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      Shipping wastewater samples to FDA-CFSAN

      Maria Balkey, Tina Lusk Pfefer

      Published: 2022-04-23 DOI: 10.17504/protocols.io.14egn797zv5d/v3
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      Abstract

      This SOP provides guidance for shipping wastewater samples to the US FDA Center for Food Safety and Applied Nutrition (CFSAN), covering specific steps for registering samples with CFSAN and for the preparation of shipments (documentation, packaging, notifications). We recommend that samples are shipped in two batches, one batch after 3 months of sampling and one batch at the conclusion of your sampling (~6 months).

      Before start

      This protocol has three sections:

      • Section 1: Submission of metadata
      • Section 2: Preparation of Shipping supplies
      • Section 3: Sample shipment

      Associated protocols:

      • http://www.protocols.io/view/ncbi-submission-protocol-for-sars-cov-2-wastewater-ewov14w27vr2/v5 for populating sample metadata.

      Steps

      Submission of metadata

      1.

      Fill out the BioSample custom wastewater template (extension of NCBI's Generic SARS-CoV-2: wastewater surveillance, v1.0 ) according to the [NCBI submission protocol for SARS-Cov-2 protocol](http://l http://www.protocols.io/view/ncbi-submission-protocol-for-sars-cov-2-wastewater-ewov14w27vr2/v5), once completed, send it to covidtrakr@fda.hhs.gov for registration. Successful registrations will receive a notification confirming the sample registration, it will will include a list of CFSAN accessions.

      Preparation of shipping supplies

      2.

      Contact your Biosafety Officer at your institution and request instructions on how to ship wastewater samples. The samples may require shipping according to Category B requirements, however, please follow the guidance from your institution.

      3.

      Make sure adequate shipping materials are available for the preparation of your package. Prepare your shipment according to your current SOPs, check your institution and courier guidelines for the shipping of dangerous goods (wastewater samples with SARS-Cov-2) before attempting any shipment.

      4.

      Prepare the following documents for your package along your permits, government and/or institution requirements.

      • Spreadsheet with the list of samples and the description of shipment contents.
      • Any notes or comments regarding your package.
      5.

      Label your samples accurately (tubes and caps) . Each sample (200 mL minimum) must be labeled with a CFSAN accession provided after completion of the metadata registration. If necessary, use printed labels and secure them with transparent tape.

      6.

      Wastewater samples shall be shipped in dry ice.

      7.

      The outer packing must be labeled accordingly. The full name and address of the sender and recipient must be included.

      Sample shipment

      8.

      Once all the above requirements are completed, ship by express/next-day air. Ship only on Tuesday, Wednesday or Thursday. Ship the isolates to the address included below.

      U.S. FDA CFSAN

      Attn: Christopher Grim/Maria Hoffmann

      5001 Campus Drive

      RM 4E009

      College Park, MD 20740

      Christopher.Grim@fda.hhs.gov

      Maria.Hoffmann@fda.hhs.gov

      Phone:240-402-1080 (Maria) or 240-402-3582 (Chris)

      9.

      Email tracking number to covidTrakr@fda.hhs.gov. Include in the notification the number of samples shipped and the corresponding list of sample identifiers.

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