APHIS/CDC Form 2 Transfers FAQs

General questions about shipping and receiving

  1. What is meant by an "unexpected shipment"?

    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.

  2. Do the select agent regulations require any physical measures (i.e., cages, safes) to secure shipments containing select agents or toxins prior to being picked up by a commercial carrier for delivery to the intended recipient?

    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.

  3. Is "chain of custody" paperwork required to track a package containing select agents or toxins until the package is provided to the commercial carrier?

    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.

  4. Is the receiving entity required to use "chain of custody" paperwork to track a package containing select agents or toxins from the time it is received by the entity from a commercial shipper until the package is received by the intended recipient?

    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.

  5. Are we required to use a commercial carrier for the domestic shipment within the United States of select agent shipments or can we hand deliver a package containing select agents or toxins to a registered recipient?

    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.

  6. Are we required to use a commercial carrier for importations of select agent shipments into the United States or can we hand deliver a package containing select agents or toxins to a registered recipient?

    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. An exception is for materials regulated under the U.S. Department of Agriculture's Plant Protection and Quarantine regulations (PPQ; 7 CFR Part 331) under certain conditions as described below. These materials may be hand-carried into the U.S. under the following conditions:

    • A request to hand-carry must be in writing including detailed reasons for the need to hand carry vs. commercial carrier, person's passport number, travel locations, date and times of itinerary; date, time, airline, arriving flight number, and first location of U.S.-landing must be supplied and in advance of the proposed foreign travel. The need for hand-carrying is considered extraordinary (i.e. not the convenience of the person).
    • The requestor must be a Federal employee who is a United States resident, be SRA-approved, and have at least a secret-level clearance. The requester must hold a valid permit (PPQ Form 526) to import the select agents that are to be hand-carried. Secure packaging of the biological material is stated in the permit conditions. Additional packaging or carrying conditions are on a case-by-case basis. Agriculture Select Agent Program writes a courier letter to the Custom and Border Patrol (CBP) workstation at the first U.S. port of entry. The letter details the individual, trip itinerary, the carrying of "biological material" (not the exact name) that is permitted by Animal and Plant Health Inspection Service (APHIS), the date, time, flight #, departing and arriving cities, the final destination of the person, and requests that CBP and Immigration expedite the individual through Customs as they are on official travel for the U.S. Government. This letter is sent through Department of Homeland Security (DHS), CBP channels for delivery to the workstation. The individual is required to carry a copy of this letter with their travel documents and to show it upon CBP request.
    • The individual must place imported select agent in the entity's inventory and update the inventory records accordingly.
    • The individual must notify Agriculture Select Agent Program of the select agent arrival to the final destination within 24 hours of arrival.

General questions about transferring a select agent or toxin

  1. What is the purpose of an APHIS/CDC Form 2?

    You use an APHIS/CDC Form 2 to request authorization to transfer a select agent or toxin. It also provides documentation of the transfer.

  2. Is a transfer authorization from APHIS or CDC needed for intra-entity transfers?

    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" at http://www.selectagents.gov/guidance-securityfacility.html.

  3. Our diagnostic laboratory, which is not listed on my entity's approved registration, would like to transfer the select agent that was identified in a clinical sample to a laboratory room listed on my entity’s approved certificate of registration. Does this require an approved APHIS/CDC Form 2?

    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.

  4. Is a transfer authorization from AgSAS or DSAT needed to transfer toxins in a quantity below the regulated amounts?

    No, a transfer authorization would not be needed for toxins under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor if the aggregate amount does not exceed the following amounts: Abrin 1000 mg, Botulinum neurotoxin 1 mg, Conotoxins (Short, paralytic alpha conotoxins) 100 mg, Diacetoxyscirpenol 10,000 mg, Ricin 1000 mg, Saxitoxin 500 mg, Staphylcoccal enterotoxin (A, B, C, D, E subtypes) 100 mg, T-2 toxin 10,000 mg, and Tetrodotoxin 500 mg.  The toxin can only be transferred after the transferor uses due diligence and documents the identification of the recipient and the legitimate need (e.g., prophylactic, protective, bona fide research, or other peaceful purpose) claimed by the recipient to use such toxin.  Information to be documented includes, but is not limited to, the recipient identity information, including the recipient’s name, institution name, address, telephone number and e-mail address; name of the toxin and the total amount transferred; and the legitimate need claimed by the recipient.  The entity must also report to CDC if they detect a known or suspected violation of Federal law or become aware of suspicious activity related to a select toxin.

  5. Is a transfer authorization from AgSAS or DSAT needed to transfer attenuated strains of select agents that have been excluded by AgSAS or DSAT from the Select Agent Regulations?

    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 at www.selectagents.gov/SelectAgentsandToxinsExclusions.html. If an attenuated strain of a select biological agent or toxin is not listed at www.selectagents.gov/SelectAgentsandToxinsExclusions.html, the agent or toxin is still considered a select agent or toxin and would need a transfer authorization from the Federal Select Agent Program.

  6. Once submitted through eFSAP, when can I expect a decision regarding my transfer request?

    A written decision from AgSAS or DSAT is usually provided within 72 hours of receipt of the request. However, please note that an APHIS/CDC Form 2 with incomplete or inaccurate information may delay a decision concerning your request.

  7. How long is a transfer authorization from the Federal Select Agent Program valid?

    Approval of the transfer of a select agent and toxin is valid for 30 days from the date of authorization. This means that the transfer of the select agent or toxin must be completed before expiration of the 30 day period. 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.

  8. We received authorization to transfer select agents and toxins to a registered entity. Can we ship multiple packages using the same transfer ID number over the next 30 days?

    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.

  9. Is a non-registered entity allowed to receive select agents?

    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.

  10. What are the requirements for importation of a select agent or toxin into the United States?

    The importation of the select agent or toxin has been authorized in accordance with 42 CFR §73.16 or 9 CFR §121.16.

  11. Is a transfer authorization from the Federal Select Agent Program required to export a select agent or toxin to a foreign country outside of the United States?

    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: http://www.access.gpo.gov/bis/index.html or http://www.bis.doc.gov/.

  12. Is a transfer authorization from Federal Select Agent Program needed to transfer a specimen presumptive for the identification of a select agent or toxin to a recipient?

    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.

  13. Is a transfer authorization from Federal Select Agent Program needed to transfer a select agent or toxin that is contained in a specimen for proficiency testing?

    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, please refer to: http://www.selectagents.gov/form4.html.

  14. What should I do if a delivery exception occurs?

    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.

  15. Is a transfer authorization from the Federal Select Agent Program required to transfer select agents or toxins identified from clinical/diagnostic specimens being sent for susceptibility testing?

    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 at: http://www.selectagents.gov/faq-reporting.html.


General questions about completing the APHIS/CDC Form 2

  1. Can the Alternate Responsible Official (ARO) sign the APHIS/CDC Form 2 if the Responsible Official (RO) is unavailable?

    Yes. The ARO can sign the APHIS/CDC Form 2 if he or she is acting as the RO in the RO's absence. However, the RO's name and contact information should be entered in Section A, Box 9 of the form even if the ARO signs the form.

  2. What do I put in Block 20 if I am not registered with Federal Select Agent Program?

    For non-registered entities, it is acceptable to list the facility director or laboratory manager.

  3. What address should be specified under Section A (Recipient Information) and Section B (Sender Information)?

    For registered entities, the address specified should be the entity's complete address, exactly as it appears on their current certificate of registration. For non-registered entities, please provide the complete, legal address of your entity. Please do not provide a P.O. Box.

  4. After a transfer authorization is received from Federal Select Agent Program, what is required of the sender that wants to ship a select agent or toxin?

    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.

  5. What does the Recipient need to do upon receipt of the select agent shipment?
    • 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 (AgSAS at 301-851-3300 (option 3) or DSAT 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 301-851-3300 (option 3) or DSAT at 404-718-2000).


General questions about transport of select agents and toxins

  1. What happens if a package containing a select agent or toxin is lost or damaged during shipment?

    Requirements for All Infectious Substances

    Infectious substanceThe 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," January 2009, available at http://www.who.int/csr/resources/publications/biosafety/WHO_HSE_EPR_2008_10/en/, 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. The manual can be found at: http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_CSR_LYO_2004_11/en/.

    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.

  2. Who can package select agents and toxins for shipment?

    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 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.


  3. How to package and label shipment containing select agents and toxins?

    Select agents and toxins should be classified as a Category A infectious substance and the proper shipping description is “UN2814, Infectious substances, affecting humans, 6.2” or “UN2900, Infectious substances, affecting animals”. Prior to being offered and transported, a Category A infectious substance must be packaged in accordance with the U.S. Department of Transportation’s (DOT’s) Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180), and be accompanied by a shipping paper, marking, labeling, and note the appropriate emergency response information. 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, 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

  4. How should packages containing select agents and toxins be received by entity?

    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.


eFSAP Submission

  1. How do I access my approved APHIS/CDC Form 2 for the transfer?

    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

  2. Is the sender able to view the recipient information in eFSAP?

    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.


  3. Will an entity be required to maintain hard copy printouts of the APHIS/CDC Form 2 for transfers documented in eFSAP?

    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.


  4. What are the APHIS/CDC Form 2 statuses?
    • 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.