BACKGROUND

1. Labeling is required to be truthful and not misleading (9 CFR 317.8(a) and 381.129). Currently, FSIS conducts a sampling and testing program for certain labeling claims under FSIS Notice 07-23, FSIS Sampling for Labeling Claims Verification. Under that earlier notice, FSIS only samples ground beef labeled with a negative claim for hormone use and nutritional labeling requirements when the consumer ready packaging bears a nutrition facts panel; no other beef product is included under that earlier notice. 
2. FSIS is conducting this new exploratory sampling program to assess whether antibiotics residues are detected in cattle intended for product with RWA claims. The Agricultural Research Service will analyze FSIS samples from eligible establishments as part of a collaborative study. Depending on the results, FSIS may consider establishing a permanent sampling and testing program for this product or may consider initiating rulemaking.

1. Establishment eligibility for the sampling program was determined based on information collected by an establishment profile questionnaire through FSIS Notice 36-23,Questionnaire for Raised without Antibiotics Special Labeling Claims on Beef.
2. IPP at cattle slaughter establishments may receive sampling tasks with the new sampling code EXP_LV_RWA if the establishment slaughters cattle intended for product with RWA claims. 
3. When samples are assigned through the Public Health Information System (PHIS), IPP are to share this notice with establishment management during the next establishment weekly meeting. IPP are to be familiar with the establishment’s records and production schedule to determine when it is producing product eligible for this sampling program. IPP are to schedule samples on the PHIS calendar on days that eligible cattle will be slaughtered for product with RWA claims and are to notify the establishment at least 24 hours before collecting the sample. Establishments are not required to hold sampled carcasses pending the sample results.
4. IPP at eligible cattle slaughter establishments are to collect samples from cattle slaughtered for products with RWA claims. Applicable RWA claims include:
   1. “No Antibiotics;”
   2. “No Antibiotics Ever;”
   3. “No Antibiotics Added;”
   4. “No Antibiotics Administered;”
   5. “Raised Without Antibiotics;”
   6. “Antibiotic Free;”
   7. "No Added Antibiotics;”
   8. "No Antibiotics in Feed, Water, or Intra-muscular Injection;”
   9. “Raised Without Antibiotics, Pesticides, or Added Growth Hormones;”
   10. “No Added Antibiotics or Added Hormones;”
   11. “No Antibiotics Administered, No Growth Stimulants or Added Hormones;”
   12. “No Antibiotics – No Added Hormones;” and
   13. Other applicable claims indicating no antibiotic use.

1. IPP are to only use sampling supplies provided by FSIS laboratories when collecting samples.
2. If IPP have not received sample supplies at least 72 hours prior to the scheduled sample collection, they are to request sampling supplies through PHIS by right-clicking on the scheduled sampling task on the Task Calendar, selecting "Order Supplies," and entering information in the fields provided.
3. If IPP are unable to request supplies via PHIS, they are to request sampling supplies via Outlook to the FSIS Western Laboratory (WL) (SamplingSupplies-WesternLab@usda.gov).
4. IPP are to include the following information in their email request for supplies:
   1. The sampling project code (EXP_LV_RWA);
   2. The establishment number and establishment name;
   3. The IPP’s name and contact phone number; and
   4. The specific supplies needed, including name and quantity to be ordered.
5. For tissue sample submissions, the shipping container should contain the following sampling supplies (Figure 1):
   
   Figure 1: RWA Sampling Supplies
   
   
   1. 1-gallon zipper lock bag (1);                                                               
   2. 1-quart zipper lock bag (4);
   3. Plastic sleeve or zipper lock bag for sample form (FSIS Form 800018) (1);
   4. FSIS Laboratory Sample Container Seal (FSIS Form 7355-2A/2B);
   5. Absorbent pad (1);
   6. Gel coolant pack (1 or more);
   7. Cardboard separator (1 or more); and
   8. FedEx pre-printed billable stamp for WL (1).

1. IPP will receive notification of a RWA sample as a task added to the establishment’s PHIS task list. IPP are to follow the instructions provided in FSIS Directive 13,000.2, Performing Sampling Tasks in Official Establishments Using the Public Health Information System for accepting, scheduling, and completing directed sampling tasks in PHIS.
2. IPP are to notify establishment management when scheduling a sample.
3. To collect a RWA tissue sample, IPP are to:
   1. Select from animals whose products will bear a RWA claim and have passed antemortem inspection on the day designated for scheduled sampling.
   2. Randomly select carcasses at the kill floor stage. IPP are not to select animals not eligible for human food.
   3. Collect and submit 1 lb. of kidney and 1 lb. of liver from the same carcass for analysis from the carcass selected for sampling.
   4. Collect tissue samples in a sanitary manner; however, unlike samples collected for microbiological testing, aseptic technique is not required.
   5. Package, secure, and ship the samples to the WL using the instructions provided in Section VI.
      1. For samples that are collected and shipped on the same day, IPP are to submit tissue as fresh samples and do not need to freeze the samples prior to shipping.
      2. For samples that cannot be shipped on the same day as collected, IPP are to place the samples in a freezer overnight and ship them on the next available shipping day.
4. IPP are to complete any sample questionnaires in PHIS and ensure that all questions are answered accurately.
5. If the sampling task has not been scheduled, and the animals eligible for sampling are not being slaughtered during the sample collection window, IPP are to delete the task from the task list and select the appropriate reason for deleting (Figure 2). All sampling tasks will be deleted from the task list, as indicated in FSIS Directive 13,000.2.
   
   Figure 2: Delete a sampling task.
   
   
    
6. If the sampling task has been scheduled on the task calendar but cannot be completed within the sample collection window, IPP are to cancel the sampling task (Figure 3), as instructed in  FSIS Directive 13,000.2. When a sampling task is cancelled, the task returns to the task list, and it can be rescheduled at a different time.
   
   Figure 3: Cancel a sampling task.
   
   
    

1. IPP are to use only the shipping materials provided by the laboratory and refer to FSIS Directive 7355.1, Use of Sample Seals for Program Samples and Other Applications, for instructions on the proper use of sample seals.
2. IPP are to ensure sample integrity when collecting, preparing, and packaging samples for testing.
3. At least 1 day prior to packing and shipping the sample, IPP are to pre-chill the shipping container in a refrigerator or freezer and place the gel coolant packs in the freezer.
4. Upon collection of the tissue samples, IPP are to:
   1. Place each type of tissue collected into separate zipper lock sample bags. Do not commingle the tissues in the same sample bag even if they are from the same carcass. Expel excess air from the bag prior to closure. Close the bag using the zipper lock closure. Place each bagged tissue specimen in a second quart size zipper lock bag., so that each tissue specimen will be double bagged.
   2. If the sample will be shipped on the same day as the collection day, place the bagged tissue specimen in a secure refrigerator and allow sufficient time for chilling, if time permits, prior to packing the sample in the shipping container. If the sample cannot be shipped on the same day as the collection, place the bagged tissue specimens in a secure freezer until the sample can be shipped overnight on the next available shipping day.
5. On the day of sample shipping, IPP are to:
   1. Retrieve the frozen gel coolant packs from the freezer and the pre-chilled shipping container.
   2. Retrieve the tissue specimens from the refrigerator or freezer.
   3. Place the absorbent pad and then the frozen gel pack on the bottom of the shipping container and place the cardboard separator on top of the frozen gel pack.
   4. Place all double bagged tissue specimens into the large zipper lock bag, expel the excess air from the bag, and close the bag using the zipper lock closure. Apply the medium sized bar-coded FSIS Laboratory Sample Identification Label (FSIS Form 7355-2B) to the zipper lock bag as described in FSIS Directive 7355.1. 
   5. Place the sample bag containing the tissue samples in the shipping container on top of the first cardboard separator.
   6. Review the information on the pre-printed FedEx billable stamp provided with the sampling supplies and confirm it is for the WL. Place the completed, signed and dated sample form in the plastic sleeve provided.  Place the plastic sleeve, the second cardboard separator and the second frozen gel pack into the shipping box.
   7. Insert the foam plug and press down. 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 a sample discard by the laboratory.
   8. Complete the information on the large, bar-coded seal from the same FSIS Form 7355-2A/2B sample seal set and sign the seal. Apply the FSIS Laboratory Sample Container Seal (FSIS Form 7355-2A) to the inner flap of the shipping container as described in FSIS Directive 7355.1. IPP are to close the box flaps so that the container closure system is secure.
   9. Affix the billable stamp on the shipping container and remove any old stamp receipts and carrier shipping bar codes from the container.
   10. Place in the designated area for pick up by FedEx.
6. IPP are to ship samples as soon as possible after collection, on the day of collection or the next day, because residues in tissues can degrade over time, resulting in false negative results. Do not ship samples on a Saturday, or the day before a federal holiday.
7. IPP are to return any unused shipping containers and sampling supplies after the sampling window closes, including the FedEx billable stamp, to the WL. IPP are not to use the FedEx billable stamp included with the sampling box to return sampling supplies. IPP are to send a request to the WL for a new pre-addressed return FedEx ground-shipping bill, using the email address provided in Section IV.C.

1.  IPP are to obtain all man-made animal identification (ID) from the establishment for animals selected for RWA testing. IPP are to refer to FSIS Directive 10,800.1, Residue Sampling, Testing and Other Verification Procedures under the National Residue Program for Meat And Poultry Products for additional information on animal identification collection.

NOTE: Refer to FSIS Directive 5,620.1, Using askFSIS, for additional information on submitting questions.