Guidelines for Work With Toxins of Biological Origin

Biotoxins are toxic substances produced by microorganisms, plants, or animals. These materials are nonreplicating, non-infectious, and pose significant health risks through accidental exposure—typically via manual handling in a laboratory setting. At Cornell University, common examples include diphtheria toxin, pertussis toxin, and botulinum neurotoxin.

Note: Some toxins are federally regulated Select Toxins. Depending on the total quantity used or stored, registration with the CDC/USDA under the Federal Select Agent Program (FSAP) may be required. For details, refer to the Select Agents and Toxins page or visit the Select Agent and Toxins List. For assistance, please contact EHS Biosafety.

Plan Ahead: Conduct a Risk Assessment and Develop a Toxin-Specific SOP

All work involving biological toxins must be supported by a Standard Operating Procedure (SOP) tailored to the specific toxin. This SOP must be reviewed by all personnel and included in applicable IBC MUAs or IACUC protocols. Download the Biotoxin SOP Template to get started.

The SOP and risk assessment must address:

1. Hazard Identification

   • Include known exposure routes, signs/symptoms of exposure, toxic dose (e.g. LD50), and target organs. Resources include the Toxin-Target Database and CDC’s BMBL 6th Edition.

2. Engineering Controls and Personal Protective Equipment (PPE)

   • Work that may generate aerosols must be conducted inside a certified BSC or chemical fume hood, depending on the toxin.
   • Use of lyophilized toxin forms requires special care—open only after dilution to minimize powder dispersal.
   • Gloves, splash protection, and respiratory protection may be required depending on the toxin’s toxicity and form.

3. Waste Decontamination and Disposal

   • Use appropriate disinfectants (e.g. bleach, Spor-Klenz). Note: under NYS law (6 CRR-NY 365-2.6(b)(5)), autoclaves cannot be used to treat certain toxins.

4. Medical Considerations

   • Consult Occupational Medicine (607-255-6960) for discussion of vaccine availability or health monitoring needs.

5. Emergency Response and Exposure Management

   • For spills of powdered toxins outside primary containment: evacuate, post signage, and allow one hour before reentry without respiratory protection. Contact EHS (607-255-8200).
   • See additional guidance: Biological Exposures and Biological Spills.

Registration and Inventory Requirements

Any biological toxin with an LD50 ≤ 100 µg/kg must be registered in the lab’s IBC protocol and tracked in Cornell’s chemical inventory system (Vertere). This includes toxins that fall under the FSAP "permissible amount" exemption.

1. Submit a completed Biotoxin SOP as part of your IBC MUA or IACUC protocol.
2. Store toxins in a locked, access-controlled location.
3. Maintain inventory logs of toxin acquisition, use, and deactivation.
4. For Select Toxins: comply with FSAP due diligence provisions during any transfer (internal or external).

Upcoming Federal Policy Update – DURC/PEPP

Beginning in May 2025, all U.S. institutions are expected to comply with the updated Policy for Oversight of Dual Use Research of Concern (DURC) and Potential Pandemic Pathogens (PEPP). Projects involving toxins with potential for misuse—such as ricin or abrin—may be subject to additional screening or oversight under this policy. Cornell’s Biosafety Office will support affected researchers with risk reviews and mitigation planning.