Select Agent Toxins
Select Agents and Toxins are certain toxins of biological origin that are subject to stringent regulatory requirements under 42 CFR 73 for their potential to pose a severe threat to public, animal, or plant health, or to animal or plant products. Review the List of Select Agents and Toxins to see which toxins are considered select agent toxins. These toxins, along with specified biological agents (e.g. viruses, bacteria, and fungi) fall under the oversight of the National Select Agents Registry (NSAR) Program.
National Select Agents Registry (NSAR) Program
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 governs the transfer, possession, and use of biological agents (e.g. viruses and bacteria) and toxins that have the potential to pose a severe threat to public or environmental health. Possession of the specified agents or toxins without registration carries severe civil and criminal penalties. Possession of more than extempt amounts of Select Agents and Toxins is not allowed at Stanford at this time and would require both prior approval from the Vice Provost and Dean of Research and registration with the NSAR Program.
For use of any biological (bacterial or viral) Select Agent, contact the Biosafety Program at esegal@stanford.edu.
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Permissible Amounts
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Requirements
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Equipment and Handling
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Possession of small quantities of Select Toxins may be exempt from registration with the National Select Agent Registry (NSAR) program. The Stanford Select Toxins Program summarizes the University's requirements for possession of NSAR Select Toxins under the exempt quantities.
Possession of Select Agent Toxins above permissible amounts
Possession of select agent toxins in quantities above permissible amounts requires prior approval from the Vice Provost and Dean of Research and registration with the NSAR Program. Note that as of December 4, 2012, Botulinum neurotoxins are categorized as Tier One agents, which trigger additional regulatory requirements. Contact EH&S for assistance at (650) 723-0448.
Permissible amounts of Select Agent Toxins:
The following Select Agent Toxins are not regulated, if the amount under the control of a PI at any time does not exceed the amounts indicated in the table below.
Select Agent Toxins/ HHS Toxins [§73.3(d)(3)]
Amount
Abrin
1000 mg
Botulinum neurotoxins
1 mg
Short, paralytic alpha conotoxins
100 mg
Diacetoxyscirpenol (DAS)
10,000 mg
Ricin
1000 mg
Saxitoxin
500 mg
Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E)
100 mg
T-2 toxin
10,000 mg
Tetrodotoxin
500 mg
Additionally, the following Select Agent Toxins are excluded:
- 1. Any Select Agent Toxin that is in its naturally occurring environment, provided it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
- 2. Nonfunctional Select Agent Toxins.
There are severe penalties for non-compliance with the NSAR rules, and it is imperative that each laboratory using and/or storing Select Agent Toxins maintains accurate and up-to-date inventory information for these substances. Failure to register with the NSAR Program is punishable by up to five years in prison and/or large monetary fines.
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<p dir="ltr">The PI is responsible for:</p><h3 dir="ltr">Inventory maintenance</h3><ul dir="ltr"><li>The inventory of Select Agent Toxins must be kept current in the <a href="https://stanford.chemtracker.org/?state=login">ChemTracker chemical inventory system</a>.</li><li>To ensure that PIs do not unintentionally exceed permissible amounts of Select Agent Toxins, inventories must be checked prior to purchase and promptly updated after every container of Select Agent Toxins is:<ul><li>Acquired (by purchase and/or intra-campus transfer)</li><li>Depleted (by consumption or by intra-campus transfer)</li><li>Inactivated</li></ul></li><li>Select Agent Toxins must be:<ul><li>Properly stored with compatible chemicals, with adequate secondary containment</li><li>Provided one layer of physical security (i.e. secured within a locked freezer or secured within a permanently fixed lockbox)</li></ul></li></ul><h3 dir="ltr">Standard operating procedures (SOPs)</h3><ul dir="ltr"><li>Prepare written standard operating procedures (SOPs) for Select Agent Toxin-involved research processes. Guidance for creating SOPs involving acutely toxic materials can be found in the <a href="/standard-operating-procedure/general-use-sop-highly-acute-toxic-materials">General Use SOP for Highly Acute Toxic Materials</a>.</li></ul><h3 dir="ltr">Personnel training</h3><ul dir="ltr"><li>Provide initial lab-specific safety training to staff and students involved in Select Agent Toxin-related processes, with updates as necessary. Maintain documented training for at least one year. Training topics must include:<ul><li>Select Agent Toxin-associated hazards</li><li>Engineering controls used to minimize exposure (e.g. fume hood use)</li><li>Personal protective equipment (PPE) to be used when handling Select Agent Toxins</li><li>Safe handling and storage</li><li>Proper decontamination, disposal, and spill response</li><li>Administrative requirements (recordkeeping, inventory maintenance, security)</li></ul></li></ul><h3 dir="ltr">List of PI-approved users</h3><ul dir="ltr"><li>Maintain a documented list of PI-approved Select Agent Toxin users (including those with access to Select Agent Toxin storage). The lab must keep track of who uses and who has access to the stock, but it is not necessary to record each use. Before becoming an approved user, the PI must ensure that each person has received training, as outlined in the prior section.</li></ul><h3>Inspections</h3><p dir="ltr">Self-inspections must be performed initially, and at least quarterly thereafter, using the <a href="/forms-tools/quarterly-exempt-quantities-cdc-select-agent-toxin-checklist">Stanford University Quarterly Select Agent Toxin Program Checklist</a>. Inspection items must include:</p><ul dir="ltr"><li>Verification that physical and online ChemTracker inventories are accurate</li><li>Review of Approved Users List, to verify authorized access to Select Agent Toxins</li><li>Verification of appropriate labeling, storage, secondary containment, and security measures</li></ul><h3 dir="ltr">Record retention</h3><p dir="ltr">Documentation of self-inspections must be maintained for at least one year after the last date of Select Toxin use, possession, or disposal.</p><h3 dir="ltr">Other inspections</h3><p dir="ltr">EH&S will conduct periodic laboratory visits to review compliance with institutional requirements for possession of permissible amounts of Select Agent Toxins.</p><h3 dir="ltr">Moving or closing labs</h3><p dir="ltr">To ensure proper safety, security, and inventory management of Select Agent Toxins during a laboratory move on campus, or if a PI is closing out his or her lab, consult with EH&S at (650) 723-0448.</p>
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Engineering controls
- Ensure the proper function (i.e. current certification) and use of any fume hood, biosafety cabinet, or glove box where Select Agent Toxin-associated procedures are performed.
Proper personal protective equipment (PPE)
- Appropriate personal protective equipment (e.g. gloves, eye protection, and lab coat) must be provided to laboratory personnel. If respirators are necessary, contact EH&S at (650) 725-0448 for respirator use approval and compliance documentation.
Inactivation
Use accepted inactivation procedures before disposing of remaining stock and/or empty containers.
Disposal
After inactivation, dispose of residual wastes (liquids and solids) as follows:
- Liquids: Collect inactivated materials in a non-leaking container constructed of compatible material and manage as hazardous waste, per hazardous waste management procedures.
- Stock vials and other materials: Deface container labeling. Collect in non-leaking container and manage as hazardous waste.
For any questions regarding NSAR Select Agent Toxin possession at Stanford University, contact EH&S.
