Import Reinspection of Meat, Poultry, and Egg Products - Revision 2

FSIS directive 9900.2

Series Type 9000 Series: Exports & Imports

Issue Date Oct 12, 2021

Full Directive

9900.2.pdf

PURPOSE
This directive provides inspection program personnel (IPP) with instructions on how to conduct import reinspection on shipments of imported meat, poultry, and egg products at official import inspection establishments (import establishment). This directive is being reissued to clarify the current procedures for Condition of Container (COC) Type of Inspection (TOI) for imported thermally processed, commercially sterile products, sampling of smaller commercial shipments, and changes made by the final rule Egg Product Inspection Regulations.

KEY POINTS:
- How to perform reinspections and how to prioritize assigned reinspections
- How to choose the appropriate reinspection sampling plan
- How to manage refused entry in the Public Health Information System (PHIS) for COC TOI failures
- Updates procedures for performing a COC TOI
- Updates Regulatory citations with the consolidated canning regulations (9 CFR 431) published on 05/31/2018 (83 FR 25302)
- Updates how to prioritize TOIs for smaller commercial shipments
- Replaces SP5 table with a sampling table used previously for imported product. The table contains an additional sampling level for smaller commercial shipments of 500 pounds or less
CANCELLATION
FSIS Directive 9900.2, Revision 1, Import Reinspection of Meat, Poultry, and Egg Products, 5/16/17
BACKGROUND
IPP perform reinspection on all amenable meat, poultry, and egg products offered for import into the United States. They verify that the certification and application, whether printed or electronic data, is complete and accurate. They access the Public Health Information System (PHIS) and obtain the reinspection assignment. IPP are to follow the instructions in this directive on how to determine whether product offered for import meets United States import requirements and FSIS standards and is not adulterated or misbranded.
PRIORITIZATION OF REINSPECTIONS
1. Each lot of meat, poultry, or egg products will be assigned at least the Certification and Label Verification TOIs. When an inspection certificate/application contains more than one lot, IPP are to prioritize the lots for reinspection based on the TOIs assigned. IPP are to perform reinspection on the lots assigned additional physical inspection TOIs (e.g., Product Exam, Condition of Container TOIs) before performing reinspection on those lots only assigned Certification and Label Verification TOIs. If the lot(s) assigned additional physical inspection TOIs fail one or more of those additional TOIs for any reason, IPP are to follow the instructions immediately below under IV B.
2. When a lot fails a physical inspection TOI because of an observed food safety defect, and there are other lots on the inspection certificate in which the identified public health defects may also be present, IPP are to add an unscheduled TOI for the appropriate physical inspection TOI and perform an inspection on the other lots of like-product from the same processing establishment.
3. IPP are to return to the PHIS Lot Manager and for each lot on the inspection certificate that is from the same processing establishment, in the same process category, and in the same product group as the lot that failed, assign an unscheduled TOI that involves the same type of physical inspection TOI that the first lot failed. IPP are to select the justification "Public Health Defect on Related Lot" from the drop-down menu.
4. IPP are to add an unscheduled TOI for the appropriate physical inspection TOI, rather than redraw the assignment from the remaining lots on the inspection certificate. This action will ensure that the Intensified Level of Reinspection is reserved for future inspection certificates and applications from the same processing establishment.
5. IPP are to collect samples from a lot when assigned a physical inspection TOI by PHIS. These samples may be subject to destructive sampling procedures (e.g., COC, Pink Juice Test TOI samples). When there is destructive sampling, the samples are to be discarded after the completion of the exam and are not to be returned to the lot after the reinspection.
  
  NOTE: Removing and defrosting a section of frozen beef trim for a physical inspection is not considered destructive sampling.
SAMPLING PLANS AND DEFECT TABLES FOR PHYSICAL INSPECTIONS
1. IPP are to follow Table 1 (below) when determining the sampling plan and defect criteria for a specific product when a Product Exam TOI has been assigned. Product Exam TOI is an organoleptic physical type of inspection in which IPP look for defects such as blood clots, bruises, bone fragments, feces and ingesta, extraneous materials (wood, glass, chemicals, and insects), hair and wool, hide, stains, pathologic lesions, and off condition. The defects are classified either as a "Public Health" (PH) concern or as an "Other Consumer Protection" (OCP) concern (e.g., quality).
2. IPP are to use the guidance in Table 1 when determining which Sampling Plan and Defect Criteria Table are to be used to determine the product’s acceptability after physical inspections.
PHYSICAL INSPECTION OF CARCASSES, WHOLE BIRDS
1. IPP are to use the following instructions when conducting a Product Exam TOI on all imported red meat carcasses (beef, veal, equine, goat, lamb, mutton, pork) or poultry (whole birds) including ratites:
  1. Inspect visually all the inside and outside portions and surfaces;
  2. Inspect the body cavity of the carcass, and
  3. For hide-on veal carcasses, visually inspect and palpate the back of the carcass to detect public health or other consumer protection defects.
2. When a Product Exam TOI is assigned to hanging carcasses from Canada, generally the Canadian Food Inspection Agency (CFIA) inspectors identify randomly selected samples by either numbering each carcass side or by marking the carcass in such a way they can be readily identified from the remainder of the lot. The selected samples are placed at the rear of the truck and sealed by CFIA.
3. IPP are to verify the CFIA seals are intact and the breaking of the seal. IPP are also to verify the seal number is recorded on the certificate and have the CFIA marked samples unloaded and staged. If the seal is not present on the conveyance or referenced on the certificate, or the samples are not properly identified, IPP are to select random samples per Table SP1 (Attachment 1). IPP are to refer to FSIS Directive 9900.5, Label Verification of Imported Meat, Poultry, and Egg Products, for further guidance on sealing of unmarked carcasses.
PHYSICAL INSPECTION OF PRIMALS AND SUBPRIMALS, CUTS, OFFAL, AND MISCELLANEOUS PARTS
1. IPP are to inspect all external, internal, and cut surfaces of the product samples, Attachment 1. Frozen product samples may need to be tempered or completely defrosted before inspection (e.g., frozen boneless beef).
2. If combos of frozen product (e.g., pork skins) are presented for reinspection, product is to be removed in a sanitary manner so that all applicable import samples can be removed from the combo. Product can be removed either frozen or using a tempering process, as long as the tempering process does not cause the product to become unwholesome. The selected sample may need to be completely defrosted before inspection.
PHYSICAL INSPECTION OF FINELY TEXTURED TRIM, ADVANCED MEAT RECOVERY (AMR) PRODUCTS, BEEF MANUFACTURING TRIMMINGS, AND MECHANICALLY SEPARATED PRODUCTS
IPP are to inspect all surfaces of the product samples, Attachment 1. It may be necessary to partially temper or completely defrost the samples to inspect internal and cut surfaces during the inspection.
PHYSICAL INSPECTION OF COOKED MEAT FROM RESTRICTED COUNTRIES
1. For a physical inspection, the sample unit is to be taken in a random, non-biased selection as follows:
  1. When the product is packed in immediate containers (e.g., tubes), select the appropriate number of sample units according to Table SP5 (Attachment 1); or
  2. When the product is bulk packed, the sample unit weight is 12 pounds of product from the shipping container.
  NOTE: The Product Exam TOI of cooked meat is different from the Pink Juice Test TOI as set out in FSIS Directive 9900.7, Physical Examinations of Cooked Meat from Regions Where Rinderpest or Foot and Mouth Disease Exists.
2. IPP are to ask the import establishment to defrost the sample units and IPP are to inspect for bones or other defects.
3. IPP are to follow FSIS Directive 9900.7 when they find bones or under-processing of processed products during a physical inspection of cooked meat from restricted countries.
PHYSICAL INSPECTION OF PARMA, PROSCIUTTO, AND SERRANO HAMS
1. IPP are to:
  1. If the product is packaged, ask import establishment personnel to remove the sample from its packaging. The packaging is to be presented with the sample on a sanitary surface for inspection;
  2. Observe the outer surface of the sample unit;
  3. Smell the outer surface for signs of off-condition; and
  4. Insert a clean and sanitized trier or knife into the hole of the aitch bone.
  5. If the bone is removed, make the insertion in the same location;
  6. Remove the trier or knife quickly and carefully smell the trier or knife for evidence of off-condition or sour smell; and
  7. Repeat this process on the stifle (ball-and-socket joint), ensuring that the trier or knife is properly sanitized (e.g., hot water, labeled sanitizer solution) between insertions into the ham.
PHYSICAL INSPECTION OF MEAT EXTRACTS, BONE STOCK, BROTH, AND SIMILAR ITEMS
IPP are to ask import establishment personnel to remove the sample from the container and place it on a sanitary tray adequate to spread the product out for thorough inspection. IPP are to spread and inspect the sample for color, odor, foreign material, and other defects.
PHYSICAL INSPECTION OF SEMI-SOLID PACKED PRODUCTS (CANNED HAMS, CANNED CORNED BEEF, TAQUITOS, AND OTHER PROCESSED PRODUCTS)
1. IPP are to:
  1. If the product is packaged, ask the import establishment personnel to remove the sample from its packaging, which is presented with the sample on a sanitary surface for inspection, Attachment 1;
  2. Observe all outer surfaces and the inside of the can or package for possible defects;
  3. Smell for possible off-condition odor;
  4. Make at least one cut with a knife through the product; and
  5. Observe the inner surfaces for off-color, which may be an indicator of under-processing.
PHYSICAL INSPECTION OF NON-SOLID PACKED PRODUCTS (BEEF IN GRAVY, STEWS)
1. IPP are to:
  1. Ask the import establishment personnel remove the sample from the container and place it on a sanitary tray adequate to spread the product out for thorough inspection;
  2. Spread product in the tray to observe for defects;
  3. Observe the inside of the can or package for possible defects; and
  4. Smell for possible off-condition odor.
PORK SKINS INTENDED FOR POPPING, RENDERING, OR GELATIN MANUFACTURING ONLY
IPP are to verify the intended use of the product using supporting documentation provided by the importer (such as a bill of lading to the manufacturing company). If the documented intended use is for popping, rendering, or gelatin manufacturing, IPP are not to classify hair or hair roots as defects. If IPP do not receive the supporting documentation, then they are to classify hair or hair roots as defects.
CONDITION OF CONTAINER EXAMINATIONS
1. When thermally processed, commercially sterile products imported in rigid metal or glass containers, semi-rigid containers that have double seams, or retorted pouches and trays are presented for reinspection, IPP are to verify the general condition of the entire lot to determine if there are any abnormal conditions (such as wet cartons or trays, ruptured containers, corroded or leaking containers, damaged cartons/trays or containers). If such conditions are noted, IPP are to add an unscheduled COC TOI if not already assigned by PHIS.
  
  NOTE: When there is obvious forklift or definite transportation damage, IPP are to permit removal of the damaged containers without refusing the lot provided the damage is not a prevailing condition throughout the lot. IPP are to follow FSIS Directive 9900.8 , Meat, Poultry, and Egg Products Refused Entry Into the United States (U.S.), and enter the damaged containers into PHIS as a partial refused entry. Damaged containers removed prior to reinspection are not to be used as a sample unit when conducting a COC TOI.
2. When the COC TOI is assigned, either randomly or unscheduled, IPP are to sample and reinspect the condition of such containers. The reinspection is intended to determine whether the containers have any critical or major defects that may indicate under-processing of the products, or whether the defects themselves may substantially affect the integrity or usability of the containers or product.
3. IPP are to use sampling plan in Table SP7 below when conducting a physical inspection of product subject to a COC TOI. IPP should inspect the shipment for general condition prior to selecting the samples as noted in A above.
  1. Any containers with obvious forklift or other obvious transportation damage should be removed from the lot prior to selecting the samples. If IPP are unable to determine that dented, leaking, or otherwise blown containers were obviously caused by physical damage incurred during the handling or transport of the product, IPP should not consider such conditions as obvious transportation damage.
    
    NOTE: During presentation, or when performing general condition, when IPP observe containers that are dented, leaking, or otherwise blown and are not considered to be transportation damage, IIP are to score the appropriate critical defect(s) in PHIS when recording the result of the COC examination.
  2. When IPP conduct a COC TOI, IPP are to visually determine the following information from the staged shipment:
    1. The type of immediate containers (e.g., cans, glass jars, flexible pouches with heat seals);
    2. The total number of immediate containers in the lot;
    3. The total number of immediate containers in the shipping container (e.g., cartons, totes, boxes);
    4. The total number of pallets;
    5. The total number of shipping containers (e.g., boxes) on a layer on a pallet; and
    6. The total number of layers on a pallet.
    NOTE: This information is required when IPP choose to use the Condition of Container Examination (COCE) tool (Available at "FSIS Applications - Tools") to generate sampling information for the lot. The COCE tool will generate sampling information such as the number of boxes to select, the number of immediate containers to select from each box and the locations of each box in the lot. Additional guidance on the use of the tool is available through FSIS Applications by going to IPP Help and then COCE Tool guidance.
  3. IPP are to randomly select shipping cartons when performing the COC TOI. The selected cartons are to be marked with the "USDA Official Import Sample" stamp as shown in Section XXI, F. The number of immediate containers to be selected from each carton is provided in Table SP7.
  4. Table SP7 provides two sampling plans, which show the number of sample units to select based on the lot size. IPP are to use the appropriate sampling plan to determine how many units are to be drawn from the lot:
    1. Normal Plan: When a COC TOI is assigned, or added as an unscheduled TOI, IPP are to always use the Normal Plan when conducting the COC examination.
    2. Tightened Plan: The tightened sampling plan is used for lots that fail the COC TOI at the normal level. When the Tightened Reinspection TOI is added by PHIS, or as an unscheduled TOI by IPP, IPP are to use the Tightened Plan. Tightened reinspection is performed under reimbursable services.
  5. If a Product Exam - 3 (PE3) TOI is assigned by PHIS along with the COC TOI, IPP are to perform the COC TOI first, and while performing the COC TOI, take the appropriate number of sample units needed to perform the product exam. For example, if the number of immediate containers needed to perform the COC TOI is 500, and the number of sample units from Table SP5 (Attachment 1) needed to perform the product exam is 20, while performing the COC TOI, IPP are to randomly select the 20 sample units from the 500 immediate containers and set them aside to perform the product exam. Intact units free of defects should be selected to perform the Product Exam TOI.
    
    If multiple TOIs are assigned in addition to the PE3 (e.g., lab sample, Incubation TOI), IPP may select the appropriate number of sample units while performing the COC TOI needed to satisfy the other TOIs.
4. IPP are to use the Defect Criteria Table SP8 to determine which defect criteria to use when performing the COC TOI. IPP are to visually and manually examine each sample unit for defects in the Defect Criteria Table, as applicable.
  
  NOTE: For COC TOI, IPP can find additional guidance on defect classification in IPP Help, page 2, available through FSIS Applications.
5. Metal Containers with Double Seams (COCE1 Table):
  1. Examine the label (if a paper label) for stains that may be evidence of leakage or rust;
  2. Apply slight end pressure on one end and observe for movement of the other end. Repeat on the other end;
  3. Gently run finger along all double seams to detect any defects;
  4. Visually examine the double seams or seams, the side seam, and any container score lines on easy-open and pull-top containers for defects or leakage;
  5. If one end of the can appears to be distended, apply pressure to the distended end, causing the end to go to the normal position. If the opposite end "flips" out, record the defect as a springer.
  6. Squeeze the can and look for movement at either end to identify a loose tin;
  7. Check whether the container has a foreign establishment number embossed or lithographed on the container as required in 9 CFR 327.14(b)(2);
  8. Check whether the container, when required, is marked with a permanent, legible identifying code mark as required in 9 CFR 431.2(e); and
  9. Check any embossing impressions on container for metal fracture or stress.
6. Glass Containers (COCE1 Table):
  1. Examine jar surfaces for obvious defects or crooked caps;
  2. Examine the exterior of the jar closure for food particles or foreign materials;
  3. Place slight pressure on the center of the cap and observe any movement that may be an indicator of a swell, loose cap, or short vacuum;
  4. Check the safety button, if present, on the cap; and
  5. Check whether the container is marked with a permanent, legible identifying code mark as required in 9 CFR 431.2(e) .
7. Flexible Pouches and Plastic Tray Containers (COCE2 Table): Visual defects of concern include misaligned seals, flex cracking, product contamination of the seal, non-bonding, seal creep, delaminating, or scratches.
  1. All surface areas of the containers are to be examined for the presence of defects;
  2. The edges of each seal are to be examined for any evidence of product in the seal area. No product (oil) should be visible;
  3. Test the seals by grasping the unsealed area of the container and exerting a steady pressure. Observe the seals for signs of seal creep or delaminating (pouches); and
  4. Check whether the container is marked with a permanent, legible identifying code mark as required in 9 CFR 431.2(e).
8. IPP are to identify defects according to the appropriate defect classification table and the following rules:
  1. If two or more of the same type of defects are found on the sample unit and indicate the same cause, the defects are considered related and scored once. For example, if two locations are corroded, IPP are to score only once;
  2. If more than one related defect is found and one is critical and the other is major, IPP are to score once as critical;
  3. If the defects on the sample unit indicate different causes, IPP are to consider the defects unrelated and score as separate defects. For example, if a can is dented and has an improper seam, IPP are to score two defects; and
  4. Abnormal containers (defined in 9 CFR 431.1) are critical defects and, when identified, IPP must refer to FSIS Directive 7530.1, Handling a Process Deviation or Abnormal Container of Thermally Processed, Commercially Sterile Canned Product, for further instructions on submitting import samples to the Western Laboratory.
RECORDING AND DISPOSITION
1. IPP are to record all defects in PHIS and use Table A, B, and C to determine the disposition of the lot.
2. When container defects (Critical or Major) are recorded in PHIS, the determinations, whether the lot is entered as "Pass" or "Fail," and whether the lot, if entered as "Fail," is sortable or not, are based on Tables A and B below. Refer to these tables when entering the results of the reinspection in PHIS.
3. Lots determined to be sortable may be sorted at the applicant’s request, sorted by the official import inspection establishment, and presented for tightened reinspection (Table C), under reimbursable services (9 CFR 327.13(c)). All defective containers removed during the sorting are to be entered into PHIS as a Partial Refused Entry in accordance with FSIS Directive 9900.8.
4. When no abnormal containers (critical defects) are found, IPP are to:
  1. Determine the disposition of the lot using Table A;
    1. If the defects in the lot do not exceed the allowable limits, as specified in Table A, IPP are to "Pass" the COC TOI in PHIS;
    2. If the defects in the lot exceed the allowable limits in Table A, IPP are to refer to Table B to determine if the lot can be sorted;
    3. If the lot is sortable, IPP are to enter the defects into PHIS, and "Fail" the COC TOI; and send the Refused Entry notice to the Applicant;
    4. Retain the lot and notify import establishment personnel of the rejection and the option to sort the lot to remove defective containers;
      1. If the importer opts to sort, IPP are to follow the guidance in Section 2. h. i - iv; or
      2. If the importer opts to not sort the lot, IPP are to refuse entry on the lot, verify the lot is stamped "United States Refused Entry," and follow FSIS Directive 9900.8.
  2. When abnormal containers are found during a COC TOI IPP are to:
    1. Enter the defects into PHIS, and "Fail" the COC TOI, complete the lot, and notify the import establishment the shipment has failed. IPP are not to send the Refused Entry notification to the applicant until a recommendation is made by the Office of Policy Program and Development (OPPD), Policy Development Staff (PDS) (see 2. g. below).
    2. Follow FSIS Directive 7530.1 Section X for contacting the laboratory about the abnormal samples.
    3. If the Western Laboratory recommends submitting the samples to the lab, IPP are to add an unscheduled Abnormal Container TOI in PHIS.
    4. Retain the lot, and wait for the disposition recommendation from the PDS/OPPD per instructions in FSIS Directive 7530.1 Section XI. If PDS recommends product to be incubated, IPP are to add an unscheduled Incubation TOI, and follow PDS recommendation and the verification and monitoring instructions in Section XVII.
    5. After the laboratory results are completed, and if PDS recommendation and Table A determine the defects do not result in a "Fail", IPP are to unlock the COC TOI in PHIS, select Update/Correct data, add remarks (e.g., defects reclassified), enter the defects as applicable, update the result to "Pass," add remarks (e.g., PDS recommendation) and then click on "Complete". This will remove the Refused Entry Notification in PHIS. Once all TOIs are complete, the shipment can be stamped and released.
    6. If the results of PDS recommendation, or Table A, are still a "Fail" in PHIS, IPP are to use PDS recommendation, or Table B to determine sortability if the lot is sortable.
    7. Open the Refused Entry for the failed COC TOI in PHIS and click on "Send to Applicant."
    8. If the lot is sortable, and the importer opts to sort the lot, IPP are to:
      1. Click on "COC TOI Refused Entry" in PHIS, click on "Rectification", and enter all sorting information as it becomes available. Once the lot is sorted, and Rectification Complete, click on "Save". The refused entry status will update to Rectified, and PHIS will add a Tightened Reinspection TOI;
      2. Select NEW, random samples in accordance with Section XV, C;
      3. Inspect the number of samples in accordance with Table SP7 Tightened Plan; and
      4. Refer to Table C for disposition after completing the tightened reinspection.
    9. If the lot is sortable, and the importer opts to not sort the lot, or the lot is not sortable IPP are to refuse entry on the lot, verify the lot is stamped "United State Refused Entry," and follow FSIS Directive 9900.8.
    10. The product needs to be brought into compliance or disposed of in accordance with FSIS Directive 9900.8 45 days after notice is given by FSIS to the Director of Customs, U.S. Customs and Border Protection (CBP) of the refused entry (9 CFR 327.13(a)(2), 381.202(a)(2), 557.13, or 590.945(a)) by clicking on "Send to Applicant" on the Refused entry page in PHIS. For example, if an importer chooses to sort canned corned beef, all the sorting, and tightened reinspection are to be completed within 45 days from the date the COC TOI refused entry notice is given by FSIS to Customs and Border Protection (CBP) by clicking Send to Applicant on the Refused Entry page in PHIS.
  3. Under Normal Reinspection, IPP are to score loose tins as an Abnormal Container and consult with the Western lab to determine the number of loose tin containers to send to the lab. During the subsequent Tightened Reinspection, IPP are not to score loose tins as Critical Defects. IPP are to use Table C to determine the acceptability of the lot.
  4. If the lot fails the Tightened Reinspection TOI, the lot is refused entry without any further sorting.
    
    If the lot passes, all critical defects are not to be returned to an accepted lot and are to be entered into PHIS as a Partial Refused Entry in accordance with FSIS Directive 9900.8.
INCUBATION OF HERMETICALLY SEALED CONTAINERS
1. When assigned by PHIS, IPP are to select the appropriate number of containers for incubation, following the instructions below.
2. When the Incubation TOI is recommended by PDS, IPP are to select the appropriate number of containers for incubation per PDS recommendation.
3. Incubator Requirements: IPP are to verify import establishments that receive shelf stable containers are able to provide an incubator. IPP are to follow the Incubation Time and Temperature requirements identified in 9 CFR 431.10.
4. Selecting Samples: When the Incubation TOI is assigned by PHIS, IPP are to:
  1. Randomly select 48 sample units from the lot. Twenty-four (24) of the sample units are used as the initial sample, and the remaining units are kept as the reserve sample. Incubation samples, including the reserve samples, are to be kept under FSIS control. Reserve samples are not to be secured in the incubator and are only used when a new incubation sample is needed for the involved lot;
  2. Select only normal appearing containers; and
  3. Randomly select the incubation samples, when applicable, from those samples selected for a condition of container examination. The incubation samples may be selected after or during the container examination.
5. Record Keeping: IPP are to:
  1. Document incubation start time, monitoring dates, and finish time, as well as results; and
  2. Maintain, in the files, the documentation of the monitoring and results, and all recording charts used during the incubation.
6. Incubation Examination Procedures - IPP are to:
  1. Verify that the import establishment personnel place the containers in the incubator in an acceptable manner (9 CFR 431.10 (b));
  2. Verify that import establishment personnel place the recording chart on the temperature-recording device;
  3. Ensure that the incubator and the recording charts are under FSIS control (e.g., government lock or seal);
  4. Check the sample containers in the incubator for abnormalities following the procedures in item 8 below, at least twice during the incubation period and at the completion of the incubation;
  5. Check the high and low thermometer inside the incubator and the recording chart daily, if practical, but at least twice during the 10-day (240 hours) period, to assess that the incubator temperature has not exceeded 100O F or gone below 90 O F. Request that the import establishment management adjust the incubator’s temperature as needed. Refer to 9 CFR 431.10 (b)(1)(ii) for additional requirements regarding the temperature for incubation of shelf-stable products;
  6. Change the chart as needed to prevent overlap on the recording chart; and
  7. Inspect the containers for abnormal containers using the appropriate criteria (Table COCE1 or COCE2 found in Section XV).
    1. If abnormal containers are identified during or at the end of the incubation period, ask import establishment personnel remove the abnormal containers from the incubator and allow them to cool to room temperature for 24 hours under FSIS control.
    2. After 24 hours, re-examine the containers. If the containers still exhibit abnormal container characteristics, select "No" under "Lot Sortable?", select "Fail" as the Incubation TOI result in the PHIS and describe the container defects in the Remarks box. IPP are not send the Refused Entry notification to the applicant until a recommendation is made by PDS.
      1. If the Incubation TOI is assigned by PHIS, a follow-up Abnormal Container laboratory TOI is assigned in PHIS, and IPP are to collect and submit containers to the laboratory as per FSIS Directive 7530.1.
      2. If the Incubation TOI is recommended by PDS, IPP are to contact PDS for further instruction.
    3. Disposition of the lot is determined when the laboratory results are forwarded to PDS, who will interpret the laboratory results. IPP are to take action indicated by PDS.
      
      If the recommendation is to "Pass," IPP are to unlock the Incubation TOI in PHIS, select Update/Correct data, add remarks (e.g., defects reclassified), update the results to "Pass," add remarks (e.g., PDS recommendation) and then click on "Complete." This will remove the Refused Entry Notification in PHIS. Once all TOIs are complete, the shipment can be stamped and released. If the recommendation is to "Fail" the lot, IPP are to open the Refused Entry for the failed Incubation TOI in PHIS and click on "Send to Applicant," and follow FSIS Directive 9900.8.
NET WEIGHT REINSPECTION
1. IPP are to follow these instructions when conducting a net weight reinspection:
  1. Scales: Verify that the scales used by the import establishment in determining the net weight of meat poultry and egg products comply with 9 CFR 442.3 and 442.4;
  2. Tare Weight: Verify that the tare weight is established using the National Institute of Standards and Technology (NIST) Handbook 133, checking the Net Contents of Packaged Goods;
    
    NOTE: FSIS does not use the Wet Tare method per clarification provided in NIST Handbook 133.
  3. Reinspection: IPP are to use NIST Handbook 133, Tables 1-1, 2-1, and 2-9 in Appendix A for net weight inspection on imported products; and
  4. IPP are to:
    1. Verify that the import establishment tests and certifies the scale, as per NIST Handbook 44;
    2. Calculate the tare weight as per NIST Handbook 133;
    3. Calculate the Maximum Allowable Variation (MAV) and record;
    4. Weigh each sample unit and record the net weight;
    5. Calculate total error and record; and
    6. Determine whether any containers are under or over the MAV and record.
TANKER SHIPMENT REINSPECTION (EDIBLE FATS AND OILS TRANSPORTED IN BULK TANKERS)
1. IPP are to verify that inspection certificate or official letterhead documentation, official seals, and labeling of imported edible fats shipped in bulk tankers, either by rail car or truck, from approved foreign producers (countries and establishments) meet all regulatory requirements.
2. Under 9 CFR 327.3, upon entry into the U.S. tanker shipments of edible fats (tallow and lard) are to be presented for reinspection at one of the following locations:
  1. Import establishment; or
  2. At a safe rail siding facility in close proximity to an import establishment. IPP are to consult with the responsible District Office (DO) for concurrence when this option is used.
3. IPP are not to perform the Certification TOI until the relevant required documentation, described in Section XIX A. above, is presented to them.
4. IPP are to perform a label verification procedure (LVP) and seal verification procedure for each tanker shipment of edible animal fat (e.g., tallow, lard, rendered fat) that is presented to them for import reinspection. When performing the seal verification, IPP are to:
  1. Verify that the seal numbers present on the tanker are the same as the numbers recorded on the inspection certificate or official letterhead documentation and application in PHIS; or
    
    NOTE: IPP are to use extreme caution when performing this inspection task and to ask import establishment management to facilitate the execution of this task in a safe manner. If the reinspection is at a rail siding, IPP are to obtain the inspection assignment prior to leaving the import establishment.
  2. "Fail" the Certification TOI in PHIS and refuse entry when the shipment is non-compliant because the seals are missing, broken, or incorrect.
5. If IPP suspect that a physical inspection of the product is necessary, they are to:
  1. Notify the DO, provide the basis for the request and request that the shipment be transported to a FSIS import establishment capable of performing the reinspection procedure;
  2. If the DO concurs, contact the applicant to determine whether the applicant wants to forward the shipment for reinspection or not;
  3. If the applicant does not want to forward for reinspection: access PHIS, refuse entry as applicable, and monitor the disposition of the shipment that has been refused entry; or
  4. If the applicant does want to forward the lot for reinspection, IPP are to tell the applicant to provide the import establishment number where the applicant would like to forward the lot to for reinspection.
6. The DO is to coordinate product movement for further inspection with the Office of Field Operations (OFO) DO with authority over the import establishment and to provide a list of concerns about the shipment.
7. Upon receipt of the inspection results from the in-plant inspection personnel, the lot disposition is to be completed in PHIS by the assigned IPP.
PHYSICAL INSPECTION OF EGG PRODUCTS
1. IPP are to verify that approved foreign establishments that export bulk-packed egg products to the U.S. adhere to the regulatory requirements as defined in 9 CFR 590.910. FSIS requires that all egg products that are offered for import be presented for reinspection. The location of the reinspection will be as indicated on the FSIS Form 9540-1, Import Inspection Application, provided by the importer of record or their agent.
2. Port of Entry Requirements
  1. Pasteurized liquid or frozen egg products and dried egg products are required to stop at an import establishment to be presented for reinspection. IPP are to follow the procedures outlined in this directive for meat, poultry, and egg products.
  2. Unpasteurized egg products are not required to stop at an import establishment prior to proceeding directly to an official egg product processing plant in the U.S. that conducts a pasteurization process. When the FSIS Form 9540-1 and official inspection certificate is received, OFO Recall Management and Technical Analysis Division is to enter the data into PHIS and obtain a reinspection assignment. FSIS reinspection will occur at the official egg plant designated on the FSIS Form 9540-1. IPP are to refer to FSIS Directive 5030.1 Inspection Methodology Utilizing the Public Health Information System (PHIS) for the Verification of Regulatory Compliance in Egg Products Plants, Chapter III, Section IV.
  NOTE: Unpasteurized egg products are permitted from Canada only.
3. Bulk Packed Shipments (tankers)
  1. When egg products packed in tanker trucks are presented at an import establishment, IPP are to verify that:
    1. The information on the FSIS Form 9540-1 is accurate;
    2. The inspection certificate complies with 9 CFR 590.915;
    3. The seal numbers on the transport vehicle match the seal numbers that are identified on the inspection certificate or on official letterhead containing the exporting country’s official seal. Refer to 9 CFR 590.935(b) when the seal numbers on the transport vehicle are missing or do not match the seal numbers identified on the inspection certificate or on official letterhead containing the exporting country’s official seal when refusing entry in PHIS for a seal noncompliance.
    4. The labeling on the product complies with 9 CFR 590.955;
    5. For pasteurized egg products, the testing results for Salmonella are presented with the shipment and reported as negative on the inspection certificate or on official letterhead for the production lot of pasteurized egg product that includes the product offered for entry; and
  2. If the labeling or certification on the shipment does not comply with any of C. 1. above, IPP are to "Fail" the appropriate TOI (Certification or Label Verification) in PHIS, refuse entry to the shipment per FSIS Directive 9900.8, and await a response from the applicant.
4. Product Exam TOI
  1. IPP will receive egg product reinspection assignments through PHIS.
  2. IPP are to ask import establishment personnel to remove the sample unit from the container and place it in a sanitary container for inspection.
  3. When conducting a Product Exam TOI, IPP are to refer to Attachment 2 (PE3) of this directive for classification of defects.
5. IPP are to verify that the establishment has the equipment and facilities needed (9 CFR 590.930) to adequately defrost or core drill sample units to reinspect the egg product as directed in Section XX, F, of this directive.
6. Core Drilling: When using a core drill to obtain samples for the product exam, IPP are to verify:
  1. The drill is a high-speed, heavy-duty drill with a rated capacity of not less than 1,800 rotations per minute (RPM) without a load. Battery operated drills are acceptable if adequately powered. The drill is to be free of adhering dirt, egg, or other extraneous matter before use;
  2. The drill bit is 11/16 inches or larger in diameter with not less than a 12-inch drilling section or shank (Twist type) and is able to be sufficiently cleaned and sanitized for product inspections and for taking microbiological samples. A stainless-steel bit is recommended;
  3. The drill and bits are designated for use in the inspection room only and not utilized for plant maintenance or other non-food usage; and
  4. Ensure that the establishment thoroughly cleans and sanitizes the drill bit immediately before it is used, after it is used, and prior to storing.
7. Frozen sample preparation: When conducting organoleptic inspections using the drill and drill bit, IPP are to verify that:
  1. Establishment use a sanitized spoon to remove all frost and ice crystals from the top of the frozen unit to be inspected;
  2. Establishment personnel drill a hole near the center of the container, as nearly straight down as possible;
  3. Establishment personnel drill to within one inch of the bottom of the container or, for larger containers, as far down as the drill bit can safely go without causing potential product contamination; and
  4. Establishment personnel let the drill bit spin at high speed to warm up the product on the edges of the hole that was created.
8. Organoleptic inspections: When conducting organoleptic inspections, IPP are to
  1. Unfrozen samples: Sample liquid or dried product while the product is in the container, if possible. If not possible, product is to be removed from the shipping unit and placed in trays or on an acceptable, cleaned and sanitized surface.
  2. Frozen samples: When using the drilling method, smell the warmed-up product in the hole. IPP are not to smell the shavings and are not to use the shavings as a laboratory sample. IPP are to verify that the utensils used to stir or remove the egg product in or from the container were cleaned and sanitized prior to use.
  NOTE: IPP are to verify "Egg Products" is marked under Import Inspection on the import establishment’s Grant of Inspection.
SAMPLING PROCEDURES FOR PHYSICAL INSPECTIONS
1. When a physical inspection TOI is assigned, refer to Attachment 1 of this directive for instructions on how many sample units are needed in order to conduct the reinspection. IPP are to randomly select samples of imported meat, poultry, or egg products from the staged lot.
2. Lot Size: The number of sample units necessary is based on the lot size. Depending on the TOI, the determination of the number of sample units may be based on the net weight of the lot or the number of containers in the lot. Verify that the lot size and sample units for the TOI to be performed are in accordance with the tables in Attachment 1 of this directive.
3. Sample Size: IPP are to take the correct number of sample units, as specified in Attachment 1, for the TOI.
4. Random Numbers: IPP are to obtain random numbers to ensure that the samples are randomly selected.
5. Sample Security: IPP are to ensure that samples are under FSIS control from the time they are identified for removal from the lot until the reinspection is completed.
6. Sample Selection: IPP are to locate the sample cartons or locations in the lot and have them identified as "USDA Official Import Sample".
7. IPP are to ensure that:
  1. Sample units removed from identified sample cartons are numbered, and that sample units are identifiable to their original sample carton and to their original packaging or can, when applicable;
  2. Exposed sample units are handled in a sanitary manner; and
  3. Units are presented for reinspection on an acceptable surface.
8. Frozen Sample Preparation: As per 9 CFR 327.21 and 381.199, IPP are to verify that:
  1. Import establishment personnel are to collect and identify random sample units from the official import sample in a manner suitable to FSIS;
  2. Establishments completely defrost frozen sample units. If all surfaces can be inspected, complete defrosting is not required; and
  3. Defrosting and tempering are accomplished using a rapid, efficient, and acceptable method:
    1. When defrost/tempering is accomplished by immersion in water, the establishments shall supply high-quality, approved plastic bags or another acceptable means of preventing the defrost water from coming in contact with, and possibly adulterating, the sample units. If a sample unit does come into contact with the defrost water, the sample units are to be condemned and a new sample is to be drawn from the same container as the original sample unit.
    2. The temperature of the defrost water is not to exceed 125°F and is not to physically affect the appearance of the product (e.g., give raw product a cooked appearance). If defrosted sample units have the appearance of being cooked, IPP are to condemn the units and to draw new sample units from the same containers as the original sample units.
IDENTIFICATION OF DEFECTS DURING PHYSICAL INSPECTION
1. IPP are to perform reinspection on the specific type of product that has been identified for reinspection.
2. When enforcing the zero tolerances for fecal material, ingesta, and milk in beef, swine, sheep, or goat, IPP are to:
  1. Ensure they use the appropriate defect table, Table PE1 - A, or Table PE1 - B, applicable to the product being inspected.
  2. Classify defects for product not subject to zero tolerance for fecal material, ingesta, or milk under Extraneous Material as an OCP. IPP are to consider the overall sanitary condition and wholesomeness of the product when determining whether to pass or fail such product.
  3. Identify foreign material as feces or ingesta only when both of the following characteristics are observed: color and texture.
  4. Identify foreign material as milk only when both of the following characteristics are observed: color and consistency.
  NOTE: Bile is a contaminant and is not counted as a zero-tolerance defect.
3. IPP are to remove the sample defects from the applicable sample unit and are to classify and identify the defects:
  1. Defects from passed lots are to be denatured and discarded in an inedible container;
  2. Defects from TOIs for which the TOI is entered as "Fail" are to be kept under FSIS control and, if necessary, refrigerated, or frozen until the final disposition of the lot. Hold the lot when a pathology defect is identified; and
  3. Pathology defects observed during a Product Exam TOI should be inspected by a Public Health Veterinarian (PHV) if possible. IPP are to notify their supervisor to request a PHV’s assistance. If the PHV cannot classify the pathology defect, or a PHV is not available, then IPP are to submit a defect sample to the laboratory following the instructions in FSIS Directive 9900.6, Laboratory Sampling Program for Imported Meat, Poultry, and Egg Products.
  NOTE: The DO may request defects be held for correlation purposes.
RESULTS ("Pass" or "Fail" Criteria) BASED ON DEFECT IDENTIFICATION DURING PHYSICAL INSPECTION (Attachment 1)
1. Recording Defects: IPP are to record all defects as follows:
  1. Public Health (PH) Defects: When IPP identify a PH health defect during inspection IPP are to record the PH defects in PHIS and ensure that the TOI result selected is "Fail." IPP are to clearly and accurately describe the defect details, e.g., size, color, texture, dimension, smell (if applicable), and any other details necessary to clearly describe the outcome of their observance during inspection. IPP are to refuse entry on the lot.
    
    NOTE: These descriptions are the official record of the defect, and in the case of a failed TOI they are used as the official description of the issue conveyed to the foreign government. Therefore, it is essential that these descriptions are as detailed and accurate as possible.
  2. Other Consumer Protection (OCP) Defects: IPP are to record all OCP defects in PHIS, which may or may not result in a failed TOI. These defects should be described in detail as referenced above in the free text section of the TOI defect table in PHIS. Once IPP reinspect all samples, IPP are to consider, but are not limited to, these additional criteria when determining if OCP defect should result in a TOI classified as a "Pass" or "Fail":
    1. Does the number, type, and/or size of defects affect the safety of the product?
    2. Are defects severe or numerous enough to affect the usability of the product?
  3. If limited to one sample unit after that carton and/or the defect itself is condemned, is there any additional evidence that the remainder of the lot is adulterated or misbranded? If not, safety and usability would not be affected once the defect and/or its carton are condemned. IPP are to consider:
    1. Was the lesion localized?
    2. If widespread throughout the sampled cartons of both sampling steps (paragraph 3 of this section), would presence of the defect in the lot result in misbranded or unwholesome product?
  4. If IPP are unable to decide based on inspection of the original sample units, IPP are to use Sampling Plan 3A (SP3A) and take additional samples. SP3A provides guidance for reinspection of additional samples when IPP are unable to make a "Pass" or "Fail" determination based on the original sample units.
    
    NOTE: The "Pass" or "Fail" determinations in PHIS for OCP defects for sampling plans other than SP3A are based on the results of the single sample set specified in the appropriate sampling plans.
2. Passed TOI with OCP defects: For any import sample under sampling plan SP3A (e.g., the 12-pound sample) identified with either an OCP pathological/parasitic lesion or OCP extraneous material, the defect and the corresponding sample carton (e.g., 60-pound box) are to be refused entry and entered in PHIS as shown in the screen shots below.
3. For any import sample under sampling plan SP3A identified with any other OCP defects but still passes the TOI, IPP do not need to refuse the entire carton. The defects themselves are to be condemned and appropriately disposed.
4. For passed TOIs with OCP defects identified as pathological/parasitic lesion or extraneous material, IPP are to:
  1. Place the 12-pound sample unit in which the defect was observed back into the corresponding sample box;
  2. Identify the box as "U.S. Refused Entry;"
  3. Record the partial refused entry in PHIS using the following from the drop-down menus:
    1. Refusal Reason: PE1 OCP - Other Pathological;
      1. Defects: Localized Abscess; Scar Tissue; Other; or
    2. Refusal Reason: PE1 OCP - Extraneous Materials;
      1. Defects: Grease; Dirt; Other; and
  4. Follow FSIS Directive 9900.8 for controlling, monitoring, and disposing of the product.
  Example 1: IPP inspect 15, 12-pound samples of boneless beef trimmings using defect classification PE1 in PHIS but use table PE1-A as the defect criteria from Attachment 2. In two sample units, two localized lesions are observed. No other defects are observed in the other sample units and surrounding tissue appears to be healthy. IPP are to record the defects in PHIS as OCP - Other Pathological and provide a detailed description in the free text area including number, frequency, size, color, texture, dimension, and any other details necessary to clearly describe the observance. IPP are to click "Save" without selecting "Pass" or "Fail". IPP are to use Sampling Plan 3A and select an additional 15 sample cartons from the lot and have the establishment remove and prepare a 12-pound sample from each additional carton. If no other lesions or defects are observed, IPP are to pass the TOI since no other defects were observed and usability of the product is not affected once the defects and their associated cartons are refused. The sample cartons corresponding to the sample units with the defects are to be refused entry and recorded into PHIS as a partial refused entry with the refusal reason classified as "PE1 OCP - Other Pathological," and stamped with the "U.S. Refused Entry" stamp. Since no other defects were found by IPP during reinspection, the TOI is recorded as "Pass."
5. IPP are to select defect classification PE1 in PHIS; however, IPP are to use defect criteria from PE1-A in (Attachment 2) and record the defects as "Other Pathological" as shown below, with details of the findings in the remarks section, and save.
6. The defects found in the lot did not result in a failure of the PE1 TOI. However, IPP are now to capture partial refused entry of cartons with pathological defects. To capture the partial refuse entry, IPP are to enter the boxes with the defects by clicking on the Refused Entry tab, then select:
  1. Refusal Reason, select PE1 - OCP;
  2. Defects, select: Other Pathological; Localized Abscesses; Scar Tissue; Other;
  3. Refused Quantity, enter 2; or
  4. Refused Net Weight, enter 120
7. A summary of the partial Refused Entry would be captured as shown.
  
  NOTE: Pathological and parasitic lesions can be classified as either OCP (any localized lesion(s) or PH (single or multiple lesions indicative of systemic disease). However, because the foreign country’s central competent authority has already inspected the product, it is rare that lesions observed at import reinspection are evidence of systemic disease (PH defect).
8. Based on the additional criteria referenced above, a lesion that is surrounded by healthy tissue, localized, is considered OCP. In such cases where OCP defects are not widespread throughout the lot (i.e., no similar defects), IPP should not fail the TOI or refuse entry on the lot. Once the defects and any associated cartons are condemned, there is no evidence that the remaining product is unwholesome.
  
  Example 2: IPP inspect 9, 12-pound samples of boneless beef trimmings using defect classification PE1 in PHIS but use table PE1-A as the defect criteria from Attachment 2. In two of the sample units, a small portion (2"x 2") of beef cheek meat is observed. In one of the other samples, a portion of a beef cheek including lymph nodes and salivary glands (3"x3") is observed. No other defects are observed in the other sample units. Beef cheeks and beef cheek meat are restricted in certain products and cannot be mixed with beef trimmings except under their true name. These defects are classified as an OCP type under "Other." IPP determine that they cannot make a determination of "Pass" or "Fail" on these samples and decide to expand the reinspection to the three additional samples, finding no additional defects. Based on these findings, IPP determine the TOI is "Pass" as the additional samples contained no more defects.
  
  Example 3: IPP inspect 15, 12-pound samples of boneless beef trimmings using defect classification PE1 in PHIS but use table PE1-A as the defect criteria from Attachment 2. In four of the sample units, a large portion (4"x 5") of beef cheek meat is observed. In three of the other samples, a large portion (5"x 6") of beef cheeks, including lymph nodes and salivary glands, is observed. No other defects are observed in the other sample units. Beef cheeks and beef cheek meat are restricted in certain products and cannot be mixed with beef trimmings except under their true name. These defects are classified as an OCP type under "Other." IPP determine that the product is misbranded based on the amount of beef cheek meat present in multiple samples inspected. Based on these findings, IPP are to recommend to the Frontline Supervisor (FLS) that the TOI is failed because the product does not meet the definition of beef trimmings. With supervisor concurrence, the TOI is "Fail", and the lot is refused entry.
9. Failed TOI: If IPP decide after reinspection of the additional samples to fail the lot, based on observation of OCP defects, and the additional criteria, IPP are to enter the TOI result as a "Fail" in PHIS, and refuse entry on the entire lot.
COMPLETING DATA ENTRY
1. IPP are to:
  1. Enter all findings and results into PHIS;
  2. Ensure that all of the information necessary to complete the assignment is entered into PHIS;
  3. Ensure that the assignment is properly completed and closed in the system;
  4. Follow FSIS Directive 9900.8 for all refused entry instructions; and
  5. Consult the DO on any problems with data entry or questions related to completing the data entry and closing the case file.
APPEALS
1. FSIS regulations 9 CFR 327.24 provide that the importer of record, owner or their representative of imported product may appeal any inspection decision including a failed TOI. Appeals are to be made to the program employee’s immediate supervisor.
2. Supervisors may receive appeals orally or in writing.
3. The following outlines the chain-of-command for appeal decisions:
  1. Immediate Supervisor;
  2. District Manager (DM)/Deputy District Manager (DDM);
  3. Executive Associate for Regulatory Operations (EARO);
  4. Deputy Assistant Administrator for (DAA) for OFO/Assistant Administrator (AA) for OFO; and
  5. Administrator for FSIS.
  NOTE: The staffs in the Office of Policy and Program Development (e.g., Import and Export Policy Development Staff, Policy Development Staff, Risk Innovation and Management Staff, Labeling and Program Delivery Staff) are not part of the supervisory chain-of-command regarding the resolution of appeals. Regulatory interpretations provided by these offices can be used to support or refute an inspection decision but are not to be considered as denying or granting an appeal.
QUESTIONS

Refer questions regarding this directive to your immediate supervisor or as needed to the Office of Policy and Program Development through askFSIS or by telephone at 1-800-233-3935. When submitting a question, complete the web form and select Import for the inquiry type.
NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.

(For completed FSIS Directive 9900.2 Revision 2, please download the PDF version)

Food Safety and Inspection Service

Import Reinspection of Meat, Poultry, and Egg Products - Revision 2

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