1. Purpose
   
   This instruction describes the procedures for pathology testing of imported fresh and cooked meat and poultry products.

2. Cancellation
   
   Part 3, Section 8, “Nutritional Labeling Testing Program”, dated November 15, 2005

3. Forms
   
   FSIS Form 9540-3, "Import Abnormal Container, Chemical, Species, Pathology Laboratory Analysis," (Table 6).

4. References
   
   FSIS Directive 10,230.6 "Submitting Tissue Specimens for Pathological or Diagnostic Microbiological Evaluation to the Laboratory", dated 01/06/06
   
   FSIS Directive 7355.1, "Use of Sample Seals for Laboratory Samples and Other Applications"
   
   Import Manual of Procedures, Part 3, Section 1, "Laboratory Sampling General Procedures"

5. Imported Products Subject to Testing
   
   Pathology testing can be performed on any imported meat or poultry product when tissue appears to be abnormal during a product exam. Pathology testing can also be performed when processed products are suspected to be out of compliance with labeling and formulation requirements. All lots of product being tested for Pathology, regardless of the sampling level of inspection (e.g., normal, increased, intensified, other), must be placed on FSIS Hold until results are received.

6. Sampling Procedures

   1. Identification of Defect, Analysis, Sampling and Product Disposition

      1. When import inspection personnel observe/find abnormal tissue, a pathology defect, or suspect that the product may contain ineligible ingredients (e.g., lung tissue in canned corned beef), they must notify the Regional Import Field Supervisor (RIFS) or Assistant RIFS if a disposition on the lot cannot be made.

      2. RIFS or ARIFS will:

         1. Assist import inspection personnel in classifying pathology tissue defects,

         2. Assist in making a lot determination, if possible,

         3. If necessary, Contact the District Office (DO) for Public Health Veterinarian (PHV) assistance.

         4. Direct the import inspection personnel to send a sample into the lab for Pathology.

      3. The PHV (if contacted) will:

         1. Attempt to make a disposition based on the sample (any disposition/analysis made by the PHV should be in writing and attached to the case file).

         2. Direct the inspector to send samples to the lab for further diagnosis when necessary.

      4. Import Inspection Personnel will:

         1. Assign an unscheduled Pathology-Physical type of inspection (TOI),

         2. Determine the lots disposition based on product examination, if possible,

         3. Take a pathology lab sample, if disposition cannot be determined,

         Send an e-mail to importinspection@fsis.usda.gov stating that a pathology lab sample has been issued. Other information that should be included in the e-mail:

         • the date the sample was taken,

         • AIIS lot number,

         • producing country, and

         • shipping marks

         4. Notify IID Headquarters if pathology results are received directly in the field. (notify importinspection@fsis.usda.gov immediately; import inspection personnel should not final disposition without concurrence from IID Headquarters).

      5. The reported laboratory will fax results to IID Headquarters. IID Headquarters may get help in analyzing the results from the PHV who assisted the RIFS or ARIFS. If a PHV was not used in the disposition IID headquarters well request help with the analysis from the FSL lab that analyzed the sample, or Technical Service Center. Based on the analysis and findings, the Import Inspection Division (IID) Headquarters (HQ) staff will:

         1. Ask for further lot details (label or ingredients) from import inspection personnel,

         2. Instruct import inspection personnel regarding lot disposition (refused entry or US Inspected and Passed),

         3. Confirm the analysis results in writing to import inspection personnel who is at the import establishment were the lot is on hold,

         4. Enter the lab results into the AIIS, and

         5. Instruct the inspector to close out the AIIS lot, after IID Headquarters has completed the initial entry of the results.

   2. Intensified or Increased Pathology Type of Inspection (TOI)
      
      For Pathology Type of Inspections assigned under an intensified or increased level of inspection import inspection personnel will e-mail importinspection@fsis.usda.gov stating that an intensified pathology lab has been assigned and taken. Other information that should be included in the e-mail:

      • the date the sample was taken,

      • AIIS lot number,

      • producing country, and

      • shipping marks.

      Import Inspection personnel will be notified of the results by IID Headquarters.

7. Samples

   1. Sample Size

      1. Samples shall be submitted to FSL Laboratory as identified in the Laboratory Electronic Application for Results Notification (LEARN).

      2. For abnormal tissue (e.g., lung tissue, salivary glands), import inspection personnel must submit the entire section of abnormal tissue.

      3. For intact products, import inspection personnel must submit the affected unit. The sample unit should not be less than 12 ounces (oz.); however, if sample units weigh less than 12 oz. as packaged, sufficient intact sample units should be submitted to equal 12 oz.

      4. Import inspection personnel will complete one FSIS Form 9540-3, "Import Abnormal Container, Chemical, Species and Pathology Laboratory Analysis" for each lot sampled.

      For further guidance refer to Laboratory Sampling General Procedures, Part 3, Section 1 of the Import Manual of Procedures.

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