Statement on the Select Agent Regulations

Publication Date: 
May 2009

Public Consultation Meeting of the Working Group on Strengthening the Biosecurity of the United States, Bethesda, Maryland

Thank you for providing me with an opportunity to provide comments on the select agent regulations and biosecurity.  Thus far, the working group appears to have adopted a very narrow definition of biosecurity in so far as the select agent regulations are concerned.  Under this approach, biosecurity is concerned with controlling unauthorized access to dangerous pathogens or preventing exposure to them.  This is demonstrated by the agenda of this meeting, which emphasizes personnel security and reliability, transportation security, physical and facility security, and facility inspections.
But if we are serious about developing policy recommendations that will strengthen the biosecurity of the United States, as this working group has been charged to do, it is essential that we also consider oversight of  select agent research itself, not just the agents or the facilities where the research occurs.  This is consistent with a recommendation from an expert panel convened by the National Research Council of the National Academy of Sciences, which in October 2003 called for independent, prior review of what it deemed dual-use “experiments of concern.”

These experiments include those that would:

- demonstrate how to render a vaccine ineffective;
- confer resistance to antibiotics or antiviral agents;
- enhance the virulence of a pathogen or render a nonpathogen virulent;
- increase the transmissibility of a pathogen;
- alter the host range of a pathogen;
- enable evasion of diagnosis or detection methods; or,
- enable weaponization of a biological agent or toxin.