FSIS Notice 65 07 Notice of Reassesment for

FSIS Notice 65 -07 Notice of Reassesment for E. Coli O 157: H 7 Control And Completion of Checklist for all beef operations 1

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ ¡ As a public health Agency, FSIS recognizes the Healthy People 2010 food safety objective to lower the number of E. coli O 157: H 7 illnesses. FSIS regulation of beef products plays a key role in reaching this goal to ensure improved public health. 2

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ During the summer of 2007, a number of unfavorable trends emerged causing concern about E. coli O 157: H 7. 3

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations Unfavorable trends: trends ¡ The percent positive rate for E. coli O 157: H 7 in FSIS samples of beef products has recently gone up. ¡ The number of recalls for E. coli O 157: H 7 went up this summer. ¡ The number of illnesses caused by E. coli O 157: H 7 increased this summer. ¡ 4

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ Food safety assessments at establishments producing product that tested positive by FSIS for E. coli O 157: H 7 raised questions about the decisions establishments made in the hazard analysis. 5

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations The section B of the checklist titled “Raw Beef Food Safety System” deals with the overall design of the control program in place for addressing E. coli O 157: H 7 in raw been. ¡ These best practices show the plant controls E. coli O 157: H 7. ¡ 6

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ Best Practice example for a beef grinding plant that determined in its Hazard Analysis that E. coli O 157 is a hazard not reasonably likely to occur. -The plant’s hazard analysis clearly explains the reason why E. coli O 157: H 7 is not likely to occur. -The reason is that the establishment has a written program as a Sanitation SOP or prerequisite program to control for E. coli O 157. 7

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations Best Practice example (continued): ¡ The prerequisite program requires that: -the supplier has at least 1 validated intervention controlled by a CCP (e. g. , applies an antimicrobial that reduces E. coli O 157) -all trim from all suppliers (including inhouse) is tested using a robust testing method, such as the N-60 method using excision, and stated so on every Certificate Of Analysis. 8

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations Best Practice example (continued): ¡ The prerequisite program requires that: - -incoming trim is tested by the grinding facility, by supplier, with proportionally greater frequency in high prevalence months than in low prevalence months 9

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations Best Practice example (continued): ¡ The prerequisite program requires that: -finished product is tested at least quarterly - each supplier is audited annually by a third party 10

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations These best practices that are shown in section B of the Checklist in FSIS Notice 65 -are interrelated ¡ This means that if an establishment fails to implement one of the best practices, the risk of producing product that is positive for E. coli O 157: H 7 increases, even if other practices are followed. ¡ 11

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ ¡ ¡ Following are scenarios that show examples of practices of concern that may have led to the unfavorable trends related to E. coli O 157: H 7. Keep the section of the set of best practice measures from the checklist titled “Raw Beef Food Safety System” in mind while reviewing the scenarios. Remember, while the best practices are not required, the Agency considers them to be essential to controlling E. coli O 157: H 7. 12

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ Scenario 1 – Establishment’s failure to ensure effectiveness of prerequisite program -In the hazard analysis, the plant determined E. coli O 157: H 7 was a hazard not reasonably likely to occur because they had a prerequisite program for testing incoming product. -But, the plant failed to follow the prerequisite program to consistently test the incoming product. 13

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ Scenario 2 – Establishment’s failure to ensure effectiveness of prerequisite program -In the hazard analysis, the plant determined E. coli O 157: H 7 was a hazard not reasonably likely to occur because they had a prerequisite program for testing finished product. -But, the plant failed to follow their prerequisite program to consistently test the finished product for E. coli O 157: H 7. 14

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ Scenario 3 – Establishment’s failure to ensure effectiveness of prerequisite program -In the hazard analysis, the plant determined E. coli O 157: H 7 was a hazard not reasonably likely to occur because they had a prerequisite program that required incoming product to have a Certificate of Analysis (COA) showing the source material had been tested for E. coli O 157: H 7. -But, the plant failed to follow their prerequisite program to consistently require the COAs be submitted for incoming product. 15

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ Scenario 4 – Establishment’s failure to ensure effectiveness of prerequisite program -In the hazard analysis, the plant determined E. coli O 157: H 7 was a hazard not reasonably likely to occur because they had a prerequisite program that required incoming product to have a Certificate of Analysis (COAs) showing the source material had been tested for E. coli O 157: H 7. -But, the establishment failed to ensure that the testing done by the supplying plant for the COAs was adequate to ensure that E. coli O 157: H 7 was non-detectable. 16

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ Scenario 5 – Establishment’s failure to ensure effectiveness of prerequisite program -In the hazard analysis, the plant determined E. coli O 157: H 7 was a hazard not reasonably likely to occur because they had a prerequisite program that required incoming product to have a Certificate of Analysis (COAs) showing the source material had been tested for E. coli O 157: H 7. -But, the establishment failed to ensure that COAs were received for product coming in from foreign countries. 17

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ Scenario 6 – Hazard not identified in raw ground beef -In the hazard analysis, the establishment determined that E. coli O 157: H 7 was a hazard not reasonably likely to occur in raw ground beef. -But the establishment used “bench trim” (trimmings from roasts and steaks) from boxes of product marked “not intended for grinding. ” 18

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ Scenario 7 – Hazard not identified in raw ground beef -In the hazard analysis, the establishment determined that E. coli O 157: H 7 was a hazard not reasonably likely to occur in raw ground beef because they received product from another inspected establishment. -But the establishment received “bench trim” (trimmings from roasts and steaks) that was not tested for E. coli O 157: H 7 before it was used in ground product. 19

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ Scenario 8 – Hazard not identified in raw ground beef -In the hazard analysis, the establishment determined that E. coli O 157: H 7 was a hazard not reasonably likely to occur in raw ground beef. -But the establishment used “bench trim” (trimmings from roasts and steaks) and did not test it for E. coli O 157: H 7 after grinding. 20

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ Scenario 9 – Hazard not identified in tenderized beef cuts -In the hazard analysis, the establishment determined that E. coli O 157: H 7 was a hazard not reasonably likely to occur in tenderized beef cuts. -But the establishment had no documentation to support this decision. 21

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ Scenario 10 – Hazard not identified in tenderized beef cuts -In the hazard analysis, the establishment determined that E. coli O 157: H 7 was a hazard not reasonably likely to occur in tenderized beef cuts. -But the establishment did not test its re-used marinade solution for E. coli O 157: H 7. 22

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ Scenario 11 – Inadequate sanitation -The establishment has no documentation to verify the sanitary conditions of tenderizing equipment, and no measures to ensure product contact surfaces are maintained in a sanitary manner sufficient to prevent contamination of products. 23

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ Scenario 12 – Rework -The establishment’s written procedures indicated that product from previous day’s production will not be used as rework. -But, the establishment collected and stored left over beef materials from one production, froze it, and re-used it in another production. 24

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ ¡ Remember the best practices that are shown in section B of the Checklist in FSIS Notice 65 -are interrelated. These best practices are not required by the regulations, however experience has shown that the best practices are an integral part of a program to control for E. coli O 157: H 7. 25

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ ¡ FSIS is responding to these trends by issuing several Notices to inspection personnel increasing its testing programs. FSIS is also issuing Notice 65 -07 related to reassessment of the HACCP plan for E. coli O 157: H 7 in beef operations. 26

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ Within 1 week of the publication of Notice 65 -07, inspection program personnel at beef operations that slaughter, fabricate, grind, mechanically tenderize, or enhance beef products by tumbling, messaging, or injecting solutions such as marinades must conduct an awareness meeting with establishment officials. 27

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ During the awareness meeting, inspection program personnel should review this Notice and discuss Attachment 2 with establishment personnel. 28

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ Inspection program personnel should document in a Memorandum of Interview who was present at this awareness meeting, the date/time of the meeting, what was discussed, and any documents shared with plant management. 29

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations Inspection program personnel are to maintain this memorandum in the official government file, and provide a copy to the establishment management. ¡ The establishment’s mandatory reassessment of its HACCP plan must be conducted by October 26 th ¡ 30

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ If inspection program personnel have any concerns related to the establishment’s reassessment, they may contact the District Office. The District Office will determine a food safety assessment will be scheduled. 31

Notice of Reassessment for E. coli O 157: H 7 and Completion of Checklist for Beef Operations ¡ At the next weekly meeting after October 26, 2007, inspection program personnel are to ascertain whether and how the establishment reassessed. Inspection program personnel are to complete the questions in Attachment 3, Responses to the Reassessment, and submit the answers by no later than November 2, 2007 32

E. coli O 157: H 7 Control Checklist ¡ FSIS inspection program personnel must also complete a checklist to record information about the plant’s HACCP system. 33

E. coli O 157: H 7 Control Checklist ¡ ¡ Section B of the checklist titled “Raw Beef Food Safety System” identifies a set of best practice measures that, while not required, the Agency considers to be essential to controlling E. coli O 157: H 7. The rest of the checklist describes known control measures and activities employed by beef operations that may affect the level of control employed by the establishment. 34

E. coli O 157: H 7 Control Checklist ¡ ¡ ¡ The best practices in Section B of the checklist gives the big picture on how the establishment is controlling E. coli O 157: H 7. The best practices for plants that produce beef product are interrelated. This means if one of the practices is not followed, the product may be at risk, even if the others are followed, because, to be fully effective, all of the practices must be employed. The rest of the checklist focuses on specific information, such as what product is produced, which procedures to control E. coli O 157: H 7 are in place, and the frequency for the applying the procedures. 35

E. coli O 157: H 7 Control Checklist At this time, there are no best practices (BPs) identified in the checklist beyond section B. ¡ However, as FSIS learns more about the steps establishments are taking to control for E. coli O 157: H 7, more BPs may be identified. ¡ 36

E. coli O 157: H 7 Control Checklist ¡ Inspection program personnel are to complete the reassessment questions in Attachment 3 in lieu of performing a food safety 01 or 02 procedure. To determine the product for which the scheduled 01 or 02 will not be performed, inspection program personnel are to use the chart in Attachment 4 of Notice 65 -07. Procedures for products with the lowest risk factor are to be replaced first. 37

E. coli O 157: H 7 Control Checklist Inspection personnel are to share a completed copy of the checklist prior submission with a designated plant management official who will be given 48 hours to review and provide an opportunity to correct any response for which a change can be substantiated. 38

E. coli O 157: H 7 Control Checklist ¡ Inspection program personnel are to save the completed checklist as a Word file and email a copy to the Front Line Supervisor and the District Analyst. 39

E. coli O 157: H 7 Control Checklist ¡ ¡ ¡ The checklist will be submitted to the Policy Analysis Division of the FSIS Office of Policy, Program and Employee Development. The inspector will also maintain a copy in the government office, provide a copy to plant management and provide a copy to the District Analyst. This checklist needs to be completed by November 30, 2007 40

E. coli O 157: H 7 Control Checklist ¡ ¡ The FSIS Office of Policy, Program and Employee Development will use information from the checklist to help in developing risk-based sampling programs for E. coli O 157: H 7 Based on the information provided in the checklist, the District may send an EIAO to conduct a food safety assessment to review the plant’s documentation for its food safety system. 41

E. coli O 157: H 7 Control Checklist ¡ ¡ In the future, FSIS will periodically request that the checklist be updated to reflect any recent changes that the establishment has made to its processes. The checklist will help highlight better practices for the industry to consider to better protect public health. 42