10.3 Registration and Security Risk Assessments

Only when the HHS secretary or APHIS issues a certificate of registration to an entity can it possess, use and/or transfer select agents and toxins.  This registration is valid for specific agents and toxins, a particular physical location and for specific activities regarding this agent/toxin.  Prior to any changes in activities or the addition or removal of agents/toxins, the University must apply for an amendment to the certificate of registration.  All certificates of registration must be renewed prior to expiration, which can range from two to three years.

All correspondence regarding the certificate of registration that takes place between the DHHS and the University is initiated through the RO (Responsible Official).  The RO is a person designated by the University and approved by the HHS Secretary, following a security risk assessment by the Attorney General.  The RO has been granted the authority and responsibility to act on behalf of the University with regard to the Select Agent Program.  One or more individuals may be designated as an ARO (alternate Responsible Official), who may act for the RO in his/her behalf.  The RO is familiar with the requirements of the Select Agent Program and ensures compliance at the University with such requirements.  All laboratories where select agents or toxins are used or stored must be inspected annually by the RO.  An inventory report of all agents or toxins in the possession of a PI or laboratory, including those identified in specimens presented for diagnosis, verification or proficiency testing, and the final disposition of all agents/toxins must be maintained by the RO.