DO NOT IMPLEMENT THIS NOTICE UNTIL FEBRUARY 1, 2023.

1. PURPOSE
   1. This notice provides instructions for inspection program personnel (IPP) to begin using the cloth sampling technique for routine verification sampling of domestic beef manufacturing trimmings and bench trim beginning February 1, 2023, instead of N60 excision sampling.
   2. IPP at import establishments will continue to sample beef manufacturing trimmings under the MT51 project code using the N60 excision technique, regardless of whether the product is frozen or unfrozen to ensure consistency in sampling at import establishments.
2. BACKGROUND
   1. FSIS currently collects raw beef manufacturing trimmings and bench trim verification samples using the N60 excision sampling procedure as described in FSIS Directive 10,010.1, Sampling Verification Activities for Shiga Toxin-Producing Escherichia coli (STEC) in Raw Beef Products. The N60 excision method is a destructive sampling method that requires IPP to cut and collect thin slices from the external surface of beef tissues.
   2. FSIS conducted an in-field surface sampling study to determine the feasibility of a non-destructive surface sample collection method (i.e., cloth) to collect raw beef manufacturing trimmings verification samples. The data collected from this study supports the use of the cloth sampling method as being equivalent to N60 excision sampling (87 FR 71291 ). Beginning February 1, 2023, IPP will utilize the cloth sampling methodology to collect beef manufacturing trimmings and bench trim verification samples.
   3. There is no change in product eligibility for raw beef sampling. Raw beef product eligibility is based on its intended use as instructed in FSIS Directive 10,010.1.
   4. New PHIS codes will replace the current raw intact beef product MTxx codes which are affected by the cloth sampling method. The cloth sample collection method will only be used when beef manufacturing trim or bench trim is to be sampled.
      1. MT60 Beef manufacturing trimmings will be replaced with MT60_C;
      2. MT65 Bench trim will be replaced with MT65_C;
      3. MT52 follow-up sampling will be replaced with MT52_C;
      4. MT53 follow-up sampling will be replaced with MT53_C; and
      5. MT44T follow-up sampling will be replaced with MT44T_C.
3. ESTABLISHMENT SAMPLING ELIGIBILITY AND PHIS SAMPLING TASK ASSIGNMENT
   1. Establishments that produce beef manufacturing trimmings eligible for MT60 sampling from cattle slaughtered onsite or at sister establishments as described inFSIS Directive 10,010.1, will now be eligible for MT60_C sampling.
   2. Establishments that produce bench trim eligible for MT65 sampling from cattle not slaughtered onsite will now be eligible for MT65_C sampling.
   3. IPP are to ensure that the Public Health Information System (PHIS) Establishment Profile information for establishments that produce beef manufacturing trimmings or bench trim is up-to-date and accurate (FSIS Directive 10,010.1, Chapter III - PHIS Profile Responsibilities).
   4. IPP are to be aware that when freezing is used as an intervention to reduce STEC presence on beef intended for non-intact use, the product is to be sampled by N60 excision and not by the cloth method. IPP can order sampling supplies for N60 excision following the instructions in Section VIII below.
4. FOLLOW-UP SAMPLING PROCEDURES USING THE CLOTH
   1. IPP are to conduct follow-up sampling procedures consistent with the sampling project code in the assigned task. For example, if the assigned task is an MT53 follow-up sample, then IPP are to collect the sample with N60 excision methodology as detailed in Chapter VII of FSIS Directive 10,010.1. However, if the assigned task is an MT53_C, then IPP are to collect the sample using the cloth methodology as described in Section X Sampling Procedure below.
      
      NOTE: PHIS follow-up sampling task assignment methodology will be based on when the triggering pathogen positive sample was collected. For positive samples detected before February 1, 2023, FSIS will assign a follow-up sampling set using the N60 methodology (sample tasks with no "_C" in the project code). All samples from that set are to be collected using N60 excision sampling even if some of those samples are collected after February 1, 2023. However, if a positive sample is detected after February 1, 2023, FSIS will assign a follow-up sampling set using the cloth sampling methodology ("C" in the project code).
   2. IPP are to be aware that a MT43 ground beef positive at a slaughter processing establishment will result in an MT53_C follow-up sampling set. In this situation, IPP are to sample beef manufacturing trimmings using the cloth sample collection method rather than ground beef.
   3. IPP are to be aware that MT53_C follow-up samples following a MT64 Ground Beef Component Other than Trim positive (e.g., head meat) are to be collected using a grab sample collection method per FSIS Directive 10,010.1 sampling procedures for that product. IPP are not to use cloth sampling for routine MT64 sampling or during follow-up sampling of components other than trim.
   4. IPP are to follow the cloth sampling procedure in Section X below for MT52_C and MT53_C follow-up sampling of trim.
   5. IPP are to be aware that MT44T_C follow-up samples can be variable depending on the beef commodity to be sampled and may or may not require the cloth sampling technique. Specific instructions to IPP will be provided through District Office in coordination with Headquarters Office of Field Operations (OFO) subject matter experts, if needed, on a case-by case basis for assigned MT44T_C sampling tasks.
5. INFORMATION SHARING WITH ESTABLISHMENT MANAGEMENT
   1. During the next weekly meeting at establishments producing beef manufacturing trimmings or bench trim, IPP are to share this updated notice with establishment management.
   2. IPP are to inform establishment management and document in a Memorandum of Information (MOI) that:
      1. MT60_C and MT65_C cloth sample collection procedures will replace MT60 and MT65 N60 excision sampling for FSIS verification samples. MT60_C and MT65_C samples will be analyzed for STEC and Salmonella as described in FSIS Directive 10,010.1;
      2. Establishments are required to hold the sampled lot until FSIS results for STEC are reported. If the STEC results are reported and negative but the Salmonella results are delayed, establishments are not required to hold the product pending Salmonella (only) results.
      
      NOTE: FSIS recommends that the randomly selected product, whether combo bins, boxes, totes, or other containers, have microbiological independence from other products produced from the same source material to minimize the amount of product on hold and to minimize the product that would be implicated by a positive result.
   3. An instructional video of the cloth sampling procedure can be seen at IPP Help, Cloth Sampling Video. IPP are to watch the video before performing the cloth sampling procedure.
6. SUPERVISOR RESPONSIBILITIES
   1. Field supervisors, including Supervisory Public Health Veterinarians (SPHVs), Supervisory Consumer Safety Inspectors (SCSIs), and Frontline Supervisors (FLSs), are to ensure that IPP assigned to collect MT60 and MT65 samples are given time to review this notice and watch the cloth sampling procedure in the instructional video as shown at IPP Help, Cloth Sampling Video.
   2. Supervisors are to ensure that IPP understand that FSIS laboratories will discard samples with the reason, "Sampling Instructions Not Followed," if nBPW is not used.
7. SAMPLE SELECTION
   1. MT60_C and MT65_C sample collection procedures are detailed below in Section X, Sampling Procedure.
   2. If the establishment packages product in combo bins, then IPP are to select one random combo bin from the specific production (e.g., day's production) available for sampling with one cloth. If the combo selected is part of a multi-combo lot, IPP are only to sample the selected combo with the cloth. However, the establishment will need to hold the entire multi-combo lot pending STEC test results.
   3. If the establishment packages product in boxes, totes, tubs, or containers other than combo bins, IPP are to use 1 cloth for up to 5 containers from the same lot of product. For example, if an establishment defines its lot as 3 boxes, IPP are to swab all 3 boxes using 1 cloth, for a total of 1 cloth collected and shipped to the laboratory.
   4. If the establishment packages eligible product in both combo bins and other containers, IPP are to randomly select combo bins or other containers. If combo bins are chosen, follow B above. If other containers are chosen, follow C above.
8. SAMPLING SUPPLIES FOR MT60_C and MT65_C
   1. The FSIS laboratories will ship the sampling supplies automatically to the Inspector-in-Charge (IIC) at the establishments collecting samples. IPP are to use only the sampling supplies provided by the FSIS laboratories.
   2. If IPP do not receive sampling supplies by the first day of the collection month, or need replacements for damaged or lost supplies, they are to request sampling supplies.
   3. To request sampling supplies via PHIS, IPP are to right-click a scheduled laboratory sampling task (e.g., "MT60_C") on the Task Calendar, then select "Order Supplies" from the drop-down menu.
   4. If unable to request supplies via PHIS, IPP are to request sampling supplies via Outlook by using one of the following addresses:
      1. SamplingSupplies-EasternLab@usda.gov;
      2. SamplingSupplies-MidwesternLab@usda.gov; or
      3. SamplingSupplies-WesternLab@usda.gov.
   5. IPP are to use the subject heading "MT60_C or MT65_ C Sampling Supplies" in the email and include the establishment name and number, the project code (MT60_C, MT65_C), the IPP's contact name, establishment number, telephone number, and a list of the supplies needed.
   6. IPP will receive new shipping containers for MT60_C/MT65_C sampling and sampling supplies that contain nBPW.
   7. IPP are to return any unused MT60, MT65 shipping containers and exploratory MT60_CLOTH sampling supplies to the FSIS Field Service Laboratories. IPP are to send a request for a pre-addressed return FedEx ground shipping label to one of the email addresses listed below.
   8. When returning supplies, IPP are not to use any shipping labels included with supplies since they are labels for express delivery that are charged more than a standard ground box. IPP are to contact the laboratory within their region listed below and use "Return Supplies" in the e-mail subject heading to send unused boxes back to the laboratories.
      1. Eastern Laboratory - Atlanta (85), Raleigh (80), Philadelphia (60), Jackson (90) SamplingSupplies-EasternLab@usda.gov
      2. Midwestern Laboratory - Des Moines (25), Springdale (35), Chicago (50) SamplingSupplies-MidwesternLab@usda.gov
      3. Western Laboratory - Alameda (05), Denver (15), Dallas (40) SamplingSupplies-WesternLab@usda.gov
9. VERIFICTION OF MT60_C and MT65_C SAMPLING SUPPLIES
   1. All the necessary sampling supplies for MT60_C and MT65_C sampling will be in the shipping box, except the alcohol sanitizer used to sanitize the gloves and sleeves. IPP are to order sanitizer from the FSIS Material Management Supply Center in advance of collecting samples. IPP are not to use sanitizer provided by the establishment.
   2. The box will include the following shipping supplies for the cloth sample collection
      1. MT60_C/MT65_C sampling supply kit
         1. 1' - 7" x 8" (quart size) resealable zip lock type bag;
         2. 1' - cloth in a roll top bag;
         3. 3' - FedEx billable stamp: (Eastern Laboratory, Midwestern Laboratory, Western Laboratory);
         4. 1' - FSIS Form 7355-2A/AB (sample seal set);
         5. 1' - 6" x 12" plastic sleeve (for the sample form);
         6. 1' - pair of plastic forearm sleeved gloves;
         7. 1' - pair of non-sterile gloves;
         8. 1' - tube of sterile nBPW (the tube contains 25 mL);
         9. 1' - shipping container;
         10. 1 or 2' - gel coolant packs;
         11. 1 or 2' - cardboard separators;
         12. 1' - absorbent pad; and
         13. 1' - foam plug.
   3. IPP are to only use the supplies provided for the specific sampling procedure being performed. The laboratories may include additional cardboard separators and gel coolant packs with the sample supplies depending upon the time of the year and IPP can request these supplies from one of the FSIS laboratories, if needed. IPP are not to use sample supplies that are not provided in the shipping container or that are not sent from any of the three FSIS laboratories for this project.
   4. IPP are not to share or split sample supplies with the establishment. However, if the establishment is interested in doing its own analysis, IPP are to be aware the establishment may use its own supplies to collect a sample at approximately the same time and point of production as the routine FSIS MT60_C and MT65_C samples.
10. SAMPLING PROCEDURES
    1. Prior to sample collection, IPP are to complete the following steps to maintain proper temperature during sample collection and shipment:
       1. Pre-chill nBPW upon receipt by placing it in a secure refrigerator (where the supplies will remain under FSIS control);
       2. Place gel coolant packs into the freezer for at least 24 hours before sample collection; and
       3. Pre-chill shipping containers by placing the pre-frozen gel pack(s) on top of the absorbent pads. The absorbent pads are used to line the bottom of the shipping containers.
       
       NOTE: IPP are not to freeze nBPW or the sample.
    2. MT60_C and MT65_C Sample Procedure
       1. IPP are to wash and dry hands to the mid-forearm;
       2. IPP are to remove the clear, perforated plastic shrink wrap from the tube of nBPW and set the nBPW aside;
       3. Prior to gloving and without touching the cloth, IPP are to drop the folded cloth onto the surface of the product using the following procedures (see photos below).
          1. Open the bag by removing the perforated strip at the top of the bag. Pull the tabs to open the wire mouth of the bag wide. Once the bag is open invert the bag to drop the cloth and allow the dry cloth to drop onto the surface of the product. If the cloth does not come out of the bag, IPP are to use one hand (on the outside of the sample bag) to push the dry cloth to the top of the sample bag and then invert again. Do not touch the cloth with bare hands at this time;
          2. Place the empty plastic outer bag in an upright position on a clean, sanitary surface such as a sample caddy/tote or table within reaching distance of the sampling area. This positioning will facilitate placement of the cloth back in the bag once the sampling procedure is complete;
       4. Put on plastic long-sleeved gloves, followed by non-sterile short gloves over the top. Using an alcohol-based spray sanitizer (available from the FSIS Material Management Supply Center), IPP are to sanitize gloved hands and plastic sleeves simultaneously. Ensure there is no excess sanitizer on the gloved hands or forearm sleeves before touching the cloth and beginning the sampling procedure. With gloved arms facing away from product, IPP are to gently shake excess sanitizer from the gloved hands while being mindful to avoid contaminating gloves by touching non- product contact surfaces.
          
          NOTE: IPP are to order sanitizer from the FSIS Material Management Supply Center in advance of collecting samples. IPP are not to use sanitizer provided by the establishment.
       5. IPP are to maintain sanitary conditions after sanitizing gloved hands and forearm sleeves. Do not touch anything except for the cloth;
       6. To perform this sampling procedure, after gloving and sanitizing as described above, IPP are to unfold the cloth, which is laying on top of the product in the combo/box;
       7. IPP are to visually identify a point on the combo to begin and end the sampling procedure because IPP will move around the combo in a uniform manner to massage the entire surface of the combo;
       8. Once a starting point for sampling has been identified, IPP are to tightly grasp the cloth with both hands. While using both hands, IPP are to apply downward pressure to vigorously massage the surface area of the product with the unfolded cloth;
       9. IPP are to vigorously massage the surface of the beef trim, including the spaces and crevices between meat pieces, to ensure as much of the product surface area is sampled as possible;
          
          NOTE: The cloth is to be held with downward pressure to massage meat with both hands. IPP are not to hold the ends of the cloth and sweep side-to-side. This "shoeshine" method is not effective for cloth sampling as it does not go between pieces of meat and does not cover the total surface area required for cloth sampling.
       10. IPP are to use one side of the cloth to massage half of the combo. From the starting point of the combo, as identified by IPP, and using one side of the cloth, IPP are to move uniformly around the perimeter of the combo, vigorously massaging the surface area and surfaces in between the meat pieces;
       11. At a point halfway around the combo, IPP are to flip the cloth and use the second side of the cloth to vigorously massage the remaining half of the combo until reaching the point in the combo where the sampling procedures started;
       12. The total sampling time will be a minimum of 1.5 minutes per combo bin. IPP are to vigorously massage for a minimum of 45–60 seconds per side of the cloth to ensure a thorough sample collection (total sampling time of 1.5 - 2 minutes);
       13. When the sampling procedure is complete, IPP are to re-fold the cloth following the original fold lines in the cloth and then add 2 additional folds to the cloth—the 2 additional folds will assist with placing the cloth into the sample collection bag. As indicated in the photo above, the cloth is to be folded while resting on the meat product in the combo;
       14. Once folded, IPP are to return the cloth to the original clear plastic sample roll top bag;
       15. Next, IPP are to carefully open the nBPW tube and aseptically pour the pre-chilled nBPW into the open bag. IPP are to ensure that the tube does not touch the inside of the bag. IPP are not to insert the tube into the bag; only the buffer should contact the inside of the bag.
           
           NOTE: IPP are to be aware that FSIS laboratories will discard samples with the reason, Sampling Instructions Not Followed, if nBPW is not used.
       16. IPP are to discard the empty nBPW tube.
       17. IPP are to use gentle pressure on the outside of the roll top bag to push the cloth down into the nBPW and remove excess air from the bag;
       18. IPP are to close the roll top bag and roll/fold the top of the bag down at least 3 times to prevent leakage. IPP are to fold in the wire tabs to secure the bag and prevent leakage; and
       19. IPP are to place at least one small, barcoded label on an individual bag per FSIS Directive 7355.1, Use of Sample Seals for Program Samples and Other Applications.
       20. IPP are to package the roll top bag containing the cloth in the box for shipping as indicated in Section XI.
11. SAMPLE SHIPPING
    1. IPP are to return the cloth sample to the respective field laboratory together in the shipping sample box. MT60_C and MT65_C samples have one set of sample seals and sample form.
    2. For sample shipment, IPP are to:
       1. Pre-chill shipping containers by placing a pre-frozen gel pack at the bottom of the container and on top of the absorbent pad; refer to Section IX, C. Cloth Sampling Procedure;
       2. Place one of the included cardboard separators on top of one of the gel packs;
       3. Place the bagged and sealed MT60_C/MT65_C sample in a 7" x 8" zipper lock bag and close it;
       4. Place the bagged MT60_C/MT65_C sample inside the insulated sample shipping box as soon as possible, place a cardboard separator on top of the sample, add a pre-frozen gel pack, and finally add the foam plug to the box;
       5. Maintain appropriate sample temperatures during collection and shipment. IPP are to avoid storing shipping containers near heaters or in areas exposed to excessive heat. Proper use of the packing materials provided for sample collection will help ensure that an appropriate temperature is maintained during shipping; and
          
          NOTE: If the cloth does not meet the acceptable criteria for sampling when received, it will be discarded.
       6. Ship the sample via overnight FedEx courier the same day the sample is collected, when possible. IPP are to hold the sample overnight if they collect a sample after FedEx has picked up. For example, MT60_C samples collected from a late production shift or second shift are to be held overnight under refrigeration and sent by overnight courier the next calendar day. IPP are to schedule, collect, and ship samples collected on Friday the same day for arrival at the laboratory on Saturday. IPP are not to ship a sample on Saturday or the day before a federal holiday.
12. QUESTIONS
    Refer questions regarding this notice to your supervisor or as needed to the Office of Policy and Program Development through askFSIS or by telephone at 1-800-233-3935. When submitting a question, complete the web form and select Sampling as the Inquiry Type.
    
    NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.