E. coli O157:H7 FSIS Actions Directive 10,010.1 Rev. 1

1. E. coli O157:H7 FSIS Actions  Directive 10,010.1 Rev. 1 In-Plant Control Transit Talking points: Presentation can be found in Section I of the workbook, after the 3rd orange sheet of paperTalking points: Presentation can be found in Section I of the workbook, after the 3rd orange sheet of paper

2. Sample Results Negative �Potential positive� �Presumptive positive� �Confirmed positive� or �positive� Talking points: Process starts with FSIS: Explain 01 and 02 procedures Negative � No further action until FSIS schedules another sampling for E. coli Potential positive � is noted in FSIS Biological Information Transfer and E-Mail System (BITES) Presumptive positive � When microbiological analysis indicates the strong possibility that E. coli O157:H7 is present, but additional steps are needed to confirm results *Clarify that this is FSIS testing, after FSIS result Talking points: Process starts with FSIS: Explain 01 and 02 procedures Negative � No further action until FSIS schedules another sampling for E. coli Potential positive � is noted in FSIS Biological Information Transfer and E-Mail System (BITES) Presumptive positive � When microbiological analysis indicates the strong possibility that E. coli O157:H7 is present, but additional steps are needed to confirm results *Clarify that this is FSIS testing, after FSIS result

3. Presumptive Positive Inspection program personnel Notify plant of the presumptive positive Inform plant that it should begin to gather supplier information, whether the source is domestic or foreign Talking points: Two things happen 24/7 Product is held or not If held, supplier information needed If in commerce � assemble distribution lists � weekends/after hours if product is in commerce The District Office may consult the Recall Management Staff (RMS) and/or the Technical Service Center (TSC) To receive test results for their plant, plant management can request a form from the District, fill in their e-mail address, and then mail or fax the form to OPHS. OPHS will automatically e-mail the results to that plant. Talking points: Two things happen 24/7 Product is held or not If held, supplier information needed If in commerce � assemble distribution lists � weekends/after hours if product is in commerce The District Office may consult the Recall Management Staff (RMS) and/or the Technical Service Center (TSC) To receive test results for their plant, plant management can request a form from the District, fill in their e-mail address, and then mail or fax the form to OPHS. OPHS will automatically e-mail the results to that plant.

4. Confirmed Positive A sample is confirmed to contain the bacterial isolate of E. coli O157:H7 when biochemical, serological, or genetic testing results in a finding of E. coli Serotype O157:H7, O157:H7NM (nonmotile), or O157:H7-indeterminate Talking points:Talking points:

5. Actions After a Positive � In-Plant District Office is notified of a positive through the FSIS Biological Information Transfer and E-Mail System (BITES) FSIS determines whether a product retention, detention, or recall is necessary Talking points: The District Office may consult the Recall Management Staff (RMS) and/or the Technical Service Center (TSC) This information from LEARN available to plants. Identify e-mail address to system If haven�t taken advantage of, should To receive test results for their plant, plant management can request a form from the District, fill in their e-mail address, and then mail or fax the form to OPHS. OPHS will automatically e-mail the results to that plant. Talking points: The District Office may consult the Recall Management Staff (RMS) and/or the Technical Service Center (TSC) This information from LEARN available to plants. Identify e-mail address to system If haven�t taken advantage of, should To receive test results for their plant, plant management can request a form from the District, fill in their e-mail address, and then mail or fax the form to OPHS. OPHS will automatically e-mail the results to that plant.

6. Actions After a Positive � In-Plant FSIS: Enters the information into the FSIS System Tracking E. coli O157:H7 � Positive Suppliers (STEPS) Notifies the supplier Analyzes the situation to determine if enforcement action is appropriate Talking points: STEPS � Systems Tracking for E. coli positive Suppliers Talking points: STEPS � Systems Tracking for E. coli positive Suppliers

7. Components Produced at Same Plant If a positive raw ground beef product was made from raw ground beef components produced at the same plant FSIS inspection program personnel conduct a HACCP 02 procedure for the source materials used in the ground product FSIS may sample and test the raw ground beef components at the plant Talking points: Note: Go to next slide � refer back to 02 procedures An 02 procedure is for verifying all regulatory requirements at all of the critical control points in a HACCP plan for a specific production. Talking points: Note: Go to next slide � refer back to 02 procedures An 02 procedure is for verifying all regulatory requirements at all of the critical control points in a HACCP plan for a specific production.

8. Actions After a Positive � In-Plant Inspection program personnel Issue a Noncompliance Record (NR), using the �verification� trend indicator Perform a HACCP 02 procedure for the specific production that tested positive As soon as possible after the plant implements its corrective action Talking points: On specific production, look at all five features of HACCP for that productTalking points: On specific production, look at all five features of HACCP for that product

9. Actions After a Positive � In-Plant Plant must Maintain control of positive product Implement corrective action Properly dispose of positive product Maintain records of proper disposition of positive product Talking points: Plant�s responsibility Requirements have been implemented for some time, so nothing new If using pre-requisite programs, go back to hazard analysis, HACCP plan References: 417.3 (a) if in HACCP 417.3 (b) if pre-requisite, reassess 416.15 SSOP � reassess (417.4 (a) (3)Talking points: Plant�s responsibility Requirements have been implemented for some time, so nothing new If using pre-requisite programs, go back to hazard analysis, HACCP plan References: 417.3 (a) if in HACCP 417.3 (b) if pre-requisite, reassess 416.15 SSOP � reassess (417.4 (a) (3)

10. Options for Disposition Options for disposition of positive product Further processing at the same plant or another plant Disposal at landfill or renderer Talking points: Establishment maintains controlTalking points: Establishment maintains control

11. Plant Responsibilities Plant must maintain control of product while in transit Plant must maintain records of proper disposition Talking points: Very important: Emphasize Control of product while in transit � 9 CFR 325.10 �Handling of products which may have become adulterated or misbranded; authorization and other requirements� Records of proper disposition � 9 CFR 320 �Records, Registration, and Reports� Talking points: Very important: Emphasize Control of product while in transit � 9 CFR 325.10 �Handling of products which may have become adulterated or misbranded; authorization and other requirements� Records of proper disposition � 9 CFR 320 �Records, Registration, and Reports�

12. Plant Noncompliance FSIS documents noncompliance if plant Does not have records indicating proper disposition Talking points: Investigates further prohibited activity Consider if additional enforcement is necessaryTalking points: Investigates further prohibited activity Consider if additional enforcement is necessary

13. If HACCP 02 Shows Noncompliance If inspection personnel identify noncompliance during the HACCP 02 procedure Issue an NR and collect one follow-up sample Talking points: After corrective, preventive action taken and verifiedTalking points: After corrective, preventive action taken and verified

14. If HACCP 02 Identifies No Problems If inspection program personnel identify no significant problems through the HACCP 02 procedure Collect one follow-up verification sample, as soon as possible after the plant takes corrective action Talking points:Talking points:

15. Plant�s HACCP System � Concerns If inspection program personnel have concerns about whether the plant�s HACCP system is adequate to ensure food safety They do not collect a follow-up verification sample They notify their front-line supervisor Talking points:Talking points:

16. In-Plant Frontline supervisor may Bring in an Enforcement Investigations and Analysis Officer (EIAO) to conduct a comprehensive assessment of the plant�s food safety systems Talking points: Front line supervisor upon notification and after conferring with DO EIAO � received training on scientific design of HAPP plans EIAO looks at: Science Validation systems Data validation Ongoing verification, monitoring DocumentsTalking points: Front line supervisor upon notification and after conferring with DO EIAO � received training on scientific design of HAPP plans EIAO looks at: Science Validation systems Data validation Ongoing verification, monitoring Documents

17. In-Plant If the EIAO determines that the plant�s corrective actions are appropriate and effective Inspection program personnel collect a follow-up verification sample Talking points: In plant personnel collect sampleTalking points: In plant personnel collect sample

18. In-Plant If the EIAO determines that the plant�s corrective actions are inappropriate or ineffective, the EIAO recommends: Enforcement action Notice of Intended Enforcement (NOIE), Withholding, or Suspension Talking points: Discussions take place regarding recommendation Plant should be informed as to what actions we are taking (30 day letter, NOIE, etc) Exit conference, information given to DM, plant should be in the loop and should never be surprised of actionTalking points: Discussions take place regarding recommendation Plant should be informed as to what actions we are taking (30 day letter, NOIE, etc) Exit conference, information given to DM, plant should be in the loop and should never be surprised of action

19. In-Plant If the District Office defers a decision to suspend the plant or takes a suspension action and then puts it into abeyance FSIS will conduct follow-up sampling to verify that the corrective action is appropriate and effective District Office will determine number of follow-up samples to be taken Talking points: Tell you what we find, what it means, and implications for regulator compliance, there are no surprises There is time for you to respond Three things plant can do Appeal Respond � defer Suspend Due process at every step of the wayTalking points: Tell you what we find, what it means, and implications for regulator compliance, there are no surprises There is time for you to respond Three things plant can do Appeal Respond � defer Suspend Due process at every step of the way

20. Components from Suppliers If a plant supplies the components used to produce raw ground beef that tests positive at a second plant or retail facility FSIS inspection program personnel conduct a HACCP 02 procedure at the supplying plant FSIS may test raw ground beef components at the supplying plant Talking points: Same thing at suppliers � Tell you what we find, what it means, and regulatory compliance, there are no surprises There is time for you to respondTalking points: Same thing at suppliers � Tell you what we find, what it means, and regulatory compliance, there are no surprises There is time for you to respond

21. Collecting Samples from Components Inspection program personnel Collect only samples from components intended for use in raw, non-intact product If the intended use is unclear, treat the product as though it were intended for use in raw non-intact product Talking points: This is where muscle cuts, etc. come into playTalking points: This is where muscle cuts, etc. come into play

22. Receiving Positive Components Inspection program personnel conduct a HACCP 01 or 02 procedure in that plant and verify that the plant: Documents the receipt of presumptive positive or positive product Maintains control of the product, and Has addressed E. coli O157:H7 in its hazard analysis and HACCP plan Talking points: Adulterated product must be under controlTalking points: Adulterated product must be under control

23. Receiving Positive Components If FSIS finds noncompliance, it takes appropriate action Talking points: Examples of appropriate action: Retain product Detain product Voluntary recall of product Talking points: Examples of appropriate action: Retain product Detain product Voluntary recall of product

24. Product Moving Off-site Presumptive Positive for E.coli O157:H7 FSIS permits product to move off-site under appropriate controls for disposition at official establishments, landfill operations, or renderers If establishment�s confirmation testing finds sample negative for pathogen, product may be shipped under normal procedures Talking points: Transition slide � Obligations of shipping and receiving plant � burden on plant to maintain control of recordsTalking points: Transition slide � Obligations of shipping and receiving plant � burden on plant to maintain control of records

25. Move Under Company Control Product that is Confirmed positive Presumptive positive and no additional testing confirmed product negative Destined for an official establishment for further processing that will destroy pathogen Talking points: Transition slide � Focus of discussion is on control of movement of product that is adulterated Move off site of presumptive positive or confirmed positive productTalking points: Transition slide � Focus of discussion is on control of movement of product that is adulterated Move off site of presumptive positive or confirmed positive product

26. Adulterated or Misbranded after Transport Product found to be adulterated or misbranded after it has been transported from an official establishment Transportation back to the establishment that originally produced the product or to another official establishment must be authorized Talking points: Must be authorized as stated in current regulations. (Background section, page three of the revised directive states this but will be modified) Talking points: Must be authorized as stated in current regulations. (Background section, page three of the revised directive states this but will be modified)

27. US Retained Tag Placed on products suspected of being adulterated During reinspection of product Talking points: As per current regulations � this will be modifiedTalking points: As per current regulations � this will be modified

28. Move Under Company Control Presumptive Positive for E.coli O157:H7 FSIS permits product to move under company control to facilitate proper disposition Company seals Under USDA seal or accompanied by FSIS form 7350-1 FSIS to modify regulations to reflect this policy Talking points: At this time FSIS is reviewing regulations but will allow this type of transportTalking points: At this time FSIS is reviewing regulations but will allow this type of transport

29. Plant Noncompliance FSIS documents noncompliance if plant Does not maintain proper control of positive product while in transit Talking points: FSIS considers this product in commerce as adulteratedTalking points: FSIS considers this product in commerce as adulterated

30. Review � Flow Diagrams Three flow diagrams cover Enforcement Concerns about a plant�s HACCP system Actions in plants which produce components Talking points:Talking points: