This instruction provides import inspection personnel with the procedures for sampling imported ready-to-eat (RTE) meat and poultry products produced in foreign establishments. Analyses will include Listeria monocytogenes AND Salmonella testing for all RTE products, and E. coli O157:H7 for cooked patties and dry or semi-dry fermented sausages. The actions to be taken following the receipt of laboratory results are also outlined. Inspection personnel shall refer to Section 1, "Laboratory General Procedures" and the specific instructions in this section when selecting samples for microbial testing for all RTE products.

Part 6, Section 4: "Microbial Sampling of Ready-to-eat (RTE) Product (Project Number IMVRTE)" dated April 1, 2002

FSIS Form 10,210-3, "Requested Sample Programs" (see Table 7)

Project Number IMVRTE is used for all samples.

After the form is completed, inspectors must make a photocopy of the form for their case file prior to shipping the sample to the laboratory.

Ready-to-eat cooked meat and/or poultry product is subjected to microbial testing at the port-of-entry. This includes any product that is intended to be consumed without any further safety preparation steps. As a guide, products with cooking instructions or labeled "Not Fully Cooked" are NOT considered RTE and should not be sampled under this program. Inspection personnel should refer to Enclosure 1 for assistance in determining the class of product. If after consulting Enclosure 1 inspection personnel have questions regarding whether a product should be sampled, he/she should contact the Technical Service Center (TSC), Technical Assistance & Correlation (TAC) staff.

Products with HEATING instructions are considered RTE and should be sampled under this program. If an inspector is unsure of the accuracy of the process category identified by the foreign country, based on labeling or other information made available, he should contact the TSC, TAC staff for guidance. FSIS samples and tests RTE products produced in process categories O3E, O3F, O3G and O3I.

• Not heat treated - shelf stable (03E)

• Heat treated - shelf stable (03F)

• Fully cooked - not shelf stable (03G)

• Products with secondary inhibitors - not shelf stable (03I)

FSIS Form 10,210-3, Project Number IMVRTE is used for all RTE samples.

FSIS Form 10,210-3 is pre-printed with a sample identification number and is distributed directly to the import establishment by FSIS, OPHS, Washington, D.C. If inspection personnel need copies of this form, they should contact the Office of International Affairs (OIA) for assistance. Because each form has an individual sample identification number, inspection personnel must not photocopy blank laboratory forms for use.

Inspection personnel should refer to FSIS Directive 7355.1 for guidance on acquiring sample packaging and sealing supplies.

1. Obtaining Assignments

   Microbial assignments for RTE products are generated by the Automated Import Information System (AIIS).

2. Sanitation Guidelines

   It is extremely important that good hygiene and product handling practices are exercised at the import establishment to avoid contaminating sample units even when conducting intact sampling. A guideline for aseptically handling products during sample collection is in Part 3, Section 5, Enclosure 1.

3. Sample Size

   1. The number of sample units randomly selected from a lot for microbial testing is based on the weight of the intact package. Enough INTACT sample units are collected so that at least two (2) pounds of product is submitted to the laboratory for analysis. When intact packages weigh:

      1. Three pounds or more, one sample unit shall be selected. For example, if cooked beef is packaged in 10-pound units, then only one 10-pound unit shall be submitted to the laboratory for analysis.

      2. More than one pound but less than three pounds, enough units are collected for a total of at least TWO POUNDS of product. For example, if cooked ham is packaged in 18-ounce units, two cooked hams shall be submitted to the laboratory for analysis.

      3. RTE products that are packaged in extremely large containers (too large to be lifted by an individual or problematic to mail) shall not be sampled. The TOI shall be exempted in the AIIS and the reason stated. Inspection personnel shall contact their supervisor prior to exempting an Intensified TOI.

4. Selecting Samples

   1. The sample units are limited to intact packages only, i.e., packages that completely enclose the product so that actual contact with the product is unlikely. The product label must accompany the sample to the laboratory. Examples of intact packages are:

      1. Individually wrapped units such as a 1-pound package of franks, a 10-pound tube of cooked beef, or a 15-pound cooked beef brisket sealed in vacuum packaging; and

      2. Sealed container units such as a 10-pound immediate container of franks or a 30-pound shipping container of cooked chicken patties.

5. Lots sampled at the Intensified level must be placed on FSIS hold pending reporting of the lab analyses.

   Exception: Canadian establishments with a laboratory TOI on Intensified may sample and pre-certify the laboratory results. Inspection personnel should refer to Part 3, Section 1, "Laboratory General Procedures", for guidance.

7. SUBMITTING SAMPLES

   1. Preparing Samples

      1. Inspectors shall submit the entire intact package. Intact packages shall not be opened nor cut prior to submission.

      2. Sample units shall be REFRIGERATED OR FROZEN when submitted to a laboratory. Note: Shelf stable product is not required to be refrigerated or frozen prior to submitting it to the laboratory.

      3. Inspectors shall complete one FSIS Form 10,210-3 for each lot sampled. The form shall be completed as per instructions in Enclosure 2.

      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".

      5. Inspectors shall refer to Section 1, "Laboratory General Procedures," for related procedures concerning preparing, securing and submitting samples.

      6. FSIS Form 10,210-3 shall be enclosed in a separate bag and inserted in a self-sealing bag along with the sample unit. Be sure to maintain a copy of the form for the case file.

   2. Laboratory

      Sample unit shall be mailed to the FSIS Field Service Laboratory (FSL) identified on the FSIS Form 10,210-3.

   3. Mailing

Samples shall be mailed via the FSIS contract overnight delivery/courier mailing service. Samples must be shipped Monday through Friday so that they arrive at the laboratory overnight. A sample box shipped on Friday must have a "Saturday Delivery" sticker on it and "Saturday Delivery" marked on the shipping label to avoid delays and discarded samples. Samples must not be shipped on Saturday or on the day before a Federal holiday.

8. LABORATORY RESULTS REPORTING PROCEDURES

Laboratory results are automatically forwarded to the AIIS by the Laboratory Electronic Application for Results Notification (LEARN) system.

1. Presumptive Positive Notification

   When a sample is reported as presumptive positive, OIA is notified of an import positive through the Biological Information Transfer and E-mail System (BITES). OIA will notify inspection personnel of the presumptive positive. Inspection personnel shall notify plant management so that the importer can place product from the shipment on hold and not distribute the product into commerce, unless the shipment is already on FSIS or Voluntary Hold.

2. Negative Results (Acceptable)

When a sample tests negative for the requested analyses, the involved lot is not subject to further testing and may be released if held, and all other reinspection criteria are acceptable.

3.  Positive Results (Not Acceptable)

   1. If a Normal or Increased RTE sample tests positive for Listeria, Salmonella, or E. coli O157:H7, the:

      1. Lot is refused entry if it was on FSIS or Voluntary Hold;

      2. Lot is subject to recall if it was not on hold;

      3. Foreign establishment that produced the lot is placed on Intensified until 15 consecutive lots of product from the same process category from that establishment are sampled and reported as "Acceptable" for the involved TOI.

      4. OIA is notified of a the positive through BITES. OIA will notify inspection personnel of action to take relating to the positive result for the shipment.

   2. Initial Violation Traceback Procedures

      1. OIA shall immediately:

         1. Contact the import inspector to verify the status of the product;

         2. Notify the inspector of any follow up action;

         3. Provide FSIS Recall Management Division with information/documents; and,

         4. Notify the immediate supervisor of the results.

      2. Inspectors shall immediately:

         1. Inform import establishment management of the positive result;

         2. Place the positive lot on hold, if available; and,

         3. Advise OIA if any portion of the positive lot has been distributed from the import establishment and, if possible, the location of all contents of the lot.

         4. Provide copies of pertinent documents to OIA.

   3. When an Intensified sample tests positive for Listeria, Salmonella, or E. coli O157:H7, the lot is refused entry. The foreign establishment that produced the product will continue on Intensified until 15 consecutive lots of product from the same process category from that establishment are sampled and reported as "Acceptable" for the involved pathogen.

Instructions for completing FSIS Form 10,210-3, Requested Sample Programs, for Project Number IMVRTE.

Block Numbers

1– 2.   Completed by OPHS.

3.   If not already completed, enter import establishment number (e.g. 00038 I).

4.   Leave blank.

5.   If not completed by OPHS, enter 92.

6.   If not completed by OPHS, enter two letter state abbreviation code.

7.   If not completed by OPHS, enter two number regional field office code (02 – Detroit; 03 – Los Angeles; 04 – Miami; 05 – Philadelphia)

8.   If not completed, enter information as requested.

9.   Completed by OPHS.

10 – 12.   Leave blank.

13.   Refer to block 18 instructions.

14.   Completed by OPHS.

15.   Enter the name of the country of origin on the product.

16.   Enter the two character UN country code from Enclosure 3 for the country of origin.

17.   Enter the foreign establishment number of the plant that produced the product.

18.   Refer to Enclosure 1 to determine if RTE sampling applies to product. If sampling is applicable, then complete as follows:

1. Ready-to-eat products (except dry or semi-dry fermented sausages and cooked patties):

1. When Listeria and/or Salmonella TOI is assigned by the AIIS, but is not at the Intensified level, mark an "X" beside the first "Yes" for both Listeria and Salmonella. An unscheduled TOI will need to be added in the AIIS for a pathogen that is not assigned by the AIIS. Do not mark an "X" shall be placed in the Intensified "Yes" blank for either pathogen.

2. When Listeria and/or Salmonella TOI is assigned at the Intensified level, an "X" shall be marked in the first "Yes" blank only for the pathogen(s) assigned by the AIIS. An additional "X" shall be marked in the Intensified level "Yes" blank. Do NOT add an unscheduled TOI in the AIIS for an unassigned pathogen.

3. When a Listeria and/or Salmonella TOI is assigned by the AIIS at the Normal or Increased level and the other is assigned at Intensified, an "X" shall be marked in the first "Yes" blank for each pathogen. An additional "X" shall be marked in the Intensified level "Yes" blank only for the pathogen that is assigned at the Intensified level by the AIIS.

1. RTE Dry or semi-dry fermented sausages and cooked patties:

1. When a Listeria, Salmonella, or E. coli O157:H7 TOI is assigned by the AIIS, but not at the Intensified level, mark an "X" beside the first "Yes" for Listeria, Salmonella, and E. coli O157:H7, respectively. An unscheduled TOI will need to be added in the AIIS for the pathogen(s) not assigned by the AIIS. Do NOT mark an "X" in the Intensified "Yes" blank for any pathogen.

2. When Listeria, Salmonella or E. coli O157:H7 TOI is assigned by the AIIS at the Intensified level, an "X" shall be marked in the first "Yes" blank only for the pathogen(s) assigned at the Intensified level. An additional "X" shall be marked in the Intensified level "Yes" blank. Do NOT add an unscheduled TOI in the AIIS for an unassigned pathogen.

3. When Listeria, Salmonella, or E. coli O157:H7 TOI is assigned by the AIIS at the Normal or Increased level and another is assigned at Intensified, an "X" shall be marked in the first "Yes" blank for all (Listeria, Salmonella, and E. coli O157:H7) TOIs. An "X" shall be marked in the Intensified level "Yes" blank only for the pathogen(s) assigned by the AIIS at the Intensified level. In additional, an unscheduled TOI will need to be added in the AIIS for the pathogen(s) not assigned by the AIIS.

19.   Enter the date the sample was collected from the lot.

20.   Enter the date the sample was mailed to the lab.

21.   Leave blank.

22.   Check the appropriate block. NOTE: Lots assigned at Intensified must be placed on FSIS Hold.

23.   Enter the health certificate number.

24.   Enter the appropriate lot number (e.g. 1, 2) from FSIS Form 9540-1.

25 - 27.   Leave blank. Do not complete.

28.   Complete all blanks as requested. If product is a sausage product, be sure to check off whether it is dry or semi-dry sausage.

29 – 32.   Complete as requested.

33.   Contact your supervisor prior to submitting any forms with this block completed.

34 – 41.   Laboratory use only.

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