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1. PURPOSE
   This directive provides instruction to inspection program personnel (IPP) for continuation of Salmonella sampling under the Raw Pork Products Sampling Program. This directive provides instruction previously issued in FSIS Notices with changes that include adding a section specifically instructing IPP on how to perform the sampling event and expansion of the results section to include instruction on how IPP are to respond to sampling results. Data from this sampling program continues to be used for FSIS policy development.

2. BACKGROUND

   1. As described in the January 26, 2015, Federal Register Notice, Changes to the Salmonella and Campylobacter Verification Testing Program: Proposed Performance Standards for Salmonella and Campylobacter in Not-Ready-to-Eat Comminuted Chicken and Turkey Products and Raw Chicken Parts and Related Agency Verification Procedures and Other Changes to Agency Sampling (80 FR 3940), FSIS implemented exploratory sampling of raw pork products to test for pathogens of public health concern, as well as for indicator organisms in May 2015.

   2. The Agency continued to collect and analyze raw pork products in an interim phase before implementing Phase II of the Raw Pork Product Exploratory Sampling Program. In Phase II, sampling focused on Salmonella and indicator organisms in both slaughter and processing establishments and Shiga toxin-producing E. coli (STEC) in slaughter establishments only. A summary of the sample results can be viewed online at: Quarterly Sampling Results for FSIS-Regulated Products, and further analysis of the data can be viewed online at: Nationwide Raw Pork Products Exploratory Sampling Program.

   3. The Agency will continue to analyze raw pork product samples for Salmonella. The sampling data will be used to develop future policies designed to reduce the levels of Salmonella in raw pork products.

   4. The raw pork sampling program remains in an exploratory phase without performance standards; therefore, IPP are not to take regulatory action in response to positive sampling results. Instead, IPP are to respond to sampling results as instructed in Section XI Results.

3. ESTABLISHMENT SAMPLING ELIGIBILTY AND PUBLIC HEALTH INFORMATION SYSTEM (PHIS) SAMPLING TASK ASSIGNMENT

   1. IPP will continue to see the raw pork products sampling tasks appear in PHIS for eligible establishments. 

      1. FSIS assigns two pork project sampling tasks to IPP: 

         1. Raw Comminuted products, project code HC_PK_COM01; and
         2. Raw Intact and Non-Intact Cuts products, project code HC_PK_CUT01.
      2. The number of sampling tasks per project per month are assigned as shown in Table 1, as determined by the establishment’s daily production volume documented in the PHIS profile.

   2. FSIS will assign:

      1. Up to two (2) samples per month for establishments producing more than 6,000 lbs. per day of all eligible comminuted product;
      2. One (1) sample per month for establishments producing more than 50,000 lbs. per day of all eligible intact and non-intact pork cuts; and
      3. No more than (1) sample per month, assigned randomly, for establishments producing between 1,001 to 6,000 lbs. per day of all eligible comminuted pork products or 1,001 to 50,000 lbs. per day of all eligible pork cuts.
      4. Establishments producing less than or equal to 1,000 lbs. per day for all eligible products within a sampling project (HC_PK_COM01 or HC_PK_CUT01) are not eligible for FSIS sampling for that sampling project.

   3. IPP are to be aware that eligible establishments will receive sampling tasks based on the establishment’s average daily volume (lbs. per day) and the number of days of production that are entered into the PHIS establishment profile across all the eligible product groups listed in Table 2 and Table 3 of this directive. IPP are to refer to Section VI for specific instructions regarding product eligibility.

   4. Descriptions and examples of products not eligible for sampling are available in Table 4. IPP are not to collect samples of ineligible products.

   5. Only domestic establishments producing finished raw pork products are eligible for this program. Imported raw pork products are not eligible for this program.
      
      
      
      
      
      
      
      

4. MAINTAINING THE PHIS ESTABLISHMENT PROFILE

   1. To assure correct task assignment, IPP are to perform the monthly PHIS Update Establishment Profile Task following FSIS Directive 5,300.1, Managing the Establishment Profile in the PHIS. Timely updates to the profile will ensure that the product is correctly documented, including Hazard Analysis Critical Control Point (HACCP) processing category, finished product category, and production volume category. IPP are to be aware that:

      1. Instructions on how to calculate the production volume information are listed under Chapter II in FSIS Directive 5,300.1, Section VIII, Production Volume Information; and
      2. Further guidance to ensure eligible products are correctly entered into the PHIS profile is provided in IPP Help.

   2. IPP are to update the PHIS Establishment Profile if the profile has inaccurate or incomplete information about the products the establishment produces.

   3. Within IPP Help, the Guidance Document for Raw Pork Sampling contains in-depth product descriptions, and product examples of the PHIS pork product groups to help IPP update the establishment profile. IPP can access IPP Help by double-clicking the FSIS Applications icon from the desktop of their government-issued computer.

5. SCHEDULING THE PHIS SAMPLING TASKS

   1. IPP are to schedule PHIS tasks as follows:

      1. IPP are to use a method for randomly selecting the product for sampling. IPP are to randomly select a day, shift, and time within the sample window after the sample collection date indicated in PHIS. IPP are to collect samples from all shifts the establishment operates and include Fridays in the random selection. There needs to be an equal chance that sampling will occur during any particular shift;
      2. Schedule the tasks such that no single eligible product type (or single primal source) is likely to be over-represented;
      3. Schedule the tasks such that IPP may collect and submit the sample to the FSIS laboratory within the sample collection window; and
      4. Schedule, if possible, at a frequency of no more than once per week.

   2. If an establishment produces more than one type or subtype of eligible pork product (e.g., multiple eligible cuts), then IPP are to alternate scheduling of the task(s) to ensure that all eligible products are captured.

   3. If sampling tasks remain in the task list at the end of the sampling window, IPP are to cancel them from the task list and provide the correct reason, as shown in the image below. If none of the listed reasons are appropriate, IPP are to select Not collected for miscellaneous reasons and provide additional details in the text box provided.
      
      

   4. If an establishment does not produce eligible product, IPP are to cancel any remaining product verification sampling tasks. IPP are to cancel these tasks from both the “Establishment Task List” (Delete this task from the Task List) and, if scheduled, the Task Calendar, using the correct option (i.e., cancel this task and remove it and all other instances of this task from the Task List). In addition, IPP are to provide the reason for canceling the task, Requested sample/product never slaughtered/produced, as shown in the image below. 

   5. IPP are to refer to FSIS Directive 13,000.2, Performing Sampling Tasks in Official Establishments Using the Public Health Information System, for instructions on how to add the task to the Task Calendar, enter the sample information, submit the sample information to the laboratory, and print a finalized sample collection form in PHIS.

6. SPECIAL ELIGIBILITY CRITERIA

   1. The following practices do not exclude products from routine sampling:

      1. Addition of ingredients such as spices, seasonings, rosemary extracts, or fruits/vegetables to eligible pork products;
      2. Application of an antimicrobial treatment or intervention (other than a treatment that achieves full lethality);
      3. Addition of meat or poultry products from a different species to eligible pork products; and
      4. Sending product to hotels, restaurants, or similar institutions (HRI).

   2. The following products are not to be included in routine sampling:

      1. Battered or breaded pork product, such as dumplings, egg rolls, or pot stickers;
      2. Products in the HACCP processing category “Heat-treated but not Fully Cooked - Not Shelf Stable,” such as partially cooked products or products that contain cooked pork and raw dough such as pot pies;
      3. Raw pork products intended for use in ready-to-eat (RTE) products at the establishment or another official federally inspected establishment;
      4. Pork primals or subprimals, unless they are the finished product. These are primary cuts derived from the carcass (typically larger than two lbs.).; and
      5. Parts that are repackaged, i.e., purchased product that is packed into smaller packages without any additional processing (examples of processing: slicing, deboning, application of interventions).
         
         NOTE: If these products are presented to retail commerce as a finished product (e.g., cuts of primals or deboned cuts of primals) they are considered a pork cut and are eligible.

   3. FSIS does not sample product that will receive full lethality treatment at the establishment or another federally inspected establishment provided that the establishment’s hazard analysis and flow chart show that the product is intended for such use.

   4. If the establishment meets the requirements in B.3 and C. of this section, IPP are to verify, during the performance of the associated HACCP verification task, that all product produced by the establishment for the intended use of RTE products, is used only for processing into RTE product (9 CFR 417.2(a)(2)). IPP are to verify that all product intended for RTE will be processed into RTE product by:

      1. Observing that all the product moves to be further processed into RTE product in the establishment or another federally inspected establishment;
      2. Reviewing records to ensure that all products are further processed into RTE products in the establishment. Records may include those containing production codes or production lot codes; or
      3. Reviewing the establishment’s HACCP plan and hazard analysis for the intended use of the products and verifying that the establishment has procedures incorporated in its food safety system that document the movement of all product from that product class to another official establishment at which the product is further processed into RTE product; and
      4. Verifying that the intended use of the product is correctly listed in the PHIS establishment profile by being marked "For RTE Cooking Only.” 

7. PERFORMING THE SAMPLING TASK

   1. On the day of the scheduled sampling event, before the event, IPP are to:

      1. Notify official establishment management just before collecting a sample. Establishments are not required to hold the sampled production lot pending the sample results;

      2. Select the product type to be sampled. Only finished products are eligible for sampling. Finished products are the products that are shipped from the establishment. IPP are not to sample source material or intermediate product;

      3. IPP are to use a method for randomly selecting the production lot for sampling and use the same method each time IPP in the same establishment perform sample collection. IPP are to randomly select a time within the sampling window shown in PHIS when the establishment is expected to produce product.

      4. IPP are to schedule sampling tasks and randomly select product types to rotate through all the eligible products produced by the establishment.

   2. At the time of the sampling event, IPP are to:
      1. Select the sampling location and designate an area nearby for preparing, gathering sampling supplies, and for performing the sampling;
      2. Not share or split samples and supplies with the establishment. If the establishment is interested in doing its own analysis, IPP are to be aware it may use its own supplies to collect a different sample at approximately the same time and point of production the FSIS pork sample is collected;
      3. Perform the sampling task using aseptic sampling technique as described in IPP Help for Sampling Technique. IPP are to consult Section VIII for raw pork cuts and Section IX for raw comminuted pork products for additional instruction specific to those sampling projects.
   3. Following the sampling event, IPP are to:
      1. Document the sample collection as directed in FSIS Directive 13,000.2, completing the sample questionnaires in PHIS. The questions for both comminuted and raw cut parts are listed in IPP Help.
         1. IPP are to ensure that all questions in the PHIS questionnaire are answered accurately.
         2. When answering the “Product name,” IPP are to provide as much detail as possible and include the full name of the product that is listed on the principal display panel.
      2. Package and ship the sample as instructed in the sample handling and packaging button on the Sampling Page of IPP Help.
8. RAW INTACT AND NON-INTACT PORK CUTS

   1. Table 2 identifies which product groups and products are eligible for sample collection under the HC_PK_CUT01 sampling task.

   2. IPP are to collect fresh, not frozen, raw pork samples in final packaging whenever possible with an appropriate number of packages to equal 2 lbs. ± 10%. IPP are to place the product collected in its final packaging into the larger, non-sterile bag provided with the sampling supplies. 

   3. For intact and non-intact pork cuts that are not available in their final packaging, IPP are to use the single larger Whirl-Pak bag and aseptically collect one or more cuts to fill the Whirl-Pak bag leaving 2 to 3 inches of space at the top of the bag. IPP are to expel as much air as possible from the bag before closing.
      
      NOTE: IPP are not to use the Whirl-Pak bags when collecting products in final packaging.

   4. For establishments with intact and non-intact pork cuts that are processed in a frozen state only (e.g., all product is received frozen and processed frozen; product further processed in frozen state only), IPP are to collect a frozen 2 lbs. sample if the establishment does not produce any other eligible pork product. IPP are to indicate whether the sample is fresh or frozen in the PHIS questionnaire.

   5. For eligible products with a finished product weight of greater than 2 lbs., IPP are to either: a) select the entire product, or b) have the establishment remove a sample size of 2 lbs. +/- 10% from the product. The Inspector-in-charge (IIC) shall coordinate with the establishment to determine which of these two methods shall be used, based upon what is most practical and safe.

   6. IPP are to access the IPP Help menu item, Sampling, then Raw Pork Sampling Program Guidance, for more detailed information for collecting raw pork samples.

9. COMMINUTED PORK PRODUCTS 

   1. Table 3 identifies which product groups and products are eligible for sample collection under the HC_PK_COM01 sampling task.

   2. IPP are to collect fresh, not frozen, comminuted pork product samples in their final packaging, whenever possible, and an appropriate number of packages to equal 2 lbs. (+/- 10%). IPP are to place the product collected in its final packaging into the larger, non-sterile bag provided with the sampling supplies.

   3. For all comminuted pork product samples not available in their final packaging, or if the packaged product is too large for the sample container, IPP are to use the two (1 lb. each) Whirl-Pak bags when collecting aseptic grab samples. The Whirl-Pak bags have fill lines to help IPP collect the desired sample weight of 2 lbs. (i.e., 1 lb. in each of the two Whirl-Pak bags). IPP are to collect enough product to fill each of the two Whirl-Pak bags to the fill-line.

      NOTE: IPP are not to use the Whirl-Pak bags when collecting products in final packaging.

   4. For comminuted pork products that are processed in a frozen state only (e.g., all product received is frozen and processed frozen; product further processed in frozen state only), IPP are to collect a frozen 2-lb. sample if the establishment does not produce any other eligible pork product. IPP are to indicate whether the sample is fresh or frozen in the PHIS questionnaire.

   5. For mechanically separated or AMR (finely textured pork) product samples, IPP are to fill each of the two Whirl-Pak bags by using the sanitized scoop and spatula contained in the enhanced sampling supplies. When needed, IPP are to request enhanced sampling supplies via Outlook email at least 3 business days before the scheduled day of sampling. The enhanced sampling supplies will contain all HC_PK_COM01 supplies plus: one 4-ounce sterile scoop, one sterile spatula, and two towelettes.

   6. To request enhanced sampling supplies via Outlook email, IPP are to select one of the following addresses:

      SamplingSupplies-EasternLab@usda.gov
      SamplingSupplies-MidwesternLab@usda.gov
      SamplingSupplies-WesternLab@usda.gov

   7. IPP are to use the e-mail subject heading “Enhanced Raw Pork Products Sampling Program sampling supplies.” IPP are to request one set of enhanced sampling supplies for each sample collection event. IPP are to include in their request the establishment name, establishment number, establishment street address (no P.O. Box), and the IPP’s contact name and telephone number.

10. SAMPLING SUPPLIES FOR RAW PORK PRODUCTS SAMPLING PROGRAM

    1. The FSIS laboratories will ship the sampling supplies automatically to the IIC at establishments selected for sampling. Supplies will arrive in a shipping container labeled with either the HC_PK_COM (comminuted products) or the HC_PK_CUT (cuts) sorting label. IPP are to refer to IPP Help for a list of sampling supplies that they should receive IPP are to use only the sampling supplies provided by the laboratories.

    2. If IPP do not receive sampling supplies by the first day of the collection window or need to request replacements for damaged or lost supplies, they are to request Raw Pork Product Sampling Program sampling supplies. For example, if raw pork products sampling tasks are assigned in PHIS in late October, IPP are to request replacement supplies only if they have not arrived by November 1. IPP requiring sampling supplies are to request them through PHIS or Outlook email 3 business days (not including weekends and holidays) before they intend to collect the sample.

       1. To request sampling supplies via PHIS, IPP are to right-click a scheduled lab sampling task (e.g., HC_PK_COM01, HC_PK_CUT01) on the Task Calendar, then select Order Supplies from the drop-down menu.
          
          
       2. To request sampling supplies via Outlook email, IPP are to select one of the following addresses:
          
          SamplingSupplies-EasternLab@usda.gov
          SamplingSupplies-MidwesternLab@usda.gov
          SamplingSupplies-WesternLab@usda.gov

    3. IPP are to use the subject heading “Raw Pork Product Sampling Program Sampling Supplies” in the email and include the establishment name and number, the project code (HC_PK_COM01, HC_PK_CUT01) the IPP’s contact name, establishment number, telephone number, and a list of the supplies needed.

    4. IPP are to return any unused shipping containers and sampling supplies for these projects 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 above.

    5. IPP are to refer to IPP Help, Requesting Sampling Tasks, Discards, or Modifications, for further help requesting additional sampling tasks, discards, or modifications to sampling tasks.

11. RESULTS

    1. Salmonella results will be posted in LIMS-Direct and PHIS as soon as results are available.

    2. IPP are to be aware that the Raw Pork Product Sampling Program remains in an exploratory phase only, without performance standards that would involve regulatory action; therefore, in response to positive results, IPP are to:
       1. be aware that individual sample results will not result in regulatory control actions;
       2. not require establishments to hold the sampled production lot pending the Salmonella sample results;
       3. be aware that repetitive positive sample results over time may indicate a concern with respect to process control and HACCP system support; and
       4. seek guidance from their supervisor for further instruction regarding these or other concerns regarding IPP response to sampling results.

12. DATA ANALYSIS
    Programs and offices of FSIS will analyze the data collected in the Raw Pork Products Sampling Program to monitor Salmonella in raw pork products.

13. QUESTIONS
    Refer questions regarding this Directive 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 5,620.1, Using askFSIS, for additional information on submitting questions.

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