Oversight Without Obstruction: The Challenge for High-Containment Labs

Abstract

A cross the nation, government agencies, industries, and academic institutions are building high-containment biological laboratories to research hazardous pathogens that might accidentally or intentionally be introduced to the United States. Experts agree that the knowledge gained from such labs is a boon to public health—these are the places where the diagnostic test for Ebola virus, antitoxins for botulism, and therapies for multidrug-resistant tuberculosis were developed. But many of these same experts also point to the need for strict oversight of high-containment labs, and some worry that unchecked proliferation of such facilities increases the odds that study pathogens will make their way into the environment. The challenge for governing agencies is to provide researchers the flexibility to do their work while ensuring public safety. In 2003, the Senate Committee on Governmental Affairs convened a hearing on the potential vulnerabilities of the U.S. food supply and agricultural sector to deliberate contamination. Two years earlier, the United Kingdom had experienced an epidemic of foot-and-mouth disease (FMD) that devastated the British livestock industry. The disease was not introduced intentionally, but many found the timing disquieting, given the subsequent events of 9/11 and deaths later that fall from anthrax sent through the mail. The U.S. agricultural sector accounts for 13% of the gross domestic product and is vulnerable to both intentional and accidental introduction of infectious disease, according to Lawrence Dyckman, director of natural resources and environment for the U.S. Government Accountability Office (GAO). In testimony at the 2003 hearing, Dyckman identified more than 40 contagious foreign animal diseases as threats to the U.S. agricultural economy. This vulnerability prompted President George W. Bush to issue Homeland Security Presidential Directive 9 in 2004. Among other provisions, the directive called for the secretaries of the U.S. Department of Agriculture (USDA) and Department of Homeland Security (DHS) to develop secure, state-of-the-art biocontainment laboratories to research and develop diagnostic capabilities for exotic animal diseases, including “zoonotic” diseases that can be transmitted to humans. Three years later, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing on the proliferation and oversight of high-containment labs. In testimony before the subcommittee, Gigi Kwik Gronvall, a senior associate with the Center for Biosecurity of the University of Pittsburgh Medical Center, said, “Protecting the nation against destabilizing large-scale epidemics, whether natural or man-made, is an urgent priority. . . . [N]ew high-containment laboratories are necessary if we are to produce the scientific advances needed to develop medical countermeasures against bioweapons and emerging diseases.” At the same time, said Gronvall and other witnesses, the need for rigorous oversight and training of personnel is paramount.