FAQ: APHIS/CDC Form 2 Transfers

An “unexpected shipment” is when an entity receives a shipment of a select agent that it had neither requested nor coordinated for, and therefore was not expecting.

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.

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.

No, but 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 following information: the select agent or toxin, quantity, date, sender, and recipient. By regulation, the record has to 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 the “Security Guidance for Select Agent or Toxin Facilities”.

No, the regulations establish a procedure by which the Federal Select Agent Program may exclude from the requirements of the select agent regulations an attenuated strain of a select biological agent or toxin determined by the Federal Select Agent Program not to pose a severe threat to public health and safety, animal and plant health, or animal and plant products. The list of approved attenuated strains can be found on the Federal Select Agent Program website here. If an attenuated strain of a select biological agent or toxin is not listed here, the agent or toxin is still considered a select agent or toxin and would need a transfer authorization from the Federal Select Agent Program.

No, a sponsor/sender may send a select agent or toxin that is contained in a specimen for proficiency testing to a recipient without obtaining prior authorization from the Federal Select Agent Program provided that, at least seven calendar days prior to the transfer, the sponsor/sender send the Federal Select Agent Program a written report that includes the select agent or toxin to be transferred and the name and address of the recipient. For further guidance on reporting the identification of a select agent or toxin contained in a proficiency test can be found here.

A delivery exception occurs when a shipment is held by the carrier or returned to the shipper due to inadequate paperwork. If this occurs, please notify the Federal Select Agent Program and the recipient entity immediately. The notification should include the following:

• New tracking number(s)
• The reason and needed action associated with the delivery exception
• Expected new date of arrival

Note: For senders who are not registered with the Federal Select Agent Program, a copy of an updated Section 2 of APHIS/CDC Form 2 must be submitted to the Federal Select Agent Program and the recipient prior to delivery. Please ensure the Form 2 is updated accordingly.

Once the delivery exception package is delivered, the recipient must:

• Ensure that the expected shipment was properly packaged, labeled, and shipped in accordance with all federal regulations.
• Ensure that the shipment information (example: updated tracking number(s)) matches the information documented in the updated Section 2 of the APHIS/CDC Form 2.

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.

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).

Requirements for All Infectious Substances

The DOT regulations (49 CFR 171.15 and 171.16) require each person in physical possession of a hazardous material, including an infectious substance, to report specific types of transportation incidents that involve these materials. Immediate reporting (no later than 12 hours) by telephone to the National Response Center at 1-800-424-8802 is required for incidents where fire, breakage, spillage, or suspected contamination occurs that involves the shipment of infectious substances other than a patient specimen or regulated medical waste ( See 49 CFR 171.15(b)(3)). In addition, a written report to DOT is required within 30 days of the discovery of the incident for any unintentional release of hazardous material from a packaging during transportation, including those covered under 49 CFR 171.15 ( See 49 CFR 171.16(a)). DOT regulations also require packages that contain infectious substances to be accompanied by several forms of hazard communication, as applicable, as well as labeled to indicate the infectious hazard (See 49 CFR 172.432 for a depiction of the required label). This label currently includes a statement for immediately reporting a leaking or damaged package to the Public Health Authority.

The WHO Guidance on regulations for the transport of infectious substances 2021-2022 also provides specific recommended procedures for spill cleanup. This guidance is available to the agencies that govern land, vessel, and air shipments. The recommended procedures reflect those contained in the WHO Laboratory Biosafety Manual, Third Edition, 2004. 

Special Requirements for Select Agents

If a package containing select agents has not been received within 48 hours after the expected delivery time or has been damaged to the extent that a release of a select agent may have occurred, the recipient must immediately report this incident to the Federal Select Agent Program in eFSAP.

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.

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.

Select agents and toxins should be classified as outlined by Department of Transportation (Reference No. 20-0035) and packaged in accordance with the U.S. Department of Transportation’s (DOT’s) Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Please see the Guidance for Completing the Shipper’s Declaration for Dangerous Goods for more information.

Labeling of Packages Containing Select Agents and Toxins

The outer container of all Category A infectious substance packages must display the following:

• Sender’s name and address
• Recipient’s name and address
• Infectious substance label
• Proper shipping name as outlined by Department of Transportation (Reference No. 20-0035), UN number, and net quantity of infectious substance
• Name and telephone number of person responsible for shipment
• Cargo Aircraft Only label (when shipping quantities of infectious substance over 50 ml or 50 g by aircraft)
• Class 9 label, including UN 1845, and net weight if packaged with dry ice and identified as Carbon Dioxide, solid, or Dry ice

Receipt of Packages by Entity

The entity offering packages containing hazardous materials for transport, including packages containing select agents and toxins, should ensure these packages are provided to the intended recipient without delay to avoid the hazardous materials from being compromised (e.g., thawing of dry ice). For example, the entity can have the shipping and receiving personnel take the package directly to the intended recipient upon package arrival; have a secured location in the shipping area for the intended recipient to retrieve the package; or have the commercial carrier deliver the package directly to the intended recipient. A package containing select agents and toxins is not considered “received” by the entity until the intended recipient takes possession of the package.

Receipt by Intended Recipient
The intended recipient, or his/her designee, must be an individual who is approved by FSAP for access to select agents and toxins. Upon receipt of the shipment, the intended recipient must verify the contents. If there is a discrepancy noted, the entity must immediately notify FSAP.

Security Plan

Section 11(c)(10) requires that the entity’s security plan contain procedures for receiving select agents and toxins. The procedures should contain documented processes to ensure select agents and toxins are safeguarded against theft, loss, intentional release or unauthorized access when a select agent or toxin is received by a person with approval to access select agents and toxins. The procedures should include:

• How the transfer is coordinated between the sender and intended recipient;
• How the package will be tracked in transit to ensure that the intended recipient is aware of the package’s expected arrival;
• How the package arrives to the intended recipient including if the individual is not available; and
• How the entity handles unexpected shipments (when an entity receives a select agent that it had neither requested nor coordinated for, and therefore was not expecting).

If the entity temporarily stores packages identified as containing select agent or toxin at the loading dock (instead of packaged for shipment labeled generically as “Category A infectious substances” (i.e., “lost in crowd” concept)), this location must be on the entity’s registration, the security plan must include how the entity temporarily stores and secures the select agents or toxins in these locations, and individuals with access to these packages must have SRA approval.

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

1. Entity landing page notification section
2. 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.