Effective February 14, 2003, diagnostic specimens are no longer exempt from the Department of Transportation (DOT) Hazardous Materials Regulations (HMR) under Docket Number HM-226. HM-226 will bring the United States regulations in line with international regulations. The major change that will affect most shippers is the packaging requirement for diagnostic specimens. DOT - How to Transport Infectious Substances (pdf). The Department of Transportation’s definition of a diagnostic specimen is: “any human or animal material, including excreta, secreta, blood and its components, tissue, and tissue fluids being transported for diagnostic or investigational purposes, but excluding live infected humans or animals.” Some of the major changes are listed below: Diagnostic specimens must be packed in a triple packaging, consisting of a primary receptacle, a secondary packaging, and an outer packaging. Primary receptacles must be packed in secondary packaging in such a way that, under normal conditions of transport, they cannot break, be punctured, or leak their contents. The secondary package must be secured in the outer packaging with suitable cushioning material. The completed package must be capable of successfully passing a drop test at a height of at least 1.2 meters (3.9 feet). The outer packaging must be clearly marked with the words “Diagnostic Specimen.” NOTE: For air shipments: the outer packing must show the text: “DIAGNOSTIC SPECIMEN PACKED IN COMPLIANCE WITH IATA PACKING INSTRUCTION 650". For specimens transported by aircraft, the primary receptacle or the secondary packaging must be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not less than 95 kPa in the range of -40° to +55° (-40°F to 130°F). An air eligible label must be placarded on outer package.