Shipping and Receiving of Select Agents and Toxins
A select agent or toxin may only be transferred to individuals or entities registered to possess, use or transfer that agent or toxin. These procedures are designed to ensure that any shipping or receiving of select agents to/from Tulane University is in complete accordance with all of APHIS/CDC rules and regulations. A select agent or toxin may only be transferred under the conditions described in 7 CFR 331.16 & 9 CFR 121.16 and 42 CFR 73.16 and must be authorized by CDC prior to transfer. The institutes RO will coordinate all communications with federal agencies.
Receipt and Transfer of Select Agents Involving Entities Outside of Tulane University
The transfer of select agents from Tulane University to another entity within the United States or Receipt by Tulane University from another entity within the United States, the PI and RO will verify that:
- The sender has a certificate of registration that covers the transfer of the particular select agent or toxin to be transferred, meets the exemption requirements under 42 CFR 73.6 (a) for the particular select agent or toxin, or is transferring the elect agent from outside the United States and all import requirements are met
- The recipient has a certification of registration for the select agent or toxin to be transferred
- Prior to the transfer the recipient and sender complete APHIS/CDC Form 2 and copies are sent to the RO as well as the HHS secretary in accordance with 42 CFR 73.21.
- CDC has authorized the transfer based on the finding that the recipient has a certificate of registration covering the transfer of the select agent or toxin.
- The sender must comply with all applicable laws concerning the packaging and shipping.
- An authorization for a transfer is only valid for 30 calendar days after issuance.
- The RO of the recipient will provide a completed paper copy or facsimile transmission to APHIS/CDC Form 2 to the sender and to the HHS Secretary within 2 business days of receipt of the select agent or toxin.
- Upon delivery of a select agent or toxin the RO or ARO will inspect the package for leaks and compliance with shipping regulations of biohazards. The recipient will immediately report to the HHS Secretary if the package received containing select agents or toxins has been compromised, or if the select agent or toxin has not been received within 48 hours after the expected delivery time.
- When the select agent or toxins are consumed or destroyed after a transfer, the recipient must, within 5 business days, report such a fact to the HHS Secretary in accordance with 42 CFR 73.21 on APHIS/CDC Form 2.
Internal Transfer of Select Agent or Toxin
Federal regulations (42 CFR 73.14) do not cover transfers of select agents or toxins within an entity where both sender and recipient are covered by the same certificate of registration. To initiate an internal transfer of a select agent at Tulane University the PI needs to contact the Office of Biosafety and the RO, who will confirm that both the recipient and sender are certified to work with the select agent to be transferred.
- The RO will coordinate the transfer of the select agent or toxin, and if the select agent or toxin will be transported across campus the RO will inspect and approve the packaging and labeling and escort the select agent or toxin to its destination.
- A copy of the Tulane University Record of Select Agent Intra-Institutional Transfer Form will be maintained on file by the PI and the original will be maintained on file by the Office of Biosafety.