In an Executive Order issued on 2 July 2010, President Barack Obama called for major changes to the government’s management and oversight of biological select agents and toxins (BSAT). The National Select Agents Registry Program, which regulates the use of dangerous pathogens and toxins in research, will now be required to identify and better secure biological agents and toxins with greater risk for misuse.

The presidential order directs the secretaries of the Departments of Agriculture and Health and Human Services, the agencies that oversee the select agent program, to identify “Tier 1” biological agents based on “risk of deliberate misuse with most significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence.” These Tier 1 agents will be subject to higher security protections than less risky agents. The agencies are also directed to consider reducing the number of agents and toxins on the Select Agent List, which currently includes 82 substances. A final rule implementing the changes should be issued by October 2012.

The select agent program has been the focus of recent attention for Congressional, the Executive Branch, and non-governmental organizations. Legislation is pending in both the Senate and the House of Representatives that would overhaul the program. A 2009 report from the National Academy of Sciences recommended the stratification of the current list of biological select agents and toxins, which includes anthrax and other deadly substances. A working group chaired by the Secretaries of the Departments of Defense and Health and Human Services also found fault with current “one-size-fits all” security measures for restricted agents.


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