Guidance on the Transfer of Select Agents and Toxins: Packaging and Labeling
Select agents and toxins should be classified as outlined by Department of Transportation (Reference No. 20-0035external icon) and packaged in accordance with the U.S. Department of Transportation’s (DOT’s) Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180)external icon. Please see the Guidance for Completing the Shipper’s Declaration for Dangerous Goods for more information.
Labeling of Packages Containing Select Agents and Toxins
The outer container of all Category A infectious substance packages must display the following:
- Sender’s name and address
- Recipient’s name and address
- Infectious substance label
- Proper shipping name as outlined by Department of Transportation (Reference No. 20-0035), UN number, and net quantity of infectious substance
- Name and telephone number of person responsible for shipment
- Cargo Aircraft Only label (when shipping quantities of infectious substance over 50 ml or 50 g by aircraft)
- Class 9 label, including UN 1845, and net weight if packaged with dry ice and identified as Carbon Dioxide, solid or Dry ice
Packaging of Select Agents and Toxins
The area where packaging of select agents and toxins occurs must be listed on the entity’s certificate of registration and must meet all the requirements outlined in the select agent regulations. An entity’s packaging and shipping area will be subject to inspection to ensure compliance with the select agent regulations.
If the container of select agents and toxins is packaged by the laboratory and has been classified as outlined by Department of Transportation (Reference No. 20-0035), the package containing select agents can be placed with other packages in the area that the entity uses for shipment of materials and does not need to be accompanied by “chain of custody” paperwork.
If the select agents and toxins are sent to another area for packaging and shipping, “chain of custody” paperwork is required to document transfer from the laboratory to the area where packaging occurs. The area where packaging and shipping occurs must be listed on the entity’s certificate of registration and must meet all the requirements outlined in the select agent regulations. If Tier 1 select agents and toxins will be packaged in the shipping and receiving area, that area must meet all provisions associated with Tier 1 requirements. All individuals who will have access to Tier 1 select agents or toxins must also meet Tier 1 requirements and be enrolled in the entity’s suitability assessment program. The area will also be inspected to ensure the entity’s compliance with the select agent regulations.
Select agents and toxins must be shipped in a triple package that consists of:
- Watertight primary receptacle or receptacles
- Watertight secondary packaging (for liquid materials, the secondary packaging must contain absorbent material in sufficient quantities to absorb the entire contents of the primary receptacles)
- Rigid outer packaging which must be of adequate strength for its capacity, mass, and intended use
The DOT “Transporting Infectious Substances Safely”pdf iconexternal icon pamphlet provides a diagram of how to properly package containing a select agent or toxin.