Title 9: Animals and Animal Products
PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS
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Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts
§ 381.76 Post-mortem inspection, when required; extent; traditional, Streamlined Inspection System (SIS), New Line Speed (NELS) Inspection System and the New Turkey Inspection (NTI) System; rate of inspection.
(a) A post-mortem inspection shall be made on a bird-by-bird basis on all poultry eviscerated in an official establishment. No viscera or any part thereof shall be removed from any poultry processed in any official establishment, except at the time of post-mortem inspection, unless their identify with the rest of the carcass is maintained in a manner satisfactory to the inspector until such inspection is made. Each carcass to be eviscerated shall be opened so as to expose the organs and the body cavity for proper examination by the inspector and shall be prepared immediately after inspection as ready-to-cook poultry. If a carcass is frozen, it shall be thoroughly thawed before being opened for examination by the inspector. Each carcass, or all parts comprising such carcass, shall be examined by the inspector, except for parts that are not needed for inspection purposes and are not intended for human food and are condemned.
(b)(1) There are five systems of post-mortem inspection: Streamlined Inspection System (SIS) and the New Line Speed (NELS) Inspection System, both of which shall be used only for broilers and cornish game hens; the New Turkey Inspection (NTI) System, which shall be used only for turkeys; Traditional Inspection; and Ratite Inspection.
(i) The SIS shall be used only for broilers and cornish game hens if:
(a) The Administrator determines that SIS will increase inspector efficiency; or
(b) The operator requests SIS and the Administrator determines that the system will result in no loss of inspection efficiency.
(ii) The NELS Inspection System shall be used only for broilers and cornish game hens if:
(a) The operator requests the NELS Inspection System, and
(b) The Administrator determines that the establishment has the intent and capability to operate at line speeds greater than 70 birds per minute, and meets all the facility requirements in §381.36(d).
(iii) The NTI System shall be used only for turkeys if:
(a) The operator requests it, and
(b) The Administrator determines that the establishment meets all the facility requirements in §381.36(e).
(iv) Traditional inspection shall be used for turkeys when the NTI System is not used. For other classes of poultry, Traditional Inspection shall be used when neither the SIS nor the NELS Inspection System is used.
(2) The requirements of paragraph (a) of this section are applicable to all four inspection systems.
(3) The following requirements are applicable to SIS:
(i) Definitions. For purposes of this paragraph, the following definitions shall apply:
(a) Cumulative sum (CUSUM). A statistical concept used by the establishment and monitored by the inspector whereby compliance is determined based on sample results collected over a period of time. For purposes of determining compliance with the finished product standards, the CUSUM is equal to the sum of prior test results plus the weighted result of the current test minus the tolerance, with the condition that the resulting CUSUM cannot go below zero.
(b) Tolerance number. A weighted measure that equates to product being produced at a national product quality level. See Table 2.
(c) Action number. A level reached by the CUSUM where the process is out of control and product action is required by the establishment or the inspector. See Table 2.
(d) “Start number”. A value halfway between zero and the action number. The start number is used to determine the starting CUSUM for the first subgroup of a shift and to reset the CUSUM value if the CUSUM is equal to or greater than the action number. See Table 2.
(e) Subgroup. A 10-bird sample collected before product enters the chiller and after product leaves the chiller.
(f) Subgroup absolute limit. The tolerance number plus 5. See Table 2.
(g) Prechill testing. Testing conducted by the establishment to determine the CUSUM on consecutive 10-bird subgroup samples collected prior to product entering the chilling system.
(h) Postchill testing. Testing conducted by the establishment to determine the CUSUM on consecutive 10-bird subgroup samples collected as the product leaves the chilling system.
(i) Rework. Reprocessing the product to correct the condition or conditions causing the nonconformances listed in Table 1.
(ii) General. (a) Under SIS, one inspector inspects the outside, inside, and viscera of each bird. There may be two inspectors on one processing line, each inspecting every other bird. For the establishment to run its processing line(s) at maximum speed, optimal conditions must be maintained so that inspection may be conducted efficiently. The inspector in charge determines the speed at which each processing line may be operated to permit inspection. A variety of conditions may affect this determination including the health of each flock and the manner in which birds are being presented to the inspector for inspection.
(b) SIS may be performed by one inspector (SIS–1) or two inspectors (SIS–2). SIS–1 requires that the establishment provide one inspection station for each line and adequate reinspection facilities so carcasses can be removed from each line for evaluation. The maximum line speed for SIS–1 is 35 birds per minute. SIS–2 requires that the establishment provide two inspection stations for each line and adequate reinspection facilities so carcasses can be removed from each line for evaluation. The maximum line speed for SIS–2 is 70 birds per minute.
(c) Under all inspection systems, including SIS, inspectors conduct post-mortem inspection and look for a number of conditions, as specified elsewhere in this subpart, which may indicate adulteration. Adulterated product is condemned and destroyed, except that carcasses and parts which may be made unadulterated by reprocessing (reworking) may be so reprocessed under the supervision of an inspector and reinspected. Under SIS, inspectors also reinspect product by sampling finished birds (both before and after chilling) for nonconformances with finished product standards (see Table 1). If such nonconformances are present at certain statistical levels, it may indicate process difficulties requiring corrective action by the establishment. If the establishment does not take adequate corrective action, the inspector shall initiate corrective actions such as conducting closer post-mortem inspections and requiring reprocessing and reinspection of previously processed carcasses and parts. Thus, SIS is conducted in two phases—a post-mortem inspection phase and a reinspection phase. The following paragraphs describe the inspection requirements (not addressed elsewhere in this subpart) under each.
(iii) Post-mortem inspection. (a) Facilities: Each inspection station must comply with the facility requirements in §381.36(c).
(b) Presentation: Each inspector shall be flanked by an establishment employee assigned to be the inspector's helper. The one inspector on the SIS–1 line shall be presented every bird. Each inspector on the SIS–2 line shall be presented every other bird on the line. An establishment employee shall present each bird to the inspector properly eviscerated with the back side toward the inspector and the viscera uniformly trailing or leading. Each inspector shall inspect the inside, viscera, and outside of all birds presented.
(c) Disposition: The inspector shall determine which birds shall be salvaged, reprocessed, condemned, retained for disposition by the veterinarian, or allowed to proceed down the line as a passed bird subject to trim and reinspection. Carcasses with certain defects not requiring condemnation of the entire carcass shall be passed by the inspector, but shall be subject to reinspection to ensure the physical removal of the defects. The helper, under the supervision of the inspector, shall mark such carcasses for trim when the defects are not readily observable. Trimming of birds passed subject to reinspection shall be performed by:
(1) The helper, time permitting, and
(2) One or more plant trimmers positioned after all giblets are harvested and prior to reinspection.
(iv) Reinspection. (a) Facilities: Reinspection stations are required at both the prechill and postchill locations. The Agency will determine the number of stations needed in those establishments having more than one processing line or more than one chiller. One or more prechill reinspection stations shall be conveniently located at the end of the line or lines prior to chilling. One or more postchill stations must be conveniently located at the end of the chiller or chillers. The prechill and postchill reinspection stations must meet the following provisions:
(1) Floor space shall consist of 3 feet along each conveyor line. The space shall be level and protected from all traffic and overhead obstructions.
(2) A table at least 2 feet wide and 2 feet deep and 3 feet in height designed to be readily cleanable and drainable shall be provided for reinspecting the sampled birds.
(3) A minimum of 200 foot-candles of shadow-free lighting with a minimum color rendering index of 85 on the table surface.
(4) A separate clip board holder shall be provided for holding the recording sheets.
(5) Hangback racks designed to hold 10 carcasses shall be provided for and positioned within easy reach of the person at the station.
(b) Disposition: An inspector shall monitor the establishment's application of the Finished Product Standards program and shall take corrective action including retaining product to prevent adulterated product from leaving the establishment when the inspector determines that the establishment has failed to apply the program as prescribed in paragraph (b)(3)(iv)(c) of this section).
(c) Finished Product Standards: Finished Product Standards (FPS) are criteria applied to processed birds before and after chill to ensure that the product being produced is consistently wholesome and unadulterated. These criteria consist of nonconformances (listed in Table 1), the incidence of which is determined from 10 bird subgroup samples, reduced to a CUSUM number, and measured against the standards (Table 2). The standards are applied to permit the Agency to estimate when the production process is in control and when it is out of control. The establishment is responsible for maintaining FPS which, in turn, is monitored by the inspector. FPS is applied in two separate parts. The first is called prechill testing. It is designed to ensure that the slaughter and evisceration procedures are in control. Compliance is measured by determining the CUSUM on consecutive 10-bird subgroup samples collected prior to product entering the chilling system. The second part of the FPS is called postchill testing. It is designed to monitor the production through the chill system to ensure that it meets the postchill FPS. This test is independent of the prechill test. Compliance is measured by determining the CUSUM on consecutive 10-bird subgroup samples as they exit the chilling system. When the system is operating within compliance, the establishment applies the FPS to product samples at the prechill reinspection station. Testing time and time between tests are such that birds represented by the test are still within the chiller. If an out-of-compliance condition is found, the product leaving the chiller is segregated for rework and retested before it may proceed into commerce. A second 10 bird subgroup sample of the birds is taken after they leave the chiller to ensure that the product meets the postchill FPS. Since the product is closer to the end of processing, the controls on releasing reworked product are stricter than controls under prechill testing, again to ensure that no adulterated product enters into commerce.
(d) Prechill testing. The prechill FPS have been divided into processing and trim categories. The processing category is designed to monitor the output of the dressing and evisceration procedures. The trim category monitors the establishment's ability to remove unwholesome lesions and conditions from inspected and passed carcasses. Each category is monitored independently of the other category using a separate CUSUM for each category.
(1) Actions to be taken when the process is in control. If the CUSUM is less than the action number and the subgroup absolute limit is not exceeded, the process is judged to be in control.
(i) Establishment Actions. The establishment shall:
(A) Randomly select and record subgroup sampling times for each production unit of time before product reaches the prechill reinspection station on the production line. In no case shall the time between tests exceed 1 hour of production time.
(B) Conduct a 10-bird subgroup test at a random time on each poultry slaughter line. These times are preselected by the establishment and available to the inspector prior to the start of the shift/day's operations. All 10 samples of the subgroup shall be collected at the random time.
(C) Obtain the weighted value of each nonconformance by multiplying the number recorded for each nonconformance by the “factor” in Table 1, sum the total of all the nonconformances, and calculate the CUSUM value for that test.
(ii) Inspector Actions. The inspector shall:
(A) Select random times for monitoring subgroup tests for each half-shift on the evisceration line. In establishments that have multiple evisceration lines on a production shift, monitor all lines of product at the random times.
(B) Collect the subgroup samples to be monitored at preselected times. All 10 samples of the subgroup shall be collected at the random time selected in paragraph (b)(3)(iv)(d)(1)(ii)(A) of this section.
(C) Conduct the 10-bird monitoring subgroup test.
(2) Actions to be taken when the subgroup absolute limit is exceeded. If either an inspector or establishment subgroup test exceeds the subgroup absolute limit of tolerance plus 5 (T+5), the establishment shall determine if any of the immediate past 5 plant prechill subgroups for that category (processing or trim) resulted in a CUSUM above the start number.
(i) If all of the past 5 plant prechill subgroups are at or below the start number, the establishment shall immediately conduct a retest subgroup on that category of prechill to determine sample validity. If retest subgroup total equals tolerance or less, the establishment resumes random time testing. If the retest subgroup total exceeds tolerance, the establishment shall proceed as if CUSUM reaches the action number and shall begin process actions as set forth in paragraph (b)(3)(iv)(d)(4) of this section. In either case, the prechill retest results will be used to calculate CUSUM.
(ii) If any of the past 5 plant prechill subgroups resulted in a CUSUM above the start number, the establishment shall proceed as if CUSUM reaches the action number and shall begin process actions as set forth in paragraph (b)(3)(iv)(d)(4) of this section.
(3) Actions to be taken when a trimmable lesion/condition is found. If either inspection or plant monitoring finds any trimmable lesion or condition as specified in item B(7) of Table 1 during a prechill subgroup test, the establishment shall immediately conduct an additional prechill subgroup test for the same trimmable lesion/condition category. This is a requirement on the subgroup testing for the prechill trim nonconformance that is in addition to the CUSUM test described in paragraph (b)(3)(iv)(d)(1) of this section.
(i) If no additional item in the same category is found on retest, the establishment shall resume random time sampling.
(ii) If an additional item in the same category is found on retest, the establishment shall proceed as if CUSUM reaches the action number and shall initiate corrective action set forth in paragraph (b)(3)(iv)(d)(4) of this section for this category only.
(4) Actions to be taken when the CUSUM reaches the action number. Once CUSUM reaches the action number, the process is judged to be not in control.
(i) Establishment Actions. The establishment shall:
(A) Immediately notify the inspector in charge and the production supervisor responsible for the affected evisceration line.
(B) Suspend random time prechill testing of the affected nonconformance category (processing or trim). Suspend random time postchill subgroup testing when the processing category is the affected nonconformance category.
(C) Conduct subgroup retests on carcasses leaving the chill system. Apply the prechill criteria in Table 1 (A) or (B), depending upon which category caused the action, and apply prechill Finished Product Standards as listed in Table 2 to determine product compliance. In no case shall the time between retests exceed 30 minutes of production time. Apply prechill standard criteria at the postchill location after notifying the establishment's production supervisor. If any of these subgroup retests on product leaving the chill system result in a subgroup total exceeding tolerance, identify for rework subsequent product at the postchill location. All noncomplying product will be brought into compliance prior to release into commerce. Product from the chiller will continue accumulating for rework until a subsequent subgroup test results in a subgroup total equal to or less than tolerance.
(D) Conduct additional subgroup tests at the prechill reinspection station to determine the adequacy of production corrective action. If the prechill tests results in a subgroup total exceeding the tolerance, notify the production supervisor. The number of additional tests at the postchill reinspection station using prechill standards is increased as required to include the product in the chiller represented by this additional prechill test.
(E) After two consecutive additional prechill subgroup tests result in subgroup totals equal to or less than tolerance:
—Resume random time prechill subgroup testing as set forth in actions to be taken when the process is in control at paragraph (b)(3)(iv)(d)(1) of this section.
—Identify product entering the chill system that will mark the end of the retest action upon arrival at the postchill sampling location. Such identification may include tagging or empty space in chillers, depending upon the establishment's identification method.
—Once all product identified as needing retesting has arrived at the postchill sampling location, random time postchill FPS testing resumes.
—If two consecutive additional prechill subgroup tests demonstrate process control with subgroup totals equal to or less than tolerance, but they do not cause CUSUM to fall to the start line or below, reset CUSUM at the start number.
(ii) Inspector Actions. The inspector shall monitor product and process actions by making spot-check observations to ensure that all program requirements are met.
(e) Postchill testing. Postchill subgroups shall be collected after the product leaves the chiller but before the product is divided into separate processes. Each bird sampled shall be observed and its conformance measured against the postchill criteria. The subgroup nonconformance weights shall be totaled and the CUSUM calculated by subtracting the tolerance from the sum of the subgroup total and the starting CUSUM.
(1) Actions to be taken when the process is in control. If the CUSUM is less than the action number and the subgroup absolute limit is not exceeded, the process is judged to be in control.
(i) Establishment Actions. The establishment shall conduct a 10-bird subgroup test for each chiller system at a randomly selected time of production. In no case shall the time between tests exceed 2 hours of production time.
(ii) Inspector Actions. The inspector shall:
(A) Select random times for postchill monitoring.
(B) Monitor each chill system twice per shift.
(C) Conduct subgroup tests at preselected random times.
(2) Actions to be taken when the subgroup absolute limit is exceeded. If either an inspector or establishment subgroup test exceeds the subgroup absolute limit of tolerance plus 5(T+5), the establishment shall determine if any of the last 5 postchill monitoring subgroups resulted in a CUSUM above the start number.
(i) If all of the past 5 postchill monitoring subgroups resulted in a CUSUM at or below the start number, the establishment shall immediately retest a subgroup to determine sample validity. If this retest subgroup total exceeds tolerance, the establishment shall proceed as if CUSUM reaches the action number and shall begin process actions as set forth in paragraph (b)(3)(iv)(e)(3) of this section.
(ii) If any of the past 5 postchill monitoring subgroups resulted in a CUSUM above the start number, the establishment shall proceed as if CUSUM reaches the action number and shall begin process actions as set forth in paragraph (b)(3)(iv)(e)(3) of this section.
(3) Actions to be taken when the CUSUM reaches the action number. Once CUSUM reaches the action number, the process is judged to be not in control.
(i) Establishment Actions. The establishment shall:
(A) Notify the inspector in charge and the production supervisor responsible for product in the chiller.
(B) Suspend random time postchill subgroup testing.
(C) Immediately conduct an additional postchill subgroup test. If the retest subgroup total exceeds tolerance, the establishment shall identify subsequent product for rework. Product will continue accumulating for rework until a subsequent subgroup test results in a subgroup total equal to or less than tolerance.
(D) After two consecutive additional postchill subgroup tests results in subgroup totals equal to or less than tolerance:
—Resume random time postchill subgroup testing as set forth in actions to be taken when the process is in control at paragraph (b)(3)(iv)(e)(1) of this section.
—If the two consecutive additional postchill subgroup totals equal to or less than tolerance do not cause CUSUM to fall to the start number or below, reset CUSUM at the start number.
(ii) Inspector Actions. The inspector shall monitor product and process actions to ensure that program requirements are met.
(v) When the prechill or postchill product has been identified as having been produced when the process was not in control, additional online subgroup testing by the establishment is required to determine its conformance to the standard. If any of the additional plant subgroup testing results in a subgroup total exceeding tolerance, offline product corrective actions must take place. The responsibilities of the establishment and the inspector change depending on the CUSUM.
All corrective actions such as identifying affected product, segregating product, and maintaining control through rework actions are the establishment's responsibility. Corrective actions by the inspector depends upon the establishment's ability to control rework of affected product. If the establishment fails in its responsibilities, the inspector will identify, segregate, and retain affected product to prevent adulterated product from reaching consumers.
(a) Offline product. The establishment shall identify the affected product so that it may be segregated and accumulated offline for rework. The inspector shall spot check the establishment's identification, segregation, and control of reworked product to ensure that program requirements are met.
(b) Reworked product. Reworked product must be tested by the establishment with a randomly selected subgroup test of the accumulated reworked lot. Before product is released, the random subgroup test must result in a subgroup total equal to or less than tolerance. If the subgroup test of a reworked lot results in a subgroup total exceeding tolerance, the lot must be reworked again before another subgroup is selected. The following actions are required.
(1) Establishment Actions. The establishment shall:
(i) Select the random subgroup from throughout the lot only after the total lot has been reworked.
(ii) Conduct the subgroup test using the same criteria (prechill or postchill) that resulted in the rework action.
(iii) Release the lot if the reworked subgroup test resulted in a subgroup total equal to or less than tolerance.
(iv) Identify and control the lot to be reworked if the reworked subgroup total again exceeds tolerance.
(2) Inspector Actions: The inspector shall spot check the rework procedure to ensure that plant monitoring and production meet the requirements of the program.
(vi) After the 10 bird subgroup tests are completed, the prechill and postchill processing nonconformances shall be corrected on all bird samples prior to returning the samples to the product flow. Samples with trim nonconformances shall be returned to the trim station for correction prior to their return to the product flow.
Table 1_Definitions of Nonconformances A Processing Nonconformances1 Extraneous material [le]\1/ 16\[inch] _Include any specks, tiny smears, or stains of material that measure \1/16\[inch] or less in the greatest dimension. Examples: Ingesta, unattached feathers, grease, bile remnants, and/or whole gall bladder or spleen, embryonic yolk, etc. _Factor is one. _1 to 5=1 defect: 6 to 10=2 defects; 11 or more=3 defects. A maximum of three incidents per carcass.2 Extraneous material >\1/ 16\[inch] to 1[inch] _The same material as line 1, but measuring >\1/ 16\[inch] to 1[inch] in the longest dimension. _Factor is one. _A maximum of three incidents per carcass.3 Extraneous material >1[inch] _The same material as lines 1 to 2, but measuring greater than one inch. _Factor is two. _A maximum of two incidents per carcass.4 Oil glands remnant_less than two whole glands _Recognizable fragment(s) of one or both oil glands equals one incident. _Factor is one. _Maximum of one incident per carcass.5 Oil glands_two whole glands _Both whole oil glands with no missing fragments equals one incident. If the oil glands are cut, but no fragment is removed, consider them to be whole. But if even a small fragment is removed, use line 4. _Factor is two. _A maximum of one incident per carcass.6 Lung >=\1/ 4\[inch] whole _Any portion less than a whole lung, and equal to or greater than \1/ 4\[inch] at the greatest dimension, equals one incident. _Factor is one. _A maximum of two incidents per carcass.7 Lung_whole _Each whole lung equals one incident. _Factor is two. _A maximum of two incidents per carcass.8 Intestine _Any identifiable portion of the terminal portion of the intestinal tract with a lumen (closed circle) present, or split piece of intestine large enough to be closed to form a lumen. _Factor is five. _A maximum of one incident per carcass.9 Cloaca _Any identifiable portion of the terminal portion of the intestinal tract with mucosal lining. _Factor is five. _A maximum of one incident per carcass.10 Bursa of Fabricius _A whole rosebud, or identifiable portion with two or more mucosal folds. _Factor is two. _A maximum of one incident per carcass.11 Esophagus _Any portion of the esophagus with identifiable mocosal lining. _Factor is two. _A maximum of one incident per carcass.12 Crop_partial_wit h mucosa _Any portion of the crop that includes the mucosal lining. _Factor is two. _A maximum of one incident per carcass.13 Crop_whole _Any complete crop. _Factor is five. _A maximum of one incident per carcass.14 Trachea [le]1[inch] _Identifiable portion of trachea less than or equal to one inch long. _Factor is one. _A maximum of one incident per carcass.15 Trachea >1[inch] _Identifiable portion of trachea greater than one inch. _Factor is two. _A maximum of one incident per carcass.16 Hair >=\1/ 4\[inch] 26 or more. _Hair which is one- fourth inch long or longer measured from the top of the follicle to the end of the hair. 26 or more hairs equal one incident. _Factor is one. _A maximum of one incident per carcass.17 Feather and/or Pinfeathers [le]1[inch] _Attached feathers or protruding pinfeathers less than or equal to one inch long. Scored 5 to 10 per carcass as one incident, 11 to 15 per carcass as two incidents, and 16 or more as three incidents. _Factor is one. _A maximum of three incidents per carcass.18 Feathers >1[inch] _Attached feathers longer than one inch. Scored 1 to 3 per carcass as one incident 4 to 6 per carcass as two incidents, and 7 or more as three incidents. _Factor is one. _A maximum of three incidents per carcass.19 Long Shank_both condyles covered _If the complete tibiotarsal joint is covered, it equals one incident. _Factor is two. _A maximum of two incidents per carcass. B Trim nonconformances1 Breast blister _Inflammatory tissue, fluid, or pus between the skin and keel must be trimmed if membrane ``slips'' or if firm nodule is greater than \1/2\[inch] in diameter (dime size). _Factor is two. _A maximum of one incident per carcass.2 Breast blister_partiall y trimmed _All inflammatory tissue, including that which adheres tightly to the keel bone, must be removed. _Factor is two. _A maximum of one incident per carcass.3 Bruise \1/ 2\[inch] to 1[inch] _Blood clumps or clots in the superficial layers of tissue, skin, muscle or loose subcutaneous tissue may be slit and the blood completely washed out. When the bruise extends into the deeper layers of muscle, the affected tissue must be removed. Very small bruises less than \1/ 2\[inch] (dime size) and areas showing only slight reddening need not be counted as defects. _Factor is one. _A maximum of five incidents per carcass.4 Bruise >1[inch] _Same criteria as in line three, but greater than one inch in greatest dimension. _Factor is two. _A maximum of three incidents per carcass.5 Bruise black/ green \1/ 4\[inch] to 1[inch] _Bruises \1/ 4\[inch] to 1[inch] that have changed from red to a black/blue or green color due to age. _Factor is two. _A maximum of three incidents per carcass.6 Bruise Black/ green >1[inch] _Same as line 5, but measuring greater that 1[inch] in greatest dimension. _Factor is five. _A maximum of two incidents per carcass.7 Trimmable lesions/ Condition _A trimmable tumor or identifiable portion of a tumor on any part of the carcass. _Trimmable Synovitis/ airsacculiti s (saddle/ frog) lesions that have not been removed. _Lesion/ condition subject to removal following an approved cleanout process. Examples: airsacculiti s, salpingitis, nephritis, spleen, or liver conditions requiring removal of the kidneys.Note: All establishments shall develop and maintain a permanent marking system that identifies carcasses with removable lesions/ conditions on the inside surfaces. When removable lesions/ conditions are identified inside the carcass by the inspector, the helper will be notified to apply the permanent mark. When removable inside lesions/ conditions are found on a subgroup sample without the permanent mark, the error is not recorded in line 7. The affected carcass(s) will be hungback for IIC disposition and corrective action. _Factor is five. _A maximum of one incident per carcass.8 Failure to complete task as indicated by marking system. Example: Synovitis, airsacculiti s, inflammatory process, contaminatio n, etc. _The helper, under the inspector's direction, will apply a mark to the carcass, indicating to the trimmer(s) that specific action must be taken on that carcass. When airsac and kidney cleanout, or synovitis part removal, or carcass removal from the line is not completed, or only partially completed, this occurrence is recorded as one defect. _Factor is five. It will also be recorded as a line 7 defect for a total factor of 10. _A maximum of one incident per carcass.9 Compound fracture _Any bone fracture (i.e., leg or wing) that has caused an opening through the skin. May be accompanied with a bruise, but not always. Do not count the bruise in line 3 or 4 if it is associated with the compound fracture. _Factor is two. _A maximum of three incidents per carcass.10 Wingtip compound fracture _Same criteria as line 9, but only for wingtips. Note: Bruises not associated with the fracture should be recorded in the appropriat e lines. _Factor is one. _A maximum of two incidents per carcass.11 Untrimmed short hock _When no cartilage of the hock surface is present and no tendons are attached to the bone. _Factor is two. _A maximum of two incidents per carcass.12 Sores, scabs, inflammatory process, etc. [le]\1/2\[inch] _Any defects such as sores, abscesses, scabs, wounds, dermatitis, inflammatory process, that measure less than or equal to \1/ 2\[inch] in the greatest dimension. _Factor is two. _A maximum of two incidents per carcass.13 Sores, scabs, inflammatory process, etc. >\1/2\[inch] _Same as line 12, but greatest dimension is greater than \1/2\[inch], or a cluster of smaller lesions in close proximity >\1/ 2\[inch], this category also includes turkey leg edema. _Factor is five. _A maximum of one incident per carcass.14 External mutilation _Mutilation to the skin and/or muscle that is caused by the slaughter, dressing or eviscerating processes. Skinned elbows (bucked wings) do not trim require unless affected wing joint capsule is also opened. _Factor is one. _A maximum of three incidents per carcass. C Postchillnonconformances_( Designed to monitor those nonconformances added to product during thechilling process)1 Extraneous material [le]\1/ 16\[inch] _Include specks, grease, or unidentifiab le foreign material that measure \1/16\[inch] or less in the greatest dimension. _Example: Ingesta, grease, or unidentifiab le foreign material. _Factor is one. _3 to 7=1 defect; 8 to 12=2 defects; 13 or more=3 defects. A maximum of three incidents per carcass.2 Extraneous material >\1/ 16\[inch] to 1[inch] _This includes ingesta, grease, or unidentifiab le foreign material measureing >\1/ 16\[inch] to 1[inch] longest dimension. _Factor is one. _A maximum of three incidents per carcass.3 Extraneous material >1[inch] _The same material as line 2, but measuring greater than one inch. _Factor is two. _A maximum of two incidents per carcass.
Table 2_Finished Product Standards SIS Prechill Processing Nonconformance Tolerance number (T)......................................... 25 Subgroup Absolute Limit (T+5)................................ 30 Action number................................................ 22 Start number................................................. 11Prechill Trim Nonconformance Tolerance number (T)......................................... 12 Subgroup Absolute Limit (T+5)................................ 17 Action number................................................ 15 Start number................................................. 8Postchill Nonconformance Tolerance number (T)......................................... 5 Subgroup Absolute Limit (T+5)................................ 10 Action number................................................ 10 Start number................................................. 5
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(4) The following requirements are also applicable to NELS inspection:
(i) Inspection under NELS is conducted in two phases, as post-mortem inspection phase and a reinspection phase.
(a) Post-mortem inspection. The establishment shall provide three inspection stations on each eviscerating line in compliance with the facility requirements §381.36(d)(1). The three inspectors shall inspect the inside, viscera, and outside of all birds presented. Each inspector shall be flanked by two establishment employees—the presenter and the helper. The presenter shall ensure that the bird is properly eviscerated and presented for inspection and the viscera uniformly trailing or leading. The inspector shall determine which birds shall be salvaged, reprocessed, condemned, retained for disposition by the veterinarian, or allowed to proceed down the line as a passed bird subject to reinspection. Poultry carcasses with certain defects not requiring condemnation of the entire carcass shall be passed by the inspector, but shall be subject to reinspection to ensure the physical removal of the specified defects. The helper, under the supervision of the inspector, shall mark such carcasses for trim when the defects are not readily observable. Trimming or birds passed subject to reinspection shall be performed by:
(1) The helper, time permitting, and
(2) One or more plant trimmers positioned after giblet harvest and prior to reinspection.
(b) A reinspection station shall be located at the end of each line. This station shall comply with the facility requirements in §381.36(d)(2). The inspector shall ensure that the establishment has performed the indicated trimming of carcasses passed subject to reinspection by visually monitoring, checking data, or gathering samples at the station or at other critical points on the line.
(ii)–(iii) [Reserved]
(iv) The maximum inspection rate for NELS shall be 91 birds per minute per eviscerating line.
(5) The following requirements are also applicable to the NTI System:
(i) Inspection under the NTI System is conducted in two phases, a post-mortem inspection phase and a reinspection phase. The NTI–1 Inspection System requires that the establishment provide one inspection station for each line and adequate reinspection facilitiates so carcasses can be removed from each line for evaluation. The NTI–2 Inspection System requires that the establishment provide two inspection stations for each line and adequate reinspection facilities so carcasses can be removed from each line for evaluation.
(a) Post-mortem inspection. Each inspection station must comply with the facility requirements in §381.36(e)(1). Each inspector shall be flanked by and establishment employee assigned to be the inspector's helper. The one inspector on an NTI–1 Inspection System shall be presented every bird. Each inspector on an NTI–2 Inspection System line shall be presented every other bird on the line. An establishment employee shall present each bird to the inspector properly eviscerated with the back side toward the inspector and the viscera uniformly trailing or leading. Each inspector shall inspect the inside, viscera, and outside of all birds presented. The inspector shall determine which bird shall be salvaged, reprocessed, condemned, retained for disposition by a veterinarian, or allowed to proceed down the line as a passed bird subject to reinspection. Turkey carcasses with certain defects not requiring condemnation of the entire carcass shall be passed by the inspector, but shall be subject to reinspection to ensure the physical removal of the specified defects. The helper, under the supervision of the inspector, shall mark such carcasses for trim when the defects of birds passed subject to reinspection shall be performed by:
(1) The helper, time permitting, and
(2) One or more plant trimmers positioned after the giblet harvest and prior to reinspection.
(b) Reinspection. A reinspection station shall be located at the end of the lines. This station shall comply with the facility requirements in §381.36(e)(2). The inspector shall ensure that establishments have performed the indicated trimming of each carcass passed subject to reinspection by visually monitoring, checking data, and/or sampling product at the reinspection station and, if necessary, at other points, critical to the wholesomeness of product, on the eviscerating line.
(ii)–(iii) [Reserved] (Recordkeeping requirements approved by the Office of Management and Budget under control number 0583–0008)
[47 FR 23435, May 28, 1982, as amended at 49 FR 42555, Oct. 23, 1984; 50 FR 37513, Sept. 16, 1985; 50 FR 38097, Sept. 20, 1985; 51 FR 3574, Jan. 29, 1986; 53 FR 46861, Nov. 21, 1988; 62 FR 5143, Feb. 4, 1997; 65 FR 34390, May 30, 2000; 66 FR 22906, May 7, 2001] § 381.77 Carcasses held for further examination.
Each carcass, including all parts thereof, in which there is any lesion of disease, or other condition which might render such carcass or any part thereof adulterated and with respect to which a final decision cannot be made on first examination by the inspector, shall be held for further examination. The identity of each such carcass, including all parts thereof, shall be maintained until a final examination has been completed. § 381.78 Condemnation of carcasses and parts: separation of poultry suspected of containing biological residues.
(a) At the time of any inspection under this subpart each carcass, or any part thereof, which is found to be adulterated shall be condemned, except that any such articles which may be made not adulterated by reprocessing, need not be so condemned if so reprocessed under the supervision of an inspector and thereafter found to be not adulterated.
(b) When a lot of poultry suspected of containing biological residues is inspected in an official establishment, all carcasses and any parts of carcasses in such lot which are condemned shall be kept separate from all other condemned carcasses or parts.
[37 FR 9706, May 16, 1972, as amended at 48 FR 22899, May 23, 1983; 48 FR 23807, May 27, 1983] § 381.79 Passing of carcasses and parts.
Each carcass and all organs and other parts of carcasses which are found to be not adulterated shall be passed for human food. § 381.80 General; biological residues.
(a) The carcasses or parts of carcasses of all poultry inspected at an official establishment and found at the time of post mortem inspection, or at any subsequent inspection, to be affected with any of the diseases or conditions named in other sections in this subpart, shall be disposed of in accordance with the section pertaining to the disease or condition. Owing to the fact that it is impracticable to formulate rules for each specific disease or conditions and to designate at just what stage a disease process results in an adulterated article, the decision as to the disposal of all carcasses, organs or other parts not specifically covered by the regulations, or by instructions of the Administrator issued pursuant thereto, shall be left to the inspector in charge, and if the inspector in charge is in doubt concerning the disposition to be made, specimens from such carcasses shall be forwarded to the Inspection Service laboratory for diagnosis.
(b) All carcasses, organs, or other parts of carcasses of poultry shall be condemned if it is determined on the basis of a sound statistical sample that they are adulterated because of the presence of any biological residues. § 381.81 Tuberculosis.
Carcasses of poultry affected with tuberculosis shall be condemned. § 381.82 Diseases of the leukosis complex.
Carcasses of poultry affected with any one or more of the several forms of the avian leukosis complex shall be condemned. § 381.83 Septicemia or toxemia.
Carcasses of poultry showing evidence of any septicemic or toxemic disease, or showing evidence of an abnormal physiologic state, shall be condemned. § 381.84 Airsacculitis.
Carcasses of poultry with evidence of extensive involvement of the air sacs with airsacculitis or those showing airsacculitis along with systemic changes shall be condemned. Less affected carcasses may be passed for food after complete removal and condemnation of all affected tissues including the exudate.
[40 FR 14297, Mar. 31, 1975] § 381.85 Special diseases.
Carcasses of poultry showing evidence of any disease which is characterized by the presence, in the meat or other edible parts of the carcass, or organisms or toxins dangerous to the consumer, shall be condemned. § 381.86 Inflammatory processes.
Any organ or other part of a carcass which is affected by an inflammatory process shall be condemned and, if there is evidence of general systemic disturbance, the whole carcass shall be condemned. § 381.87 Tumors.
Any organ or other part of a carcass which is affected by a tumor shall be condemned and when there is evidence of metastasis or that the general condition of the bird has been affected by the size, position, or nature of the tumor, the whole carcass shall be condemned. § 381.88 Parasites.
Organs or other parts of carcasses which are found to be infested with parasites, or which show lesions of such infestation shall be condemned and, if the whole carcass is affected, the whole carcass shall be condemned. § 381.89 Bruises.
Any part of a carcass which is badly bruised shall be condemned and, if the whole carcass is affected as a result of the bruise, the whole carcass shall be condemned. Parts of a carcass which show only slight reddening from a bruise may be passed for food. § 381.90 Cadavers.
Carcasses of poultry showing evidence of having died from causes other than slaughter shall be condemned. § 381.91 Contamination.
(a) Carcasses of poultry contaminated by volatile oils, paints, poisons, gases, scald vat water in the air sac system, or other substances which render the carcasses adulterated shall be condemned. Any organ or other part of a carcass which has been accidentally multilated in the course of processing shall be condemned, and if the whole carcass is affected, the whole carcass shall be condemned.
(b)(1) Any carcass of poultry accidentally contaminated during slaughter with digestive tract contents shall not be condemned if promptly reprocessed under the supervision of an inspector and thereafter found not to be adulterated. Contaminated surfaces that are cut shall be removed only by trimming. Contaminated inner surfaces that are not cut may be cleaned by trimming alone, or at an approved reprocessing station away from the main processing line, by any method that will remove the contamination, such as vacuuming, washing, and trimming, singly or in combination. All visible specks of contamination must be removed, and if the inner surfaces are reprocessed other than soley by trimming, all surfaces of the carcass shall be treated with chlorinated water containing 20 ppm available chlorine.
(2) An area will be designated as an approved reprocessing station only if the Administrator determines that reprocessing operations can be conducted in that area in accordance with all of the requirements of this part, and that the reprocessing methods to be utilized are capable of removing all visible specks of contamination on the inner surface of a carcass. Requests for such approval shall be submitted to the inspector in charge and shall describe the proposed area, proposed methods of reprocessing, and proposed equipment to be utilized. Whenever the Administrator finds that reprocessing operations cannot be conducted in such area in accordance with all of the requirements of this part or that the reprocessing methods utilized are not capable of removing all visible specks of contamination on the inner surface of a carcass, he may withdraw approval of such area, effective upon oral or written notification, whichever is earlier, to the operator of the establishment. In the event of oral notification, a written confirmation thereof shall be given to the operator as promptly as circumstances permit. The notification shall specify the reasons for such withdrawal and shall afford the operator of the establishment an opportunity to present his views. In any instance where there is a conflict as to the facts, a hearing shall be held to resolve such conflict.
[37 FR 9706, May 16, 1972, as amended at 43 FR 12847, Mar. 28, 1978] § 381.92 Overscald.
Carcasses of poultry which have been overscalded, resulting in a cooked appearance of the flesh, shall be condemned. § 381.93 Decomposition.
Carcasses of poultry deleteriously affected by post mortem changes shall be disposed of as follows:
(a) Carcasses which have reached a state of putrefaction or stinking fermentation shall be condemned.
(b) Any part of a carcass which is green struck shall be condemned and, if the carcass is so extensively affected that removal of affected parts is impracticable, the whole carcass shall be condemned.
(c) Carcasses affected by types of post mortem change which are superficial in nature may be passed for human food after removal and condemnation of the affected parts. § 381.94 Contamination with Microorganisms; process control verification criteria and testing; pathogen reduction standards.
(a) Criteria for verifying process control; E. coli testing.
(1) Each official establishment that slaughters poultry shall test for Escherichia coli Biotype I (E. coli). Establishments that slaughter more than one type of poultry and/or poultry and livestock, shall test the type of poultry or livestock slaughtered in the greatest number. The establishment shall:
(i) Collect samples in accordance with the sampling techniques, methodology, and frequency requirements in paragraph (a)(2) of this section;
(ii) Obtain analytic results in accordance with paragraph (a)(3) of this section; and
(iii) Maintain records of such analytic results in accordance with paragraph (a)(4) of this section.
(2) Sampling requirements.
(i) Written procedures. Each establishment shall prepare written specimen collection procedures which shall identify employees designated to collect samples, and shall address location(s) of sampling, how sampling randomness is achieved, and handling of the sample to ensure sample integrity. The written procedure shall be made available to FSIS upon request.
(ii) Sample collection. A whole bird must be taken from the end of the chilling process. If this is impracticable, the whole bird can be taken from the end of the slaughter line. Samples must be collected by rinsing the whole carcass in an amount of buffer appropriate for that type of bird. Samples from turkeys or ratites also may be collected by sponging the carcass on the back and thigh.1
1 A copy of FSIS's “Guidelines for Escherichia coli Testing for Process Control Verification in Poultry Slaughter Establishments,” and “FSIS Turkey Microbiological Procedures for Sponge Sample Collection and Methods of Analysis” are available for inspection in the FSIS Docket Room.
(iii) Sampling frequency. Slaughter establishments, except very low volume establishments as defined in paragraph (a)(2)(v) of this section, must take samples at a frequency proportional to the establishment's volume of production at the following rates:
(A) Chickens: 1 sample per 22,000 carcasses, but a minimum of one sample during each week of operation.
(B) Turkeys, Ducks, Geese, Guineas, Squabs, and Ratites: 1 sample per 3,000 carcasses, but at a minimum one sample each week of operation.
(iv) Sampling frequency alternatives. An establishment operating under a validated HACCP plan in accordance with §417.2(b) of this chapter may substitute an alternative frequency for the frequency of sampling required under paragraph (a)(2)(iii) of this section if,
(A) The alternative is an integral part of the establishment's verification procedures for its HACCP plan and,
(B) FSIS does not determine, and notify the establishment in writing, that the alternative frequency is inadequate to verify the effectiveness of the establishment's processing controls.
(v) Sampling in very low volume establishments. (A) Very low volume establishments annually slaughter no more than 440,000 chickens, 60,000 turkeys, 60,000 ducks, 60,000 geese, 60,000 guineas, 60,000 squabs, 6,000 ratites, or a combination of all types of poultry not exceeding 60,000 turkeys and 440,000 birds total. Very low volume establishments that slaughter turkeys, ducks, geese, guineas, squabs, or ratites in the largest number must collect at least one sample during each week of operation after June 1 of each year, and continue sampling at a minimum of once each week the establishment operates until June of the following year or until 13 samples have been collected, whichever comes first.
(B) Upon the establishment's meeting the requirements of paragraph (a)(2)(v)(A) of this section, weekly sampling and testing is optional, unless changes are made in establishment facilities, equipment, personnel or procedures that may affect the adequacy of existing process control measures, as determined by the establishment or by FSIS. FSIS determinations that changes have been made requiring resumption of weekly testing shall be provided to the establishment in writing.
(3) Analysis of samples. Laboratories may use any quantitative method for analysis of E. coli that is approved as an AOAC Official Method of the AOAC International (formerly the Association of Official Analytical Chemists)2 or approved and published by a scientific body and based on the results of a collaborative trial conducted in accordance with an internationally recognized protocol on collaborative trials and compared against the three tube Most Probable Number (MPN) method and agreeing with the 95 percent upper and lower confidence limit of the appropriate MPN index.
2 A copy of the current edition/revision of the “Official Methods of AOAC International,” 16th edition, 3rd revision, 1997, is on file with the Director, Office of the Federal Register, and may be purchased from the Association of Official Analytical Chemists International, Inc., 481 North Frederick Ave., Suite 500, Gaithersburg, MD 20877–2417.
(4) Recording of test results. The establishment shall maintain accurate records of all test results, in terms of CFU/ml of rinse fluid. Results shall be recorded onto a process control chart or table showing at least the most recent 13 test results, by type of poultry slaughtered. Records shall be retained at the establishment for a period of 12 months and shall be made available to FSIS upon request.
(5)(i) Criteria for Evaluation of test results. An establishment is operating within the criteria when the most recent E. coli test result does not exceed the upper limit (M), and the number of samples, if any, testing positive at levels above (m) is three or fewer out of the most recent 13 samples (n) taken, as follows:
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Table 1_Evaluation of E. Coli Test Results---------------------------------------------------------------------------------------------------------------- Maximum number Lower limit of Upper limit of Number of permitted in Types of poultry marginal range marginal range samples tested marginal range (m) (M) (n) (c)----------------------------------------------------------------------------------------------------------------Chickens........................................ \1\ 100 \1\ 1,000 13 3Turkeys......................................... *NA *NA *NA *NADucks........................................... *NA *NA *NA *NAGeese........................................... *NA *NA *NA *NAGuineas......................................... *NA *NA *NA *NASquabs.......................................... *NA *NA *NA *NARatites......................................... *NA *NA *NA *NA----------------------------------------------------------------------------------------------------------------\1\ CFU/ml.* Values will be added upon completion of data collection programs.
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(ii) For types of poultry appearing in paragraph (a)(5)(1) Table 1 of this section that do not have m/N criteria, establishments shall evaluate E. coli test results using statistical process control techniques.
(6) Failure to meet criteria. Test results that do not meet the criteria described in paragraph (a)(5) of this section are an indication that the establishment may not be maintaining process controls sufficient to prevent fecal contamination. FSIS shall take further action as appropriate to ensure that all applicable provisions of the law are being met.
(7) Failure to test and record. Inspection will be suspended in accordance with rules of practice that will be adopted for such proceeding, upon a finding by FSIS that one or more provisions of paragraphs (a) (1)–(4) of this section have not been complied with and written notice of same has been provided to the establishment.
(b) Pathogen reduction performance standards; Salmonella—(1) Raw poultry product performance standards for Salmonella. (i) An establishment's raw poultry products, when sampled and tested by FSIS for Salmonella as set forth in this section, may not test positive for Salmonella at a rate exceeding the applicable national pathogen reduction performance standard, as provided in Table 2:
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Table 2_Salmonella Performance Standards---------------------------------------------------------------------------------------------------------------- Performance Standard Number of Maximum number Class of product (percent samples tested of positives to positive for (n) achieve standard salmonella) \a\ (c)----------------------------------------------------------------------------------------------------------------Broilers.................................................. 20.0% 51 12Ground chicken............................................ 44.6 53 26Ground turkey............................................. 49.9 53 29Turkeys................................................... b NA NA NASquabs.................................................... b NA NA NARatites................................................... b NA NA NA----------------------------------------------------------------------------------------------------------------a Performance Standards are FSIS's calculation of the national prevalence of Salmonella on the indicated raw products based on data developed by FSIS in its nationwide microbiological baseline data collection programs and surveys. (Copies of Reports on FSIS's Nationwide Microbiological Data Collection Programs and Nationwide Microbiological Surveys used in determining the prevalence of Salmonella on raw products are available in the FSIS Docket Room.)b Not available; baseline targets for turkeys, squabs, or ratites will be added upon completion of the data collection programs for that product.
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(2) Enforcement. FSIS will sample and test raw poultry products in an individual establishment on an unannounced basis to determine prevalence of Salmonella in such products to determine compliance with the standard. The frequency and timing of such testing will be based on the establishment's previous test results and other information concerning the establishment's performance. In an establishment producing more than one class of product subject to the pathogen reduction standard, FSIS may sample any or all such classes of products.3
3 A copy of FSIS's “Sample Collection Guidelines and Procedure for Isolation and Identification of Salmonella from Raw Meat and Poultry Products” is available for inspection in the FSIS Docket Room.
(3) Noncompliance and establishment response. When FSIS determines that an establishment has not met the performance standard:
(i) The establishment shall take immediate action to meet the standard.
(ii) If the establishment fails to meet the standard on the next series of compliance tests for that product, the establishment shall reassess its HACCP plan for that product.
(iii) Failure by the establishment to act in accordance with paragraph (b)(3)(ii) of this section, or failure to meet the standard on the third consecutive series of FSIS-conducted tests for that product, constitutes failure to maintain sanitary conditions and failure to maintain an adequate HACCP plan, in accordance with part 417 of this chapter, for that product, and will cause FSIS to suspend inspection services. Such suspension will remain in effect until the establishment submits to the FSIS Administrator or his/her designee satisfactory written assurances detailing the action taken to correct the HACCP system and, as appropriate, other measures taken by the establishment to reduce the prevalence of pathogens.
[61 FR 38866, July 25, 1996, as amended at 62 FR 26218, May 13, 1997; 62 FR 61009, Nov. 14, 1997; 64 FR 66553, Nov. 29, 1999; 67 FR 13258, Mar. 22, 2002]
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