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.
|Botulinum neurotoxins||0.5 mg|
|Short, paralytic alpha conotoxin containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7)1||100 mg|
|Diacetoxyscirpenol (DAS)||1000 mg|
|Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E)||5 mg|
|T-2 toxin||1000 mg|
1 C = Cysteine residues are all present as disulfides, with the 1st and 3rd Cysteine, and the 2nd and 4th Cysteine forming specific disulfide bridges; The consensus sequence includes known toxins α-MI and α-GI (shown above) as well as α-GIA, Ac1.1a, α-CnIA, α-CnIB; X1 = any amino acid(s) or Des-X; X2 = Asparagine or Histidine; P = Proline; A = Alanine; G = Glycine; X3 = Arginine or Lysine; X4 = Asparagine, Histidine, Lysine, Arginine, Tyrosine, Phenylalanine or Tryptophan; X5 = Tyrosine, Phenylalanine, or Tryptophan; X6 = Serine, Threonine, Glutamate, Aspartate, Glutamine, or Asparagine; X7 = Any amino acid(s) or Des X and; “Des X” = “an amino acid does not have to be present at this position.” For example if a peptide sequence were XCCHPA then the related peptide CCHPA would be designated as Des-X.
Notify the biosafety officer at the Department of Environmental Health & Safety (DEHS) 612-626-6002 if you anticipate obtaining any quantity of the above toxins.
Notify the 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.