Last Revised: April 15, 2026

Guidelines for Work with Biological Toxins

Biotoxins are toxic substances produced by microorganisms, plants, or animals. These materials pose significant health risks through accidental exposure in a laboratory setting. Common examples include diphtheria toxin, cholera toxin B, pertussis toxin, Lipopolysaccharide (LPS), Staphylococcal enterotoxin B (SEB), and Tetrodotoxin. Some toxins are federally regulated Select Agent Toxins. For details, refer to the CDC’s Select Agent and Toxins List. Depending on the total quantity used or stored, registration with the CDC/USDA under the Federal Select Agent Program (FSAP) may be required.

Note: Penn does not currently maintain a Select Agent Program. So only “permissible amounts” of Select Agent Toxins are allowed. Aggregate amounts in possession of a single PI must never exceed the Select Agent toxin permissible amount. For Permissible Select Agents amounts, refer to the CDC/USDA’s Permissible Toxin Amounts website.

For assistance, please contact the Biosafety Team at BIOSAFETY@LISTS.UPENN.EDU.

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Laboratory Handling Recommendations

It is recommended to upload an Standard Operating Procedure (SOP) or a Hazard Work Plan (HWP) to the ‘documents’ folder in BioRAFT.
If possible, purchase toxins in liquid form rather than powder form. If only a powder form of the toxin is available, vials with a rubber septum and crimped metal caps are preferred.
Use a biosafety cabinet or chemical fume hood for all work when handling dry powder or aliquoting toxins. If vials are sealed, dry powder is reconstituted with an appropriate liquid under the original sealed conditions to produce the concentrated stock solution.
Wear appropriate personal protective equipment (PPE), including at a minimum, eye protection, laboratory coat, gloves, long pants, and close toe shoes. Avoid contact with eyes, skin, and clothing. Cover all breaks in the skin (including cuts, scrapes, and fresh tattoos).
Any area where toxins are handled must be labeled as an OSHA “Designated Area.” This includes all chemical fume hoods and benchtops. Please mark those spaces with yellow label tape that reads "designated area".
Wash hands thoroughly after handling.
Toxins used in vivo must follow Animal Biosafety Levels as described in the Biosafety in Microbiological and Biomedical Laboratories (https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf) Please contact BIOSAFETY@LISTS.UPENN.EDU for a risk assessment.
For detailed “Additional Precautions” visit the BMBL6 p.475-476

Toxin Inactivation Procedures

Many toxins can be inactivated with fresh 20% household bleach or ≥0.5% NaOCl (sodium hypochlorite solution) for 30 minutes. Inactivate T2-mycotoxin and Brevetoxin (PbTx-2) with ≥ 2.5% NaOCl for 30mins. Check Toxin Safety Data Sheet for additional information.
For all Select Agent toxins, review detailed inactivation processes found in the BMBL6 page 478-480.
Surfaces are decontaminated using 20% fresh bleach or ≥0.5% NaOCl).
Use disposable supplies. All waste must be discarded through the biohazard waste stream, such as red biohazard bags or biohazard sharps container.

Medical Considerations

Consult Occupational Medicine or your Primary Care Physician for discussion of vaccine availability or health monitoring needs.

Emergency Response and Exposure Management

In case of a spill, notify others working in the lab, if spill happened outside of the fume hood or BSC, all lab members must evacuate the area. Allow aerosols to settle for 30min. Don appropriate PPE. Cover area of the spill with paper towels and apply fresh 20% household bleach (check with inactivation table in the BMBL6 or the Toxin Safety Data Sheet). Allow 30 minutes of contact time before cleanup and disposal of spill materials into the biohazard waste stream.
In case of a potential exposure, depending on affiliation go to Occupational Medicine located at HUP Ravdin or Student Wellness located at 3535 Market St or after hours go to the ER.

Registration Requirements

All toxins and Select Agent Toxins must be registered in the lab’s Biological Registration and Chem Tracker in BioRAFT.

Inventory and Security Requirements for Permissible Amounts of Select Agent Toxins

Labs are required to maintain inventory logs of toxin acquisition, use, and inactivation.
Select Agent toxins must be stored in a designated, secure (locked) location, such as a lockbox.
Labs must comply with FSAP due diligence provisions for the interinstitutional or external transfer of Select Agent Toxins. Please use the “Transfer Form” found in the Forms section. Additional information can be found here: https://www.selectagents.gov/compliance/guidance/toxin/transfer.htm

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