska

67 DETERMINING COMPLIANCE
Sanitary Dressing and Process Control Correlation Presentation DETERMINING COMPLIANCE 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 OPPD Policy Development Division Omaha, Nebraska

68 DETERMINING COMPLIANCE
Sanitary Dressing and Process Control Correlation Presentation DETERMINING COMPLIANCE The thought process for determining compliance of the sanitary dressing and process control procedures is different because it is about a system A single, specific event of finding contamination on a carcass may not be significant as it relates to the system (Read slide) OPPD Policy Development Division Omaha, Nebraska

69 INCIDENTAL CONTAMINATION
KEY POINT If IPP find that insanitary conditions exist as a result of incidental contamination, they are to document their findings using the PHIS SPS Verification task citing 9 CFR (a) and the appropriate SPS regulations related to incident OPPD Policy Development Division Omaha, Nebraska

70 Sanitary Dressing and Process Control Correlation Presentation
NOTE A finding of incidental contamination that demonstrates the creation of an insanitary condition is to be addressed as a specific SPS incident (e.g., SPS/employee hygiene) HOWEVER, one specific incident will not normally be documented as a failure of the sanitary dressing or process control procedures (i.e., is not a failure of the system) 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 OPPD Policy Development Division Omaha, Nebraska

71 DETERMINING NONCOMPLIANCE
Use the information gathered while performing verification procedures to determine compliance Remember: A series of questions that IPP can ask in order to assist in the determination of compliance are provided in the directive OPPD Policy Development Division Omaha, Nebraska

72 DOCUMENTING NONCOMPLIANCE
Document the creation of the insanitary condition using the Poultry Sanitary Dressing task on a Noncompliance Record (NR) (9 CFR and (a)) Cite 9 CFR (a) to address the contamination of carcasses Cite the appropriate SPS regulations to address the creation of the insanitary condition. Example: cite 9 CFR 416.5(a) if improper employee hygiene practices have resulted in contamination of the carcass Read Slide OPPD Policy Development Division Omaha, Nebraska

73 DOCUMENTING NONCOMPLIANCE
Review available NRs to determine if a trend is developing. NRs can be associated as necessary in accordance with the instructions in FSIS PHIS Directive , Chapter 5, VII to document that a trend of noncompliance is occurring. OPPD Policy Development Division Omaha, Nebraska

74 SUPERVISORY RESPONSIBILITY
OPPD Policy Development Division Omaha, Nebraska

75 SUPERVISORY RESPONSIBILITY
NOTE: “Supervisory personnel” refers to any Office of Field Operations (OFO) personnel that supervise IPP who conduct off-line verification activities in poultry slaughter operations. FSIS supervisory personnel are to discuss the key points addressed in the directive with IPP. The supervisor plays a key role in ensuring that decisions made by IPP are consistent with FSIS statutory authority and Agency policy, and that duties are performed in accordance with prescribed inspection methods and procedures addressed in this directive. OPPD Policy Development Division Omaha, Nebraska

76 SUPERVISORY RESPONSIBILITY
Supervisory personnel are to discuss the potential contamination points in the slaughter process addressed in this directive to ensure that IPP understand their role in verifying whether the establishment is initiating measures designed to prevent the creation of insanitary conditions by preventing the contamination of carcasses. OPPD Policy Development Division Omaha, Nebraska

77 SUPERVISORY RESPONSIBILITY
FSIS supervisory personnel are to emphasize that IPP are to verify that establishments have documentation, in accordance with 9 CFR 417.5(a)(1), sufficient to support any food safety decisions that they make based on the implementation of sanitary dressing and process control procedures. Read Slide OPPD Policy Development Division Omaha, Nebraska

78 SUPERVISORY RESPONSIBILITY
Supervisors are to discuss how sanitary dressing and process control procedures have an impact on pathogens such as Salmonella and Campylobacter testing results or raw ground poultry. Supervisors are to emphasize that IPP in the slaughter areas are to conduct a purposeful evaluation of the establishment’s sanitary dressing and process control procedures. Supervisors are to correlate with IPP in processing areas whenever poor implementation of the procedures could lead to positive results in Salmonella set sampling and in raw ground poultry testing. Read Slide OPPD Policy Development Division Omaha, Nebraska

79 SUPERVISORY RESPONSIBILITY
Supervisory personnel are to ensure that IPP are correctly applying the inspection methodology, are making informed decisions, are properly documenting findings, and are taking the appropriate enforcement actions as instructed in this directive. Supervisory personnel are to refer to the current version of the FSIS Guide for conducting In-Plant Performance System Assessments (IPPS) for additional guidance and instructions. Read Slide OPPD Policy Development Division Omaha, Nebraska

80 Sanitary Dressing and Process Control Correlation Presentation
Summary The slaughter process is a system Sanitary dressing and process control procedures are key to preventing insanitary conditions and carcass contamination Reducing Salmonella is a regulatory requirement & is essential to ensuring food safety (Read Slide) OPPD Policy Development Division Omaha, Nebraska

81 Sanitary Dressing and Process Control Correlation Presentation
Summary (Continued) Interventions need to be capable of reducing or eliminating a food safety hazard and not be overwhelmed by the amount of contamination or number of pathogens on the carcass (Read Slide) OPPD Policy Development Division Omaha, Nebraska

82 OPPD Policy Development Division Omaha, Nebraska
Summary (Continued) Incidental contamination that creates an insanitary condition is documented as SPS noncompliance SSOP OPPD Policy Development Division Omaha, Nebraska

83 OPPD Policy Development Division Omaha, Nebraska
Summary (Continued) Sanitary dressing noncompliances are determined based on cumulative information reflecting the food safety system Sanitary Dressing noncompliance is not documented in regard to one point in the process. Sanitary Dressing noncompliance is not documented in regard to one contamination incident. So…we have seen this slide before…we started the presentation with it and we will reiterate it here at the end…. Read slide OPPD Policy Development Division Omaha, Nebraska

84 Weekly Meeting MOIs Incidental contamination NRs Failure to implement prerequisite programs Sanitary dressing noncompliance is about what the pieces of the slaughter system is showing related to the establishment’s ability to prevent the creation of insanitary conditions that result in carcass contamination IPP will consider slaughter conditions and documented noncompliances well as a variety of other information to determine if that information and observations demonstrates that the sanitary dressing, and any process control procedures, are out of control Determine if all the puzzle pieces fit together to create the picture of noncompliance Employee Hygiene NRs Positive sample results (e.g., generic e-coli, Salmonella) Zero Tolerance NRs OPPD Policy Development Division Omaha, Nebraska

85 Sanitary Dressing and Process Control Correlation Presentation
Questions ? OPPD Policy Development Division Omaha, Nebraska


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