Procedures for Labs Working with Federally Regulated Select Agents
Select Agents and toxin quantities (per principal investigator), exceeding those shown in the following tables, are subject to federal select agent registration and regulations. Follow the University of Minnesota procedures outlined below to assure federal compliance.
|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.
Procedure to Apply for Select Agent Use
Notify the biosafety officer in Environmental Health & Safety (DEHS) 612-626-6002 if you wish to receive a select agent. All transfers of select agents require approval by both The Center for Disease Control (CDC) and the University of Minnesota's select agent program Responsible Official. Shipping and receiving of all select agents must be done through DEHS.
In addition, you must obtain approval from the Institutional Biosafety Committee (IBC) before receiving and/or using select agents at the University. Click here to learn more about applying for IBC review and approval.
Procedures for Approved Select Agent Use
Possession of select agents requires regular communication with DEHS. The procedures below are organized around the timing or frequency with which they occur.
Contact DEHS 626-6002 during regular business hours or after hours call 911 and ask for a hazardous materials response for any of the following situations:
- Security breaches such as break-in or other unauthorized access
- Theft, loss, or release of a select agent
- Spills (to determine if hazardous material assistance is needed)
- Request by an outside agency auditor for laboratory entrance
Notify As Soon As Possible
Contact DEHS 626-6002 for:
- Worker exposures such as ingestion, needle stick, or face splash (after first seeking medical attention)
- Any changes that need to be made to the University's federal Certificate of Registration on file with the CDC. This includes a change in location of select agent, change in authorized users, or a significant change in select agent protocol or research objective. Both IBC approval and federal registration need to be renewed every three years. View or download Select Agent Federal Registration Changes and Renewal Form (Word doc).
- Approval to ship or receive a select agent outside of the University
- Notification of transfer of a select agent to another approved location within the University. Record of transfer and change in inventory forms required.
- Approval to inactivate or destroy a select agent stock
- New employee training and authorized access requests
- Verify that physical inventory matches paper inventory
DEHS will audit labs to:
- Review lab access logs to verify they are kept up to date
- Verify that work is being done as indicated on the University's federal Certificate of Registration on file with the CDC
- Review safety/security protocols and implementation
- Collect inventory forms
- Change access codes
- Review and update security, biosafety, and incidence response plans with DEHS
- Complete select agent update training for all individuals with authorized access. Keep all training records for three years. View or download Select Agent Research Lab Record of Training (Word doc).
- Notify DEHS whenever there is a change in lab workers and/or when acess codes or keys have been changed
- Follow pertinent lab practices in the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories and in the Biosafety Manual section of this web site.
- Follow all procedures as outlined in the University's Security Plan for Select Agents
- Maintain up-to-date standard operating procedures (SOPs). 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.
- Maintain up-to-date inventory and access logs. Contact a DEHS biosafety specialist at 624-5479 with record keeping questions.