Additional Info - Biosafety
Biological toxins consist of any toxic substance produced by microorganisms, plants, or animals. They include metabolites of living organisms, degradation products of nonliving organisms, and those materials rendered toxic by the metabolic activity of microorganisms. Examples include botulinum toxins (A-G), tetanus toxin, and staphylococcal enterotoxins (A-F), which are produced by bacteria; tetrodotoxin, and ciguatoxin, which are produced by animals; and ricin toxin, tricothecence mycotoxins, and abrin, which are produced by plants. They can cause acute toxic disease as well as long-term effects. These guidelines specifically address work with exotoxins produced by microorganisms, primarily bacteria but also fungi. Most toxins are highly toxic in minute quantities.
Some of these biological toxins are "Select Agents" and require registration with
the CDC. The possession, use, and transfer of select agents and toxins are under the
U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) and the
published are 42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121. The biological
toxins that fall under the prevue of the National Select Agent Registry (NSAR) are:
Abrin; Botulinum neurotoxins; Short, paralytic alpha conotoxins; Diacetoxyscirpenol
(DAS); Ricin; Saxitoxin; Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E);
T-2 toxin, and Tetrodotoxin. These toxins must be registered as Select Agents unless the amount of the toxin does not exceed at any time an amount set by the NSAR. See Permissible Toxic Amounts.
Due Diligence for Select Agent Toxins
The recently revised DHHS select agent and toxin rule [i.e. 42 CFR § 73.3(d)(3)], now has a "toxin due diligence" provision of for Principal Investigators that possess, use or store select toxin amounts that are excluded from the requirements of the select agent registration. The Federal Select Agent Program developed the provision to address the concern that someone might stockpile toxins by receiving multiple orders below the excluded amount. The "toxin due diligence" provision requires a person transferring toxins in amounts which would otherwise be excluded from the provisions to: (1) use due diligence to assure that the recipient has a legitimate need to handle or use such toxins; and (2) report to Federal Select Agent Program if they detect a known or suspected violation of Federal law or become aware of suspicious activity related to the toxin.
This requires a record of the process for due diligence when a request for transfer of select agent toxins (Abrin, Botulinum neurotoxins, Short, paralytic alpha conotoxins, Diacetoxyscirpenol (DAS), Ricin, Saxitoxin, Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E), T-2 toxin, and Tetrodotoxin), is received by the PI possessing such a toxin. USF Division of Research Integrity and Compliance has developed a simple form to address this need in case of such a request.
Please complete the following USF Select Agent Toxin Due Diligence Form (MS Word) which records the transfer of the select agent toxin (under the excluded
amount) to document that due diligence was taken. The form requires information from
both the transferor and the transferee. Once it has been completed by both parties,
it is sent to the Biosafety Office and will be signed by the Responsible Official
or Alternate Responsible Official of the Select Agent program at the University of
Institutional Biosafety Committee Registration
However, no matter the amount of biological toxin you have on hand, registration and
approval by the Institutional Biosafety Committee (IBC) application is required for the use and/or storage of all Select Agent biological toxins here at University of South Florida (USF). The IBC application for the use of Select
Agent biological toxins can be found at our Biosafety Forms webpage.
Working with Biological Toxins
If you will be working with biological toxins there are some things that you need to consider.
- All work with toxins requires the use of BSL-2 work practices and procedures. The Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition (PDF) contains specific requirements in Appendix I.
- A Chemical Hygiene Plan specific to the toxin used must be developed. This needs to include containment (fume hoods, biosafety cabinets), PPE, spill management, exposure, and accident response.
- An inventory must be kept of the toxin and the toxin must be kept under lock and key. USF Biological Toxin Record of Use (MS Word)
- Preparation of primary containers of toxin stock solutions and manipulations of primary containers of dry forms of toxins should be conducted in a chemical fume hood, a glove box, or a biological safety cabinet or equivalent containment system approved by the IBC. HEPA and/or charcoal filtration of the exhaust air may be required, depending on the toxin.
- When toxins are in use, the room should be posted to indicate "Toxins in Use Authorized Personnel Only.'' Any special entry requirements should be posted on the entrance(s) to the room. Only those necessary to the experiment should be in the room while the toxin is in use. We can provide laminated signs. Toxins in Use Authorized Personnel Only (PDF)
- Be sure you are knowledgeable about the toxin that you will be working with (Read the MSDS!) and have a knowledgeable partner working with you in case of an accident. Know the signs and symptoms of exposure; know what to do and who to call.
- Know how to inactivate/decontaminate your specific toxin. This should be assessed for each toxin by consulting current literature, as the optimal procedures for each toxin vary widely. When working with infectious organisms in conjunction with their toxins, care must be taken to ensure that both the infectious agent and the toxin are neutralized.
For additional information, please contact the IBC program support staff.