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Oklahoma State University
University Research Compliance

A unit in the Division of the Vice President for Research

Biosafety - Shipping and Receiving

Shipping and Receiving (Inter-Institutional Transfers)

The CDC or USDA/APHIS must give prior approval before a select agent can be transferred. It is imperative that investigators understand the regulations as outlined in the legislation. To ensure compliance with this legislation, OSU has implemented a highly centralized set of procedures.

These procedures are designed to ensure that all information required by 42 CFR Part 73.10 and the Institutional Biosafety Plan regarding select agent or toxin transfers, or select agent or toxin identification via clinical samples, is properly completed and documented. Appropriate forms must be filled out for each of the instances referenced above. Oklahoma State University's Office of University Research Compliance (URC), on behalf of the Responsible Official, will provide assistance and guidance regarding these procedures. In addition, URC personnel will coordinate communication with federal agencies. If you have questions or concerns regarding any of these procedures, please contact the Biological Safety Officer at 744-3203.

When an OSU investigator would like to request a select agent or toxin from another registered entity, the following procedure must be followed.

  • The OSU investigator must contact URC and provide information as required in Section 1.
  • URC personnel will ensure that the form is signed by the RO at the bottom of Section 1 of Form 2. The ARO will ensure that the form is sent to CDC for review of the request and approval of the transfer. Other USDA permits or import/export permits may be required. It is the responsibility of the investigator to obtain any of these permits, and the ARO will verify these are in place.
  • CDC will return the form back to OSU and will send a copy to the sender. The authorization number will only be valid for 30 days after issuance of the Transfer Authroization.
  • Upon receipt of the shipment, the RO must complete section 3 and send one copy of page 2 of the form to the sender and one copy to CDC within 2 business days of receipt.
  • If the select agent or toxin has not been received within 48 hours after the expected delivery time, the package received containing select agents or toxins has been damaged to the extent that a release of the select agent or toxin may have occurred, or the amount received differs from that indicated by the sender, URC personnel, on behalf of the RO, will immediately report to CDC and complete Form 3 (Report of theft, loss, or release of select agents and toxins).
  • Oklahoma State University has established the following tracking and communication procedures, including chain of custody forms, which must be followed:
    • After the recipient investigator and an ARO are advised that the CDC confirmation has been obtained, the OSU Mailing Services Hazardous Materials Division is notified of the pending arrival of a select agent. A restricted number of trained personnel in that division may receive or send select agents or toxins. The investigator determines the approximate time frame of the expected shipment from the sender, and communicates this information to URC by telephone and facsimile.
    • The ARO notifies the sender's contact person by facsimile that the biological agent or toxin is to be sent directly to University Mailing Services Hazardous Materials Division, and includes appropriate address and contact information. That information is conveyed to the staff in University Mailing Services.
    • The ARO determines a mutually agreeable date between the recipient and the sender for the receipt of the select agent or toxin, and communicates this date to University Mailing Services Hazardous Materials Division. The OSU investigator is required to personally receive the package in the laboratory where the material is registered to be stored. The shipment is tracked through the use of the Chain of Custody form by an ARO with the specifics of the shipment. The ARO then provides the form to the approved individual in University Mailing Service that is designated to receive the package. The approved personnel from University Mailing Service must complete the next portion of the form upon arrival of the package and then delivers the package to the investigator. The UMS employee signs off on the Chain of Custody form once the package is hand delivered to the PI. The Chain of Custody form accompanies the package until completed and returned to an ARO for validation.
    • The Manager or designee of University Mailing Services is the responsible administrator for ensuring that the shipment process conforms to relevant federal transportation regulations. University Mailing Service's staff notifies the ARO that the shipment has been received and delivered to the investigator.
  • The investigator must document all aspects of the increase in inventory, to be verified during inventory reconciliation by the BSO.
  • All tracking information is maintained centrally in the Office of University Research Compliance (URC) and in the respective laboratory.

When an OSU investigator is asked to transfer a select agent or toxin in his/her laboratory to another entity, the following procedure must be followed:

  • Upon receipt of the Form 2 with CDC or APHIS authorization for transfer, the sender (OSU principal investigator (PI) in conjunction with URC) will complete Section 2 and sign and date at the bottom of Section 2.
  • One of Oklahoma State University’s AROs will then advise the investigator and OSU Mailing Services that a shipment to another entity is forthcoming, and one copy of page 2 of Form 2 must be placed in the shipment and one copy must be sent to CDC or APHIS.
  • Oklahoma State University has established the following tracking including chain of custody forms and communication procedures, which must be followed:
    • After the recipient investigator and the ARO are advised by CDC of the confirmation of transfer and authorization number, the OSU Mailing Services Hazardous Materials Division is notified of approval to ship the select agent. A restricted number of trained personnel in that division may send select agents.
    • The investigator shall determine the approximate time frame for delivery of the expected shipment to the sender, and communicates this information to URC by telephone and facsimile.
    • The ARO notifies the recipient’s contact person by facsimile that the agent or toxin is ready to be shipped. The recipient shall confirm the appropriate shipping address and contact information. That information is conveyed to the staff in University Mailing Services.
    • The ARO determines a mutually agreeable date between the recipient and the sender for the receipt of the select agent or toxin, and communicates this date to University Mailing Services Hazardous Materials Division.
    • The Chain of Custody form for shipping of select agents is initiated by the PI upon removal of agent from inventory. Once the employee of University Mailing Services has inspected and accepted the packaging of the agent the Chain of Custody form accompanies the package and the employee of University Mailing Services to delivery of the properly packaged shipment directly to the shipping carrier. The employee of University Mailing Services completes the tracking information of the package and delivers the completed form to an ARO.
    • The Manager or designee of University Mailing Services is the responsible administrator for ensuring that the shipment process conforms to relevant federal transportation regulations. University Mailing Service's approved staff will hand deliver the package to the carrier drop off and notify the ARO that the shipment has been shipped.
  • A shipment of a select agent will not occur on a Friday or during University holidays.
  • Receipt of a select agent must be coordinated so it does not arrive when the University is not officially open. It should be coordinated to arrive Monday -- Thursday.