Select Toxin Guidance: Regulation if Registered for a Select Toxin Regardless of the Quantity Possessed
The Select Agent Regulations state that a registered entity must comply with all SAR requirements for each select toxin listed on the entity’s registration, regardless of the amounts of select toxin in possession.
Consider the following situation. An entity has a PI that is registered to possess, use, and transfer a select toxin, but the PI does not currently possess any of the select toxin for which the PI is registered. The PI must still be in compliance with all the SAR for that select toxin since the PI has been approved to obtain and possess that select toxin at any time.
A person who meets the SAR definition of a PI, but is not listed as a PI on the entity’s registration, is excluded from the SAR as long as the aggregate amount of select toxin under their control is below the regulatory threshold.