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Division of Regulatory Science and Compliance: History of FSAP and CDC

History of FSAP and CDC

In response to the 2001 U.S. anthrax attacks and as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the “Bioterrorism Act”), Congress sought to increase the security and oversight of select agents and toxins by creating a regulatory organization that would have the authority to create and enforce regulations that dictate who, how, and where select agents and toxins could be possessed, used, and transferred.

The result was the Federal Select Agent Program (FSAP), which is managed jointly by CDC and USDA’s Animal and Plant Health Inspection Service (APHIS)/Division of Agricultural Select Agents and Toxins (DASAT). CDC provides oversight for the select agents and toxins that cause diseases in people, and USDA provides oversight for select agents and toxins that cause diseases in animals and plants (CDC and USDA share the responsibility for agents that threaten both humans and animals, such as anthrax). FSAP also works closely with The Federal Bureau of Investigation/Criminal Justice Information Services Division to conduct security background checks of employees who access select agents or toxins.

Within CDC, the Division of Regulatory Science and Compliance (DRSC), a part of CDC’s Office of Emergency Preparedness and Response, took on the responsibility of facilitating CDC’s role in FSAP. DRSC oversees both the CDC arm of FSAP as well as CDC’s Import Permit Program, which regulates the importation of infectious biological agents, infectious substances, and vectors of human disease into the United States.

Progress of FSAP

FSAP oversees organizations that are registered to possess, use or transfer select agents and toxins. These organizations range from university and government laboratories to private and commercial organizations.

The research conducted on select agents and toxins provides important scientific discoveries that have led to improved surveillance, prevention, diagnostics and treatment options for diseases and toxins considered to be the most threatening to people’s health. While some of the diseases and toxins considered to be select agents and toxins are not inherently dangerous in their natural form, many of these organisms, if manipulated or released in large quantities, can cause serious health threats to humans or agriculture. By balancing the importance of the research being done and the risk of working with select agents and toxins, FSAP helps make it possible to conduct this vital research critical to national security in a safe and secure manner.

To date, CDC’s DRSC has conducted 2,000 inspections of organizations registered with the FSAP. This milestone marks a continued commitment to our nation’s defense against naturally occurring disease and bioterrorism – a commitment that has been central to the mission of the Federal Select Agent Program since its creation in 2002.

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