A United States federal panel of scientists and security experts has identified 11 microorganisms that it wants designated as Tier 1 select agents, a new category of biological agents that would be subject to higher security standards than other pathogens and toxins used in biomedical research. The category would include anthrax, Ebola, Variola major and Variola minor (the two viruses that cause small pox), the Marburg virus, the virus that causes foot and mouth disease, and bacterial strains that produce the botulinum neurotoxin. At the same time, the panel has recommended dropping 19 pathogens and six toxins from the broader list of 82 agents that are currently governed by the select agent program.
The Federal Experts Security Advisory Panel, led by biodefense expert George Korch of the U.S. Department of Health and Human Services and veterinarian Gregory Parham of the U.S. Department of Agriculture, was formed after President Barack Obama issued an executive order in July 2010 announcing that the government would overhaul the select agent program . The order said that select agents would be categorized by risk with a view to tightening security for the most dangerous pathogens while eliminating burdensome restrictions for agents that don't pose a serious threat.
The panel's report, released on 14 June, makes a host of recommendations aimed at reducing the so-called "insider threat"—the possibility that a rogue researcher might use select agents to cause deliberate harm, as U.S. Army researcher Bruce Ivins allegedly did with anthrax.
To enhance background checks of researchers who work with select agents, the panel recommends giving screeners access to databases of individuals adjudicated mentally defective in order to identify researchers with a known history of mental health problems; Ivins had such problems but they were largely ignored. The panel also recommends that foreign nationals be screened against terrorist databases on an ongoing basis rather than the current norm of once every 5 years.
Researchers working with Tier 1 agents would undergo more rigorous screening and monitoring. According to one recommendation, foreign nationals in the United States who want to do research involving Tier 1 agents could be required to furnish a criminal background check conducted by authorities in their home country. The panel proposes periodic checking of credit statements and other financial records for personnel with access to Tier 1 agents. The panel does not rule out the use of behavioral assessment tools to determine if researchers are psychologically fit to work with pathogens such as anthrax.
It is now up to the Administration whether to accept or ignore the panel's specific recommendations. Once that process is completed, the government will issue a notification spelling out proposed changes to the select agent program. That is expected to happen in the coming months.
*This item has been corrected to reflect that the panel, as reported in the previous version, did not recommend creating a new mental health database.