Guidance on the Inventory of Select Agents and Toxins: Appendix I – Labelling Guidance

The guidance below is to enhance material accountability through

• The establishment of standards for labeling samples that are flexible, not overly prescriptive, and assist with prompt identification from the entity’s inventory record.

Labels on agent or toxin containers (e.g., tubes) should:

• Be legible
• Be indelible and able to survive surface decontamination with an appropriate disinfectant and the time and temperature extremes expected during storage
• Be permanently affixed to the container
• Contain enough information for a rapid, visual assessment of the contents by a knowledgeable viewer, including (at a minimum):
  • Agent or toxin name
    • Agent strain or toxin isoform (if such information changes the risk, such as an attenuated strain)
  • Date of creation
  • A clear indication of whether the agent is inactivated or not (lack of information will lead to a presumption that the agent is viable, or the toxin is in a toxic form)
  • Name of PI or responsible individual (although this could be included in the inventory records instead, it may be beneficial for laboratories to include this on labels to quickly identify who the responsible PI is or who generated/owns the samples and help resolve any issues with the samples)

If an unlabeled primary container is found while accessing the inventory or during an audit, an entity should try to reconcile with the current inventory in order to identify the select agent or toxin. If unable to reconcile the unlabeled vial and it results in a loss of a select agent or toxin, please refer to TLR guidance.