MSU Biological Toxin Policy
Biosafety Officer: Ryan Bartlett, [email protected], (406) 994-6733
MSU Office of Research Compliance
Biological toxins are toxic substances that can be produced by microorganisms, animals, or plants. Biological toxins are nonreplicating, noninfectious biological materials that can be hazardous even in small quantities.
This document describes Montana State University’s (MSU) policies and relevant Federal regulations that may apply to research with biological toxins. This policy includes Institutional Biosafety Committee (IBC), Federal Select Agent and Export Compliance regulations.
Biological Toxins Requiring IBC Approval
Research at MSU involving biological toxins on the Select Agent list or have an LD50
in vertebrates of ≤100 ng/kg must be approved by the IBC prior to initiation of work.
To determine if the toxin in requires IBC approval, please consult the Toxin Table
in Appendix 1 or contact the MSU Biosafety Officer Ryan Bartlett, [email protected], (406) 994-6733. Investigators working with a biological toxin that require IBC approval
must complete the IBC protocol form.
Work involving recombinant or synthetic DNAs that encode the active subunit(s) of a biological toxin with an LD50 of ≤100 μg/kg in vertebrates, cells, organisms, or viruses must also have IBC approval before initiation of the biological toxin work. In some cases, additional review by the National Institutes of Health Office of Biotechnology Activities (NIH-OBA) as indicated in Section III-B-1 of the NIH guidelines may be required.
Select Agent Toxins
Certain biological toxins are classified by the Federal Government as Select Agent due to their potential threat to public safety and health. The possession, use, or transfer of these biological toxins is highly regulated by the Federal Select Agent Program. Investigators using Select Agent Toxins are not required to register with the Select Agent Program if the amount does not exceed the permissible toxin amounts (see Appendix 1).
Investigators that possess a Select Agent Toxin less than or equal to the permissible amount must maintain an inventory of the amount of the Select Agent Toxin present in the laboratory. This inventory should document the number of vials, amount in each, amount remaining (if applicable) after each use, and how the toxin was inactivated when no longer needed for experiments. To meet this requirement, investigators should use the MSU Toxin Inventory Form.
The Federal Select Agent Program states that Investigators must show due diligence
regarding any transfer of a Select Agent Toxin in order to prevent attempts by nefarious
parties to stockpile toxins classified as a Select
Agent Toxin. In accordance with 42 CFR 73.16, Investigators must document the recipient(s) of any Select Agent Toxin and provide evidence that the individual(s) has a legitimate purpose to possess toxins. Prior to any transfer of a Select Agent Toxin, Investigators must submit an Application for Request of an Excluded Select Agent Toxin form. This form must be approved by the IBC prior to shipping the toxin to the recipient.
Export Controlled Toxins
Certain biological toxins, including genetic elements encoding these toxins, are restricted for export by the U.S. Department of Commerce and are subject to Export Control regulations. To see if the toxin requires IBC approval, please consult the table in Appendix 1 or contact the Director of Research Compliance Kirk Lubick, [email protected], (406) 994-6998.
Appendix 1 - Table of Biological Toxins
The table indicates the LD50 for some acute biological toxins, the permissible amounts of Select Agent Toxins, and the toxins that are subject to Export Control regulations.
|Toxin||LD50 (μg/kg)||Requires IBC Approval||Select Agent||Export Compliance|
Y (1000 mg)
|Botulinum toxins||0.0004 to 0.0025||Y||Y (1 mg)||Y|
|Cereolysin||40 to 80|
|Clostridium difficile||0.5 to 220|
|Clostridium perfringens||0.1 to 1500||Y||Y|
|Conotoxins||12 to 30||Y||a-conotoxins only, (100 mg)||Y|
|Crotoxin||12 to 30|
|Diacetoxyscripenol toxin||Y||Y (10,000 mg)||Y|
|HT-2 toxin||5 to 10||Y|
|Listeria listeriolysin or hemolysin||3 to 10|
|Modeccin toxin||1 to 10||Y|
|Nematocyst toxins||33 to 70|
|Pseudomonas aeruginosa exotoxin A||3|
|Ricin||2.7||Y||Y (1000 mg)||Y|
|Saxitoxin||8||Y||Y (500 mg)||Y|
|Shigella dysenteriae neurotoxin||1.3|
|Staphylococcal aureus toxins||2 to 25||Y||Subtypes A-E (100 mg)||Y|
|T-2 toxin||5 to 10||Y||Y (10,000 mg)||Y|
|Tetrodotoxin||8||Y||Y (500 mg)||Y|
|Viscum Album lectin 1 (Vixumin)||2.4 to 80||Y|
|Yersinia pestis murine toxin||10|