Physical Examinations of Meat from Regions Where Foot-and-Mouth Disease Exist and Reporting of APHIS-Restricted Material - Revision 1

FSIS directive 9900.7

Series Type 9000 Series: Exports & Imports

Issue Date Nov 19, 2024

Full Directive

9900.7.pdf

PURPOSE
This directive provides inspection program personnel (IPP) with instructions on how to conduct import reinspection physical examinations of cooked or raw meat from regions where foot-and-mouth disease (FMD) exists. The Animal and Plant Health Inspection Service (APHIS) restricts the eligibility for import of products from these countries, and FSIS performs examinations of these products in accordance with a memorandum of understanding (MOU) between the agencies. FSIS has updated this directive to include procedures IPP are to use to report certain material (e.g., bones, blood clots, lymphoid tissue) observed during physical examination of raw meat when specifically restricted by APHIS, to remove references to Rinderpest, add additional instructions about the establishment profile, and to update titles to reflect current FSIS organization structure.

KEY POINTS:
- Explains how the Public Health Information System (PHIS) will assign types of inspections to cooked meat from countries with APHIS restrictions
- Outlines the verification and final disposition of cooked meat restricted by APHIS
- Provides additional guidance on the verification and final disposition of raw meat restricted by APHIS when bones or visually identifiable blood clots or lymphoid tissue is found
- Provides guidance on the approval of an Official Import Inspection Establishment for conducting Pink Juice Test (PJT)
CANCELLATION
FSIS Directive 9900.7, Physical Examinations of Cooked Meat from Regions where Rinderpest or Foot and Mouth Disease Exists, 11/3/15
BACKGROUND
1. APHIS restricts the importation of perishable cooked and raw meat from countries affected with FMD or other APHIS-designated program diseases, although Customs and Border Protection (CBP) has inspection authority and verifies APHIS requirements at ports-of-entry (POE). Through an MOU between APHIS and FSIS and the authority vested in APHIS under the Animal Health Protection Act, APHIS has authorized FSIS to act on its behalf to conduct specific examinations on certain APHIS-restricted products.
2. APHIS allows the importation of shipments of raw intact beef (chilled or frozen) into the United States from APHIS-restricted countries, provided such shipments are accompanied by certification from the central competent authority that all bone, visually identifiable blood clots, and lymphoid tissue have been removed. Beef parts/products that may not be imported include all parts of the bovine head, feet, hump, hooves, internal organs, and ground products.
3. PHIS will assign the appropriate Type of Inspection (TOI) associated with the animal health restriction. IPP can refer to the following link on the APHIS website to verify the APHIS animal disease status for a country/region: Animal Disease Status.
4. FSIS reports the results of its examinations to APHIS and CBP. If a violation or a defect is observed upon reinspection, FSIS identifies the failure in PHIS, refuses entry of the product, and notifies APHIS and CBP. CBP takes regulatory action on behalf of APHIS against the product because of the animal health risks to U. S. livestock.
ESTABLISHMENT PROFILE (FOR COOKED MEAT SUBJECT TO PINK JUICE TEST ONLY)
1. If an import establishment requests approval to become an APHIS-approved defrost facility (AADF), the Grant Curator (GC) is to take the following steps:
  1. GC is to request the establishment submit an updated FSIS Form 5200-2, Application for Federal Inspection, to include under section 21D the checked box for "Frozen from an APHIS restricted country 9 CFR 94.4 (b)", and then notify the frontline supervisor (FLS);
  2. FLS are to verify the establishment has the equipment to perform the PJT, e.g., a freezer, saw, defrost tank, white tray, scale large enough to verify the weight of cooked product packed in tubes. If the establishment has the equipment to perform the activity, the GC is to then forward the application to APHIS at APIE@usda.gov. The profile in PHIS should not be updated until the GC receives confirmation the establishment has been approved by APHIS;
  3. Once the GC receives approval from APHIS, the GC is to notify the FLS and IPP of the newly approved AADF;
  4. The GC is to update the establishment profile in PHIS. The Office of Planning, Analysis and Risk Management (OPARM) will generate an updated AADF list when changes are made to AADF status of an establishment profile and coordinate with the Office of Public Affairs and Consumer Education's Digital and Executive Communications Staff (DECS) to maintain the list on the Import Guidance page of the FSIS website at https://www.fsis.usda.gov/inspection/import-export/import-guidance.
2. When an AADF establishment has its Federal Grant of Inspection withdrawn, the FLS determines the establishment is no longer eligible to act as an AADF facility, or the establishment submits an updated FSIS Form 5200-2 indicating they no longer want to act as an AADF establishment, the GC is to update the establishment profile in PHIS and notify APHIS at APIE@usda.gov. The AADF list posted on the website will be updated by OPARM and DECS.
  
  NOTE: PHIS refers to these facilities as APHIS-approved defrost facilities; however, APHIS refers to them as APHIS-approved rapid defrost facilities, which is how they are listed on the FSIS website.
CERTIFICATION
1. APHIS requires specific certifications for restricted cooked meat products from countries affected with FMD (9 CFR 94.4 or 9 CFR 94.29). CBP verifies the specific certifications referenced in 9 CFR 94.4, determines whether a PJT is necessary, and controls the movement of the shipment to an AADF for PJT as part of reinspection by FSIS (see VI. "CBP Notification for Pink Juice Test" below). APHIS also requires specific certifications for raw meat products from specific regions affected with FMD (9 CFR 94.29). CBP verifies these certifications to determine admissibility of raw meat products from an animal health perspective. Once CBP determines raw meat products meet APHIS requirements for admissibility, CBP releases the shipment, and the importer is responsible for ensuring it is delivered and presented to FSIS for import reinspection. IPP, following FSIS Directive 9900.1, Imported Product Shipment Presentation, are to verify that the foreign inspection certificate meets the requirements set out in 9 CFR 327.4.
2. When shipments of cooked beef requiring a PJT are accompanied by a separate container of indicator pieces, IPP are to verify the batch codes on the certificate and indicator pieces to confirm each batch code listed on the accompanying certificate has a corresponding indicator piece. IPP are to fail the product under the Certification TOI when the information related to the batch codes on the inspection certificate does not match the batch codes identified on the indicator pieces. When IPP fail the product under the Certification TOI, they are to go to the refused entry page for the lot and send the refused entry notification to the applicant.
3. Sample shipments of restricted cooked meat products for research or evaluation require a PJT unless the importer furnishes an APHIS Veterinary Services (VS) import permit to CBP at the time of import. CBP will direct and control the movement of samples requiring PJT to an appropriate AADF when required.
4. IPP are to verify that non-shelf-stable cooked meat from restricted countries is handled in a sanitary manner so as to preclude contamination of other product. The defrost tanks are to be cleaned and sanitized before and after use. The defrost tank water is not to be reused for other type of product examinations, and restricted cooked meat is not to be thawed in the same tank at the same time that other products are being thawed. Multiple lots of cooked meat from restricted countries/regions with the same disease status, or multiple lots of meat from the same restricted country/region, may be thawed in the same defrost tank at the same time.
5. APHIS has negotiated with Argentina, Brazil, and Uruguay to allow the use of a raw meat inspection certificate (9 CFR 94.29) for fully cooked intact beef skeletal muscle meat from Northern Argentina, 14 states in Brazil, and Uruguay. CBP verifies certificates and will continue to notify FSIS when a PJT is necessary. IPP are not responsible for verifying the region on the certificate:
  1. IPP are to accept the raw meat inspection certificate for fully cooked beef skeletal muscle meat from the specified countries. CBP will not send a notification and IPP are not to perform a PJT on cooked beef skeletal muscle meat products from the specified countries when the shipment is accompanied by a raw meat inspection certificate. IPP are to exempt the PJT TOI in PHIS and select "Not Applicable."
  2. CBP will notify IPP to perform the PJT TOI on fully cooked bovine meat and meat products from countries that are not accompanied by a raw meat inspection certificate using an AI-629 (see Section VI below). IPP are to continue to follow the instructions in this directive when performing the PJT, which would include IPP receiving an AI-629 from CBP.
  3. CBP will notify IPP to perform the PJT TOI on fully cooked head meats (tongue or cheek meat only) and non-intact fully cooked beef skeletal muscle, including pinned/needled/blade tenderized or ground beef from Argentina, Brazil, and Uruguay. Shipments of head meats and non-intact beef certified on a raw meat inspection certificate should be rejected by CBP at the port of arrival. If IPP receive a raw meat inspection certificate for any meat from the head or any non-intact beef, IPP are to retain the shipment and contact APHIS at FSIS.PJT.Results@usda.gov using the subject line "Head Meat Certified with a Raw Meat Inspection Certificate" or "Non-intact Beef Certified with a Raw Meat Inspection Certificate" for guidance.
CBP NOTIFICATION FOR PINK JUICE TEST
1. CBP completes Section A and uses Form AI-629 (Notification for Perishable Cooked Ruminant or Cooked Swine Meat from Restricted Countries) to notify FSIS of the need for PJT and control the movement and seal number of imported restricted cooked meat shipments from the POE to the official import inspection establishment. IPP are not to inspect perishable cooked meat from countries affected with FMD or other APHIS designated program diseases until they have received this form from CBP.
2. Specific POEs may have a CBP e-mail mailbox that FSIS can use to send or receive the AI-629 Notification Form electronically. The FLS may set up procedures for these mailboxes on a case-by-case basis. When there is an e-mail outage, or where e-mail service is not available, CBP will use a professional courier service (e.g., FedEx or DHL) in lieu of e-mail to send the AI-629 to FSIS IPP. CBP will place the form in a sealed official government envelope to prevent tampering. IPP are to note in Section A of the form if the envelope has been tampered with or opened.
3. In reinspecting cooked meat products from countries restricted by APHIS, IPP are to:
  1. Retain any shipments requiring a PJT when they have not received the AI-629 Notification Form and contact their supervisor;
  2. Verify the seal number on the container matches the seal number on AI-629;
  3. Notify the FLS, who in turn is to contact and coordinate with CBP, APHIS, and the district office if:
    1. There is evidence of tampering with the sealed envelope transmitting AI-629 Notification Form;
    2. An AI-629 Notification Form is not received with a shipment;
    3. An AI-629 Notification Form is received but the shipment is not presented at the official import inspection establishment for reinspection. IPP are to follow the instructions in FSIS Directive 9900.1 for a potential failure to present;
    4. A shipment is presented for reinspection, but the container is not sealed, the seal on the shipment was broken during transit, or the container seal number doesn't match the AI-629; or
    5. There are issues requiring notification of the applicant regarding the shipment's location.
  4. Complete Section B of the AI-629 Notification Form; and
  5. 5. E-mail the AI-629 Notification Form to the CBP office identified in Section A of the form and send a copy to APHIS at FSIS.PJT.Results@usda.gov using the subject line "Form AI-629 and FSIS Reinspection Completed" as confirmation that the FSIS reinspection was completed before releasing the product into commerce:
    1. IPP are to e-mail completed forms on the same day of the reinspection; and
    2. IPP are to print the notification that they sent back to CBP and attach it to the case file.
4. If IPP receive an AI-629 for product that does not require a PJT, they are to return the form to CBP with "Product Not Applicable" marked on it and e-mail a copy of the form to APHIS at FSIS.PJT.Results@usda.gov using the subject line "Product Not Applicable."
PINK JUICE TEST FOR COOKED PRODUCT PACKED IN TUBES
1. IPP are to conduct a PJT TOI on every lot of cooked meat imported from a country that is restricted for FMD by APHIS if the product is certified on a cooked meat certificate and the test is requested by CBP using an AI-629. IPP are to add an unscheduled PJT TOI, if PHIS does not assign the TOI, and notify the Recall Management and Technical Analysis Staff (RMTAS) by e-mail at foimports@usda.gov. RMTAS will investigate why PHIS did not assign a PJT TOI for product from a restricted country.
2. Tube Weight Requirements
  1. IPP are to verify that the packaged tubes of cooked meat from FMD countries meet APHIS weight restriction requirements and weigh no more than 5 kg (11.05 lbs.) per tube when conducting a PJT (9 CFR 94.4(b)(5)). The weight of every tube selected for the PJT is to be verified before defrosting the tubes.
  2. If IPP find that any lots include tubes of product that weigh in excess of 5 kg (11.05 lbs.), they are to place the lot on hold in PHIS and contact APHIS at FSIS.PJT.Results@usda.gov using the subject line "Guidance Requested: Cooked Meat Tubes Exceed Allowable Weight" for guidance. IPP are to include with the e-mail a copy of the AI-629 form that was received with the overweight product. IPP are not to perform any other TOIs until a response is received from APHIS.
  3. If APHIS requests that FSIS refuse entry to a shipment based on the weight of the tubes, IPP are to report the PJT TOI as a "Fail" in PHIS and document the reason for the failure in the comments box for the TOI. The weight of the tubes is part of the requirement for cooking by APHIS. Even though the PJT is not performed, the TOI still fails as the process is out of control. IPP are not to continue the inspection and are not to perform any other assigned TOIs. IPP are to follow the instructions in FSIS Directive 9900.8, Meat, Poultry, and Egg Products Refused Entry Into the United States (U.S.).
  4. If APHIS requests that FSIS release the shipment, IPP are to continue the inspection and perform all remaining assigned TOIs.
3. Sample units (tubed) to be tested for pink juices are either packaged in a tube with:
  1. An indicator piece (one solid piece of meat) no smaller than a 1½ inch cube in size at the cold spot of the tube (normally in the center of the tube or at the end of the tube); or
  2. A temperature indicating device (TID) at the approximate center (TID may not be used unless the TID has been approved by APHIS VS).
    
    NOTE: While permitted by 9 CFR 94.4, there are no APHIS VS-approved TIDs at this time.
4. IPP are to:
  1. Select the number of sample units using the sampling plan for a product examination of frozen cooked meat in tubes from an APHIS-restricted country (See Table SP6 in FSIS Directive 9900.2, Import Reinspection of Meat, Poultry, and Egg Products);
  2. Remove and defrost one tube from each carton and place the sample in a plastic bag suitable for low temperature thawing;
  3. Thaw the sample tubes using a water temperature in the defrost tank that is as low as possible to achieve efficient thawing of the samples but not warm enough to either cook the indicator pieces or physically affect the appearance of the product;
  4. Examine each sample unit of cooked meat to verify that at least one solid piece of meat is located in the cold spot (normally in the center of the tube), and that piece is no smaller than a 1½" cube in size; and
  5. If no indicator piece is present, have the establishment cut an indicator piece no smaller than a 1½" cube in size from the center.
5. For tubes having an indicator piece (one solid piece of meat):
  1. After the sample tube has been completely thawed, manually separate and remove the indicator piece; and
  2. Slice the indicator piece in half, squeeze the juices onto a white impermeable board, (e.g., tray) that is provided by the official import inspection establishment, and observe for the presence of pink juice on the tray. If IPP observe pink juice, they are to follow the procedures in Section IX.
6. Because of the restrictions on product from countries that are restricted for FMD, IPP are to report any bone or bone fragments observed as they conduct the PJT. Refer to Section IX of this directive if bones or bone fragments are observed.
PINK JUICE TEST UTILIZING THE REPRESENTATIVE BATCH SAMPLES
IPP are to verify that containers of ground, flaked, or diced cooked meat from restricted countries not packaged in tubes and certified on a cooked meat certificate are accompanied by representative sample packages (indicator pieces) of cooked meat that are placed in separate bags along with the shipment, as required by APHIS (9 CFR 94.4).
1. IPP are to verify:
  1. That a representative indicator piece from each cooker batch code identified on the official inspection certificate is present;
  2. That each indicator piece shipped with the lot corresponds to a specific batch identified on the official inspection certificate;
  3. That the shipment cooker batch code certified on the official inspection certificate (certificates may have more than one cooker batch code) is consistent with the number of cases for each lot of product;
  4. The indicator pieces are:
    1. Individually sealed;
    2. Properly labeled with the cooking date and cooker and batch number; and
    3. Enclosed together in one sealed box that accompanies the shipment.
2. IPP are to:
  1. Use the sealed representative test piece to determine thoroughness of cooking; and
  2. Thaw the product samples using a water temperature in the defrost tank to be kept as low as possible to reduce the possibility of cooking; and examine each sample unit of cooked meat to verify for the absence of pink juice. Cut the middle of the test piece and squeeze the juice onto a white impermeable tray and observe for the presence of pink juice on the tray. If IPP observe pink juice, they are to follow the procedures in Section IX.
DISPOSITION OF PRODUCT WHEN PINK JUICES OR DEFECTS ARE FOUND DURING PINK JUICE TEST ON COOKED MEAT
1. If IPP observe pink juice, IPP are to:
  1. Retain the lot and place it on hold in PHIS;
  2. Notify local CBP as stated in Section VI;
  3. E-mail a copy of the AI-629 to APHIS at FSIS.PJT.Results@usda.gov with the subject line "Pink Juice Test Failure" for guidance and disposition of the lot. Include the following information:
    1. Production code (complete tube or representative batch sample and carton identification);
    2. Country of origin and establishment number;
    3. Type and amount of product; and
    4. Location of retained product.
  4. For cooked meat subject to the PJT, fail the PJT TOI in PHIS and do not perform any other TOIs;
  5. Defer to APHIS VS regarding final disposition of the lot as agreed in the MOU; and
  6. Verify that the official import inspection establishment addresses sanitation issues to prevent cross-contamination.
2. IPP are to retain the shipment if any bones are found in cooked meat during the PJT. IPP are to:
  1. Retain the lot and place it on hold in PHIS;
  2. Notify local CBP as stated in Section VI;
  3. Remove the defects from the sample unit and keep them under FSIS control, refrigerated or frozen if necessary, until final disposition of the lot;
  4. E-mail a copy of the AI-629 to APHIS at FSIS.PJT.Results@usda.gov with the subject line "Bones Found in Cooked Meat" for guidance and disposition of the lot and include the same information as required in A. 3. of this Section. Clearly and accurately describe the defect details, e.g., size, color, texture, dimension, and any other details necessary to clearly describe the outcome of their observance during inspection;
  5. Report the results in PHIS as "Fail" under the PJT TOI and identify reasons for failure in the comment block;
  6. Refuse entry of the shipment if APHIS VS so instructs. APHIS VS is to make the disposition of the lot as agreed in the MOU; and
  7. Verify that the official import inspection establishment addresses sanitation issues to prevent cross-contamination.
PHYSICAL EXAMINATIONS ON RAW MEAT WHEN ASSIGNED A PRODUCT EXAM TOI BY PHIS
When a Product Exam TOI is assigned by PHIS to raw intact meat from FMD-restricted countries and IPP observe bones, or visually identifiable blood clots or lymphoid tissue, IPP are to:
1. Retain the lot and place it on hold in PHIS;
2. Remove the defects from the sample unit and keep them under FSIS control, refrigerated or frozen if necessary, until final disposition of the lot;
3. Notify APHIS VS, Import Animal Products Staff at headquarters using the e-mail address FSIS.PJT.Results@usda.gov with the subject line "Guidance Requested: Defects Found in Raw Meat" for guidance and disposition of the lot and include the same information as required in Section IX A. 3. Clearly and accurately describe the defect details, e.g., size, color, texture, dimension, and any other details necessary to clearly describe the outcome of their observance during inspection;
4. Classify the defects under OCP - Non-critical, "Bone Fragments" for bones, or "Other" for visible blood clots or lymphoid tissue. It is important to remember that although the presence of bones, visually identifiable blood clots or lymphoid tissue is classified as a non-critical defect by FSIS, their presence significantly affects the usability of the lot because APHIS considers this material a critical defect due to animal health concerns;
5. Report the result as "Fail", and then enter the findings in the remarks block.
6. Refuse entry to the shipment if APHIS VS so instructs. APHIS VS will make the disposition of the lot as agreed in the MOU;
7. IPP are to enter all other TOIs as not performed into PHIS, and select APHIS rejection;
8. Verify that the official import inspection establishment addresses sanitation issues to prevent cross-contamination; and
9. Add any communication with APHIS to the case file.
QUESTIONS
Refer questions regarding this directive to your supervisor or 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.

Food Safety and Inspection Service

Physical Examinations of Meat from Regions Where Foot-and-Mouth Disease Exist and Reporting of APHIS-Restricted Material - Revision 1

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