Select Agents and Toxins are biological agents that have been declared by the U.S. Department of Health and Human Services (HHS) or by the U.S. Department of Agriculture (USDA) to have the “potential to pose severe threat to public, animal or plant health or to animal or plant products.” The Federal Select Agent Program regulates laboratories which may possess, use, or transfer select agents within the United States. For more information on the federal select agent program including a complete list of biological agents and toxins subject to these regulations, go to www.selectagents.gov.
The UW-Madison Select Agent Program Responsible Official (RO) provides oversight and guidance to the IBC, OBS, UW researchers, and other partners of the program for areas pertaining to research with Select Agents and Toxins performed at UW-Madison. The RO is charged by the Federal Select Agent regulations to have the responsibility to act on behalf of UW-Madison to oversee and manage the security, biocontainment and biosafety, and incident response of select agents and toxins at UW-Madison. The AROs have the responsibility to act for the RO in the absence of the RO.
Subthreshold Select Agent Toxins (Permissible Amounts)
The Federal Select Agent Program does not regulate certain Select Agent (SA) toxins if the amount under the control of a PI does not exceed, at any time, the amounts indicated on their website (https://www.selectagents.gov/permissibletoxinamounts.html). UW-Madison requires that PIs maintain an accurate inventory of SA toxins and secure the toxins in their laboratory. Inventory reports should be submitted semi-annually (every 6 months) to the Office of Biological Safety (firstname.lastname@example.org).
Permissible amounts are allowed of the following SA Toxins:
Short, paralytic alpha conotoxins
Staphylococcal enterotoxins (Subtypes A, B, C, D, and E)