May 17, 2013
Notification changes in the select agent program
Researchers are asked to review inventories and notify the university select agent program if using any listed biological toxins.
The U.S. government has been closely watching the transfer of certain biological organisms and toxins to combat terrorism since 1995. This select agent program, as it is called, was developed to regulate the possession, use and transfer of biological agents and toxins that could pose a severe threat to public health and safety. Throughout the years, the program has changed to keep up with science, to remove research barriers and to simplify coordination between agencies.
New regulatory requirements are in effect for the country's list of select agent toxins. Because of these changes, we are asking researchers using these toxins to notify the university's select agent responsible official as soon as possible.
In late 2012, the departments of Health and Human Services, and Agriculture published final rules amending the regulations that govern the possession, use and transfer of select agents and toxins (42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121). Among the changes are new requirements for transferring select agent toxins, regardless of the quantity. The select agent toxins are:
- Botulinum neurotoxins
- Staphyloccoccal enterotoxins
- T-2 toxin
Prior to these changes, we only needed to track select agent toxins over a certain quantity. Now we need to know who has any quantity of these biological toxins. All university principal investigators are asked to review their inventories to verify if they possess any of these toxins. Please notify Julie Johnson, the responsible official for the university select agent program, at email@example.com or 785-532-3248 by May 31.