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
Form 2
Material to be transferred
Inter-entity transfer of select agent or regulated amounts of toxin:
Form 2
Material to be transferred
Between two registered entities
Form 2
Material to be transferred
From an unregistered entity to a registered entity
Form 2
Material to be transferred
Imported into the U.S.
Form 2
Material to be transferred
Exported from the U.S.
*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 Securityexternal icon.
Form 2
No*
Material to be transferred
Select agent or regulated amounts of toxin transferred (intra-entity):
Form 2
Material to be transferred
Between two registered Principal Investigators at the same institution
Form 2
No
Material to be transferred
From an unregistered area to a registered area at the same institution
Form 2
Material to be transferred
Excluded amounts of select toxin:
Form 2
Material to be transferred
Inter- or intra-entity, either registered or unregistered entities
Form 2
No
Material to be transferred
Excluded strains of select agents listed on the FSAP website:
(Note: Attenuated strains that are not listed as excluded strains are considered select agents.)
Form 2
Material to be transferred
Inter- or intra-entity, either registered or unregistered
Form 2
No
Material to be transferred
Specimen that has been presented for diagnosis:
Form 2
Material to be transferred
That has not been identified to contain a select agent or toxin
Form 2
No
Material to be transferred
That has been identified to contain a select agent or toxin
Form 2
Material to be transferred
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.)
Form 2
Material to be transferred
That do not contain a select agent or toxin
Form 2
No
Material to be transferred
That contain a select agent or toxin
Form 2
No