Division of Regulatory Science and Compliance: About Us
What We Do
Scientific research in laboratories, especially on select agents and toxins, leads to discoveries that can save lives and help protect the health, safety, and security of the American people. Because this research is critical, CDC works to ensure that it is conducted as safely and securely as possible.
What are Select Agents and Toxins?
Select agents and toxins are biological materials that have the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal or plant products. Common examples of select agents and toxins include the organisms that cause anthrax, bubonic plague, and smallpox, as well as the toxin ricin.
How We Do It
Federal Select Agent Program
In order to help ensure that potentially risky biological materials are handled safely and securely, research with select agents and toxins is done in labs that are registered with the Federal Select Agent Program (FSAP). The program is managed jointly by DRSC and the Animal and Plant Health Inspection Service’s Division of Agricultural Select Agents and Toxins (or DASAT, part of the U.S. Department of Agriculture). DRSC regulates agents that cause disease in humans, while DASAT regulates agents that cause disease in animals and plants.
Import Permit Program
The CDC Import Permit Program regulates the importation of infectious biological materials that could cause disease in humans in order to prevent their introduction and spread into the U.S. The program ensures that the importation of these agents is monitored and that facilities receiving permits have appropriate biosafety measures in place to work with the imported agents.
Through these programs, we:
- Develop regulations for laboratories that work with select agents and toxins
- Conduct inspections and registration for facilities that work with select agents and toxins
- Enforce regulation compliance for programs that work with select agents and toxins
- Issue import permits required for the importation of infectious biological agents, infectious substances, and vectors of human disease into the United States
- Select agents and toxins are biological materials that have the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal or plant products.
- In 2021, 233 entities were registered with FSAP to possess a select agent or toxin.
- Academic, non-federal government, federal government, commercial, and private facilities all work with select agents and toxins.
- FSAP currently regulates 68 select agents and toxins. The list is reviewed every two years to determine if agents or toxins need to be added to or deleted from the list.
- FSAP conducted 206 inspections of registered entities in 2021.
- More than 2,000 import permits are issued by the program annually. Most permits are issued to laboratory facilities at government agencies and universities, or to private and commercial laboratories conducting research studies or diagnostic activities.