Created by on 10/15/2012 12:00:00 AM

On October 5th, the Centers for Disease Control and Prevention (CDC) released a final rule identifying an updated list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Department of Health and Human Services (HHS) must review and republish the list every two years. As a result of the most recent review, HHS/CDC have added three select agents and toxins to the list (Chapare virus, Lujo virus, and SARS-associated coronavirus) and deleted twelve others (Cercopithecine Herpesvirus 1, Clostridium perfringens epsilon toxin, Coccidioides posadasii/Coccidioides immitis, South American type ofEastern Equine Encephalitis virus, Flexal virus, West African clade of Monkeypox virus, Rickettsia rickettsii, the non-short, paralytic alpha conotoxins containing the following amino acid sequence: X1CCX2PACGX3X4X5X6CX7, Shigatoxins, Shiga-like ribosome inactivating proteins, non-A, non-B, non-C, non-D, and non-E subtypes of Staphyloccal Enterotoxins, and the Central European subtype of Tick-borne encephalitis complex viruses). The entire revised list can be viewed on the National Select Agent Registry website.
HHS/CDC has also, in accordance with Executive Order 13546, “Optimizing the Security of Biological Select Agents and Toxins in the United States,” designated a list of “Tier 1” select agents and toxins. These select agents and toxins present 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. The Tier 1 select agents and toxins are: Ebola virus, Francisella tularensis, Marburg virus, Variola major virus, Variola minor virus, Yersinia pestis, Botulinum neurotoxin, Botulinum neurotoxin producing species of Clostridium, Bacillus anthracis, Burkholderia mallei, and Burkholderia pseudomallei. With the creation of the tiered list, HHS/CDC also established new security requirements for entities possessing Tier 1 agents, such as requiring pre-access assessments and on-going monitoring of personnel with access to Tier 1 agents and toxins, and they have clarified regulatory language concerning security, training, biosafety, and incident response.