Jul 17, 2009 (CIDRAP News) – Federal health officials are proposing to list the virus that causes SARS (severe acute respiratory syndrome) as a select agent, which means that dozens of laboratories possessing it will have to register with the government and adopt various security measures.
Agents are added to the federal list of "select agents and toxins" if the Department of Health and Human Services (HHS) regards them as potentially posing a severe threat to public health and safety.
The proposal regarding the SARS-associated coronavirus was announced by the Centers for Disease Control and Prevention (CDC) in a Jul 13 Federal Register notice. The agency said the designation is needed because the virus is potentially fatal and easily spread, there is no vaccine or effective treatment for it, and it can persist in the environment.
The World Health Organization counted 8,098 cases and 774 deaths in the SARS epidemic of 2003. The virus spreads mainly by respiratory droplets, but people also can become infected by touching contaminated surfaces, the CDC notice says.
CDC records show that 138 entities, most of them commercial, currently possess the SARS virus, and 73 of them are already registered with the Select Agent Program of either HHS or the US Department of Agriculture, the notice says. That means 65 labs or facilities will need to register if the virus is listed as a select agent.
Besides registering with the program, those groups will have to provide adequate biosafety and physical security measures, screen personnel with access to the virus, and meet record-keeping requirements, the CDC says.
The average cost for a facility to register with the CDC and comply with the regulations is estimated to range from $15,300 to $170,000, the notice says. Under the proposal, facilities would have 180 days to comply with the regulations, once the final rule is published.
The CDC is inviting the public to comment on the proposal by Sep 11, but it says comments received after that may still be considered. Comments on the proposal should be marked "SARS-CoV" and e-mailed to SAPcomments@cdc.gov, the agency said.