VERIFYING SANITARY DRESSING AND PROCESS CONTROL PROCEDURES

BY OFF-LINE INSPECTION PROGRAM PERSONNEL (IPP) IN ESTABLISHMENTS

THAT SLAUGHTER SWINE

I. PURPOSE

This directive instructs off-line inspection program personnel (IPP) on how to verify that establishments that slaughter swine are implementing sanitary dressing and process control procedures in manner that will prevent contamination of carcasses and will ensure that insanitary conditions are not created. In addition, this directive provides information describing how IPP are to assess the sanitary dressing and process controls that swine slaughter establishmentsemploy in their food safety systems.

KEY POINTS:

  • Defines Process Control Procedures; Sanitary Dressing; and Contamination of Carcasses and Parts.
  • Describes the purpose of sanitary dressing and process control procedures
  • Describes the points in the slaughter process where carcass contamination with pathogens known to be food safety hazards is most likely to occur
  • Describes how an establishment’s failure to properly execute its sanitary dressing and process control procedures can increase the risk of contamination of carcasses and parts at various points in the slaughter operation
  • Provides instruction to IPP regarding how to verify that swine slaughter operations are implementing effective sanitary dressing and process control procedures to prevent contamination of carcasses and are properly applying decontamination and antimicrobial intervention treatments to carcasses and parts to address any contamination that may occur
  • Provides information regarding slaughter food safety systems and how each aspect of the food safety system (e.g., sanitary dressing and process control procedures, intervention treatments, product sampling, supporting documentation) is a factor to be considered when determining whether there is regulatory compliance
  • Provides clarification regarding the differences between documenting noncomplianceunder Public Health Information System (PHIS) tasks with the Sanitation Performance Standards (SPS) and Operational SSOP requirements.
  • Provides information regarding supervisory responsibilities, including instructions to Public Health Veterinarians (PHV), Supervisory Public Health Veterinarians (SPHV), Supervisory Consumer Safety Inspectors (SCSI), the Inspector-in-Charge (IIC), Multi-IPPs Supervisors, and Front Line Supervisors (FLS).

II.DEFINITIONS

Process Control Procedure: 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 clean, safe, and wholesome meat food products. The procedures typically include some means of observing or measuring system performance, analyzing the results generated in order to define a set of control criteria, and taking action when necessary to ensure that the system continues to perform within the control criteria. The procedure is likely to include planned measures that the establishment will take in response to any loss of process control. In addition, the procedures can be used as support for decisions made in the hazard analysis.

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, and wholesome meat food product in a sanitary environment.

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. The carcasses and parts are condemnable unless they can be effectively reprocessed. Contamination may occur from:

  1. Substances not inherent to the species being slaughtered (e.g., volatile oils, paints, rail dust, rust, unidentifiable foreign material (UFM), condensate, poisons, or gases); or
  1. Substances inherent to the species being slaughtered (e.g., digestive tract content, bile). NOTE: Sanitary dressing procedures minimize this type of contamination.

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. Evaluation on a case-by-case basis is needed to determine whether the conditions observed have resulted in either the creation of an insanitary condition or the adulteration of product.

III. BACKGROUND

A. FSIS is aware that Salmonella and Campylobacterhave been found on swinecarcasses. Ineffective sanitary dressing and process control procedures that create insanitary conditions during slaughter are likely contributors to their presence. The FSIS National Microbiological Baseline Data Collection Program: Market Hog Survey, August 2010-August 2011indicates that poor sanitation plays a key role in the increase of microbiological contamination of carcasses in multiple-shift swine slaughter operations. In addition, available attribution data published by the Centers for Disease Control (Attribution of Foodborne Illnesses, Hospitalizations, and Deaths to Food Commodities by using Outbreak Data, United States, 1998–2008) indicate that foodborne illness due to consumption of pork continues to be of concern.

NOTE: For the purposes of this directive, “Swine” refers to only the species from the Family Suidae(i.e., Sus scrofa,Sus scrofa domestica and Sus scrofa fera) that are amenable to the Federal Meat Inspections Act (FMIA). It includes boars, sows, barrows, gilts, and roasters.

B. Effective sanitary dressing and process control procedures affect the level of control at the critical control points (CCPs) that an establishment has in place to prevent, eliminate, or reduce to an acceptable level food safety hazards that are reasonably likely to occur in the slaughter process. They alsosupport that the HACCP system, as a whole, is functioning as intended. IPP in swine slaughter establishments are to be aware that management in slaughter operations should consistently focus on the sanitary dressing and process control procedures in order to prevent carcass contamination and the creation of insanitary conditions in their operations.

IV.GENERAL INFORMATION

A. The following discussion provides IPP with an introduction to sanitary dressing, its importance, and the importance for an establishment to use sanitary dressing procedures as a means to reduce Salmonella and Campylobacterand to maintain process control.

B. 9 CFR 416.1provides the general requirement that official establishments, including slaughter operations, be operated and maintained in a manner that does not create an insanitary condition andthat does not contaminate or adulterate product. 9 CFR 416.1 through 416.5 provide specific requirements that establishments must meet to prevent the contamination of carcasses during operations.

C. In addition, IPP verify that, as set out in 9 CFR 310.18(a), establishments handle swinecarcasses, organs, and other parts in a sanitary manner to prevent contamination with fecal material, urine, bile, hair, dirt, or foreign matter. Because these sources of contamination, whether visible or not, may contain pathogens, a principal objective of proper sanitary dressing and process control procedures is to reduce the potential for exposure of carcasses and parts to the spread of pathogens during evisceration (i.e., removal of, feet, head, gastrointestinal tract, and other internal organs). IPP need to verify that the design of the establishment’s slaughter operation includes a means to measure how well the sanitary dressing and process control procedures accomplish this purpose, and that the establishment responds if the measure shows that carcasses are being exposed to food safety hazards.

D. IPPare to verify that establishments slaughter and process swine in a manner designed to prevent contamination from occurringat any step in the process. In addition, IPP are to verify that the establishmentsrespond to any contamination that may result from the implementation of the slaughter process or that may otherwise occur on the carcasses and parts. To meet these requirements,establishments may employ practices such as:

  1. Maintaining adequate separation of carcasses, parts, and viscera during dressing in order to prevent cross contamination;
  1. Routinely cleaning and sanitizingor sterilizing equipment and hand tools that are used to remove contamination or to make cuts into the carcass to avoid cross contamination;
  1. Designing and arranging equipment to prevent the contact of successive carcasses and parts with contaminated equipment;
  1. Frequently washing hands and aprons that come in contact with the carcass and parts; and
  1. Implementingdecontamination and antimicrobial intervention treatments, such as washes or sprays on carcasses and parts, in accordance with the limits selected by the establishment and determinedto be adequate to address contamination.

IPP are to assess whether these practices are successful in preventing or responding to contamination that may occur.

E. Establishments may elect to maintain written sanitary dressing and process control procedures as part of their HACCP plans, Sanitation SOP, Good Manufacturing Practices (GMP), or other pre-requisite programs. IPP are to use the information gathered through their verification activities regarding sanitary dressingand review of the written programsto help determine whether there is regulatory compliance.

F. Regardless of whetherestablishments elect to maintain any written sanitary dressing and process control procedures, verification of sanitary dressing and process control procedures are to be conducted using the Swine Sanitary Dressing task in PHIS.

G. IfIPP determine that the sanitary dressing and process control procedures are used to support decisions in the hazard analysis in accordance with 9 CFR 417.5(a)(1), they are to verify that establishments maintain records of the performance of the sanitary dressing and process control program. IPP are to assess whether the records demonstrate that the program, as implemented, is effective and whether the decisions made in the hazard analysis are supported on an ongoing basis.

V. FSIS VERIFICATION OF SANITARY DRESSING AND PROCESS CONTROL PROCEDURES

A. Performance of the SwineSanitary Dressing task involves gathering information over time about the slaughter system and determining whether the establishment has lost control of its slaughter processes and of the ability to handle carcasses in a sanitary manner. The Swine Sanitary Dressing task is not to be used to document single incidental contamination events. Incidental contamination events observed between stunning and final inspection are to be documented in PHIS as Sanitation Performance Standard (SPS) noncompliances.

NOTE:Incidental contaminants are substances observed on carcasses and parts during slaughter and further processing.Incidental contaminants originate from the processing environment (e.g., volatile oils, paints, flaking rust) and from the carcass (e.g., digestive tract content).Facility and equipment maintenance minimizes environmental contaminants.Sanitary dressing procedures minimize contaminants that come from the carcass.

B. IPPhave received training regarding the Gather, Assess, Determine (GAD) methodology addressed inFSIS Directive 5000.1, Chapter I, Section VIII. IPP are to use their training to consider the observations they have made and their knowledge of the in-plant operations in order to determine whether regulatory compliance with 9 CFR 416.1- 416.5and 9 CFR 310.18(a) exists. If IPP have difficulty making the determination, they are to discuss their observations and concerns with their immediate supervisor for guidance and correlation.

C. IPP that perform off-line slaughter verification duties are to verify sanitary dressing and the process control procedures conducted by a swine slaughter establishment in accordance with the instructions in this section. In addition, because verification of sanitary dressing and process control necessarily involves assessing the entire slaughter system, IPP are to evaluate the sanitary dressing and process control procedures as a whole.

NOTE: The verification activities addressed in this directive are to be used in conjunction with (and can be conducted simultaneously with) those activities addressed in FSIS Directive 6100.1, Ante-mortem Livestock Inspection and FSIS Directive 6100.2, Post-mortem Livestock Inspection. Verification of procedures for controlling fecal material, ingesta, and milk in slaughter operations are to be conducted in accordance with FSIS Directive 6420.2, Verification of Procedures for Controlling Fecal Material, Ingesta, and Milk in Slaughter Operations.

D. In PHIS, the Swine Sanitary Dressingtask is used to verify compliance with9 CFR 416.1 through the implementation of sanitary dressing and process control procedures.In order to verify that all regulatory requirements associated with the task are met, IPP that perform off-line slaughter verification duties, including the following:

  1. Perform the Swine Sanitary Dressing task to verify that insanitary conditions are not being created. In performing this procedure, IPP are to evaluate the sanitary dressing and process control procedures as part of the establishment’s food safety system and not just as a single aspect of the slaughter process. They are to verify that the sanitary dressing and process control procedures are sufficient to prevent the contamination of carcasses during slaughter operations.
  1. Continue to verify that establishments are controlling fecal material, ingesta, and milk in slaughter operationsin accordance with the instructions in FSIS Directive 6420.2.

NOTE: If IPP observe feces, ingesta or milk while performing the Livestock Zero Tolerance verification task, they are to document the noncompliance in accordance with the instruction in FSIS Directive 6420.2.

3Inan 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 the establishment takes in response to any SPC observations and results.

E. To verify that all regulatory requirements associated with the Swine Sanitary Dressing task are met, IPP are to do the following:

  1. Verify the establishment’s sanitary dressing and process control procedures at the frequency indicated in PHIS. The verification is to focus on all aspects of the establishment’s sanitary dressing and process control procedures.
  1. Determine whether the establishment has taken measures to bring the process back under control when the information gathered suggests that the establishment has lost process control. Examples of measures an establishment may take include, but are not limited to, cleaning of contaminated equipment, adjusting equipment, or conducting additional checks to verify that the process is back under control.

F. Conditions that could affect the sanitary dressing and process control system and thus prompt IPP to investigate further include, but are not limited to, the following:

  1. An increased number of positive establishment or FSIS Salmonella or Campylobacter test results;
  1. An increased number of establishment generic E.coli test results that exceed either the establishment’s or regulatory limits;
  1. An increase in zero tolerance noncompliances; and
  1. Documented evidence of carcass contamination(e.g., incidental contamination documented under SPS, or noncompliances related to fecal contamination)that demonstrates a repeated or ongoing loss of process control.

G. IPP are to gather information using the suggested questions in Section VIof this directive to determine whether an establishment’s slaughter operation meets the requirements of 9 CFR 416.1 through 416.5 or is creating insanitary conditions that may result in product adulteration.

  1. The questions provided are not all-inclusive, and those that IPP ask may vary depending on the type of slaughter operation being conducted (e.g., a highly automated line vs. traditional hand operated line);
  1. The questions are not intended to be a checklist but are to be considered when gathering information about the establishment’s food safety system; and
  1. It is not necessary for IPP to ask the establishment for information or to examine records or data for every single one of the questions.

H.A negative response to one of the questions in this directive isnot an automatic indication of regulatory noncompliance or of a system failure. A negative response may simply mean that IPP need to gather additional information,or that 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. This assessment could include, but is not limited to, considering the following information:

  1. Information regarding sanitary dressing and process control procedures and decontamination and antimicrobial intervention treatments;
  1. Feedback from further processing operations to the slaughter operation on its effectiveness relative to microbial testing on carcasses and parts; and
  1. Observations of the plant employees performing their assigned duties at particular points in the process because appropriate performance by establishment personnel is necessary for adequate process control.

NOTE:A response to one of the questions in Section VI that suggests loss of control does not automatically mean that there is regulatory noncompliance or a system failure.

I.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 Swine Sanitary Dressing task in PHIS. They are to consult their immediate supervisor if they need guidance. The following are examples of findings that can indicate a loss of control:

  1. An increase in contamination occurancesdetermined based on the comparison of data reviewed during previous IPP verification tasks. For example, has there been a recent cluster of contamination events following a period of substantial compliance?
  1. Evidence that contamination events are not being effectively prevented (e.g., on-line IPP are finding contamination or observing improper dressing procedures more frequently than expected); and
  1. An increase in positive pathogen results in either FSIS or establishment microbiological testing, beyond what is expected, explained, and documented under conditions in which effective sanitary dressing and process controls are implemented.

J. IPP are to gather information using the example questions in Section VII of this directiveto assist them in determining whether an establishment’s slaughter operationmeets the requirements of 9 CFR 416.1 through 416.5.

K. When verifying that the establishment has an adequate food safety system as set out in,

FSIS Directive 5000.1. IPP are to determine whether the establishment has CCPs or other written programs that address any of the potential contamination points identified below in this directive and verify that the establishment properly implements its controls or programs.