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
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of Page
Notify As Soon As Possible
Contact UMD Enivronmental Health and Safety Office
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 Principles
and Practices 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
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