US lawmakers and scientists at odds over how to regulate high-containment labs.
Researchers are pushing back against moves in the US Congress to regulate more strictly the laboratories that handle the most dangerous pathogens. The scientists argue that adding rules to those already implemented since the anthrax attacks of 2001 could hobble work on countermeasures for killer pathogens, and drive researchers from the field.
"It took a number of years and substantial effort to arrive at the careful equilibrium that currently exists," Ronald Atlas, a past president of the American Society for Microbiology, told a panel at the House of Representatives on 22 September. "Precipitous, excessive policy changes could upset this delicate balance."
Days earlier, three top officials from the Galveston National Laboratory at the University of Texas Medical Branch wrote to express "grave concerns" about a bill introduced last month by senators Joseph Lieberman (Independent, Connecticut) and Susan Collins (Republican, Maine). The bill would transfer authority over work on human pathogens at high-biosecurity-level labs — Galveston is one of seven labs nationwide at the highest, biosafety level (BSL) 4 — from the Department of Health and Human Services to the Department of Homeland Security (DHS).
Members of Congress have raised concerns about oversight of the growing complex of biosafety labs (see 'Security measures'). Those concerns heightened after August 2008, when the Federal Bureau of Investigation identified Bruce Ivins, a scientist at the US Army Research Institute for Infectious Diseases at Fort Detrick, Maryland, as the "sole culprit" behind the anthrax attacks. Ivins had killed himself days earlier.
In a report released last week, the Government Accountability Office (GAO) noted that the number of BSL-3 and BSL-4 laboratories registered with the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, more than tripled between 2004 and 2008 (see chart). But this number doesn't include all such labs, because labs working with some dangerous pathogens, including those that can cause tuberculosis and severe acute respiratory syndrome, are not required to register.
"No federal agency knows how many such laboratories exist," Nancy Kingsbury, director for applied research and methods at the GAO, told a Senate hearing. Hence no one knows whether the current capacity is what is needed. Kingsbury recommended that the United States centralize oversight and regulation of its high-risk laboratories, as the United Kingdom did following a foot-and-mouth outbreak in 2007.
Any such centralization would be largely in the hands of Congress. Lieberman says he is "very sensitive" to scientists' concerns about restrictive regulations. "The whole thrust here is to not get in the way of research," he told Nature after a Senate homeland security committee hearing last week. "We want it to go forward. But we want it to go forward while we set up systems that will ferret out wrongdoers." He told the hearing that he and Collins will push forwards the bill this month.
But many take issue with the bill's proposal to consolidate lab oversight in the DHS. Jean Patterson, who heads a BSL-4 laboratory at the Southwest Foundation for Biomedical Research in San Antonio, Texas, recently decided to walk away from a US$1.2-million DHS grant after calculating that the costs of a DHS-imposed compliance review would outstrip the amount of the award. In addition, she says, during a site inspection visit, "the DHS reviewers were not as qualified as they needed to be. We would like only trained people to be inspecting us," she says, "and at this point, the CDC has that expertise."
Researchers and Congress are awaiting a new review on the topic, ordered by then-President George W. Bush and co-chaired by the secretaries of defence and health and human services. It is expected within weeks.
For a Q&A with a researcher who stopped working with dangerous microbes because of regulations, see http://tinyurl.com/yhspcve
Related links in Nature Research
Related external links
About this article
Effects of the USA PATRIOT Act and the 2002 Bioterrorism Preparedness Act on select agent research in the United States
Proceedings of the National Academy of Sciences (2010)