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Fiscal Year 2024 Dioxin Survey For Domestic Farm-Raised And Wild Caught Siluriformes Fish

FSIS Notice 57-23
Issue Date Oct 16, 2023
Expiration Date Nov 01, 2024
Full Notice
FSIS Notice 57-23
  1. PURPOSE
    This notice informs inspection program personnel (IPP) assigned to federally inspected Siluriformes fish processing establishments that the Fiscal Year (FY) 2024 Dioxin Survey for Siluriformes fish will be conducted over 12 months. The survey will be used to determine dioxin levels in farm-raised and wild-caught United States (U.S.) Siluriformes fish.
  2. BACKGROUND
    1. FSIS, in conjunction with the USDA Agricultural Research Service (ARS), Edward T. Schafer Agricultural Research Center in Fargo, ND, is conducting the FY 2024 Dioxin Survey to determine levels of dioxins and dioxin-like compounds in the domestic Siluriformes fish products FSIS regulates. Dioxins are a group of compounds of public health concern. These compounds are ubiquitous but generally occur at very low levels throughout the environment as persistent environmental contaminants.
    2. FSIS will issue instructions to IPP on cattle and swine sampling for the 2024 Dioxin Survey in a separate notice.
  3. REFERENCES AND REVIEW OF MATERIALS
    Upon issuance of this notice, IPP assigned to establishments that are eligible to participate in the FY 2024 Dioxin Survey are to become familiar with the information provided in this notice and the following FSIS issuances:
    1. FSIS Directive 7,355.1, Use of Sample Seals for Laboratory Samples and Other Applications.
    2. FSIS Directive 13,000.2, Performing Sampling Tasks in Official Establishments Using the Public Health Information System.
  4. AWARENESS MEETING WITH ESTABLISHMENT MANAGEMENT
    1. Upon issuance of this notice, the Inspector-in-Charge (IIC) at an establishment that is a primary processor of Siluriformes fish will conduct an awareness meeting with establishment management to inform them of the survey. Primary processors of Siluriformes fish are establishments that receive live fish directly from the water sources (farmed or wild caught) for processing.
    2. IPP are to refer the establishment to the information in Attachment 1, "Information for Establishments on the Dioxin Survey for Siluriformes Fish" prior to sample collection.
    3. The IIC is to advise establishment management that it is eligible and can be randomly selected for sampling. If the establishment is selected for sampling:
      1. Sample collection will begin on or after November 1, 2023;
      2. IPP will collect two fillets prior to the final intervention and final packaging from the same lot.
      3. As part of the sampling task, IPP will collect and record all information pertinent to the fish, including farm information and pond number, if available. If wild-caught, IPP will include the fishery company that caught the fish and any other information available from the establishment as to the location where the fish was caught, i.e., name of a river and State;
      4. Individual sample results from the FY 2024 Dioxin Survey will not be the basis for regulatory actions;
      5. Fish selected for sampling under this project do not need to be held pending the reporting of test results; and
      6. Sample results for the FY 2024 Dioxin Survey will not be reported through the Public Health Information System (PHIS) but will be posted to the FSIS website as aggregate data once the project is completed.
  5. SAMPLE TASK ASSIGNMENT
    1. IPP will receive FY 2024 Dioxin Survey sample requests through PHIS with the sampling project code DIOX_FI.
    2. The sample request will appear in PHIS as a sampling task on the establishment task list. IPP are to add the task to their task calendar and follow the instructions in FSIS Directive 13,000.2 for completing the task.
    3. IPP will have 37 days from the date of the sample request (sampling window) to collect and ship the sample to the ARS laboratory. After this 37-day window has closed, IPP will no longer be able to collect the sample.
  6. SAMPLING SUPPLIES FOR THE DIOXIN SURVEY
    1. Approximately one week before the sampling task appears on the task list, IPP will receive the Dioxin Survey sampling supplies, which will be labeled "ARS-Special Project." If supplies do not arrive within one week of the scheduled Dioxin Survey sample date for the establishment, IPP are to request sampling supplies.
    2. To request sampling supplies via PHIS IPP are to right-click a scheduled laboratory sampling task on the Task Calendar, then select "Order Supplies" from the drop-down menu.
    3. If unable to request supplies via PHIS or supplies listed below are damaged or missing, IPP are to contact FSIS Midwestern Laboratory (MWL) via Outlook using the following email address:

      SamplingSupplies-MidwesternLab@usda.gov
    4. IPP are to include the establishment name and number, IPP name and phone number and the project code, "ARS Special Project," in the request.
    5. The shipping container will contain the following supplies:
      1. FSIS Laboratory Sample Container Seal (FSIS Form 7355-2A/2B);
      2. Absorbent pad/paper towel;
      3. Gel pack;
      4. Laboratory gloves;
      5. Aluminum foil;
      6. Glass jar(s) with Teflon-coated lids;
      7. Bubble wrap to protect the glass jars;
      8. Rubber bands;
      9. 10"x12" zipper lock plastic bag for shipment of glass jar;
      10. Plastic sleeve for sample form; and
      11. FedEx shipping label.
    6. If the sampling task has not been scheduled, and the sample cannot be collected during the sample collection window, IPP are to delete the task from the task list and select the appropriate reason for deleting (Figure 1). All sampling tasks will be deleted from the task list, as instructed in FSIS Directive 13,000.2.

      Figure 1: Delete a sampling task.57-23-Picture1
    7. 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 2), 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 2: Cancel a sampling task.57-23-Picture2
    8. IPP are to return any unused shipping containers and sampling supplies for this project, including the ARS Laboratory FedEx shipping label, to the MWL. Ground shipping labels to return sampling supplies can be requested via email to the MWL, as described in Section VI.C. of this notice. Do not use the shipping labels sent with the sampling supplies to return unused supplies.
  7. COLLECTING THE SAMPLE
    1. When collecting the sample, IPP are to prevent contamination of the sample collection equipment, as this may affect the test results.
      1. IPP are not to use paper towels and are not to wipe gloved hands or knife with paper towels. Paper towels may be contaminated with dioxin and polychlorinated biphenyls (PCBs). Low levels of dioxin are often present in the environment.
      2. IPP are to transfer the tissue samples directly from the aluminum foil provided and transfer the specimen to an acceptable table in the establishment to place it in the glass jar provided.
      3. IPP will place the specimen in the glass sampling jar provided. Close the jar immediately. IPP are to exercise caution to ensure that the specimen does not become contaminated during this process.
      4. IPP are not to open the glass sampling jar until they are ready to transfer the specimen (two fillets) to the glass sampling jar.
      NOTE: Do not use plastic or paper to transfer the sample. IPP are to only use the aluminum foil that is provide in the sampling kit to transfer the specimen.
    2. IPP are to randomly select 2 fillets. IPP are to collect the sample prior to final intervention(s) and final packaging. To collect the sample, the IPP are to:
      1. Affix the barcoded label to the glass jar;
      2. Wash and sanitize hands;
      3. Don the gloves provided with the sampling supplies using IPP Help - Gloving Technique.;
      4. Collect two fillets from the same lot, combined weight of approximately one half (0.5) pound, prior to final intervention(s) and final packaging;

        NOTE: Fillets can be skin on or with the skin removed.
      5. Place the 2 fillets on the aluminum foil and transfer the specimen to the glass jar and close the lid immediately. Be sure that the lid is tightly seated on the glass jar. Place the bubble wrap provided around the glass jar (wrapped around the jar and fastened with rubber bands);
      6. Place the closed glass jar containing the two fillets that has been wrapped with bubble wrap in the freezer and freeze contents thoroughly for a minimum of 8 hours. Place all the gel packs provided with sample supplies in the freezer; and

        NOTE: The sample must be shipped frozen to the laboratory.
      7. Maintain sample security during collection, freezing, and shipping.
  8. HOW TO COMPLETE THE SAMPLING TASK AND SHIP THE SAMPLE
    1. IPP are to follow the instructions provided in FSIS Directive 13,000.2 for completing sampling tasks in PHIS and FSIS Directive 7,355.1 on the use of sample seals (FSIS Form 7355-2A/2B) to maintain sample security and identification.
    2. IPP are to obtain all information pertinent to the fish, including farm information and pond number, if available, and enter it into PHIS when completing the sampling task. If wild-caught, IPP are to obtain information on the fishery company that caught the fish and any other information available from the establishment as to the location where the fish was caught.
    3. Following freezing of the sample, IPP are to pack and ship the sample as follows:
      1. Remove gel packs and shipping container from the freezer. Place the absorbent pad, cardboard separator, and gel pack in the shipping container (in the order described). Refer to IPP Help – Handling and Packaging for more information;
      2. Remove the sample jar from the freezer. Remove the bubble wrap, apply the barcoded label to the glass jar and rewrap the glass jar with the bubble wrap. Ensure that the sample jar and printed form have a barcoded label affixed, using instructions provided in FSIS Directive 7,355.1. Do not remove the sample from the freezer until the sample is ready to be packed and shipped;
      3. Place the completed form in the plastic sleeve provided;
      4. Test the glass jar lid to assure it is securely closed to prevent leakage. Place the wrapped glass jar and sample form in the 10"x 12" zipper lock and seal the zipper closure. Apply the barcoded Sample Identification Label (FSIS Form 7355-2B) on the zipper lock bag;
      5. Place the jar in the shipping container as shown in Figure 3. Place the gel packs on opposite sides of the glass jar, with the cardboard separators placed between the gel packs and the glass jar;

        Figure 3 - Shipping Container Showing Placement of Sample Jar and Gel Packs57-23-Picture3
      6. Complete and sign the FSIS Laboratory Sample Seal (FSIS Form 7355-2A) and apply it to the shipping container, using the instructions provided in FSIS Directive 7355.1; and
      7. Samples collected Monday through Thursday can be sent to the lab via overnight FedEx courier to ARS Biosciences Research Laboratory in Fargo, ND, using the FedEx shipping label provided. Samples collected on Fridays are to be held frozen under FSIS control and shipped on Monday. Samples are not to be shipped on Friday, Saturday, or the day before a federal holiday. The shipping address for the laboratory is:
        1. Sara Lupton
        2. USDA-ARS-Biosciences Research Lab
        3. 1616 Albrecht Blvd
        4. Fargo, ND 58102-2765
        5. Phone: 701-239-1236
  9. SAMPLE RESULTS REPORTING
    Sample results for this project will not be posted in PHIS. Upon completion of the FY 2024 Dioxin Survey, FSIS will summarize and publish the survey results as an official report which will be accessible on the FSIS website. The report will present a summary of findings on a national basis. Individual establishment results will not be published.
  10. DATA ANALYSIS
    ARS and FSIS will analyze the data collected under the nationwide FY 2024 Dioxin Survey to continue to monitor dioxin levels in Siluriformes fish. These data will be used to detect and identify possible sources of dioxin in the food supply and to determine whether regulatory actions by FDA and EPA are warranted.
  11. 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 5,620.1, Using askFSIS, for additional information on submitting questions.

Attachment 1

Information for Establishments on the Fiscal Year (FY) 2024 Dioxin Survey

  • The FY 2024 Dioxin Survey for Siluriformes Fish began on November 1, 2023, as a Tier 2 project under the U.S. National Residue Program to gather information on dioxin levels in Siluriformes fish. Tissue samples will be collected in federally inspected establishments and the survey data will be used to determine if dioxin levels in Siluriformes fish remain low and if further reduction is possible.
  • This study will include farm-raised and wild-caught Siluriformes fish processed in federally-inspected establishments.
  • IPP will collect and record all identification information in PHIS.
  • Samples will be packaged and shipped to the Agricultural Research Service (ARS) laboratory in Fargo, ND, for analysis. In the event of a test result significantly different from background dioxin levels, FDA and EPA will seek additional information about the sample and about the animal from which that sample was taken.
  • FSIS will not report individual sample test results. Establishments are not required to hold product pending laboratory results for samples collected in this survey. ARS will report analytical findings to FSIS approximately four to six weeks after a sample is taken. If there is reason for additional follow up or investigation, FSIS will notify the establishment within approximately six weeks from the time an initial sample was collected.
  • In the event of a very high dioxin test result or an unusual finding, FSIS will conduct additional investigation and consider other actions to identify possible sources of dioxin entering the food chain. If sources can be identified, FSIS will take steps to see that further dioxin inputs into the food supply are stopped.
  • The survey results will be presented in a publicly available final report summarizing the survey findings and characterizing the general dioxin levels in U.S. Siluriformes fish. Individual establishments will not be identified, and all participants will receive a copy of the final report.
  • If you have questions about the survey, please refer questions to the Office of Policy and Program Development by phone at 1-800-233-3935 or through askFSIS. When submitting a question, complete the web form and select Sampling as the Inquiry Type.