The United States currently has 82 viruses and bacteria on its list of select agents, pathogens whose handling requires compliance with a number of safety and security rules mandated by the federal government. A new bill introduced in the U.S. Senate yesterday proposes to overhaul the select agent program by creating a tiered system that would dial up the security requirements for the most dangerous pathogens on the list while relaxing them for others.
The Weapons of Mass Destruction (WMD) Prevention and Preparedness Act of 2009, introduced by Senator Joe Lieberman (I–CT), chairman of the Senate Homeland Security and Governmental Affairs committee, and the committee's ranking member, Senator Susan Collins (R–ME), is a response to increasing concerns about biosecurity in the United States. Public anxiety over the issue has risen since the implication of Army researcher Bruce Ivins in the 2001 anthrax attacks and a December 2008 report from the WMD Commission warning of the high likelihood of a bioterrorist attack on U.S. soil in the next 5 years. At the same time, scientists have expressed concerns that excessive regulatory controls may stifle biomedical research and hurt public health in the long run. For example, vaccine researchers who need some of the viruses on the list to test drug delivery systems already complain about the restrictions stemming from the current rules.
We dare not bury our heads in the sand and ignore the very real risks we face from a terrorist WMD attack," Lieberman said at a news conference yesterday. "This legislation would help prevent such an attack and better prepare the nation to respond should one occur."
The bill attempts to strike a balance between the need for greater security and research progress. Under it, the most feared pathogens—anthrax, small pox, and a dozen others—would be designated as Tier 1 agents.
The Department of Homeland Security (DHS) would establish and enforce new security standards for labs and individuals working with these pathogens, including more extensive background checks and monitoring of researchers. While the current select agent rules are overseen by the Department of Health and Human Services and the U.S. Department of Agriculture, the new bill would bring DHS in to work with these two agencies. The bill also authorizes DHS to award $50 million in grants every year from 2010 to 2013 to help institutions handling Tier 1 agents to improve biosecurity. The remaining pathogens on the select agent list would be designated as Tier 2 agents, and those would be governed by less stringent rules. The bill would also add to the list a third tier of yet other, less dangerous pathogens; labs working with those would have to register with the government to enable a rapid response in case of an outbreak. A companion bill has yet to be introduced in the House of Representatives.