2018 Annual report of the Federal Select Agent Program
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Filetype[PDF-985.27 KB]


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      The Federal Select Agent Program regulates the possession, use, and transfer of biological select agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products. The Federal Select Agent Program is jointly managed by the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention/Division of Select Agents and Toxins and the U.S. Department of Agriculture, Animal and Plant Health Inspection Service/Agriculture Select Agent Services. Common examples of select agents and toxins include the organisms that cause anthrax, smallpox, Foot-and- Mouth disease, and Ralstonia solanacearum, as well as the toxin ricin. While potentially dangerous if not conducted safely and securely, work with select agents and toxins provides important scientific discoveries that have led to improved detection, prevention, diagnostic and treatment options. The Federal Select Agent Program regulates laboratories that conduct research on these pathogens and toxins that are potentially dangerous to public, animal, and plant health, or to animal and plant products, while making sure it is done as safely and securely as possible. This report summarizes calendar year 2018 data for the Federal Select Agent Program and marks the fourth annual report for the purpose of communicating operational metrics to further public understanding of the Program. A similar report will continue to be published annually. As of December 31, 2018, 253 entities were registered with the Federal Select Agent Program: 34 entities are registered with the Agriculture Select Agent Services as the lead agency and 219 entities with the Division of Select Agents and Toxins as the lead agency. Lead agency is a term used by the Federal Select Agent Program to indicate which agency the entity uses as its primary contact (i.e., Agriculture Select Agent Services or Division of Select Agents and Toxins). Entities can be jointly overseen by both the Agriculture Select Agent Services and the Division of Select Agents and Toxins if the entity is registered with one lead agency but is also registered for an agent or toxin regulated solely by the other agency. In 2018, 46 of the 253 total entities registered with the program were jointly managed: the Agriculture Select Agent Services served as the lead agency for 9 of those entities and the Division of Select Agents and Toxins served as the lead agency for 37 of those entities. During 2018, three entities applied to the Federal Select Agent Program for new registrations, and the approval process was still underway as of December 31, 2018. Ten entities withdrew their registrations with the Federal Select Agent Program: six that were registered with the Division of Select Agents and Toxins and four that were registered with the Agriculture Select Agent Services. CS314015-A Publication date from document properties. FSAP_Annual_Report_2018_508.pdf
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