Select Toxin Guidance: Tier 1 Requirements for Botulinum Neurotoxin and Botulinum Neurotoxin Producing Species of Clostridium

A subset (Tier 1) of select agents and toxins have been identified as presenting the greatest risk of deliberate misuse with most significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence. In addition to Botulinum neurotoxins (BoNT) and BoNT-producing species of Clostridium being regulated as Tier 1, the nucleic acids that encode for the functional forms of Botulinum neurotoxins and can be expressed are also regulated as Tier 1 agents. See the Guidance on the Regulation of Select Agent and Toxin Nucleic Acids for more information. Additional guidance regarding the Tier 1 requirements can be found in the guidance documents pertaining to security, occupational health, incident response, and training on the Compliance Assistance page.