September 8, 2009 - ASM Comments on the Proposed Addition of SARS-CoV to the List of Select Agents and Toxin

Centers for Disease Control and Prevention
1600 Clifton Road
MS A 46
Atlanta, Georgia 30333

Re: Comments on the Proposed Addition of SARS-CoV to the List of Select Agents and Toxins

The American Society for Microbiology (ASM) wishes to comment on the proposal to add SARS associated Coronavirus (SARS-CoV) to the list of HHS select agents and toxins, published in the July 13, 2009, Federal Register, Vo. 74, No. 132. The Centers for Disease Control and Prevention (CDC) states that it is proposing this action because 1) SARS CoV can cause significant mortality, especially in the elderly, 2) the virus has the capability of easily being transmitted from human to human 3) there is currently no vaccine or antiviral approved for the prevention or treatment of infections caused by the SARS CoV virus and 4) it has been documented that the virus may persist in the environment. The CDC states that it has consulted with subject matter experts from the CDC, NIH, FDA and other federal agencies. The CDC recognizes that there may be individuals and entities that are not currently registered under the HHS Select Agent Program who possess SARS CoV and would be required to register with HHS should the proposal be finalized.

The ASM believes the proposal to add the SARS CoV virus to the HHS list of select agents and toxins deserves further deliberation of the biosafety and biosecurity issues involved with this agent and the implications for research and public health activities. The list of select agents and toxins should represent a broad consensus by the scientific, public health and security communities.  It should include consideration of the public health and security consequences and likelihood of the agent being used for bioterrorism, which is paramount to the basis for requiring additional oversight. The ASM, therefore, recommends that the National Science Advisory Board for Biosecurity (NSABB) be consulted and asked to review biosafety and biosecurity issues related to the SARS CoV virus and to make recommendations about the proposal to add SARS CoV to the HHS list of select agents. We recommend that the NSABB in their deliberations consider whether making SARS CoV a select agent will substantively reduce the number of investigators able to perform research on this agent as well as the impact on development of prevention and control countermeasures against natural outbreaks of SARS or use of the virus for bioterrorism.  We also recommend that NSABB consider the impact on international collaboration and public health efforts.

Thank you for the opportunity to comment.

Sincerely,

Roberto Kolter, Ph.D., President, ASM

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