FAQ: APHIS/CDC Form 2 Transfers

General questions about shipping and receiving

If the package containing select agents and toxins is labeled generically as “Category A infectious substance” and does not identify the package as containing a select agent or toxin, the package can be placed with other packages in the area the entity uses for shipment of materials.

If the container of select agents and toxins is packaged by the laboratory and has the generic name “suspected Category A infectious substance” entered in place of the technical name as part of the proper shipping description, as required by the DOT regulations, the package can be placed with other packages in the area that the entity uses for shipment of materials and does not need to be accompanied by “chain of custody” paperwork.

However, if the select agents and toxins are sent to another area for packaging and shipping, “chain of custody” paperwork is required to document transfer from the laboratory to the area where packaging occurs. The area where packaging occurs must be listed on the entity’s certificate of registration and must meet all the requirements outlined in the select agent regulations as for other registered areas listed on the entity’s certificate of registration. If Tier 1 select agents and toxins will be packaged in the shipping and receiving area, that area must meet all provisions associated with Tier 1 requirements. All individuals who will have access to Tier 1 select agents or toxins must also meet Tier 1 requirements and be enrolled in the entity’s suitability assessment program. The area will also be inspected to ensure the entity’s compliance with the select agent regulations.

No, the package will not be identified as containing select agents or toxins and will be considered “lost in the crowd” until received by the intended recipient or his/her designee. It should be noted that the package containing select agents and toxins is not considered “received” by the entity until the intended recipient takes possession of the package.

The select agent regulations do not require the use of a commercial carrier for select agent shipments. However, even if an entity chooses to hand deliver a package containing a select agent or toxin to another registered entity it must still comply with section 16 (Transfers) and the transfer must be authorized by Select Agent Program. To initiate the transfer authorization, a CDC/APHIS Form 2 must be completed and submitted to the Federal Select Agent Program through eFSAP. In addition, the individual who is hand carrying the package must be SRA approved. The entity also remains responsible for ensuring that all local, state or federal transportation requirements for the transportation of hazardous materials are followed.

[Note: If the entity moves the select agent or toxin “in commerce” using a common, contract, or private carrier, U.S. Department of Transportation hazardous materials regulations will apply.] The entity must ensure that adequate precautions are taken to prevent a theft, loss or release of the select agents and toxins. In addition, for plant pathogens, interstate and certain intrastate movements will require a valid APHIS permit.

Yes. The Select Agent Program, in order to ensure the security and safety of select agents, will not approve the importation of select agent material unless it is to be transported into the United States via a commercial carrier.

General questions about transferring a select agent or toxin

Yes, 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 is NOT considered an intra-entity transfer. Intra-entity transfers involve the transfer of select agents from one registered location to another registered location covered by the same certificate of registration.

Approval of the transfer of a select agent and toxin is valid for 30 days from the date of authorization. Additionally, approval of a transfer becomes void should there be a change in any of the conditions upon which the approval was based (e.g., change in the certificate of registration for the sender or recipient or change in the application for transfer). Each transfer ID number is valid for only one transfer of select agents or toxins during the 30 day period.

It depends. Each transfer ID number is valid for only one transfer of select agents or toxins during the 30-day period. Therefore, multiple shipments occurring on different days would require separate authorizations from the Federal Select Agent Program. Large shipments that include multiple packages of select agents shipped on the same day can be shipped under the same transfer ID number. Tracking information for each package of the large shipment needs to be provided in eFSAP.

No, within the United States (U.S.), only entities that are registered with the Federal Select Agent Program are allowed to receive agents that have been identified as select agents. This includes the importation of select agents from outside the U.S.

No, however; the Department of Commerce regulates the exportation of a wide variety of etiologic agents of human, plant and animal disease and may require an export license. Information may be obtained by calling the DOC Bureau of Export Administration at (202) 482-4811, or at: https://www.bis.doc.gov/index.php/licensing/embassy-faq or https://www.bis.doc.gov/.

No, a transfer authorization from the Federal Select Agent Program is not needed to transfer a specimen presumptive for the identification of select agent or toxin to a receipt.

Yes, prior authorization from the Federal Select Agent Program is required for the transfer of the identified select agent(s) or toxin(s) being sent for susceptibility testing.

Additional information on reporting the identification of a select agents and toxins is available here.

General questions about completing the APHIS/CDC Form 2

Yes. The ARO can sign the APHIS/CDC Form 2 if he or she is acting as the RO in the RO’s absence.

The sender must:

Notify the Recipient of the expected shipment and document this notification in Section 2 of the form.
Ensure the material is properly packaged, labeled, and shipped in accordance with all federal regulations.
Ensure that the individual’s information and description of the package are documented in eFSAP.
Registered entities complete APHIS/CDC Form 2 (Section 2) in eFSAP prior to shipment and include a copy with the select agent package.
In the case of an import shipment or a shipment form a non -registered entity the sending entity should notify the recipient entity with all relevant shipping information including the expected shipment date arrival. The receiving entity will update eFSAP.

First, confirm that all the select agents and toxins listed in eFSAP were received. Document any discrepancies in eFSAP and notify the sender. If it is determined that there was a theft or loss during packaging or in transit, immediately update eFSAP or contact Federal Select Agent Program (DASAT at 301-851-2070 or DRSC at 404-718-2000) and submit APHIS/CDC Form 3 “Report of Theft, Loss or Release of Select Agents and Toxins If it is determined that the discrepancy is due to an administrative error, send an explanation of the error in eFSAP before completing Section 3 of the form
Inspect the package to verify that it is not damaged or leaking and that the material was packaged, labeled and shipped in accordance with federal regulations. If the package is received damaged or leaking to the extent that a release of the select agent or toxin may have occurred, immediately contact the Federal Select Agent Program in eFSAP and submit an APHIS/CDC Form 3 “Report of Theft, Loss or Release of Select Agents and Toxins.” and follow the reporting procedures. The U.S. Department of Transportation also has reporting requirements for release of hazardous materials. Refer to the next section regarding Department of Transportation Hazardous Materials Regulations requirements.
Complete the information for Section 3 in eFSAP within 2 business days of receipt.

If the package is not received within 48 hours of expected delivery time immediately contact the Federal Select Agent Program ( AgSAS at 301-851-2070 or DRSC at 404-718-2000).

General questions about transport of select agents and toxins

The packaging of a select agent or toxin must be performed by an individual approved by the HHS Secretary or APHIS Administrator for access to select agents and toxins. The individual who packages the select agent or toxin must ensure compliance with all applicable laws concerning packaging and shipping.

“Chain of Custody” paperwork

If the container of select agents and toxins is packaged by the laboratory and labeled as outlined by Department of Transportation (Reference No. 20-0035), the package containing a select agent can be placed with other packages in the area that the entity uses for shipment of materials and does not need to be accompanied by “chain of custody” paperwork.

eFSAP Submission

A registered entity can access the APHIS/CDC Form 2 approval information via eFSAP. This information is available in two locations:

Entity landing page notification section
Entity Form 2 tab, Section 1 – Under general notification

The sender from a registered entity can see information in the Section 1 and Section 3 of the APHIS/CDC Form 2 but cannot edit/modify information (read-only access). Similarly, the recipient is able to see the information in Section 2 but cannot edit/modify it.

The electronic documentation in eFSAP serves as the official record required by the select agent regulations. If the complete Form 2 is not available within the eFSAP (electronic documentation) information system, it is the entity’s responsibility to ensure the record is available for inspection.

Currently, only Section 2 of the approved Form 2 is available to print directly from eFSAP to accompany the shipment containing select agents and toxins.

Draft – Section has been started but has not been submitted. Forms in draft mode are not reviewed by FSAP staff.
Transfer in Review – Section 1 submitted by the RO of the recipient entity pending review by the FSAP staff.
Approved Section 2 Pending – Section 1 submitted by the RO (receiving – entity) has been approved by FSAP. Awaiting submission of Section 2 by the RO (sender-entity).
Section 3 Pending – Awaiting submission of Section 3 after the completion of the transfer by the RO (receiving – entity).
Transfer Completed – The transfer has been successfully completed and the recipient has submitted Section 3. FSAP is in receipt of the complete APHIS/CDC Form 2 (Sections 1, 2 and 3).
Transfer Cancelled – If a transfer does not occur within 30 days from the date of authorization, the recipient must answer “No” for question number #33 within Section 3. The status from “Section 3 Pending” changes to “Transfer Cancelled.”
Transfer Denied – If the transfer is not approved by FSAP, Section 1 will be denied.