December 19, 2005 - ASM Comments on Possession, Use, and Transfer of Select Agents and Toxins--Reconstructed Replication Competent Forms of the 1918 Pandemic Influenza Virus Containing Any Portion of the Coding Regions of All Eight Gene Segments
- Federal Register Notice: Possession, Use, and Transfer of Select Agents and Toxins—Reconstructed Replication Competent Forms of the 1918 Pandemic Influenza Virus Containing Any Portion of the Coding Regions of All Eight Gene Segments
Centers for Disease Control and Prevention
Division of Select Agents and Toxins
1600 Clifton Road, MS E-79
Atlanta, GA 30333
Subject: Comments on the reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments
The American Society for Microbiology (ASM) recognizes that the reconstructed strain of the 1918 influenza virus represents a potential serious public health threat if it were to infect humans, and supports the classification of this virus as a select agent in order to exercise control over the conditions under which it may be possessed. In our view the dissemination of the virus to laboratories should be limited significantly and should be made available only to those laboratories with demonstrated abilities to handle such infectious agents to prevent the risk of accidental infections.
The ASM agrees that a containment level of BSL-3+ or higher should be required for work with the reconstructed 1918 influenza virus. In particular, the use of prophylaxis and respiratory protection by researchers should be considered essential to augment the normal containment requirements of BSL-3 laboratories. Additionally, the ASM urges that careful consideration be given to health surveillance of researchers who work with the reconstructed strain and that laboratories working with this agent have response plans for isolating any laboratory personnel who develop signs of influenza to ensure containment. Any recombinant experiments using genes from the virus should be done under conditions that ensure biosafety. It would be prudent to add prophylaxis and respiratory protections to the normal protocols of biosafety level 3 laboratories that work with influenza viruses. The October 7 Science paper reporting the characterization of the reconstructed 1918 virus states that the research was done by staff taking antiviral prophylaxis and stringent biosafety precautions, and we recommend such precautions be used for recombinant experiments using genes from the 1918 virus.
With regard to the definition of the 1918 strain, we note that severe pathogenicity is associated with the combination of the eight specific genes of this virus. We, therefore, recommend clarification of the language "replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments" to make clear that it is the 1918 pandemic influenza virus containing all eight gene segments that is being regulated and that a gene segment for purposes of this regulation is defined as any portion of the coding regions of those gene segments.
Ruth L. Berkelman, Ph.D., Chair, Public and Scientific Affairs Board
Ronald M. Atlas, Ph.D., Co-Chair, Task Force on Biological Weapons Control
Kenneth I. Berns, M.D., Ph.D., Task Force on Biological Weapons Control