I. PURPOSE

This directive instructs Enforcement, Investigations, and Analysis Officers (EIAOs) and other inspection program personnel (IPP) on the steps that they are to take for traceback investigations when FSIS or another Federal or State agency finds that ground beef or bench trim have tested presumptive-positive for

E. coli O157:H7. Additionally, this directive provides information on how IPP are to determine whether an establishment has experienced a high-event period (HEP), and information on when EIAOs or other IPP are to contact the Office of Field Operations (OFO) Recall Management and Technical Analysis Staff (RMTAS) to request a recall from suppliers.

KEY POINTS:

• Instructs EIAOs and other IPP on how to conduct product traceback from the grinder or bench trim establishment
• Instructs EIAOs and other IPP on what an HEP is, and on the steps that they are to take to verify that an establishment’s action in response to an HEP is appropriate
• Instructs District Office (DO) personnel and OFO RMTAS personnel on actions that they are to take during a product traceback
• Provides information on requesting that a sole source originating supplier slaughter establishment recall product when FSIS laboratories or another Federal or State agency identifies that establishment as having sent product into commerce from a lot that tested positive in a sample collected at the grinder or bench trim (receiving) establishment

NOTE: For the purpose of this directive, the term “EIAO” includes Public Health Veterinarians trained in EIAO methodology.

II. BACKGROUND

The Agency announced in a Federal Register notice (79 FR 47417), dated August 13, 2014, that it was implementing new procedures for when FSIS or another Federal or State agency finds raw ground beef presumptive-positive for E. coli O157:H7. This methodology will improve FSIS’ ability to determine whether the establishments that produced the source materials for contaminated product have produced other product that may not be microbiologically independent from the contaminated product. The Agency also announced that it will request a recall if an establishment was the sole supplier of beef trim source

materials for ground product that FSIS or another Federal or State agency finds positive for E. coli O157:H7, evidence suggests that contamination most likely occurred at the supplier establishment, and a portion of the product from the originating source lot was sent to other establishments. Finally, it announced the availability of a compliance guideline concerning establishment sampling and testing for Shiga toxin-producing E. coli (STEC) organisms or virulence markers and a compliance guideline on E. coli O157:H7 sampled and tested labeling claims. In the first compliance guideline, FSIS provides guidance on HEP.

III. DO RESPONSIBILITIES

A. The DO is to assign an EIAO or other IPP to conduct a product traceback investigation at the grinder or at the bench trim establishment and at any suppliers that provided source materials for that product as needed following the receipt of a Biological Information Transfer and E-mail System (BITES) notification of a presumptive-positive test result or notification by another State or Federal agency of such a result.

B. IPP are to follow the applicable procedures concerning the Administrative Enforcement Reporting (AER) System as described in FSIS Directive 5100.3, Administrative Enforcement Reporting (AER) System, and FSIS Directive 8010.3, Procedures for Evidence Collection, Safeguarding and Disposal.

C. The District Manager (DM) or designee is to assign an EIAO or other IPP to trace product to an originating slaughter establishment as needed for the traceback investigation. If the DO in an assisting district receives notification through System Tracking E. coli O157:H7 – Positive Suppliers (STEPS) that an establishment in its district has produced positive product, or that slaughter establishments in its district supplied product found positive at a grinder, it is to dispatch an EIAO or other IPP to conduct a traceback investigation within 1 business day of the STEPS notification if necessary.

D. The DM or designee in the District in which originated the product that was the subject of the positive test result at the grinder or bench trim establishment, is to review and evaluate the product traceback information to determine whether adulterated product entered commerce, or whether additional enforcement action is warranted.

E. When a supplier establishment is located in a foreign country, the DO has to notify RMTAS to notify the foreign government. The DO is to inform RMTAS whether the foreign establishment is a sole-source supplier or a multiple-source supplier and is to provide foreign supplier information collected during the product traceback.

IV. OFO-RMTAS-IMPORTS HEADQUARTERS RESPONSIBILITIES

A. OFO RMTAS-Imports Headquarters staff is to notify the Central Competent Authority (CCA) of the involved exporting country as soon as the DO contacts OFO RMTAS in order to identify whether the foreign establishment has any other production lots associated with the presumptive-positive production lot on route to or in the United States. OFO RMTAS-Imports Headquarters is to request that the foreign establishment conduct a traceback investigation at the foreign producing establishments and identify all source materials and potential suppliers of beef components used as source materials in the production of the sampled lot of ground beef or bench trim.

B. OFO RMTAS-Imports Headquarters is to review documentation received from the foreign country.

C. OFO RMTAS-Imports Headquarters is to issue an alert to import inspection personnel to refuse entry for the same lot of product with the same production codes that the foreign country presents for FSIS import reinspection after the confirmed positive result.

V. EIAO OR OTHER IPP RESPONSIBILITIES FOR CONDUCTING PRODUCT TRACEBACK

A. EIAO or other IPP product traceback investigations are to identify all source materials and potential suppliers of beef components used as source materials in the production of the sampled lot of ground beef or bench trim. The EIAO is to consider the slaughter process, sanitary dressing, and fabrication process employed at the original source slaughter establishment.

B. The EIAO or other IPP are to examine the results of any sampling conducted by either the grinding or bench trim establishment at which the positive was found or by the slaughter establishment that produced the source materials.

C. EIAOs or other IPP are to:

1. Review the supplier and source material information collected by the IPP at the time of the sample collection (see Attachment 1), including information documenting whether any source material that has been co-mingled with other product or potentially contaminated product is available for sampling, as well as the volume (e.g., weight) of the product;

2. Document evidence as described in FSIS Directive 5100.3 and FSIS Directive 8010.3 and prepare a written analysis that provides a summary of the findings and any recommendations for further action when:

a. Product may be in commerce, and the DM may need to contact the RMTAS;

b. An enforcement action is warranted; or

c. A food safety assessment (FSA) is needed.

3. Provide the Case Specialist the final analysis with the summary of the findings for the Case Specialist to create a Case File in AER categorized as “Other.”

4. Stop the investigation if the “presumptive-positive” test result confirms as “negative” during the course of the investigation;

5. Contact the DO immediately whenever traceback findings indicate that adulterated product entered commerce, or that additional administrative action is warranted; and

6. Use the questions in Attachment 2 as a guide when conducting a traceback investigation.

D. As part of their traceback investigation, EIAOs or other IPP are to review slaughter establishment test results to determine whether the establishment has experienced a HEP.  If establishments have developed their own HEP definition based on their unique operations, IPP are to verify that establishments have support for their definition of HEP. For purposes of FSIS traceback activities, FSIS will identify HEP occurrences based on the establishment’s HEP criteria, provided the establishment’s criteria are appropriately supported. If the establishment has not developed its own HEP criteria, or its criteria are not supported, IPP are to determine whether the establishment experienced a HEP based upon the following criteria:

1. For a local HEP: 3 or more STEC (or virulence markers) positive results out of 10 consecutive samples from production lots containing same source materials; that is, the trim was produced from one or more carcasses slaughtered and dressed consecutively or intermittently within a defined period of time (e.g., shift); and

2. For a systemic HEP: 7 or more STEC (or virulence markers) positive results out of 30 consecutive samples from production lots containing same source materials.

3. Table 1 in Attachment 3 for HEP criteria if an establishment tests more than 60 samples per day or local HEP for 10 consecutive samples.

Based on the results of their traceback activities, IPP are to make recommendations on whether regulatory and enforcement actions are warranted. The DM is then to determine whether adulterated product entered commerce. If it has, the DM is to decide whether to contact the FSIS RMTAS, and whether an enforcement action is appropriate.

VI. RECALLS FROM SOLE SOURCE SUPPLIERS

If IPP become aware that contaminated product has entered commerce and meets the following criteria, they are to contact the DO. The DO is to contact RMTAS to convene the recall committee to determine whether a recall is warranted.

1. FSIS or other Federal or State agencies find raw ground beef positive for E. coli O157:H7 at a grinding establishment;

2. FSIS determines that E. coli O157:H7 cross-contamination is unlikely to have occurred at the grinding establishment where the sample was taken (based on FSIS’s assessment of the grinding establishment’s handling practices);

3. FSIS determines that the grinding establishment did not combine material from multiple source lots to create the lot of product that tested positive;

4. After conducting traceback to identify the slaughter and trim fabrication supplier that provided the sole source material, FSIS determines that the supplier or downstream users split the implicated lot before sending it to the establishment where the positive sample was taken; and

5. Some portion of the split lot sent to the grinder was sent into commerce for further processing into product that does not receive a full lethality to eliminate E. coli O157:H7 in a federally inspected establishment.

VII. QUESTIONS

Refer questions regarding this directive to the Risk and Innovations Management Staff through askFSIS or by telephone at 1-800-233-3935 (press 5). When submitting a question, use the Submit a Question tab, and enter the following information in the fields provided:

Subject Field: Enter Directive 10,010.3
Question Field: Enter question with as much detail as possible.
Product Field: Select General Inspection from the drop-down menu.
Category Field: Select Sampling E. coli O157:H7 from the drop-down menu.
Policy Arena:     Select Domestic (U.S.) Only from the drop-down menu.

When all fields are complete, press Continue and at the next screen press Finish Submitting Question.

NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.
 

Assistant Administrator
Office of Policy and Program Development

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