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Biosafety - Notification for Theft, Loss, Release, or Destruction
Notification for Theft, Loss, Release, or Destruction
Entities have specific notification requirements that are applicable under certain conditions, and the investigator using or storing select agents or toxins must be familiar with these. The requirements are detailed in the federal document titled Guidance Document for Report of Theft, Loss or Release of Select Biological Agents and Toxins and the federal regulations (42 CFR 73 and 7 CFR 331 & 9 CFR 121).
Upon discovery of a theft, loss, or release (occupational exposure or release of an agent or toxin outside of the primary barriers of the biocontainment area) of a select agent or toxin, the following process must be followed, as it is required:
In the event of theft, loss, or release, (as described above) the PI must immediately contact the Office of University Research Compliance. An Alternate Responsible Official (ARO) will ensure that proper notification is immediately made to the Center for Disease Control and Prevention (CDC) and OSU's Responsible Official (RO). Additionally, the ARO will ensure that State and local law enforcement (theft or loss) or appropriate State and local public health agencies (release) are notified.
The Office of University Research Compliance will assist in completing and obtaining appropriate signatures on the appropriate form.
- For reporting a theft or loss: Sections 1 and 2 of Form 3. If the incident occurred during transfer: the Office of University Research Compliance will assist in completing Sections 1, 2, and 3 of Form 3 and include a copy of the APHIS/CDC Form 2.
- For reporting a release: complete sections 1, 2, and 4. For reporting a release that occurred during transfer, complete all sections of the form and include a copy of the APHIS/CDC Form 2.
An ARO will ensure that these documents are forwarded to the CDC within 7 calendar days, as required.
If at any point select agents are to be completely removed from an inventory for the purpose of destruction, the PI must contact the Biological Safety Officer (BSO) prior to destruction. A time will be arranged for the BSO to witness the destruction. Additionally, the Destruction of Inventory form will be filled out by the BSO and signed by all involved parties.