1. PURPOSE

   This directive is a consolidation of relevant information from Section VII, Verification of Good Commercial Practices for Poultry, of FSIS Directive 6100.3, Ante-mortem and Post-mortem Poultry Inspection and expired FSIS Notice 44-16, Instructions For Writing Poultry Good Commercial Practices Noncompliance Records and Memorandum of Interview Letters For Poultry Mistreatment. The directive provides instructions to inspection program personnel (IPP) for writing a noncompliance record (NR) for noncompliance with the regulations requiring the slaughter of poultry in accordance with Good Commercial Practices (GCP), as well as instructions for composing a Memorandum of Interview (MOI) when documenting a meeting between IPP and establishment management regarding an observation of the mistreatment of live poultry before slaughter.

   KEY POINTS:

   • Provides IPP instructions on how to gather and assess information when verifying poultry GCP
   • Clarifies that video surveillance can be used by the establishment as a form of GCP record
   • Provides instructions on how to properly write GCP NRs and poultry mistreatment MOIs
   • Provides instructions to the District Veterinary Medical Specialist (DVMS) on how to review NRs and MOIs to assess accuracy
2. BACKGROUND
   1. In poultry operations, following GCP, including the employment of humane methods of handling and slaughtering, increases the likelihood of producing unadulterated product. The Poultry Products Inspection Act (PPIA) (21 U.S.C. 453(g)(5)) and the regulations (9 CFR 381.90) provide that poultry carcasses showing evidence of having died from causes other than slaughter are considered adulterated and must be condemned. The regulations (9 CFR 381.65(b)) also require that poultry be slaughtered in accordance with GCP. Poultry are to be slaughtered in a manner that ensures that breathing has stopped before scalding, so that the birds do not drown, and that slaughter results in thorough bleeding of the poultry carcass. Compliance with these requirements helps ensure that poultry are treated humanely. In general, poultry should be handled in a manner that prevents needless injury and suffering in order to produce a commercially marketable product.
   2. If birds hung on the slaughter line die before slaughter because of mishandling, or if birds are being killed in a manner that does not comply with GCP as defined in 9 CFR 381.65(b), the resultant product is adulterated under the PPIA. This includes the treatment of all birds brought onto the official premises of a slaughter plant, not just those entering production. IPP are to issue an NR for noncompliance with 9 CFR 381.65(b) (failure to handle the birds in accordance with GCP) when an ongoing pattern or trend develops where birds are not being slaughtered in a manner that results in thorough bleeding of the carcasses , that results in birds entering the scalder before their breathing has stopped, or that otherwise involves their being handled in a systematic way that results in their dying otherwise than by slaughter.
      
      NOTE: Additional discussion and guidelines for industry poultry handling and slaughter are found in the Federal Register notice “Treatment of Live Poultry Before Slaughter”, 70 Fed. Reg. 56624 (September 28, 2005).
       
3. PERFORMING THE GCP VERIFICATION TASK
   1. The Public Health Veterinarian (PHV), Inspector-in-Charge (IIC), or designee, on a per-shift basis, when the establishment slaughters, is to perform either a routine or a directed poultry GCP task to systematically observe the conditions from the receiving to pre-scald areas, unless performing the weekly records review. Once a week the PHV, IIC, or designee is to review establishment records , when available, documenting adherence to poultry GCP, randomly selecting the day of the week on which to perform the review.
   2. During this records review, IPP are to ask the establishment for, and review, any records regarding GCP. An establishment may use video surveillance of live poultry handling areas and can offer this as a form of record. IPP are to refer to FSIS Directive 5000.9, Verifying Video or Other Electronic Monitoring Records, for instructions for reviewing records created by video. When reviewing any records, IPP are to assess whether there is evidence that the establishment is monitoring its GCP from receiving through pre- scald areas. If IPP find that such records do not exist, or that they do not provide a basis to make a judgment on whether the establishment is following GCP, they are to visit the establishment areas from receiving through pre-scald and make observations. If the records provide a basis upon which IPP can make a judgment that the establishment is following GCP, then a poultry GCP task can be entered into the Public Health Information System (PHIS) as completed.
      
      NOTE: Establishments are not required to keep written or video GCP records. However, if establishments do keep such records and make them available, IPP are to review a sample of the records.
       

   3. During observation, IPP are to visit areas from receiving or holding through pre-scald to observe whether establishment employees are mistreating birds or handling them in a way that will cause death or injury or will prevent thorough bleeding or result in excessive bruising. For example, IPP should determine whether:

      1. Establishment employees are breaking the legs of birds to hold the birds in the shackle, squeezing them into shackles or otherwise mishandling birds while transferring them from the cages to the shackles;

      2. In cold weather, birds are frozen inside the cages or frozen to the cages themselves; or

      3. The birds are dead from heat exhaustion. The main observable symptom of heat stress in poultry is heavy panting, in addition to dead or dying birds in cages.
         
         NOTE: These examples do not necessarily describe prohibited activities and noncompliance, but can still warrant documentation through an MOI.

4. DOCUMENTATION OF POULTRY GCP NONCOMPLIANCE AND MISTREATMENT OF POULTRY
   1. During poultry handling and poultry slaughter, IPP are to document through NRs or MOIs establishment failure to follow GCP. From a regulatory perspective, adherence to GCP is a process control issue and not a bird-by-bird performance standard issue. IPP are to write NRs for GCP noncompliance only when they can demonstrate that an establishment has lost process control and there is an ongoing pattern or trend of birds dying otherwise than by slaughter. An NR is also appropriate if the birds are not being appropriately bled out, with the establishment's handling practices resulting in the production of adulterated product [9 CFR 381.1(b)(v) and PPIA 21 U.S.C. 453(g)(5)]. But if IPP cannot support a loss of process control by an establishment, they are to document poultry mistreatment in MOIs.
      
      NOTE: Refer to Attachment 1, a question and answer scenario that clarifies verification of GCP for poultry.
       
   2. Writing a GCP NR
      1. IPP are to document that the establishment lost control of its process for handling birds, and thus is not operating in accordance with GCPs, when there is the repeated occurrence of birds:

         1. Dying otherwise than by slaughter (e.g., repeatedly entering the scalding tank while still breathing); and

         2. Not being appropriately bled out (e.g., as evidenced by equipment malfunction that results in increased numbers or clusters of cadavers being disposed of or condemned); or

         3. Being intentionally and repeatedly mistreated by establishment personnel.

      2. In determining whether there has been a loss of process control, IPP are to consider, among other factors, whether the cause of the problem is that the establishment’s equipment (e.g., bleeding or stunning equipment) is not functioning properly by asking the following questions:

         1. What is the problem?

         2. Is the establishment’s equipment (e.g., bleeding or stunning equipment) not functioning properly?
            
            NOTE: Stunning is not a requirement in poultry slaughter, but if stunning system malfunction contributes to other process control concerns then this should be noted by IPP.
             

         3. When did the problem occur?

         4. How long did the problem last?

         5. How did the establishment react?

         6. What did the establishment do to correct the problem?

         7. Were there periods of control?; and

         8. Did the problem reoccur?

      3. IPP are to document noncompliance with 9 CFR 381.65(b) when the establishment is found not following GCP. For example, an NR would be warranted when IPP observe frequent or repeated instances of birds not being slaughtered in a manner that results in thorough bleeding of the carcasses or of birds still breathing when they enter the scalder, and the process that the establishment is employing is not able to prevent these problems from reoccurring.
         
         NOTE: An isolated instance does not represent a loss of process control and is to be documented in a mistreatment MOI, not an NR.
          
      4. IPP are to follow instructions in FSIS Directive 5000.1, Verifying an Establishment’s Food Safety System, Chapter V, Section II. D., for entering the noncompliance. In the PHIS Poultry Good Commercial Practice task, when documenting GCP noncompliance, IPP are to include the following additional information in the description of noncompliance (Block 10):

         1. Enter the date and approximate time when, and identify the location where, the IPP observed the noncompliance;

         2. Describe the event and explain how it is noncompliant with 9 CFR 381.65(b) (e.g., birds observed breathing when entering scalder; birds not bleeding out (cadavers));

         3. Describe any actions taken by the establishment to address or correct the noncompliance;

         4. Document any regulatory control action taken and include the U.S. Reject tag number if a tag is utilized; and

         5. Refer to Attachment 2, an example of an NR for 9 CFR 381.65(b) noncompliance in PHIS.

   3. Poultry mistreatment MOIs are primarily issued when, based on findings by the IPP, the establishment is mistreating birds before or during shackling or elsewhere in the slaughter operation, up until the kill step, but the mistreatment event does not demonstrate that the establishment’s process is out of control (e.g., only single or small numbers of birds are involved, or an isolated incident that does not represent an ongoing problem), and therefore, there is not noncompliance with 9 CFR 381.65(b). The MOI documents the discussion between IPP and establishment management about the poultry mistreatment event.
      
      NOTE: FSIS Directive 8010.2, Investigative Methodology, Chapter IV, Section III, provides additional details for writing an MOI.
       
      1. IPP are to document poultry mistreatment when, for example:

         1. Isolated instances of poultry mistreatment occur after the normal kill step, such as a bird that is still breathing when entering the scalder; or

         2. There is an unusually high number of injuries to the birds, e.g., broken legs or wings, but there is no evidence of intentional mistreatment.

      2. IPP, after they have observed poultry mistreatment, are to:

         1. Notify the establishment immediately;

         2. Discuss the mistreatment with the establishment as soon as possible after the event is resolved and advise the establishment that preventing the mistreatment of poultry decreases the chances of producing adulterated carcasses;

         3. Document the discussion and any of the establishment’s planned actions by writing a mistreatment MOI in the poultry GCP task:

            1. Open a poultry GCP task in PHIS and verify 9 CFR 381.65(b) from the Regulations tab;

            2. On the Findings tab, check “Non-Regulatory Concerns”;

            3. Click on the “Save” button; and

            4. Click on “Create/Edit MOI”.

         4. Create the MOI in the Issues tab:

            1. Begin with the establishment number, establishment name, and the date and time of the meeting. List all the participants in the meeting, including IPP;

            2. Include a description of the mistreatment event, when it was observed, where it was observed, and the names of those who witnessed the event. IPP are to describe the observations that led them to the determination of the mistreatment;

            3. Summarize any actions taken directly by the establishment in response to the event and its response to any discussion between establishment management and IPP regarding the event;
               
               NOTE: IPP are not to quote the Humane Methods of Slaughter Act of 1978, the National Chicken Council Audit Guidelines, the Federal Register notice - “Treatment of Live Poultry Before Slaughter,” or any of the establishment’s written poultry handling plans.

            4. Enter MOI text and click on the “Save” button;

            5. Click on “Finalize” to complete the MOI; and

            6. Provide copies of the MOI to the establishment, the DVMS, and the inspection file.

         5. Refer to Attachment 3, an example of an MOI for poultry mistreatment.

5. DVMS REVIEW OF GCP NRs AND POULTRY MISTREATMENT MOIs
   1. ​​​​​​​In keeping with the instructions in FSIS Directive 6910.1 Rev 1, District Veterinary Medical Specialist (DVMS)—Work Methods, the DVMS is to correlate with IPP about FSIS policies and procedures that pertain to GCP in poultry. The correlation includes the review of GCP NRs and mistreatment MOIs to determine the accuracy and consistency of this documentation. In addition to Agency training provided on GCP principles, this additional DVMS involvement will help ensure that IPP are familiar with the issues that determine whether to document a GCP NR or a poultry mistreatment MOI and ensure that IPP consistently document these issues in the proper format.
      
      NOTE: The DVMS can generate a PHIS report of “Noncompliance Records for a District” using a filter for the GCP regulation, 9 CFR 381.65(b).
       
   2. In specific situations, after DVMS review of a mistreatment MOI, there may be a need for additional notification of the appropriate state officials. If so, the DVMS is to:
      1. Collaborate with the in-plant inspection team and the District Case Specialist to prepare a Letter of Concern (LOC) and a cover letter and send:

         1. The LOC to establishment management;

         2. A cover letter and a copy of the LOC to the appropriate state official;

         3. Copies of the LOC to the IIC at the establishment and the Frontline Supervisor; and

         4. Keep one copy of the LOC in the District Office (DO).

6. IPP AWARENESS OF ESTABLISHMENT’S RESPONSES TO NRs AND MOIs
   1. IPP are to be aware that, if establishments have a PHIS e-authentication account, the establishment can respond individually to NRs and MOIs in PHIS. After the IPP finalize an NR or MOI in PHIS, IPP are to advise the establishment that it can go to its individual documents and add a response in the Plant Response text field or upload an attachment using instructions in the PHIS Industry User Guide.
   2. Specifically with regard to an MOI, if the establishment does not have access to PHIS, IPP are to document the objection, if presented verbally, on the MOI, or if written, IPP are to attach the objection to the MOI. IPP are to reference the attachment in the MOI and provide a copy of the MOI with the establishment response to plant management as soon as the MOI response is complete.

      
      NOTE: If the establishment elects to provide any other response, such as a proactive change to their program, this also may be attached to the MOI using these same methods.

7. QUESTIONS

   Refer questions regarding this directive to the Policy Development Staff through askFSIS or by telephone at 1-800-233-3935. When submitting a question, use the Submit a Question tab, and enter the following information in the fields provided:

   Subject Field:       Enter Directive 6110.1.
   Question Field:    Enter question with as much pertinent detail as possible.
   Product Field:      Select General Inspection Policy from the drop-down menu.
   Category Field:    Select Slaughter/ Poultry from the drop-down menu.
   Policy Arena:    Select Domestic (U.S.) Only from the drop-down menu.

   When all fields are complete, press Continue and at the next screen press Finish Submitting Question.
   
   NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.

(Note: Download PDF for complete information)

​​​​​​​​​ATTACHMENT 1 - Clarification of Verification of Good Commercial Practices for Poultry 
ATTACHMENT 2 - Example of a GCP NR
ATTACHMENT 3 - Example of a Poultry Mistreatment MOI