Division of Select Agents and Toxins: What is a Select Agent?

In determining whether to include an agent or toxin on the HHS select agent list, the “Public Health Security and Bioterrorism Preparedness and Response Act” requires that the following criteria be considered:

• The effect on human health of exposure to the agent or toxin;
• The degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans;
• The availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or toxin; and
• Any other criteria, including the needs of children and other vulnerable populations that the Secretary considers appropriate.

The lists are required to be reviewed and republished every two years, or revised more often if determined necessary.

Protecting the health, safety, and security of Americans is paramount. We do research on diseases and poisons that are considered select agents and toxins as an important part of America’s defense against naturally occurring disease and bioterrorism.  This research allows us to protect our communities should danger occur.

While some of the diseases and toxins considered to be select agents are not naturally dangerous, we know that many of these organisms, if manipulated or released in large quantities, can cause serious health threats to humans or agriculture. Research of these select agents and toxins allows for the development of new tests for prevention and rapid identification, as well as the development of vaccines, drugs, and treatments that can save lives. 

Laboratories registered to work with select agents and toxins must abide by biosafety and biosecurity guidelines and policies of the Federal Select Agent Program. Theses biosafety and security guidelines are developed based on:

• the natural risk of different infectious or potentially infectious diseases or toxins,
• the type of research being conducted on these diseases and toxins, and,
• the amount of the agent or toxin being used in research.

The Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition provides guidance for laboratories on the safety requirements for working with different diseases and toxins.

Biosafety levels ranging from BSL1-BSL4 are used to outline the different safety and security measures that must be implemented by any laboratory that works with potentially infectious diseases or toxins. These safety and security requirements are in place to protect the health and safety of staff and the public. They are there to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially dangerous diseases or toxins.