Select Agent Overview
As part of regulations provided for by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PL 107-188), researchers are required to register with the federal government and obtain approval to possess or use any pathogen or toxin defined as a select agent. These regulations are designed to ensure that these infectious agents and toxins are shipped only to institutions or individuals equipped to handle them appropriately and only to those who have legitimate reasons to use them; and to implement a system whereby scientists and researchers involved in legitimate research may continue transferring and receiving these agents without undue burdens.
The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published final rules, which implement the provisions of the USA PATRIOT Act and Public Health Security and Bioterrorism Preparedness and Response Act of 2002 setting forth the requirements for possession, use, and transfer of select agents and toxins. The select agents and toxins identified have the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products.