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Traceback Methodology for E.coli O157:H7 in Raw Ground Beef Products - Current Thinking FSIS Public Meeting March 10,

This notice provides new instructions to Enforcement Investigations and Analysis Officers (EIAOs) and Public Health Veterinarians who were trained in the EIAO methodology for conducting product traceback when raw ground beef tests or beef trim tests presumptive positive for E.coli O157:H7 under the

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Traceback Methodology for E.coli O157:H7 in Raw Ground Beef Products - Current Thinking FSIS Public Meeting March 10,

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    1. Traceback Methodology for E.coli O157:H7 in Raw Ground Beef Products - Current Thinking FSIS Public Meeting March 10, 2010

    2. This notice provides new instructions to Enforcement Investigations and Analysis Officers (EIAOs) and Public Health Veterinarians who were trained in the EIAO methodology for conducting product traceback when raw ground beef tests or beef trim tests presumptive positive for E.coli O157:H7 under the FSIS verification testing program. Purpose

    3. New product traceback responsibilities are designed to help identify affected product and beef suppliers where the contaminant most likely was incorporated on the source materials used to produce ground beef. The notice also provides instructions to the District Office for managing information gathered during a product traceback. Purpose

    4. EIAOs and District Office Personnel are informed of presumptive positive test results within 48 hours that a test result in confirmed either positive or negative. FSIS intends to identify all affected product and potential suppliers earlier in the process to respond more rapidly to protect public health. Rapid Response

    5. Now at the presumptive positive stage, the EIAO is to determine whether a sole source supplier or multiple suppliers produced the source materials used in the positive raw ground beef product. Presumptive Positive Stage

    6. Within 48 hours of being notified of the presumptive positive result EIAOs are to: Collect information and report investigative findings in accordance with the FSIS Administrative Enforcement Reporting (AER) System. Document their findings to a series of questions as found in Section A and Section B of Attachment 1 of the notice. EIAOs are to use the decision tree in the notice to determine which questions apply to a particular traceback situation. EIAO Traceback Responsibilities

    7. EIAOs are to prepare a memorandum to the attention of the District Manager, Deputy District Manager, and District Case Specialist that summarizes the results of the investigation and any recommendations for further action. EIAOs are to communicate with the District Office to ensure that all necessary information has been collected regarding their findings and are to discuss any issues that need to be clarified or may warrant further follow-up action. EIAO Traceback Responsibilities

    8. Section A: Product Traceback for Originating Slaughter Establishments and Grinders of Source Materials Derived From Cattle Slaughtered at the Establishment. Section B: Product Traceback for Grinders of Source Materials Derived from Cattle NOT Slaughtered at the Establishment. Section A and Section B

    10. Provide the following for each source material used in the implicated product. Supplier lot number(s) Production date(s) Name of beef component(s) used in the production of the implicated product. Amount of beef component produced in each lot (in lbs). Section A: Product Traceback for Originating Slaughter Establishments and Grinders of Source Materials Derived from Cattle Slaughter at the Establishment

    11. (1) What information does the establishment have about slaughter, dressing and fabrication of source materials? What were the results of the establishment’s sanitary dressing and process control procedures that are included in their HACCP plan, sanitation SOP, GMP or other pre-requisite programs for the production day in question? Section A- Product Traceback Questions

    12. Process Changes: Were there any changes in the process for the production period in question such as a new process or procedure introduced, a new intervention being applied, a non-routine event? Are there any documented failures by the establishment or by inspection personnel of establishment’s sanitary dressing and process control measures for the production period in question (e.g. event changes, zero tolerance failures, NRs, improper sanitary dressing)? Section A- Product Traceback Questions

    13. (4) Generic E.coli testing programs: What are the results of the establishment’s generic E.coli testing program? Do the results for the time period in question indicate a loss of control? (5) PR Salmonella Sampling: What category is the plant in? Is sampling set currently being conducted by FSIS? Does the establishment do its on testing? Do the results indicate a loss of control? Section A- Product Traceback Questions

    14. (6) Does the establishment have E.coli O157:H7 Verification Testing Programs during slaughter fabrication? Was sampling performed during the production in question? If 100% testing of all trimmings is not designated and controlled to ensure RTE processing is not conducted, what is the rationale? Did the establishment receive positive test results? Do results indicate occurrence of a “high event” period. If the establishment received a positive, did the establishment take appropriate corrective action? Do sampling results provide a clear definition? Section A- Product Traceback Questions

    15. (7) Rework: Is there any carry over (e.g., rework) product or any other evidence of overlap for the production period(s) or production lot(s) in question? Section A- Product Traceback Questions

    16. (8) Are any of the source materials associated with positive test results used in the production of other raw products? If yes, name the products produced. List whether the products are intact or non-intact. Were the source material on the same production lines or food contact surfaces of source materials implicated by the positive ground beef test results? Are interventions or other processes used? Are products under establishment control or have they been shipped? Section A- Product Traceback Questions

    17. Provide the following for each domestic supplier and each source material used. Domestic supplier establishment (name establishment number, phone number, fax number, email, point of contact). Source material information (supplier lot numbers, production dates, name of beef components used in the production of implicated product, amount of beef component produced in each lot (in lbs). Section B: Product Traceback for Grinders of Source Materials Derived from Cattle NOT Slaughtered at the Establishment.

    18. Provide the following for source material received from Foreign Establishment: Foreign establishment supplier (country of origin, foreign establishment number, U.S. import establishment number stamped on shipping cartons, import establishment and importer of record point of contact information). Section B: Product Traceback for Grinders of Source Materials Derived from Cattle NOT Slaughtered at the Establishment.

    19. Foreign Source Material Information Health certificate number Production date or any other information, such as bar codes or production codes Shipping marks Date the imported product entered the country Name or description of supplied source material used in the production of implicated product Section B: Product Traceback for Grinders of Source Materials Derived from Cattle NOT Slaughtered at the Establishment.

    20. (1) What information does the establishment have of the source materials? What were the results of the establishment’s processes that are included in their HACCP plan, sanitation SOP, GMP, or other pre-requisite programs for the production date in question? Section B – Product Traceback Questions

    21. (1)(a) Did the establishment implement any decontamination and antimicrobial intervention for the production period in question? (b) Does the establishment implement controls that are more rigorous during the high prevalence season (April-Oct)? (c) Does the establishment have purchase specifications requiring the establishment to conduct validated interventions during slaughter or fabrication, testing of carcasses or trim for E.coli O157:H7? Do the source materials used in the production of ground beef have a certificate of analysis associated (COA)with it? Section B – Product Traceback Questions

    22. (2) Process Changes: Were there any changes in the process for the production period such as: - A new process or procedure introduced (e.g. new employees or new equipment? - A new intervention applied or a change in the application method of the current intervention(s)? - A non-routine event that may have affected the product? Section B – Product Traceback Questions

    23. (3)Upon review of the SSOP or other pre-requisite programs and all associated sanitation records for there time period in question, were there any: -Documentation indicating that an event occurred that would distinguish between the time period in question an other production periods. - SSOP Noncompliance records documenting events such as insanitary conditions. - SPS Noncompliance documenting events such as improper employee hygiene. Section B – Product Traceback Questions

    24. (4) Does the establishment have an E.coli O157:H7 Verification Testing Program? Was sampling performed during the period in question? Did the establishment receive positive test results? Did the test results indicate a systematic cause of breakdown of process controls for the time period in question? Did the establishment take appropriate corrective action? Section B – Product Traceback Questions

    25. (5) Rework: Is there any carry over (e.g., rework) product or any other evidence of overlap for the production period(s) or production lot(s) in question? Section B – Product Traceback Questions

    26. (6) Are any of the source materials associated with positive test results used in the production of other raw products? If yes, name the products produced. List whether the products are intact or non-intact. Were the source material on the same production lines or food contact surfaces of source materials implicated by the positive ground beef test results? Are interventions or other processes used? Are products under establishment control or have they been shipped? Section B- Product Traceback Questions

    27. The District Office is to assign an EIAO to conduct product traceback at the establishment that received the presumptive positive test result and at each originating slaughter establishment : After a presumptive positive E.coli O157:H7 test from FSIS testing or from another State or Federal entity. When FSIS is notified of an epidemiological investigation associated with a foodborne outbreak involving beef concerning E.coli O157:H7, and at each originating slaughter establishment if multiple suppliers are involved. District Office Responsibilities

    28. If the EIAO reports that one or more supplier establishments is located in another District, the DCS is to provide the supplier information to the Supervisory EIAO and the DDM in the District Office where the establishment is located. In this situation the District Office is to dispatch an EIAO within 24 hours of notification of the supplier information to conduct product traceback at the originating establishment. Communications Between District Offices

    29. If one or more supplier establishments is from a foreign country, the District Office is to notify OIA so that the foreign government can conduct equivalent procedures. Communication the Office of International Affairs (OIA)

    30. Product Investigative Findings are to be documented in the FSIS Administrative Enforcement Reporting (AER) system. These types of investigations fall under the category of “Other” report types and are to be designated as “Traceback Methodology” for reporting purposes. Reporting Product Traceback Findings

    31. Whenever any product traceback investigation occurs, the District Case Specialist in the District Office where the product traceback investigation occurred, is responsible for ensuring that a copy of the AER is provided to the District Case Specialist located in the District Office where the positive that prompted the investigation occurs. Reporting Product Traceback Findings

    32. At the District Office where the positive that prompted the investigation occurred, a full AER report concerning all product traceback investigative findings concerning the positive E.coli O157:H7 in raw ground beef at issue. Reporting Product Traceback Findings

    33. Product Traceback Flow

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