Appendix C – Transportation of Infectious Substances

Appendix C:  Transportation of Infectious Substances

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  1. Sandia National Laboratories International Biological and Chemical Threat Reduction's Gravatar Sandia National Laboratories International Biological and Chemical Threat Reduction
    May 12, 2016    

    Expand beyond IATA/DOT and consider alternate modes of transport. Also discuss the need to conduct a risk assessment for transport.

  2. Julie Johnson's Gravatar Julie Johnson
    May 10, 2016    

    The section on CDC and USDA import/transport permits are quite out of date – especially contact information.
    Some examples:
    – include current infomraiton on the USDA ePermitting process;
    – make it clear when a CDC permit USDA permit, Select Agent Form 2, etc., is needed, including when multiple permits/approvals are requried.
    My suggestion to make this section more user friendly is to order the section by type of material to be imported/transported, and then list which regulations apply, rather than ordering by regulations and listing under those what types of shipment they would apply to.

  3. ABSA Member's Gravatar ABSA Member
    May 10, 2016    

    The United States has taken great strides over the past several years to harmonize its infectious substances and diagnostic/clinical specimen shipping requirements with the rest of the world. This effort has largely been concluded at the time that the 5th Edition of the BMBL has been made available for review, and you have done well with managing this topic. Of practical value to the readers who may not be fully versed with these applicable shipping requirements for these hazardous materials is the fact that individual International Air Transport Association (IATA) members may have requirements that need to be addressed that may by more stringent than the requirements noted in the IATA Dangerous Good Regulations. Shippers of infectious and diagnostic/clinical specimens would be well advised to consult these regulations before bringing a shipment to an IATA carrier if rejection of the shipment is to be avoided by the IATA carrier.

    It would also be helpful to provide the specific reference to the hazardous material security planning requirement in the list of regulations and to note the “security plan” and the “hazardous material security plan” referenced in those standards. These clarifications would provide better linkage of the regulation and better prepare shippers to address these aspects in their site’s security planning efforts. There could be some confusion if a shipper of Select Agent mistook the security plan that is required under the CDC Select Agent and Toxin as fully addressing all of the provisions of the U.S. Department of Transportation’s hazardous material security plan requirements. The CDC Select Agent security plan requirement are focused on the security of the Select Agent at the facility whereas the U.S. Department of Transportation’s security plan requirements are focused on security of the Select Agent while in transit to or from the Select Agent facility. The specific U.S. Department of Transportation standard requiring the preparation of these security plans is: 49 CFR Subpart I, 172.800, Security Plans.

    General DOT Packaging Requirements for Transport of Infectious Substances by Aircraft

    Comment: It would be helpful to indicate that the required emergency response information on the Shipper’s Declaration of Dangerous Goods must in include an emergency phone number staffed 24/7/365 by someone knowledgeable about the hazardous materials being shipped in the package.

    Comment: The reference to “Biological Specimen, Category B” is incorrect. The correct reference is Biological Substances, Category B. This reference should be corrected within the text of this section and in Diagram 2 of this appendix.

    Although the references to Category A Infectious Substances and Biological Substances, Category B specimen provides useful information, the reality is that due to the time sensitive nature of many of these shipments, they are shipped via aircraft, and most common air carriers and commercial airlines are IATA members. IATA members require shipments which they are to carry to be prepared as per the Dangerous Goods Regulations of the IATA. It would be practical and beneficial to note this and to reference the IATA packaging instructions 620 and 650 in this section. It would be good to show examples of packaging and shipping of these hazardous materials as per these packaging instructions versus the U.S. DOT references.

  4. CSHEMA Biosafety Community of Practice's Gravatar CSHEMA Biosafety Community of Practice
    May 9, 2016    

    General: This section should include brief information regarding the rules for shipping the following: exempt human specimens, exempt animal specimens, genetically modified organisms, genetically modified microorganisms, biological toxins, regulated medical waste, refrigerants (examples: dry ice, liquid nitrogen), chemicals used for stabilization purposes.
    Page 340: The 95 kPa requirement only applies to the primary or secondary container, not the package as a whole.
    Page 340: Change shipping paper to shipper’s declaration.
    General: Need to include some information on the training requirements for shippers.