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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.
| 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 |
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.
Notify Immediately
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
Monthly
- Verify that physical inventory matches paper inventory
Quarterly
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
Annual
- 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).
Continuous
- 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.
View or download the following documents:
Select Agent Inventory Record of Changes to Long-term Storage
Select Agent Use or Storage Area Access Log – Authorized Individuals
Select Agent Use or Storage Area Access Log – Unauthorized Individuals
Approved Access Individual Signature Log