Guidance on the Transfer of Select Agents and Toxins

Intra-Entity Transfers

An intra-entity transfer is limited to those instances where a select agent or toxin is moved from one location within an entity to another (e.g., A Principal Investigator transferring part of his select agent inventory to another Principal Investigator from the same entity). The entity doing an intra-entity transfer must create a record of the intra-entity transfer that must include: the select agent or toxin, quantity, date, sender, and recipient. By regulation, this record must be maintained for a minimum of three years. If an entity does intra-entity transfers, its security plan must include a protocol for intra-entity transfers, including chain-of-custody documents and provisions for safeguarding against theft, loss, or release. For more information regarding intra-entity transfers, refer to Appendix I: Security Plan Provisions for Transfers and the Security Plan Guidance for Select Agent or Toxin Facilities.

The transfer of a select agent from an area not listed on your entity’s approved registration to a laboratory room listed on your entity’s approved registration can occur when a select agent is identified in a diagnostic specimen and an APHIS/CDC Form-4 is completed to retain this specimen. Most common intra-entity transfers involve the transfer of select agents from one registered location to another registered location covered by the same certificate of registration.