Procedures for Labs Working with Federally Exempt
Quantities of Select Agents
Toxin
quantities, per principal investigator, not exceeding those shown in
the following tables are exempt from federal select agent registration
and regulations. However, labs using or possessing exempt quantities of
select agent toxins must follow the University of Minnesota procedures
outlined below.
| HHS Toxins |
Amount |
| Abrin |
100 mg |
| Conotoxin |
100 mg |
| Diacetoxyscirpenol (DAS) |
1000 mg |
| Ricin |
100 mg |
| Saxitoxin |
100 mg |
| Shiga-like ribosome inactivating proteins |
100 mg |
| Tetrodotoxin |
100 mg |
| HHS/USDA Overlap Toxins |
Amount |
| Botulinum neurotoxins |
0.5 mg |
| Staphylococcal enterotoxins |
5.0 mg |
| Clostridium perfringens epsilon toxin |
100 mg |
| Shigatoxin |
100 mg |
| T-2 toxin |
1000 mg |
Notify
a biosafety officer at the Department of Environmental Health &
Safety (DEHS) 612-626-6002 if you anticipate obtaining any quantity of
the above toxins.
Notify a DEHS biosafety officer at
612-626-6002 if you already possess one of the above toxins and
anticipate obtaining additional amounts so that the total quantity may
approach the above threshold limits.
Use of select agent
toxins, in any quantity, must receive prior approval from the
Institutional Biosafety Committee (IBC). IBC approvals are subject to
continuing review and expire after three years. Click here
to learn more about applying for IBC review and approval.
All
select agents must be kept in locked storage (i.e., refrigerator, or
freezer) when not under the control of a trained worker.
Waste
and unwanted biologically-derived toxins cannot be sent to the
hazardous waste facility (Fay Thompson Center for Environmental
Management). Notify a DEHS biosafety officer at 612-626-6002 if you
wish to dispose of a toxin. For more information, see Disposal of
Select Agents & Other Biologically-Derived Toxins.
All
laboratories using biologically-derived toxins must have written
standard operating procedures (SOPs) for their use. SOPs should
include: potential exposure hazards during sample preparation and
experimental manipulations (e.g. aerosol generation when transferring,
mixing, or centrifuging; use of sharps; excretion by animals; etc.),
safety procedures that will be employed to minimize risk (e.g.
protective clothing, use of biological safety cabinet, sharps disposal
procedures, waste disposal procedures, etc.), proper material disposal
techniques, and accidental spill/exposure procedures.
All laboratories possessing exempt quantities of
select agents will be audited annually to review quantities on hand and
SOPs.
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