Security Plan Guidance: Shipping and Transfers
Section 11(c)(10) Shipping and Transfers
The security plan must contain provisions and policies for shipping, receiving, and storage of select agents and toxins. This includes procedures for receiving, monitoring, and shipping of all select agents and toxins.
With exception of exports out of the country, shipments containing select agents and toxins between entities must be authorized by FSAP, coordinated through an APHIS/CDC Form 2, and tracked so the receiving entity knows when the shipment will arrive. Both the sender (unless the sender is outside of the United States) and the recipient (unless the recipient is outside the United States) of the package must be approved for access to select agent or toxins.
The individual who packages the BSAT for shipment must have an SRA approval and appropriately trained.
The package containing select agents and toxins is not considered “received” by the entity until the intended recipient takes possession of the package. The intended recipient must have SRA approval and, if the agent is Tier 1, have gone through the entity’s pre-access suitability and is subject to the entity’s ongoing assessment.
When received by the intended recipient, the shipment should immediately be secured in a registered space. Ideally, the shipment is taken to the receiving laboratory; however, the package may be temporarily stored in other registered spaces.
Shipping and receiving areas must be registered if the select agents or toxins packages are identified or accessed. For example:
- If packaging or un-packaging of a select agent or toxin is performed in these areas.
- If the plan to temporarily store identified select agents.
If select agent or toxin packages are not identified or accessed, the shipping and receiving area may not need to be registered.
The entity must also have a written contingency plan for receipt and security for unexpected shipments. An “unexpected shipment” is when an entity receives a legitimate shipment of a select agent that it had neither requested nor coordinated for. The entity must have a contingency plan to have approved personnel gain control of the unexpected shipment of BSAT without delay and secure it in a registered area.
Section 11(d)(5) – Intra-Entity Transfers
An intra-entity transfer is a physical transfer of select agents or toxins that takes place between two individual with access approval, preferably two SRA approved PIs, at the same registered entity, e.g., a PI removes a select agent or toxin from his long term storage and gives it to another PI at the same entity.
Entities that conduct intra-entity transfers must describe in their security plan how these transfers will take place, including chain-of-custody documents and provisions for safeguarding the select agents and toxins against theft, loss, or release. Please see the example intra-entity transfer form to see what information should be captured according to section 17 (Records) of the select agent regulations. Transfers must include a chain-of-custody document and ensure that select agents and toxins will not be left unattended. See the sample Intra-Entity Transfer Form for an example. The entity is not required to cover intra-entity transfers in the security plan if they do not conduct them.
Section 11(d)(4) – Inspection of Suspicious Packages
A suspicious package is any package or item that enters or leaves registered areas that does not appear to be consistent with what is expected during normal daily operations.
The entity should consider the following indicators of suspicious packages:
- Misspelled words
- Addressed to a title only or an incorrect title
- Badly taped or sealed
- Lopsided or uneven
- Oily stains, discolorations, or crystallization on the wrapper
- Excessive tape or string
- Protruding wires
- Return address does not exist or does not make sense
The security plan must describe how the entity will inspect packages based on the site-specific risk assessment. The entity should inspect all packages and items before they are brought into or removed from areas where select agents and toxins are used or stored (registered laboratory, etc.). Suspicious packages should be inspected visually or with noninvasive techniques before they are brought into, or removed from the area where select agents and toxins are stored or used. See the USPS guidelines for recognizing suspicious packagespdf iconexternal icon for more detailed information.