Select Agent Program Regulations and High-Containment Laboratories

By June 26, 2008

On June 12, 2008 Senators Richard Burr (R- North Carolina) and Edward Kennedy (D- Massachusetts) introduced S.3127, a bill to reauthorize the Select Agent Program by amending the Public Health Service Act and the Agricultural Bioterrorism Protection Act of 2002 and to improve oversight of high containment laboratories. To provide a context for the content of the bill, the AAAS Center for Science, Technology and Security Policy hosted a briefing featuring Gigi Kwik Gronvall from the UPMC Center for Biosecurity, Nancy Connell from the University of Medicine and Dentistry of New Jersey and David Relman from Stanford University.

Gronvall gave a brief background of the Select Agent Program which is run jointly by the Center for Disease Control and Prevention and Animal and Plant Health Inspection Service at the US Department of Agriculture. She also made the point that the SA program is focused on security, but high containment laboratories and protocols are designed primarily to provide safety, not security.

Connell, a research scientist who works with select agents, contrasted the week or two it took to plan an experiment before the SA program was put in place to the 6-12 months it takes now. Experiments are also much more expensive, cumbersome, and according to Connell “what is missing now is an environment of transparency and collaboration.”

Relman, who is also a member of the National Science Advisory Board for Biosecurity (NSABB) underscored the fact that there are risks associated with expanding biotechnology, but there are also enormous benefits. For example, he highlighted the new NIH Human Microbiome Project “basically the human genome project on steroids”, an initiative to map the genomes of all the microorganisms that live on the human body – providing a tremendous amount of information. Relman also expressed concerns about overusing and over-relying on the SA program because regulates access to agents that are found naturally and provides a very specific list that could be circumvented with synthetic or engineered agents.

The bill has now been referred to the Committee on Health, Education, Labor, and Pensions.

Categories: Biosecurity