PHVs are to be aware that establishments are not required to hold products pending NARMS results.

1. PURPOSE
   This directive provides instruction changes and updates to Public Health Veterinarians (PHVs) who collect the National Antimicrobial Resistance Monitoring System (NARMS) cecal samples at selected slaughter establishments. The updates include additional slaughter classes - veal, sheep, lamb, and goat, and replacement of Salmonella molecular serology with Whole Genome Sequencing (WGS)-based serotype interpretations.
   
   KEY POINTS:
   • Notifies Public Health Veterinarians (PHV) of the change from molecular serotyping to WGS
   • Includes minor slaughter classes for intermittent cecal sampling
   • Announces a minor change of supplies available in kits for PHVs in the appendix
   • Notifies PHVs of change in the available days to sample and ship
2. CANCELLATION
   FSIS Directive 10,100.1 Rev. 1, FSIS Cecal Sampling Under the National Antimicrobial Resistance Monitoring System (NARMS) Surveillance Program, 10/29/2019
3. BACKGROUND
   1. The NARMS is an interagency, collaborative partnership with state and local public health departments, the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture (USDA). This national public health surveillance system was established in 1996 to track antimicrobial susceptibility among foodborne enteric bacteria from humans, retail meats, and food animals. The CDC NARMS program focuses on bacterial isolates from case-patients. FDA's Center for Veterinary Medicine (CVM) NARMS program focuses on retail meats, and the USDA FSIS NARMS program focuses on food animals at slaughter and processing through two sampling points - the samples that are collected from intestinal (cecal) content and selected products from routine Salmonella verification sampling (i.e., samples collected under performance standards) to include carcass and food commodity samples. The FSIS and CVM NARMS programs include isolations of Salmonella, Escherichia coli (E. coli), Campylobacter, and Enterococcus spp. Additional information and web links are available on the FSIS NARMS web page.
   2. In addition to monitoring antimicrobial susceptibility, the NARMS partners collaborate on epidemiologic and microbiologic studies and conduct research to better understand the emergence, persistence, and spread of antimicrobial resistance among foodborne bacteria. Additional information on the FDA NARMS program is available at The National Antimicrobial Resistance Monitoring System. Information on the CDC NARMS program is available at National Antimicrobial Resistance Monitoring System for Enteric Bacteria (NARMS).
   3. The FSIS NARMS sampling program is being conducted in support of the National Action Plan for Combating Antibiotic Resistant Bacteria (CARB) and the USDA Antimicrobial Resistance (AMR) Action Plan. This sampling provides data on the presence and antimicrobial resistance profile of selected enteric microorganisms in food animal slaughter classes. As part of this sampling program, FSIS's Office of Public Health Science's (OPHS) Eastern Laboratory (EL) in Athens, Georgia processes samples of cecal contents collected by Public Health Veterinarians (PHVs) and tests for the presence of Salmonella, E. coli, Campylobacter, and Enterococcus spp. This FSIS laboratory performs the primary isolation and identification of these microorganisms and completes further characterization of the isolates to include antimicrobial susceptibility testing and WGS-based serotype interpretations. The resulting NARMS data is used to monitor trends in antimicrobial resistance and susceptibility among enteric bacteria in food animals and in FDA's CVM animal antimicrobial drug approval and evaluation processes.
      
      NOTE: The routine molecular serotyping approach for Salmonella isolates was discontinued in January 2020 and replaced with WGS.
   4. PHVs are to collect samples of cecal contents from swine (market swine and sow), cattle (dairy cow, beef cow, steer, and heifer), veal (bob veal, non-formula-fed veal, or formula-fed veal), sheep, lamb, goat, young chicken, and young turkey in FSIS-regulated livestock and poultry slaughter establishments. Samples are to be shipped to the FSIS Eastern Laboratory for testing, as described in Section XI of this directive.
4. ESTABLISHMENT ELIGIBILITY FOR THE FSIS NARMS SAMPLING PROGRAM
   1. Livestock and poultry slaughter establishments are eligible for the NARMS sampling program based on data in the FSIS Public Health Information System (PHIS): the animal classes slaughtered and annual slaughter volumes. Sampling tasks for the NARMS sampling program will be assigned at the frequencies in the chart below, using the previous 12 months of slaughter data. The number of sampling tasks assigned in PHIS may vary from the monthly targets below in order to reach annual isolate targets:

      Slaughter Volume	Maximum Number of Sampling Tasks per Month per Sampling Project
      Top 25% of Slaughter Establishments	4
      Second 25% of Slaughter Establishments	2
      Lowest 50% of Slaughter Establishments	1

   2. PHVs will receive sampling tasks through PHIS and are to order supplies for each sampling event from the Eastern Laboratory (see Section VI). PHVs are to respond to each sampling task using the instructions provided in this directive.
5. DIRECTIVES AND REVIEW OF TRAINING MATERIALS
   PHVs assigned to establishments eligible for the FSIS NARMS sampling program are to be familiar with the following FSIS issuances and the information provided in this directive:
   1. FSIS Directive 13000.2, Performing Sampling Tasks in Official Establishments Using the Public Health Information System;
   2. FSIS Directive 7355.1, Use of Sample Seals for Laboratory Samples and Other Applications; and
   3. NARMS Training Video - Link will bring up the IPP Help Sampling page. Click on the NARMS Sampling Icon, then the NARMS video.
6. SAMPLING TASK ASSIGNMENT
   1. PHVs will receive a PHIS alert when NARMS sampling tasks have been distributed. The sampling tasks are directed tasks on the establishment task list with one or more of the following sampling project codes:

      Project Code	Slaughter Class to Sample	Number of Animals/Cecal Contents Represented in Each Sample
      NARMS_YC	Young Chicken	5
      NARMS_YT	Young Turkey
      NARMS_DC	Dairy Cow	1
      NARMS_BC	Beef Cow
      NARMS_ST	Steer
      NARMS_HF	Heifer
      NARMS_MS	Market Swine
      NARMS_SW	Sow
      NARMS_BV	Bob Veal*	1
      NARMS_FFV	Formula-Fed Veal*
      NARMS_NFFV	Non-Formula-Fed Veal*
      NARMS_SH	Sheep*
      NARMS_LB	Lamb*
      NARMS_GO	Goat*

      
      *FSIS may assign sampling of these slaughter classes periodically during certain years; FSIS will notify PHVs via an FSIS Notice before assigning these tasks.
      
      NOTE: All of the livestock slaughter classes listed above require one sample of cecal contents from one carcass per sampling task, except for young chicken and turkey. For young chicken and turkey, five ceca, from the same lot, are to be composited into the supplied specimen cups as one sample.
   2. The sampling task can be located on the task list in PHIS by using the "sampling" filter. PHVs are to refer to FSIS Directive 13000.2 for instructions on how to add the task to the task calendar, enter the sample information, submit the sample information to the lab, and print a finalized sample collection form in PHIS.
   3. The sample collection window for each NARMS sampling project is 37 days. PHVs are to schedule sample collection as soon as possible to preserve laboratory capacity. Samples cannot be scheduled once the laboratory has met its daily testing capacity.
   4. If a scheduled task will not be collected on the date reserved in the task calendar, the PHV is to remove or reschedule that task as soon as they become aware of the change so that laboratory capacity is as accurate as possible and space is free for additional PHV task scheduling.
   5. If sampling tasks remain in the task list at the end of the sampling window, PHVs are to cancel them from the task list and provide the correct reason. If none of the listed reasons are appropriate, PHVs are to select "Not collected for miscellaneous reasons" and provide additional details in the text box provided (see figure 1). PHVs are not to allow sampling tasks to remain at the end of the sampling window.
      
      Figure 1: Cancellation Window in PHIS
      
   6. Under extenuating scheduling circumstances (e.g., intermittent producers in which there is short notice for a sampling opportunity), the PHV is to consult IPP Help's Requesting Lab Capacity section to determine the solution. PHVs are to use the laboratory inquiry mailing list to reach the NARMS point of contact: FSIS - Laboratory Inquiry - Eastern Lab.
7. ORDERING SAMPLING SUPPLIES
   1. For Initial sampling, the PHV is to request NARMS sampling supplies necessary for the slaughter class scheduled to sample at least 72 hours before the scheduled sample collection date. As the lab receives samples from PHVs, they will automatically repack the box with fresh supplies and send it back to the establishment from which it came. The PHV is to use only the sampling supplies provided by the Eastern Laboratory that are specific to the slaughter class scheduled for sample collection.
   2. The PHV is to refer to the Sampling Supply List in the Appendix for a list of sampling supplies provided by the Eastern Laboratory. These supplies do not include isopropyl alcohol, isopropyl alcohol wipes or pads, or a caddy. The PHV is to attempt to order these supplies through the Materiel Management Service Center (MMSC) as available; otherwise, they must be procured locally. The PHV is to contact the Frontline Supervisor (FLS) for guidance on obtaining these supplies.
   3. The PHV is to order sampling supplies through the PHIS task calendar. To order sample supplies, PHVs are to right-click on the scheduled NARMS sampling task and select Order Supplies from the drop-down menu. A pop-up window will appear that displays the project code and the name of the FSIS Laboratory that will fill the sampling supply request; see figure 2 below. When necessary, PHVs are to enter requests for specific supplies (e.g., extra gloves) in the Comments field and click Submit Request. If no specific supplies are needed, enter "N/A" into the Comments field and click Submit Request. A confirmation message will appear.
      
      Figure 2. Pop-up Window for Ordering Supplies
      
   4. As an alternative in situations where the PHV is unable to order supplies through the task calendar (e.g., because of PHIS connectivity issues), the PHV may send a request for sampling supplies using Outlook to the FSIS - Sampling Supplies - Eastern Lab mailbox.
   5. The PHV is to include "NARMS Sampling Supplies" in the subject heading of the email. The body should include the establishment's name and number, the project code, the PHV's contact name and telephone number, along with a list of the supplies needed.
8. SAMPLE SELECTION
   1. The PHV is to refer to the NARMS sampling task for information on the slaughter class to be sampled.
   2. The PHV is to randomly select from the lots of animals presented for slaughter on the scheduled sampling day that have passed ante-mortem inspection. The PHV is to select a carcass post-mortem for each scheduled sampling event. The PHV is to note the lot information and animal identification information for the animals selected and record this information in the appropriate data fields in the Sample Collection screen in PHIS for the sampling task.
   3. The PHV is to work with establishment management to identify:
      1. The point in the slaughter process where the viscera/large intestines will be retrieved for sampling;
      2. The location in the establishment where the sample selection will be performed;
      3. The establishment employee designated to retrieve the selected viscera and transport it to the pre-determined sample collection location in the livestock slaughter establishment; and
      4. A cleanable work surface (i.e., table) in the sample collection location for staging the sampling supplies and sample collection.
   4. The PHV is to perform sample collection in a location and in a manner that ensures their personal safety, maintains sanitary conditions, prevents the contamination of edible product, and does not interfere with inspection activities. Examples of sampling locations may include, but are not limited to, the veterinary disposition area on the kill floor or the intestine harvesting area (in an establishment that harvests intestines for edible purposes).
9. SAMPLE COLLECTION PREPARATION (ALL SLAUGHTER CLASSES)
   1. PHVs are responsible for collecting the NARMS cecal samples.
   2. PHVs are not to delegate this task to a Consumer Safety Inspector (CSI) or any establishment employee.
   3. In preparation for cecal sampling, the PHVs are to review the NARMS Training video within IPP Help to understand how to use the sampling supplies to retrieve and ship cecal samples to FSIS's Eastern Laboratory. When tasks to sample minor species are assigned in PHIS (veal, goat, sheep, etc.), PHVs are to review the NARMS Training Cattle Video within IPP Help. Cecal sampling instructions are also available in the Appendix.
   4. Sample collection is to be performed Monday through Friday. Samples collected Monday through Thursday can be sent to the lab via Next Day Shipping. Samples collected on Fridays are to be held refrigerated under FSIS control until shipping on Monday. More information on shipping of NARMS cecal samples can be found in Section XI of this directive.
10. COMPLETING THE SAMPLING TASK IN PHIS
    1. The PHV is to follow the instructions provided in FSIS Directive 13000.2and in the PHIS User Guide (level-2 e-authentication is needed to access this site) for accepting, scheduling, and completing the sampling task using PHIS. To assist in the sampling task, the PHV may choose to print a copy of the sample form from PHIS for use during sample collection and to document lot information to enter into PHIS.
    2. The PHV is to enter lot information, the owner/producer name and address, and animal identification information into the appropriate Sample Collection data fields in PHIS for each sample collected. The PHV is to ensure that all requested information is entered into PHIS. When sample collection data entry is completed, the PHV is to click the "Submit to Lab" button, print a finalized form, and sign and date the form. PHIS will display a message stating that the sample collection information has been successfully submitted. The PHV is to place the signed sample form in the sample box under the foam plug with the corresponding sample.
11. SHIPPING THE SAMPLE
    1. The PHV is to use only the shipping materials provided by the FSIS laboratory specific to the NARMS sampling program and refer to FSIS Directive 7355.1, for complete instructions on the proper use of sample seals.
    2. PHVs are to ship samples via overnight FedEx courier the same day as they collect the sample, when possible. Samples collected prior to FedEx arrival are to be shipped the same calendar day the samples were collected. Samples collected after FedEx pickup are to be held refrigerated under FSIS control overnight. PHVs are not to ship any samples Friday for delivery on Saturday. Any Friday collected samples are to be held in a refrigerator and shipped on Monday. PHVs are also not to ship a sample on Saturday or the day before a Federal holiday.
    3. Upon completion of the sample collection, the PHV is to perform the steps below.
       1. Apply one small barcode label from FSIS Form 7355-2A/2B, Laboratory Sample Container Seal Set, to the sample collection container;
       2. Place the sample collection container in a quart-size zipper lock bag. Expel excess air from the bag and close the bag using the zipper lock closure. Place the bagged specimen into the gallon- size zipper lock bag, expel the excess air from the bag, and close the bag using the zipper lock closure;
       3. Apply the medium sized bar-coded FSIS Laboratory Sample Identification Label (FSIS Form 7355-2B) to the gallon-size zipper lock bag;
       4. Affix one small, bar-coded sample label from FSIS Form 7355-2A/2B sample seal set to the completed and signed printed sample form;
       5. Affix the bar-coded label in the space provided at the top center of the sampling form;
       6. Place the completed sample form in the plastic sleeve provided;
       7. Retrieve the frozen gel coolant packs from the freezer and retrieve the pre-chilled shipping container;
       8. Place the cardboard separator and absorbent pad on the bottom of the shipping container;
       9. Place the frozen gel coolant pack on top of the absorbent pad and then place the corrugated cardboard pad on top of the frozen gel coolant pack. Place the bagged sample on top of the corrugated cardboard pad;
          
          NOTE: When needed in the warmer months, place a second frozen gel coolant pack in the shipping container to ensure that the sample arrives at the laboratory at an acceptable temperature.
       10. Review the information on the pre-printed carrier shipping billable stamp (e.g., FedEx billable stamp) provided with the sampling supplies, and ensure that the sample is addressed to the FSIS Eastern Laboratory. Enter the return address information, establishment number, and the PHV phone number on the pre-printed billable stamp;
       11. Place the completed sample form and any unused sample seals in the container;
       12. Insert the foam plug and press down to minimize the space between the sample and foam plug. If the shipping container does not have a foam plug, place the insulated lid on the container. Do not overfill the shipping container;
           
           NOTE: Do not tape or wrap the samples or use any newspaper or similar material as packing material. Use of such materials may result in the sample being discarded by the laboratory.
       13. Complete the information on the large, bar-coded seal from the same FSIS Form 7355-2A/2B sample seal set, sign the seal, and affix the signed, large bar code seal across the seam of the closed sample box flap;
           1. For shipping containers with self-sticking closures, apply the seal across the closed inner flap of the box parallel to the edge of the closed flap. Then close the outer flap over the seal.
       14. Affix the pre-printed carrier shipping billable stamp on the shipping container and remove any old stamp receipts and carrier shipping bar codes from the container; and
       15. Ensure that the sample remains under FSIS control until pickup by the carrier (e.g., FedEx).
    4. The PHV is to ensure that the sample container lid is securely closed prior to shipping. If the sample container is leaking upon arrival, the laboratory may discard the sample. The PHV is to avoid storing shipping containers near heaters or in areas exposed to excessive heat.
    5. Regarding the return of unused sample supplies:
       1. The PHV is to hold any unused sample supplies for future NARMS sampling tasks unless otherwise advised that no additional NARMS sampling tasks will be assigned to the establishment.
       2. If at any time there is a need to return unused sampling supplies, the PHV is to send a request for a Ground shipping label by email through the FSIS - Sampling Supplies - Eastern Lab mailbox in Outlook.
       3. The PHV is to include the establishment name, establishment number, mailing address, and project code in the email request. The PHV is to return any unused sampling supplies for the FSIS NARMS sampling program via ground shipping to the address below.
          
          USDA/FSIS/Eastern Laboratory
          Attn: NARMS-Microbiology
          Russell Research Center
          950 College Station Rd.
          Athens, GA 30605-2720
12. SAMPLE RESULTS
    Results from the NARMS Cecal sampling program are to be shared with the establishment upon request via askFSIS or for information sharing purposes. Results from NARMS Cecal sampling programs are published quarterly on the FSIS website (The National Antimicrobial Resistance Monitoring System).
    
    Starting FY2023, establishment specific NARMS cecal results will be available through the PHIS industry sampling report prior to publication on FSIS' NARMS website. Industry users will be able to access the report in the same manner as the existing sampling reports.


13. 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.