Before any experiments with reconstructed 1918 influenza were done at the CDC facility, they were reviewed by both the Institutional Biosafety Committee and the Animal Care and Use Committees. When the reconstruction experiments were performed, the 1918 influenza was not designated as a select agent, but the CDC stated that “all procedures were carried out using the heightened biosecurity elements mandated by the CDC’s select agent program.”
Just two weeks after the reconstruction of the 1918 influenza virus was published, the CDC and the Department of Health and Human Services (HHS) published an interim final rule in the Federal Register on the possession, use, and transfer of reconstructed replication competent 1918 pandemic influenza virus that contained any portion of the coding regions of all eight gene segments. Based on the “degree of pathogenicity, communicability, ease of dissemination, route of exposure, environmental stability, ability to genetically manipulate or alter, long term health effects, acute morbidity, acute mortality, available treatment, status of immunity, vulnerability of special populations and the burden or impact on the health care system,” it was determined that the reconstructed virus could pose a threat to public health or national security. For these reasons it was added to the HHS list of Select Agents and Toxins and the CDC would review proposed experiments with the reconstructed virus on a case-by-case basis. In addition, any work with the virus was recommended to be done under enhanced BSL-3 conditions at minimum, and with researchers receiving antiviral prophylaxis.