Guidance on the Transfer of Select Agents and Toxins
- Determining When an APHIS/CDC Form 2 is Necessary
- Process for Completing a Transfer Request
- Packaging and Labeling
- Shipping Select Agents and Toxins
- Receiving Packages Containing Select Agents and Toxins
- Intra-Entity Transfers
- Due Diligence
- Appendix I: Shipping Regulations
- Appendix II: Import of Select Agents and Toxins
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Appendix II: Import of Select Agents and Toxins
A select agent or toxin does not require import permit as long as the importation and interstate movement of these select agents and toxins are authorized for transfer in accordance with the requirements for movement with a Form 2 under 42 CFR § 73.16, 9 CFR § 121.16, or 7 CFR § 331.16.
In order to ensure the security and safety of select agents, FSAP will not approve the importation of select agent material unless it is to be transported into the United States via a commercial carrier. Please see the FSAP policy statement Requests for Transfer of Select Agents and Toxins for more information. An exception is for materials regulated under USDA’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 and include 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 and should not be requested for the convenience of the person.
- The requestor must be a Federal employee who is a United States resident, has been SRA-approved, and has 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. AgSAS 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 AgSAS of the select agent arrival to the final destination within 24 hours of arrival.