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