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.
Select Agents Registry
Since 1996, 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, known as the WMD Commission, issued its report entitled “A World at Risk.” The report recommended conducting a comprehensive review of programs that secure dangerous pathogens and tightening government oversight over laboratories.
The National Research Council’s “Responsible Research with Biological Select Agents and Toxins” report recommended that select agents be stratified into groups based on the risk they pose. 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 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 in a statement during a Sept. 22nd hearing of the Homeland Security and Government Affairs Committee.
The bill would create a Tier 1 category of select agents and toxins and put the Department of Homeland Security in charge of inspections of Tier 1 agent laboratories to ensure compliance with security standards.
But not all senators were convinced by the bill’s approach. During subsequent hearings on Oct. 28 and Nov. 4, U.S. Sens. Carl Levin, D-Mich., and George Voinovich, R-Ohio, questioned the increased role of the Department of Homeland Security and a system of overlapping regulations.
Saying that the bill was in conflict with commission’s recommendations, Levin cited letters from a number of scientific societies, including the Federation of American Societies for Experimental Biology, expressing their concerns about the effects of new regulations on research.
Against the vocal objections of Levin, the senate committee passed Lieberman and Collins’ bill. However, Lieberman acknowledged that it is unlikely to be considered by the full U.S. Senate.
Since the senate bill’s passage, the House Committee on Homeland Security passed a similar bill. Introduced by U.S. Reps. Bill Pascrell, D-N.J., and Peter King, R-N.Y., the House version diminishes the role of DHS, giving HHS and the USDA the authority to conduct inspections of laboratories while coordinating simultaneous lab inspections and creating common inspection procedures.
An Executive Order
Not waiting for the outcome of a potentially lengthy and uncertain legislative process, on July 2, Obama issued an executive order to address many of the WMD Commission and Working Group recommendations.
As it implements many of the recommendations of the Working Group, the NRC and the WMD Commission, the president’s executive order is likely to take some of the momentum away from biosecurity legislation in Congress.
Following the Working Group’s recommendations, the executive order creates different categories of select agents. Agents that pose the most risk are designated as “Tier 1,” and laboratories that use them would be subject to a higher level of scrutiny.
The executive order also directs HHS and the USDA to consider “reducing the number of agents and toxins on the select agent list” while working to coordinate inspections and oversight of select agent labs.
It will be some time before scientists know exactly how the executive order will affect their research. But there is hope among researchers that “tiering” and potentially shrinking the select agents list while coordinating regulations and inspections may help to reduce the burden that many labs face.
The executive order should be fully implemented within the next two years.