Federal officials released a new policy this week requiring agencies to systematically review the potential risks associated with federally funded studies involving pathogens and toxins considered high consequence risk, including the H5N1 avian influenza virus and 14 other targets. The reviews are designed to reduce the risks associated with “dual use” research in an effort to prevent information gained from the studies to be misused for harmful purposes.
The review applies to experiments which enhance the harmful consequences of the agent or toxin; disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical or agricultural justification; confers to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions; increases the stability, transmissibility, or the ability to disseminate the agent or toxin; or alters the host range or tropism of the agent or toxin. The Select Agents included in the new policy are:
- Avian influenza virus (highly pathogenic)
- Bacillus anthracis
- Botulinum neurotoxin
- Burkholderia mallei
- Burkholderia pseudomallei
- Ebola virus
- Foot-and-mouth disease virus
- Francisella tularensis
- Marburg virus
- Reconstructed 1918 Influenza virus
- Toxin-producing strains of Clostridium botulinum
- Variola major virus
- Variola minor virus
- Yersinia pestis
The new policy was spurred by recent controversy over publication of two H5N1 transmission studies and was released just prior to reconvening of the National Science Advisory Board for Biosecurity (NSABB) to further discuss the studies at the center of the debate. The policy also follows a demand from Congressman Jim Sensenbrenner (R-Wisc) to the White House Office of Science and Technology to explain why NSABB did not have a better plan in place to deal with dual use research issues in order to better protect Americans against biological attacks.
The policy builds upon an existing review system in place at the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) for intramural studies proposed by staff scientists which may have dual use implications. Those agencies will now extend the reviews to extramural projects. All other federally-funded agency research, including unclassified Department of Defense life science research, will have to initiate the policy effective immediately.
Agencies have 60 days for an initial review of all currently funded and proposed projects to identify research meeting the new criteria. In these instances, a risk mitigation plan will be put in place, which could include efforts to modify how the research is conducted, movement of the research to a more secure facility, and a plan for how the science is communicated to the public. Agencies may further “request voluntary redaction of the research publications or communications” or classify the research findings if the risks cannot be mitigated by more standard measures.
