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 Federal Select Agents Program. This page outlines Stanford University’s institutional requirements for possession of permissible amounts of select agent toxins and was established to ensure:
- Safe laboratory handling, use, and storage procedures.
- Effective tracking and security of the Select Agent Toxins.
- Compliance with federal regulations (42 CFR Part 73).
Federal Select Agents 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.
Stanford University currently is not registered for the possession of select agents and does not have the programmatic support in place for their use; to use these agents would require both prior approval from the Vice Provost and Dean of Research and registration with the Federal Select Agents Program. Please contact Biosafety if you would like to discuss implications for the use of Select Agents.
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 Federal Select Agent Program. Also note that effective 12/4/12, Botulinum neurotoxins are categorized as Tier 1 agents that trigger additional regulatory requirements. Contact EH&S for assistance at 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)]
Botulinum neurotoxins* (see note below)
Short, paralytic alpha conotoxins
Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E)
Additionally, the following Select Agent Toxins are excluded:
- 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.
- Nonfunctional Select Agent Toxins.
There are severe penalties for non-compliance with the Federal Select Agent Program 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 Federal Select Agent Program is punishable by up to five years in prison and/or large monetary fines.
(Public Health Security & Preparedness Response Act of 2002, Section 231(c), 18 USC 175(b), & Public Law (USA Patriot Act) 107-56 Sec. 817)
*As of September 24, 2015, Botulinum neurotoxin use in a research setting is also regulated by Life Sciences Dual Use Research of Concern Oversight Policy. Please see the following link for more information: (Institutional Oversight of Life Sciences Dual Use Research of Concern)
If experiments are being planned with full or partial select agent toxin nucleic acid sequences, please contact EH&S for evaluation.
The PI is responsible for:
Inventory of Select Agent Toxins must be kept current in the ChemTracker 4 chemical inventory system. Please enter the amount in ChemTracker 4 as an aggregate solid (e.g. the total mg purchased)
To ensure PIs do not unintentionally exceed permissible amounts of Select Agent Toxins, inventories must be checked prior to purchase and be promptly updated after every container of Select Agent Toxin is:
- Acquired (by purchase and/or intra-campus transfer – see requirements in #6)
- Depleted (by consumption or by intra-campus transfer); OR
Storage & Security
Select Agent Toxins must be:
- Properly stored with compatible chemicals with adequate secondary containment; AND
- Provided one layer of physical security (e.g., within a lockbox)
Standard operating procedures (SOPs)
Prepare written SOPs for Select Agent Toxin-involved research processes. Guidance for creating SOPs may be found in the https://ehs.stanford.edu/sop-guidance.
Provide initial lab-specific safety training to staff/students involved in Select Agent Toxin related processes, with updates as necessary. Ensure documented training is maintained for at least one year (Cal-OSHA 8CCR 3203). Training topics to include:
- Select Agent Toxin-associated hazards
- Engineering controls used to minimize exposure (e.g., fume hood use)
- Personal protective equipment (PPE) to be used when handling Select Agent Toxins
- Safe handling and storage
- Proper decontamination, disposal, and spill response
- Administrative requirements (recordkeeping, inventory maintenance, security)
Section 42 CFR §§ 73.3(d)(3)(i), 73.16 (l) requires that if a PI is transferring a select agent toxin to another individual internally or externally they must take reasonable action to ensure that the recipient is eligible to receive the select agent toxin and has a legitimate need. PIs must log the recipient’s name, institution, address, telephone number, email address. The information must also include the name of the toxin, the amount transferred, and the legitimate need (ie. bonafide research). Please utilize this due diligence form. Maintain transfer records for at least three years.
Using a commercial carrier to ship a package that contains a select agent toxin requires special labeling and packaging as well as documenting “Due Diligence” (See above). Additionally, shipping Select agents outside of the United States requires an export certification. Please consult EH&S at 723-0448 prior to shipping any packages that contain a select agent toxin.
Ensure 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
Appropriate personal protective equipment is to be provided (i.e., gloves, eye protection, lab coat) to laboratory personnel. NOTE: To determine if respirators are necessary, contact EH&S at 723-0448 for a respirator assessment.
Use accepted inactivation procedures prior to disposal of remaining stock and/or empty containers.
- Disposal: After inactivation, dispose of residual wastes (liquids/solids) as follows:
- Liquids: Collect inactivated materials (e.g. material treated with 10% Bleach) in a non-leaking container constructed of compatible material, and manage as hazardous waste per Stanford Hazardous Waste Management procedures.
- Stock Vials and other materials: Collect in non-leaking container and manage as hazardous waste.
Moving & Closing Labs
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/her lab, consult with EH&S at 723-0448.
For any questions regarding Select Agent Toxin possession at Stanford University, contact the Laboratory Safety Program in the Department of Environmental Health and Safety at 723-0448.