Select Agent ToxinsMy EH&S
Select Agent Toxins are certain toxins of biological origin which are to 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. These toxins, along with specified biological agents (viruses, bacteria, fungi), fall under the oversight of the National Select Agents Registry (NSAR) Program which requires registration for possession, use, and transfer of the listed Select Agents. However, possession of small amounts of Select Agent Toxins as described below is exempt from registration with the NSAR Program. See the Select Agent Toxins subtopic for more information.
Possession of Permissible Amounts of Select Agent Toxins
The following Select Agent Toxins are not regulated if the amount under the control of a principal investigator does not exceed, at any time, the amounts indicated in the table below.
|Select Agent Toxins / HHS Toxins [§73.3(d)(3)]||Amount|
|Botulinum neurotoxins* (see note below)||0.5 mg|
|Short, paralytic alpha conotoxins||100 mg|
|Diacetoxyscirpenol (DAS)||1000 mg|
|Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E)||5 mg|
|T-2 toxin||1000 mg|
*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 Institutional Oversight of Life Sciences Dual Use Research of Concern for more information.
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
Use of these Select Agent Toxins in permissible amounts requires strict adherence to Stanford University’s requirements that address critical safety and compliance information including safe use, storage/security, and inventory management.
- Follow the Requirements for Possession of Permissible Amounts of Select Agent Toxins at Stanford University
- Sections 7.1 and 7.2 of this Chemical Hygiene Plan address storage and inventory requirements, respectively.
Possession of Select Agent Toxins Above Permissible Amounts
Possession of Select Agent Toxins in amounts above permissible amounts requires prior approval from the Vice Provost and Dean of Research and registration with the National Select Agent Registry Program. Also note, that effective 12/4/12, botulinum neurotoxins are categorized at Tier 1 agents which trigger additional regulatory requirements.
Failure to register with the NSAR Program is potentially 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).
Contact EH&S for assistance at (650) 723-0448.