Division of Select Agents and Toxins: About Us
What We Do
Scientific research in laboratories is an important part of our nation’s defense against naturally occurring diseases and bioterrorism. The research done on biological and select agents and toxins leads to discoveries that can save lives and help protect the health, safety, and security of the American people. Common examples of select agents include anthrax, bubonic plague, smallpox and ricin.
Some organisms, if in the wrong hands, have the potential to harm human health. CDC is charged with regulating the possession, use, transfer and importation of these infectious agents to protect human health in the United States.
How We Do It
To ensure that lifesaving research with select agents and toxins is conducted as safely and securely as possible, we oversee two important programs: the Federal Select Agent Program and the Import Permit Program. 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
- Issue Import Permits required for the importation of infectious biological agents, infectious substances, and vectors of human disease into the United States
- Enforce regulation compliance for programs that work with select agents and toxins
Why It’s Important
Laboratory inspections are an important aspect of the Federal Select Agent Program since they ensure that labs and research facilities are complying with guidelines and regulations specific to biological research. Laboratories that possess and use rare and potentially dangerous biologic agents and toxins for manufacturing purposes, research use, or diagnostics must be registered through this program. When they register they agree to follow all requirements in the regulation, including, safety, incident response, security, and have appropriate training in place. Our job is to ensure that all precautions are being taken at laboratories so that the public remain unexposed and unharmed by these potential health threats.
The Import Permit Program regulates how select agents and toxins are transferred in the U.S., making sure they will be handled appropriately both during transit and after they arrive. Researchers who want to bring these potentially dangerous materials into the U.S. must apply for a permit. The program monitors the transfer of materials that could cause disease in humans in order to prevent their introduction and spread into the U.S.
- Select agents are biological agents and toxins 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.
- On average, CDC issues 1,600 permits annually to allow for the importation of select agents and toxins.
- There are 65 select agents and toxins regulated by the Federal Select Agent Program (FSAP)
- FSAP is managed jointly by CDC and USDA and produced its first joint annual report in June 2016.
- CDC, through the division, provides oversight for the select agents and toxins that cause diseases in people, and USDA, through its Animal and Plant Health Inspection Service/Agriculture Select Agent Services provides oversight for select agents and toxins that cause diseases in animals and plants.
- CDC has conducted more than 2,000 inspections of organizations registered with the Federal Select Agent Program and publishes ongoing reviews on how we can improve our performance in this program.
- Page last reviewed: July 20, 2016
- Page last updated: July 20, 2016
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