Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review

In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and is proposing to amend and republish the list as required by the Bioterrorism Response Act. Further, on July 2, 2010, the President signed Executive Order 13546, "Optimizing the Security of Biological Select Agents and Toxins in the United States" that directed the Secretaries of HHS and Agriculture (USDA) to designate a subset of the select agents and toxins list (Tier 1) that presents the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure; or public confidence; explore options for graded protection for these Tier 1 agents and toxins to permit tailored risk management practices based upon relevant contextual factors; and consider reducing the overall number of agents and toxins on the select agents and toxins list. E.O. 13546 also established the Federal Experts Security Advisory Panel (FESAP) to advise the HHS and USDA Secretaries on the designation of Tier 1 agents and toxins, reduction in the number of agents on the Select Agent List, establishment of suitability standards for those having access to Tier 1 select agents and toxins, and establishment of physical security and information security standards for Tier 1 select agents and toxins. The tiering of the select agents and toxins list will allow the application of more optimized security measures for those select agents or toxins which pose a higher risk to public health and safety should they be stolen or otherwise misused. In addition to addressing the FESAP recommendations in this Notice of Proposed Rulemaking (NPRM), we are also proposing to add two agents, Lujo and Chapare viruses to the list; adding definitions; and clarifying language concerning security, training, biosafety, and incident response. These changes will increase the usability of the select agents and toxins regulations as well as providing for enhanced program oversight.