Risk Groups

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HISTORICAL INFORMATION





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On February 14, 2003, new regulations take effect for shipping infectious substances & diagnostic specimens.  

Under these rules, many specimens that were previously considered by air carrier groups and others as Infectious Substances (such as hepatitis-b or HIV) may now be shipped as Diagnostic Specimens under the new regulations. The rule change applies to human or animal material that is being transported for treatment or diagnosis.  Diagnostic Specimens classified in Risk Group IV must be assigned to Division 6.2 and shipped as Infectious Substances.

Cultures of Infectious Substances in Risk Groups 2, 3, & 4 are considered Infectious Substances, assigned to Division 6.2, and must be packaged, marked, & labeled in UN/4G certified containers, unless excepted in Risk Groups 2 & 3 in certain modes of ground transportation.

 (For surface transport exceptions, please refer to the HM226 Summary under "Regulatory Updates" for information on the Materials of Trade exceptions, specification performance packaging for Infectious Substances under the Materials of Trade exception, and the exception from federal regulation available to shippers using private or contract carriers using dedicated vehicles to transport diagnostic specimens.)
    
HIV and hepatitis-b are two examples of pathogens that classified in Risk Groups 2 or 3.  A complete listing of pathogens by WHO Risk Group,  is available on the Home page in the Classification Section along with Material Safety Data Sheets for Infectious Substances.

If you offer shipments of dangerous goods to the International Air Transport Association ("IATA") member carriers such as FedEx, you should follow IATA Packing Instruction 650 (IATA Dangerous Goods Regulations effective January 1, 2003.)

All shipments of Diagnostic Specimens with FedEx and other IATA carriers must be marked with the  designation "Diagnostic Specimen" and must be accompanied with the mark:  "Packed in Compliance with IATA Packing Instruction 650".  On January 1, 2004, each diagnostic specimen package must be accompanied by the mark:  "Air Eligible".

Under these new regulations, there are new packaging requirements for Diagnostic Specimen shipments that are determined by the mode of transportation (air or ground) and whether the specimens are in a liquid or solid state.

Legal Authority for Risk Group 2 & 3 Diagnostic Specimens:  please see "HM226" under "Regulatory Notices" on the Home page.   Federal Register August 14, 2002; Vol 67, Number 157, p53123, 9th paragraph, beginning:  

"Accordingly, this final rule adopts the provisions applicable to the transportation of diagnostic specimens meeting the definition of a Risk Group 4 material must be classed and transported as Division 6.2 materials, UN 2814 or UN 2900. Diagnostic Specimens known or suspected to contain a Risk Group 2 or 3 infectious substance must be packed in primary receptacles packed inside secondary packaging to preclude breakage, punctures, or leakage........."

 

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