New Poultry Inspection System: Post-Mortem Inspection and Verification of Ready-To-Cook Requirement - Revision 1
FSIS directive
6500.1
Series Type
6000 Series: Slaughter Inspection
Issue Date
Aug 17, 2023
Full Directive
NOTE: DO NOT IMPLEMENT THIS DIRECTIVE UNTIL: SEPTEMBER 18, 2023
CHAPTER I - GENERAL
- PURPOSE
- This directive provides instructions to inspection program personnel (IPP) on how to perform online and offline post-mortem inspection procedures at poultry slaughter establishments operating under the New Poultry Inspection System (NPIS) and how to verify that those establishments operating under the NPIS are producing ready-to-cook (RTC) poultry. This directive has been updated to clarify duties for the Inspector-in-Charge (IIC), to remove previous instructions on avian visceral leukosis flock checks for young chickens, and to remove criteria for carcass condemnation for skin leukosis.
- IPP are to continue to follow instructions on how to perform ante-mortem inspection procedures and verify Good Commercial Practices (GCP) according to instructions in FSIS Directive 6100.3, Ante-Mortem and Post-Mortem Poultry Inspection, FSIS Directive 6110.1, Verification of Poultry Good Commercial Practices, and other directives for duties assigned by their supervisor that are not specific to poultry slaughter including, but not limited to FSIS Directive 5000.1, Verifying an Establishment's Food Safety System, and FSIS Directive 12600.1, Voluntary and Other Reimbursable Inspection Services.
KEY POINTS:
- How to perform online and offline post-mortem inspection procedures at young chicken and turkey slaughter establishments operating under NPIS
- How to perform verification procedures for Ready-to-Cook requirements at slaughter establishments operating under NPIS
- How to use Public Health Information System (PHIS) tasks: Poultry NPIS Zero Tolerance Food Safety Verification task and Poultry Ready-to-Cook task. (Poultry Finished Product Standards and Poultry Zero Tolerance Verification tasks are not used in NPIS establishments)
- Instructions when carcass inspector finds fecal contamination or Septicemia or Toxemia (Sep/Tox) and the establishment's Critical Control Point (CCP) or other monitoring is located after or before the carcass inspector
- Instructions for Consumer Safety Inspectors (CSIs) to work with the IIC
- Instructions that beginning September 18, 2023, avian leukosis is a trimmable condition
- CANCELLATION
FSIS Directive 6500.1, New Poultry Inspection System: Post-Mortem Inspection and Verification of Ready-To-Cook Requirement, dated 2/1/2017 - BACKGROUND
- On August 21, 2014, FSIS published a final rule to modernize poultry slaughter inspection (see Modernization of Poultry Slaughter Inspection, 79 FR 49565). The final rule established a new inspection system called NPIS for the inspection of young chickens, and all turkeys. NPIS is in addition to, not a replacement for, the current Streamlined Inspection System (SIS), New Line Speed Inspection System (NELS), New Turkey Inspection System (NTIS), or Traditional Inspection system. Establishments that slaughter classes of poultry other than young chickens and turkeys may request a waiver of slaughter regulations in accordance with the Salmonella Initiative Program (SIP) (76 FR 41186 July 13, 2011) to operate under NPIS. The effective date of the new requirements is the date the establishment starts to operate under NPIS.
- On August 17, 2023, FSIS published a final rule (88 FR 55909, Condemnation of Poultry Carcasses
- Affected With Any Form of Avian Leukosis Complex; Recission), to amend the poultry products inspection regulations to rescind several regulations related to the inspection and condemnation of poultry carcasses affected with any of the forms of avian leukosis complex. This rule is effective on September 18, 2023. This final rule:
- Rescinds 9 CFR 381.82, which requires condemnation of poultry carcasses affected with one or more of the forms of the avian leukosis complex;
- Rescinds 9 CFR 381.36(f)(3), which requires NPIS young chicken establishments to provide a leukosis inspection area along the slaughter line;
- Rescinds 9 CFR 381.76(b)(6)(iv), which prescribes inspection procedures for avian visceral leukosis in NPIS young chicken establishments; and
- Revises 9 CFR 381.87 to provide that any organ or other carcass part affected with tumors may be trimmed and that the unaffected parts of the carcass may be inspected and passed.
CHAPTER II - POST-MORTEM INSPECTION AND OFFLINE VERIFICATION UNDER NPIS
- ONLINE AND OFFLINE CONSUMER SAFETY INSPECTOR DUTIES
- One Consumer Safety Inspector (CSI) is assigned to perform online carcass inspection (CI) duties, and one CSI is assigned to offline verification inspection (VI) duties for each evisceration line. CSIs are to rotate equally between the VI and CI positions and correlate with the IIC to ensure that poultry products leaving the slaughter line are safe and wholesome. Inspectors assigned to establishments operating under NPIS are trained to perform both CI and VI duties.
- CSIs are not authorized to slow line speeds but are to stop the line in order to ensure their safety and health, when establishment employees report that an imminent danger is present, or when immediate intervention is needed to prevent the production of adulterated or unwholesome product. CSIs are to notify the IIC of line speed concerns, the IIC is to follow the instructions in Chapter III. II. CIs are also to stop the line to have carcasses removed from the line that:
- Are contaminated with feces or Sep/Tox;
- Demonstrate non-food safety conditions that warrant condemnation of the entire carcass;
- Arrive at the CI station without being opened and eviscerated;
- The CI is unable to determine whether a carcass is condemnable; or
- Show signs of being dead-on-arrival (DOA).
- The CI duties include a continuous online inspection of each carcass at a fixed location before the chiller with a focus on food safety to determine whether each carcass is not adulterated. CIs are presented with carcasses that have been sorted, trimmed, and reprocessed by establishment employees, and thus CIs are to focus on identifying carcasses affected with food safety conditions.
- The VI duties are to monitor and evaluate establishment process controls and verify that establishments follow GCPs. CSIs perform offline activities throughout the establishment, including the slaughter area and along the evisceration and picking lines to verify compliance with Sanitation Standard Operating Procedures (Sanitation SOPs), Sanitation Performance Standards (SPS), Hazard Analysis and Critical Control Point (HACCP) regulatory requirements, and GCPs.
- The VI duties also include conducting verification checks of carcass samples collected just before the CI station to ensure that the establishment is effectively sorting carcasses and producing products that comply with the Agency's zero visible fecal tolerance and other performance standards.
- ONLINE POST-MORTEM INSPECTION UNDER NPIS
- The CI is stationed on the production line at a fixed point before the chiller and after the establishment has completed all sorting, trimming, and reprocessing activities as required by 9 CFR 381.76(b)(6)(ii)(A).
- The CI is to visually inspect each carcass to determine whether the carcass is adulterated either because of a food safety condition or other condition such as generalized Inflammatory Process (IP) that warrants condemnation of the entire carcass. The CI is to follow procedures listed below in paragraph D. of this section to condemn carcasses affected with condemnable conditions. If the CI is unable to determine whether the entire carcass is condemnable, the CI is to direct the establishment to hang back the carcass for IIC disposition.
NOTE: Beginning September 18, 2023, avian leukosis is a trimmable condition under 9 CFR 381.87. CIs are to take action the same as when other lesions and tumors are observed. - If the CI identifies a carcass with food safety defects, i.e., a carcass contaminated with feces or with Sep/Tox, the CI is to:
- Stop the evisceration line and direct the establishment to hang back the affected carcass for condemnation or reprocessing as applicable;
- Restart the line once the carcass is removed from the evisceration line; and
- Write a Noncompliance Record (NR) after rotating to the VI assignment if the establishment's CCP or other monitoring to prevent carcasses with food safety defects from entering the chiller is located before the CI station.
- The CSI is to use the PHIS Poultry NPIS Zero Tolerance Food Safety Verification task to document finding a Sep/Tox carcass or a carcass contaminated with fecal material.
- If the CSI finds a Sep/Tox carcass they are to describe the carcass, state that the establishment is not preventing carcasses with septicemic and toxemic conditions from entering the chiller and cite 9 CFR 381.76(b)(6)(ii)(C) and 381.83 on the NR.
- If the CSI finds a carcass with visible fecal contamination, they are to describe the fecal contamination, state that the establishment is not preventing carcasses with fecal material from entering the chiller and cite 9 CFR 381.65(f) and 381.65(g) on the NR.
- The CSI is to verify the establishment's corrective actions as described for offline verification in Chapter II. Section III. D. 6.
- Do not write an NR if the establishment's CCP or other monitoring to prevent carcasses contaminated with food safety defects from entering the chiller is located after the CI station. Instead, the IIC or designee is to notify the establishment management and perform applicable PHIS tasks based on where the establishment has incorporated its written procedures into its HACCP system to verify that:
- The establishment has written procedures and is meeting the requirement to prevent fecal contamination and enteric pathogens throughout the slaughter process (9 CFR 381.65(g)) as described in FSIS Directive 6420.5 Verifying Poultry Slaughter Establishments Maintain Adequate Procedures for Preventing Contamination with Feces and Enteric Pathogens; and
- The establishment has written sorting procedures and its sorting activities, disposing of carcasses and parts are in control to meet 9 CFR 381.76(b)(6)(ii) requirements.
- Instructions for recording the number of carcasses with fecal contamination by the CI on the FSIS Form 6000-36, New Poultry Inspection - Lot Tally Sheet, are described in Chapter III. Section IV Forms Documentation.
- If the CI identifies a carcass affected with a non-food safety animal disease condition that warrants condemnation of the entire carcass, they are to stop the line and direct the establishment to hang back the carcass for condemnation. The CI is to condemn carcasses that clearly exhibit condemnable conditions. Criteria for carcass condemnation are found in the following regulations and other criteria in this directive:
- Tuberculosis (9 CFR 381.81);
- Airsacculitis (generalized) (9 CFR 381.84);
- IP (generalized) (9 CFR 381.86);
- Parasites (infestation or show lesions of infestation) (9 CFR 381.88);
- Tumors that have spread (metastasized) or affected the carcass due to its size, position or nature (9 CFR 381.87) and keratoacanthoma tumors that have coalescing tumors (9 CFR 381.87);
- Bruises (generalized) (9 CFR 381.89);
- Cadavers (9 CFR 381.90);
- Mutilation (excessive) (9 CFR 381.91(a));
- Overscald (excessive) (9 CFR 381.92);
- Turkey Osteomyelitis Complex (TOC) (if evidence of general systemic disturbance) (9 CFR 381.86); and
- Certain other conditions, that if generalized to the extent that the carcass cannot be trimmed or salvaged, the entire carcass is to be condemned by the CSI.
- The CI is to stop the line and direct the establishment to hang back any uneviscerated (not drawn) carcasses that are presented for inspection for IIC disposition. The IIC or designee is to further evaluate whether the establishment is effectively sorting carcasses.
NOTE: If the CI identifies a DOA carcass (9 CFR 381.71(a)), the CI is to stop the line and direct the establishment management to hang back the carcass for condemnation. The CI is to restart the line after the carcass is removed from the line. The CI is to notify the IIC or designee to verify that the establishment's controls for preventing DOAs from entering the establishment are effective. (See FSIS Directive 6100.3.) - The CI is to record the number of non-food safety carcasses that the CI condemns, but not the cause of condemnation, on the FSIS Form 6000-36 as described in Chapter III. Section IV. Forms Documentation. Users need an e-authentication account to access this form.
- Presentation: The CI is to notify the IIC or designee when the CI believes that a carcass-by-carcass inspection cannot be adequately performed within the time available because of the manner in which the birds are being presented to the CI, or because of factors that may indicate a loss of process control, such as persistent, unattended defects. The CI is to be aware that proper presentation of carcasses under the NPIS is described in 9 CFR 381.76 (b)(6)(iii) and requires that:
- Each carcass, except carcasses and parts identified as “major portions” under 9 CFR 381.170(b)(22), must be held by a single shackle;
- Both hocks (when available) of each carcass are held by the shackle;
- The back side of the carcass must face toward the inspector; and
- There must be minimal carcass swinging motion.
- The CI is to notify the IIC or designee if the CI observes persistent, unattended non-food safety trim and processing defects on carcasses.
- Persistent trim and processing defects mean the defects on carcasses continue to occur repetitively; and
- Unattended means the establishment has been given the opportunity to respond to persistent defects and has not effectively corrected the problem.
- Follow instructions in Chapter IV of this directive to verify the Ready-to-Cook requirement.
- OFFLINE VERIFICATION INSPECTION UNDER NPIS
- The VI conducts offline food safety related verification inspection activities to verify that an establishment complies with regulatory requirements in the HACCP system in accordance with FSIS Directive 5000.1. The HACCP system includes the HACCP Plans and Sanitation SOPs or other prerequisite programs.
- The VI is to verify that the establishment has developed written procedures to prevent carcasses with visible fecal contamination from entering the chiller and has incorporated them into its HACCP system and is to document any noncompliance. See FSIS Directive 6420.5.
- The VI is to verify that the establishment has developed written procedures for preventing carcasses with Sep/Tox from entering the chiller and has incorporated the procedures into its HACCP system and is to document any noncompliance.
- Verification of Food Safety: The VI is to verify that food safety hazards, i.e., Sep/Tox carcasses (9 CFR 381.83) and carcasses with fecal contamination (9 CFR 381.65(f)), are prevented from entering the chiller by examining sets of 10 carcasses using the PHIS Poultry NPIS Zero Tolerance Food Safety Verification task.
- Each day, the VI is to conduct eight 10-bird carcass checks (that is, a 10-bird check each hour) for each evisceration line for every shift. In large establishments with many eviscerating lines the IIC may schedule random times for each CSI.
- The VI is to conduct food safety checks by randomly selecting 10 carcasses just before the CI station and examining them offline to verify that the establishment produces product free of visible fecal and Sep/Tox contamination before the chiller.
- The VI is to examine each 10-bird sample set at the prechill VI station to identify feces according to the identification guidelines for feces (see Attachment 1) and is to identify Sep/Tox carcasses according to disposition criteria in 9 CFR 381.83. The VI is to use the following inspection procedure to examine each carcass.
- Outside back: While holding the carcass, with the back of the carcass toward the inspector and starting at the hock area, observe the hocks, back part of the legs, tail area, back of the carcass, and top side of the wings;
- Outside Front: Turn the carcass and observe the bottom side of the wings, breast, and front part of the legs;
- Inside: Observe the inside surfaces of the carcass and the abdominal flaps and fat; and
- Neck Flap Area: Observe the neck flap and the thoracic inlet area.
- If the VI performs the PHIS Poultry NPIS Zero Tolerance Food Safety Verification task and does not observe fecal material or Sep/Tox contamination on any of the carcasses, they are to indicate compliance was verified with 9 CFR 381.76(b)(6)(ii)(C), 381.83, and 381.65(f) in PHIS and mark the task as “Inspection Completed” each time the task is performed.
- If the VI detects food safety conditions on any of the 10 birds in a set, they are to notify the establishment of the noncompliance with 9 CFR 381.65(f) or with 9 CFR 381.83 and 381.76(b)(6)(ii)(C) and complete the PHIS Poultry NPIS Zero Tolerance Food Safety Verification task by writing an NR. An NR is written regardless of where the establishment has located its CCP or other monitoring to meet these requirements.
- If the VI finds fecal material on one or more carcasses, they are to describe the fecal material and state on the NR that the establishment has failed to prevent carcasses with fecal material from entering the chiller and cite 9 CFR 381.65(f).
- If the VI finds signs of Sep/Tox in one or more carcasses, they are to describe the carcass and state on the NR that the establishment has failed to prevent Sep/Tox carcasses from entering the chiller and cite 9 CFR 381.83 and 9 CFR 381.76(b)(6)(ii)(C).
- If the VI finds fecal material on one or more carcasses and one or more Sep/Tox carcasses in the same 10-bird sample, they are to document an NR and cite 9 CFR 381.65(f), 381.83, and 381.76(b)(6)(ii)(C).
- After notifying the establishment of the noncompliance, the VI is to verify that the establishment's corrective actions are effective.
- If the establishment's written procedures are incorporated into its HACCP plan, then the VI is to perform the PHIS Slaughter HACCP Verification task to verify that the corrective actions meet the requirements of 9 CFR 417.3(a).
- If the establishment's written procedures are incorporated into its Sanitation SOP, then the VI is to perform the PHIS Operational Sanitation SOP Review and Observation task to verify that the corrections meet the requirements of 9 CFR 416.15.
- If the establishment's written procedures are incorporated into another prerequisite program, then the VI is to perform the PHIS Slaughter HACCP Verification task to verify that the corrective actions meet the requirements of 9 CFR 417.5(a)(1).
- The VI is to condemn any Sep/Tox carcasses found on the 10-bird verification check and record the number condemned, but not the cause of condemnation, on the FSIS Form 6000-36 as described in Chapter III, Section IV. Forms Documentation.
- Verification of Non-food Safety Animal Disease: If the VI observes carcasses affected with non-food safety animal disease conditions that warrant condemnation of the entire carcass during the performance of the PHIS Poultry NPIS Zero Tolerance Food Safety Verification task, they are to follow the instructions below.
- The VI is to condemn the carcass and record the condemnation on the FSIS Form 6000-36 described in Chapter III. Section IV. Forms Documentation. The VI is to retain the affected carcass for IIC disposition if they have a question as to whether the entire carcass is condemnable.
- If the VI finds more than two carcasses in the 10-bird set with a disease condition warranting condemnation of the entire carcass, the VI is to write an NR and use the appropriate PHIS task according to the location in the establishment's HACCP system where the establishment has elected to include its sorting procedures (9 CFR 381.76(b)(6)(ii)(C)).
- On the NR, the VI is to describe the observations of the disease condition warranting condemnation of the entire carcass, citing the appropriate regulation for the disease condition. The VI is also to cite 9 CFR 381.76(b)(6)(ii)(A) and state that the establishment did not dispose of carcasses and parts exhibiting likely condemnable conditions before presenting carcasses to the CI, and that the sorting activities are not effective.
- If the VI observes persistent, unattended non-food safety trim or processing defects on carcasses during the performance of the PHIS Poultry NPIS Zero Tolerance Food Safety Verification task, the VI is to complete the task, orally notify the establishment management and the IIC or designee that the products resulting from the establishment's slaughter operation may not meet the definition of RTC poultry in 9 CFR 381.1 and thus are not meeting the requirement in 9 CFR 381.76(b)(6)(ii)(D). The IIC or designee is to further evaluate the situation to determine if the process is out of control and an NR should be written as described in Chapter IV, Section II. C.3.
- VIs are to use the PHIS task applicable to where the establishment's procedures and processes are incorporated into its HACCP system to verify the requirements listed below. Verification activities by the VI include, but are not limited to, evaluating establishment records, observing establishment employees perform monitoring tasks according to written procedures or processes, and inspecting carcasses and parts to ensure that adulterated carcasses, parts, tissues, or exudates are removed and disposed of properly.
- VIs are to perform PHIS tasks throughout the facility, including tasks to verify that the establishment is complying with the following requirements:
- Conducts carcass with associated viscera sorting activities, disposes carcasses and parts exhibiting likely condemnable conditions and conducts appropriate trimming and reprocessing activities before carcasses are presented to the CI (9 CFR 381.76(b)(6)(ii)(A)). VIs are to complete the applicable PHIS task by writing an NR if the VI finds the establishment does not have written procedures or does not meet the criteria described in its sorting procedures and cite 9 CFR 381.76(b)(6)(ii);
- Monitors carcasses after completion of all trimming, washing, or a combination of trimming and washing followed by chlorine (or other approved Offline Reprocessing (OFLR) antimicrobial rinse) to ensure that the OFLR effectively removes visible contamination from internal and external surfaces (9 CFR 381.91(b)(2)) before returning carcasses to the evisceration line for inspection by the CI. The establishment makes available reprocessed carcasses for VIs to periodically select a representative sample to verify the effectiveness of the OFLR by inspecting the internal and external surfaces. This verification is in addition to the offline inspection of all parts described in number 4. below.
- Returns carcasses or major portions (as defined in 9 CFR 381.170(b)(22)) back to the evisceration line before the CI station after completing OFLR and salvaging activities, as required by 9 CFR 381.76(b)(6)(ii)(B). VIs are to be aware that under NPIS major portions are carcasses missing some parts or are from transversely cut carcasses with at least one wing and the breast in the front portion and at least one leg and back in the back portion for hanging on the line before the CI. If the establishment does not return such product to the evisceration line, then the VI is to complete the applicable PHIS task by writing an NR, citing 9 CFR 381.76(b)(6)(ii)(B.)
- Has a written process in its HACCP system that ensures that all parts (e.g., legs, wings, thighs, breasts, backs and quarters except major portions) are available for offline inspection by the VI or IIC after reprocessing or salvage activities are completed (9 CFR 381.76(b)(6)(ii)(B)). The VI or IIC is to visually inspect all parts presented in a single layer using mostly a hands-free procedure. If the establishment does not have a process or does not follow the process to allow FSIS to inspect parts, then the VI is to complete the applicable PHIS task by writing an NR, citing 9 CFR 381.76(b)(6)(ii)(B) and stating that such product will not receive the benefit of inspection.
- Ensures that the corresponding viscera, feet, and necks are also identified and disposed of in accordance with 9 CFR 381.76(b)(6)(iii)(E) when the CI condemns a carcass. Individual viscera do not need to be identified if the establishment discards all viscera produced within the time period in which the carcass was condemned by the CI.
- Establishments using approved Online Reprocessing (OLR) and OFLR have written procedures in their HACCP system to ensure visible contamination is removed from internal and external surfaces and applicable operating parameters are monitored (9 CFR 381.91(b)).
NOTE: VIs are to follow the establishment's procedures to periodically verify as applicable that giblets, feet and necks are produced in a sanitary manner and meet regulatory definitions of “Ready -to-Cook poultry” and “Giblets” provided in 9 CFR 381.1 and in accordance with 9 CFR 381.76(b)(6)(ii)(D).
CHAPTER III - IIC RESPONSIBILITIES
- CONDUCTING FOOD SAFETY INSPECTION UNDER NPIS
- IICs assigned to an establishment operating under NPIS are to assess the overall design and implementation of all establishment processes described in the HACCP system and process control procedures in accordance with FSIS Directive 5000.1.
- The IIC is to work with the CSIs performing VI and CI duties to ensure that food safety defects or other conditions do not impair the CI's ability to perform post-mortem inspection of each carcass. (See paragraph II below for instruction on verifying line speed.)
- The IIC is to review NRs to evaluate when there may be a trend of noncompliances for not removing or properly disposing of carcasses exhibiting signs consistent with condemnable animal disease. This trend may indicate that the establishment is not maintaining process control in its sorting procedures (9 CFR 381.76(b)(6)(ii)). If the IIC finds that the NRs are repetitive with association (linkage), they are to follow the instructions in FSIS Directive 5000.1.
- In establishments that have located their CCP or other monitoring such as Sanitation SOPs or prerequisite programs to prevent food safety defects from entering the chiller after the CI station, an NR is not written by the CI. Instead, the IIC or designee is to perform appropriate PHIS HACCP and Sanitation SOP tasks to evaluate the overall effectiveness of the establishment's written procedures for preventing fecal and enteric pathogen contamination throughout the slaughter and dressing operations (9 CFR 381.65(f),381.65(g), and 381.65(h)). If the IIC determines that there is evidence that written procedures are not in control to prevent contamination, for example, the establishment is relying on reconditioning and reprocessing to remove contamination from product instead of preventing contamination, the IIC is to slow the line speed until the process is consistently in control (9 CFR 381.69(c)) and document as appropriate in an NR that written procedures are not being effectively applied. Also see Section II. Verification of Evisceration Line Speed.
- The IIC is to evaluate and assess the situation when notified by the CSIs that persistent unattended non-food safety trim and processing defects are interfering with carcass inspection (9 CFR 381.69(c)), or that the establishment's sorting process is not in control (9 CFR 381.76(b)(6)(ii)) to meet the RTC definition (9 CFR 381.1). The IIC is to evaluate the situation to determine whether the establishment is complying with those requirements. The evaluation is to involve:
- Conducting or assigning directed PHIS Poultry RTC tasks to review establishment records documenting that products resulting from its slaughter operations are meeting the definition of RTC and taking samples;
- Observing carcasses at the CI station to determine whether the establishment's process is in control, or whether the presentation of the carcasses is affecting the CI‘s ability to inspect carcass-by-carcass (9 CFR 381.76(b)(6)(iii)); and
- If the IIC determines that the presence of persistent, unattended trim or processing defects indicate that the process is not in control or is interfering with carcass-by-carcass inspection, they are to follow instructions in Section II. Verification of Evisceration Line Speed and as needed consult with their immediate supervisor.
- The IIC or designee is to verify that the establishment meets facility requirements that are specific to NPIS (9 CFR 381.36(f) and 381.76(b)(6)(i)) as often as necessary. The IIC or designee is to issue an NR documenting the noncompliance using the PHIS Other Inspection Requirements task if a requirement is not met and citing on the NR the specific applicable regulation.
- VERIFICATION OF EVISCERATION LINE SPEED
- The IIC is to verify that the establishment's line speed does not exceed the maximum speed of 140 birds per minute (bpm) authorized for young chickens (9 CFR 381.69(a)) or 55 bpm for turkeys (9 CFR 381.69(b)) as often as necessary to ensure that the CI can adequately perform a visual carcass-by-carcass inspection within the time available.
- The IIC is to measure line speed using physical methods. The maximum allowed line speed is a whole number. Any line speed measurement resulting in a fraction is to be rounded up. If the maximum line speed is exceeded, the IIC is to write an NR using the PHIS Other Inspection Requirements task, citing 9 CFR 381.69, and slow the line to comply with 9 CFR 381.69. In establishments where line speed cannot be determined by counting each carcass, the establishment is to establish a procedure that assures line speeds are not exceeding the maximum allowed. An example may be counting shackles in such a manner to support that the establishment's electronic counter is accurate.
- The IIC is to assess presentation of birds to the CI and evaluate the health status of the flock or other factors that may indicate loss of process control, such as persistent unattended defects, to determine whether these factors are having any impact on the ability of IPP to perform the proper inspection procedures at a given line speed (9 CFR 381.69(c)). The IIC, if not a Veterinary Medical Officer (VMO), is to consult with a VMO when presentation concerns are related to the health status of the flock. If in the judgment of the IIC a carcass-by-carcass inspection cannot be adequately performed, the IIC is to reduce the line speed to a speed at which the CI can perform the proper inspection procedures, and at which process control can be restored. IICs are to use the PHIS Other Inspection Requirements task to write an NR citing 9 CFR 381.69(c) and 381.76(b)(6)(iii).
- POST-MORTEM DISPOSITIONS AND CORRELATION
- The IIC plays a critical role in ensuring that the public health is protected by verifying that the establishment is effectively sorting. The IIC evaluates the results of the VIs carcass verification checks and verifies that there is an appropriate disposition of affected carcasses and parts. The final responsibility for disposition determinations rests with the IIC. The IIC is to conduct a post-mortem examination of carcasses or parts that are held for their examination. When the IIC is not a VMO, they are to consult with the frontline supervisor when they determine that a veterinary disposition or other veterinary expertise is necessary. The IIC or VMO may seek diagnostic assistance from the pathology laboratory and consider the laboratory's report within the context of ante-mortem and post-mortem findings.
- During work unit meetings, the IIC is to meet with the inspection team as necessary to review pathology and regulatory requirements for addressing food safety conditions (Sep/Tox and fecal contamination) and non-food safety disease conditions warranting condemnation of the entire carcass.
- The IIC may use the Poultry Post-Mortem information in the Multi-Species Disposition Guide for PHV's or the Poultry Carcass Disposition information for correlation. This information can be found in IPP Help.
- The IIC is to verify that establishments slaughtering turkeys have trained employees to identify TOC lesions and determine whether the flock is positive. If the flock is positive, then turkeys are salvaged to remove lesions affected with TOC.
- If requested by establishment management, the IIC is to correlate with the establishment management on dispositions.
- FORMS DOCUMENTATION
- Under NPIS, IPP record the number of condemned carcasses, but not the cause on FSIS Form 6000-36 by entering a hash mark under columns “No. Condemned by FSIS”. FSIS Form 6000-36 is available on the Inside FSIS intranet site, FSIS Forms function.
- When an establishment has located its CCP or other monitoring control after the CI station to prevent carcasses contaminated with feces from entering the chiller, the CI is to record any finding of fecal contamination on the FSIS Form 6000-36 by entering a hash mark under Special Survey codes found at the bottom of the form.
- Under the NPIS, IPP are to enter in PHIS the total head slaughtered and total head condemned by FSIS or disposed of by the establishment into PHIS Animal Disposition Reporting (ADR). IPP are not to report condemnation categories.
- IPP are to enter the number of head condemned by FSIS as recorded on FSIS Form 6000-36, the total head disposed by the establishment, and other slaughter data as recorded on FSIS Form 6510-7, Poultry Lot Information. Users need an e-authentication account to access this form.
- If requested by establishment management (9 CFR 381.103), the IIC or designee is to provide a copy of the current FSIS Form 9061-2, Poultry Condemnation Certificate, which is generated in PHIS ADR. The form can be printed by clicking on the “Condemnation Certificate” printer icon.
- The establishment and the IIC or their designees are to sign the form and retain a copy after establishment management signs the form. The copy is retained for the current fiscal year plus one additional fiscal year.
NOTE: The post-mortem “Total No. of Head Condemned/Disposed of.” category heading in Form 9061-2, reflects the NPIS. The number recorded under this heading reflects the total number of heads condemned by the inspector and the total number of heads disposed of by the establishment.
CHAPTER IV - VERIFICATION THAT ESTABLISHMENT IS PRODUCING READY-TO-COOK POULTRY
- REQUIREMENTS
- Establishments operating under the NPIS are required to maintain records documenting that the products resulting from their slaughter operations meet the definition of RTC poultry (9 CFR 381.76(b)(6) (ii)(D)). Establishments that operate under SIS, NELS or NTIS are required to continue to meet Finished Product Standards (FPS) regulations (9 CFR 381.76 (b)(3)(iv)).
- Establishments operating under the NPIS may adopt any of the following criteria to determine whether they are producing RTC poultry:
- Other Consumer Protection (OCP) standards developed for the Hazard Analysis Critical Control Points-based Inspection Models Project (HIMP) pilot;
- The parameters in the FPS regulations (9 CFR 381.76 (b)(3)(iv));
- Alternative FPS procedures allowed under a SIP waiver; or
- Other OCP performance standards or defect criteria as defined in a published study or a scientifically or statistically-based study that the establishment conducted itself to document they are meeting the RTC definition.
- IPP RESPONSIBILITIES
- IPP are to verify the RTC requirements using the routine and directed PHIS Poultry RTC task when the establishment starts to operate under NPIS. At that time, IPP will update the establishment profile to include the new PHIS Poultry Ready-to-Cook task and the PHIS Poultry NPIS Zero Tolerance Food Safety task and to disable the Poultry Finished Product Standards task and the Poultry Zero Tolerance Verification task.
- Routine PHIS Poultry RTC task: When the task is scheduled, IPP are to verify that the establishment maintains records, as required under 9 CFR 381.76(b)(6)(ii)(D), to document that the products resulting from their slaughter operations meet the definition of RTC poultry in 9 CFR 381.1. IPP are to review the establishment's records to verify that the records contain, at a minimum, the information below.
- Data to support that the establishment is producing RTC poultry. For example, an establishment may use statistical process control charts, HACCP records, or other documentation;
- The points in the operation where the establishment monitors carcasses or other parts of poultry to determine whether they meet the RTC definition and records results of these monitoring activities. For example, an establishment may monitor and record the results at a pre-chill and a post-chill station;
- The frequency with which the establishment conducts monitoring activities. The records should specify the sample set size and how often the establishment monitors carcasses per line per shift. For example, an establishment may conduct and document its monitoring activities at least every 2 hours per line per shift at the pre-chill location and at least twice per shift per line at the post- chill location;
- The definitions of the OCP non-conformances or processing and trim defects for which the establishment is monitoring. For example, the establishment may be monitoring carcasses for processing and trim non-conformances as specified in the FPS regulations; trim and processing defects used under its FPS SIP waiver; OCP defects established under the HIMP pilot; or another OCP standard defined in a published study or a scientifically or statistically-based study that the establishment conducted itself. If the establishment references a study, it should give a brief description of the study and have the supporting information on file;
- The evaluation criteria that the establishment uses to determine whether the products resulting from its slaughter operation meet the RTC definition. For example, an establishment may follow the subgroup limits for non-conformances and defects in the FPS regulations, the limits established in its FPS SIP waiver, the trim and processing defect levels for the HIMP OCP performance standards, or other OCP evaluation criteria based on a published study or the establishment's scientifically or statistically-based study to determine the upper limits for non-conformances; and
- The corrective actions that the establishment plans to take if the levels of defects and non- conformances exceed its evaluation criteria for RTC poultry.
- Directed PHIS Poultry RTC task: IPP are not to perform a directed PHIS Poultry RTC task unless assigned by the IIC or designee.
- If, during the performance of the PHIS Poultry Zero Tolerance Food Safety task, VIs observe persistent, unattended trim or processing OCP defects that cause them to suspect that the establishment is not effectively sorting carcasses to meet the RTC definition, they are to notify the establishment and the IIC.
- If, during the performance of the online carcass inspection, CIs observe persistent, unattended OCP defects, they are to notify the IIC.
- Persistent trim and processing defects means the defects on carcasses continue to occur repetitively. Trim and processing defects that are persistent include observing numerous carcasses, either in a row or in clusters, which have obvious, severe or numerous problems that could affect the usability of the product. Examples of obvious or severe problems include sores and scabs on the skin that indicate deep tissue involvement with or without trimmable IP. A defect is persistent if, for example, IPP find multiple broken crops that may indicate loss of process control related to proper feed withdrawal or improper equipment alignment.
- Unattended means the establishment has been given the opportunity to respond to persistent defects and has not effectively corrected the problem. Defects are unattended if the establishment fails to effectively address the problem even though it has had an opportunity to do so.
NOTE: Examples of non-food safety trim and processing defects include: sores, breast blisters, bruises, trimmable tumors, trimmable synovitis or airsacculitis, compound fractures, scabs, dermatitis, salpingitis, nephritis, kidney removal where applicable, oil glands, lungs, intestines, cloaca, bursa of Fabricius, esophagus, crop, trachea, and feathers. - If the CI or VI informs the IIC that persistent unattended non-food safety trim and processing defects are interfering with carcass inspection, or that the establishment's sorting process is not in control to meet the RTC definition, the IIC is to evaluate the situation to determine whether an NR should be written. The evaluation is to involve, but is not limited to:
- Observing carcasses at the CI station to determine whether the establishment's process is in control, or whether the presentation of the carcasses is affecting the CI's ability to inspect carcass-by -carcass; or
- Conducting or assigning a directed PHIS Poultry RTC task.
- When performing the directed Poultry RTC task, IPP are to verify that the establishment's records contain the required information and are to examine and verify that products resulting from the establishment's slaughter operations are meeting the establishment's evaluation criteria.
- If IPP find a food safety defect while performing a Poultry RTC task, IPP are to perform an appropriate PHIS food safety task and take any necessary action.
- DOCUMENTATION FOR RTC
- IPP are to write an NR if the establishment does not have records to document that the products resulting from its slaughter operation meet the definition for RTC poultry, or if the records that the establishment has do not include the minimum information required in 9 CFR 381.76(b)(6)(ii)(D) and 9 CFR 381.1. IPP are to issue the NR using the PHIS Poultry RTC task and cite those regulations. The NR is to state that the establishment's records did not document that the products resulting from its slaughter operations meet the RTC definition.
- IPP are to also issue an NR using the PHIS Poultry RTC task and citing 9 CFR 381.76(b)(6)(ii)(D) and 9 CFR 381.1 if they examine product as directed and find that:
- The results exceed the criteria that the establishment uses to determine that the products resulting from its slaughter operation meet the RTC definition; or
- The establishment did not take necessary corrective actions to restore process control when the evaluation criteria are exceeded.
- If the IIC determines that the presentation of persistent unattended trim or processing defects indicates a loss of process control, and in turn affects the CI's ability to adequately conduct a carcass-by- carcass inspection, the IIC has the authority to direct the establishment to reduce the line speed (9 CFR 381.69(c)). If the IIC directs the establishment to reduce the line speed, then they are to issue an NR using the PHIS Poultry RTC task and citing 9 CFR 381.69(c), 9 CFR 381.1 and 381.76 (b)(6)(ii)(A).
- IPP are to associate the NRs that are issued for the failure to meet the RTC definition and associated documentation requirements when they identify a pattern or trend of systemic failure to meet these requirements. IPP are to discuss with their supervisor and notify the District Office (DO) when establishment management is unwilling or unable to take necessary steps to re-establish control of its process necessary to meet RTC regulatory requirements.
- The DO is to notify the establishment in writing that repeated noncompliances may lead to a regulatory control action (9 CFR 500.2) that would affect the entire production of the product in question because product is economically adulterated or misbranded or was produced under conditions that preclude FSIS from determining that product is not adulterated or misbranded.
CHAPTER V - QUESTIONS
Refer questions regarding this directive to your supervisor or if needed to OPPD through askFSIS or by telephone at 1-800-233-3935. When submitting a question, complete the web form and select General Inspection Policy for the inquiry type.
NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.