On July 2, President Obama issued an executive order that will restructure biosecurity regulations at the nation’s laboratories within the next two years.
On July 2, President Obama issued an executive order that will restructure biosecurity regulations at the nation’s laboratories. Building on previous efforts to keep dangerous pathogens secure while protecting vital research, Obama’s executive order “balances security and the scientific enterprise,” a White House press release said.
Since 1996, the U.S. Congress has passed several pieces of legislation to regulate research with bacteria, viruses or chemicals that pose a severe threat to human, animal or plant health. More than 80 deadly and disease-causing pathogens and chemicals have been designated as “select agents and toxins” by either the U.S. Department of Health and Human Services or the U.S. Department of Agriculture.
To conduct research on these agents, laboratories must register with the government, develop and submit biosafety and biosecurity plans and allow for inspections “without prior notification.”
Rethinking the Registry
But, several reports have highlighted concerns about the select agent program.
In 2008, the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism issued report that recommended conducting a comprehensive review of programs that secure dangerous pathogens and tightening government oversight over laboratories. A report by the National Research Council recommended select agents be stratified into groups based on their level of risk. The NRC also recommended that researchers and government inspectors be provided with adequate training and scientific expertise to appropriately conduct research and inspections.
Created by a presidential executive order in 2009, the Working Group on Strengthening the Biosecurity of the United States agreed that the select agent list should be stratified and recommended that the “numerous, uncoordinated inspections” to which labs are subjected be coordinated among the various government agencies.
In September 2009, U.S. Sens. Susan M. Collins, R-Maine, and Joseph Lieberman, I-Conn., introduced legislation to address the concerns of the WMD Commission with a particular focus on heightening security at laboratories that work with select agents.
“Some of the world’s most dangerous pathogens are not secure,” said Collins during a Sept. 22 hearing of the Homeland Security and Government Affairs Committee.