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US announces rules for potential bioterror agents

A long-awaited US government policy on biological research that could be used for terrorism or other nefarious purposes is little changed from a draft released 19 months ago, despite receiving 38 comments from institutions and researchers concerned that it goes either too far or not far enough. The centrepiece of the policy, released on 24 September, is a set of guidelines for researchers working on 15 specific pathogens or toxins. But the rules do not regulate experiments that engineer pathogens not on the list to make them more deadly – so-called gain-of-function research.  Officials from the White House and US National Institutes of Health (NIH) say the government will be addressing these concerns in coming weeks.

The White House released its first draft policy on dual-use research of concern, or DURC, in February 2013. The policy requires researchers at institutions that receive funding from the US government and are working with one of 15 specific pathogens or toxins to notify their institutions if there is potential that their work could be misused. The institutions will then assess whether or not the research qualifies as DURC. In parallel, the federal government will assess whether such research should receive funding. It will work with the institutions to plan how to manage concerns such as containment of listed pathogens and the public release of information that could allow them to be misused. Amy Patterson, director of the NIH Office of Science Policy, says that it is “incumbent upon investigators”  to report projects that have become potentially dangerous since they were funded, such as the discovery of a new pathogen, at which point the institutions and government would review the project again. Institutions that do not comply will have their government funding withdrawn.

The rules apply only to labs that receive government funding. All institutions are required to register with the US Centers for Disease Control and Prevention (CDC) if they are using one of a longer list of “select agents” defined by the government. But experiments that would, for instance, make a pathogen not on the list more dangerous “would be outside the scope of the current framework,” Patterson says.

Such experiments would include the controversial creation of a mutant flu virus that is deadlier and more transmissible between animals.

Marc Lipsitch, an epidemiologist at the Harvard School of Public Health in Boston, thinks the policy may be of limited use for biosecurity. “I think any list of agents is a temptation, if you’re trying to get around it, to find another agent to do mischief with,” he says.

Patterson says the National Science Advisory Board for Biosecurity (NSABB), which monitors and advises on biological threats to the NIH and federal government, will discuss regulating gain-of-function research at an upcoming meeting on 22 October — its first meeting in two years.  Possible dangers include not just misuse but unintentional releases of pathogens. In two recent incidents at the CDC, H5N1 virus was accidentally shipped to a lab instead of a harmless virus, and dozens of workers were potentially exposed to anthrax.

The 15 pathogens and toxins on the list include:

  • Avian influenza virus (highly pathogenic)
  • Bacillus anthracis
  • Botulinum neurotoxin6
  • Burkholderia mallei
  • Burkholderia pseudomallei
  • Ebola virus
  • Foot-and-mouth disease virus
  • Francisella tularensis
  • Marburg virus
  • Reconstructed 1918 influenza virus
  • Rinderpest virus
  • Toxin-producing strains of Clostridium botulinum
  • Variola major virus
  • Variola minor virus
  • Yersinia pestis


Clarification: The original version of this post failed to identify the source of the quote in the third paragraph. The post has been amended to add the source.


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