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Guidelines for Work With Toxins of Biological Origin

Biotoxins are toxic substances that can be produced by microorganisms, animals, and plants.  Biological toxins are nonreplicating and non-infectious materials that are primarily transferred to individuals through manual contamination, which can occur in a laboratory setting. Common biological toxins handled at Cornell University include the Diphtheria toxin, Pertussis toxin, and Botulinum neurotoxin.

Please note, that one of the toxins listed above, Botulinum neurotoxin, is a “Select Toxin” which means there are specific regulatory requirements for working with that toxin. Depending upon the mass of the toxin used, it may require registrations with the CDC and/or USDA for possession, use, storage and/or transfer of Select Agent Toxins. For more information or the full list of Select Toxins, please visit “Select Agents and Toxins” or the Select Agent and Toxins List. Please contact EHS Biosafety if you need to use Select Toxins.

Plan Ahead, Perform a Risk Assessment and Develop a Toxin-Specific SOP

When working with any toxins that pose a risk to human health, standard operating procedures relevant to each individual toxin must be generated. There are several areas of information that will be included in these standard operating procedures (SOP), please download the SOP template and see instructions for developing toxin-specific SOPs. Through the development of the SOP, a thorough risk assessment can be developed and implemented to ensure the toxin is handled in a safe manner. These standard operating procedures must be provided in IBC MUAs and/or IACUC protocols and reviewed by all researchers prior to starting work with biological toxins.

Perform a risk assessment and develop an SOP to understand:

  1. All potential hazards associated with the toxin

  2. Appropriate controls required to prevent potential exposure to the toxin

    • If procedures are performed that could produce aerosol generation, all work should be performed in a BSC or fume hood, depending on the toxicity of the agent. If the agent is highly toxic, there may be a need for added protection through wearing a respirator or using a charcoal-based filter in addition to the HEPA filter. 
    • Lyophilized toxins are typically shipped in stoppered serum bottles which should only be opened after reconstitution with an appropriate diluent to avoid spreading lyophilized powder through the lab.
    • Gloves should always be worn when handling toxins and if there is potential for splash or droplet generation, additional PPE will be prescribed. 
  3. Decontamination and handling of waste

    • Bleach is commonly used to disinfect surfaces and liquid waste. Other methods may be more appropriate.
      • Please note, Per New York State Law (6 CRR-NY 365-2.6(b)(5)) an autoclave may not be used for the treatment of several toxins.

  4. Medical resources are available to researcher

    •  A consultation with a primary care clinician or Cornell Heath to discuss the risks of working with the specific toxin may be recommended. Researchers can contact Occupational Medicine at 607-255-6960 to discuss vaccination availability.
  5. How to respond to a spill or emergency exposure 

    • In most cases for a spill, if it involves dry, powdered, toxin spilled outside primary containment: Exit the laboratory and keep others from entering the laboratory. Post signage on laboratory doors. Allow 1 hour before entering the laboratory without respiratory protection. Contact EHS by calling 607-255-8200. Do not attempt to clean up powder outside of primary containment without respiratory protection.

Downloadable SOP Template and Instructions

Select Toxins and Biologically-derived Toxins with LD50 ≤ 100µg/kg

The Federal Select Agent Program (FSAP) oversees the possession, use, and transfer of Select Toxins in the United States. Possession, use or transfer of any of the select toxins requires special measures; however, there are permissible amounts of select toxins where registration with FSAP is not required.

If a laboratory is working with a "permissible amount" of a select toxin and/or biologically derived toxins with LD50 ≤ 100 µg/kg, the researcher is required to:

  1. Register information with the IBC.

    • Complete Biotoxin SOP and attach to IBC MUA
  2. Ensure the materials are stored in a secure location.

  3. Document and keep inventory control logs containing toxin amounts received, deactivated, and transferred.

  4. Select Toxins Only: Follow FSAP Select Toxin due diligence provisions when transferring any amount of select toxin from one Cornell University laboratory to another laboratory or institution. 

More Information

  1. Biosafety in Microbiological and Biomedical Laboratories, 6th Edition. (2020)
  2. Johnson-, B., Mastnlaks, R., & Resnick, I. G. (2001). Safety and Health Considerations for Conducting Work with Biological Toxins. Applied Biosafety (Vol. 6).
  3. Select Agent List