TITLE: Shipping wastewater samples to FDA-CFSAN
AUTHORS: Maria   Balkey, Tina.Pfefer  

[DESCRIPTION]
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:
https://www.protocols.io/view/ncbi-submission-protocol-for-sars-cov-2-wastewater-ewov14w27vr2/v5 for populating sample metadata. 


[STEPS]
SECTION: 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, 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.   

SECTION: Preparation of shipping supplies
2. Contact your Biosafety Officer at your institution and request instructions on how to ship wastewater samples. The samples shall be shipped according to Category B requirements at the least. Please follow the guidance from your institution for further shipping requirements. 

For additional guidance on shipping according to Category B, please visit the APHL site below and navigate to the link to a PDF titled "Packing and Shipping Guidance for Biological Substances, Category B Specimens".
Packaging and Shipping Toolkit (aphl.org)
SECTION: Preparation of shipping supplies
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.
SECTION: Preparation of shipping supplies
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. 
SECTION: Preparation of shipping supplies
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.  It is imperative to label containers so that the labels do not come off during shipment. It is strongly recommended that you use Cryo-babies Labels, use printed labels and secure them with transparent tape, or write directly on the container with permanent marker.
SECTION: Preparation of shipping supplies
6. Wastewater samples shall be shipped in dry ice.
SECTION: Preparation of shipping supplies
7. The outer packing must be labeled accordingly. The full name and address of the sender and recipient must be included.
SECTION: Sample shipment
8. Once all the above requirements are completed, ship by express/next-day air.  Ship only on Monday, Tuesday, or Wednesday.  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)


SECTION: Sample shipment
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. 
SECTION: Sample shipment
10. If you have doubts about any of these steps, please email covidTrakr@fda.hhs.gov.