Federal Select Agent Program - Guidance on the Transfer of Select Agents and Toxins

Guidance on the Transfer of Select Agents and Toxins

Determining When an APHIS/CDC Form 2 is Necessary

See the chart below to determine whether a Form 2 is necessary in order to conduct a transfer.

Material to be transferred
*Note: The exportation of a select agent or toxin requires an export license issued by the Department of Commerce. For more information, contact the DOC Bureau of Export Administration at the Bureau of Industry and Security.

Form 2

Inter-entity transfer of select agent or regulated amounts of toxin:
Between two registered entities Yes
From an unregistered entity to a registered entity Yes
Imported into the U.S. Yes
Exported from the U.S. No
Select agent or regulated amounts of toxin transferred (intra-entity):
Between two registered Principal Investigators at the same institution No
From an unregistered area to a registered area at the same institution Yes
Exempt amounts of select toxin:
Inter- or intra-entity, either registered or unregistered entities No
Excluded strains of select agents listed on the FSAP website:
(Note: Attenuated strains that are not listed as excluded strains are considered select agents.)
Inter- or intra-entity, either registered or unregistered No
Specimen that has been presented for diagnosis:
That has not been identified to contain a select agent or toxin No
That has been identified to contain a select agent or toxin Yes
Proficiency samples:
(Note: At least 7 days prior to the transfer, the sender must provide a written report to FSAP detailing the select agent or toxin to be transferred and the name and address of the recipient.)
That do not contain a select agent or toxin No
That contain a select agent or toxin No