DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES NOTICE OF PROPOSED RULEMAKING ON SELECT AGENT LIST Created by on 10/24/2011
In the October 3rd
edition of the Federal Register
, the Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking
regarding the biennial review of the Possession, Use, and Transfer of Select Agents and Toxins. In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Centers for Disease Control and Prevention (CDC) evaluated 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 modify and republish the list. The CDC has also designated as Tier I a subset of select agents that have the greatest risk of being deliberately misused, per President Obama’s directive
to HHS to identify and implement ways to enhance the security of the nation’s biological laboratories. Classifying certain agents as Tier I will promote the use of more targeted safety measures, such as increased security at facilities, improved cyber security, and enhanced personnel reliability programs.
In modifying the current proposed list of select agents and toxins and identifying those that should comprise the Tier 1 list, CDC considered input from the Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC), Federal Experts Security Advisory Panel (FESAP), the National Science Advisory Board for Biosecurity (NSABB), the National Academies, and comments received from professional societies and the pubic in response to the Advanced Notice of Proposed Rulemaking
. CDC recommends the removal of six select agents (Herpes B virus, Coccidioides posadasii
, Coccidioides immitis,
South American genotypes of eastern equine encephalitis virus, Flexal virus, and
Central European subtype oftick-borne encephalitis virus), addition of two select agents (Lujo and Chapare viruses), and the naming of 11 select agents and toxins as Tier 1 (Ebola virus, Franciisella tularensis
, Marburg virus, Variola major virus, Variola minor virus, Yersinia pestis
, Botulinum neurotoxin, Toxin-producing strains of Clostridium botulinum
, Bacillus anthracis
, Burkholderia mallei
, and Burkholderia pseudomallei)
. Additionally, the CDC clarified language concerning security, training, biosafety, and incident responses.
HHS is specifically seeking comment on 1) the appropriateness of the current list of select agents and toxins, 2) the appropriateness of the proposed tiering of the select agents and toxins list, 3) whether minimum standards for personnel reliability, physical and cyber security should be prescribed for identified Tier 1 agents, and 4)any other aspect of the proposed amendments to the select agent regulations. Comments to HHS are due on or before December 2, 2011.