Guidance on the Transfer of Select Agents and Toxins: Receiving Packages Containing Select Agents and Toxins

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.

Loss or Damage to Package

If a package containing select agents or toxins 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 FSAP. In addition to the initial reporting, the entity must follow up with a written report (APHIS/CDC Form 3 – Report of Theft, Loss, or Release of Select Agents and Toxins) within 7 calendar days of the incident.

In addition to the select agent requirements to report a loss or damaged package, DOT also requires reporting of specific types of transportation incidents that involve hazardous materials. For more information, see 49 CFR 171.15 and 171.16.

Unexpected Shipments

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

The entity should have a written contingency plan for receipt and security for unexpected shipments to ensure that approved personnel gain control of the unexpected shipment of select agents and toxins immediately and secure it in a registered area. The entity should inform FSAP of all unexpected select agent and toxin shipments immediately (within 24 hours of receipt).

Delivery Exception

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

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

Note: If returned to sender, the sender must notify FSAP and complete Section 2 of Form 2 with the new information and submit it to FSAP or enter into eFSAP at the time of shipment.

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, if applicable
• Verify the contents and shipment information (example: updated tracking number(s)) for the transfer authorization).
• If there is a discrepancy noted, the entity must immediately notify FSAP.