Select Agents & Toxins

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Subtitle A of Public Law 107–188 requires the Department of Health and Human Services (HHS) to establish and regulate a list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. The Agricultural Bioterrorism Protection Act of 2002 requires the United States Department of Agriculture (USDA) to establish and regulate a list of biological agents that have the potential to pose a severe threat to animal health and safety, plant health and safety, or to the safety of animal or plant products (Select Agents). CDC and APHIS share responsibility for some agents because they potentially threaten both humans and animals (overlap agents).

Per the Code of Federal Regulations (7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73), possession, use or transfer of agents deemed Select Agents or Toxins requires registration with the Centers for Disease Control and Prevention and/or the United States Department of Agriculture. Non-compliance with these regulations may result in criminal penalties, including fines and incarceration, affecting the University of Kentucky and/or the individual in possession of the material. Additionally, per University of Kentucky policy, research involving these materials must be registered with the Institutional Biosafety Committee.

A full list of biological agents and toxins that have been determined to have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products, is available below.

Select Agents & Toxins List

The UK Department of Research Safety, Office of Biological Safety administers the UK Exempt Quantities Program to ensure compliance with Federal Select Agent Regulations. The program is designed to ensure that laboratories with exempt quantities of listed toxins maintain:

• Exempt quantities
• Secure storage
• Safe handling practices

If at any time the exempt amount is exceeded, the laboratory is in violation of Federal Select Agent Regulations. Violations of Federal Select Agent Regulations may result in serious monetary and/or criminal penalties.

Annual Survey

An annual survey is sent out across the UK community from the UK Responsible Official, Delena Mazzetti, requesting that labs identify what, if any, Select Agents, Toxins, or other High Consequence Biohazardous Materials (HCBM) possessed by the lab. 

Annual Inspection

The Responsible Official and/or Alternate Responsible Office will conduct an annual Federal Select Agent Program (FSAP) Select Toxin Inspection to verify the quantity of toxin, method of storage, and ensure safe handling practices.

Secure Storage

To prevent unauthorized usage or theft, access to toxins should be restricted at all times.

Recommendations for Secure Storage:

• 2 levels of security
  • In a standard lab setting, this would mean locking the main lab door when the lab is unoccupied AND locking the freezer/refrigerator where toxin is stored. Alternatively, a locked box stored within the freezer/refrigerator can be utilized if the freezer/refrigerator is not equipped with a lock.
  • In an open lab setting, the main entrance to the lab must be restricted by card access (or other means) AND the freezer/refrigerator must be locked. If the freezer/refrigerator is not equipped with a lock, a chain or cable lock can be retrofitted for the freezer/refrigerator.
• Primary container of toxin and all dilutions must be labeled with the toxin symbol. Additionally, if material is stored in a box or other secondary container, this container must also be labeled. The outside of the freezer/refrigerator need not be labeled. Contact biosafety@uky.edu for labels.
• It is crucial to maintain inventory records for toxins to prevent theft and/or loss. Inventory records must include the amount of toxin currently on hand, the date the toxin is used, amount used, and the name of the user. FSAP Select Toxin Inventory Record form is available online here. 

Safe Handling Practices

• Toxins should be utilized inside a containment device such as a fume hood or biological safety cabinet (BSC).
• Many toxins are utilized in minute quantities and can be difficult to weigh. It is recommended that stock solutions of toxins be made by adding diluent directly to the original containers. Dilutions for experimental use can then be prepared from this stock solution.
• Appropriate personal protective equipment should always be utilized when working with toxins. This includes lab coats and gloves.
  • Double gloving is recommended and glove selection may vary based upon the solvent that will be used to dilute the toxin.
  • For aqueous diluents, a nitrile inner glove and latex outer glove would be ideal. This allows for easy visualization of holes or tears in the outer glove.
  • Be careful to remove gloves inside out and always wash hands after removing gloves.
• Proper disposal is crucial for all materials that come in to contact with toxins.
  • Autoclaving is not an effective means of destruction for many toxins. Chemical inactivation is preferred.
  • Contact the Office of Biological Safety for recommendations for inactivation of the specific toxin utilized in your laboratory.
  • Undiluted toxins or high concentration stock solutions MUST be inactivated prior to being ticketed as hazardous waste and picked up by Environmental Quality Management. Inactivation must be witnessed & documented by UK Office of Biological Safety representatives. Email biosafety@uky.edu for more information.