FSIS E. coli O157:H7 Agency Verification Sampling 9 CFR 417.8g Project Codes

1. January 30, 2010 Work Unit Meeting Correlation Material 1 FSIS E. coli O157:H7Agency Verification Sampling9 CFR 417.8(g)Project Codes This presentation was designed to assist inspection program personnel understand the policy associated with FSIS verification sampling of raw ground beef and raw beef component . 9 CFR 417.8 (g) FSIS will verify the adequacy of the HACCP plan(s) by determining that each HACCP plan meets the requirements of this part and all other applicable regulations. Such verification may include: Sample collection and analysis to determine the product meets all safety standards.This presentation was designed to assist inspection program personnel understand the policy associated with FSIS verification sampling of raw ground beef and raw beef component . 9 CFR 417.8 (g) FSIS will verify the adequacy of the HACCP plan(s) by determining that each HACCP plan meets the requirements of this part and all other applicable regulations. Such verification may include: Sample collection and analysis to determine the product meets all safety standards.

2. January 30, 2010 Work Unit Meeting Correlation Material 2 FSIS E. coli 0157:H7 Purpose: Outline current FSIS verification sampling of raw beef (or veal) products for E. coli O157:H7 in official establishments (Imports and Retail Sampling Not Included) Several FSIS Notices alter policy in FSIS Directive 10,010.1 Rev. 2 (July 2009) The purpose of this presentation is to outline current changes in FSIS verification sampling of raw beef products for E. coli O157:H7 in official establishments. Import sampling and Retail Sampling is not discussed. Several FSIS Notices have again changed policy provided in FSIS Directive 10,010.1 Rev. 2 which was issued on July 2009. These policy changes were a direct result of analysis of recalls and the associated Food Safety Assessments and AMS testing program. The purpose of this presentation is to outline current changes in FSIS verification sampling of raw beef products for E. coli O157:H7 in official establishments. Import sampling and Retail Sampling is not discussed. Several FSIS Notices have again changed policy provided in FSIS Directive 10,010.1 Rev. 2 which was issued on July 2009. These policy changes were a direct result of analysis of recalls and the associated Food Safety Assessments and AMS testing program.

3. January 30, 2010 Work Unit Meeting Correlation Material 3 FSIS E. coli 0157:H7 MT43 (FSIS Dir 10,010.1) MT43S (FSIS Notice 08-09) MT44 (FSIS Dir 10,010.1) MT44T (FSIS Dir 10,010.1) MT50 (FSIS Dir 10,010.1) MT52 (FSIS Dir 10,010.1) MT53 (FSIS Dir 10,010.1) MT54 (FSIS Dir 10,010.1, Notice 07-10) MT55 (FSIS Notice 51-09) Here is a list of the new projects in Official establishment, which include both routine random and follow-up verification sampling: MT43 � Routine Testing of Raw Ground Beef or Veal; may need to also collect MT43S � Salmonella in low volume producing establishments MT44 � Follow-up Sampling of Raw Ground Beef Product in Response to a MT43+ MT44T � Any follow-up raw ground beef or raw ground beef component sampling outside of projects MT44 and MT52 MT50 � Routine Testing of Domestic Raw Beef Manufacturing Trimmings MT51 � Routine Testing of Imported Beef Manufacturing Trimmings and Components MT52 � Testing of Beef Manufacturing Trimmings or Other Components From Originating Slaughter Suppliers, Based on an MT43 Positive Result, MT53 � Follow-up Testing of Positives from: 1) Routine Testing of Beef Manufacturing Trimmings (MT50); 2) Routine Testing of Other Components (MT54); or 3) Positive Follow-up Testing at Suppliers (Positive MT52 Samples) MT54 � Routine Testing of Domestic Components Other than Trim MT55 � Routine Testing of Raw Beef Manufacturing Trimmings at other than slaughterHere is a list of the new projects in Official establishment, which include both routine random and follow-up verification sampling: MT43 � Routine Testing of Raw Ground Beef or Veal; may need to also collect MT43S � Salmonella in low volume producing establishments MT44 � Follow-up Sampling of Raw Ground Beef Product in Response to a MT43+ MT44T � Any follow-up raw ground beef or raw ground beef component sampling outside of projects MT44 and MT52 MT50 � Routine Testing of Domestic Raw Beef Manufacturing Trimmings MT51 � Routine Testing of Imported Beef Manufacturing Trimmings and Components MT52 � Testing of Beef Manufacturing Trimmings or Other Components From Originating Slaughter Suppliers, Based on an MT43 Positive Result, MT53 � Follow-up Testing of Positives from: 1) Routine Testing of Beef Manufacturing Trimmings (MT50); 2) Routine Testing of Other Components (MT54); or 3) Positive Follow-up Testing at Suppliers (Positive MT52 Samples) MT54 � Routine Testing of Domestic Components Other than Trim MT55 � Routine Testing of Raw Beef Manufacturing Trimmings at other than slaughter

4. January 30, 2010 Work Unit Meeting Correlation Material 4 FSIS E. coli 0157:H7 Dir 10,010.1: Raw Ground or Comminuted Beef Product Routine Sample projects: MT43 Risk-based Sampling (formerly MT03) New � collect mixture of ground beef and non-beef species, unless the establishment labels the product in a manner to show that beef is not the predominant species in the product. MT43S added for Salmonella sp. Low Volume Producers (< 1000 lbs/day) The Raw Ground or Comminuted Beef Product Routine Sample projects: 9 CFR 319.15(a), (b), or (c) product. FSIS began sampling product that contains a mixture of ground beef and non-beef species, unless the establishment labels the product in a manner to show that beef is not the predominant species in the product. Note, when the directive references beef, veal is included as beef. MT43 Risk-based Sampling (formerly MT03) This risk-based sampling program will take into account establishment volume and whether the establishment has had any FSIS or Agriculture Marketing Service positive results within the past 120 days. Routine is the where establishments are selected randomly based on a risk algorithm based on parameters like the amount of raw ground beef produced that is entered on FSIS Form 10,210-3 Requested Sample Programs from the Block 28 and PBIS establishment extension production volume profile data. It is important that IIC review the PBIS establishment extension product volume profile data every 120 days and update the information with any production changes. It is also important to fill in all the information requested on the form. The MT43S in establishments reported to product less than 1000 lbs/day of raw ground beef or comminuted beef product (like ground veal). The Agency randomly samples and tests for Salmonella at each establishment that produces less than 1000 pounds of raw ground beef products in a typical day�s production. FSIS tests the ground beef samples collected for both Salmonella and E. coli O157:H7. The Agency will not schedule the establishments sampled under this program in the regular Salmonella verification testing program (9 CFR 310.25(b)). When IPP receive FSIS Form 10,210-3 with MT43S as the project code (Block 14), they are to hold the form until they also receive FSIS Form 10,210-3 with MT43 as the project code and then collect a sample. See FSIS Notice 08-09 http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/08-09.pdf The Raw Ground or Comminuted Beef Product Routine Sample projects: 9 CFR 319.15(a), (b), or (c) product. FSIS began sampling product that contains a mixture of ground beef and non-beef species, unless the establishment labels the product in a manner to show that beef is not the predominant species in the product. Note, when the directive references beef, veal is included as beef. MT43 Risk-based Sampling (formerly MT03) This risk-based sampling program will take into account establishment volume and whether the establishment has had any FSIS or Agriculture Marketing Service positive results within the past 120 days. Routine is the where establishments are selected randomly based on a risk algorithm based on parameters like the amount of raw ground beef produced that is entered on FSIS Form 10,210-3 Requested Sample Programs from the Block 28 and PBIS establishment extension production volume profile data. It is important that IIC review the PBIS establishment extension product volume profile data every 120 days and update the information with any production changes. It is also important to fill in all the information requested on the form. The MT43S in establishments reported to product less than 1000 lbs/day of raw ground beef or comminuted beef product (like ground veal). The Agency randomly samples and tests for Salmonella at each establishment that produces less than 1000 pounds of raw ground beef products in a typical day�s production. FSIS tests the ground beef samples collected for both Salmonella and E. coli O157:H7. The Agency will not schedule the establishments sampled under this program in the regular Salmonella verification testing program (9 CFR 310.25(b)). When IPP receive FSIS Form 10,210-3 with MT43S as the project code (Block 14), they are to hold the form until they also receive FSIS Form 10,210-3 with MT43 as the project code and then collect a sample. See FSIS Notice 08-09 http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/08-09.pdf

5. January 30, 2010 Work Unit Meeting Correlation Material 5 FSIS E. coli 0157:H7 Dir 10,010.1: Raw Ground Beef Component or Raw Beef Patty Routine Sample projects: MT50 Raw Beef Manufacturing Trimmings used to make raw ground beef products � domestic Includes two piece chucks. MT54 Raw Ground Beef Components (including raw beef patty components) other than beef manufacturing trimming Raw Ground Beef Component or Raw Beef Patty Component Routine Sample projects: MT50 Raw Beef Manufacturing Trimmings used to make raw ground beef products - Two piece chucks (i.e., the blade portion and an arm roast from the forequarter individually packaged and placed into the same container), raw beef source materials from subprimal cuts (e.g., steaks and roasts) or primal cuts (e.g., round, loin, rib and other primal cuts listed in 9 CFR 316.9, or boxed beef parts of boneless beef that establishments frequently use as components of raw ground beef. MT54 Raw Ground Beef Components (including raw beef patty components) other than beef manufacturing trimming 1. Product from AMR (Advanced Meat Recovery) Systems Low Temperature Rendered LFTB (lean finely textured beef) Partially Defatted Beef Fatty Tissue Partially Defatted Chopped Beef Weasand Meat Head Meat Cheek Meat Heart Meat Ammoniated Beef (new)Raw Ground Beef Component or Raw Beef Patty Component Routine Sample projects: MT50 Raw Beef Manufacturing Trimmings used to make raw ground beef products - Two piece chucks (i.e., the blade portion and an arm roast from the forequarter individually packaged and placed into the same container), raw beef source materials from subprimal cuts (e.g., steaks and roasts) or primal cuts (e.g., round, loin, rib and other primal cuts listed in 9 CFR 316.9, or boxed beef parts of boneless beef that establishments frequently use as components of raw ground beef. MT54 Raw Ground Beef Components (including raw beef patty components) other than beef manufacturing trimming 1. Product from AMR (Advanced Meat Recovery) Systems Low Temperature Rendered LFTB (lean finely textured beef) Partially Defatted Beef Fatty Tissue Partially Defatted Chopped Beef Weasand Meat Head Meat Cheek Meat Heart Meat Ammoniated Beef (new)

6. January 30, 2010 Work Unit Meeting Correlation Material 6 FSIS E. coli 0157:H7 Policy Changes to Dir 10,010.1: Raw Ground Beef Component or Raw Beef Patty Routine Sample projects: MT54 (FSIS Notice 07-10) Ammoniated Beef Collection of ammoniated (pH enhanced) beef products Cancels Ch. II, Section IV. F Policy changes to FSIS Dir 10,010.1 Microbiological Testing Program for Escherichia Coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components include : FSIS Notice 07-10, Instructions for Sampling Ammoniated Beef Products New directions to inspection program personnel (IPP) to implement routine sampling of all ammoniated (pH enhanced) beef products for E. coli O157:H7 in raw beef products in both slaughter and processing (non-slaughter) establishments. This notice cancels Ch. II, Section IV. F of FSIS Directive 10,010.1, Verification Activities for Escherichia coli O157:H7 in raw beef products. Uses the MT54 Routine Raw Ground Beef Components This change only affects a few establishments that produce this product. Policy changes to FSIS Dir 10,010.1 Microbiological Testing Program for Escherichia Coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components include : FSIS Notice 07-10, Instructions for Sampling Ammoniated Beef Products New directions to inspection program personnel (IPP) to implement routine sampling of all ammoniated (pH enhanced) beef products for E. coli O157:H7 in raw beef products in both slaughter and processing (non-slaughter) establishments. This notice cancels Ch. II, Section IV. F of FSIS Directive 10,010.1, Verification Activities for Escherichia coli O157:H7 in raw beef products. Uses the MT54 Routine Raw Ground Beef Components This change only affects a few establishments that produce this product.

7. January 30, 2010 Work Unit Meeting Correlation Material 7 FSIS E. coli 0157:H7 Policy Changes to Dir 10,010.1: Raw Ground Beef Component or Raw Beef Patty Routine Sample projects: MT55 (FSIS Notice 51-09) Bench Trim Collection of raw beef manufacturing trimmings derived from cattle not slaughtered on site at the establishment Do not collect if all bench trim goes to another official establishment to receive a lethality treatment Policy changes to FSIS Dir 10,010.1 IPP now implement routine sampling of all raw beef �bench� trim which is defined as beef manufacturing trimmings derived from cattle not slaughtered on site at the establishment. Such trim may include secondary trimming of primals and subprimals resulting in small or large pieces, or any other cuts designated for non-intact use. Such trim would not already be sampled under the current routine trim testing program or the routine testing program for other raw ground beef or patty components (MT50 and MT54). Note if all bench trim produced has an intended use to be cooked at an other official establishment, and the establishment has documents to support the intended use, then the form is returned marking in Block 33 code 72. Do not use code 60 because this will take the plant out of the sampling frame and when they change the intended use, the product will not be sampled. Code 72 provides the IIC with an opportunity to review the intended use and support.Policy changes to FSIS Dir 10,010.1 IPP now implement routine sampling of all raw beef �bench� trim which is defined as beef manufacturing trimmings derived from cattle not slaughtered on site at the establishment. Such trim may include secondary trimming of primals and subprimals resulting in small or large pieces, or any other cuts designated for non-intact use. Such trim would not already be sampled under the current routine trim testing program or the routine testing program for other raw ground beef or patty components (MT50 and MT54). Note if all bench trim produced has an intended use to be cooked at an other official establishment, and the establishment has documents to support the intended use, then the form is returned marking in Block 33 code 72. Do not use code 60 because this will take the plant out of the sampling frame and when they change the intended use, the product will not be sampled. Code 72 provides the IIC with an opportunity to review the intended use and support.

8. January 30, 2010 Work Unit Meeting Correlation Material 8 FSIS E. coli 0157:H7 Raw Beef Not Sampled per Dir 10,010.1: **Fabricated steaks and finely sliced beef (9 CFR 319.15(d)) Raw beef sausage Ground buffalo or bison Beef Meatloaf **Needle Tenderized; Marinated; non-intact beef steaks or roasts. ** This may change in the near future. Not currently sampled: Fabricated steaks and finely sliced beef (9 CFR 319.15(d)) do not meet the standard of identity for ground or chopped beef product and, therefore, would not be subject to E. coli O157:H7 sampling. Raw beef sausage products are not subject to FSIS� E. coli O157:H7 sampling and testing. Ground buffalo or bison is also not a raw ground beef product subject to this FSIS verification sampling. The Agency is always evaluating their sampling programs. Changes to MT55 (may collect trim even if all goes for cooking) or new projects may be added based on recalls and protecting public health associated with food borne illness and outbreaks in the near future.Not currently sampled: Fabricated steaks and finely sliced beef (9 CFR 319.15(d)) do not meet the standard of identity for ground or chopped beef product and, therefore, would not be subject to E. coli O157:H7 sampling. Raw beef sausage products are not subject to FSIS� E. coli O157:H7 sampling and testing. Ground buffalo or bison is also not a raw ground beef product subject to this FSIS verification sampling. The Agency is always evaluating their sampling programs. Changes to MT55 (may collect trim even if all goes for cooking) or new projects may be added based on recalls and protecting public health associated with food borne illness and outbreaks in the near future.

9. January 30, 2010 Work Unit Meeting Correlation Material 9 FSIS E. coli 0157:H7 Key Points in Dir 10,010.1: Raw Ground Beef IPP do not to wait until the establishment completes pre-shipment review before submitting raw beef samples to the laboratory for E. coli O157:H7 testing. Key Points in FSIS Dir 10,010.1 Microbiological Testing Program for Escherichia Coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components include : Do not wait until the establishment completes pre-shipment review before submitting raw beef samples to the laboratory for E. coli O157:H7 testing. Rather, inspection program personnel are to submit the raw beef sample to the laboratory after the establishment has completed all interventions, except for any intervention that is based on microbiological test results. Thus, inspection program personnel, in many cases, will be collecting and submitting FSIS samples to the laboratory before the establishment completes pre-shipment review. Key Points in FSIS Dir 10,010.1 Microbiological Testing Program for Escherichia Coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components include : Do not wait until the establishment completes pre-shipment review before submitting raw beef samples to the laboratory for E. coli O157:H7 testing. Rather, inspection program personnel are to submit the raw beef sample to the laboratory after the establishment has completed all interventions, except for any intervention that is based on microbiological test results. Thus, inspection program personnel, in many cases, will be collecting and submitting FSIS samples to the laboratory before the establishment completes pre-shipment review.

10. January 30, 2010 Work Unit Meeting Correlation Material 10 FSIS E. coli 0157:H7 Key Points in Dir 10,010.1: Raw Ground Beef IPP need to be familiar with the establishment�s lotting system ( clean-up to clean-up alone not supportable) IPP need to be aware of prior notification time and discuss the amount of time needed if the process changes. Key Points in FSIS Dir 10,010.1 Microbiological Testing Program for Escherichia Coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components include : It is important for the IPP to understand the establishment�s production practices and lotting determination prior to sampling. It also important for the IPP to discuss the issue of prior notification and the time needed by the establishment. If the process changes, this should be discussed again to ensure that the timeframe has not changed and is agreeable to both parties.Key Points in FSIS Dir 10,010.1 Microbiological Testing Program for Escherichia Coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components include : It is important for the IPP to understand the establishment�s production practices and lotting determination prior to sampling. It also important for the IPP to discuss the issue of prior notification and the time needed by the establishment. If the process changes, this should be discussed again to ensure that the timeframe has not changed and is agreeable to both parties.

11. January 30, 2010 Work Unit Meeting Correlation Material 11 FSIS E. coli 0157:H7 Key Points in Dir 10,010.1: Raw Ground Beef Sample projects: IPP may submit the raw beef sample to the laboratory after the establishment has completed all interventions, except for any intervention that is based on microbiological test results. Key points to FSIS Dir 10,010.1 Microbiological Testing Program for Escherichia Coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components include : IPP are to submit the raw beef sample to the laboratory after the establishment has completed all interventions, except for any intervention that is based on microbiological test results. Thus, inspection program personnel, in many cases, will be collecting and submitting FSIS samples to the laboratory before the establishment completes pre-shipment review. This new policy will better ensure that inspection program personnel�s work time is productive and provides better public health protection. In addition, this new policy will provide FSIS greater access to and awareness of E. coli O157:H7 in raw beef products. Key points to FSIS Dir 10,010.1 Microbiological Testing Program for Escherichia Coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components include : IPP are to submit the raw beef sample to the laboratory after the establishment has completed all interventions, except for any intervention that is based on microbiological test results. Thus, inspection program personnel, in many cases, will be collecting and submitting FSIS samples to the laboratory before the establishment completes pre-shipment review. This new policy will better ensure that inspection program personnel�s work time is productive and provides better public health protection. In addition, this new policy will provide FSIS greater access to and awareness of E. coli O157:H7 in raw beef products.

12. January 30, 2010 Work Unit Meeting Correlation Material 12 FSIS E. coli 0157:H7 Key Points in Dir 10,010.1: IPP may submit the sample either in final packaged form prior to freezing (preferred method unless CCP for freezing) if held overnight before shipment then the final package is frozen or� IMPORTANT Policy that did not change in FSIS Dir 10,010.1 Microbiological Testing Program for Escherichia Coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components include : How in-plant inspection program personnel may submit the sample either in final packaged form prior to freezing (preferred method unless CCP for freezing) if held overnight before shipment then the final package is frozen or�when possible the samples should be in the finished packaging. If there is a CCP for freezing, inspection must wait to collect the sample and send it frozen. Freezing the product does affect the ability to recover the pathogen in the sample, so freezing the sample is discouraged except in limited circumstances as outlined in the directive. IPP are to refrigerate the samples held overnight. IPP are not to freeze the sample. If IPP are not able to ship the sample so that it arrives at the laboratory within 48 hours, then IPP are to freeze the sample. NOTE: Freezing and thawing the product may increase the growth of pathogens .IMPORTANT Policy that did not change in FSIS Dir 10,010.1 Microbiological Testing Program for Escherichia Coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components include : How in-plant inspection program personnel may submit the sample either in final packaged form prior to freezing (preferred method unless CCP for freezing) if held overnight before shipment then the final package is frozen or�when possible the samples should be in the finished packaging. If there is a CCP for freezing, inspection must wait to collect the sample and send it frozen. Freezing the product does affect the ability to recover the pathogen in the sample, so freezing the sample is discouraged except in limited circumstances as outlined in the directive. IPP are to refrigerate the samples held overnight. IPP are not to freeze the sample. If IPP are not able to ship the sample so that it arrives at the laboratory within 48 hours, then IPP are to freeze the sample. NOTE: Freezing and thawing the product may increase the growth of pathogens .

13. January 30, 2010 Work Unit Meeting Correlation Material 13 FSIS E. coli 0157:H7 Key Points in Dir 10,010.1: IPP may submit the sample either in aseptic collection in a sterile whirl pak bag from the FSIS Field Services Laboratory Note: use of anything other than a sterile bag will result in a discard from the laboratory. More IMPORTANT Policy that did not change in FSIS Dir 10,010.1 Microbiological Testing Program for Escherichia Coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components include : How in-plant inspection program personnel may submit the sample before the final package if the sample is collected aseptically and in a STERILE bag. Please ensure the bag is a STERILE Bag and not the bags sent with the seals to send samples to the laboratory in their final package. This is very important in order to avoid discards.More IMPORTANT Policy that did not change in FSIS Dir 10,010.1 Microbiological Testing Program for Escherichia Coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components include : How in-plant inspection program personnel may submit the sample before the final package if the sample is collected aseptically and in a STERILE bag. Please ensure the bag is a STERILE Bag and not the bags sent with the seals to send samples to the laboratory in their final package. This is very important in order to avoid discards.

14. January 30, 2010 Work Unit Meeting Correlation Material 14 FSIS E. coli 0157:H7 Key Points in Dir 10,010.1: When positive �+� FSIS sample occurs� IPP should routinely collect follow-up samples as soon as possible following the FSIS positive result IPP do not wait for an establishment to complete corrective actions Key Points in FSIS Dir 10,010.1 Microbiological Testing Program for Escherichia Coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components include : When positive �+� FSIS sample occurs� IPP will routinely collect follow-up samples as soon as possible following the FSIS positive result and do not wait for an establishment to complete corrective actions. When the FSIS sample is positive, if the establishment held the product sampled (or maintained control of the product) pending its own test results, and FSIS and the establishment both found the product positive for E. coli O157:H7, FSIS inspection program personnel are not to issue a noncompliance record (NR). Inspection program personnel are to verify that the establishment performs the appropriate corrective actions and follow instructions.Key Points in FSIS Dir 10,010.1 Microbiological Testing Program for Escherichia Coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components include : When positive �+� FSIS sample occurs� IPP will routinely collect follow-up samples as soon as possible following the FSIS positive result and do not wait for an establishment to complete corrective actions. When the FSIS sample is positive, if the establishment held the product sampled (or maintained control of the product) pending its own test results, and FSIS and the establishment both found the product positive for E. coli O157:H7, FSIS inspection program personnel are not to issue a noncompliance record (NR). Inspection program personnel are to verify that the establishment performs the appropriate corrective actions and follow instructions.

15. January 30, 2010 Work Unit Meeting Correlation Material 15 FSIS E. coli 0157:H7 Key Points in Dir 10,010.1: Multiple follow-up FSIS samples after a �+� MT43, MT50, or MT05 (Retail) 16 or 8 samples (less than 1,000 lbs/day) (max 2/shift from different lots; minimum 3/week) Key points FSIS Dir 10,010.1 Microbiological Testing Program for Escherichia Coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components include : When positive �+� FSIS sample occurs there are now multiple follow-ups taken depending upon production volume. 16 forms will be sent, but if this is a less than 1,000 lb/day establishment, only 8 forms will be used. The other 8 forms must be mailed back to the laboratory that is identified in block 9 on the FSIS Form 10,210-3 Requested Sample Programs form. IPP collect 8 samples for low volume establishments or 16 for all other establishments, at the following daily and weekly frequencies: a. a maximum of 2 follow-up samples per shift per day from different lots (or up to 4 samples per day at a 2-shift establishment), unless the establishment cannot continue to operate under that sampling frequency (e.g., because the establishment cannot fill orders and hold all sampled product), or the IPP�s workload cannot accommodate that sampling frequency; and b. a minimum of 3 follow-up samples per week, unless the establishment produces the product in question less than three times per week, the establishment cannot continue to operate under that sampling frequency, or the inspection program employee�s workload cannot accommodate that sampling frequency.Key points FSIS Dir 10,010.1 Microbiological Testing Program for Escherichia Coli O157:H7 in Raw Ground Beef Products and Raw Ground Beef Components and Beef Patty Components include : When positive �+� FSIS sample occurs there are now multiple follow-ups taken depending upon production volume. 16 forms will be sent, but if this is a less than 1,000 lb/day establishment, only 8 forms will be used. The other 8 forms must be mailed back to the laboratory that is identified in block 9 on the FSIS Form 10,210-3 Requested Sample Programs form. IPP collect 8 samples for low volume establishments or 16 for all other establishments, at the following daily and weekly frequencies: a. a maximum of 2 follow-up samples per shift per day from different lots (or up to 4 samples per day at a 2-shift establishment), unless the establishment cannot continue to operate under that sampling frequency (e.g., because the establishment cannot fill orders and hold all sampled product), or the IPP�s workload cannot accommodate that sampling frequency; and b. a minimum of 3 follow-up samples per week, unless the establishment produces the product in question less than three times per week, the establishment cannot continue to operate under that sampling frequency, or the inspection program employee�s workload cannot accommodate that sampling frequency.

16. January 30, 2010 Work Unit Meeting Correlation Material 16 FSIS E. coli 0157:H7 Dir 10,010.1: Follow-up Raw Ground Beef Sample project codes: MT44 (formerly know as MT04) multiple follow-ups after �+� MT43 If slaughter/processing produced ground product �+�, the MT44 is not collected; only processing establishments MT04T trace back to originating grinding establishment when �+� found at retail MT05 Follow-up Raw Ground Beef Sample project codes: MT44 (formerly know as MT04) multiple follow-ups after �+� MT43.If the IIC does not receive sampling forms within 14 days of the positive sample result, IPP email SamplingFormsHeadquarters@fsis.usda.gov mailbox and request the forms for follow-up sampling of the MT43 positive. Multiple follow-up sample will be collected from raw ground beef product samples under MT44 sampling project number . At low volume establishments (establishments that produce less than 1,000 pounds per day of product in question), IPP are only to submit 8 samples and mail the remaining 8 follow-up forms with the last sample collected. In combination slaughter/processing establishments, if FSIS or another Federal or State entity finds ground product positive, and the establishment produced the source materials used to produce the ground product, PAD will generate MT52 sample request forms. IPP are to collect either 8 or 16 MT52 samples, based on establishment size, of the type of source materials used in the positive raw ground beef product. IPP are not to collect follow-up samples of ground product. In this situation, PAD is to notify the DO to instruct the IIC to mail the forms for multiple follow-up samples of raw ground product back to the laboratory via the United States postal service. MT04T trace back to originating grinding establishment when �+� found at retail MT05 Please note this project is rarely used at this time. Follow-up Raw Ground Beef Sample project codes: MT44 (formerly know as MT04) multiple follow-ups after �+� MT43.If the IIC does not receive sampling forms within 14 days of the positive sample result, IPP email SamplingFormsHeadquarters@fsis.usda.gov mailbox and request the forms for follow-up sampling of the MT43 positive. Multiple follow-up sample will be collected from raw ground beef product samples under MT44 sampling project number . At low volume establishments (establishments that produce less than 1,000 pounds per day of product in question), IPP are only to submit 8 samples and mail the remaining 8 follow-up forms with the last sample collected. In combination slaughter/processing establishments, if FSIS or another Federal or State entity finds ground product positive, and the establishment produced the source materials used to produce the ground product, PAD will generate MT52 sample request forms. IPP are to collect either 8 or 16 MT52 samples, based on establishment size, of the type of source materials used in the positive raw ground beef product. IPP are not to collect follow-up samples of ground product. In this situation, PAD is to notify the DO to instruct the IIC to mail the forms for multiple follow-up samples of raw ground product back to the laboratory via the United States postal service. MT04T trace back to originating grinding establishment when �+� found at retail MT05 Please note this project is rarely used at this time.

17. January 30, 2010 Work Unit Meeting Correlation Material 17 FSIS E. coli 0157:H7 Dir 10,010.1: Follow-up Raw Ground Beef Component or Raw Beef Patty Sample projects: Multiple samples for follow-up to the FSIS routine verification sampling �+� at establishment that grind beef or at retail store. On a monthly basis, the PAD, OPPD reviews data from STEPS to schedule follow-up sampling of suppliers. During the high prevalence season, PAD is to review the data bi-monthly. Follow-up Raw Ground Beef Component or Raw Beef Patty Sample projects: Multiple samples for follow-up to the FSIS routine verification sampling �+� at establishment that grind beef or at retail store. (= 2 lbs) MT52 Follow-up Raw Beef Manufacturing Trimmings �+� � Originating slaughter establishment sampled based on an MT43 Positive Result, or MT55 Positive Results at Federal Establishments *If IPP receive forms to collect 16 follow-up samples under the MT52 project code and any sample of this set tests positive. IPP then receive 16 follow-up samples for MT53 as a result of this positive sample result, IPP would collect the rest of the 16 follow-up samples from the MT52 project code as well as the 16 follow-up. IPP may determine that it is necessary to sample other product, in addition to the components used in the positive raw ground product samples from the MT53 project code. If IPP determine that sampling of additional products would be useful, they are to contact the DO. Sampling continues unless the DO makes a determination to initiate an enforcement action that would stop production. Follow-up Raw Ground Beef Component or Raw Beef Patty Sample projects: Multiple samples for follow-up to the FSIS routine verification sampling �+� at establishment that grind beef or at retail store. (= 2 lbs) MT52 Follow-up Raw Beef Manufacturing Trimmings �+� � Originating slaughter establishment sampled based on an MT43 Positive Result, or MT55 Positive Results at Federal Establishments *If IPP receive forms to collect 16 follow-up samples under the MT52 project code and any sample of this set tests positive. IPP then receive 16 follow-up samples for MT53 as a result of this positive sample result, IPP would collect the rest of the 16 follow-up samples from the MT52 project code as well as the 16 follow-up. IPP may determine that it is necessary to sample other product, in addition to the components used in the positive raw ground product samples from the MT53 project code. If IPP determine that sampling of additional products would be useful, they are to contact the DO. Sampling continues unless the DO makes a determination to initiate an enforcement action that would stop production.

18. January 30, 2010 Work Unit Meeting Correlation Material 18 FSIS E. coli 0157:H7 Multiple Follow-up Sample Verification MT52 Follow-up Raw Beef Manufacturing Trimmings �+� � Originating slaughter establishment sampled Recommendation by OPPD RAD/OFDER DAIG Review of STEPS If originating slaughter establishment only supplier If multiple originating establishments identified in STEPS PAD is responsible for the scheduling of MT52. PAD is to determine whether IPP are to collect a single follow-up sample or multiple follow-up samples (based on the criteria in paragraph 4. below) at supplier establishments. If the originating supplying slaughter establishments produced more than one type of component that the grinding establishment used, PAD will generate sample request forms for each type of component. If a supplier is not a sole supplier or a repeat supplier in STEPS, PAD will request a single follow-up sample from the supplier for each component used in the positive raw ground beef product. If PAD determines that an originating slaughter establishment was the only supplier, or that any of the originating slaughter establishments were suppliers that had been identified in STEPS within approximately 4 months (or 120 days) of the current raw ground product positive result, PAD is to request 16 MT52 follow-up sample forms for the originating slaughter establishments identified for each component used in the positive raw ground beef product. PAD is to determine whether IPP are to collect a single follow-up sample or multiple follow-up samples (based on the criteria in paragraph 4. below) at supplier establishments. If the originating supplying slaughter establishments produced more than one type of component that the grinding establishment used, PAD will generate sample request forms for each type of component. If a supplier is not a sole supplier or a repeat supplier in STEPS, PAD will request a single follow-up sample from the supplier for each component used in the positive raw ground beef product. If PAD determines that an originating slaughter establishment was the only supplier, or that any of the originating slaughter establishments were suppliers that had been identified in STEPS within approximately 4 months (or 120 days) of the current raw ground product positive result, PAD is to request 16 MT52 follow-up sample forms for the originating slaughter establishments identified for each component used in the positive raw ground beef product.

19. January 30, 2010 Work Unit Meeting Correlation Material 19 FSIS E. coli 0157:H7 Multiple Follow-up Sample Verification MT53 multiple follow-up samples: �+� MT50 at slaughter establishments �+� MT54 at slaughter establishments , or �+� MT52 at slaughter establishment Follow-up Testing of Positives From Routine Testing of Beef Manufacturing Trimmings (Positive MT50); 2) Routine Testing of Other Components (Positive MT54); or 3) Positive Follow-up Testing at Suppliers (Positive MT52 Samples) Follow-up Testing of Positives From Routine Testing of Beef Manufacturing Trimmings (Positive MT50); 2) Routine Testing of Other Components (Positive MT54); or 3) Positive Follow-up Testing at Suppliers (Positive MT52 Samples)

20. January 30, 2010 Work Unit Meeting Correlation Material 20 FSIS E. coli 0157:H7