1. PURPOSE
   
   The Food Safety and Inspection Service, Office of International Affairs (OIA) administers residue testing programs to detect the presence of drug or chemical compounds in imported meat and poultry products. Inspection personnel shall refer to Section 1, "Laboratory General Procedures," and the specific instructions in this section when selecting import samples for residue testing.

2. CANCELLATION
   
   Part 3, Section 6, “Residue Testing Program,” dated November 15, 2003

3. FORMS
   
   FSIS Form 9770-2, "Import Residue Program" (see Table 9)

4. IMPORTED PRODUCTS SUBJECT TO RESIDUE TESTING

    
   1. The Automated Import Information System (AIIS) generates residue assignments for fresh/frozen and processed products based on the annual sampling plan provided by the Office of Public Health and Science (OPHS).

   2. Inspection personnel shall refer to Table 10 (Fresh/Frozen Products) and Table 11 (Processed Products) for the list of residue compounds and species subject to testing. Inspection personnel shall follow the instructions on these charts when selecting residue samples to avoid sample discards.

5. SUPPLIES
   
   Inspection personnel shall refer to FSIS Directive 7355.1 for guidance on obtaining sampling supplies.

6. SAMPLING PROCEDURES

   1. Obtaining Assignments
      
      Assignments for residue TOIs are generated by the AIIS.

   2. Sample Size
      
      Inspection personnel shall refer to Table 10 and Table 11 for the exact sample size required for each residue compound subject to testing.

   3. Selecting Samples
      
      Residue samples will be assigned by the AIIS. Inspection personnel shall verify that the compounds assigned by the AIIS are listed in Tables 10 or 11 for the species. A Form FSIS 9770-2 will be completed for each assigned residue.

      1. Lots may have more than one compound assigned for analyses.

         1. Example 1 - If 2 residue samples are assigned and scheduled to be analyzed at the same laboratory than two residue samples should be collected and submitted to the laboratory. A Form FSIS 9770-2 will be completed for each assigned residue.

         2. Example 2 - If the assigned residues samples are analyzed at different laboratories, separate samples must be collected and submitted to the designated laboratories. A Form FSIS 9770-2 will be completed for each assigned residue.

      2. Unless otherwise instructed, inspection personnel shall send the sample units to the designated laboratory without further preparation (e.g., grinding).

      3. When inspection personnel determine that an assigned residue compound is not applicable to the type of product/species presented for inspection, the compound shall be exempted in the AIIS and the reason given (too fat, too lean, etc.). In addition, more specific details regarding the exemption should be typed into the comment box provided by the AIIS, if applicable.

   4. Boneless Fresh or Frozen Manufacturing Meat or Meat Cuts

      1. For each laboratory to which a residue sample is to be submitted, inspection personnel shall randomly select a single piece of product which equals the required sample size (i.e., 1 or 3 pounds). When a single piece of product is not available, inspection personnel shall select enough adjacent pieces of product to obtain the required sample size.

      2. If product is frozen together solidly, then the sample carton should be tempered. After tempering, the import establishment shall pry apart the sample pieces. If prying apart the sample pieces becomes too difficult, the import establishment shall use a saw to remove a sample section.

      3. If product is in combo bins, inspection personnel shall randomly select 1 combo bin from the lot randomly chose one selection site within the combo bin for each lab to which a residue sample is assigned and remove a single piece of meat which equals the required sample size (i.e., 1 or 3 pounds). When a single piece of product is not available, inspection personnel shall select enough adjacent pieces to obtain the required sample size. The import establishment shall assist inspection personnel by removing the product, entire layer by entire layer, until the samples may be removed.

   5. Processed Product

      1. For each laboratory to which a residue sample will be submitted, inspection personnel shall randomly select enough cans or packages to meet the required sample size (i.e., 1 or 3 pounds).

   6. Intensified Samples
      
      Lots assigned a residue sample at the Intensified level must be held pending laboratory results. EXCEPTION: For Canadian establishments on Intensified, the results can be certified by Canadian Food Inspection Agency personnel. See Part 3, Section 1, Laboratory General Procedures, for guidance.

7. PREPARING, SECURING, AND SUBMITTING SAMPLES

   1. Refer to Part 3, Section 1, "Laboratory General Procedures," for procedures related to preparing, securing, and submitting samples. All residue samples must be submitted to the laboratory either frozen, cold or soft with no signs of spoilage. Also refer to Tables 10 or 11 for specific requirements for samples.

   2. Inspection personnel shall complete one FSIS Form 9770-2, "Import Residue Program," for each residue sample. The FSIS Form 9770-2 will accompany each sample to the appropriate laboratory. Instructions for completion of the form are in Enclosure 1.

   3. Residue samples shall be submitted to the appropriate Field Service Laboratory (FSL) designated in Tables 10 and 11. EXCEPTION: When requested by the importer/broker or representative, residue samples selected for any of the following three residue compounds (Arsenic, Chlorinated Hydrocarbons (CHC), and Sulfonamides) may be submitted to an accredited laboratory, provided the accredited lab has been approved by FSIS to conduct the analyses. A list of Accredited Labs is available in Outlook (outlook:\\Public Folders\All Public Folders\Accredited Laboratories). Accredited labs shall fax the results to the Eastern Lab and to the Regional Import Field Office. The supervisor or designee shall consult with the Technical Service Center, Technical Assistance and Correlation Residue staff to determine whether the results for the compound analyses are acceptable or not. The supervisor or designee shall write the result ("Not Detected", "Positive, Not Violative", or "Violative") for each compound tested on the form and fax it to the Eastern Lab. The results will then be posted to Laboratory Electronic Application for Results Notification (LEARN) and reported in the AIIS.
      
      NOTE: When samples are submitted to an accredited laboratory, the importer/broker or representative is responsible for the laboratory and mailing charges associated with the sample.

   4. Complete instructions and illustrations for securing samples and attaching seals are contained in FSIS Directive 7355.1, "Use of Sample Seals for Laboratory Samples and Other Applications."

8. LABORATORY RESULTS REPORTING PROCEDURES
   
   Laboratory results are automatically forwarded into the AIIS from the Laboratory Electronic Application for Results Notification (LEARN) system.

   1. Not Detected" or "Positive, Not Violative" Results
      
      When a sample analysis result is reported as "Not Detected" or "Positive, Not Violative", the lot is not subject to further testing. Any lot that is on either FSIS or voluntary hold may be released if all other reinspection criteria have been met.

   2. Violative Results

      1. When a chemical residue sample analysis is reported as Violative, inspection personnel shall e-mail information on the involved lot or the page from LEARN to ImportInspection@fsis.usda.gov and copy their supervisor. The involved lot is not subject to further testing. If the lot was on either FSIS or voluntary hold, the lot is refused entry.

      2. If the product has been stamped "U.S. Inspected & Passed", the lot is subject to recall.

      3. The OIA confirms Violative results with inspection personnel at the import establishment where the lot was sampled. Inspection personnel must retain all or any part of the lot still located at the import establishment. If possible, inspection personnel will advise OIA of the locations, number of units, and weight of the violative lot at each location.

      4. The foreign establishment that produced the product is placed on Intensified status in the AIIS until 15 consecutive laboratory analyses are either "Not Detected" or "Positive, Not Violative" for the failed residue TOI.

For samples sent to either an FSIS lab or an accredited lab, inspection personnel shall submit a FSIS Form 9770-2 with the samples. A copy of the form should be made and attached to the case file for reference.

[Return to Main Table of Contents]