- College of American Pathologists Accreditation
- Permit for Importation & Transportation
- CDC Permit to Import Infectious Biological Agents
Shipping and Packaging
Please be advised that the U.S. Department of Transportation (USDOT) and the United States Postal Service (USPS) have made regulatory changes about the shipment of infectious substances, diagnostic specimens, and clinical specimens.
The rules harmonize the Federal regulations with those of the 51st edition of the UN Recommendations for the Transport of Dangerous Goods, the International Civil Aviation Organization (ICAO) Technical Instructions for the Safe Transport of Dangerous Goods By Air, and the International Air Transport Association (IATA) Dangerous Goods Regulations.
The Changes Include:
The USPS will not accept packages with the markings Clinical or Diagnostic Specimens. In addition, the USPS will no longer accept any Category A, Infectious substances packages. The regulations also allow the shipper NOT to put the Technical Name of the contents on the package IF the shipper enters A140 in the far right column of the shipper’s Declaration of Dangerous Goods document. However, the Technical Name still has to be entered on the document.
The proper shipping names “Diagnostic Specimens” or “Clinical Specimens” are to be replaced with the proper shipping name “Biological substance, Category B”. This also includes culture isolates.
In order to meet these requirements, the marking on the STP230 top flap that states “DIAGNOSTIC SPECIMENS OR CLINICAL SPECIMENS” must be covered with a label which states: Biological substance, Category B Adjacent to this label you need to place a diamond-shaped UN3373 label. On mail-able pieces, these labels need to be on the same side as the address label.
From the Public Health Laboratory of East Texas (PHLET)
Dear LRN Sentinel Laboratories:
Changes to FedEx requirements in how a Shipper’s Declaration Form must be prepared may impact your success in shipping submissions to us at PHLET, your LRN Reference Laboratory. This document must now be prepared using one of a few FedEx-approved programs, many of which are costly or cumbersome to use. FedEx has a program usable for billing and for generating the Shipper’s Declaration, but feedback from other laboratories suggests it may be problematic for some institutions to use.
Within our network of LRN laboratories, it has been discovered that Saf-T-Pak, one of the vendors for dangerous goods shipping materials, offers a FREE, stand-alone online program to generate the Shipper’s Declaration that has been approved by FedEx. Go to www.saftpak.com and on the left side of their homepage is a link to generating an FX-18 compliant form. You will need to set up a username and password to perform this function, but this is also FREE.
As always, we are available here at PHLET to assist you with any questions you may have regarding such submissions.
Public Health Laboratory of East Texas
11949 US Highway 271 Tyler, Texas 75708
Phone: (903) 877 – 5071
Fax: (903) 877 – 5259